chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity
Clinical narrative: She is having an on and off pain on the left side of her chest and left arm; She is having an on and off pain on the left side of her chest and left arm; This is a spontaneous report from a Pfizer sponsored program. A contactable Other-HCP female patient (girlfriend) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on unknown date at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient was having an on and off pain on the left side of her chest and left arm, it subsided then came back. The outcome was unknown.   Information on Lot/Batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A male patient of an unspecified age received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced headaches after the 2nd dose of the vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Aggression, Anger, Chills, Fatigue, Irritability
Clinical narrative: irritability (anger/aggressive feelings); irritability (anger/aggressive feelings); irritability (anger/aggressive feelings); chills/shaking; chills/shaking; body aches; congestion; severe fatigue; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Patient received the first dose of vaccine on an unknown date for covid-19 immunization. The patient medical history and concomitant medications were not reported. After receiving 2nd Covid vaccination, patient was experiencing irritability (anger/aggressive feelings), chills/shaking, body aches, congestion, severe fatigue. The outcome of events was unknown.  Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Tremor
Clinical narrative: irritability (anger/aggressive feelings); irritability (anger/aggressive feelings); irritability (anger/aggressive feelings); chills/shaking; chills/shaking; body aches; congestion; severe fatigue; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Patient received the first dose of vaccine on an unknown date for covid-19 immunization. The patient medical history and concomitant medications were not reported. After receiving 2nd Covid vaccination, patient was experiencing irritability (anger/aggressive feelings), chills/shaking, body aches, congestion, severe fatigue. The outcome of events was unknown.  Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Left shoulder inflammation of the shoulder capsule lasting more than a week after vaccination injection.; This is a spontaneous report from a contactable Other HCP reported for herself  A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL3248 on 06Jan2021 09:15 Intramuscular at single dose for COVID-19 immunization, vaccine location: left arm, dose number:1, facility type vaccine: hospital. The patient medical history and concomitant medications were not reported. The patient previously took zithromax and sulfa and experienced drug hypersensitivity. On 08Jan2021 13:00 the patient experienced left shoulder inflammation of the shoulder capsule lasting more than a week after vaccination injection with outcome of not recovered. The action taken was not applicable. The patient was treated with steroid medication orally.
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Feeling jittery, Paraesthesia, Paraesthesia oral
Clinical narrative: feeling a lump in her throat; clammy hands; lightheadedness/lightheaded; tingling of her lips and face; tingling of her lips and face; Each time patient would sit up, she would feel jittery and lightheaded; This is a spontaneous report from a contactable pharmacist. An adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL1283) intramuscularly on 04Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. Patient received her COVID vaccine. During the observation period, the patient reported feeling a lump in her throat, clammy hands, lightheadedness, and tingling of her lips and face. Patient was taken back to an exam room. Orange juice provided, patient laid down. Each time patient would sit up, she would feel jittery and lightheaded. After having the patient stay in the patient exam room for 45 minutes with clinical staff monitoring her status, the patient did not report any improvement in symptoms, therefore, she was transported to the ED. Patient discharged from ED after evaluation. Events started from 04Jan2021. No treatment received. No other vaccine in four weeks. It was unknown if patient had covid prior vaccination. It was unknown if covid tested post vaccination. The outcome of the events was recovered on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Sensation of foreign body
Clinical narrative: feeling a lump in her throat; clammy hands; lightheadedness/lightheaded; tingling of her lips and face; tingling of her lips and face; Each time patient would sit up, she would feel jittery and lightheaded; This is a spontaneous report from a contactable pharmacist. An adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL1283) intramuscularly on 04Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. Patient received her COVID vaccine. During the observation period, the patient reported feeling a lump in her throat, clammy hands, lightheadedness, and tingling of her lips and face. Patient was taken back to an exam room. Orange juice provided, patient laid down. Each time patient would sit up, she would feel jittery and lightheaded. After having the patient stay in the patient exam room for 45 minutes with clinical staff monitoring her status, the patient did not report any improvement in symptoms, therefore, she was transported to the ED. Patient discharged from ED after evaluation. Events started from 04Jan2021. No treatment received. No other vaccine in four weeks. It was unknown if patient had covid prior vaccination. It was unknown if covid tested post vaccination. The outcome of the events was recovered on an unspecified date.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Severe headache; severe body aches; severe joint aches; chills; sweats; fatigue; loss of appetite; This is a spontaneous report from a contactable pharmacist (patient). This 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EJ1686), via an unspecified route of administration on 11Jan2021 17:30 at single dose on the left arm for COVID-19 immunization. The patient's medical history included depression and gastrooesophageal reflux disease (GERD). No known allergies. The patient's concomitant medications included bupropion, famotidine and birth control medication received in two weeks. The patient previously took the first dose of BNT162B2 (Lot number=Ej1685) on 23Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. No other vaccine received in four weeks. Facility type vaccine was workplace clinic. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient experienced severe headache, severe body aches, severe joint aches, chills, sweats, fatigue, loss of appetite on 12Jan2021. No treatment received. Outcome of the events was recovered in Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain
Clinical narrative: Severe headache; severe body aches; severe joint aches; chills; sweats; fatigue; loss of appetite; This is a spontaneous report from a contactable pharmacist (patient). This 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EJ1686), via an unspecified route of administration on 11Jan2021 17:30 at single dose on the left arm for COVID-19 immunization. The patient's medical history included depression and gastrooesophageal reflux disease (GERD). No known allergies. The patient's concomitant medications included bupropion, famotidine and birth control medication received in two weeks. The patient previously took the first dose of BNT162B2 (Lot number=Ej1685) on 23Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. No other vaccine received in four weeks. Facility type vaccine was workplace clinic. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient experienced severe headache, severe body aches, severe joint aches, chills, sweats, fatigue, loss of appetite on 12Jan2021. No treatment received. Outcome of the events was recovered in Jan2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: just a little sore at the injection site; 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 MRNA VACCINE, Solution for injection; batch/lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he got the first round of the COVID vaccine and stated that everything was okay; he was just a little sore at the injection site on an unspecified date. The patient was just wondering if he was to be exposed to COVID prior to getting his next dose in three weeks; he was wondering what the recommendations would be regarding the second dosage. He was just wondering, because he had been pretty isolated as he lives out in the woods and he had been following protocols about wearing the mask and using hand sanitizer and such, but he was just wondering if something did happen and he got exposed, what would be the recommendations for the second dose. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Axillary pain, Chills, Dehydration, Dizziness
Clinical narrative: For her feeling like she was going to pass out, patient states that she was probably dehydrated; Right sided Neck Pain and Right sided armpit pain; Right sided Neck Pain and Right sided armpit pain; right side neck swelling; Felt like going to pass out; Felt light headed like she was going to pass out; Nausea; Vomiting; Upset stomach; Body chills and aches; Body chills and aches; Headache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: 31Mar2021) solution for injection, via an unspecified route of administration on right arm on 11Jan2021 at a single dose for Covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient was not pregnant. Patient reported she got the first dose on 20Dec2020 and on an unknown date in Dec2020, she experienced right side neck pain, right side armpit pain, arm pain where she received the vaccine on the right side, right neck swelling, tenderness, and lymph node thing. Patient reported that on 11Jan2021, she got the second dose at 9AM and by 5-6 PM she felt the symptoms. Then by 7:30PM felt terrible and had to have her sister come get her, she felt like she was going to pass out. She experienced the nausea before 7:30PM on 11Jan2021. The vomiting happened on 11Jan2021 at night 12 hours after the vaccine, she vomited the next day also around 10 in the morning on 12Jan2021. The upset stomach started 11Jan2021. Patient confirmed that she did not actually pass out but she felt light headed like she was going to pass out, it started on 11Jan2021 and went into 12Jan2021 she was just light headed and not well. The body chills aches started 11Jan2021 around the 5-6PM time, she felt fine most of the day but it was that evening she was achy. The headache started 11Jan2021 at night continued to 12Jan2021 and was still ongoing today. The right sided neck and armpit pain started yesterday 12Jan2021 and she still has it at the moment. She stated that she was probably dehydrated and still feels like she was recovering. She had right side neck swelling on 11Jan2021 and right sided under armpit pain on 12Jan2021. She has never been tested for Covid or had any antibody tests. She has had no issues with vaccines in the past. Outcome of the events 'Felt like going to pass out', 'Nausea, Vomiting', 'Upset stomach', 'Body chills and aches' was recovered on 12Jan2021; 'Headache' and 'dehydrated' were recovering; 'Right sided Neck Pain and Right sided armpit pain' was not recovered; 'dizziness' and 'right side neck swelling' were unknown.  No follow-up activities are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Neck pain, Pain, Presyncope
Clinical narrative: For her feeling like she was going to pass out, patient states that she was probably dehydrated; Right sided Neck Pain and Right sided armpit pain; Right sided Neck Pain and Right sided armpit pain; right side neck swelling; Felt like going to pass out; Felt light headed like she was going to pass out; Nausea; Vomiting; Upset stomach; Body chills and aches; Body chills and aches; Headache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: 31Mar2021) solution for injection, via an unspecified route of administration on right arm on 11Jan2021 at a single dose for Covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient was not pregnant. Patient reported she got the first dose on 20Dec2020 and on an unknown date in Dec2020, she experienced right side neck pain, right side armpit pain, arm pain where she received the vaccine on the right side, right neck swelling, tenderness, and lymph node thing. Patient reported that on 11Jan2021, she got the second dose at 9AM and by 5-6 PM she felt the symptoms. Then by 7:30PM felt terrible and had to have her sister come get her, she felt like she was going to pass out. She experienced the nausea before 7:30PM on 11Jan2021. The vomiting happened on 11Jan2021 at night 12 hours after the vaccine, she vomited the next day also around 10 in the morning on 12Jan2021. The upset stomach started 11Jan2021. Patient confirmed that she did not actually pass out but she felt light headed like she was going to pass out, it started on 11Jan2021 and went into 12Jan2021 she was just light headed and not well. The body chills aches started 11Jan2021 around the 5-6PM time, she felt fine most of the day but it was that evening she was achy. The headache started 11Jan2021 at night continued to 12Jan2021 and was still ongoing today. The right sided neck and armpit pain started yesterday 12Jan2021 and she still has it at the moment. She stated that she was probably dehydrated and still feels like she was recovering. She had right side neck swelling on 11Jan2021 and right sided under armpit pain on 12Jan2021. She has never been tested for Covid or had any antibody tests. She has had no issues with vaccines in the past. Outcome of the events 'Felt like going to pass out', 'Nausea, Vomiting', 'Upset stomach', 'Body chills and aches' was recovered on 12Jan2021; 'Headache' and 'dehydrated' were recovering; 'Right sided Neck Pain and Right sided armpit pain' was not recovered; 'dizziness' and 'right side neck swelling' were unknown.  No follow-up activities are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vomiting
Clinical narrative: For her feeling like she was going to pass out, patient states that she was probably dehydrated; Right sided Neck Pain and Right sided armpit pain; Right sided Neck Pain and Right sided armpit pain; right side neck swelling; Felt like going to pass out; Felt light headed like she was going to pass out; Nausea; Vomiting; Upset stomach; Body chills and aches; Body chills and aches; Headache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: 31Mar2021) solution for injection, via an unspecified route of administration on right arm on 11Jan2021 at a single dose for Covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient was not pregnant. Patient reported she got the first dose on 20Dec2020 and on an unknown date in Dec2020, she experienced right side neck pain, right side armpit pain, arm pain where she received the vaccine on the right side, right neck swelling, tenderness, and lymph node thing. Patient reported that on 11Jan2021, she got the second dose at 9AM and by 5-6 PM she felt the symptoms. Then by 7:30PM felt terrible and had to have her sister come get her, she felt like she was going to pass out. She experienced the nausea before 7:30PM on 11Jan2021. The vomiting happened on 11Jan2021 at night 12 hours after the vaccine, she vomited the next day also around 10 in the morning on 12Jan2021. The upset stomach started 11Jan2021. Patient confirmed that she did not actually pass out but she felt light headed like she was going to pass out, it started on 11Jan2021 and went into 12Jan2021 she was just light headed and not well. The body chills aches started 11Jan2021 around the 5-6PM time, she felt fine most of the day but it was that evening she was achy. The headache started 11Jan2021 at night continued to 12Jan2021 and was still ongoing today. The right sided neck and armpit pain started yesterday 12Jan2021 and she still has it at the moment. She stated that she was probably dehydrated and still feels like she was recovering. She had right side neck swelling on 11Jan2021 and right sided under armpit pain on 12Jan2021. She has never been tested for Covid or had any antibody tests. She has had no issues with vaccines in the past. Outcome of the events 'Felt like going to pass out', 'Nausea, Vomiting', 'Upset stomach', 'Body chills and aches' was recovered on 12Jan2021; 'Headache' and 'dehydrated' were recovering; 'Right sided Neck Pain and Right sided armpit pain' was not recovered; 'dizziness' and 'right side neck swelling' were unknown.  No follow-up activities are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dysgeusia, Hypoaesthesia, Vaccination site pain
Clinical narrative: some pain in both sides of her chest; Bad taste in mouth; Pain injection site; Arm and fingers went numb; This is a spontaneous report from a contactable consumer (patient) reported for self. A 21-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EJ1689) via an unspecified route of administration in left upper arm on 11Jan2021 at single dose for COVID-19 immunization. There was no medical history. There were no concomitant medications. The day of the vaccine on 11Jan2021, her arm and fingers went numb, she had pain at the injection site and had a bad taste in her mouth which has all resolved, states the following day after the vaccine, 12Jan2021, she woke up and had some pain in both sides of her chest. Wondering if these side effects are expected and about getting the second vaccine. Events outcome of arm and fingers went numb, bad taste in mouth was recovered on 12Jan2021, for pain in both sides of her chest was recovering, for pain at injection site was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm really hurt when getting it/pain in the arm the shot was given/uncomfortable pain/in their arm after receiving the injection; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the second of two reports.  A male patient of an unspecified age received BNT162B2 via an unspecified route of administration in his left arm on 06Jan2021 at a single dose for COVID vaccine. Medical history and concomitant medications were not reported. The reporter remarked that on 06Jan2021, with this shot her arm really hurt when getting it and that day but that was all (pain in the arm the shot was given). She and her husband both ooo'd and ahhh'd after getting their shot, she was referring to the very uncomfortable pain they experienced in their arm after receiving the injection. They both had the same exact pain in the arm the shot was given but he had no headache on 06Jan2021. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026017 same reporter and product, similar event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pain in extremity
Clinical narrative: swelling of the joint at the base of left thumb; Pain with movement, especially with carrying a mug or large glass; This is a spontaneous report from a contactable physician (patient). This physician reported that a 57-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration, on 24 Dec2020 08:15 in left arm at single dose, for COVID-19 immunisation, at workplace clinic. Medical history included sulfa allergy; hypothyroid; high cholesterol; mitral valve prolapse. There were no other vaccine in four weeks. Patient was not pregnant. There was no COVID prior vaccination. Concomitant medications included levothyroxine; liothyronine; atorvastatin calcium. The patient previously took nitrofurantoin and experienced allergy to it. Patient reported that swelling of the joint at the base of left thumb starting at 10:00 AM on 26Dec2020. Pain with movement, especially with carrying a mug or large glass. Some improvement with time but still present on 13Jan2021. There was no treatment received. Outcome of the events was recovering. COVID-19 was not tested post vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: joint pain; chills; headache; severe injection arm pain; Fever; This is a spontaneous report from a contactable nurse.   A 44-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in arm right, on 13Jan2021 14:15 at single dose for covid-19 immunisation.  The patient previously received the first dose of BNT162B2, intramuscular in arm right, on 23Dec2020 13:15 at single dose for covid-19 immunisation.  The vaccine was administered at Physician Office.  No other vaccine was administered in four weeks. COVID was not tested post vaccination. No known allergies. Medical history included migraines from an unknown date and unknown if ongoing.  The patient had COVID prior vaccination.  The patient's concomitant medications included butalbital, caffeine, paracetamol (FIORICET). On 13Jan2021 the patient experienced joint pain, chills, headache, severe injection arm pain, fever. The patient was treated for the events with OTC fever and pain reducer and IBUPROFEN. The outcome of the events was resolving.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Mild swelling (2" x 1" area) near injection site on left deltoid area; noticeable redness and warm to touch; noticeable redness and warm to touch; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284) via an unspecified route of administration at left arm (deltoid), on 06Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included sulfa allergy. Patient was not pregnant at the time of vaccination. Patient did not have COVID prior vaccination. Concomitant medication included tocopherol (VITAMIN E). Patient did not receive other vaccine in four weeks. Patient experienced mild swelling (2" x 1" area) near injection site on left deltoid area, noticeable redness and warm to touch, appeared 8 days after injection on 14Jan2021 05:00. No treatment received. No COVID tested post vaccination. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia oral, Paraesthesia oral, Rash, Urticaria
Clinical narrative: rash/ Rash on chest, back, around hair line, injection site and behind ears; rash/ Rash on chest, back, around hair line, injection site and behind ears; hives; dizziness; numbness and tingling of tongue; numbness and tingling of tongue; This is a spontaneous report from a contact pharmacist.  An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 03Jan2021 as single dose for covid-19 immunization.  Medical history included known allergy to sulfa.  The patient's concomitant medications were not reported.  The patient experienced rash/ rash on chest, back, around hair line, injection site and behind ears on 03Jan2021 with outcome of not recovered; hives on 03Jan2021 with outcome of unknown; dizziness on 03Jan2021 with outcome of unknown; numbness and tingling of tongue on 03Jan2021 with outcome of not recovered.  No. Adverse event: Symptoms started 5 minutes after receiving vaccine: rash/hives, dizziness, numbness and tingling of tongue. Rash on chest, back, around hair line, injection site and behind ears. Patient was taken to ER as rash and tingling of tongue was persisting after taking diphenhydramine (BENADRYL), 50 mg and cetirizine (ZYRTEC)  10mg. An epinephrine (EPIPEN) was provided at discharge from the emergency department. Therapeutic measures were taken as a result of rash/ rash on chest, back, around hair line, injection site and behind ears and numbness and tingling of tongue as aforementioned; no treatment was provided for the other events.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash/ Rash on chest, back, around hair line, injection site and behind ears; rash/ Rash on chest, back, around hair line, injection site and behind ears; hives; dizziness; numbness and tingling of tongue; numbness and tingling of tongue; This is a spontaneous report from a contact pharmacist.  An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 03Jan2021 as single dose for covid-19 immunization.  Medical history included known allergy to sulfa.  The patient's concomitant medications were not reported.  The patient experienced rash/ rash on chest, back, around hair line, injection site and behind ears on 03Jan2021 with outcome of not recovered; hives on 03Jan2021 with outcome of unknown; dizziness on 03Jan2021 with outcome of unknown; numbness and tingling of tongue on 03Jan2021 with outcome of not recovered.  No. Adverse event: Symptoms started 5 minutes after receiving vaccine: rash/hives, dizziness, numbness and tingling of tongue. Rash on chest, back, around hair line, injection site and behind ears. Patient was taken to ER as rash and tingling of tongue was persisting after taking diphenhydramine (BENADRYL), 50 mg and cetirizine (ZYRTEC)  10mg. An epinephrine (EPIPEN) was provided at discharge from the emergency department. Therapeutic measures were taken as a result of rash/ rash on chest, back, around hair line, injection site and behind ears and numbness and tingling of tongue as aforementioned; no treatment was provided for the other events.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt ill; This is a spontaneous report from a contactable other health care professional (hcp). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received the first dose of BNT162B2 for COVID-19 immunization on an unknown date. The patient (an MD - intensivist) felt ill from the second dose of Covid 19 vaccine on an unknown date. The outcome of the event felt ill was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report from a contactable other health care professional (hcp). This other hcp reported similar events for three patients. This is the first of three reports.   A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 for COVID-19 immunization on an unknown date. The patient (a CCU RN (nurse)) called in sick the following day after receiving the 2nd dose of the vaccine on an unknown date. The outcome of the event sick was unknown.   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-2021039442 Same reporter, same product, same event, different patients;US-PFIZER INC-2021039440 Same reporter, same product, same event, different patients
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: 3 CCU RNs called in sick the following day after receiving their 2nd dose of the vaccine; This is a spontaneous report from a contactable other health care professional (hcp). This other hcp reported similar events for three patients. This is the second of three reports.   A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 for COVID-19 immunization on an unknown date. The patient (a CCU RN (nurse)) called in sick the following day after receiving the 2nd dose of the vaccine on an unknown date. The outcome of the event sick was unknown.   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-2021039437 Same reporter, same product, same event, different patients.;US-PFIZER INC-2021039442 Same reporter, same product, same event, different patients.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: 3 CCU RNs called in sick the following day after receiving their 2nd dose of the vaccine; This is a spontaneous report from a contactable other health care professional (hcp). This other hcp reported similar events for three patients. This is the third of three reports.   A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 for COVID-19 immunization on an unknown date. The patient (a CCU RN (nurse)) called in sick the following day after receiving the 2nd dose of the vaccine on an unknown date. The outcome of the event sick was unknown.   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-2021039437 Same reporter, same product, same event, different patients;US-PFIZER INC-2021039440 Same reporter, same product, same event, different patients.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 14Jan2021, it was reported that Spouse is having intense itching since taking vaccine today. States she has taken Tylenol and pain killers but to no effect. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Soreness on her arm side; This is a spontaneous report from a contactable other HCP Pfizer-sponsored program. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache and soreness on her arm side after her first dose of vaccine. The patient was also asking if she could take Ibuprofen and Tylenol. Outcome of the events was unknown.   Information on the Lot/Batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 59-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 at 12:00 at single dose in left arm for COVID-19 immunisation at the age of 59-year-old. Lot number was EJ1686. Medical history and concomitant medications were unknown. Patient received SHINGRIX in 2020 and shingles vaccine in 2011 (also reported in 2020), flu shot in 2020 (Sep2020 or Oct2020); all vaccines received for immunisation. On 12Jan2021, the patient developed Shingles; the patient did not visit the emergency room. The patient was due for the second dose of suspect vaccine on the 19Jan2021. The patient did not recover from the event.
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: It was like a bad flu; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. This consumer reported similar events for 3 patients. This is 1st of 3 reports.  A patient of unknown gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The consumer reported that everyone that she/ he knew had gotten the vaccine so far, they had all gotten sick for 24 to 48 hours (that's only three people); it was like a bad flu. The outcome of the event was unknown.  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-2021040406 same reporter,event, suspect and different patient;US-PFIZER INC-2021040405 same reporter,event, suspect and different patient
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hypoaesthesia, Lethargy, Paraesthesia
Clinical narrative: numbness and tingling in fingers; tingling in fingers; chills; fever; lethargy; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history included COVID-19. Concomitant medications were not reported. It was reported the patient contracted COVID-19, 11 days after first 'jab'. Had adverse reaction after 2nd jab. Reaction lasted 16 hrs and included numbness and tingling in fingers, chills, fever and lethargy. Symptoms subsided 16 hours after onset.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021062909 same patient, same drug, different event
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: numbness and tingling in fingers; tingling in fingers; chills; fever; lethargy; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history included COVID-19. Concomitant medications were not reported. It was reported the patient contracted COVID-19, 11 days after first 'jab'. Had adverse reaction after 2nd jab. Reaction lasted 16 hrs and included numbness and tingling in fingers, chills, fever and lethargy. Symptoms subsided 16 hours after onset.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021062909 same patient, same drug, different event
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Somnolence
Clinical narrative: lightheadedness; drowsiness; This is a spontaneous report from a non-contactable healthcare professional (patient). A 58-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9231, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 10:45 at single dose for COVID-19 immunisation. Medical history was none. Concomitant medication included ibuprofen (ADVIL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient experienced lightheadedness and drowsiness on Jan2021 15:00. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Injection site pain; fever; chills; fatigue; myalgia; This is a spontaneous report from a non-contactable pharmacist (patient). A 43-year-old female patient (no pregnancy) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at site of left arm at 13:30 on 08Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced injection site pain, fever, chills, fatigue and myalgia in Jan2021. Facility type vaccine was in hospital. No other vaccine in four weeks. Adverse reactions did not result any serious consequences. The patient received paracetamol (TYLENOL) as treatment for adverse event. No covid prior vaccination. No covid tested post vaccination. The outcome of events was recovered in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; fever; chills; fatigue; myalgia; This is a spontaneous report from a non-contactable pharmacist (patient). A 43-year-old female patient (no pregnancy) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at site of left arm at 13:30 on 08Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced injection site pain, fever, chills, fatigue and myalgia in Jan2021. Facility type vaccine was in hospital. No other vaccine in four weeks. Adverse reactions did not result any serious consequences. The patient received paracetamol (TYLENOL) as treatment for adverse event. No covid prior vaccination. No covid tested post vaccination. The outcome of events was recovered in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pyrexia
Clinical narrative: fever of 102; chills; nausea; vomiting; headache; injection site pain; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 28-year-old female patient (no pregnancy) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), intramuscularly at site of left arm at 07:00 on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 (lot number: EL3248), intramuscularly at site of left arm at 7:00 AM on 22Jan2020 for COVID-19 immunization and experienced injection site pain. The patient experienced fever of 102, chills, nausea, vomiting, headache and injection site pain, all at 23:00 on 12Jan2021. Facility type vaccine was in hospital. No other vaccine received in four weeks. No other medications received in two weeks. No treatment received for adverse event. Adverse reactions did not result any serious consequences. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: fever of 102; chills; nausea; vomiting; headache; injection site pain; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 28-year-old female patient (no pregnancy) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), intramuscularly at site of left arm at 07:00 on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 (lot number: EL3248), intramuscularly at site of left arm at 7:00 AM on 22Jan2020 for COVID-19 immunization and experienced injection site pain. The patient experienced fever of 102, chills, nausea, vomiting, headache and injection site pain, all at 23:00 on 12Jan2021. Facility type vaccine was in hospital. No other vaccine received in four weeks. No other medications received in two weeks. No treatment received for adverse event. Adverse reactions did not result any serious consequences. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, SARS-CoV-2 test
Clinical narrative: myalgia; chills; fatigue; This is a spontaneous report from a non-contactable pharmacist. This pharmacist reported for 42-year-old female (pregnant: No) patient received 2nd dose of BNT162B2 (lot number=EL3246) Intramuscular on 12Jan2021 09:00 AM at single dose for covid-19 immunization. Medical history was Known allergies: sulfa, COVID prior vaccination. Concomitant drug was not reported. Historical Vaccine was 1st dose of BNT162B2 (lot number=EK5730, 22Dec2020, 09:00 AM, Intramuscular). No other vaccine in four weeks. After 12 hrs of taking 2nd dose of covid-19 vaccine (12Jan2021 08:00 PM), patient experienced myalgia, chills, and fatigue. The patient took Tylenol. All events resolved 24 hrs after. COVID tested post vaccination with unknown results.  No follow-up attempts are possible. Information about lot/batch number has been obtained.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The reporter heard that the second Covid shot really hurts and that someone (patient) she knew got a headache after the Covid vaccine, but the reporter knew that everyone was different. The outcome of the event was unknown.  Information about lot/batch number has been requested.