chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vision blurred
Clinical narrative: About 20 hrs after second dose, I experienced low grade fever (100.4 degree f).; chills; fogginess; This is a spontaneous report from a contactable consumer.   A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: En6201) on 16Feb2021 at 16:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. The patient didn't have medical history. Concomitant drug included metformin and melatonin. The patient received first dose of BNT162B2 on 22Jan2021 at 04:00 pm on left arm. On 17Feb2021 at 13:00 about 20 hours after second dose, patient experienced low grade fever (100.4 degree f). The patient recovered from the events on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: if she pressed on the vaccine injection site, the vaccine injection site was slightly tender; This is a spontaneous report from a contactable consumer (patient herself).  This 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EL3247 with Expiration Date 31May2021), via intramuscular in the left upper arm, on 27Jan2021 15:00 (at the age of 74-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. No relevant medical history was provided. Relevant concomitant medications included levothyroxine. On 27Jan2021, the patient stated if she pressed on the vaccine injection site, the vaccine injection site was slightly tender. The patient had recovered from the event on 28Jan2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021183324 same patient, same product (second dose), different event
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: fever; joint pain; 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), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included gout and osteoarthritis. Concomitant medications included indomethacin [indometacin] and colchicine. The patient got the first dose of the covid vaccine and has developed fever, joint pain and headache. The patient has gout and osteoarthritis and she take indomethacin and colchicine however she has not taking those medications lately and she mentioned that she usually gets joint pain from her osteoarthritis. She went to her primary doctor and to the hospital and no one wanted to attend her since she has fever. She would like to know which medication she can take for her fever. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache
Clinical narrative: Chills but no fever; Headaches for one and a half weeks; Dizziness; This is a spontaneous report from a contactable consumer reported for herself.  A 94-year-old female consumer reported that received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on 06Feb2021 12:00 AM (at the age of 94-years-old) at single dose for COVID-19 immunization. medical history included Allergies to Penicillin. Concomitant drugs were unknown. On 08Feb2021 the patient had chills but no fever. Headaches for one and a half weeks and Dizziness. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Nausea
Clinical narrative: symptoms of nausea and lethargy; symptoms of nausea and lethargy; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. A 75 (unspecified unit) old male patient (husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient also received first dose of BNT162B2 on unspecified date (unknown lot number and expiration) for COVID-19 immunization. It was reported that the patient experienced symptoms of nausea and lethargy a week later in Jan2021. Outcome of the events was unknown. The events were assessed as non-serious.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: just a sore arm; This is a spontaneous report from a Pfizer sponsored program from a non-contactable consumer reported for a female patient (friend) A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. he patient medical history and concomitant medications were not reported. The patient experienced just a sore arm at the injection site on an unspecified date with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient reported that with the past flu shots that she has received she has experienced fever and body aches. The patient experienced a sore arm for around 5 hours a several hours after receiving the vaccine on 14Feb2021 with outcome of unknown.    Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Pyrexia
Clinical narrative: I had a fever; weird strange dream; This is a spontaneous report from a contactable consumer (patient).  A 82-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced fever with outcome of unknown , weird strange dream with outcome of unknown.    Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: experienced pain in his shoulder; This is a spontaneous report from a contactable consumer (patient himself). A male patient of unspecified age (reported as 'Age:68; Unit: Unknown') received received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. Medical history included injury unrelated to the COVID-19 vaccine. The patient's concomitant medications were not reported. The patient stated he only experienced pain in his shoulder on an unspecified date. He had several injuries unrelated to the COVID-19 vaccine and wanted to know how long he had to wait to take a pain pill for his other injuries. Outcome of the event was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: gradually being short of breath/ huffing and puffing; This is a spontaneous report from a non-contactable consumer (patient's wife). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. About 8 days after the first dose in Jan2021, the patient started noticing gradually being short of breath. He would walk for 50 yards and he would be huffing and puffing which is unusual because he can walk a lot.  It gradually got worse. Outcome of the event was not recovered. Patient received his second dose on 10Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pain
Clinical narrative: It's just a discomfort; pain; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer (patient herself) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated she was due to receive the second dose on 25Feb2021. She wanted to go to the orthopedic doctor to discuss an underlying medical condition. She wanted to know in case she was to receive cortisone shot, if it would it impact the efficacy of the vaccine. She stated "I am going hold off going to the doctor. It's doesn't bother me as much. It's just a discomfort. I am not in excruciating pain. I will wait and take Tylenol for the pain. However I won't take Tylenol right before my shot." The events occurred on an unspecified date with outcome of unknown.  Follow-up attempts are completed. No further information is expected. Information about the batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Affected my Menstrual cycle. Got my period 2 weeks early.; This is a spontaneous report from a non-contactable other healthcare professional.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9265) via intramuscular, administered in right arm, on an unspecified date, as 2nd dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. Historical vaccine included 1st dose of COVID-19 vaccine on unspecified date. The patient had no COVID prior vaccination and she was not tested for COVID post vaccination. The patient was not pregnant at the time of report. It was reported that the patient's menstrual cycle was affected on unspecified date and got her period 2 weeks early.   No follow-up attempts are possible. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: involuntary muscle twitching on the arm right after the 1st dose taken on 23Jan2021; This is a spontaneous report received from a contactable consumer (patient). A male patient with age reported as 39 (unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via unspecified route of administration in right arm on 23Jan2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient mentioned that he received both doses of the Pfizer COVID vaccine. He experienced muscle twitching on the arm right after the 1st dose taken on 23Jan2021. He was asking if that was reported as a common side effect. He was also asking if Amyotrophic Lateral Sclerosis (ALS) was a contraindication to vaccination or if it was reported to be a comorbidity in the clinical trials. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: after his dose he had a warm/burning sensation at the injection site; after his dose he had a warm/burning sensation at the injection site; This is a spontaneous report from a contactable consumer who reported on behalf of her husband. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration in his left arm on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. About 1 to 2 hours after his dose, he had a warm/burning sensation at the injection site, which resolved on an unspecified date. Reporter was curious as to why the nurse told patient the vaccine goes in his left arm, even though he was left handed. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test, X-ray
Clinical narrative: I developed a dry cough 3 days after getting the 2nd dose of Pfizer vaccine; This is a spontaneous report from a contactable consumer(patient).  A 59-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, in left arm on 08Jan2021 (at 59 years) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had previous known allergy to flurbuprophen. Previously on 18Dec2020 at 14:45 (at 59 years) the patient took the first dose of the vaccine in left arm for covid-19 immunization. On 11Jan2021, 3 days after getting the 2nd dose of the vaccine, the patient developed a dry cough.The event required doctor or other healthcare professional office/clinic visit. Patient was tested negative for Covid (via Nasal Swab) on 05Feb2021; X-ray in Feb2021 was negative for pneumonia. Patient had a course of antibiotics, a corticosteroid and cough medicines. As of 23Feb2021 patient still had the cough. The final outcome of the event was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: eyes were blood red; This is a spontaneous report received from a contactable consumer (patient). A female patient with age reported as 77 (unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on 22Feb2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient received the first dose of the vaccine the day before the present report (22Feb2021) in the afternoon. The day of this report (23Feb2021), she noticed her eyes were blood red. She also asked if there were any reports of eyes being blood red. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: tired and not feeling like herself; tired and not feeling like herself; This is a spontaneous report from a Non-contactable consumer.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 23Feb2021 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 23Feb2021 the patient experienced tired and not feeling like herself. At the time of the reporting events outcome was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Swelling
Clinical narrative: I started feeling some excruciating pain in my neck; it is a little bit swollen; This is a spontaneous report from a contactable consumer (patient).  A 77-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient stated that had first shot on the 16th of the month and was supposed to go back for second shot on the 16th (as reported), it was supposed to go this afternoon. Today (as reported) the patient started feeling some excruciating pain in neck, she had been taking things (as reported)  and now it's changed a little and it's the back of my neck. The patient done heat and ice because it was a little bit swollen, coming from the vaccine 3 weeks after getting vaccine. Outcome of the event neck pain was recovering while outcome of the event neck swelling was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Erythema, Feeling hot, Flushing, Hypersensitivity
Clinical narrative: allergic reaction; face was flushed.warm; face was flushed,warm; swelling; ears were red and hot; ears were red and hot; felt a bit off; This is a spontaneous report from a non-contactable Consumer.  A 72-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 72) on 20Feb2021 10:45 as single dose for covid-19 immunisation. Medical history included Follicular Non-Hodgins lymphoma, sleep apnoea syndrome, coronary artery disease, drug hypersensitivity to sulfur and penicillin, iodine contrast dye allergy. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient experienced allergic reaction on 20Feb2021 10:45, face was flushed.warm  on 20Feb2021 10:45, swelling on 20Feb2021 10:45, ears were red and hot on 20Feb2021 10:45, felt a bit off on 20Feb2021 10:45. No treatment received. The events outcome was recovered ('by 11PM most of this resolved' as reported).    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Swelling
Clinical narrative: allergic reaction; face was flushed.warm; face was flushed,warm; swelling; ears were red and hot; ears were red and hot; felt a bit off; This is a spontaneous report from a non-contactable Consumer.  A 72-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 72) on 20Feb2021 10:45 as single dose for covid-19 immunisation. Medical history included Follicular Non-Hodgins lymphoma, sleep apnoea syndrome, coronary artery disease, drug hypersensitivity to sulfur and penicillin, iodine contrast dye allergy. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient experienced allergic reaction on 20Feb2021 10:45, face was flushed.warm  on 20Feb2021 10:45, swelling on 20Feb2021 10:45, ears were red and hot on 20Feb2021 10:45, felt a bit off on 20Feb2021 10:45. No treatment received. The events outcome was recovered ('by 11PM most of this resolved' as reported).    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a little soreness to his arm where he had the injection; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Feb2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient had his first shot and was scheduled for his second dose on 15Mar2021. The patient experienced a little soreness to his arm where he had the injection. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Headache; fever; aches; sleepiness; brain fog; flu-like symptoms (Just like Covid that I had); This is a spontaneous report from a contactable consumer (patient).   A 62-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right (at the age of 62) on 22Feb2021 10:00 (Lot Number: EL9267) as single dose for covid-19 immunisation. The patient medical history included covid prior to vaccination. No known allergies. Concomitant medications included imipramine, propranolol. The patient experienced headache on 22Feb2021 14:00, fever on 22Feb2021 14:00, aches on 22Feb2021 14:00, sleepiness on 22Feb2021 14:00, brain fog on 22Feb2021 14:00, flu-like symptoms on 22Feb2021 14:00. No treatment received. No covid tested post vaccination. The events outcome was recovering.     No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Headache; fever; aches; sleepiness; brain fog; flu-like symptoms (Just like Covid that I had); This is a spontaneous report from a contactable consumer (patient).   A 62-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right (at the age of 62) on 22Feb2021 10:00 (Lot Number: EL9267) as single dose for covid-19 immunisation. The patient medical history included covid prior to vaccination. No known allergies. Concomitant medications included imipramine, propranolol. The patient experienced headache on 22Feb2021 14:00, fever on 22Feb2021 14:00, aches on 22Feb2021 14:00, sleepiness on 22Feb2021 14:00, brain fog on 22Feb2021 14:00, flu-like symptoms on 22Feb2021 14:00. No treatment received. No covid tested post vaccination. The events outcome was recovering.     No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (Patient).   A 65-year old male consumer patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified headache the patient experienced. At the time of the reporting outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; fever; This is a spontaneous report from a non-contactable consumer (patient) by a a Pfizer sponsored program COVAX US Support.  A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills and fever following first dose in Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive in Dec2020. 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: Laryngitis
Clinical narrative: Caller reports that her mom also has laryngitis, but no fever; This is a spontaneous report from a contactable consumer (daughter).  A 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced caller reports that her mom also has laryngitis, but no fever on an unspecified date. The  outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Disease recurrence, Headache, Malaise, Pain in extremity
Clinical narrative: running a temperature; headache; arm was swollen; arm was swollen; arm was swollen and very sore; Not feeling well; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 73 years old, administered in arm left on 22Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient stated she hasn't taken anything before or after the vaccine and was not on any medication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via an unspecified route of administration at the age of 73 years old, on 18Jan2021 as single dose for covid-19 immunisation and had arm was swollen. The patient received the second dose on 22Feb2021 and she was not feeling well left on 22Feb2021. Her arm was swollen and very sore, she was running a temperature and each time that she took it is going up, she also had a headache. The patient said that her arm was swollen after the first dose too. She did not know what to do with herself. She said that she wanted directions on what she should do, is there anything that she can take to bring her temperature down. The patient said that her arm started getting sore last evening, on 22Feb2021. She massaged it and iced it. She had swelling this morning on 23Feb2021. This happened the last time, but she did not run a fever last time. The patient said that her temperature was 98.5, then 98.7, then 100.2. She woke up on 23Feb2021 with the temperature and the headache. She stated that the writing after the 6 in the lot number was not clear and was scribbled on the card. The patient provided the second dose Lot as EN6 and the rest was unclear. The outcome of the event not feeling well was not recovered, of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: running a temperature; headache; arm was swollen; arm was swollen; arm was swollen and very sore; Not feeling well; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 73 years old, administered in arm left on 22Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient stated she hasn't taken anything before or after the vaccine and was not on any medication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via an unspecified route of administration at the age of 73 years old, on 18Jan2021 as single dose for covid-19 immunisation and had arm was swollen. The patient received the second dose on 22Feb2021 and she was not feeling well left on 22Feb2021. Her arm was swollen and very sore, she was running a temperature and each time that she took it is going up, she also had a headache. The patient said that her arm was swollen after the first dose too. She did not know what to do with herself. She said that she wanted directions on what she should do, is there anything that she can take to bring her temperature down. The patient said that her arm started getting sore last evening, on 22Feb2021. She massaged it and iced it. She had swelling this morning on 23Feb2021. This happened the last time, but she did not run a fever last time. The patient said that her temperature was 98.5, then 98.7, then 100.2. She woke up on 23Feb2021 with the temperature and the headache. She stated that the writing after the 6 in the lot number was not clear and was scribbled on the card. The patient provided the second dose Lot as EN6 and the rest was unclear. The outcome of the event not feeling well was not recovered, of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Laryngitis, Malaise, SARS-CoV-2 antibody test
Clinical narrative: malaise; chills; discomfort under armpit; laryngitis; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date in Feb2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was tested positive for COVID on 18Dec2020. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Pyrexia
Clinical narrative: fever; nausea; get sick after it; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.   The patient medical history was not reported.  The patient's concomitant medications were not reported.   The patient experienced fever on an unspecified date with outcome of unknown, nausea  on an unspecified date with outcome of unknown , get sick after it (illness) on an unspecified date with outcome of unknown.    Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Headache, Nausea
Clinical narrative: Queasiness; headache; dizziness; Queasiness, headache, dizziness. Which keeps progressing; This is a spontaneous report from a contactable consumer, the patient. A 67-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EN6200) via an unspecified route of administration in left arm on 14Feb2021 at 12:00 PM as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not take any other medications in two weeks. Patient did not receive any other vaccine within 4 weeks. Patient neither diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 after the vaccination. On 14Feb2021 at 13:15, the patient experienced queasiness, headache and dizziness which kept progressing. Patient did not receive any treatment. Outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Nausea
Clinical narrative: Symptoms of full-body chills; swelling of lymph nodes; headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received second dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number not reported) (non-pregnant at the time of vaccination) via intramuscular route of administration on 23Feb2021 15:15 in arm left as single dose for COVID-19 immunisation. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included hypertension. Concomitant medication included escitalopram, alprazolam, amlodipine taken for an unspecified indication. Historical vaccine included first dose of BNT162B2 on 03Feb2021 in the right arm at single dose for COVID-19 immunisation. No COVID prior vaccination. The patient was not tested for COVID post vaccination. On 24Feb2021 04:00, the patient experienced full-body chills, swelling of lymph nodes, headache and nausea. Outcome of the events were not recovered.  Follow-up attempts are completed. No further information was expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable consumer (patient's sister). A 67-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 19Feb2021 at 67 years, as single dose, for COVID-19 immunisation. Patient was not pregnant and was not pregnant at time of vaccination. The patient's medical history and concomitant medications were not reported. The patient has not been diagnosed with COVID-19 prior to vaccination. Patient did not have known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced sore arm (non-serious) on 19Feb2021 with outcome of recovered. No therapeutic measures were taken. Patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I have developed deep red, almost purple hives on both sides of my buttock.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient (67 years age at vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9269, Expiration date not reported), via an unspecified route of administration, in right arm on 29Jan2021 at 14:45 as single dose for covid-19 immunisation. It was reported that the patient received her second dose of BNT162B2 (Lot/Batch Number: EN6198) on 23Feb2021 at 14:45 in right arm. The patient's medical history included multiple sclerosis from an unknown date and unknown if ongoing. She was not diagnosed with covid-19 prior to vaccination nor was diagnosed post vaccination. She was unaware of any known allergies. Her concomitant medication(s) included dimethyl fumarate (TECFIDERA), tramadol hydrochloride (TRAMADOL), atorvastatin (ATORVASTATIN), losartan (LOSARTAN) and methylphenidate hydrochloride (RITALIN) taken for unspecified indication two weeks at the time of report. The patient developed deep red, almost purple hives on both sides of her buttock on 03Feb2021.She went to an urgent care and as treatment medication, she was put on Benadryl and Prednisone pack (unspecified formulation and dosage regimen) for 6 days. The outcome of the event was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: diarrhea; Tired; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 78-Year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EM9809), via an unspecified route of administration on 25Feb2021 in left arm as 1st dose, single for COVID-19 immunization. Medical history included allergic to soy and dairy products, allergic to naproxen, diabetes, high blood pressure, supplementation therapy. Patient previously took and statins and developed joint pain. Concomitant medications included metformin 500mg 2 tablets in the morning and 1 tablet at night for diabetes, lisinopril 20mg twice a day by mouth for high blood pressure, vitamin d3 at 50mcg once a day by mouth as supplementation therapy. It was reported that metformin, ER > She said that she thinks she is over medicated. No further details provided. Vitamin D3, extra strength. stated that they put white writing on a white label. 31Jan2022, Lot 20123519, natures way. Patient was calling about the Covid-19 vaccine. She said that she had a reaction she believes. She said that she had the shot between 10-1030 today (25Feb2021) and left the facility and was home by about 1130 and all of a sudden she had a overwhelming diarrhea attack with no warning or anything. She did not eat anything to cause it. She said that she is afraid to take the next shot. She said that she had allergies to Statins and Naproxen and they make her throw up. Patient clarified that Statins gave her joint pain, but she does not remember what the drug names are. There was another drug that she got muscle cramps and joint pain, but she was unable to provide that information. She can not take Zetia and had a reaction. She said that she always throws up from pain killers. Patient had no NDC, lot, or expiration date for any of the above mentioned medications. It was samples that the doctors gave her. She said that some of them made her joints locked up and the others caused muscles cramps. No further details provided. She said that she was tired and did not sleep last night. Patient said that she shrunk. Patient said that it was just one episode of diarrhea at this time. She said that she was also very tired. She was tired for about a hour and it went away,. She is still a little tired, not the overwhelming tiredness she had earlier. She said that she was doing a puzzle and could not even focus on it. She had to lay her head down on the table to rest. She said that there was a little bit of pain when they stuck the needle in her arm, but no pain since. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: fairly ill; This is a spontaneous report from a non-contactable consumer. An adult patient of an unspecified gender received the 2nd dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The day after vaccination the patient felt fairly ill (non-serious) with outcome of recovered. It was unknown if therapeutic measures were taken.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: VERY tired the next day; This is a spontaneous report from a non-contactable consumer (patient).  A 68-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5318), via an unspecified route of administration, in Right Arm on 06Feb2021 at 16:00 (at 68 years) at single dose for covid-19 immunisation. Medical history included Stage 4 polycystic kidney disease (PKD), osteoporosis, hypothyroidism, breast cancer survivor.  Patient had no covid prior vaccination and was not covid tested post vaccination. Known allergies to erythromycin. Patient received other unspecified medication in two weeks. On 07Feb2021 the patient was very tired. No treatment given and patient recovered on an unspecified date in Feb2021.No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue, Headache, Hyperhidrosis
Clinical narrative: fatigue; mild headache; elevated temperature; sweating concurrently with temperature; very sore arm; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date patient experienced fatigue, mild headache, elevated temperature, sweating concurrently with temperature, very sore arm. It was reported that in the evening after receiving the vaccine, patient reported fatigue, mild headache, and elevated temperature (patient reported sweating concurrently with temperature). The morning after receiving the vaccine, patient reported very sore arm. Outcome of the events was unknown.  The batch/lot number for the vaccine, BNT162B2, is not available despite the follow-up attempts made.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: fatigue; mild headache; elevated temperature; sweating concurrently with temperature; very sore arm; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date patient experienced fatigue, mild headache, elevated temperature, sweating concurrently with temperature, very sore arm. It was reported that in the evening after receiving the vaccine, patient reported fatigue, mild headache, and elevated temperature (patient reported sweating concurrently with temperature). The morning after receiving the vaccine, patient reported very sore arm. Outcome of the events was unknown.  The batch/lot number for the vaccine, BNT162B2, is not available despite the follow-up attempts made.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report from a non-contactable consumer.   A 96-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient was consistently tired. The outcome of the event was unknown.  No follow up attempts are possible. Information about lot/batch number could not be requested.  No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Heavy menstrual bleeding, Menstrual disorder, Oropharyngeal pain
Clinical narrative: I got my period the day after the shot, only 2 weeks after the last one, which is very unusual for me; Bleeding much more heavily than normal; Severe joint pain; achiness; Headache; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 24Feb2021 at 15:30 (reported at 03:30 PM) (at the age of 46 years old) as first dose, single for COVID-19 immunisation in a hospital. Patient has known allergies to Penicillin, sulfa drugs, and mangoes, all from an unknown date.  Patient was not pregnant at the time of vaccination and prior to vaccine the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), naproxen sodium (ALEVE), montelukast sodium (SINGULAIR), loratadine (CLARITIN [LORATADINE]), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in 4 weeks. On 26Feb2021 at 00:00, patient experienced to have her period the day after the shot, only 2 weeks after the last one, which was very unusual for the patient. The patient also reported that she was bleeding much more heavily than normal. The patient had severe joint pain and achiness, a headache and a sore throat, which she saw on the list of possible side effects. No treatment was received for the adverse event. After vaccination, the patient has not been tested for COVID-19. Outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I got my period the day after the shot, only 2 weeks after the last one, which is very unusual for me; Bleeding much more heavily than normal; Severe joint pain; achiness; Headache; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 24Feb2021 at 15:30 (reported at 03:30 PM) (at the age of 46 years old) as first dose, single for COVID-19 immunisation in a hospital. Patient has known allergies to Penicillin, sulfa drugs, and mangoes, all from an unknown date.  Patient was not pregnant at the time of vaccination and prior to vaccine the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), naproxen sodium (ALEVE), montelukast sodium (SINGULAIR), loratadine (CLARITIN [LORATADINE]), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in 4 weeks. On 26Feb2021 at 00:00, patient experienced to have her period the day after the shot, only 2 weeks after the last one, which was very unusual for the patient. The patient also reported that she was bleeding much more heavily than normal. The patient had severe joint pain and achiness, a headache and a sore throat, which she saw on the list of possible side effects. No treatment was received for the adverse event. After vaccination, the patient has not been tested for COVID-19. Outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.