chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom, Tremor
Clinical narrative: tremor or shaking of her entire body; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient seemed to have some sort of neurological effect of causing a tremor or shaking of her entire body (hospitalization) on an unspecified date with outcome of not recovered. Date of onset of the adverse event was unknown, but the earliest that caller was aware of could be 12Jan2021, which could be the date of admission to the hospital related to this event; but event onset and hospitalization could have occurred earlier than 12Jan2021, she was not sure of exact dates. Patient age at onset was unknown but if caller had to guess probably 58 or 59 years. Height was guessed approximately 5 feet 5 inches. Weight was guessed approximately 130lbs.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: pain on her arm for over a year; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on 02Dec2019 via an unspecified route of administration in the arm at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received a pneumonia shot (unspecified trade name) on 02Dec2019 then she had been suffering with pain on her arm for over a year. The patient was seeing an orthopedic, she has had been on steroid pills, shots, done physical therapy, everything, and she didn't know the problem, why she was still hurting. The patient was concern that when that COVID vaccine, that Pfizer or Moderna, she doesn't know which she will get, but she was afraid to get the vaccine, so she was trying to find out, if there is any place else she can get it, like the butt or someplace else, she is afraid to get the shot in the arm. The vaccine was still bothering her. The outcome of the event was not recovered.  Information regarding lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: Within 30 minutes of vaccine administration, lower back myalgia developed.  Myalgia worsened over the next 24 hours with gradual improvement by 72 hours after injection.  Fatigue developed 7 hours after injection and improved by 24 hours after injection given.  Chills developed 9 hours after injection and resolved by 24 hours after injection given.  Moderately severe injection site tenderness developed 4 hours after injection given and improved after 48 hours.  Still with some low back pain, but slowly improving .
Sex: U
Vaccine: COVID19
Symptoms: Lung neoplasm malignant
Clinical narrative: had lung cancer diagnosed after receiving the vaccine first dose; This is a spontaneous report from Pfizer-sponsored program . A contactable other health profession (patient's friend) reported that a patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had lung cancer diagnosed after receiving the vaccine first dose on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Based on known pathophysiology of lung malignancies, reported lung cancer is considered intercurrent and unrelated to suspect BNT162B2. Carcinogenesis takes years. 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Feeling cold, Feeling hot, Headache
Clinical narrative: I woke up the day after receiving my COVID vaccination with cold chills and nausea. Once I got to work, took temp. was 99.3. After meeting, I took my temp. again because I was having intense cold chills but felt warm and it was 102.9. I still have cold chills, nausea, headache, and 101.1 fever now.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: I woke up the day after receiving my COVID vaccination with cold chills and nausea. Once I got to work, took temp. was 99.3. After meeting, I took my temp. again because I was having intense cold chills but felt warm and it was 102.9. I still have cold chills, nausea, headache, and 101.1 fever now.
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Asthenia, Diet refusal, Dizziness, Gait inability
Clinical narrative: health has totally deteriorated; She sleeps, barely opens her eye; refuses to eat or drink; dizzy; didn't feel well; she can't talk, walk or anything; she can't talk, walk or anything; She is weak and frail; This is a spontaneous report from a contactable consumer (patient's daughter). A 100-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. Medical history included dementia from an unknown date and unknown if ongoing and walking aid user from an unknown date and unknown (prior to the vaccine, she walked well with her walker). Concomitant medication included quetiapine. The reporter reported that the patient's health has totally deteriorated as of a few days after receiving the vaccine on 13Jan2021. She is dying. She sleeps, barely opens her eyes and refuses to eat or drink. Three days after receiving the vaccine on 13Jan2021, she said she was dizzy and didn't feel well. Now she can't talk, walk or anything. She is weak and frail. Prior to the vaccine, she walked well with her walker, ate well and had energy. The reporter visited with her and had conversations but the patient doesn't talk or respond. She is her daughter and POA. She lives in the facility due to dementia. No treatment was received for the events. The patient did not recover from the events.  Information on the lot/batch number has been requested.
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: General physical health deterioration, Hypersomnia, Malaise, Unresponsive to stimuli
Clinical narrative: health has totally deteriorated; She sleeps, barely opens her eye; refuses to eat or drink; dizzy; didn't feel well; she can't talk, walk or anything; she can't talk, walk or anything; She is weak and frail; This is a spontaneous report from a contactable consumer (patient's daughter). A 100-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. Medical history included dementia from an unknown date and unknown if ongoing and walking aid user from an unknown date and unknown (prior to the vaccine, she walked well with her walker). Concomitant medication included quetiapine. The reporter reported that the patient's health has totally deteriorated as of a few days after receiving the vaccine on 13Jan2021. She is dying. She sleeps, barely opens her eyes and refuses to eat or drink. Three days after receiving the vaccine on 13Jan2021, she said she was dizzy and didn't feel well. Now she can't talk, walk or anything. She is weak and frail. Prior to the vaccine, she walked well with her walker, ate well and had energy. The reporter visited with her and had conversations but the patient doesn't talk or respond. She is her daughter and POA. She lives in the facility due to dementia. No treatment was received for the events. The patient did not recover from the events.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Headache, Rash, Rash vesicular, Tongue pruritus
Clinical narrative: surface blisters, like deep blisters all over her body/blistering rash all over; Hives; Itchy tongue; Headache; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176 and expiry date: unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  After receiving the vaccine, patient had hives and an itchy tongue on an unspecified date in Jan2021. Patient received some Benadryl at site. She spoke for about two hours and it seemed to ease a little bit. Patient came home and slept a quite a bit. As soon as she woke up, patient had the itchy tongue and hives again, so she took another the Benadryl. She woke up and then had a blistering rash all over on Jan2021. But the blisters were like surface blisters, like deep blisters all over her body. She went to the urgent care and received some IM steroid and Benadryl as treatment. Patient also had the headache on Jan2021. Outcome of the events was unknown. Patient was asking if she should get her second dose as back in the emergency room, they said they would not suggest to get the second dose.; Sender's Comments: Based on the time association, the blistery rash is possibly related to suspect BNT162B2 administration. 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: surface blisters, like deep blisters all over her body/blistering rash all over; Hives; Itchy tongue; Headache; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176 and expiry date: unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  After receiving the vaccine, patient had hives and an itchy tongue on an unspecified date in Jan2021. Patient received some Benadryl at site. She spoke for about two hours and it seemed to ease a little bit. Patient came home and slept a quite a bit. As soon as she woke up, patient had the itchy tongue and hives again, so she took another the Benadryl. She woke up and then had a blistering rash all over on Jan2021. But the blisters were like surface blisters, like deep blisters all over her body. She went to the urgent care and received some IM steroid and Benadryl as treatment. Patient also had the headache on Jan2021. Outcome of the events was unknown. Patient was asking if she should get her second dose as back in the emergency room, they said they would not suggest to get the second dose.; Sender's Comments: Based on the time association, the blistery rash is possibly related to suspect BNT162B2 administration. 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: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Acute cardiac event, Cerebrovascular accident, Mechanical ventilation, Respiratory arrest, SARS-CoV-2 test negative
Clinical narrative: Heart event stopped him from breathing; stroke; lack of air; This is a spontaneous report from a contactable consumer, the patient.  A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm on 13Jan2021 (at the age of 40-years-old) as a single dose for COVID-19 immunization.  Medical history included nut allergy from an unknown date and unknown if ongoing.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included zolpidem tartrate (AMBIEN) and doxepin (MANUFACTURER UNKNOWN).  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jan2021 at 13:00, the patient experienced heart event that stopped him from breathing and the lack of air caused a stroke; all reported as life-threatening.  On 14Jan2021, the patient underwent lab tests and procedures which included COVID-19 test which was negative.  The patient was treated for the events which included being put on a ventilator and sedation.  The clinical outcomes of the heart event stopped him from breathing, lack of air, and stroke, were not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature increased, Chills, Cold sweat, Dizziness
Clinical narrative: 1/25/21 5PM-Fever chills , red hot arm. 830PM-Fever, increased chills, increased heat and pain to L arm until 0345 on 1/26/21., but then started with hot/cold sweats, and achy everywhere.  0900AM-started feeling very nauseated and dizzy, 10AM-couldn't stand up , arms and legs felt hot and kinda fluttery, then both hands "ceased up" and couldn't move fingers for about 10 minutes, increased anxiety, then started with complete cold sweat and hands started to relax, after 20 minutes symptoms subsided and felt like a covid headache and aches every where.  Husband took temperature throughout experience, hovered around 100.00. 1/26/21-2:00PM symptoms improving, still have headache, achy everywhere and increased fatigue. 1/27/21 0900AM-Felt like "I did a full body workout for 6 hours yesterday but much improved".
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Hyperhidrosis, Mobility decreased, Muscle spasms
Clinical narrative: 1/25/21 5PM-Fever chills , red hot arm. 830PM-Fever, increased chills, increased heat and pain to L arm until 0345 on 1/26/21., but then started with hot/cold sweats, and achy everywhere.  0900AM-started feeling very nauseated and dizzy, 10AM-couldn't stand up , arms and legs felt hot and kinda fluttery, then both hands "ceased up" and couldn't move fingers for about 10 minutes, increased anxiety, then started with complete cold sweat and hands started to relax, after 20 minutes symptoms subsided and felt like a covid headache and aches every where.  Husband took temperature throughout experience, hovered around 100.00. 1/26/21-2:00PM symptoms improving, still have headache, achy everywhere and increased fatigue. 1/27/21 0900AM-Felt like "I did a full body workout for 6 hours yesterday but much improved".
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: 1/25/21 5PM-Fever chills , red hot arm. 830PM-Fever, increased chills, increased heat and pain to L arm until 0345 on 1/26/21., but then started with hot/cold sweats, and achy everywhere.  0900AM-started feeling very nauseated and dizzy, 10AM-couldn't stand up , arms and legs felt hot and kinda fluttery, then both hands "ceased up" and couldn't move fingers for about 10 minutes, increased anxiety, then started with complete cold sweat and hands started to relax, after 20 minutes symptoms subsided and felt like a covid headache and aches every where.  Husband took temperature throughout experience, hovered around 100.00. 1/26/21-2:00PM symptoms improving, still have headache, achy everywhere and increased fatigue. 1/27/21 0900AM-Felt like "I did a full body workout for 6 hours yesterday but much improved".
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance, Skin warm
Clinical narrative: 1/25/21 5PM-Fever chills , red hot arm. 830PM-Fever, increased chills, increased heat and pain to L arm until 0345 on 1/26/21., but then started with hot/cold sweats, and achy everywhere.  0900AM-started feeling very nauseated and dizzy, 10AM-couldn't stand up , arms and legs felt hot and kinda fluttery, then both hands "ceased up" and couldn't move fingers for about 10 minutes, increased anxiety, then started with complete cold sweat and hands started to relax, after 20 minutes symptoms subsided and felt like a covid headache and aches every where.  Husband took temperature throughout experience, hovered around 100.00. 1/26/21-2:00PM symptoms improving, still have headache, achy everywhere and increased fatigue. 1/27/21 0900AM-Felt like "I did a full body workout for 6 hours yesterday but much improved".
Sex: U
Vaccine: COVID19
Symptoms: Death, SARS-CoV-2 test positive
Clinical narrative: died several hours after receiving a Covid-19 vaccine; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died several hours after receiving a Covid-19 vaccine on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The person had tested positive for the virus (Covid-19) in late Dec2020.  Information on the batch/lot number has been requested.; Reported Cause(s) of Death: died several hours after receiving a Covid-19 vaccine
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral coldness
Clinical narrative: within a few minutes after the vaccination, patient felt her arm go cold and numb.  Patient has never had this happen before.  She denies any other symptoms.  Both hands are cold to touch.  She soon felt better but symptoms did not completely resolve.  Patient is refusing any treatment or transport.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Neurological symptom
Clinical narrative: Fell twice and looks like he may have had a stroke; Fell twice and looks like he may have had a stroke; This is a spontaneous report from a Pfizer-sponsored program "Pfizer First Connect" from a contactable consumer (patient's wife). A 77-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient fell twice and looks like he may have had a stroke on 16Jan2021 with outcome of unknown.  The information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Death
Clinical narrative: Autoimmune disease; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse. A male patient of an unspecified age received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced autoimmune disease on an unspecified date. The patient died on an unspecified date due to autoimmune disease. It was unknown if an autopsy was performed.  The information on the lot/batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. The company cannot completely exclude a causal relationship between the fatal autoimmune disease and suspect vaccine BNT162B2. Additional information regarding therapy duration, relevant medical history, underlying conditions, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. 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.; Reported Cause(s) of Death: Autoimmune disease
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Respiratory tract infection
Clinical narrative: got the worst respiratory infection/  deathly sick; Initial information received on 23-Nov-2020 regarding an unsolicited valid serious case received from a physician and consumer or non-healthcare professional.  This case involves female patient (age not reported) who experienced got the worst respiratory infection/ deathly sick (respiratory tract infection), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious got the worst respiratory infection due to which she was deathly sick for 12 long weeks (respiratory tract infection) within a week following the administration of INFLUENZA VACCINE (patient took the influenza vaccine once in his life).   This event was assessed as medically significant.  It was the sickest he had ever been. She will never take another flu shot. She said they are poison and that is not debatable. Then she made it a mission after that to get educated about these things like vaccines and what she found was astonishing. They have crippled and killed many caused autism, polio, nervous system disorders just to name a few by the thousands but they will always tell you they are safe. She just have one simple question that everyone should think about how in the world does it make any sense at all to inject poisons and toxins into your natural immune system as a means to stay healthy. Staying truly healthy is to not do that  Laboratory details were not reported.   Patient had to make three trips to the Doctor and they had to put her on three different strong antibiotics that didn't work. Finally had to be put on complete bed rest to recover.  On an unknown date, the patient recovered from respiratory tract infection (patient haven't been sick again once recovered).  Batch number has been requested for suspect product for this case.; Sender's Comments: A female patient (age not reported) who presented with respiratory tract infection within a week following the vaccination with INFLUENZA VACCINE (unknown manufacturer). Time to onset is compatible. Medical history, concomitant medication, precise final diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Electrocardiogram, Hypoaesthesia eye, Hypoaesthesia oral, Jaw disorder
Clinical narrative: Patient describes increased blood pressure, tachycardia, queezy feeling, tremors, tingling/numbness of the lips and eyes, and heavy feeling in tongue and jaw that started to develop ~15 minutes after vaccine administration and worsened overtime. Patient took Benadryl which provided minimal relief,  then presented to the ED.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Paraesthesia oral, Tachycardia, Tremor
Clinical narrative: Patient describes increased blood pressure, tachycardia, queezy feeling, tremors, tingling/numbness of the lips and eyes, and heavy feeling in tongue and jaw that started to develop ~15 minutes after vaccine administration and worsened overtime. Patient took Benadryl which provided minimal relief,  then presented to the ED.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, Myalgia, Pharyngeal swelling, Pyrexia
Clinical narrative: swelling in the back of throat and nasopharyngeal area; myalgia; chills; fever; malaise; Initial information regarding an unsolicited valid non-serious case was received from a consumer via The Agency (Reference number- 00416318) on 05-Jan-2021.  The case involved a female patient of unknown age who experienced swelling in the back of throat and nasopharyngeal area (pharyngeal swelling), myalgia, chills, fever (pyrexia) and malaise, while she received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   On an unknown date in 2016, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UI691AA, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious significant reactions of swelling in the back of throat and nasopharyngeal area (pharyngeal swelling), myalgia, chills, fever (pyrexia) and malaise, unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  The patient had not received a flu vaccine since. Now that she had to get a Covid vaccine, the patient wanted to know what agents in the vaccine might possibly had caused the reaction so that she could avoid those things in the Covid vaccine if possible. The doctor only listed the name and she assumed lot number above and told the patient to contact you for more specific information.  Relevant laboratory test was not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.
Age: 17.0
Sex: U
Vaccine: DTAP, TD
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 17 year old patient was given DAPTACEL with no adverse event; 17 year old patient was supposed to be given TENIVAC but was given DAPTACEL instead with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health professional  (physician assistant) via Medical Information (Reference number- 00428721) and transmitted to Sanofi on 13-Jan-2021.  The case involves a 17 year old patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age) instead of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (wrong product administered).  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day).  At the time of reporting, no adverse event was reported.  The reporter wanted to know if patient should be revaccinated. The reporter stated that the patient had left the office and was doing fine.   This suspected adverse reaction report was 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 was 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 had contributed to or was to be held liable for the occurrence of this medication error.  There would be no information available on batch number for this case.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nasal congestion
Clinical narrative: Employee suffering from headache, congestion, chills & muscle ache.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Migraine, Paranasal sinus discomfort, Peripheral coldness
Clinical narrative: Fever; migraine; sinus pressure; chills; fatigue; feet/arms cold
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; migraine; sinus pressure; chills; fatigue; feet/arms cold
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: modern shot #2. Beginning 23 hours after dose, lasting 4 hours,   1.  sustained high fever 102-103 , even after Advils.  2.  Teeth chattering Shivering,  3.  Sustained tachycardia 4 hours when lying down 96+ 4. booming headache 5. sore arm, sore neck 6. achy body 7. pulsatile tinnutis ( I thought workers were hammering outside) 8. incredible thirst, drank (2) 27 oz thermoses of water at the 27 hour mark
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Thirst, Thunderclap headache, Tinnitus
Clinical narrative: modern shot #2. Beginning 23 hours after dose, lasting 4 hours,   1.  sustained high fever 102-103 , even after Advils.  2.  Teeth chattering Shivering,  3.  Sustained tachycardia 4 hours when lying down 96+ 4. booming headache 5. sore arm, sore neck 6. achy body 7. pulsatile tinnutis ( I thought workers were hammering outside) 8. incredible thirst, drank (2) 27 oz thermoses of water at the 27 hour mark
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: One week after the injection in my left arm  the area swelled, reddened, warmed , became itchy and hives developed. I?ve taken ibuprofen  for symptoms. 24hrs later site remains reddened, warm and itchy but remains manageable with ibuprofen. No office visit.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest X-ray normal, Electrocardiogram normal, Fatigue, Feeling abnormal
Clinical narrative: * 01/14/21 - Received first Pfizer COVID Vaccine. Felt really strange for first 10 mins after vaccine.  * 01/17/21 - Noticed my heart rate was at 120 bpm and I was extremely tired.  * 01/24/21 - I noticed that I?ve started getting headaches more frequently. I rarely got headaches before (maybe 3-4 per year) * 1/25/21 - Had one of the worst migraines I?ve ever had. Blurred vision.  * 1/26/21 - Went to the E.R. to get my heart checked because my heart rate was high and I was extremely tired. Also had a minor headache.  * 1/27/21 - I still do not feel right. My heart flutters. Come and go headache. Very sleepy, though I had good sleep the night before.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Laboratory test normal, Migraine, Somnolence
Clinical narrative: * 01/14/21 - Received first Pfizer COVID Vaccine. Felt really strange for first 10 mins after vaccine.  * 01/17/21 - Noticed my heart rate was at 120 bpm and I was extremely tired.  * 01/24/21 - I noticed that I?ve started getting headaches more frequently. I rarely got headaches before (maybe 3-4 per year) * 1/25/21 - Had one of the worst migraines I?ve ever had. Blurred vision.  * 1/26/21 - Went to the E.R. to get my heart checked because my heart rate was high and I was extremely tired. Also had a minor headache.  * 1/27/21 - I still do not feel right. My heart flutters. Come and go headache. Very sleepy, though I had good sleep the night before.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: * 01/14/21 - Received first Pfizer COVID Vaccine. Felt really strange for first 10 mins after vaccine.  * 01/17/21 - Noticed my heart rate was at 120 bpm and I was extremely tired.  * 01/24/21 - I noticed that I?ve started getting headaches more frequently. I rarely got headaches before (maybe 3-4 per year) * 1/25/21 - Had one of the worst migraines I?ve ever had. Blurred vision.  * 1/26/21 - Went to the E.R. to get my heart checked because my heart rate was high and I was extremely tired. Also had a minor headache.  * 1/27/21 - I still do not feel right. My heart flutters. Come and go headache. Very sleepy, though I had good sleep the night before.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: I felt fine after the first shot.  The second shot brought me chills, headache, and severe body aches approximately 24 hours after receiving it.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Headache
Clinical narrative: Headache, back pain, brain fog
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Facial paralysis, Hemiparesis, Magnetic resonance imaging
Clinical narrative: hemiparesis left, facial droop, weakness on left upper and lower extremity
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pyrexia
Clinical narrative: Fever 99.9 Dry cough Mild headache
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Arm became itchy, reddened, hot, swollen, and hard. Approx. 3 by 4 inches round.  Used Benedryl 50mm, next morning some better progressing. More Benedryl and Tylanol. Contacted Primary doctor, added pepsid and antibiotic. Antibiotic ordered out of caution for possible skin infection. Symptoms greatly resolved after 24 hours...by 48 hours gone.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Heart rate increased, Oral discomfort, Rash
Clinical narrative: 1320 Patient here for Moderna Covid Injection; states "I'm feeling really anxious about this injection" Moderna Injection discussed with patient including risk associated with injection; allergies noted; patient states "I want the vaccine rather than get covid". 1323 Moderna vaccine given, patient encouraged to wait 30 minutes after receiving Moderna vaccine, with patient verbalizing understanding through teach back. 1330 Nurse at patient's side, patient state's I'm feeling okay, thanks"; patient's husband at side 1346 patient c/o of fast heart rate; pulse taken with 90 bpm noted; pharmacist at side and RRT notified and at side. 1350 Rash noted on patient's neck, face is flushed and patient complains of lips burning. doctor notified of patients complaints and instructed to tell patient that she can go to the ER if symptoms persist with patient verbalizing understanding through teach back. 1351 Benadryl 25 mg given po as ordered; wash cloth applied to patient's face. 1400 Patient states "I'm not feeling any better, I would like to go to the ER", patient taken to ER. -------------------------------------------------------------------------------
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Balance disorder, Ear discomfort, Electrocardiogram, Flushing
Clinical narrative: 1320 Patient here for Moderna Covid Injection; states "I'm feeling really anxious about this injection" Moderna Injection discussed with patient including risk associated with injection; allergies noted; patient states "I want the vaccine rather than get covid". 1323 Moderna vaccine given, patient encouraged to wait 30 minutes after receiving Moderna vaccine, with patient verbalizing understanding through teach back. 1330 Nurse at patient's side, patient state's I'm feeling okay, thanks"; patient's husband at side 1346 patient c/o of fast heart rate; pulse taken with 90 bpm noted; pharmacist at side and RRT notified and at side. 1350 Rash noted on patient's neck, face is flushed and patient complains of lips burning. doctor notified of patients complaints and instructed to tell patient that she can go to the ER if symptoms persist with patient verbalizing understanding through teach back. 1351 Benadryl 25 mg given po as ordered; wash cloth applied to patient's face. 1400 Patient states "I'm not feeling any better, I would like to go to the ER", patient taken to ER. -------------------------------------------------------------------------------
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Heart rate increased, Laboratory test, Lacrimation increased, Nervousness
Clinical narrative: 1320 Patient here for Moderna Covid Injection; states "I'm feeling really anxious about this injection" Moderna Injection discussed with patient including risk associated with injection; allergies noted; patient states "I want the vaccine rather than get covid". 1323 Moderna vaccine given, patient encouraged to wait 30 minutes after receiving Moderna vaccine, with patient verbalizing understanding through teach back. 1330 Nurse at patient's side, patient state's I'm feeling okay, thanks"; patient's husband at side 1346 patient c/o of fast heart rate; pulse taken with 90 bpm noted; pharmacist at side and RRT notified and at side. 1350 Rash noted on patient's neck, face is flushed and patient complains of lips burning. doctor notified of patients complaints and instructed to tell patient that she can go to the ER if symptoms persist with patient verbalizing understanding through teach back. 1351 Benadryl 25 mg given po as ordered; wash cloth applied to patient's face. 1400 Patient states "I'm not feeling any better, I would like to go to the ER", patient taken to ER. -------------------------------------------------------------------------------
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral discomfort, Palpitations, Pruritus, Tremor, Vertigo
Clinical narrative: 1320 Patient here for Moderna Covid Injection; states "I'm feeling really anxious about this injection" Moderna Injection discussed with patient including risk associated with injection; allergies noted; patient states "I want the vaccine rather than get covid". 1323 Moderna vaccine given, patient encouraged to wait 30 minutes after receiving Moderna vaccine, with patient verbalizing understanding through teach back. 1330 Nurse at patient's side, patient state's I'm feeling okay, thanks"; patient's husband at side 1346 patient c/o of fast heart rate; pulse taken with 90 bpm noted; pharmacist at side and RRT notified and at side. 1350 Rash noted on patient's neck, face is flushed and patient complains of lips burning. doctor notified of patients complaints and instructed to tell patient that she can go to the ER if symptoms persist with patient verbalizing understanding through teach back. 1351 Benadryl 25 mg given po as ordered; wash cloth applied to patient's face. 1400 Patient states "I'm not feeling any better, I would like to go to the ER", patient taken to ER. -------------------------------------------------------------------------------
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Headache, muscle aches, sore throat, and chills
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hypertension, Tachycardia
Clinical narrative: EE  develop tachycardia, hypertension, and face flushing within 40 mins of receiving dose. Symptoms resolved without treatment.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Dizziness, Mental impairment, Musculoskeletal stiffness, Pallor
Clinical narrative: Patient had a syncopal episode after receiving dose of vaccine and after asking for some water stating she felt dizzy and faint, pale, stiff, unaware of surroundings, nonverbal for approximately 1 minute. Hx of getting anxious at times and hx of seizures. EMS activated - and patient went with EMS for further evaluation.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient had a syncopal episode after receiving dose of vaccine and after asking for some water stating she felt dizzy and faint, pale, stiff, unaware of surroundings, nonverbal for approximately 1 minute. Hx of getting anxious at times and hx of seizures. EMS activated - and patient went with EMS for further evaluation.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: T 99.9, Chills, aching, no breathing pblms. I/2 dollar size red hot to touch, pain @ insertion site the same day & night. T down to to 98.6, no further chills,  no aching today. Site is still painful & painful & hot to touch. Dr notified. Took Benadryl  when obtained vaccine per drs recommendation.u
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: T 99.9, Chills, aching, no breathing pblms. I/2 dollar size red hot to touch, pain @ insertion site the same day & night. T down to to 98.6, no further chills,  no aching today. Site is still painful & painful & hot to touch. Dr notified. Took Benadryl  when obtained vaccine per drs recommendation.u
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: vaccine site is itchy warm to touch, swollen red with a bump. on day 6 post vaccine
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Injection site rash, Rash
Clinical narrative: Three days After the second shot was given,  a rash appeared from the injection site, up the arm toward the shoulder, then the rash ran down the patient's back towards his waistline. The rash was approximately 3 inches wide at places on the patinet's back.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Discomfort, Ear pain, Eye pain
Clinical narrative: Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick. within 30 minutes of then end escalating over the next hour, I had a severe headache, bilateral, occipital, pressure in entire head and neck. The headache as also in my eyes and in my ears.  Back was also painful - not as bad as neck, but i can't explain how horribly a hope a massage could fix me.  There was no comfortable position to alleviate any of that.  I also got the chills, constantly, suddenly switching from shivering cold to so hot i needed to take blankets off - but soon as i took the blankets off I'd be freezing cold again. I was also super nauseous, though i didn't vomit. I pretty much couldn't get out of bed much for 24-36 hours. During that time, i was unable to sleep as well, i think mostly due to the chills, constantly having to move about to keep warm or cool off, but not sure.      I did take acetaminophen around 10pm 1/26 (36 hours after injection)- i felt like I knew you're not supposed to, but I couldn't take it any more and it might have less anti-inflammatory impact than ibuprofen.  It dulled the pains some, but didn't make it stop. the chills and nausea mostly stopped and was able to sleep more the second night, last night.       I'm now up and trying to work today (1/27). Head still has pressure headache throughout. Neck is still sore, like a pressure headache. I feel generally foggy and heavy.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling of body temperature change, Head discomfort, Headache, Impaired work ability
Clinical narrative: Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick. within 30 minutes of then end escalating over the next hour, I had a severe headache, bilateral, occipital, pressure in entire head and neck. The headache as also in my eyes and in my ears.  Back was also painful - not as bad as neck, but i can't explain how horribly a hope a massage could fix me.  There was no comfortable position to alleviate any of that.  I also got the chills, constantly, suddenly switching from shivering cold to so hot i needed to take blankets off - but soon as i took the blankets off I'd be freezing cold again. I was also super nauseous, though i didn't vomit. I pretty much couldn't get out of bed much for 24-36 hours. During that time, i was unable to sleep as well, i think mostly due to the chills, constantly having to move about to keep warm or cool off, but not sure.      I did take acetaminophen around 10pm 1/26 (36 hours after injection)- i felt like I knew you're not supposed to, but I couldn't take it any more and it might have less anti-inflammatory impact than ibuprofen.  It dulled the pains some, but didn't make it stop. the chills and nausea mostly stopped and was able to sleep more the second night, last night.       I'm now up and trying to work today (1/27). Head still has pressure headache throughout. Neck is still sore, like a pressure headache. I feel generally foggy and heavy.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Neck pain, Sleep disorder
Clinical narrative: Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick. within 30 minutes of then end escalating over the next hour, I had a severe headache, bilateral, occipital, pressure in entire head and neck. The headache as also in my eyes and in my ears.  Back was also painful - not as bad as neck, but i can't explain how horribly a hope a massage could fix me.  There was no comfortable position to alleviate any of that.  I also got the chills, constantly, suddenly switching from shivering cold to so hot i needed to take blankets off - but soon as i took the blankets off I'd be freezing cold again. I was also super nauseous, though i didn't vomit. I pretty much couldn't get out of bed much for 24-36 hours. During that time, i was unable to sleep as well, i think mostly due to the chills, constantly having to move about to keep warm or cool off, but not sure.      I did take acetaminophen around 10pm 1/26 (36 hours after injection)- i felt like I knew you're not supposed to, but I couldn't take it any more and it might have less anti-inflammatory impact than ibuprofen.  It dulled the pains some, but didn't make it stop. the chills and nausea mostly stopped and was able to sleep more the second night, last night.       I'm now up and trying to work today (1/27). Head still has pressure headache throughout. Neck is still sore, like a pressure headache. I feel generally foggy and heavy.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes
Clinical narrative: vaginal herpes, Dr. consultation over the phone, RX Valtrex
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: 1/19- 6 hours after receiving vaccine, patient experienced fever, weakness, joint pain 1/20- developed a severe throbbing headache and fatigue.  1/21- headache continued 1/22- severe dizziness, extremely weak and pale: presented to Hospital Emergency Dept presently still experiencing  headaches and dizziness
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pallor, Pyrexia
Clinical narrative: 1/19- 6 hours after receiving vaccine, patient experienced fever, weakness, joint pain 1/20- developed a severe throbbing headache and fatigue.  1/21- headache continued 1/22- severe dizziness, extremely weak and pale: presented to Hospital Emergency Dept presently still experiencing  headaches and dizziness
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: Fever; body aches; chills; vomiting
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Mental status changes, Vomiting
Clinical narrative: Loose stools, vomiting, change in mental status
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling abnormal, Headache, Hyperhidrosis, Night sweats
Clinical narrative: Fever, chills, headache, sweating around 3:30a after getting shot. Felt worse than flu for 12 hours. After waking up the next morning (1/27), sweating and headache remains.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, chills, headache, sweating around 3:30a after getting shot. Felt worse than flu for 12 hours. After waking up the next morning (1/27), sweating and headache remains.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm for two days, fatigue for one day