chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy thyroid gland normal, Blood test, Diagnostic aspiration, Goitre, SARS-CoV-2 test positive
Clinical narrative: she had positive COVID test; she had positive COVID test; This is a spontaneous report from a contactable nurse. A 52-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly in the left arm on 28Dec2020 16:00 at a single dose for covid-19 immunisation. The patient's medical history included tested positive for covid on 06Nov2020. The patient had recent physical in Dec2020,  patient did blood work. Twelve years ago (2009) she had a partial thyroidectomy and at the physical they noticed a lump. The goiter was enlarged on her neck. She doesn't know if it a result from COVID, but she has Hashimoto's disease in Dec2020. She has to have surgery to removed the goiter, but she can't because of COVID. She has looked it up and it is an autoimmune disease. She had a fine needle biopsy and it was negative and she had a full thyroid work up that was fine in the beginning of Jan2021.The patient's concomitant medications were not reported. On 14Jan2021, the patient's test came back positive for covid. It was further reported that the patient tested negative on the Friday after holiday. She has been getting tested twice weekly since that time and they had all been negative. Patient was scheduled to get her second dose of the vaccine today (18Jan2021). The outcome of the event was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Sensation of foreign body, Thyroid function test normal
Clinical narrative: she had positive COVID test; she had positive COVID test; This is a spontaneous report from a contactable nurse. A 52-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly in the left arm on 28Dec2020 16:00 at a single dose for covid-19 immunisation. The patient's medical history included tested positive for covid on 06Nov2020. The patient had recent physical in Dec2020,  patient did blood work. Twelve years ago (2009) she had a partial thyroidectomy and at the physical they noticed a lump. The goiter was enlarged on her neck. She doesn't know if it a result from COVID, but she has Hashimoto's disease in Dec2020. She has to have surgery to removed the goiter, but she can't because of COVID. She has looked it up and it is an autoimmune disease. She had a fine needle biopsy and it was negative and she had a full thyroid work up that was fine in the beginning of Jan2021.The patient's concomitant medications were not reported. On 14Jan2021, the patient's test came back positive for covid. It was further reported that the patient tested negative on the Friday after holiday. She has been getting tested twice weekly since that time and they had all been negative. Patient was scheduled to get her second dose of the vaccine today (18Jan2021). The outcome of the event was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Head discomfort, Headache, Illness
Clinical narrative: arm soreness/Arm hurt; headache; swollen glands; head "felt stuffy"; very weak muscles (had to be helped to the bathroom); very weak; not feeling well; very sick; This is a spontaneous report from a contactable consumer (patient).  This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 12Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 70-year-old. Medical history included Sars-Cov-2 infection (Mar2020), sick for 5 or 6 days, who knowingly has antibodies, and has donated plasma on multiple occasions, asthma but does not report respiratory symptoms, mild hypertension, migraines, vascular problems, and chronic portal vein thrombosis (PVT). Concomitant medications included linaclotide (LINZESS), hydrochlorothiazide, rosuvastatin, montelukast, levothyroxine, clopidogrel.   On 13Jan2021 at night, she reports arm soreness/arm hurt, and that when she woke up the next day she 'felt like she had Covid all over again' with: headache, swollen glands, head 'felt stuffy', very weak muscles (had to be helped to the bathroom), no fever but caller did state that she took a Tylenol. From Wednesday to Saturday she didn't feeling well, but every day she felt a little better. She has asthma - drug out my peak flow meter (as reported). No asthma sx during this whole thing. She reported adverse events and thinks some might have been stunted by the Tylenol she took after the first dose. She reported she was very sick, she still had like waves of not feeling well. She had most of the symptoms that she had was when she had Covid. She was sick, she was in bed and could not move. The most severe symptoms were on 13th and slowly each day felt better and it was until Saturday was when she really started to feel a 100 percent herself. Events were reported as non-serious. She had recently lab test within the last month or so. She had two or one and blood and everything was negative, everything was normal. Outcome of very sick and not feeling well is not recovered, while the outcome of the other events is recovering. She should receive the second dose on 02Feb2021. Information about lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Lymphadenopathy, Malaise, Muscular weakness, Pain in extremity
Clinical narrative: arm soreness/Arm hurt; headache; swollen glands; head "felt stuffy"; very weak muscles (had to be helped to the bathroom); very weak; not feeling well; very sick; This is a spontaneous report from a contactable consumer (patient).  This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 12Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 70-year-old. Medical history included Sars-Cov-2 infection (Mar2020), sick for 5 or 6 days, who knowingly has antibodies, and has donated plasma on multiple occasions, asthma but does not report respiratory symptoms, mild hypertension, migraines, vascular problems, and chronic portal vein thrombosis (PVT). Concomitant medications included linaclotide (LINZESS), hydrochlorothiazide, rosuvastatin, montelukast, levothyroxine, clopidogrel.   On 13Jan2021 at night, she reports arm soreness/arm hurt, and that when she woke up the next day she 'felt like she had Covid all over again' with: headache, swollen glands, head 'felt stuffy', very weak muscles (had to be helped to the bathroom), no fever but caller did state that she took a Tylenol. From Wednesday to Saturday she didn't feeling well, but every day she felt a little better. She has asthma - drug out my peak flow meter (as reported). No asthma sx during this whole thing. She reported adverse events and thinks some might have been stunted by the Tylenol she took after the first dose. She reported she was very sick, she still had like waves of not feeling well. She had most of the symptoms that she had was when she had Covid. She was sick, she was in bed and could not move. The most severe symptoms were on 13th and slowly each day felt better and it was until Saturday was when she really started to feel a 100 percent herself. Events were reported as non-serious. She had recently lab test within the last month or so. She had two or one and blood and everything was negative, everything was normal. Outcome of very sick and not feeling well is not recovered, while the outcome of the other events is recovering. She should receive the second dose on 02Feb2021. Information about lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Fatigue, SARS-CoV-2 test positive
Clinical narrative: tested positive; tested positive; being a little tired/she was tired after it; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: 30Apr2021) solution for injection, via an unspecified route of administration on 15Jan2021 at a single dose for Covid-19 immunization. Medical history included hearing aid. There were no concomitant medications. The patient reported she received her first dose on Friday 15Jan2021 and she lost her sense of smell and taste on Sunday 17Jan2021 and she went and got tested today, Monday 18Jan2021 and her rapid test was positive (Covid test). her taste and smell ability disappeared. She stated that yesterday at 3:30PM all of sudden that her taste and smell ability disappeared. Stated that she just had a rapid test done. Stated that she had not felt bad and had no symptoms before the shot. Patient wanted to know if they had any reactions like this. Stated that she will know more when the test comes back, and she will hear shortly. Patient stated that she was tired after it (Jan2021). She was being a little tired. Stated she has a hearing aid which she had prior to getting the vaccine. Outcome of the events lost her sense of smell and taste/her taste and smell ability disappeared were not recovered, while outcome of the other events was unknown.  No follow-up activities are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: high blood pressure/her blood pressure is 165/114; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EK9231), via an unspecified route of administration in the left arm on 12Jan2021 at 09:30 as a single dose for COVID-19 immunization. The patient had no relevant medical history and had no concomitant medications. History of all previous immunizations with Pfizer Vaccine considered as suspect was reported as none (this was the first dose received), did not have additional vaccines administered on the same date as the Pfizer vaccine, and did not have any prior vaccinations within four weeks. The patient mentioned that after getting the first shot of the COVID-19 vaccine, her blood pressure was 165/114 in the morning of 14Jan2021. She has never had high blood pressure and wanted to know if this was normal after getting the vaccine. The last three days she has been taking her blood pressure and it had been high. On 18Jan2021, the patient's blood pressure was 165/108. Her previous blood pressure readings have been in the 160's over 108-114. Reiterated that she has never had high blood pressure before. She was scheduled to get second dose on 02Feb2021. The event did not require a visit to the Emergency Room or Physician's Office and she has not gone yet to the hospital. Everyone wanted her to, but she did not want to go. She stated she did not like hospitals. Outcome of the event was not recovered.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: 101F fever/101 degree fever; chills; headache; Sore arm; This is a spontaneous report from a contactable consumer reporting for herself. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via unspecified route of administration, on right arm, on 14Jan2021 15:30 at single dose for COVID-19 immunization. Vaccination Facility type was at Health department gave it at the fairgrounds. Medical history included ongoing COPD, blood pressure high, GERD, former smoker she quit 30 years ago, had COVID while she was in a rehab center in Aug2020, for which she said it felt like bronchitis; broke her hip last August (Aug2020). Ongoing concomitant medications included hydrochlorothiazide, telmisartan (TELMISARTAN HCTZ) for blood pressure high, pantoprazole for GERD, vitamins, ascorbic acid (VITAMIN C), zinc, colecalciferol (VITAMIN D), acetylsalicylic acid (ASPIRIN), magnesium. On 15Jan2021, patient had a 101F fever, a headache and chills all day. Her concern was that she had never had any kind of reaction to any kind of vaccine before. From what she's heard, people have had a worse reaction to the 2nd shot, and since the first shot was so bad she was worried about getting the 2nd one. She was scheduled for her 2nd dose on 02Feb2021, and she had an appointment scheduled with a specialist on 03Feb2021. The morning after getting the vaccine, she woke up and got dressed but kept thinking that she was cold so she put on an extra sweater. Stated that even with the extra sweater on, she still had the chills, then she started to get the headache, and then she took her temperature. Stated that she had also had a sore arm, it's finally starting to feel better today. The outcome of event sore arm was resolving, outcome of other events were resolved on 16Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Headache, Lymphadenopathy, Pruritus, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 06Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient received the vaccine on 06Jan2021. A week after, she started getting itchy on may Wednesday or Thursday. She went outside at night, and maybe got bitten by mosquito bites, but she itched. Saturday night, her back was really itching and she put alcohol on it, and it stopped the itching. On Sunday, it was really getting itchy, and her doctor said to get Benadryl. She got Benadryl by pharmacy. She got vaccine in left arm and her left shoulder got red. She thought it was hives but never seen before and it went away within 5 minutes. When she took the Benadryl, the itching went away after half an hour. Now it's almost 12 hours later, and she's starting to get a little itchy, but not as bad. Her doctor said she needed one more dose of Benadryl. She had also had a very, very slight headache on the right side and she felt her glands were swollen in her neck. All event started on Jan2021. She was due for her next dose on 27Jan2021. Outcome of event itchy was recovering. Outcome of other events was unknown. Information on the lot/ batch number has been requested. Follow-up (18Jan2021): New information reported from a contactable consumer (patient) includes: reaction data (add hives). Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 06Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient received the vaccine on 06Jan2021. A week after, she started getting itchy on may Wednesday or Thursday. She went outside at night, and maybe got bitten by mosquito bites, but she itched. Saturday night, her back was really itching and she put alcohol on it, and it stopped the itching. On Sunday, it was really getting itchy, and her doctor said to get Benadryl. She got Benadryl by pharmacy. She got vaccine in left arm and her left shoulder got red. She thought it was hives but never seen before and it went away within 5 minutes. When she took the Benadryl, the itching went away after half an hour. Now it's almost 12 hours later, and she's starting to get a little itchy, but not as bad. Her doctor said she needed one more dose of Benadryl. She had also had a very, very slight headache on the right side and she felt her glands were swollen in her neck. All event started on Jan2021. She was due for her next dose on 27Jan2021. Outcome of event itchy was recovering. Outcome of other events was unknown. Information on the lot/ batch number has been requested. Follow-up (18Jan2021): New information reported from a contactable consumer (patient) includes: reaction data (add hives). Information on the lot/ batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: rash on left leg between knee and ankle, rash itched; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (left arm) on 16Jan2021 (14:45) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on an unspecified date for Covid-19 immunization. The patient's medical history included Myasthenia Gravis, MOHS surgery 2 times, Type 2 Diabetes, both knees and back surgeries, high blood pressure, and Penicillin allergy. Concomitant medications included unspecified medications for high blood pressure and diabetes Type 2 maintenance. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received the shot in left arm on 16Jan2021. The next day (17Jan2021, 14:00) he noticed rash on left leg between knee and ankle. He added that the rash itched. There was no treatment received for the adverse event. The outcome of event was recovering. The patient has not been tested for COVID-19 since the vaccination.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Blood pressure measurement, Headache, Hypertension
Clinical narrative: General weakness; nausea; stomach cramps; high blood pressure; aches all over the body especially in lower extremities; aches all over the body especially in lower extremities; severe headaches; This is a spontaneous report from a contactable nurse reported for self. This 56-year-old female patient the second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) via an unspecified route of administration on 12Jan2021 at single dose in left arm for COVID-19 immunisation. The patient is not pregnant. The patient had no other medical history. The patient had no known allergies. The patient concomitant medication was none. The patient previously received first dose of BNT162B2 (Lot number EL0140) at 22Dec2020 09:00 AM at single dose in left arm for COVID-19 immunisation. The patient experienced general weakness, nausea, stomach cramps, high blood pressure, aches all over the body especially in lower extremities, severe headaches on 17Jan2021. These events resulted in emergency room/department or urgent care. The patient received amlodipine besilate (NOVARSC) 5mg, hydroxyzine (ATARAX) for treatment. The patient had no COVID prior and post vaccination. The patient was recovering from the events.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: General weakness; nausea; stomach cramps; high blood pressure; aches all over the body especially in lower extremities; aches all over the body especially in lower extremities; severe headaches; This is a spontaneous report from a contactable nurse reported for self. This 56-year-old female patient the second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) via an unspecified route of administration on 12Jan2021 at single dose in left arm for COVID-19 immunisation. The patient is not pregnant. The patient had no other medical history. The patient had no known allergies. The patient concomitant medication was none. The patient previously received first dose of BNT162B2 (Lot number EL0140) at 22Dec2020 09:00 AM at single dose in left arm for COVID-19 immunisation. The patient experienced general weakness, nausea, stomach cramps, high blood pressure, aches all over the body especially in lower extremities, severe headaches on 17Jan2021. These events resulted in emergency room/department or urgent care. The patient received amlodipine besilate (NOVARSC) 5mg, hydroxyzine (ATARAX) for treatment. The patient had no COVID prior and post vaccination. The patient was recovering from the events.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hyperhidrosis, Laboratory test
Clinical narrative: fever; chills; headache; bad body aches; continuous migraine; developed bad body sweats; This is a spontaneous report from a contactable Other HCP reporting for herself. A 29-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number eL0142), intramuscular on 05Jan2021 10:00 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Patient age at time of vaccination was 29 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730) intramuscular administered on 16Dec2020 at 03:00 PM at single dose in right arm. Medical history included hypothyroidism, polycystic ovarian syndrome, low vitamin D from Apr2020, was diagnosed with COVID19 in Apr2020. The patient has no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), spironolactone, ergocalciferol (VIT D) birthcontrol pill. On 16Jan2021 at 03:00 PM, all of a sudden developed fever, chills, headache and bad body aches out of nowhere. Fever continued to progress despite Tylenol. Went to the hospital she worked at, and was COVID (Nasal Swab) and respiratory panel tested same night as symptom development at 11pm. Both have since come back negative. The fever and symptoms lasted for another 24 hours and the patient also developed bad body sweats even after fever had been broken. She had no other symptoms like congestion or sore throat that would signify another cause of the fever and symptoms, and  ears and throat where checked at the hospital. The headache she had was similar to the headache when she had covid back in Apr2020. The headache was icepick like along with a continuous migraine. The only thing she did differently was the day before symptom onset, she did a pretty high intensity cardio workout for an hour. The events resulted in emergency room/department or urgent care and were resolving. No treatment was given other than Tylenol for fever.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: fever; chills; headache; bad body aches; continuous migraine; developed bad body sweats; This is a spontaneous report from a contactable Other HCP reporting for herself. A 29-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number eL0142), intramuscular on 05Jan2021 10:00 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Patient age at time of vaccination was 29 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730) intramuscular administered on 16Dec2020 at 03:00 PM at single dose in right arm. Medical history included hypothyroidism, polycystic ovarian syndrome, low vitamin D from Apr2020, was diagnosed with COVID19 in Apr2020. The patient has no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), spironolactone, ergocalciferol (VIT D) birthcontrol pill. On 16Jan2021 at 03:00 PM, all of a sudden developed fever, chills, headache and bad body aches out of nowhere. Fever continued to progress despite Tylenol. Went to the hospital she worked at, and was COVID (Nasal Swab) and respiratory panel tested same night as symptom development at 11pm. Both have since come back negative. The fever and symptoms lasted for another 24 hours and the patient also developed bad body sweats even after fever had been broken. She had no other symptoms like congestion or sore throat that would signify another cause of the fever and symptoms, and  ears and throat where checked at the hospital. The headache she had was similar to the headache when she had covid back in Apr2020. The headache was icepick like along with a continuous migraine. The only thing she did differently was the day before symptom onset, she did a pretty high intensity cardio workout for an hour. The events resulted in emergency room/department or urgent care and were resolving. No treatment was given other than Tylenol for fever.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive to SARS-COV2; tested positive to SARS-COV2; This is a spontaneous report from a contactable consumer (reported for himself). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive to SARS-COV2 on 08Jan2021. Today (18Jan2021), he got his appointment to get the second dose. He just wanted to know if he should go to get it or not. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Pain
Clinical narrative: chills; body aches at night/ body aches/ aches/ pain; cold; This is a spontaneous report from a contactable Registered Nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (lot number and expiry date unknown) for the first dose and on 08Jan2021 (lot number and expiry date unknown) for the second dose, both at a single dose for COVID-19 immunization. The patient's medical history included allergy to azithromycin and sulfa antibiotics; patient never had an allergic reaction to a vaccine. Concomitant medications were not reported. The patient previously took amoxicillin and had an allergy, she gets hives. The patient reported to have received the second dose of the vaccine last 08Jan2021 and experienced chills and body aches at night. She took Advil and Tylenol for it and it resolved with gradually decreasing symptoms over the week. Yesterday at work she got cold (pending clarification) and started experiencing body aches again. She took an Advil for it again. She reported that she did not have a fever at all. She is asking if this could be possibly related to the vaccine and how many days should the side effects last. She is also asked if she should get tested for COVID given the symptoms. The patient further reported that she was not having a fever, but she is still getting chills and aches. She said that she was not around anyone that has COVID and wears her mask when out. She asked if this could be from the vaccine. She said that she felt this way when she first got the vaccine as well. No fever, just body aches, pain, and chills like she can't get warm, and got cold (pending clarification). She takes Tylenol and Ibupriofen and she is fine, but she has to take them. Patient wanted to know if this is the vaccine working its way through her system. Does she need to get COVID tested? Is this from the Vaccine? The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Chest pain, Chills
Clinical narrative: Pain at site; shortness of breath; palpitations; elevated blood pressure; positive D-dimer; tachycardia; abnormal ekg; headache; chest pain; achy; fatigue; fever; chills; Covid/Flu like symptoms; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 11Jan2021 at 13:00 at single dose in left arm for covid-19 immunization. Medical history included hypothyroidism, known allergies: penicillin and dexamethasone. Concomitant medication included thyroid (ARMOUR THYROID), lisdexamfetamine mesilate (VYVANSE), amitriptyline, zolpidem. The patient previously received the first dose bnt162b2 (lot number: EK5730) on 21Dec2020 at 13:00 in left arm for covid-19 immunization. The patient experienced pain at site, shortness of breath, palpitations, elevated blood pressure, positive D-dimer, tachycardia, abnormal EKG, headache, chest pain, achy, fatigue, fever, chills and Covid/Flu like symptoms; all on 12Jan2021 at 18:00. The events resulted on doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received treatment for the events with Sodium Chloride and Dulera Inhaler. The patient did not have COVID prior vaccination, the patient had been tested for COVID post vaccination, which included SARS-CoV-2 (Nasal Swab): negative on 15Jan2021, and Novel Coronovirus PCR (Blood test): negative on 15Jan2021. The outcome of all events was not resolved.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Electrocardiogram abnormal, Fatigue, Fibrin D dimer
Clinical narrative: Pain at site; shortness of breath; palpitations; elevated blood pressure; positive D-dimer; tachycardia; abnormal ekg; headache; chest pain; achy; fatigue; fever; chills; Covid/Flu like symptoms; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 11Jan2021 at 13:00 at single dose in left arm for covid-19 immunization. Medical history included hypothyroidism, known allergies: penicillin and dexamethasone. Concomitant medication included thyroid (ARMOUR THYROID), lisdexamfetamine mesilate (VYVANSE), amitriptyline, zolpidem. The patient previously received the first dose bnt162b2 (lot number: EK5730) on 21Dec2020 at 13:00 in left arm for covid-19 immunization. The patient experienced pain at site, shortness of breath, palpitations, elevated blood pressure, positive D-dimer, tachycardia, abnormal EKG, headache, chest pain, achy, fatigue, fever, chills and Covid/Flu like symptoms; all on 12Jan2021 at 18:00. The events resulted on doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received treatment for the events with Sodium Chloride and Dulera Inhaler. The patient did not have COVID prior vaccination, the patient had been tested for COVID post vaccination, which included SARS-CoV-2 (Nasal Swab): negative on 15Jan2021, and Novel Coronovirus PCR (Blood test): negative on 15Jan2021. The outcome of all events was not resolved.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Headache, Influenza like illness, Pain, Palpitations
Clinical narrative: Pain at site; shortness of breath; palpitations; elevated blood pressure; positive D-dimer; tachycardia; abnormal ekg; headache; chest pain; achy; fatigue; fever; chills; Covid/Flu like symptoms; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 11Jan2021 at 13:00 at single dose in left arm for covid-19 immunization. Medical history included hypothyroidism, known allergies: penicillin and dexamethasone. Concomitant medication included thyroid (ARMOUR THYROID), lisdexamfetamine mesilate (VYVANSE), amitriptyline, zolpidem. The patient previously received the first dose bnt162b2 (lot number: EK5730) on 21Dec2020 at 13:00 in left arm for covid-19 immunization. The patient experienced pain at site, shortness of breath, palpitations, elevated blood pressure, positive D-dimer, tachycardia, abnormal EKG, headache, chest pain, achy, fatigue, fever, chills and Covid/Flu like symptoms; all on 12Jan2021 at 18:00. The events resulted on doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received treatment for the events with Sodium Chloride and Dulera Inhaler. The patient did not have COVID prior vaccination, the patient had been tested for COVID post vaccination, which included SARS-CoV-2 (Nasal Swab): negative on 15Jan2021, and Novel Coronovirus PCR (Blood test): negative on 15Jan2021. The outcome of all events was not resolved.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Tachycardia, Vaccination site pain
Clinical narrative: Pain at site; shortness of breath; palpitations; elevated blood pressure; positive D-dimer; tachycardia; abnormal ekg; headache; chest pain; achy; fatigue; fever; chills; Covid/Flu like symptoms; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 11Jan2021 at 13:00 at single dose in left arm for covid-19 immunization. Medical history included hypothyroidism, known allergies: penicillin and dexamethasone. Concomitant medication included thyroid (ARMOUR THYROID), lisdexamfetamine mesilate (VYVANSE), amitriptyline, zolpidem. The patient previously received the first dose bnt162b2 (lot number: EK5730) on 21Dec2020 at 13:00 in left arm for covid-19 immunization. The patient experienced pain at site, shortness of breath, palpitations, elevated blood pressure, positive D-dimer, tachycardia, abnormal EKG, headache, chest pain, achy, fatigue, fever, chills and Covid/Flu like symptoms; all on 12Jan2021 at 18:00. The events resulted on doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received treatment for the events with Sodium Chloride and Dulera Inhaler. The patient did not have COVID prior vaccination, the patient had been tested for COVID post vaccination, which included SARS-CoV-2 (Nasal Swab): negative on 15Jan2021, and Novel Coronovirus PCR (Blood test): negative on 15Jan2021. The outcome of all events was not resolved.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature abnormal, Dizziness, Feeling abnormal, Feeling hot, Hyperhidrosis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration in Jan2021 (on Thursday) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller received the first dose of the vaccine on Thursday in Jan2021 and she's felling bad, she couldn't go to work and would like to know what she could do. Had been down ever since. Couldn't get out of bed. Has a temperature. Felt so bad she couldn't go into work today (18Jan2021). Not sure what's going on. Clarified she's referring to the Pfizer COVID-19 Vaccine. Had she known what she knows now she would not have taken it. The patient was hot, sweating, and dizzy. (Facility name) administered the COVID-19 Vaccine. Didn't know if she needs to go get tested. Felt like crap. Felt bad. Hasn't been out of bed in three days. Requested to be transferred. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient received the first vaccine and then tested positive for Covid.; patient received the first vaccine and then tested positive for Covid.; This is a spontaneous report from a contactable nurse. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection NDC number: 59267-1000-2, lot number: EL1283, expiry date: Apr2021), via an unspecified route of administration on unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter is a nurse in (City name) who said that they have a patient received the first vaccine and then tested positive for Covid. She was calling to ask what they should do about it, and should the patient get the 2nd dose? Nurse states that the office called her and said that the patient was now positive with Covid, and asked her what they should do and if the patient would be able to get the 2nd dose. Nurse stated she had no idea, which is why she called, but she did tell them that it wasn't from the vaccine; that the patient must have had it prior to getting the vaccine.  The nurse states that they only received 1 Lot at their facility, so the patient's first dose must have been of that same Lot, which was EL1283. States that she remembers that the Expiry was Apr2021.  Caller was able to get into the patient's chart while on hold and provided the patient's date of birth and the NDC number for the vaccine after being introduced. The outcome of events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19  test positive and suspected LOE  due to temporal relationship.   There is limited information provided in this report.   This case will be reassessed once additional information is 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Headache, Malaise
Clinical narrative: felt really sick; chest pain; bad headache; it spiked blood pressure the very first day/Her blood pressure spiked the first day; This is a spontaneous report from contactable consumers (one is patient). A 64-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly on left arm on 28Dec2020 at single dose for COVID-19 prophylaxis. The patient medical history included: Chronic hypertension and elevated cholesterol levels. Concomitant medication included ongoing acetylsalicylic acid (BABY ASPIRIN) for chronic hypertension and elevated cholesterol levels, then developed GI problems and she skipped days. On 28Dec2020 she received the 1st dose of the Pfizer vaccine. She was scheduled for her 2nd dose on 22Jan2021 (Friday). The patient developed a bad headache on 28Dec2020 that evening was better by the next morning then came back, it spiked my blood pressure the very first day, it usually responded to the medication but this time it didn't. The patient's blood pressure stayed like that for 2 to 3 days, she felt really sick on unknown date, on the 3rd day on 31Dec2020 the patient had some chest pain, but later that day she was feeling back to normal. Right now she felt fine, her blood pressure was back to my normal, baseline. Weight 153-154 lbs. Reporter said that what concerned her most was that her blood pressure spiked. She said that has never happened in the past that with her blood pressure before. Her blood pressure did not respond to her medication. The patient was trying to research the high blood pressure and hadn't been able to find any information and want to know if there was any information can provide. The patient wanted to take the vaccine, she just wanted to be sure she would be okay. The outcome of event headache was not recovered. The outcome of events blood pressure increased and chest pain was recovered on unknown date. The event of rest event was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: felt really sick; chest pain; bad headache; it spiked blood pressure the very first day/Her blood pressure spiked the first day; This is a spontaneous report from contactable consumers (one is patient). A 64-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly on left arm on 28Dec2020 at single dose for COVID-19 prophylaxis. The patient medical history included: Chronic hypertension and elevated cholesterol levels. Concomitant medication included ongoing acetylsalicylic acid (BABY ASPIRIN) for chronic hypertension and elevated cholesterol levels, then developed GI problems and she skipped days. On 28Dec2020 she received the 1st dose of the Pfizer vaccine. She was scheduled for her 2nd dose on 22Jan2021 (Friday). The patient developed a bad headache on 28Dec2020 that evening was better by the next morning then came back, it spiked my blood pressure the very first day, it usually responded to the medication but this time it didn't. The patient's blood pressure stayed like that for 2 to 3 days, she felt really sick on unknown date, on the 3rd day on 31Dec2020 the patient had some chest pain, but later that day she was feeling back to normal. Right now she felt fine, her blood pressure was back to my normal, baseline. Weight 153-154 lbs. Reporter said that what concerned her most was that her blood pressure spiked. She said that has never happened in the past that with her blood pressure before. Her blood pressure did not respond to her medication. The patient was trying to research the high blood pressure and hadn't been able to find any information and want to know if there was any information can provide. The patient wanted to take the vaccine, she just wanted to be sure she would be okay. The outcome of event headache was not recovered. The outcome of events blood pressure increased and chest pain was recovered on unknown date. The event of rest event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contracted Covid; contracted Covid; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient was due for his second dose but was in the middle of the period where he contacted COVID on an unspecified date. The outcome of the event was unknown.   Information on lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Feeling hot
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the right arm on 15Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included diabetic, allergies, asthma and allergies to mold, pollen and iodine. Concomitant medications included metformin, glimepiride, simvastatin, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and amitriptyline. The patient previously took cefaclor (CECLOR) and experienced allergies. On 15Jan2021 at 15:15, the patient's face, chin and chest turned bright red. The patient also experienced hot sensation all over and tightness when breathing. No treatment was received. The outcome of the events was recovered on an unspecified date.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: acquired covid19 had mild to moderate symptoms; acquired covid19 had mild to moderate symptoms; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received 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 immunisation. The patient's medical history and concomitant medications were not reported. The physician reported that the patient was vaccinated 2 and a half weeks ago and a week ago, in Jan2021, she acquired Covid19 had mild to moderate symptoms. Event was reported as non-serious. The physician wanted to know when the 2nd dose should be given. The outcome of the event was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19  and suspected LOE  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: she has an infection; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 19Jan2020, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified) via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced an infection. It was reported that the patient was scheduled for minor surgery next week. She was going to be given antibiotics and she wants to make sure that one won't interfere with the vaccination. She was going to be on two or three antibiotics because she has an infection. She wanted to make sure no issue. Patient clarified that she was looking for information about COVID vaccine and antibiotics and just wanted the medical information to pass along to her doctor. Outcome of event was unknown.  Information on the lot/batch number has been requested.