chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Disease recurrence, Fatigue
Clinical narrative: my temperature was 101.5f to 100 f 24hrs. and 100-99.5f neck and head heaviness another 8hrs; neck to shoulder, chill; head heaviness; neck and head heaviness another 8hrs; still felt the pain on the injection site but not too much; fatigue; shoulder pain; sleepy; sleepy; This is a spontaneous report from a contactable nurse (patient). A 50-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via an unspecified route of administration on 08Jan2021 11:00, at left arm, at single dose for covid-19 immunization. Medical history included Hx of hypothyroidism. not now, known allergies was none. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration on 18Dec2020 14:00, at left arm, at single dose for covid-19 immunization and after the first dose, the patient had a pain from left side neck to elbow at next day but it was gone, she felt little sleepy the day she got vaccine. The patient received the second dose on 08Jan2021, and the patient was little sleepy so she went to sleep 8pm (20:00), from 11pm (23:00) 100f she woke up due to neck to shoulder, chill, 11:30pm (23:30) 101.3f after that she had same symptoms and her temperature was 101.5f to 100 f 24hrs, and 100-99.5f neck and head heaviness another 8hrs, she took Advil 200mg x4 in the 32hrs. She still felt the pain on the injection site but not too much. She went back to work 12Jan2021 but feel fatigue until yesterday (16Jan2021) but no more shoulder pain. No treatment was received for all events except fever. The outcome of the event fatigue was not recovered, the outcome of the event pain on the injection site was recovering, the outcome of the other events was recovered in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Musculoskeletal discomfort, Pyrexia, Somnolence, Vaccination site pain
Clinical narrative: my temperature was 101.5f to 100 f 24hrs. and 100-99.5f neck and head heaviness another 8hrs; neck to shoulder, chill; head heaviness; neck and head heaviness another 8hrs; still felt the pain on the injection site but not too much; fatigue; shoulder pain; sleepy; sleepy; This is a spontaneous report from a contactable nurse (patient). A 50-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via an unspecified route of administration on 08Jan2021 11:00, at left arm, at single dose for covid-19 immunization. Medical history included Hx of hypothyroidism. not now, known allergies was none. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration on 18Dec2020 14:00, at left arm, at single dose for covid-19 immunization and after the first dose, the patient had a pain from left side neck to elbow at next day but it was gone, she felt little sleepy the day she got vaccine. The patient received the second dose on 08Jan2021, and the patient was little sleepy so she went to sleep 8pm (20:00), from 11pm (23:00) 100f she woke up due to neck to shoulder, chill, 11:30pm (23:30) 101.3f after that she had same symptoms and her temperature was 101.5f to 100 f 24hrs, and 100-99.5f neck and head heaviness another 8hrs, she took Advil 200mg x4 in the 32hrs. She still felt the pain on the injection site but not too much. She went back to work 12Jan2021 but feel fatigue until yesterday (16Jan2021) but no more shoulder pain. No treatment was received for all events except fever. The outcome of the event fatigue was not recovered, the outcome of the event pain on the injection site was recovering, the outcome of the other events was recovered in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Body temperature, Body temperature abnormal, Chills
Clinical narrative: Dizzy; Symptoms included temperature; Sweating; Chills; Headache; Stomach ache; Weakness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 13Jan2021 at 11:00, at a single dose, for COVID-19 immunization. The patient's medical and concomitant medications were not reported. On 13Jan2021 at 11:00 AM, the patient had a human exposure from the COVID-19 vaccine. The patient received the COVID-19 vaccine on Wednesday at 11 AM. On 13Jan2021 at 11 AM, the following symptoms included temperature, sweating, chills, headache, stomach ache, weakness, and dizzy. The following first aid measures have been taken. The patient went to the emergency room last night where they advised her to self-quarantine. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hyperhidrosis
Clinical narrative: Dizzy; Symptoms included temperature; Sweating; Chills; Headache; Stomach ache; Weakness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 13Jan2021 at 11:00, at a single dose, for COVID-19 immunization. The patient's medical and concomitant medications were not reported. On 13Jan2021 at 11:00 AM, the patient had a human exposure from the COVID-19 vaccine. The patient received the COVID-19 vaccine on Wednesday at 11 AM. On 13Jan2021 at 11 AM, the following symptoms included temperature, sweating, chills, headache, stomach ache, weakness, and dizzy. The following first aid measures have been taken. The patient went to the emergency room last night where they advised her to self-quarantine. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal pain, Nausea, Vaccination site pain
Clinical narrative: Intestinal cramps; urgency to go to the bathroom/the urgency is almost like diarrhea; nausea; sore arm; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored Program. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231, expiration date 30Apr2021) on her left deltoid, intramuscular on 14Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the patient that she is having intestinal cramps since last night. The patient also said that she is also experiencing nausea, urgency to go to the bathroom (the urgency is most likely diarrhea), and she has a sore arm; all on 14Jan2021. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from two contactable physicians (patient) via Pfizer Sales Representative. Both physicians reported same event for 2 patients.   A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. It was reported patient had a sore arm. The two physicians both had the vaccine at the same time. The adverse event took place after Pfizer Product use. Outcome of the event was unknown.   Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021044462 same reporter/drug, different patient/event
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from two contactable physicians (patient) via Pfizer Sales Representative. Both physicians reported same event for 2 patients. This is second of 2 report. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. It was reported patient had a sore arm. The two physicians both had the vaccine at the same time. The adverse event took place after Pfizer Product use. Outcome of the event was unknown.   Information on lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021044461 same product/AE/ reporter, different patient
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: fever; chills; malaise; body aches; This is a spontaneous report from a contactable nurse (patient). A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified at a single dose for COVID-19 immunization. Medical history included covid-19 on summer of 2020. The patient's concomitant medications were not reported. The patient experienced fever, chills, malaise, and body aches the day after receiving the Covid vaccine. The symptoms were such that patient had to leave work at 1pm and the "fever" broke at 5:30 after taking Motrin. Outcome of the event fever was recovered, while for the remaining events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Headache; Fatigue; localized muscle soreness at injection site; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, fatigue, localized muscle soreness at injection site on an unspecified date, which are general post-vaccine symptoms. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: eyelids are a little swollen; This is spontaneous report from a contactable consumer. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, "Pfizer vaccine" as reported, lot number: unknown), via an unspecified route of administration on an unspecified date (06:30AM) at single dose for Covid-19 immunization. The patient's medical history included allergy to antibiotics (reported as "she is allergic to other things, but they are antibiotics"). Concomitant medications were not reported. The patient reported that she had the vaccine at 6:30AM (unspecified date) which she thought was Moderna (pending clarification). She clarified that she was supposed to get Pfizer's but that she thought that she was allergic to some of things in it (pending clarification). She further stated that her eyelids are a little swollen on an unspecified date. She did not know if she should take Benadryl or what. She reported that she was having slight reaction to the shot. She stated that she is allergic to other things, but they are antibiotics. The outcome of event was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk, Menstruation irregular
Clinical narrative: one woman has been breastfeeding; early menses after receiving the vaccine; This is a spontaneous report from a Pfizer sponsored program, from a contactable consumer. This consumer reported information for both mother and baby. This is the maternal report.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. Medical history included "has not had a period since 2019". The patient's concomitant medications were not reported. The patient had early menses after receiving the vaccine. She has been breastfeeding. Outcome of the event "early menses after receiving the vaccine" was unknown.  Information on lot number/batch number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: no longer has periods due to hormone therapy got a period a few days after receiving the vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included that patient had no longer has periods due to hormone therapy since an unknown date and unknow if ongoing.  The patient's concomitant medications were not reported. This patient has no longer has periods due to hormone therapy got a period a few days after receiving the vaccine on an unknown date. The outcome of the event "no longer has periods due to hormone therapy got a period a few days after receiving the vaccine" was unknown.   Information on the lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lethargy, Pain, Pyrexia
Clinical narrative: Chills; Fever; very lethargic; a lot of aches and pains; Exhaustion; This is a spontaneous report from a contactable consumer (patient's wife). A 75-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EL1283, expiration date: Apr2021), intramuscularly on the right arm (also reported as upper right arm) on 11Jan2021 at 10:15 at a single dose for COVID-19 immunization administered at the hospital (medical center). The patient had no medical history. There were no concomitant medications. The patient had no history of previous immunization with the Pfizer vaccine. The patient had no prior vaccinations within 4 weeks. He had no adverse events following prior vaccinations. He had never had a flu shot. The patient had the shot on Monday, 11Jan2021 and that early evening, he got chills, fever, and since then he had been very lethargic and had a lot of aches and pain and exhaustion. He had difficulty getting up in the morning. He just felt exhausted. She had him go have a Covid test on 12Jan2021 in the late afternoon to make sure he did not have Covid; he took the test that was a 98% accurate Covid test, and it was negative. The reporter was asking if that was a common reaction or if the patient had some type of virus. The reporter was asking if the patient should get the second shot. The patient experienced the chills at night, the day he received the vaccine and by the next morning they were gone. The reporter stated that the patient was still exhausted and lethargic. He was normally a very active person and now he was down and out. The events did not require a visit to the emergency room or the physician office. The patient did not receive any treatment for the events. The patient recovered from the events "chills and fever" on 12Jan2021. The patient was not recovered from the events "very lethargic, a lot of aches and pains, and exhaustion."
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Chills; Fever; very lethargic; a lot of aches and pains; Exhaustion; This is a spontaneous report from a contactable consumer (patient's wife). A 75-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EL1283, expiration date: Apr2021), intramuscularly on the right arm (also reported as upper right arm) on 11Jan2021 at 10:15 at a single dose for COVID-19 immunization administered at the hospital (medical center). The patient had no medical history. There were no concomitant medications. The patient had no history of previous immunization with the Pfizer vaccine. The patient had no prior vaccinations within 4 weeks. He had no adverse events following prior vaccinations. He had never had a flu shot. The patient had the shot on Monday, 11Jan2021 and that early evening, he got chills, fever, and since then he had been very lethargic and had a lot of aches and pain and exhaustion. He had difficulty getting up in the morning. He just felt exhausted. She had him go have a Covid test on 12Jan2021 in the late afternoon to make sure he did not have Covid; he took the test that was a 98% accurate Covid test, and it was negative. The reporter was asking if that was a common reaction or if the patient had some type of virus. The reporter was asking if the patient should get the second shot. The patient experienced the chills at night, the day he received the vaccine and by the next morning they were gone. The reporter stated that the patient was still exhausted and lethargic. He was normally a very active person and now he was down and out. The events did not require a visit to the emergency room or the physician office. The patient did not receive any treatment for the events. The patient recovered from the events "chills and fever" on 12Jan2021. The patient was not recovered from the events "very lethargic, a lot of aches and pains, and exhaustion."
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Neuralgia
Clinical narrative: Lower extremity joint pain; Nerve pain; Fatigue; This is a spontaneous report from a contactable Pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) 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. On an unspecified date, the patient experienced lower extremity joint pain and nerve pain along with fatigue after receiving the Pfizer/BioNTech vaccine. Symptoms started at 3 am, the morning after the vaccine was administered and persisted until 5 pm that day. Outcome of the events was unknown.  No follow-up attempts are possible. Information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Soreness in arm; Body aches; This is a spontaneous report received from a contactable (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced soreness in arm and body aches on 15Jan2021. The patient wanted to know if she can take Tylenol or ibuprofen. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Pain
Clinical narrative: body aches; muscle pain; joint pain; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received his first dose of bnt162b2 (BNT162B2 also reported as Covid-19 Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 14Jan2021 at single dose, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced body aches, muscle pain, joint pain and headache on Jan2021. The outcome of events was unknown.    Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Somnolence
Clinical narrative: Has been a little sleepy; Swollen stomach; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that her husband (patient) seems fine but has been a little sleepy and has a swollen stomach on an unspecified date. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: injection site pain to right arm; Chills; Headache; light fever; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELL742) on his right arm, via an unspecified route of administration on 14Jan2021 07:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got injection site pain to right arm, chills, headache and a light fever; all on 14Jan2021 19:00. It was also stated that the injection site pain was severe and is now less. Also reported that the patient recovered from the chills during the night completely. The patient took a couple of aspirin last night and will take some more this morning as treatment. The outcome of the event chills was recovered on 14Jan2021, not recovered for event light fever while recovering for the remaining events.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slightly sore arm where the needle went in; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the arm on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer COVID vaccine 8 days ago and had no side effects other than a slightly sore arm where the needle went in on 07Jan2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Throat irritation
Clinical narrative: experiencing a scratchy throat; runny nose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 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's husband stated that his wife (patient) experiencing a scratchy throat and runny nose after the first dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Her arm killed her and was painful for two days, she could barely move her arm; Her arm killed her and was painful for two days, she could barely move her arm; She also experienced numbness in her face, jaw, cheeks, mouth that lasted for about 3 hours; She also experienced numbness in her face, jaw, cheeks, mouth that lasted for about 3 hours; This is a spontaneous report from a contactable nurse. A 51-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK5730), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included ongoing asthma for approximately 25 years ago. There were no concomitant medications. After she took the first dose, on an unknown date, her arm killed her and was painful for two days, she could barely move her arm. She also had numbness in her mouth, face, jaws, and cheeks that lasted about 3 hours. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: tired; achy; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), 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 received the vaccine two weeks ago on an unspecified date. On an unspecified date, he was achy and tired and was wondering if this was normal. The outcome of the events pain and fatigue was unknown.   Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: dark coloration in urine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included unspecified drugs. The patient got the 1st dose of Covid 19 Vaccine yesterday and experienced side effects on 17Jan2021). The patient reported dark coloration in urine, but it's not blood and it's like dark coffee color or dark rust in color, slightly red, but the next morning it's gone. The patient was worrying and wanted to know more information. She also added, maybe it's just in the other medication that she is taking. The patient recovered from the event on 18Jan2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable other HCP via the Pfizer sponsored program. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 04Jan2021 to 04Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient got her 1st dose of the Covid-19 vaccine dated 04Jan2021. She has a scheduled 2nd dose for the said vaccine this coming Saturday however, she suddenly got shingles and asking if she still can get the second dose. Outcome of the event was unknown.   Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: really sick; shortness of breath; fever; diarrhea; hot and cold chills; headache; really tired; she can't talk very long nor walk very long; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (Patient's mother). A female patient (daughter) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. Medical history included Covid in Aug2020. The patient's concomitant medications were not reported. Consumer and daughter got their 1st dose of Covid-19 vaccine. Daughter was really sick, it seems like she got it all over again. Because they got covid back in August. Patient was experiencing a lot, shortness of breath, fever, diarrhea, hot and cold chills, headache, really tired, she can't talk very long nor walk very long. The event outcome was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Pyrexia
Clinical narrative: really sick; shortness of breath; fever; diarrhea; hot and cold chills; headache; really tired; she can't talk very long nor walk very long; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (Patient's mother). A female patient (daughter) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. Medical history included Covid in Aug2020. The patient's concomitant medications were not reported. Consumer and daughter got their 1st dose of Covid-19 vaccine. Daughter was really sick, it seems like she got it all over again. Because they got covid back in August. Patient was experiencing a lot, shortness of breath, fever, diarrhea, hot and cold chills, headache, really tired, she can't talk very long nor walk very long. The event outcome was unknown.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: feeling tired; This is a spontaneous report from a contactable consumer via a Pfizer sales representative. An 8-decade-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 for COVID-19 immunization. On an unspecified date, the patient experienced feeling tired after receiving the second vaccination which did not last long, maybe half a day. It was reported that the patient was not tired after the first vaccination. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: feeling tired; This is a spontaneous report from a contactable consumer via a Pfizer sales representative. An 8-decade-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 for COVID-19 immunization. On an unspecified date, the patient experienced feeling tired after receiving the second vaccination which did not last long, maybe half a day. It was reported that the patient was not tired after the first vaccination. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site pain
Clinical narrative: Administered 1st dose on the Tricep Area; Experienced soreness in the tricep area; This is a spontaneous report from a contactable consumer, reporting for the spouse, from a Pfizer-sponsored program.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the triceps area on an unknown date as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient received the vaccine in the triceps area instead of the deltoid. The patient experienced soreness in the triceps area. The clinical outcome of soreness in the triceps area was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Body aches, nausea, chills, headache, and fatigue; Body aches, nausea, chills, headache, and fatigue; Body aches, nausea, chills, headache, and fatigue; Body aches, nausea, chills, headache, and fatigue; Body aches, nausea, chills, headache, and fatigue; This is a spontaneous report from a non-contactable other health care professional. A 26-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose via an unspecified route of administration on an unspecified date at SINGLE DOSE; then second dose (lot number: El1243) via intramuscular on 12Jan2021 14:30 at SINGLE DOSE on arm right for COVID-19 immunization. Medical history included allergy: Ni, covid-19 on an unspecified date.  The patient's concomitant medications were not reported. On 13Jan2021 05:15, the patient experienced Body aches, nausea, chills, headache, and fatigue. The patient did not receive treatment for the events. The outcome of the events was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nasal congestion, Pyrexia
Clinical narrative: fevers; congestion/stuffiness; This is a spontaneous report from contactable consumer (patient). This consumer reported similar events for two patients. This report is for the first of two patients.   A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medication included metoprolol for high blood pressure. The patient experienced fevers and congestion/stuffiness on 15Jan2021. Patient stated that she and her husband got the first shot of the COVID 19 vaccine on 09Jan2021. She began to run a fever today and has stuffiness. Patient wanted to know are these side effects of the vaccine and would these side effects start so many days after the vaccine. She was told that she can not get tested for COVID because she has had the vaccine. Patient is supposed to go back on the 30th for second shot. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046472 same reporter, drug, event, different patient
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Lip swelling, Nasal oedema, Urticaria
Clinical narrative: severe cough; left nostril swelling; generalized hives throughout abdomen and hips; lower lip swollen/upper lip on left side swelling; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 07Jan2021 at 13:00 at a single dose on the right arm for COVID-19 immunization. The patient's medical history included allergies to dust, pollen, and dog and cat dander. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on 17Dec2020 at 13:00 on the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 12Jan2021 at 21:00 (five days after second vaccine dose, for clarification), the patient had lower lip swollen. Second episode occurred (on an unspecified date) with severe cough, upper lip on left side swelling, left nostril swelling, and generalized hives throughout abdomen and hips. The patient took Benadryl for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: dizziness; muscle pain; headache; fatigue; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 14Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced dizziness, muscle pain, headache and fatigue on an unspecified date in Jan2021. Outcome of the events was unknown.   No follow-up attempts are possible. Information about batch/ lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: fever/fever of 101; very tired; This is a spontaneous report from a contactable nurse via the Pfizer-sponsored program. A male patient of an unspecified age received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was running a fever of 101 and very tired on 17Jan2021. The patient got Tylenol. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: fever of 99.4; feeling kind of rotten; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received bnt162b2 on 14Jan2021 10:00 am first dose intramuscularly on left arm at single dose for Covid-19 immunization. Vaccination Facility Type was Health Department. Vaccine Administered not at Military Facility. Medical history included ongoing Congestive heart failure diagnosed a few weeks ago and had covid in Apr2020. Concomitant medications were none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations: reaction with pneumonia vaccine, could not use his arm for a few days and they told him that was normal. She does not know the name of the vaccine she thinks it was the pneumococcal and does not have lot, ndc, or expiration. She is wondering if it is normal to not have side effects till two days after. She is calling for a male that is 90 years old and cannot hear very well. States he got the vaccine on Thursday (14Jan2021) and he has a fever of 99.4 degrees, she clarified this is one day later (15Jan2021), not two days later. He was feeling kind of rotten all day and he just realized about 30 minutes ago that he had a fever. He had covid in Apr2020. Doctor thinks he is a long hauler. He did not have heart trouble before covid and now he has congestive failure which was diagnosed a few weeks ago. Adverse events not require a visit to Emergency Room or Physician Office. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema
Clinical narrative: Right arm lymphedema; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date: unknown), intramuscular in the right arm, on 11Jan2021 13:00 at a single dose for covid-19 immunization. Medical history included migraines and penicillin allergy. Concomitant medication included rizatriptan. The patient took first dose of bnt162b2 (lot number: EL0140) on 23Dec2020 via intramuscular in the left arm for covid-19 immunization. The patient is not pregnant. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 12Jan2021, the patient experienced right arm lymphedema. Event was not treated. Outcome of the event was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: stated that she could not walk; This is a spontaneous report from a contactable physician. A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730 and expiry date: unknown), intramuscular on the left arm, on 28Dec2020 11:30 at a single dose for COVID-19 immunization.  Medical history two knee replacements one two years ago and one over 12 years ago; she had Bilateral knee replacements right in 2008 and left in 2018. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient previously took minocycline and experienced allergies. The patient stated that she could not walk on 09Jan2021 14:00. On 09Jan to 11Jan2021, she had problems walking and was unable to use the right leg which has not had any problems for 10 years. Never even after surgery have the patient been unable to walk . There was no pain or swelling, just unable to walk. This resolved without any treatment on 11Jan2020. Patient described it as a very scary situation and was afraid to get another vaccine if it was possible to get a more severe reaction since this lasted 3 days. She was supposed to get her second dose on Monday and wanted to know if she needed to get it.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported after the first one her arm was sore and then she took some ibuprofen. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report from contactable Nurse via Pfizer Sales Representative (family friend). A 4-decade (reported as in her 30s) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had first dose of BNT162B2 on an unspecified date for covid-19 immunization. On an unspecified date, it was reported that the patient's reaction was flu like symptoms for a couple days after her second dose. She says that it was likely more or different from the first dose since there was commentary made after second dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle spasms, Muscle twitching, Pain in extremity, Tendon pain
Clinical narrative: Leg pain; Back pain; Lips twitching; Achilles tendon pain in her left leg; back pain is almost like a spasm; This is a spontaneous report from a contactable other hcp (patient).  A 50-year-old female patient received BNT162B2 (lot number: EL1283), via an unspecified route of administration on 13Jan2021 12:04 at single dose for COVID prophylaxis. There were medical history and concomitant medications.  It was reported that the patient experienced leg pain, back pain and lips twitching after injection which occurred two days ago on 13Jan2021. Stated that leg pain is like Achilles tendon pain in her left leg and back pain is almost like a spasm. She doesn't know if this is an expected side effect. Second dose is scheduled 09Feb2021. She wants to know if she should proceed with that. The outcome of the event "lips twitching" was unknown wile for the other events was recovering. The reporter assessed the events to be related to the suspect vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) 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 had the COVID vaccine on Tuesday night (date unspecified) and experienced a headache on an unspecified date. Patient reported that within 5 minutes of receiving the vaccine, she took two Tylenol.  She would like to know if that lowers her immunity. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Headache, Injection site pain, Insomnia
Clinical narrative: Muscle pain; injection site pain; insomnia and could not sleep the whole night; had a little loss of balance; severe chills and the chills got worse; severe headache; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK9231), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (lot EL0140) on an unspecified date for COVID-19 immunization. Patient reported that he wants to give a follow up on the second vaccine. On 13Jan2021 21:00, the patient experienced severe chills and the chills got worse and he had a severe headache. On an unspecified date, the patient had muscle pain and injection site pain. He said that he had insomnia and could not sleep the whole night and he also had a little loss of balance. The patient does not know if he was running a fever or not. He said that he took Tylenol that night and rested the next day and took Tylenol the next day and he was fine now. Patient said that he did not work yesterday, but started working today and physically, he was feeling fine now. The symptoms were similar to the shingles vaccine, but the shingles vaccine symptoms were a little milder. Outcome of events was unknown.