chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Feeling hot, Headache, Myalgia
Clinical narrative: I fell and must have passed out; I fell and must have passed out; painful, large red swollen arm at injection site (size of half a baseball in height and about 6 inches down my arm); painful, large red swollen arm at injection site (size of half a baseball in height and about 6 inches down my arm); Body pain; severe headache; fever (100/sweating); chills (shaking with temp drop- 97.2; normal 97.6); vomiting; loose stools; Lost 6 lbs; abrasion on her right side forehead; dizzy; weak; fever (100/sweating); nausea; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation, at 68 years old. Medical history included Metastatic breast cancer, thyroid, glaucoma, osteo  arthritis, neuropathy, sulfa allergy, Fish/shellfish allergy, penicillin allergy, MS (Multiple sclerosis), and Phenothiazines allergy. No other vaccines in four weeks were received. The patient is not pregnant at the time of vaccination. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included amlodipine, levothyroxine sodium (SYNTHROID), gabapentin, timolol, and cyanocobalamin (B12), therapy dates and indications unspecified, in two weeks. The patient previously took Cytoxan, cipro, Demerol and experienced allergies. On 28Jan2021 20:00 (also reported as about 8 hours), the patient experienced body pain; severe headache; fever (100/sweating); chills (shaking with temp drop- 97.2; normal 97.6); Nausea; vomiting; loose stools; painful, large red swollen arm at injection site (investigation: size of half a baseball in height and about 6 inches down her arm); dizzy; weak; and she fell and must have passed out. Woke up on floor with abrasion on her right-side forehead. The patient also reported she lost 6 lbs. The events lasted from Thursday evening to Sunday morning. Treatment for the adverse events included BENARDRYL. Outcome of the events was recovered on 29Jan2021. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9267) via an unspecified route of administration (right arm) on 18Feb2021 09:30 for COVID-19 immunisation.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Taste disorder
Clinical narrative: I fell and must have passed out; I fell and must have passed out; painful, large red swollen arm at injection site (size of half a baseball in height and about 6 inches down my arm); painful, large red swollen arm at injection site (size of half a baseball in height and about 6 inches down my arm); Body pain; severe headache; fever (100/sweating); chills (shaking with temp drop- 97.2; normal 97.6); vomiting; loose stools; Lost 6 lbs; abrasion on her right side forehead; dizzy; weak; fever (100/sweating); nausea; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation, at 68 years old. Medical history included Metastatic breast cancer, thyroid, glaucoma, osteo  arthritis, neuropathy, sulfa allergy, Fish/shellfish allergy, penicillin allergy, MS (Multiple sclerosis), and Phenothiazines allergy. No other vaccines in four weeks were received. The patient is not pregnant at the time of vaccination. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included amlodipine, levothyroxine sodium (SYNTHROID), gabapentin, timolol, and cyanocobalamin (B12), therapy dates and indications unspecified, in two weeks. The patient previously took Cytoxan, cipro, Demerol and experienced allergies. On 28Jan2021 20:00 (also reported as about 8 hours), the patient experienced body pain; severe headache; fever (100/sweating); chills (shaking with temp drop- 97.2; normal 97.6); Nausea; vomiting; loose stools; painful, large red swollen arm at injection site (investigation: size of half a baseball in height and about 6 inches down her arm); dizzy; weak; and she fell and must have passed out. Woke up on floor with abrasion on her right-side forehead. The patient also reported she lost 6 lbs. The events lasted from Thursday evening to Sunday morning. Treatment for the adverse events included BENARDRYL. Outcome of the events was recovered on 29Jan2021. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9267) via an unspecified route of administration (right arm) on 18Feb2021 09:30 for COVID-19 immunisation.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Fall, Fracture, Head injury
Clinical narrative: led to a fall (possible faint) that caused a head injury (bone chip above her eye).; led to a fall (possible faint) that caused a head injury (bone chip above her eye); led to a fall (possible faint) that caused a head injury (bone chip above her eye); led to a fall (possible faint) that caused a head injury (bone chip above her eye); Nausea; shivers; fever; dehydration; This is a spontaneous report from a non-contactable consumer (patient) 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (batch/lot number and expiry date not reported) via an unspecified route of administration, on 22Feb2021 (in the age of 71-years-old) at single dose for covid-19 immunization. Medical history included chronic headaches, high cholesterol, high blood pressure and minor heart condition. Patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included candesartan, rosuvastatin, gabapentin, topiramate, amitriptyline and erenumab aooe (AIMOVIG), all from an unspecified date for an unspecified indication.  It was reported that 2 days after second dose (reported as 24Feb2021), the patient experienced nausea, shivers, fever and dehydration which led to a fall  (possible faint) that caused a head injury (bone chip above her eye). As a result, the patient had an ER visit and they provided her with fluids and stitches. The outcome of events was reported as 'recovering'.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Syncope
Clinical narrative: led to a fall (possible faint) that caused a head injury (bone chip above her eye).; led to a fall (possible faint) that caused a head injury (bone chip above her eye); led to a fall (possible faint) that caused a head injury (bone chip above her eye); led to a fall (possible faint) that caused a head injury (bone chip above her eye); Nausea; shivers; fever; dehydration; This is a spontaneous report from a non-contactable consumer (patient) 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (batch/lot number and expiry date not reported) via an unspecified route of administration, on 22Feb2021 (in the age of 71-years-old) at single dose for covid-19 immunization. Medical history included chronic headaches, high cholesterol, high blood pressure and minor heart condition. Patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included candesartan, rosuvastatin, gabapentin, topiramate, amitriptyline and erenumab aooe (AIMOVIG), all from an unspecified date for an unspecified indication.  It was reported that 2 days after second dose (reported as 24Feb2021), the patient experienced nausea, shivers, fever and dehydration which led to a fall  (possible faint) that caused a head injury (bone chip above her eye). As a result, the patient had an ER visit and they provided her with fluids and stitches. The outcome of events was reported as 'recovering'.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Dyspnoea, Headache, Pruritus
Clinical narrative: Shortness of breath; joint pain in hands; Headache; coughing with extreme pain and described a feeling of bugs crawling in her lungs, bugs front and back/ painful cough; itching; This is a spontaneous report from a contactable nurse. This case was also received from Pfizer sponsored program.  A 62-year-old female patient received the 2nd dose (at the age of 62-years-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# not provided), via an unspecified route of administration in Feb2021 at SINGLE DOSE for COVID-19 immunization. Medical history included lung and back problems (back pain). It was reported that the patient normally took an inhaler (not steroid inhaler because she didn't want to interfere with immune response), and other things. The patient previously took prednisone which started at 40mg for 2 days, 30 for 2 days, 20 for 2 days then goes down to zero for back pain (stopped taking 4 days before the second dose of the vaccine). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot# not provided) on 29Jan2021 (at the age of 62-years-old) for COVID-19 immunization. The patient's 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE was administered a week ago (Feb2021) Friday. It was reported that she got very ill initially which she said joint pain in hands and headache noted in Feb2021 (Saturday) which wasn't so bad. On Saturday afternoon, she reported shortness of breath, coughing with extreme pain (painful cough) and described a feeling of bugs crawling in her lungs, bugs front and back, and itching, and no one else reported it. The patient kept sleeping and waking up, thinking she was alright, but the coughing and lasted until Sunday evening, it was a very painful cough, and a creeping sensation in lungs front and back. She missed work on Monday. The events (joint pain in hands, headache, shortness of breath, coughing with extreme pain (painful cough) and itching) were medically significant as she was unable to go to work. It was also mentioned that since the patient stopped taking the Prednisone 4 days before the second dose of the vaccine. The patient had an exacerbation of pain (it came back). The patient was also wondering when can she start the inhaler and steroid for the back as she has lung and back problems. Outcome of the events were unknown.   Information on lot number/batch number has been requested.; Sender's Comments: Based on data provided, the reported events are assessed as possibly related to BNT162B2. This case will be reviewed upon receipt of further information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Joint stiffness, Joint swelling, Pain, Peripheral swelling
Clinical narrative: was in so much pain she was crying; Right ankle and foot was swollen and shiny/wrist was swollen and shiny/knee was swollen and shiny; knee was shiny with a lump she did not have before; arm, hand was swollen and shiny/foot was swollen; right elbow is messed up/its swollen and stiff; right elbow is messed up/its swollen and stiff; This is a spontaneous report from a contactable consumer.   An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), first dose on 28Jan2021 at 12:30 then second dose at 18Feb2021 at 11:25, both via an unspecified route of administration at a single dose on left arm for COVID-19 immunisation. Medical history included diabetes mellitus (diagnosed 40 years ago) and a heart condition (had 5 stents, angioplasty, open heart surgery, clarified as triple bypass, in 98, 7 heart caths- 2 of them in one day, a stroke and a heart attack) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had the vaccine, the second one on 18Feb2021, last Thursday. She was in the hospital yesterday. On 21Feb2021,  the patient experienced her right ankle and foot was swollen and shiny, her knee was swollen and shiny and knee was shiny with a lump she did not have before, arm, hand and wrist were swollen and shiny and her shoulder, and her right elbow was messed up. The doctor is the current county health advisor, he said to report all these things. On 21Feb2021, the patient was in so much pain she was crying. She went to the emergency room because it hurt so bad and then was admitted and kept overnight. The patient was put on prednisone to help with swelling. The patient's right elbow being messed up is improved and persisting, its swollen and stiff. The outcome of the events knee was shiny with a lump she did not have before and pain was recovering, right elbow messed up was not recovered, while of the rest was unknown.  Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dysphagia, Fatigue, Headache
Clinical narrative: lymph nodes so big hard to swallow on left side and could not lay down; lymph nodes so big hard to swallow on left side and could not lay down; sore arm/arm hurt badly; couldn't sleep/hard to sleep; felt right side of body start to swell/Neck underarm shoulder; Painful lymph nodes/tender nodes; diarrhea through tout day; sore muscles; Tired low energy; Tired low energy; bad headache all over head; This is a spontaneous report from a contactable consumer who reported about self that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in upper right arm on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that Thursday 10:00 vaccine upper right arm. Felt fine very sore arm couldn't sleep because arm hurt badly. Friday went for easy walk at around 1:30 and felt right side of body start to swell. Neck underarm shoulder patient took 400 mg ibuprofen (MOTRIN). Took MOTRIN again before bed. Painful lymph nodes hard to sleep with MOTRIN. Saturday lymph nodes painful and diarrhea through tout day and evening sore muscles. Tired low energy. Saturday night lymph nodes so big hard to swallow on left side and could not lay down. Took 800 mg MOTRIN and was able to swallow better. And able to sleep with mild pain. Sunday lymph nodes decreased in pain and size. Was feeling better as day went on. Took MOTRIN for bed diarrhea stopped. Monday woke up with bad headache all over head. And still tender nodes but decreased in size. Patient went to doctors to make sure it wasn't something else. Doctor confirmed vaccine immune response. Return in 2 weeks. Outcome of the event diarrhea was recovered/resolved; of headache was unknown; while of remain was recovering/resolving.  Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Lymph node pain, Lymphadenopathy, Myalgia, Pain in extremity
Clinical narrative: lymph nodes so big hard to swallow on left side and could not lay down; lymph nodes so big hard to swallow on left side and could not lay down; sore arm/arm hurt badly; couldn't sleep/hard to sleep; felt right side of body start to swell/Neck underarm shoulder; Painful lymph nodes/tender nodes; diarrhea through tout day; sore muscles; Tired low energy; Tired low energy; bad headache all over head; This is a spontaneous report from a contactable consumer who reported about self that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in upper right arm on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that Thursday 10:00 vaccine upper right arm. Felt fine very sore arm couldn't sleep because arm hurt badly. Friday went for easy walk at around 1:30 and felt right side of body start to swell. Neck underarm shoulder patient took 400 mg ibuprofen (MOTRIN). Took MOTRIN again before bed. Painful lymph nodes hard to sleep with MOTRIN. Saturday lymph nodes painful and diarrhea through tout day and evening sore muscles. Tired low energy. Saturday night lymph nodes so big hard to swallow on left side and could not lay down. Took 800 mg MOTRIN and was able to swallow better. And able to sleep with mild pain. Sunday lymph nodes decreased in pain and size. Was feeling better as day went on. Took MOTRIN for bed diarrhea stopped. Monday woke up with bad headache all over head. And still tender nodes but decreased in size. Patient went to doctors to make sure it wasn't something else. Doctor confirmed vaccine immune response. Return in 2 weeks. Outcome of the event diarrhea was recovered/resolved; of headache was unknown; while of remain was recovering/resolving.  Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: lymph nodes so big hard to swallow on left side and could not lay down; lymph nodes so big hard to swallow on left side and could not lay down; sore arm/arm hurt badly; couldn't sleep/hard to sleep; felt right side of body start to swell/Neck underarm shoulder; Painful lymph nodes/tender nodes; diarrhea through tout day; sore muscles; Tired low energy; Tired low energy; bad headache all over head; This is a spontaneous report from a contactable consumer who reported about self that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in upper right arm on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that Thursday 10:00 vaccine upper right arm. Felt fine very sore arm couldn't sleep because arm hurt badly. Friday went for easy walk at around 1:30 and felt right side of body start to swell. Neck underarm shoulder patient took 400 mg ibuprofen (MOTRIN). Took MOTRIN again before bed. Painful lymph nodes hard to sleep with MOTRIN. Saturday lymph nodes painful and diarrhea through tout day and evening sore muscles. Tired low energy. Saturday night lymph nodes so big hard to swallow on left side and could not lay down. Took 800 mg MOTRIN and was able to swallow better. And able to sleep with mild pain. Sunday lymph nodes decreased in pain and size. Was feeling better as day went on. Took MOTRIN for bed diarrhea stopped. Monday woke up with bad headache all over head. And still tender nodes but decreased in size. Patient went to doctors to make sure it wasn't something else. Doctor confirmed vaccine immune response. Return in 2 weeks. Outcome of the event diarrhea was recovered/resolved; of headache was unknown; while of remain was recovering/resolving.  Information on the lot/ batch number has been requested.
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Muscular weakness, Oxygen consumption decreased, Oxygen saturation
Clinical narrative: blood oxygen level dropped; chills and shaking; severe coughing; chills and shaking; profound leg weakness; This is a spontaneous report from a contactable consumer (patient). A 98-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Right arm (at age of 98-year-old) on 19Feb2021 at 12:30 PM as a single dose for COVID-19 immunisation, lot number: EL9267. Medical history included normal incident to old age. Patient had no known allergies. It was reported that patient received other medications in two weeks prior to the vaccination, no further details provided. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On unknown date in Feb2021 at 10:30 PM patient experienced severe coughing, chills and shaking, blood oxygen level dropped, profound leg weakness. Events resulted in Doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event). Patient was treated for the events, hospice was called, oxygen machine was attached. Patient was not tested for Covid post vaccination. Patient was recovering from the events, at the time of the report.
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: blood oxygen level dropped; chills and shaking; severe coughing; chills and shaking; profound leg weakness; This is a spontaneous report from a contactable consumer (patient). A 98-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Right arm (at age of 98-year-old) on 19Feb2021 at 12:30 PM as a single dose for COVID-19 immunisation, lot number: EL9267. Medical history included normal incident to old age. Patient had no known allergies. It was reported that patient received other medications in two weeks prior to the vaccination, no further details provided. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On unknown date in Feb2021 at 10:30 PM patient experienced severe coughing, chills and shaking, blood oxygen level dropped, profound leg weakness. Events resulted in Doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event). Patient was treated for the events, hospice was called, oxygen machine was attached. Patient was not tested for Covid post vaccination. Patient was recovering from the events, at the time of the report.
Sex: U
Vaccine: FLUX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient got two flu shots at once and didn't have a problem, no AE; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves patient who got two INFLUENZA VACCINE shot (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination at once on an unknown date (extra dose administered)  Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   It was a case of an actual medication error due to extra dose administered (latency same day).  It was unknown if patient's physician provided consent to be contacted and age group is actually not provided  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 2.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Product dispensing error, Product preparation issue
Clinical narrative: forgot to put the powder in the Pentacel, no ae; patient was given only the DTaP-IPV (liquid) portion and did not give the powder part of ActHIB, No AE; Initial information received on 25-Feb-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a two-year-old patient who was forgot to put the powder in the pentacel,(product dispensing error) and patient was given only the dtap-ipv (liquid) portion and did not give the powder part of acthib (product administered to patient of inappropriate age) after receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  The patient developed a non-serious forgot to put the powder in the pentacel,(product dispensing error) and patient was given only the dtap-ipv (liquid) portion and did not give the powder part of acthib (product administered to patient of inappropriate age following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  (This was an actual medication error due to inappropriate reconstitution technique (PT: product preparation issue) (latency was same day).  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet count, Platelet count decreased, SARS-CoV-2 test
Clinical narrative: Platelet count low; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. El3247) at single dose, in the right arm, on 08Feb2021 at 15:45, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included HIV disease; cancer (6 years before this report) and small stroke on an unspecified date, in 2019. No known allergies were reported. The patient previously, on 18Jan2021, at 02:00 PM, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. El8982) at single dose, in the left arm, for COVID-19 immunisation. Concomitant medications included metoprolol tartrate, rosuvastatin, gabapentin and cobicistat, darunavir ethanolate, emtricitabine, tenofovir alafenamide fumarate (SYMTUZA). On 17Feb2021, the patient had platelet count low and hospitalization was required (duration of hospitalization: 9 days). Normal range of 157000 platelets from blood work completed in Oct2020 that went to a dangerous level of 3800 confirmed on 17Feb2021. Treatment was received (platelets, IVIG infusions and prednisone). Post the vaccination, the patient has been tested for COVID-19 (Nasal Swab) on 23Feb2021 and resulted negative. The adverse event was assessed as serious (hospitalization and life-threatening illness, immediate risk of death from the event). The patient did not recover from the adverse event at time of this report.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Platelet disorder
Clinical narrative: Platelet count low; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. El3247) at single dose, in the right arm, on 08Feb2021 at 15:45, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included HIV disease; cancer (6 years before this report) and small stroke on an unspecified date, in 2019. No known allergies were reported. The patient previously, on 18Jan2021, at 02:00 PM, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. El8982) at single dose, in the left arm, for COVID-19 immunisation. Concomitant medications included metoprolol tartrate, rosuvastatin, gabapentin and cobicistat, darunavir ethanolate, emtricitabine, tenofovir alafenamide fumarate (SYMTUZA). On 17Feb2021, the patient had platelet count low and hospitalization was required (duration of hospitalization: 9 days). Normal range of 157000 platelets from blood work completed in Oct2020 that went to a dangerous level of 3800 confirmed on 17Feb2021. Treatment was received (platelets, IVIG infusions and prednisone). Post the vaccination, the patient has been tested for COVID-19 (Nasal Swab) on 23Feb2021 and resulted negative. The adverse event was assessed as serious (hospitalization and life-threatening illness, immediate risk of death from the event). The patient did not recover from the adverse event at time of this report.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Body including legs are achy; Body including legs are achy; This case was reported by a consumer and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 26th February 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced general body pain and leg pain. On an unknown date, the outcome of the general body pain and leg pain were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and leg pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the second dose of Shingrix and then her body including legs were achy. No additional information was provided. The reporter did not consent to follow-up and did not wanted to provide address, date of birth or any additional information.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: COVID-19 arm; red itchy ring that appeared more than a week post vaccine.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms, 100 degree fever, body ache, general weakness, lasted for one and a half days.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Malaise, Pain in extremity
Clinical narrative: First fatigue, starting five hours post-shot. Then 11 hours post-shot, incredible chills lasting until around hour 23. Achey joints until hour 23-24. Malaise. Mild nausea lasting through hour 32.  Sore arm.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Dry mouth, Palpitations
Clinical narrative: About 10 minutes after pt received the vaccine, she started to feel dizzy. After that, she developed a racing heart and dry mouth. She has a history of palpitations. EMS was called to evaluate her
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue, Vaccine positive rechallenge
Clinical narrative: Patient had some subjective tongue swelling after receiving the 2nd dose of Pfizer vaccine today. She also experienced this after the first dose from lot #EM9809 on 02/16/2021 but did not bring it to anyone's attention at the time. She pre-dosed with 25mg of Benadryl today before receiving the vaccine. She was observed for over an hour without worsening before being discharged from the observation area with instructions to take an additional 25 mg Benadryl after returning home.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Swollen tongue
Clinical narrative: Patient had some subjective tongue swelling after receiving the 2nd dose of Pfizer vaccine today. She also experienced this after the first dose from lot #EM9809 on 02/16/2021 but did not bring it to anyone's attention at the time. She pre-dosed with 25mg of Benadryl today before receiving the vaccine. She was observed for over an hour without worsening before being discharged from the observation area with instructions to take an additional 25 mg Benadryl after returning home.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: Patient had some subjective tongue swelling after receiving the 2nd dose of Pfizer vaccine today. She also experienced this after the first dose from lot #EM9809 on 02/16/2021 but did not bring it to anyone's attention at the time. She pre-dosed with 25mg of Benadryl today before receiving the vaccine. She was observed for over an hour without worsening before being discharged from the observation area with instructions to take an additional 25 mg Benadryl after returning home.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue, Vaccine positive rechallenge
Clinical narrative: Swelling tongue, flushed face
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Swollen tongue
Clinical narrative: Swelling tongue, flushed face
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: Swelling tongue, flushed face
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Aversion, Migraine, Nasal congestion
Clinical narrative: Severe migraine. Stuffy nose. I have experienced only one migraine before in my life, 34 years ago. This one included flashing lights, smell and sound aversion and upset stomach. This was in addition to body aches, fever. Well beyond a headache that the CDC lists as a possibility.  I also experienced a stabbing sensation in my shoulder blade after the first injection.  This lasted for 3 weeks. I currently have one after this second dose. It is manageable, but not indicated on the CDC list.  It is not an "ache" - it's a stabbing sensation. My mother also received the Moderna vaccine and I just found out she too had a migraine in addition to other symptoms.  I don't mind the aches and pain and fever and potential headache.  But this was a terrible migraine in a person not prone to migraines.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Parosmia, Photopsia, Pyrexia
Clinical narrative: Severe migraine. Stuffy nose. I have experienced only one migraine before in my life, 34 years ago. This one included flashing lights, smell and sound aversion and upset stomach. This was in addition to body aches, fever. Well beyond a headache that the CDC lists as a possibility.  I also experienced a stabbing sensation in my shoulder blade after the first injection.  This lasted for 3 weeks. I currently have one after this second dose. It is manageable, but not indicated on the CDC list.  It is not an "ache" - it's a stabbing sensation. My mother also received the Moderna vaccine and I just found out she too had a migraine in addition to other symptoms.  I don't mind the aches and pain and fever and potential headache.  But this was a terrible migraine in a person not prone to migraines.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site rash, Myalgia, Rash, Swollen tongue
Clinical narrative: Within 4 hours of shot, I had tongue swelling, throat tightening, and wheezing. I took 2 Benadryl capsules, and felt relief in about 20 minutes. Withing 1 day, rash appeared. By day 5, large rash on entire upper left arm. Sore muscles and joints on 2nd day.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat tightness, Wheezing
Clinical narrative: Within 4 hours of shot, I had tongue swelling, throat tightening, and wheezing. I took 2 Benadryl capsules, and felt relief in about 20 minutes. Withing 1 day, rash appeared. By day 5, large rash on entire upper left arm. Sore muscles and joints on 2nd day.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling cold, Headache, Injection site erythema, Injection site pain
Clinical narrative: On 3/9 in the evening I began chilling and had a fever - this continued through the night and through the  next day.  On 3/11 I felt better but was dizzy and still had headaches but no fever - site of shot has become red with a rash and it itches slightly. And feels warm and tender to the touch.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: On 3/9 in the evening I began chilling and had a fever - this continued through the night and through the  next day.  On 3/11 I felt better but was dizzy and still had headaches but no fever - site of shot has become red with a rash and it itches slightly. And feels warm and tender to the touch.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Herpes zoster, Pain, Rash
Clinical narrative: Shingles with severe pain and rash, took acyclovir and oxy for pain.  I was bedridden for 2 1/2 weeks with pain,.  Still having pain at the end of 4 weeks.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Full blood count, Metabolic function test, Pain in extremity, Peripheral swelling
Clinical narrative: Right leg pain and swelling 8 days after second dose. Started on Eliquis in the ER following positive ultrasound exam.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: Right leg pain and swelling 8 days after second dose. Started on Eliquis in the ER following positive ultrasound exam.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Palpitations, Tuberculin test
Clinical narrative: Racing heart, heat inside my body from my shoulders through my arms and my stomach. Last maybe a minute.   I didn't tell the pharmacist.;/ it went away but my mom.daodni should report it
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: Extreme muscle soreness at injection site. Headache. Fatigue.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: fever the day after shot, headache, chills,  body aches, joint aches, exhaustion,  so far 2 full days. This is now the end of the 2nd day. sight pain and swelling which is nothing compared to the other .
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: fever the day after shot, headache, chills,  body aches, joint aches, exhaustion,  so far 2 full days. This is now the end of the 2nd day. sight pain and swelling which is nothing compared to the other .
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling, Injection site warmth, Swelling
Clinical narrative: Swelling developed, area got hot, got purplish, and felt acute pain.   The area where injection was given was lower than usual about 5 " from shoulder joint..   Saw MD for regular check up and he commented then " thats where they gave you your injection.?"  Have been applying heat compresses and cold packs alternating.  Today still has some discomfort on touch but not painful like it was and swelling has decreased but still slightly purple.   Md stated she was doing what would help and to take Ibuprofen or tylenol. This was the 2nd injection for the Covid 19.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Nausea, SARS-CoV-2 test negative, Vertigo
Clinical narrative: vertigo nausea weakness
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Flushing, Headache, Nausea
Clinical narrative: Fever, chills, nausea, flushed face, headache, dizziness, fever
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, chills, nausea, flushed face, headache, dizziness, fever
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives started about 6 hours after injection.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Balance disorder, Facial paralysis, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: Immediate vertigo and vomiting, heart palpitations. The vertigo lasted for 2 years, every day. I had a low grade fever for over a month, left side facial paralysis/numbness, a stiff neck, headache pain on left side, brain fog for 12 months, an itchy burning rash on back, nausea and vomiting. I was in bed for 7 months.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Magnetic resonance imaging, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Immediate vertigo and vomiting, heart palpitations. The vertigo lasted for 2 years, every day. I had a low grade fever for over a month, left side facial paralysis/numbness, a stiff neck, headache pain on left side, brain fog for 12 months, an itchy burning rash on back, nausea and vomiting. I was in bed for 7 months.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Palpitations, Pyrexia, Rash, Rash pruritic
Clinical narrative: Immediate vertigo and vomiting, heart palpitations. The vertigo lasted for 2 years, every day. I had a low grade fever for over a month, left side facial paralysis/numbness, a stiff neck, headache pain on left side, brain fog for 12 months, an itchy burning rash on back, nausea and vomiting. I was in bed for 7 months.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Skin burning sensation, Vertigo, Vomiting
Clinical narrative: Immediate vertigo and vomiting, heart palpitations. The vertigo lasted for 2 years, every day. I had a low grade fever for over a month, left side facial paralysis/numbness, a stiff neck, headache pain on left side, brain fog for 12 months, an itchy burning rash on back, nausea and vomiting. I was in bed for 7 months.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site swelling, Urticaria
Clinical narrative: swelling ,hardness around the injection site, red hard rash down the same arms long the injection site on my back of my forearm.. looks like welts.  It is not itching
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Choking, Dysphagia, Dyspnoea
Clinical narrative: About 10 minutes after the shot I felt a warm sensation inside my arm running all the way down to my arm and my hand went numb .  I waited a few more minutes then I was released.  Then 1/2 hour later my eyes were very sensitive to light I wore sunglasses. Then five hours after the shot I had chest discomfort on left side of my chest which felt like I was having a heart attack pain subsided then every 2 hours it came and went until the middle of the night. Then next day still having same chest pain. Then I had difficulty swallowing was choking so I called my doctor. I also had trouble breathing. Dr. Advised to go to ER if I needed to. I rested and rested and monitored myself. Blood pressure fluctuated somewhat. Still had chest pain and discomfort 24 hours after the vaccine. I had never had chest pain or discomfort before. It was quite alarming. Not being able to swallow was alarming also. Several years ago I had an allergic reaction to a cleaning problem some of the same symptoms it was very scary no heart or chest pain with that allergic reaction to a cleaning product that had bleach in the product.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia, Photophobia
Clinical narrative: About 10 minutes after the shot I felt a warm sensation inside my arm running all the way down to my arm and my hand went numb .  I waited a few more minutes then I was released.  Then 1/2 hour later my eyes were very sensitive to light I wore sunglasses. Then five hours after the shot I had chest discomfort on left side of my chest which felt like I was having a heart attack pain subsided then every 2 hours it came and went until the middle of the night. Then next day still having same chest pain. Then I had difficulty swallowing was choking so I called my doctor. I also had trouble breathing. Dr. Advised to go to ER if I needed to. I rested and rested and monitored myself. Blood pressure fluctuated somewhat. Still had chest pain and discomfort 24 hours after the vaccine. I had never had chest pain or discomfort before. It was quite alarming. Not being able to swallow was alarming also. Several years ago I had an allergic reaction to a cleaning problem some of the same symptoms it was very scary no heart or chest pain with that allergic reaction to a cleaning product that had bleach in the product.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain, Pyrexia
Clinical narrative: 103.1 fever, chills, severe.body aches, weakness, severe headache.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Paraesthesia, Rash
Clinical narrative: Patient complained tingling on her fingers, toes, chill about to be fainted.  Rashes appeared on her neck.  Gave her 50mg liquid diphenhydramine at 5:05pm.  About 10 min later, she said she felt better, and her rash seems to calm down, but her tingling on her extremities didn't improve much.  Call 911. EMT suggested her to call home and said she may have anxiety related.  Check with her again tonight at 9:13pm.  She said she is a lot better.  Recommend her to check with her PCP
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cerebral artery occlusion, Cerebrovascular accident, Chills, Computerised tomogram head abnormal
Clinical narrative: Patient received 2nd dose of Moderna COVID vaccine at approx. 10am on 03/10/21. At approx. 5pm on 03/10/21, he developed typical side effects including fever, chills, and lethargy. Additionally, he became confused. The next morning, he remained lethargic and minimally responsive. He was febrile to 106 F per daughter and somewhat hypotensive with SBP into the 80s. The afternoon of 03/11/21, he also developed right facial droop and weakness. EMS was called and he was found to have suffered a left MCA stroke. He was admitted to the hospital for this  and underwent thrombectomy. Of note, he was febrile and hypotensive on admission.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Facial paralysis, Hyporesponsive to stimuli, Hypotension, Lethargy
Clinical narrative: Patient received 2nd dose of Moderna COVID vaccine at approx. 10am on 03/10/21. At approx. 5pm on 03/10/21, he developed typical side effects including fever, chills, and lethargy. Additionally, he became confused. The next morning, he remained lethargic and minimally responsive. He was febrile to 106 F per daughter and somewhat hypotensive with SBP into the 80s. The afternoon of 03/11/21, he also developed right facial droop and weakness. EMS was called and he was found to have suffered a left MCA stroke. He was admitted to the hospital for this  and underwent thrombectomy. Of note, he was febrile and hypotensive on admission.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count decreased, Pyrexia, Thrombectomy, Thrombocytopenia
Clinical narrative: Patient received 2nd dose of Moderna COVID vaccine at approx. 10am on 03/10/21. At approx. 5pm on 03/10/21, he developed typical side effects including fever, chills, and lethargy. Additionally, he became confused. The next morning, he remained lethargic and minimally responsive. He was febrile to 106 F per daughter and somewhat hypotensive with SBP into the 80s. The afternoon of 03/11/21, he also developed right facial droop and weakness. EMS was called and he was found to have suffered a left MCA stroke. He was admitted to the hospital for this  and underwent thrombectomy. Of note, he was febrile and hypotensive on admission.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Muscle spasms, Myalgia, Nausea
Clinical narrative: Fever body aches shakes chills muscle cramping and pain headache nausea, awoken from sleep with symptoms.