chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Caller states all of them, have a low temperature of 97.2; Vomiting; diarrhea heavily; it was bile and tasted like medicine, very bile tasting; she was feeling strange/she had that awful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 95 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 (Lot number: EN6073) at the age of 95 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing), notes: drops in both eyes twice a day; "gone down from 140 lbs to 90 lbs" (unspecified if ongoing), notes: it was all before and she had some other problems; "height has gone down from 5 feet 4 inches to about 5 feet 2 inches" (unspecified if ongoing); "she does have a small esophagus" (unspecified if ongoing); "one of the lungs has a little problem breathing" (unspecified if ongoing); "one of the lungs has a little problem breathing" (unspecified if ongoing), notes: breathe into the lungs and she does it for 5-6 minutes twice a day.; "she has nothing but bones with skin stretched over" (unspecified if ongoing); "she has nothing but bones with skin stretched over" (unspecified if ongoing), notes: pinch the skin and he put the covid in that; "She lost so much of her fat and muscle" (unspecified if ongoing); "She lost so much of her fat and muscle" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 15Mar2021, outcome "unknown", described as "she was feeling strange/she had that awful"; VOMITING (non-serious) with onset 16Mar2021, outcome "recovered" (16Mar2021), described as "Vomiting"; DIARRHOEA (non-serious) with onset 16Mar2021, outcome "recovered" (16Mar2021), described as "diarrhea heavily"; TASTE DISORDER (non-serious) with onset 16Mar2021, outcome "recovered", described as "it was bile and tasted like medicine, very bile tasting"; BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "Caller states all of them, have a low temperature of 97.2". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, diarrhoea.   Additional information: The concomitant medication included drops for eyes for glaucoma in both eyes twice a day.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: fatigue; headache; chills; This is a spontaneous report received from a contactable reporter (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 31Mar2021, outcome "unknown", described as "fatigue"; HEADACHE (non-serious) with onset 31Mar2021, outcome "unknown", described as "headache"; CHILLS (non-serious) with onset 31Mar2021, outcome "unknown", described as "chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Dizziness, Headache, Lymphadenopathy, Peripheral swelling
Clinical narrative: lightheaded; mild headache; right armpit swelling, hurting, feels like the little glands in there are swollen; right armpit swelling, hurting, feels like the little glands in there are swollen; right arm was affected; tender, not like crazy but just like sore, could feel like bumps in there on the right side; right arm was affected; tender, not like crazy but just like sore, could feel like bumps in there on the right side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "lightheaded"; HEADACHE (non-serious), outcome "unknown", described as "mild headache"; LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious), outcome "unknown" and all described as "right armpit swelling, hurting, feels like the little glands in there are swollen"; TENDERNESS (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "right arm was affected; tender, not like crazy but just like sore, could feel like bumps in there on the right side".  Additional information: Caller reported he called about the vaccination; everything is pretty much fine. He got the vaccination yesterday, first shot, and he was a little bit lightheaded, got a mild headache. He noticed before he went to bed his right armpit swelling, hurting, feels like the little glands in there are swollen. Like reading online they were saying that the arm that the shot went in, but for him it was the opposite, actually, his shot was in the left arm, but his right arm was affected; tender, not like crazy but just like sore, could feel like bumps in there on the right side. He asked is this normal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: lightheaded; mild headache; right armpit swelling, hurting, feels like the little glands in there are swollen; right armpit swelling, hurting, feels like the little glands in there are swollen; right arm was affected; tender, not like crazy but just like sore, could feel like bumps in there on the right side; right arm was affected; tender, not like crazy but just like sore, could feel like bumps in there on the right side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "lightheaded"; HEADACHE (non-serious), outcome "unknown", described as "mild headache"; LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious), outcome "unknown" and all described as "right armpit swelling, hurting, feels like the little glands in there are swollen"; TENDERNESS (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "right arm was affected; tender, not like crazy but just like sore, could feel like bumps in there on the right side".  Additional information: Caller reported he called about the vaccination; everything is pretty much fine. He got the vaccination yesterday, first shot, and he was a little bit lightheaded, got a mild headache. He noticed before he went to bed his right armpit swelling, hurting, feels like the little glands in there are swollen. Like reading online they were saying that the arm that the shot went in, but for him it was the opposite, actually, his shot was in the left arm, but his right arm was affected; tender, not like crazy but just like sore, could feel like bumps in there on the right side. He asked is this normal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Nausea, Vaccination site pain
Clinical narrative: After 3 days, experienced nausea, fatigue and migraine; After 3 days, experienced nausea, fatigue and migraine; After 3 days, experienced nausea, fatigue and migraine; After vaccination, experienced arm pain that felt like it was ran over by a bulldozer; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Mar2021 (Lot number: ER8733) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "After vaccination, experienced arm pain that felt like it was ran over by a bulldozer"; NAUSEA (non-serious), FATIGUE (non-serious), MIGRAINE (non-serious) all with onset 30Mar2021, outcome "unknown" and all described as "After 3 days, experienced nausea, fatigue and migraine".  Additional information: The events were reported to patient by friend (withheld) (consumer) who personally sent a message in Facebook messenger. The patient recently was vaccinated with BNT162B2.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I just didn't want to lay on my arm/It was sore; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "I just didn't want to lay on my arm/It was sore". It went away in about 2 days.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Pfizer 1st Shot gave me loud Tinnitus and hasn't stopped. I know 2 other people personally that have this same side effect; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (005570).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "Pfizer 1st Shot gave me loud Tinnitus and hasn't stopped. I know 2 other people personally that have this same side effect".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Patient knew 2 other people personally that had this same side effect and they never had COVID ever. This is really scary stuff. Since day 2 of shot which patient got on (withheld) Day 17Mar2021. Patient was on Day 13 of this new hell with no end in site.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366081 Same reporter/drug/AE, different patient;US-PFIZER INC-2021359745 Same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Language disorder, Malaise, Mobility decreased, Pollakiuria
Clinical narrative: had some confusion, and was speaking  (which she normally spoke to me in); frequent urination 2-3 weeks; Did not feel well for a few days; Did not want to get out of bed for a few days; Was speaking a different language; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An elderly female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONFUSIONAL STATE (non-serious), outcome "unknown", described as "had some confusion, and was speaking English to me instead of French (which she normally spoke to me in)"; POLLAKIURIA (non-serious), outcome "unknown", described as "frequent urination 2-3 weeks"; MALAISE (non-serious), outcome "unknown", described as "Did not feel well for a few days"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "Did not want to get out of bed for a few days"; LANGUAGE DISORDER (non-serious), outcome "unknown", described as "Was speaking a different language".  Additional Information: The reporter (daughter of the patient) stated that her mother also had severe pain in her back and leg after second vaccine dose. Reporter wanted to know if this is a neuro response to Pfizer vaccine. Reporter called the pharmacist to review the Pfizer vaccine ingredients and she was looking specifically for beef and anything that comes from a cow. Reporter get anaphylactic reactions to anything that has beef. Reporter declined to complete report. Reporter stated that her mother is living in a retirement facility.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Myalgia
Clinical narrative: muscle body aches; Diarrhea; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the parent.  A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 31Mar2021 11:27 (Lot number: ER8737) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Diagnosed when he was about 5 or 6 years old.; "Covid" (unspecified if ongoing), notes: Verbatim: Covid. The patient took concomitant medications. The following information was reported: MYALGIA (non-serious) with onset 01Apr2021, outcome "not recovered", described as "muscle body aches"; DIARRHOEA (non-serious) with onset 01Apr2021, outcome "unknown", described as "Diarrhea". Therapeutic measures were not taken as a result of myalgia. Additional Information: The mother reported that her son received Pfizer Vaccine 31Mar2021. Her son was feeling good until started feeling muscle body aches. The onset of muscle body aches was probably about 00:00 or 01:00 on 01Apr2021. The patient also had diarrhea, just a little, not a lot. The patient just went 1 time and she really does not know if recovered. The patient wanted to get the vaccine because of the pandemic and that they're going through because they had covid before. The patient was in hospital for 7 days. The patient has asthma. The patient took medication, but it was nothing to do with the body aches, he was healthy, doing fine. He didn't have no body aches or nothing until yesterday. Especially if he mowed the yard or something, he got it you know. He took an inhaler. The patient did not treat the muscle aches in any way. The mother was going to give him Advil. The patient has no history of all previous immunization and has no additional administered vaccines on the same day. The adverse events did not require emergency room nor physician office visit. The patient has no prior vaccinations within 4 weeks and has no family medical history related to the adverse events. No relevant tests were done.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Movement disorder, Sleep disorder
Clinical narrative: woke up thrashing and had incredible chills; could not keep her arms straight; teeth were chattering and her body would not calm down/and had incredible chills; had no control of anything; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 10:30 (Lot number: ER8734) at the age of 82 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN B12 [COBAMAMIDE]; VITAMIN D [ERGOCALCIFEROL]. Vaccination history included: Bnt162b2 (Dose 1, lot EP6955), administration date: 11Mar2021, when the patient was 82 years old, for Covid-19 Immunisation. The following information was reported: SLEEP DISORDER (non-serious) with onset 31Mar2021, outcome "recovered" (2021), described as "woke up thrashing and had incredible chills"; MOVEMENT DISORDER (non-serious) with onset 31Mar2021, outcome "recovered" (2021), described as "could not keep her arms straight"; CHILLS (non-serious) with onset 31Mar2021, outcome "recovered" (2021), described as "teeth were chattering and her body would not calm down/and had incredible chills"; FEELING ABNORMAL (non-serious) with onset 31Mar2021, outcome "recovered" (2021), described as "had no control of anything". Therapeutic measures were not taken as a result of sleep disorder, movement disorder, chills, feeling abnormal.  Additional information: She got the 2nd shot of the Pfizer Vaccine on Tuesday around 10:30 and was ok but in the middle of the night at 02:00-03:00 she woke up thrashing and had incredible chills and could not keep her arms straight and her teeth were chattering and her body would not calm down, states she had no control of anything. Patient keeps getting shorter all the time and stated lets cheat a little bit and say her height is 54; states she weighed herself this morning. She did not look at the clock because it would not do her any good to look at the clock for the time the reported event occurred but states the reported events are not ongoing and resolved but all day yesterday she was not worth anything and poked around. She did not have treatment for the reported events. She is very lucky because she has no prescription medications and has not had prescription medications for a while. She has taken these vitamins for years and years. Her 2nd visit for the 2nd dose was very quick and it might have been a few minutes before 10:30 and they are laid out very well and she went to the next room for 15 minutes to sit and they have movies playing. No prior Vaccinations (within 4 weeks). Her sister is elsewhere and got the whole deal and had COVID and was on a ventilator and everything but she smoked and does not smoke anymore and has heart problems.    No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: I woke up and started puking; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 10:00 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "I woke up and started puking"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mammogram, Muscle twitching, Paraesthesia
Clinical narrative: thumb starts twitching; little tingling down her arm to her hand; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (States with her first shot, she had chills and muscle pain), for COVID-19 immunisation, reaction: "chills", "muscle pain". The following information was reported: MUSCLE TWITCHING (non-serious), outcome "unknown", described as "thumb starts twitching"; PARAESTHESIA (non-serious), outcome "unknown", described as "little tingling down her arm to her hand". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021136742 same reporter and vaccine, different dose number and event
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling cold, Mammogram, Muscle twitching, Myalgia
Clinical narrative: thumb starts twitching; little tingling down her arm to her hand; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (States with her first shot, she had chills and muscle pain), for COVID-19 immunisation, reaction: "chills", "muscle pain". The following information was reported: MUSCLE TWITCHING (non-serious), outcome "unknown", described as "thumb starts twitching"; PARAESTHESIA (non-serious), outcome "unknown", described as "little tingling down her arm to her hand". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021136742 same reporter and vaccine, different dose number and event
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Tremor
Clinical narrative: thumb starts twitching; little tingling down her arm to her hand; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (States with her first shot, she had chills and muscle pain), for COVID-19 immunisation, reaction: "chills", "muscle pain". The following information was reported: MUSCLE TWITCHING (non-serious), outcome "unknown", described as "thumb starts twitching"; PARAESTHESIA (non-serious), outcome "unknown", described as "little tingling down her arm to her hand". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021136742 same reporter and vaccine, different dose number and event
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches like a Migraine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headaches like a Migraine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Thumbs tingling 40 min after injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 38-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Apr2021 09:15 (Lot number: Er8727) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "injuring my elbow tendons" (unspecified if ongoing), notes: did heavy lifting for years injuring my elbow tendons at times. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE lot number: En6205 administration time: 09:15, Left arm; intramuscular route), administration date: 13Mar2021, when the patient was 38 years old, for COVID-19 immunisation, reaction(s): "Numbness of fingers", "Itchy skin", "Skin irritation", "Swelling of wrists", "Swelling of elbows", "Inflammation", "Tingling". The following information was reported: PARAESTHESIA (non-serious) with onset 03Apr2021 09:55, outcome "recovering", described as "Thumbs tingling 40 min after injection". Therapeutic measures were not taken because of paraesthesia.  Additional information: The patient did not have any allergies to medications, food, or other products. Concomitant medications included unspecified multivitamin gummies (MANUFACTURER UNKNOWN) received on unspecified date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 09:55, 40 minutes after injection, the patient experienced thumbs tingling, which was not as bad as tingling experienced by patient after dose one vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The patient had no idea how an upper arm muscle injection would do this to thumbs, did not make sense to the patient but he would report it to be safe. The clinical outcome of the event thumbs tingling 40 min after injection was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Fatigue; Arm pain; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Feb2021 (Lot number: EL9267) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ovarian cysts" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYZINE; ESTRACE. Past drug history included: Codeine, reaction(s): "Drug allergy", notes: known allergies: codeine. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "Fatigue"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Arm pain"; HEADACHE (non-serious), outcome "recovered", described as "Headache". Therapeutic measures were not taken as a result of fatigue, pain in extremity, headache.  Additional information: Patient was not pregnant at the time of vaccination. Prior to the 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 four weeks prior to the COVID-19 vaccine. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: I have a swollen lymph node under my right under arm pit the size of an orange.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 (Lot number: ER8737, Expiration Date: 02Jul2021) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN CALCIUM. Vaccination history included: Bnt162b2 (Lot number: EN6206, Administration time: 10:00 AM, Vaccine location:  Right arm, Dose number: 1), administration date: 11Mar2021, when the patient was 60 years old, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 02Apr2021 22:00, outcome "not recovered", described as "I have a swollen lymph node under my right under arm pit the size of an orange.". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: It was reported that the patient did not had any other vaccine in four weeks. The patient did not taken any prior COVID vaccination and the patient did not had COVID tested post vaccination. The patient did not had any known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: minor lightheaded feeling; minor arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 18:00 (Lot number: EN6199) at the age of 25 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Environmental allergy" (unspecified if ongoing), notes: environmental allergies; "Asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; DAPSONE; EPIDUO FORTE; ALBUTEROL [SALBUTAMOL]. Past drug history included: Chlora-prep/chlorhexidine gluconate, reaction(s): "known allergies: Chlora-Prep/Chlorhexidine gluconate", notes: known allergies: Chlora-Prep/Chlorhexidine gluconate. The following information was reported: DIZZINESS (non-serious) with onset 10Mar2021, outcome "recovered" (11Mar2021), described as "minor lightheaded feeling"; PAIN IN EXTREMITY (non-serious) with onset 10Mar2021, outcome "recovered" (11Mar2021), described as "minor arm soreness". Therapeutic measures were not taken as a result of dizziness, pain in extremity.  Additional Information: The patient had first injection and in first 15 minutes after injection she had very minor lightheaded feeling, and minor arm soreness which lasted for 24 hours.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Feeling abnormal, Headache, Nausea
Clinical narrative: I was waiting at the center I felt a pull in my upper left forehead; Since the date of the vaccine I have had constant headaches; Dizziness; Nausea; Stomach ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 11:45 (Batch/Lot number: unknown) at the age of 50 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Acid Reflux" (unspecified if ongoing); "Gastroenteritis" (unspecified if ongoing); "thyroid" (unspecified if ongoing), notes: For thyroid 50 ug. The patient took concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 24Mar2021 12:45, outcome "not recovered", described as "I was waiting at the center I felt a pull in my upper left forehead"; HEADACHE (non-serious) with onset 24Mar2021 12:45, outcome "not recovered", described as "Since the date of the vaccine I have had constant headaches"; DIZZINESS (non-serious) with onset 24Mar2021 12:45, outcome "not recovered", described as "Dizziness"; NAUSEA (non-serious) with onset 24Mar2021 12:45, outcome "not recovered", described as "Nausea"; ABDOMINAL PAIN UPPER (non-serious) with onset 24Mar2021 12:45, outcome "not recovered", described as "Stomach ache". The events "i was waiting at the center i felt a pull in my upper left forehead", "since the date of the vaccine i have had constant headaches", "dizziness", "nausea" and "stomach ache" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of feeling abnormal, headache, dizziness, nausea, abdominal pain upper.  Additional information: clinical course: patient doesn't not have any Allergies to medications, food, or other products. No treatment medication was reported. Patient had not diagnosed with COVID-19 Prior to vaccination and Since the vaccination, patient did not tested for COVID-19. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination is reported as For thyroid 50 ug (Not specified). Facility where the most recent COVID-19 vaccine was administered is reported as clinic.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Slight headache and fatigue; Slight headache and fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "obesity" (unspecified if ongoing); "depression" (unspecified if ongoing); "Penicillin Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), HEADACHE (non-serious) all with onset 31Mar2021, outcome "recovered" (2021) and all described as "Slight headache and fatigue". It was unknown if therapeutic measures were taken as a result of fatigue, headache.  Additional information: It was unknown whether the patient received any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Unknown if patient had COVID-19, Since the vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Wound
Clinical narrative: small cut; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as DOSE 1, SINGLE for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WOUND (non-serious), outcome "unknown", described as "small cut". Therapeutic measures were taken as a result of wound.  Additional Information: Caller was calling on behalf of husband who had a tetanus shot for a small cut last week. Her husband got first dose 12Mar2021. He got a TETANUS shot two weeks ago. He was scheduled to receive his second dose of the PFIZER COVID-19 vaccine on 03Apr2021 and wants to know if it was okay since he had the tetanus shot.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A 74-year-old male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history included high blood pressure (unspecified if ongoing) and high cholesterol (unspecified if ongoing). Concomitant medications not reported. The patient experienced influenza-like illness (flu-like symptoms for 2 days post vaccination), with outcome of recovered. No therapeutic measures taken as a result of influenza-like illness. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, patient diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: throat and mouth all tingling; tongue, throat and mouth all tingling; numbing feeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 16:30 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Blood clots" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE; WARFARIN; SINGULAIR; VITAMIN C [ASCORBIC ACID]; TURMERIC CURCUMIN. The following information was reported: PHARYNGEAL PARAESTHESIA (non-serious) with onset 13Mar2021 16:30, outcome "not recovered", described as "throat and mouth all tingling"; PARAESTHESIA ORAL (non-serious) with onset 13Mar2021 16:30, outcome "not recovered", described as "tongue, throat and mouth all tingling"; HYPOAESTHESIA (non-serious) with onset 13Mar2021 16:30, outcome "not recovered", described as "numbing feeling". The events "throat and mouth all tingling" and "tongue, throat and mouth all tingling" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pharyngeal paraesthesia, paraesthesia oral and hypoaesthesia.  Additional Information: Benadryl was administered as Treatment. other medications in two weeks: prednisone, warfarin, singular, tumeric, vitamin c  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 30Mar2021, outcome "unknown", described as "tiredness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Gastroenteritis viral, Headache, Nausea
Clinical narrative: Stomach virus; Nausea; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 15:55 (Lot number: EN6206) at the age of 70 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Flu shot, for shot, reaction(s): "Flu". The following information was reported: GASTROENTERITIS VIRAL (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Stomach virus"; NAUSEA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Nausea"; HEADACHE (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Headache". Therapeutic measures were taken as a result of headache.  Additional information: The patient reported that the second vaccine was scheduled at 20 days. The patient was at risk for missing second vaccine due to illness. She confirmed that second dose was scheduled for 01Apr2021. Patient stated she was due for her second shot tomorrow, and she had no reaction to the first vaccine. Patient stated she had stomach virus. She did not know when it occur but it was probably 8 am. Patient stated she experienced nausea in the morning and headache probably about 8 am. patient reported about another suspect product she stated that when she took Tylenol, to treat her headache, it let's up and then comes back. She also reported issue with clarifying the Lot number of Tylenol. She reported Lot number as PGAO or zero, 61. She did not know if it is an O, letter, or 0, number. Manufacturer name not given. Extra strength reported was 325 count of 500mg caplets. Expiration date of Tylenol was Dec2022.   No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain
Clinical narrative: body aches; feeling pretty miserable; worn out; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 80 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 30Mar2021 11:30 (Batch/Lot number: unknown) at the age of 80 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications for blood pressure, cholesterol and a stroke. Vaccination history included: Bnt162b2 (dose 1), administration date: 09Mar2021, for Covid-19 Immunisation. The following information was reported: PAIN (non-serious) with onset 30Mar2021, outcome "not recovered", described as "body aches"; FEELING ABNORMAL (non-serious) with onset 30Mar2021, outcome "not recovered", described as "feeling pretty miserable"; FATIGUE (non-serious) with onset 30Mar2021, outcome "unknown", described as "worn out". Therapeutic measures was taken as a result of pain, feeling abnormal, fatigue that included Tylenol.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366836 same reporter/drug/different events, different patient.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Muscle aches upper body; neck stiffness; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 25Mar2021 15:45 (Lot number: ER8733) at the age of 68 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Drug allergy" (unspecified if ongoing), notes: Known Allergies: all cillins; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, the patient diagnosed with COVID-19; "Diabetic" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Coronary artery disease" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included: SYMBICORT; ATENOLOL; HUMALOG; FUROSEMIDE; SPIRONOLACTON. Past drug history included: Versed, reaction: "Drug allergy"; Epinephrine, reaction: "Drug allergy"; Cephalexin, reaction: "Drug allergy". The following information was reported: MYALGIA (non-serious) with onset 26Mar2021 04:00, outcome "not recovered", described as "Muscle aches upper body"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 26Mar2021 04:00, outcome "not recovered", described as "neck stiffness". Therapeutic measures were not taken as a result of myalgia, musculoskeletal stiffness.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Glycosylated haemoglobin, Sinusitis
Clinical narrative: Sinus infection; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 15Mar2021 13:00 (Lot number: EL9265, Expiration Date: 31May2021) at the age of 74 years as dose 1, 0.3 ml single for COVID-19 immunisation. Relevant medical history included: "Diabetic/Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetic. Concomitant medication included: GLIPIZIDE/METFORMIN taken for diabetes mellitus (ongoing). The following information was reported: SINUSITIS (non-serious), outcome "unknown", described as "Sinus infection". The event "sinus infection" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: she is confused; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONFUSIONAL STATE (non-serious), outcome "unknown", described as "she is confused".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Tiredness; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Mar2021 (Lot number: EN6199) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "Headache"; FATIGUE (non-serious), outcome "recovered", described as "Tiredness".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oral pain
Clinical narrative: This is a spontaneous report received from a contactable other HCP. A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in left arm, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for immunization. The patient experienced oral pain/sore mouth, onset Mar 25, 2021, with outcome of recovered. No therapeutic measures taken as a result of oral pain. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021355634 same reporter/drug/AE, different patient.