chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 04Nov2021 14:30 (at the age of 51 years old) (Lot Number: FF2593) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history was not reported. No pregnancy at time of Vaccination. Concomitant medication included influenza vaccine (FLU) on 12Oct2021. No other medications the patient received within 2 weeks of vaccination. The patient previously received the BNT162B2, first dose (Batch/Lot No: EN6208) on 12Mar2021, second dose (Batch/Lot No: EW0150) on 02Apr2021, both in left arm at the age of 50 years old for Covid-19 immunization. The patient experienced felt extremely dizzy on 05Nov2021, the vertigo (dizziness) was accompanied with vomiting on 05Nov2021, nausea on 05Nov2021, fever on 05Nov2021, chills on 05Nov2021, injection site pain on 05Nov2021, body aches on 05Nov2021, physical inability to get out of bed on 05Nov2021, feeling tired on 05Nov2021. Clinical course: She took her Covid booster shot at around 2:30 on Thursday afternoon (04Nov2021). About 10 hours later, she felt extremely dizzy. The dizziness continued the whole of the next day where she was unable to get out of bed. The vertigo (dizziness) was accompanied with vomiting every time she stood up to go to the bathroom. She was unable to keep down any food or water for the entire next day. She is an otherwise healthy person but she needed physical help to get to the bathroom all of Friday (05Nov2021). On Saturday (06Nov2021), the nausea went away but the vertigo persisted mildly. It is now Monday (08Nov2021) and she is still feeling tired and not back to her usual self. In addition to the vertigo and nausea, she did have fever, chills, injection site pain and body aches. The most debilitating symptom was the vertigo and nausea. Her husband informed the primary care doctor about the reaction and they wanted me to get admitted in the hospital for IV fluids. But, they decided against it due to her physical inability to get out of bed. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been has not tested for COVID-19. The outcome of the event nausea was recovered on 06Nov2021, of the other events was recovered with sequel. Follow-up (11Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Immunisation, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (parent). A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 04Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, and received dose 3 via an unspecified route of administration, administered in Arm Left on 04Nov2021 (Batch/Lot Number: FF2093) as DOSE 3 (BOOSTER), SINGLE (at the age of 19-year-old) for covid-19 immunisation. Medical history included ongoing juvenile idiopathic arthritis (Conditions: diagnosed 11 years ago). There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 19Mar2021 (at the age of 19-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Caller stated that her daughter had the, first two Pfizer Covid vaccines and after the second vaccine, her daughter developed a lump under her left arm, it was a rather large lump. She stated they could not figure out what it was, it did not really go away. Caller reported after the second vaccine arm hurt really bad all the way down her arm, it was her left arm. Caller stated her daughter just had a booster and the lump got bigger, it was really large, almost the size of a softball but maybe not as round, and her arm was really hurting again. Caller clarified that the lump appeared the day after her second dose of the vaccine. The outcome of events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she was sick with Covid even though she had the vaccine; she was sick with Covid even though she had the vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication(s) included palbociclib (IBRANCE) taken for malignant neoplasm of upper-outer quadrant of left female breast.  The patient experienced sick with covid even though she had the vaccine on an unspecified date with outcome of unknown.    The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Asthenia, COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; joint pain; fatigue; loss of taste; shortness of breath; I don't have the energy; This is a spontaneous report from a non-contactable other healthcare professional reported for unknown female that: A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included rheumatoid arthritis which has been diagnosed for greater than 10 years. Past drug included Xeljanz, Medrol Dosepak, LEFLUNOMIDE for Rheumatoid arthritis. The patient's concomitant medication was not reported. The patient experienced covid-19, drug ineffective which led to hospitalization on an unspecified date with outcome of unknown; joint pain, fatigue, loss of taste, shortness of breath, don't have the energy an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of shortness of breath.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and covid19 cannot be totally excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue
Clinical narrative: COVID; COVID; joint pain; fatigue; loss of taste; shortness of breath; I don't have the energy; This is a spontaneous report from a non-contactable other healthcare professional reported for unknown female that: A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included rheumatoid arthritis which has been diagnosed for greater than 10 years. Past drug included Xeljanz, Medrol Dosepak, LEFLUNOMIDE for Rheumatoid arthritis. The patient's concomitant medication was not reported. The patient experienced covid-19, drug ineffective which led to hospitalization on an unspecified date with outcome of unknown; joint pain, fatigue, loss of taste, shortness of breath, don't have the energy an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of shortness of breath.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and covid19 cannot be totally excluded.
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: Polymyalgia rheumatica; This is a spontaneous report from a contactable consumer reporting for her husband. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization and experienced mild body aches. The patient  body aches worsened dramatically after dose #2 on unspecified date. He was diagnosed yesterday by his physician with polymyalgia rheumatica with the outcome unknown. Treatment were received as a result of polymyalgia rheumatica. While not 100% certain, it appears to have developed from the vaccine.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Echocardiogram, Electrocardiogram, Fatigue, Pulmonary thrombosis
Clinical narrative: She experienced a little bit of feeling tired with those.; blood clots in her lungs; This is a spontaneous report from a Pfizer. A contactable 79-year-old female consumer (patient) reported for herself that: A female patient of 79-year-old received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 16Feb2021 (Lot Number: EN6201) (at the age of 78-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient had no medical history. The patient previously took BNT162B2 (first dose, lot number:EL9263) administrated in arm left on 28Jan2021 for covid-19 immunization and experienced with tired. Concomitant medications included levothyroxine (LEVOTHYROXINE) 50 ug taken for thyroid disorder. The patient experienced blood clots in her lungs on 2021 with outcome of recovering and felt a little bit of feeling tired on an unspecified date with outcome of unknown. Patient did a CT scan, ultra sound, echocardiogram, and EKG. Everything looked fine. Event required an emergency room visit and a physician office visit. Therapeutic medication oxygen was taken for blood clots in her lungs.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: She experienced a little bit of feeling tired with those.; blood clots in her lungs; This is a spontaneous report from a Pfizer. A contactable 79-year-old female consumer (patient) reported for herself that: A female patient of 79-year-old received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 16Feb2021 (Lot Number: EN6201) (at the age of 78-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient had no medical history. The patient previously took BNT162B2 (first dose, lot number:EL9263) administrated in arm left on 28Jan2021 for covid-19 immunization and experienced with tired. Concomitant medications included levothyroxine (LEVOTHYROXINE) 50 ug taken for thyroid disorder. The patient experienced blood clots in her lungs on 2021 with outcome of recovering and felt a little bit of feeling tired on an unspecified date with outcome of unknown. Patient did a CT scan, ultra sound, echocardiogram, and EKG. Everything looked fine. Event required an emergency room visit and a physician office visit. Therapeutic medication oxygen was taken for blood clots in her lungs.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report from a contactable other healthcare professional. This other healthcare professional (patient) reported for self that: A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 27Sep2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE, dose 2 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on Dec2020 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was an inpatient healthcare provider (SLP) and have been working with COVID-19 patients since the start of the pandemic, lived in an area with a low infection rate (withheld county in withheld country, currently at 2% positivity) and tested positive on 04Nov2021. Outcome of covid-19 and drug ineffective was unknown. The patient underwent lab tests and procedures included SARS-CoV-2 test showed positive on 04Nov2021.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Parosmia, Taste disorder
Clinical narrative: Change in Taste & Smell; Change in Taste & Smell; Hot & Cold Flashes; This is a spontaneous report from a contactable consumer (Patient) or other non hcp.  A 28-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0161) as dose 2, via an unspecified route of administration, administered in Arm Left on 15Apr2021 12:45 (Age at vaccination 27 year) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient past drug include known allergies - Imodium. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8730), via an unknown route of administration on 22Mar2021 at 11:00 (Age at vaccination 27 year) in arm left as dose 1, single for covid-19 immunisation and experienced left arm ache, weakness from fingertip to shoulder blade, Pins and Needles, tingling, Began experiencing changes in cognitive ability, acute onset psychosis, debilitating OCD, schizophrenia like symptoms, visions, delusions, hallucinations, paranoia, intrusive thoughts, anxiety, panic attacks, short term memory loss and depression. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. On 15Apr2021, the patient experienced Change in Taste and Smell and Hot and Cold Flashes. The patient underwent lab tests and procedures which included sars-cov-2 test NAT was negative on 28May2021 Nasal Swab. Patient was received treatment for events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient was not received other medications within 2 weeks of vaccination. Patient was visited to emergency room and physician office. Physical Testing, Mental Therapy, Medication was performed as treatment. The outcome for all the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood
Clinical narrative: really pretty much down; This is a spontaneous report from a contactable consumer (patient's spouse). A 37-year-old female patient received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at the age of 37 years old as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. During the first vaccine, the patient had been hospitalized. On an unspecified date, she was really pretty much down and in bed for about 3 days. Outcome of the event was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, COVID-19, Cataract, Chills
Clinical narrative: covid again; Started with palpitations; then I became extremely sick for 3 days; Fever; chills; too weak to even get to the bathroom; body aches; began to have joint pain in all of my joints; my eyesight has declined; I have developed a cataract in one eye; my tongue swelled with ulcers with the pinkeye type symptoms; my tongue swelled with ulcers with the pineye type symptoms; my tongue swelled with ulcers with the pineye type symptoms; The worst part is how much my legs have not stopped hurting; This is a spontaneous report from a contactable Nurse (patient). A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EK5730) via intramuscular, administered in Arm Left on 23Dec2020 (at the age of 48-years-old) as dose 1, single for COVID-19 immunization. Medical history included fibromyalgia, egg sensitivity, allergy to molds and COVID-19 from an unknown date and unknown if ongoing. There were no concomitant medications. No other medications in two weeks. No vaccine in four weeks. On 23Dec2020, the patient experienced COVID again, started with palpitations, then I became extremely sick for 3 days, fever, chills, too weak to even get to the bathroom, body aches, began to have joint pain in all of my joints, my eyesight has declined, I have developed a cataract in one eye that I didn't have previously. This has not stopped and its been almost a year; my tongue swelled with ulcers with the pinkeye type symptoms along with all other symptoms and the worst part is how much my legs have not stopped hurting since I got this vaccine, but I haven't been able to see a doctor because of no insurance. The patient underwent lab tests and procedures which included SARS-CoV-2 test: unknown results on Nasal Swab. The case was considered as Serious. The adverse events resulted in disability or permanent damage. No treatment was given for the adverse events. The outcome of the events was not recovered.  No follow-up attempts were possible. No further information was expected.; Sender's Comments: Based on the temporal relation, the association between the events of COVID-19, palpitations, illness, pyrexia, chills, asthenia, pain, arthralgia, visual impairment, cataract, swollen tongue, tongue ulceration, conjunctivitis and pain in extremity and the suspect product of BNT162B2 cannot be completely ruled out. 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Illness, Pain, Pain in extremity, Palpitations
Clinical narrative: covid again; Started with palpitations; then I became extremely sick for 3 days; Fever; chills; too weak to even get to the bathroom; body aches; began to have joint pain in all of my joints; my eyesight has declined; I have developed a cataract in one eye; my tongue swelled with ulcers with the pinkeye type symptoms; my tongue swelled with ulcers with the pineye type symptoms; my tongue swelled with ulcers with the pineye type symptoms; The worst part is how much my legs have not stopped hurting; This is a spontaneous report from a contactable Nurse (patient). A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EK5730) via intramuscular, administered in Arm Left on 23Dec2020 (at the age of 48-years-old) as dose 1, single for COVID-19 immunization. Medical history included fibromyalgia, egg sensitivity, allergy to molds and COVID-19 from an unknown date and unknown if ongoing. There were no concomitant medications. No other medications in two weeks. No vaccine in four weeks. On 23Dec2020, the patient experienced COVID again, started with palpitations, then I became extremely sick for 3 days, fever, chills, too weak to even get to the bathroom, body aches, began to have joint pain in all of my joints, my eyesight has declined, I have developed a cataract in one eye that I didn't have previously. This has not stopped and its been almost a year; my tongue swelled with ulcers with the pinkeye type symptoms along with all other symptoms and the worst part is how much my legs have not stopped hurting since I got this vaccine, but I haven't been able to see a doctor because of no insurance. The patient underwent lab tests and procedures which included SARS-CoV-2 test: unknown results on Nasal Swab. The case was considered as Serious. The adverse events resulted in disability or permanent damage. No treatment was given for the adverse events. The outcome of the events was not recovered.  No follow-up attempts were possible. No further information was expected.; Sender's Comments: Based on the temporal relation, the association between the events of COVID-19, palpitations, illness, pyrexia, chills, asthenia, pain, arthralgia, visual impairment, cataract, swollen tongue, tongue ulceration, conjunctivitis and pain in extremity and the suspect product of BNT162B2 cannot be completely ruled out. 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Swollen tongue, Tongue ulceration, Visual impairment
Clinical narrative: covid again; Started with palpitations; then I became extremely sick for 3 days; Fever; chills; too weak to even get to the bathroom; body aches; began to have joint pain in all of my joints; my eyesight has declined; I have developed a cataract in one eye; my tongue swelled with ulcers with the pinkeye type symptoms; my tongue swelled with ulcers with the pineye type symptoms; my tongue swelled with ulcers with the pineye type symptoms; The worst part is how much my legs have not stopped hurting; This is a spontaneous report from a contactable Nurse (patient). A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EK5730) via intramuscular, administered in Arm Left on 23Dec2020 (at the age of 48-years-old) as dose 1, single for COVID-19 immunization. Medical history included fibromyalgia, egg sensitivity, allergy to molds and COVID-19 from an unknown date and unknown if ongoing. There were no concomitant medications. No other medications in two weeks. No vaccine in four weeks. On 23Dec2020, the patient experienced COVID again, started with palpitations, then I became extremely sick for 3 days, fever, chills, too weak to even get to the bathroom, body aches, began to have joint pain in all of my joints, my eyesight has declined, I have developed a cataract in one eye that I didn't have previously. This has not stopped and its been almost a year; my tongue swelled with ulcers with the pinkeye type symptoms along with all other symptoms and the worst part is how much my legs have not stopped hurting since I got this vaccine, but I haven't been able to see a doctor because of no insurance. The patient underwent lab tests and procedures which included SARS-CoV-2 test: unknown results on Nasal Swab. The case was considered as Serious. The adverse events resulted in disability or permanent damage. No treatment was given for the adverse events. The outcome of the events was not recovered.  No follow-up attempts were possible. No further information was expected.; Sender's Comments: Based on the temporal relation, the association between the events of COVID-19, palpitations, illness, pyrexia, chills, asthenia, pain, arthralgia, visual impairment, cataract, swollen tongue, tongue ulceration, conjunctivitis and pain in extremity and the suspect product of BNT162B2 cannot be completely ruled out. 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Cold sweat, Cold-stimulus headache, Pruritus, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 60-year-old (age at vaccination) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 04Nov2021 09:54 (Batch/Lot Number: FF2593; Expiration Date: 31Dec2021) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included diabetes, COPD, rheumatoid arthritis, breathing issues and shrunk from unknown dates. There were no concomitant medications. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 59-years-old on 04Feb2021 (Batch/Lot number: EN531B) which may have received in left arm for covid-19 immunisation and experienced no side effects, second dose at the age of 59-years-old on 25Feb2021 (Batch/Lot number: EN531B) which may have received in left arm for covid-19 immunisation and experienced slight headache for about a week. The patient received a flu shot 34 days before the 3rd booster dose for immunization.  On 08Nov2021, the patient experienced itching and cold sweat. She has not gotten cold sweats before, but after getting the vaccine. The patient stated that it is not listed among the side effects. She further reported that she has had all 3 doses. She had the booster on the 4th, last Thursday. On Monday, during the day, she started itching. States that she didn't think any of it until the evening. It kept her up until the following day when she took 2 Benadryl and then it finally went away. The patient clarifies that she took 2 Benadryl on Monday night and 1 more Benadryl on Tuesday during the day, and now the itching is gone. She is calling to report this, but she also has a question. She has also noticed having cold sweats, out of nowhere; she has never had cold sweats before. States that it has been happening for a couple of days. The paper doesn't say this is one of the common side effects, so she wants to know if it could still be a side effect of the vaccine. She had a hard time remembering the doctor's phone number; stated she got a brain freeze and had to look the phone number up in her phone. She thinks she has shrunk. States that it goes with age. Verified that this occurred prior to getting the vaccines. The patient reported that she may have received the vaccine in the left arm. States that the injection site doesn't hurt anymore so she really doesn't remember which arm it was. Therapeutic measures were taken as a result of itching which included treatment with Benadryl. The patient recovered from itching on 10Nov2021, did not recover from cold sweat while the outcome of the other events was unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Initial insomnia, Tinnitus
Clinical narrative: Tinnitus of right ear; I couldn't fall asleep; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 24May2021 at 12:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression, subclinical hypothyroidism and allergy to soy bean and peanut. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 03May2021 at 12:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient reported tinnitus of right ear since 24Jul2021, till the day of report (reported as till today). She could hear constant ringing sound from her right ear. This happened all the sudden at one night when she was trying to sleep. The patient never had tinnitus before. Initially it happened more frequent and the patient couldn't fall asleep, then it happened almost for a consecutive 7 days each month. The patient stated that tinnitus was most impactful at night when trying to sleep when surroundings was very quiet. The patient was diagnosed with depression and anxiety prior getting her first Pfizer vaccine, however at the time when tinnitus happened, she was feeling emotionally stable and calm. The patient wasn't having a panic attack or feeling anxious. Tinnitus just happened to her for no reason. The events tinnitus of right ear due to which the patient couldn't fall asleep resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus of right ear and couldn't fall asleep was not resolved at the time of this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Immunisation, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 13Nov2021 at 15:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included influenza vaccine (MANUFACTURER UNKNOWN) within 4 weeks of vaccination in left arm from 30Oct2021 and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER7830) via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 60-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6704) via an unspecified route of administration in the left arm on 14Apr2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 15Nov2021 at 04:00, the patient experienced muscle and joint pain - severe, severe headache, exhaustion and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events muscle and joint pain - severe, severe headache, exhaustion and nausea was resolving at the time of this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 13Nov2021 at 15:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included influenza vaccine (MANUFACTURER UNKNOWN) within 4 weeks of vaccination in left arm from 30Oct2021 and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER7830) via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 60-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6704) via an unspecified route of administration in the left arm on 14Apr2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 15Nov2021 at 04:00, the patient experienced muscle and joint pain - severe, severe headache, exhaustion and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events muscle and joint pain - severe, severe headache, exhaustion and nausea was resolving at the time of this report.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Headache, Immunisation, Joint stiffness
Clinical narrative: Severe left sided chest pain; Heart palpitations; Severe left upper back pain; Excruciating left arm pain; Excruciating left jaw pain/ Too ache left lower jaw; Muscle spams to left upper body; Joint stiffness left side; Headache; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 11Nov2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any medications within two weeks of vaccination. The patient received influenza vaccine (FLU VACCINE) on 20Oct2021 within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration in the left arm on 16Dec2020 at 12:00 (at the age of 48-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0142) via an unspecified route of administration in the left arm on 04Jan2021 at 01:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021 at 21:00, the patient experienced severe left sided chest pain, heart palpitations, severe left upper back pain, excruciating left arm and left jaw pain, muscle spasms to left upper body, joint stiffness left side, too ache left lower jaw and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of reported events which included treatment with pain medicine and muscle relaxers. The clinical outcome of the events severe left sided chest pain, heart palpitations, severe left upper back pain, excruciating left arm and left jaw pain, muscle spasms to left upper body, joint stiffness left side, too ache left lower jaw and headache was resolved with sequelae on an unknown date in Nov2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity, Pain in jaw, Palpitations
Clinical narrative: Severe left sided chest pain; Heart palpitations; Severe left upper back pain; Excruciating left arm pain; Excruciating left jaw pain/ Too ache left lower jaw; Muscle spams to left upper body; Joint stiffness left side; Headache; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 11Nov2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any medications within two weeks of vaccination. The patient received influenza vaccine (FLU VACCINE) on 20Oct2021 within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration in the left arm on 16Dec2020 at 12:00 (at the age of 48-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0142) via an unspecified route of administration in the left arm on 04Jan2021 at 01:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021 at 21:00, the patient experienced severe left sided chest pain, heart palpitations, severe left upper back pain, excruciating left arm and left jaw pain, muscle spasms to left upper body, joint stiffness left side, too ache left lower jaw and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of reported events which included treatment with pain medicine and muscle relaxers. The clinical outcome of the events severe left sided chest pain, heart palpitations, severe left upper back pain, excruciating left arm and left jaw pain, muscle spasms to left upper body, joint stiffness left side, too ache left lower jaw and headache was resolved with sequelae on an unknown date in Nov2021.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Off label use, Syncope
Clinical narrative: prev dose brand=Moderna / prev dose number=1 / prev dose number=2; prev dose brand=Moderna / prev dose number=1 / prev dose number=2; Fainted about 10 minutes after my booster shot.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 43-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Nov2021 15:00 (at 43-years age old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient had no relevant medical history and no allergies. Concomitant medication(s) included allopurinol (ELAVIL [ALLOPURINOL]) for unspecified indication, start/stop date not reported. The historical vaccines include Moderna vaccine (batch/Lot number: Unknown), via an unspecified route of administration on 14Feb2021 (at 43-years age old) as DOSE 1 and via an unspecified route of administration on 14Mar2021(at 43-years age old) as DOSE 2 SINGLE for COVID-19 immunisation. The patient had no COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The patient fainted about 10 minutes after her booster shot on 15Nov2021. The event was assessed as serious (medically significant). No treatment was taken for the events. The event outcome was reported as recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Peripheral swelling, Skin discolouration
Clinical narrative: prev dose brand=Moderna / prev dose number=1 / prev dose number=2; prev dose brand=Moderna / prev dose number=1 / prev dose number=2; Fainted about 10 minutes after my booster shot.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 43-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Nov2021 15:00 (at 43-years age old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient had no relevant medical history and no allergies. Concomitant medication(s) included allopurinol (ELAVIL [ALLOPURINOL]) for unspecified indication, start/stop date not reported. The historical vaccines include Moderna vaccine (batch/Lot number: Unknown), via an unspecified route of administration on 14Feb2021 (at 43-years age old) as DOSE 1 and via an unspecified route of administration on 14Mar2021(at 43-years age old) as DOSE 2 SINGLE for COVID-19 immunisation. The patient had no COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The patient fainted about 10 minutes after her booster shot on 15Nov2021. The event was assessed as serious (medically significant). No treatment was taken for the events. The event outcome was reported as recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Dizziness, Eye pain, Facial pain
Clinical narrative: This is a spontaneous report from a contactable nurse, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020 / FH8029) via an unspecified route of administration in the left arm on 12Nov2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included topiramate (TOPAMAX) and duloxetine hydrochloride (CYMBALTA), both for an unknown indication from an unknown date and unknown if ongoing. On 12Nov2021 at 11:00, immediately after the shot, the patient experienced dizzy, lightheaded, stabbing in her left eye, left arm was numb and left side of face had pain. From 13Nov2021, for the next 3 days, the patient had extreme joint pain, nausea, stomach ache, exhaustion, headache, lethargic, fever and rapid heart rate, with all the listed possibilities of side effects. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy, lightheaded, stabbing in her left eye, left arm was numb, left side of face had pain, extreme joint pain, nausea, stomach ache, exhaustion, headache, lethargic, fever and rapid heart rate were not resolved at the time of this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Hypoaesthesia, Lethargy
Clinical narrative: This is a spontaneous report from a contactable nurse, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020 / FH8029) via an unspecified route of administration in the left arm on 12Nov2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included topiramate (TOPAMAX) and duloxetine hydrochloride (CYMBALTA), both for an unknown indication from an unknown date and unknown if ongoing. On 12Nov2021 at 11:00, immediately after the shot, the patient experienced dizzy, lightheaded, stabbing in her left eye, left arm was numb and left side of face had pain. From 13Nov2021, for the next 3 days, the patient had extreme joint pain, nausea, stomach ache, exhaustion, headache, lethargic, fever and rapid heart rate, with all the listed possibilities of side effects. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy, lightheaded, stabbing in her left eye, left arm was numb, left side of face had pain, extreme joint pain, nausea, stomach ache, exhaustion, headache, lethargic, fever and rapid heart rate were not resolved at the time of this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020 / FH8029) via an unspecified route of administration in the left arm on 12Nov2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included topiramate (TOPAMAX) and duloxetine hydrochloride (CYMBALTA), both for an unknown indication from an unknown date and unknown if ongoing. On 12Nov2021 at 11:00, immediately after the shot, the patient experienced dizzy, lightheaded, stabbing in her left eye, left arm was numb and left side of face had pain. From 13Nov2021, for the next 3 days, the patient had extreme joint pain, nausea, stomach ache, exhaustion, headache, lethargic, fever and rapid heart rate, with all the listed possibilities of side effects. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy, lightheaded, stabbing in her left eye, left arm was numb, left side of face had pain, extreme joint pain, nausea, stomach ache, exhaustion, headache, lethargic, fever and rapid heart rate were not resolved at the time of this report.