chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Received the vaccine on 23Dec2020. She tested positive for COVID on 31Dec2020.; Received the vaccine on 23Dec2020. She tested positive for COVID on 31Dec2020.; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable other healthcare professional (patient herself) reported that a 37-year-old female patient received bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899), via an unspecified route of administration in the left arm 23Dec2020 at single dose, for Covid-19 immunization. Medical history included migraine (takes a migraine medication). Her height was 168cm, weight of 72.5kg. There were no concomitant medications. Received the vaccine on 23Dec2020. She tested positive for COVID on 31Dec2020. Then she had another test and was negative for COVID on 03Jan2021 and was also negative for another test on 05Jan2021. She was wondering if this was like a super vaccine and knocked it out or if there was an error with the test. She acknowledged that there was a lag time for the second dose of 21 days. She was wondering if there was a grace period for that since she cannot be cleared for work. She was also wondering what to do before her second dose of the vaccine. The outcome of event was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported positive Sars-Cov-2 test, which is considered ineffective of BNT162B2, and the administration of BNT162B2.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: Nausea; fatigue; muscle aches; chills; transient SOB; runny nose; weird headaches or fullness; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), intramuscularly on 22Dec2020 at 15:00 on Left arm at single dose for COVID-19 immunization. The patient medical history included known allergies with Chloreseptic spray. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included ergocalciferol (VIT D); ascorbic acid (VIT C); probiotics (reported as probiotic); alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME); trazodone (reported as trazadone) for sleep; fluticasone. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Nausea, fatigue, muscle aches, chills, transient SOB (Shortness of breath), and runny nose, weird headaches or fullness on 22Dec2020 at 19:00. Since the vaccination, patient had been tested for COVID-19 via Nasal Swab on 04Jan2021, result: Negative. No treatment was received for the events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Nausea; fatigue; muscle aches; chills; transient SOB; runny nose; weird headaches or fullness; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), intramuscularly on 22Dec2020 at 15:00 on Left arm at single dose for COVID-19 immunization. The patient medical history included known allergies with Chloreseptic spray. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included ergocalciferol (VIT D); ascorbic acid (VIT C); probiotics (reported as probiotic); alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME); trazodone (reported as trazadone) for sleep; fluticasone. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Nausea, fatigue, muscle aches, chills, transient SOB (Shortness of breath), and runny nose, weird headaches or fullness on 22Dec2020 at 19:00. Since the vaccination, patient had been tested for COVID-19 via Nasal Swab on 04Jan2021, result: Negative. No treatment was received for the events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Heart rate, Heart rate increased
Clinical narrative: Shortness of breathe; Rapid heart rate; migraines; Fever; Chills; Body aches; Muscle tightness; Headaches; This is a spontaneous report from a contactable Other Health Professional (patient). A 35 years old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose (lot EK5230) via Intramuscular on 16Dec2020 11:30 in the left arm at single dose, second dose via Intramuscular on 06Jan2021 11:00 in the left arm at single dose for COVID-19 prophylaxis. Medical history and concomitant medications were none. Caller did not experience any side effects after the first dose.  After the second dose, caller experienced, fever, chills, body aches, muscle tightness and headache. Today the caller also experienced shortness of breathe and a rapid heart rate. Fever; She said that she noticed her fever at 0130 07Jan2021. He fever started at 100.3 at 0130 and at 0400 it was 100.8. She took it at 1000 and it was 101. She has not taken her temperature since. Chills: She woke her up at 0130 07Jan2021 she said that she sleeps with a electric heated blanket and she woke up cold. Body aches: She noticed that she had the body aches and pain at 0130 07Jan2021. She said that she has not been able to sleep because the pain has been so bad. Muscle tightness: She said that it hurts to stand up and walk. She stated that she had to get a Covid test this morning so she had to move. She noticed the muscle tightness at 0130 07Jan2021 along with the body aches. Headaches: caller said that she noticed her headache around 0130 07Jan2021. She said that it is a dull achy headache. She stated that she get migraines and thought it was because of her fever. Shortness Of Breath: She said that she noticed she was short of breath around 1230 07Jan2021. She stated that it is hard to breath right now and feels like someone is standing on her chest. Rapid heart rate: Her watch at 1230 07Jan2021 said that she had a 116 heart rate and that was at rest. Outcome of event Chills was recovering, while outcome of other events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Muscle tightness, Pain, Pyrexia
Clinical narrative: Shortness of breathe; Rapid heart rate; migraines; Fever; Chills; Body aches; Muscle tightness; Headaches; This is a spontaneous report from a contactable Other Health Professional (patient). A 35 years old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose (lot EK5230) via Intramuscular on 16Dec2020 11:30 in the left arm at single dose, second dose via Intramuscular on 06Jan2021 11:00 in the left arm at single dose for COVID-19 prophylaxis. Medical history and concomitant medications were none. Caller did not experience any side effects after the first dose.  After the second dose, caller experienced, fever, chills, body aches, muscle tightness and headache. Today the caller also experienced shortness of breathe and a rapid heart rate. Fever; She said that she noticed her fever at 0130 07Jan2021. He fever started at 100.3 at 0130 and at 0400 it was 100.8. She took it at 1000 and it was 101. She has not taken her temperature since. Chills: She woke her up at 0130 07Jan2021 she said that she sleeps with a electric heated blanket and she woke up cold. Body aches: She noticed that she had the body aches and pain at 0130 07Jan2021. She said that she has not been able to sleep because the pain has been so bad. Muscle tightness: She said that it hurts to stand up and walk. She stated that she had to get a Covid test this morning so she had to move. She noticed the muscle tightness at 0130 07Jan2021 along with the body aches. Headaches: caller said that she noticed her headache around 0130 07Jan2021. She said that it is a dull achy headache. She stated that she get migraines and thought it was because of her fever. Shortness Of Breath: She said that she noticed she was short of breath around 1230 07Jan2021. She stated that it is hard to breath right now and feels like someone is standing on her chest. Rapid heart rate: Her watch at 1230 07Jan2021 said that she had a 116 heart rate and that was at rest. Outcome of event Chills was recovering, while outcome of other events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a non-contactable nurse (patient) and a contactable consumer. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID Prevention because of occupation. The patient's medical history and concomitant medications were not reported.  The patient experienced tested positive for COVID on 02Jan2021 with outcome of unknown.  The patient underwent lab tests and procedures which included COVID test: positive on 02Jan2021. The patient got the first dose of the COVID vaccine, and then tested positive for COVID afterward. The patient was inquiring about if there are any recommendations for getting the second dose, if the person tested positive for COVID after getting the first dose. The patient did not provide prescriber information. The patient should come off of quarantine on 15Jan2021. It was unknow if the patient received any other vaccines on the same day as the COVID vaccine and if there were any concomitant medications, history or investigations other than the COVID test. The type of COVID test the patient received was unknown, just that she got the positive result on 02Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: felling dizziness; nausea; not feeling strong; This is a spontaneous report from a contactable consumer (patient).  A 93-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at left arm on unspecified date in Dec2020 at SINGLE DOSE for COVID-19 immunization and lubiprostone (AMITIZA) , via an unspecified route of administration from Dec2020 to an unspecified date at 1 DF, 2x/day as laxative..Medical history included:TIA started in Dec2020, bowel problem, fell (she fell about 3 weeks before she got the Pfizer COVID-19 shot) and some memory loss ( not serious).She wanted to know if she should receive her second dose of the COVID-19 vaccine if she was presenting the following side effects: felling dizziness, nausea and not feeling strong. She was currently taking Amitiza as a laxative. She believed these side effects were not related to the administration of the first dose of the vaccine and were rather common conditions for her age , she also stated that she did not have any "negative feelings" with the first shot of the vaccine.   Consumer said she had an appointment today for her second shot of the Pfizer COVID-19 vaccine and got a letter yesterday that said she could get it at 03:00PM today at the center where she got the first vaccination. She said that they gave the shot in her left arm for her first vaccination. She said it was very common at this age that she very often didn't feel well, and she was on a new laxative that might be causing some upset. She said she had no fever, she was not nauseated, she had no headache, there was nothing wrong. However the outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events dizziness, nausea and asthenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. Further details about the patient's medical history, concomitant conditions and the events would be helpful. The contributory role of the concomitant laxative also cannot be excluded. This case will be reassessed once additional information becomes available. 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: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Hypogeusia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: He is losing some taste/but reduced by 30-40%; received first dose of vaccine 21DEC2020 and SARS-Cov-2 positive/Nasal swab COVID positive; received first dose of vaccine 21DEC2020 and SARS-Cov-2 positive/Nasal swab COVID positive; Sniffles; This is a spontaneous report received from Pfizer sponsored program Pfizer First Connect via a contactable other HCP (parent) reported for the patient (son). A 22-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EK5730) intramuscularly in left arm on 21Dec2020 (15:00-16:00) at single dose for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient received first dose of vaccine 21Dec2020 and SARS-Cov-2 positive 06Jan2021 13:00. The patient got COVID vaccine 21Dec2020, and was scheduled to get second dose on 11Jan2021. He had a sniffle the other day on 05Jan2021 night time and tested positive for COVID on 06Jan2021, so reporter wanted to know if he should still get second dose. His symptoms are stable. He is quarantining. He is on his way to do a PCR now. Reporter read somewhere people could have false positive in nasal. He is losing some taste from 07Jan2021 (01:00 - 02:00). Most things he can taste. Some he cannot. It is not completely gone but reduced by 30-40%. He did a mouthwash with a sting and is not feeling that sting anymore. He said last night, same thing. He did a mouth wash and did not really taste much. It is not as prevalent as it was before. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 06Jan2021, positive COVID test 06Jan2021, 13:00, Nasal swab COVID. Event outcome of sniffles was recovering, while for other events was unknown.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported event ___ cannot be 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dysgeusia, Erythema, Nausea
Clinical narrative: throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Was pretty weak; This is a spontaneous report from a contactable nurse(patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration in the right arm on 17Dec2020 at single dose for covid-19 immunization; diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL), both via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included high blood pressure from 2008 and ongoing. Concomitant medication included amlodipine from 2017 and ongoing at 5 mg at night for high blood pressure, losartan from 2017 and ongoing at 12mg once in the morning for high blood pressure. Following her 1st dose of the COVID vaccine on 17Dec2020, the patient had throat tightening, metallic taste in her mouth. She was scheduled to have her 2nd dose today (07Jan2021) and would like to know what to do and if she was still covered 80% from the 1st dose of her COVID vaccine shot. When she got her first COVID shot 3 weeks ago she got a metallic taste in her mouth and her throat tightened up a little. Throat tightening happened right after she got the shot and lasted about less than 2 minutes. She also turned red when she got it. Then about 14 hours later, on the same day she got nausea, diarrhea, and was pretty weak. This lasted until about 20Dec2020 as well. She was supposed to get 2nd dose today (07Jan2021). Before her first shot she had taken paracetamol and hydrochloride prior. She also took both of those today (07Jan2021). But then she was reading through the paperwork and it says that a severe reaction includes tightening of the throat. She was not sure if what she had was truly a reaction or not. She did not have other allergies. She had many flu shots and never had any difficulty with those. She was a nurse, she wanted the second dose, but she was concerned about the throat tightening, and it getting worse with the second dose. She was unsure of seriousness. She figured that she would get aches and pains. Everyone else who got it said their arm hurt, but nothing else. She thought it was weird. She was just wired differently she guesses. The action taken in response to the events for paracetamol and hydrochloride was  unknown. The outcome of events throat tightening, turned red was recovered on 17Dec2020. The outcome of event metallic taste in her mouth, nausea, diarrhea, and was pretty weak was recovered on 20Dec2020.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Was pretty weak; This is a spontaneous report from a contactable nurse(patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration in the right arm on 17Dec2020 at single dose for covid-19 immunization; diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL), both via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included high blood pressure from 2008 and ongoing. Concomitant medication included amlodipine from 2017 and ongoing at 5 mg at night for high blood pressure, losartan from 2017 and ongoing at 12mg once in the morning for high blood pressure. Following her 1st dose of the COVID vaccine on 17Dec2020, the patient had throat tightening, metallic taste in her mouth. She was scheduled to have her 2nd dose today (07Jan2021) and would like to know what to do and if she was still covered 80% from the 1st dose of her COVID vaccine shot. When she got her first COVID shot 3 weeks ago she got a metallic taste in her mouth and her throat tightened up a little. Throat tightening happened right after she got the shot and lasted about less than 2 minutes. She also turned red when she got it. Then about 14 hours later, on the same day she got nausea, diarrhea, and was pretty weak. This lasted until about 20Dec2020 as well. She was supposed to get 2nd dose today (07Jan2021). Before her first shot she had taken paracetamol and hydrochloride prior. She also took both of those today (07Jan2021). But then she was reading through the paperwork and it says that a severe reaction includes tightening of the throat. She was not sure if what she had was truly a reaction or not. She did not have other allergies. She had many flu shots and never had any difficulty with those. She was a nurse, she wanted the second dose, but she was concerned about the throat tightening, and it getting worse with the second dose. She was unsure of seriousness. She figured that she would get aches and pains. Everyone else who got it said their arm hurt, but nothing else. She thought it was weird. She was just wired differently she guesses. The action taken in response to the events for paracetamol and hydrochloride was  unknown. The outcome of events throat tightening, turned red was recovered on 17Dec2020. The outcome of event metallic taste in her mouth, nausea, diarrhea, and was pretty weak was recovered on 20Dec2020.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Stress
Clinical narrative: tiredness; stress; feeling terribly; This is a spontaneous report from a contactable consumer (patient).  A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date Apr2021) intramuscular on 31Dec2020 11:30 at single dose in the left arm for COVID-19 immunisation. The patient had no medical history.  There were no concomitant medications. The patient called for information about if severe tiredness and stress are symptoms reported for the administration of the Pfizer's COVID-19 vaccine and how to properly manage them. The patient reported that she was administered with the Pfizer's COVID-19 vaccine on 31Dec2020 and since then she has been experiencing severe tiredness and stress (31Dec2020). The patient reported that she has spoken with her physician and he could not provide guidance about how to proceed with this particular situation. She received the first dose of Pfizer Biontech Covid vaccine on 31Dec2020. She was feeling terribly, she has severe, severe tiredness that comes over her and stress. She was overwhelmed by what was happening to her and she was asking if anybody else has experienced this. Her second dose was supposed to be on 21Jan2021. The outcome of the events severe tiredness, feeling terribly and stress was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: an employee who received the first dose of the Covid 19 vaccine, has tested positive for Covid 19 today; an employee who received the first dose of the Covid 19 vaccine, has tested positive for Covid 19 today; This is a spontaneous report from a contactable other HCP and a nurse. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient employee who received the first dose of the COVID 19 vaccine, has tested positive for COVID 19 today, 07Jan2021. The outcome of the event was unknown. The reporter would like to know if the patient can get the second COVID-19 vaccine.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported event.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Dysgeusia, Headache
Clinical narrative: Chills; headache; nausea; diarrhea; muscle and joint pain; muscle and joint pain; strange coffee taste; This is a spontaneous report from a contactable Nurse (patient). A 63-year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 05Jan2021 14:30 on right arm at a single dose for COVID-19 immunization. The patient known allergy included Penicillin allergy and other medical history included Diabetes 2, Hypertension, Reynauds and obesity. There is no other vaccine in the four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications in two weeks included losaeten, metformin, hydrochlorthiazide, duloxetine hydrochloride (CYMBALTA). The patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Dec2020 14:30 on left arm at a single dose for COVID-19 immunization. The patient experienced chills, headache, nausea, diarrhea, muscle and joint pain, strange coffee taste on 06Jan2021 02:00 and result in doctor or other healthcare professional office/clinic visit. No treatment received for these adverse events. The patient did covid test post vaccination via Nasal Swab on 07Jan2021 and result negative. The outcome of the events was not recovered.  Information on lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, SARS-CoV-2 test
Clinical narrative: Chills; headache; nausea; diarrhea; muscle and joint pain; muscle and joint pain; strange coffee taste; This is a spontaneous report from a contactable Nurse (patient). A 63-year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 05Jan2021 14:30 on right arm at a single dose for COVID-19 immunization. The patient known allergy included Penicillin allergy and other medical history included Diabetes 2, Hypertension, Reynauds and obesity. There is no other vaccine in the four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications in two weeks included losaeten, metformin, hydrochlorthiazide, duloxetine hydrochloride (CYMBALTA). The patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Dec2020 14:30 on left arm at a single dose for COVID-19 immunization. The patient experienced chills, headache, nausea, diarrhea, muscle and joint pain, strange coffee taste on 06Jan2021 02:00 and result in doctor or other healthcare professional office/clinic visit. No treatment received for these adverse events. The patient did covid test post vaccination via Nasal Swab on 07Jan2021 and result negative. The outcome of the events was not recovered.  Information on lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Oral herpes, Pain, Stress
Clinical narrative: cold sore; body aches; They have worsened as the day went on; stress; This is a spontaneous report from a contactable other healthcare professional (patient, Physical Therapist) from a Pfizer-sponsored program. A 29-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. Medical history included cold sores. Concomitant medication included valaciclovir hydrochloride (VALTREX) from 2009 and ongoing for cold sores, ongoing fluticasone propionate (FLONASE ALLERGY RELIEF), ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20) from 2006 and ongoing for birth control. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) on 15Dec2020 for COVID-19 immunization and experienced fever and body aches. The reporter wanted to verify if it was an interaction. She didn't feel like it was a drug interaction. She was questioning if there could be a drug interaction. She took Valtrex for cold sores on her face. She received her second dose of the COVID vaccine yesterday on 06Jan2021. Today 07Jan2021, she got a cold sore this morning and took Valtrex. She was wondering if the Valtrex, being an antiviral, could affect the vaccine in any way. She got the cold sores randomly anyway. They come on because of stress. She has a history with them. Caller didn't have a prescribing doctor. She got the vaccine through work. This time for second dose she developed body aches only. She received the vaccine yesterday 06Jan2021, and developed body aches today 07Jan2021. They have worsened as the day went on, but she was at work. Since she was home now and not moving around as much they weren't as bad. She got the vaccine because she worked in a nursing home. She was an essential worker who was at high risk. The outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Lymphadenopathy
Clinical narrative: "baseball size lump under his armpit "; "baseball size lump under his armpit "/like a swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on 06Jan2021 at SINGLE DOSE for COVID-19 immunization.  Medical history and concomitant medications were not reported. The patient received the Pfizer COVID vaccine on Sunday (06Jan2021), and the next day (07Jan2021), he woke up with a baseball size lump under his armpit. His doctor said it sounded like a swollen lymph node. He thought it was a side effect and wanted to find out if that was expected. Outcome of the events were unknown.   Information on lot/batch has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash is itching; rash under his arms from armpit to elbows underneath and on his sides below his belly button and in the groin area and on his buttocks; This is a spontaneous report from a contactable consumer (patient's wife). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at the right arm on 02Jan2021 00:45 at a single dose for COVID-19 immunization. Medical history included hard of hearing, surgery to remove the cancer, cancer broke his arm and he had a reverse shoulder replacement (medical conditions predating treatment with Pfizer COVID 19 vaccination); kidney failure that is better, muscle (disorder), blood pressure (abnormal), anxiety and radiation. The patient was previously given oxycodone, Ativan, and Xanax to take as needed after his surgery, but he has not taken them since Oct2020. Concomitant medication included sertraline hydrochloride (ZOLOFT) for anxiety, amlodipine for blood pressure, metoprolol for blood pressure, tamsulosin hydrochloride (FLOMAX) from Sep2020 for kidney, carisoprodol (SOMA) from 22Oct2020 for muscle relaxant, ferrous sulfate, docusate sodium (STOOL SOFTENER), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) all were ongoing and other unspecified products. The reporter stated that she and her husband got the vaccine on 02Jan2021 and the husband has developed a rash under his arm from his arm pit to elbow underneath, on his sides, below his belly button and in the groin area and on the buttocks. Rash was itching on 06Jan2021. She wanted to know could the COVID 19 vaccine cause this 4 days later. The patient noticed the itchy rash four days later on Wednesday afternoon 06Jan2021. He took Benadryl 25mg tablet by mouth that night before bed and then in the morning and put over the counter itch relief cream on it so in the night around 0200AM not too long after taking the Benadryl, the rash went away, pretty much gone. Today it seems to have come back and now it was worse because he has it on his buttocks. He didn't have it there at first. Mentioned that the patient also took a cool shower before going to bed. Wife mentioned that she just looked the rash right now and it was improved. Asking should he continue taking his relief or stop and let the doctor look at it? Advised caller to consult HCP. He is planning to get the next vaccine 23Jan2021. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The events did not require a visit to physician office and ER. No prior vaccinations (within 4 weeks). No relevant family medical history. No relevant tests done. Outcome of the events was recovering.   Information on the Lot/Batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Swelling, Vaccination site pruritus
Clinical narrative: armpit swelling; Itchiness, injection site and armpit swelling/It started itching and it is a little swollen; It is like the injection site reaction; Redness and swelling around the injection site; Redness and swelling around the injection site; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EJ1685, expiry date: Mar2021) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation. Medical history included asthma, anxiety. Concomitant medication included salbutamol (ALBUTEROL) for asthma, venlafaxine hydrochloride (EFFEXOR) for anxiety. The patient had noticed redness and swelling around the injection site. It doesn't seem like an infection but a typical reaction. This happened to the patient on day 8 post vaccination (06Jan2021). She also reported itchiness, injection site and armpit swelling since last night (06Jan2021). She had her vaccine on 29Dec2020 and then the last night (06Jan2021) it started itching and it is a little swollen. It is like the injection site reaction but she did not know it was normal this far after getting it. Like she was just curious that sort of reaction is normal this far after getting the vaccine. Events outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: After getting my vaccine I got a headache on both side of my head for seven days; This is a spontaneous report from a non-contactable physician, the patient. A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown), via an unknown route of administration on an unknown date as a single dose for COVID-19 vaccination.  The patient's medical history was unknown. The patient's concomitant medications were not reported. The  patient reported that "after getting my vaccine, I got a headache on both sides of my head for seven days." The event was reported as non-serious. Treatment for headache was unknown. The clinical outcome of headache was unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Vaccination site pain
Clinical narrative: swollen lymph nodes under left clavicle; tiredness; pain at the site; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number: EK9231) via an unspecified route of administration on his left arm on 28Dec2020 at a single dose for COVID-19 immunization. The patient had no medical history and no relevant family medical history. There were no concomitant medications. The patient worked at 12-13 different hospitals and around first responders and COVID positive patients. The patient got the first dose of the Pfizer BioNTech COVID vaccine on 28Dec and he has developed adverse events as of 'yesterday'. Reported he was tired and having swollen lymph nodes under the left clavicle, no fever or other symptoms. The patient noticed the swollen lymph nodes on 06Jan2021 when coming out of the shower. Since he worked in the hospital he asked a few Physicians about it. Mentioned he did do something with the (Public health agency name) and signed up and they sent him text messages every day to see how he was feeling the first 7-8 days. He never had symptoms that day except for pain at the site and a little tiredness post day (29Dec2020) of getting vaccine and then nothing after that. The Physicians he spoke to were only to palpate the one lymph node, it was pretty visible. He had none visible or palpated in the neck and they couldn't feel anymore there or anywhere else. He has had some tiredness today also, but no fever or anything else. He did not receive any other vaccines the same day or 4 weeks prior. Has not had any problems with previous vaccines. He was to go back for the second vaccine scheduled on 15Jan, but not sure if he should hold off. He worked with medical Devices, pacemakers, defibrillators, pacemaker devices. He does not take any medications and has not had any bloodwork. Patient was asking what should he do if he still has the swollen lymph nodes when he is due to get the second vaccine. The patient had no relevant tests done. Outcome of the events swollen lymph nodes and tiredness was not recovered, while unknown for the other event.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse, the patient. A female patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown), via an unknown  route of administration on 04Jan2021 as a single dose for COVID-19 vaccination. The patient's medical history included ear infection prior to receiving the COVID-19 vaccine. The patient's concomitant medications were not reported. On an unknown date in Jan2021, the patient experienced dizziness. The event dizziness was reported as non-serious. Treatment for dizziness was unknown. The clinical outcome of dizziness was unknown.    Information on the lot/batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Fatigue, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: constipation; neck stiffness; headaches; fatigue; soreness/Body soreness; soreness (both body soreness and injection site soreness); This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 12:00 pm at single dose at left arm for covid-19 immunization. There were no concomitant medications. Patient previously had the flu vaccine and had what was described as a less reaction, like a sensitivity. He had a slight fever and fatigue, like his body was fighting something. The patient has no product name, NDC, Lot, or Expiry for that product. Patient had no other medical history (including any illness at time of vaccination). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of the Pfizer suspect. On 07Jan2021 01:00, patient had the side effect of constipation after getting the vaccine, neck stiffness, and headaches, patient was experiencing these as well as fatigue and soreness (both body soreness and injection site soreness). The body soreness was like he worked out and his whole body was sore, the injection site soreness was more sore than his body but this was to be expected and it was about the same though didn't feel at first but felt it more on 07Jan2021. All the events started at about 1am on 07Jan2021. No history of all previous immunization with the Pfizer vaccine considered as suspect. No family medical history relevant to adverse events. Outcome of events neck stiffness, and headaches was recovering, and outcome of other events was not recovered. This report is considered as non-serious. The adverse events didn't require a visit to emergency room nor physician office.   Information on Lot/Batch has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: constipation; neck stiffness; headaches; fatigue; soreness/Body soreness; soreness (both body soreness and injection site soreness); This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 12:00 pm at single dose at left arm for covid-19 immunization. There were no concomitant medications. Patient previously had the flu vaccine and had what was described as a less reaction, like a sensitivity. He had a slight fever and fatigue, like his body was fighting something. The patient has no product name, NDC, Lot, or Expiry for that product. Patient had no other medical history (including any illness at time of vaccination). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of the Pfizer suspect. On 07Jan2021 01:00, patient had the side effect of constipation after getting the vaccine, neck stiffness, and headaches, patient was experiencing these as well as fatigue and soreness (both body soreness and injection site soreness). The body soreness was like he worked out and his whole body was sore, the injection site soreness was more sore than his body but this was to be expected and it was about the same though didn't feel at first but felt it more on 07Jan2021. All the events started at about 1am on 07Jan2021. No history of all previous immunization with the Pfizer vaccine considered as suspect. No family medical history relevant to adverse events. Outcome of events neck stiffness, and headaches was recovering, and outcome of other events was not recovered. This report is considered as non-serious. The adverse events didn't require a visit to emergency room nor physician office.   Information on Lot/Batch has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID after receiving the first dose of the vaccine; Tested positive for COVID after receiving the first dose of the vaccine; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ-685, expiration date: Mar2021), via an unspecified route of administration in the right arm on 21Dec2020 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient tested positive for COVID on 26Dec2020. Now, she is wanting to know if she should still get the second dose. Outcome of the events was unknown.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 21Dec2020, and COVID-19 test positive on 26Dec2020.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Pain
Clinical narrative: fever of 101.4F; chills; bodyache; headache; joint pain; This is a spontaneous report from a contactable Nurse (the patient).  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date in Dec2020 (at an unknown age) at an unspecified dose for COVID-19 vaccination.The patient's medical history was not reported. The patient's allergies were not reported. The patient's concomitant medications were not reported. The reporter stated that she is scheduled for her second dose of the vaccine today (07Jan2021), as it is the end of the 21-day period. With her first dose she experienced fever of 101.4F, chills, bodyache, headache and joint pain - all of which lasted for 48 hours. She was concerned about getting the second dose. Treatment information was not provided. The clinical outcomes of the events fever, chills, body ache, headache and joint pain was reported as recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 101.4F; chills; bodyache; headache; joint pain; This is a spontaneous report from a contactable Nurse (the patient).  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date in Dec2020 (at an unknown age) at an unspecified dose for COVID-19 vaccination.The patient's medical history was not reported. The patient's allergies were not reported. The patient's concomitant medications were not reported. The reporter stated that she is scheduled for her second dose of the vaccine today (07Jan2021), as it is the end of the 21-day period. With her first dose she experienced fever of 101.4F, chills, bodyache, headache and joint pain - all of which lasted for 48 hours. She was concerned about getting the second dose. Treatment information was not provided. The clinical outcomes of the events fever, chills, body ache, headache and joint pain was reported as recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.