chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: has a problem today not good; fever; headache; teeth ache; felt bad; arm can't lift up; This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of an unspecified age reported for himself that he received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hepatitis disease of liver and constipation; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient had a problem, reported as today, not good and had fever last night, headache and teeth ache. The patient could not go to walk. He stated that when he felt bad last night with fever, headache, and teeth ache, he took Tylenol but it did not help. The patient stated he had hepatitis disease of liver and had constipation and he told his doctor but they said that was ok no problem his doctor told him ok you wait until you're strong and then go to get vaccine. The patient stated when he told then he was not feeling good and asked if he had medicine which he could have that sounds good for headache, teeth ache and arm can't lift up. Therapeutic measures were taken as a result of fever, headache and teeth ache. The outcome of the events fever headache, teeth ache was not recovered while other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Deafness, Drug ineffective, Pain
Clinical narrative: hearing loss; COVID-19; COVID-19; Pain; This is a solicited non-interventional study report received from Pfizer (Mfr control no: 21K-163-4055090-00) via the marketing program facilitated collect received from a non-contactable consumer or other non hcp (patient). A 56-years-old female patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported), dose 1 via an intramuscularly administered on 05Apr2021 (age at vaccination 56-years-old) as DOSE 1, SINGLE and dose 2 (Lot number: not reported) via an intramuscularly administered on 15May2021 as DOSE 2, SINGLE both for covid-19 immunisation. Co-suspect of adalimumab (HUMIRA, batch/lot number and dose: not reported) via subcutaneous route of administration on an unspecified date for polyosteoarthritis. Medical history included fibromyalgia, penicillin allergy, lost hearing in right ear and children's neuropathy from an unknown date and unknown if ongoing. There were no concomitant medications reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On an unspecified date, the patient experienced covid-19, drug ineffective, hearing loss and pain. It was reported that mfr opinion was that there was no reasonable possibility that the events of lost hearing, taking humira for years still having pain unknown onset, covid and taking humira for years still having pain unknown onset are related to humira. Therapeutic measures were taken as a result of lost hearing, covid-19 and pain taking humira for years still having pain and covid. The outcome of the event hearing loss was not recovered and other events were unknown.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the events drug ineffective, COVID-19, deafness, pain and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative
Clinical narrative: Colitis ulcerative aggravated; This is a solicited report based on the information received by Pfizer from a company (Mfr. Control No: 21K-163-4052708-00).  A non-contactable consumer (patient) reported a 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular on 15Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular on 22Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) at unspecified dose for moderate to severe ulcerative colitis.  The patient's medical history and concomitant medications was not reported. The patient experienced ulcerative colitis flare (Colitis ulcerative aggravated) on an unspecified date with outcome of unknown.  The action taken in response to the event(s) for adalimumab was unknown. Causality as per reporter of bnt162b2 was possible.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of serious event Colitis ulcerative aggravated cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Arthralgia, COVID-19, Dyspnoea, Headache, Nausea
Clinical narrative: Headache; Breathing difficult/Trouble Breathing; Nausea/Sick to stomach; Rheumatoid arthritis; Arthralgia aggravated; COVID-19; This is a spontaneous report based on the information received from a contactable consumer by Pfizer (Mfr Control No#: 21K-163-4051052-00). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), intramuscularly in Jan2021 at dose 1, single and in Feb2021 at dose 2, single for COVID-19 immunisation; abatacept (ORENCIA), via an unspecified route of administration from 2011 (Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication; adalimumab (HUMIRA), subcutaneously from 2011 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported. Patient previously had major problems on Methotrexate, specifically pain all over body could not get out of bedridden. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced covid-19 in Dec2020, arthralgia aggravated in 2021, had rheumatoid arthritis, headache, breathing difficult/trouble breathing, nausea/sick to stomach. The outcome of the events was unknown. The causality between Pfizer vaccine, Humira (Adalimubab) and events was not provided  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Headache; Breathing difficult/Trouble Breathing; Nausea/Sick to stomach; Rheumatoid arthritis; Arthralgia aggravated; COVID-19; This is a spontaneous report based on the information received from a contactable consumer by Pfizer (Mfr Control No#: 21K-163-4051052-00). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), intramuscularly in Jan2021 at dose 1, single and in Feb2021 at dose 2, single for COVID-19 immunisation; abatacept (ORENCIA), via an unspecified route of administration from 2011 (Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication; adalimumab (HUMIRA), subcutaneously from 2011 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported. Patient previously had major problems on Methotrexate, specifically pain all over body could not get out of bedridden. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced covid-19 in Dec2020, arthralgia aggravated in 2021, had rheumatoid arthritis, headache, breathing difficult/trouble breathing, nausea/sick to stomach. The outcome of the events was unknown. The causality between Pfizer vaccine, Humira (Adalimubab) and events was not provided  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative
Clinical narrative: Colitis ulcerative aggravated; This is a Solicited report based on the information received by Pfizer from a company (Manufacturer Control No: 21K-163-4052522-00). A contactable  consumer (patient) reported a 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 01Mar2021, dose 2 on 23Mar2021, both via intramuscular (at age of 59-year-old) at single dose for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneously from an unspecified date, at unspecified dose for moderate to severe ulcerative colitis. The patient's medical history and concomitant medications were not reported.  The patient experienced colitis ulcerative aggravated on an unspecified date in 2021. The event was reported as non-serious ulcerative colitis flare after COVID vaccine with adalimumab. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. The action taken in response to the event for adalimumab was unknown. The outcome of the event was unknown. The reporter's causality for the event of ulcerative colitis flare after COVID vaccine with adalimumab was not provided. The reporter's causality for the event of ulcerative colitis flare was possible related to bnt162b2.   No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the event colitis ulcerative and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Fibromyalgia, Menstrual disorder, Nodule
Clinical narrative: The hospital doctor diagnosed the caller with possible fibromyalgia; The pain has gone into the caller's joints; the right side of the caller's body she had baseball size knots but it wouldn't go away; restarted menstrual cycle; the caller woke up in the most pain she has ever been in in her entire life; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.   A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA7484  and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 07Aug2021 at the age of 36-years-old as DOSE 1, SINGLE for Covid-19 immunization.  Medical history included arthritis from an unknown date and unknown if ongoing Diagnosed 2 years ago , asthma from an unknown date and unknown if ongoing Diagnosed about 5 years ago , mental disorder from an unknown date and unknown if ongoing Diagnosed at age 22 , thyroid disorder from 2020 to an unknown date. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for an unspecified indication, start and stop date were not reported. On 2021 the patient experienced the caller woke up in the most pain she has ever been in in her entire life. on 09Aug2021 the patient experienced restarted menstrual cycle and it hasnt stopped since, on 13Aug2021 the patient experienced the right side of the caller's body she had baseball size knots but it wouldn't go away. on an unspecified date the patient experienced the hospital doctor diagnosed the caller with possible fibromyalgia, on an unspecified date the patient experienced the pain has gone into the caller's joints. The patient is on birth control and everything has controlled her period always until now. The birth control is called Lo Loestrogen FE also known as Lo E.The patient underwent lab tests and procedures which included blood test: unknown results   on   something with her muscles is elevated , sars-cov-2 antibody test: positive on 01Jan2021.Therapeutic measures were taken as a result of the caller woke up in the most pain she has ever been in in her entire life , the pain has gone into the caller's joints. The outcome of events was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 antibody test
Clinical narrative: The hospital doctor diagnosed the caller with possible fibromyalgia; The pain has gone into the caller's joints; the right side of the caller's body she had baseball size knots but it wouldn't go away; restarted menstrual cycle; the caller woke up in the most pain she has ever been in in her entire life; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.   A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA7484  and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 07Aug2021 at the age of 36-years-old as DOSE 1, SINGLE for Covid-19 immunization.  Medical history included arthritis from an unknown date and unknown if ongoing Diagnosed 2 years ago , asthma from an unknown date and unknown if ongoing Diagnosed about 5 years ago , mental disorder from an unknown date and unknown if ongoing Diagnosed at age 22 , thyroid disorder from 2020 to an unknown date. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for an unspecified indication, start and stop date were not reported. On 2021 the patient experienced the caller woke up in the most pain she has ever been in in her entire life. on 09Aug2021 the patient experienced restarted menstrual cycle and it hasnt stopped since, on 13Aug2021 the patient experienced the right side of the caller's body she had baseball size knots but it wouldn't go away. on an unspecified date the patient experienced the hospital doctor diagnosed the caller with possible fibromyalgia, on an unspecified date the patient experienced the pain has gone into the caller's joints. The patient is on birth control and everything has controlled her period always until now. The birth control is called Lo Loestrogen FE also known as Lo E.The patient underwent lab tests and procedures which included blood test: unknown results   on   something with her muscles is elevated , sars-cov-2 antibody test: positive on 01Jan2021.Therapeutic measures were taken as a result of the caller woke up in the most pain she has ever been in in her entire life , the pain has gone into the caller's joints. The outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died in his sleep; This is a spontaneous report from a non-contactable consumer.  A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient died in his sleep (death).  The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died in his sleep
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Eating disorder, Magnetic resonance imaging head
Clinical narrative: Couldn't eat for 3-5 days after both doses; This is a spontaneous report from a contactable consumer (patient).   A 29-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration on 11Apr2021 (Batch/Lot number was not reported) as single dose (at the age of 29) for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included famotidine, ibuprofen (DUEXIS). No covid prior vaccination. No covid tested post vaccination. The patient previously took dexamethasone and experienced drug hypersensitivity. The patient experienced couldn't eat for 3-5 days after both doses on 14Apr2021 12:00. Patient was treated with Niacinamide B6 vitamins. The outcome was not recovered. The patient underwent lab tests and procedures which included blood test: unknown, magnetic resonance imaging head: unknown.    The lot number for BNT162b2 was not provided and will be requested during follow up
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Fatigue, Feeding disorder, Hypoaesthesia, Magnetic resonance imaging head
Clinical narrative: Couldn't eat for 3-5 days after both doses; This is a spontaneous report from a contactable consumer (patient).   A 29-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration on 11Apr2021 (Batch/Lot number was not reported) as single dose (at the age of 29) for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included famotidine, ibuprofen (DUEXIS). No covid prior vaccination. No covid tested post vaccination. The patient previously took dexamethasone and experienced drug hypersensitivity. The patient experienced couldn't eat for 3-5 days after both doses on 14Apr2021 12:00. Patient was treated with Niacinamide B6 vitamins. The outcome was not recovered. The patient underwent lab tests and procedures which included blood test: unknown, magnetic resonance imaging head: unknown.    The lot number for BNT162b2 was not provided and will be requested during follow up
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Couldn't eat for 3-5 days after both doses; This is a spontaneous report from a contactable consumer (patient).   A 29-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration on 11Apr2021 (Batch/Lot number was not reported) as single dose (at the age of 29) for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included famotidine, ibuprofen (DUEXIS). No covid prior vaccination. No covid tested post vaccination. The patient previously took dexamethasone and experienced drug hypersensitivity. The patient experienced couldn't eat for 3-5 days after both doses on 14Apr2021 12:00. Patient was treated with Niacinamide B6 vitamins. The outcome was not recovered. The patient underwent lab tests and procedures which included blood test: unknown, magnetic resonance imaging head: unknown.    The lot number for BNT162b2 was not provided and will be requested during follow up
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Eating disorder, Magnetic resonance imaging head
Clinical narrative: Couldn't eat; heavy fatigue; facial tingling and numbness; facial tingling and numbness; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at a pharmacy or drug store facility on 02May2021 16:00 (Batch/Lot Number: ER8736) as DOSE 2, SINGLE for covid-19 immunisation. The patient had no covid prior to vaccination and has not been tested for covid post vaccination. The patient had known allergies to dexamethasone. Concomitant medication included famotidine, ibuprofen (DUEXIS). Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 11Apr2021 (at the age of 29-year-old) for covid-19 immunisation and experienced couldn't eat for 3-5 days after and heavy fatigue. On unspecified date, the patient experienced couldn't eat for 3-5 days, heavy fatigue, and facial tingling and numbness. The events resulted in doctor or other healthcare professional office/clinic visit and was considered serious due to permanent disability. The patient underwent lab tests and procedures which included blood test: unknown results and magnetic resonance imaging (MRI) of brain: unknown results on unspecified date. Therapeutic measures were taken as a result of the events which included Heprin, Niacinamide B6, vitamins, MRI of brain, and bloodwork. The patient had not yet recovered from the events.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Fatigue, Feeding disorder, Hypoaesthesia, Magnetic resonance imaging head
Clinical narrative: Couldn't eat; heavy fatigue; facial tingling and numbness; facial tingling and numbness; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at a pharmacy or drug store facility on 02May2021 16:00 (Batch/Lot Number: ER8736) as DOSE 2, SINGLE for covid-19 immunisation. The patient had no covid prior to vaccination and has not been tested for covid post vaccination. The patient had known allergies to dexamethasone. Concomitant medication included famotidine, ibuprofen (DUEXIS). Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 11Apr2021 (at the age of 29-year-old) for covid-19 immunisation and experienced couldn't eat for 3-5 days after and heavy fatigue. On unspecified date, the patient experienced couldn't eat for 3-5 days, heavy fatigue, and facial tingling and numbness. The events resulted in doctor or other healthcare professional office/clinic visit and was considered serious due to permanent disability. The patient underwent lab tests and procedures which included blood test: unknown results and magnetic resonance imaging (MRI) of brain: unknown results on unspecified date. Therapeutic measures were taken as a result of the events which included Heprin, Niacinamide B6, vitamins, MRI of brain, and bloodwork. The patient had not yet recovered from the events.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Couldn't eat; heavy fatigue; facial tingling and numbness; facial tingling and numbness; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at a pharmacy or drug store facility on 02May2021 16:00 (Batch/Lot Number: ER8736) as DOSE 2, SINGLE for covid-19 immunisation. The patient had no covid prior to vaccination and has not been tested for covid post vaccination. The patient had known allergies to dexamethasone. Concomitant medication included famotidine, ibuprofen (DUEXIS). Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 11Apr2021 (at the age of 29-year-old) for covid-19 immunisation and experienced couldn't eat for 3-5 days after and heavy fatigue. On unspecified date, the patient experienced couldn't eat for 3-5 days, heavy fatigue, and facial tingling and numbness. The events resulted in doctor or other healthcare professional office/clinic visit and was considered serious due to permanent disability. The patient underwent lab tests and procedures which included blood test: unknown results and magnetic resonance imaging (MRI) of brain: unknown results on unspecified date. Therapeutic measures were taken as a result of the events which included Heprin, Niacinamide B6, vitamins, MRI of brain, and bloodwork. The patient had not yet recovered from the events.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Herpes zoster
Clinical narrative: Heavy period with large amounts of blood clots; Shingles; This is a spontaneous report from a contactable consumer (patient).   A 32-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number FA7485), via an unspecified route of administration, in the left arm, on 27Aug2021, at 01:15 PM, at single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included shingles from an unspecified date. The patient had not experienced Covid-19 prior vaccination. Concomitant medication included fluoxetine from an unspecified date (within 2 weeks of vaccination), at an unknown dose, for an unspecified indication. On 28Aug2021, at 12:00 AM, the patient experienced heavy period with large amounts of blood clots and shingles. The patient was treated for shingles with Valtrex. Clinical outcome of the adverse events was unknown at time of this report. Post the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure timing unspecified, Sjogren's syndrome
Clinical narrative: Sjogren's; is pregnant/received her first two doses of the Pfizer BioNTech Covid 19 vaccine while pregnant.; This is a spontaneous report from a contactable consumer (mother) from the Pfizer-sponsored program. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), (age at vaccination was at 31 years old) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single, and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunisation. Medical history was not reported. Concomitant medication included hydroxychloroquine (HYDROXYCHLOROQUINE) taken for an unspecified indication, start and stop date were not reported. The patient has Sjogren's and is pregnant and received her first two doses of the Pfizer BioNTech Covid 19 vaccine while pregnant. The event outcome was unknown.   The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Herpes zoster, Hypoaesthesia, Paraesthesia, Swelling
Clinical narrative: Frozen arm that turned into numbness and tingling in both arms and hands; Frozen arm that turned into numbness and tingling in both arms and hands; Had an outbreak of shingles; Swelling; Burning; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 03Mar2021 at 12:30 hours as dose 1, single for COVID-19 immunisation. Medical history included polymyalgia rheumatica and heart conditions from an unknown date and unknown if ongoing. Patent family history included father had everything, was overweight and diabetic, and died at 58 years old and mother died at 91 years old from bone cancer. Patient mother and brother both had polymyalgia rheumatica. Concomitant medication(s) included meloxicam taken for swollen ankles from an unspecified start date and ongoing. Patient had no prior Vaccinations (within 4 weeks). Patient had no history of previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. On an unspecified date of 2021, after the first dose, patient had a mild side effects, patient had an outbreak of shingles and after the shingles was treated and went away, he was left with a frozen arm that turned into numbness and tingling in both arms and hands. Patient had polymyalgia rheumatica in the past, but rheumatologist told him this wouldn't cause numbness and tingling in both hands, only one side so they don't think that was what was going on. Patient still having this in both hands and swelling and burning. Therapeutic measures were taken as a result of outbreak of shingles and treatment included unknown medication. Patient had physician office visit for shingles. Patient had no emergency room visit for the events. The outcome of outbreak of shingles was recovered on an unspecified date of 2021, and unknown for rest of the events.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Dysstasia, Gait disturbance, Movement disorder, Pain
Clinical narrative: I can't hardly get up or lift my legs; when she gets up to walk she can hardly lift her legs; when she gets up to walk she can hardly lift her legs; my bones, legs, arms, everything aches; my bones, legs, arms, everything aches; my bones, legs, arms, everything aches; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the left arm on 09Aug2021, between 12-1 PM (Batch/Lot Number: FC3180) at the age of 54-years-old, single, for COVID-19 immunization (reported as "to keep from catching the virus"). Medical history included back pain from an unknown date and unknown if ongoing (takes an inhaler and takes Flexeril a muscle relaxer and an aspirin a day). Concomitant medication aspirin and an inhaler (unspecified), from unspecified dates and for unspecified indications. The patient previously received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine) via an unspecified route of administration in the left arm on 19Jul2021 (Lot number: FA7484) and had no adverse effect. The patient did not have other prior Vaccinations (within 4 weeks) and did not have AE's with prior vaccinations. The patient stated that she got her second Pfizer COVID-19 shot on 09Aug2021 and wanted to know why she was still hurting. She further stated that since then, on an unspecified date in 2021, her bones, legs, arms, and everything ached when she gets up to walk. She can't hardly get up or lift her legs. She had to stand up straight before she could walk. According to the patient, this started about a week ago and it's the same. For treatment, she was prescribed a muscle relaxer, Flexeril, and it's not helping. Stated it was 10mg once a day. The patient clarified that she had the Flexeril before this and used it to see if it would help. The events did not require a visit to the Emergency Room or Physician office. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I can't hardly get up or lift my legs; when she gets up to walk she can hardly lift her legs; when she gets up to walk she can hardly lift her legs; my bones, legs, arms, everything aches; my bones, legs, arms, everything aches; my bones, legs, arms, everything aches; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the left arm on 09Aug2021, between 12-1 PM (Batch/Lot Number: FC3180) at the age of 54-years-old, single, for COVID-19 immunization (reported as "to keep from catching the virus"). Medical history included back pain from an unknown date and unknown if ongoing (takes an inhaler and takes Flexeril a muscle relaxer and an aspirin a day). Concomitant medication aspirin and an inhaler (unspecified), from unspecified dates and for unspecified indications. The patient previously received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine) via an unspecified route of administration in the left arm on 19Jul2021 (Lot number: FA7484) and had no adverse effect. The patient did not have other prior Vaccinations (within 4 weeks) and did not have AE's with prior vaccinations. The patient stated that she got her second Pfizer COVID-19 shot on 09Aug2021 and wanted to know why she was still hurting. She further stated that since then, on an unspecified date in 2021, her bones, legs, arms, and everything ached when she gets up to walk. She can't hardly get up or lift her legs. She had to stand up straight before she could walk. According to the patient, this started about a week ago and it's the same. For treatment, she was prescribed a muscle relaxer, Flexeril, and it's not helping. Stated it was 10mg once a day. The patient clarified that she had the Flexeril before this and used it to see if it would help. The events did not require a visit to the Emergency Room or Physician office. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Photophobia, Pyrexia, Visual impairment
Clinical narrative: very bad light sensitivity to eyes and vision was affected. Felt like her eyes were dilated; very bad light sensitivity to eyes and vision was affected. Felt like her eyes were dilated; Fever; Chills; Body aches; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 31Aug2021 16:00 (Batch/Lot Number: FE3592) (at the age of 49 years old) as single dose for Covid-19 immunisation. The patient medical history was not reported. Family history and relevant tests were none. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 09Aug2021 (Batch/Lot Number: FA7484) (at the age of 49 years old) via an unspecified route of administration in left upper arm for Covid-19 immunisation. There were no concomitant medications. After the second dose of vaccine, on 01Sep2021, the patient had fever, chills, and body aches. On 03Sep2021, the patient had very bad light sensitivity to eyes and vision was affected. Felt like her eyes were dilated. She consulted her ophthalmologist. Now with her eyes, she was worried and hoping it will go away. The patient had not recovered from light sensitivity to eye and vision abnormal. Outcome of the other events was recovering.    No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest discomfort
Clinical narrative: Heart hurts feels really tight; Heart hurts feels really tight; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Sep2021 11:00 at the age of 41 years old (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced heart hurts feels really tight on 03Sep2021 13:00. The outcome of events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment given for the events.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: gave a "whole vial, 6 doses to one patient."; This is a spontaneous report from a contactable Pharmacist.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. Reporter informed that the Clinic across the street gave a whole vial, 6 doses to one patient. HCP was unsure if the Vaccine was diluted or undiluted because They weren't answering their phone, so he can't find out right now. HCP was also unable to provide any patient information at this time. Reporter was at a hospital and he was got a safety issue at one his clinics across the street (as reported). They gave a whole vial to a patient, he clarified as six doses. He didn't know if they should send them to the ER or just monitor them at the clinic for an hour. He was concerning for any guidance on that. The patient experienced overdose on an unspecified date with outcome unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Sender's Comments: Based on plausible dose, event relationship post vaccination, and the causal role of BNT162B2 vaccine cannot be excluded for the reported even. The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Energy increased, Fatigue, Insomnia, Malaise
Clinical narrative: couldn't sleep at all; she was rushing, she had a lot of energy and she couldn't settle down; extremely fatigued; shaking; diarrhea; doesn't feel well / She doesn't  feel well and she wants to know if she is okay; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Sep2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. The patient medical history was not reported. Historical vaccine included Flu vaccine in 1998 (23 years ago) for immunization which she had an adverse reaction. The patient's concomitant medications were not reported. The patient stated she got the first dose of the vaccine on Wednesday night (01Sep2021) and was having some issues and wanted to talk to someone because she was alone and doesn't feel well (Sep2021). She was fine with no pain or side effects all day yesterday. Thursday she was fine. Friday (03Sep2021), well last night, she couldn't sleep at all. It was like she was rushing, she had a lot of energy and she couldn't settle down. She didn't sleep an hour and now was extremely fatigued today. On an unknown date in Sep2021, she has been shaking, didn't sleep, had diarrhea and was fatigued but has no pain at the site of the injection. She can't tell if these are normal things. She just can't tell if it was from the vaccine or what was going on and thought someone should be told. She said she consulted the doctor about her symptoms and they referred her. She stated because she had an adverse reaction to a flu shot many years ago, where she had an immediate reaction with that, she just didn't feel right and wanted to make sure the symptoms she has were normal and she stated it does not say anything about how long they last in the paperwork she received. She also wanted to know how soon a bad reaction would occur after the vaccine, if it was within an hour. She didn't feel well and she wanted to know if she was okay. She stated she was fine and she was expecting a reaction early and didn't have anything and said that it was good to hear [regarding when severe allergic reactions usually occur vs side effects] and made her feel a little calmer. She stated she will keep sipping water and rest as much as she can. She stated if she did get worse she may not be able to call anybody. Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: couldn't sleep at all; she was rushing, she had a lot of energy and she couldn't settle down; extremely fatigued; shaking; diarrhea; doesn't feel well / She doesn't  feel well and she wants to know if she is okay; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Sep2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. The patient medical history was not reported. Historical vaccine included Flu vaccine in 1998 (23 years ago) for immunization which she had an adverse reaction. The patient's concomitant medications were not reported. The patient stated she got the first dose of the vaccine on Wednesday night (01Sep2021) and was having some issues and wanted to talk to someone because she was alone and doesn't feel well (Sep2021). She was fine with no pain or side effects all day yesterday. Thursday she was fine. Friday (03Sep2021), well last night, she couldn't sleep at all. It was like she was rushing, she had a lot of energy and she couldn't settle down. She didn't sleep an hour and now was extremely fatigued today. On an unknown date in Sep2021, she has been shaking, didn't sleep, had diarrhea and was fatigued but has no pain at the site of the injection. She can't tell if these are normal things. She just can't tell if it was from the vaccine or what was going on and thought someone should be told. She said she consulted the doctor about her symptoms and they referred her. She stated because she had an adverse reaction to a flu shot many years ago, where she had an immediate reaction with that, she just didn't feel right and wanted to make sure the symptoms she has were normal and she stated it does not say anything about how long they last in the paperwork she received. She also wanted to know how soon a bad reaction would occur after the vaccine, if it was within an hour. She didn't feel well and she wanted to know if she was okay. She stated she was fine and she was expecting a reaction early and didn't have anything and said that it was good to hear [regarding when severe allergic reactions usually occur vs side effects] and made her feel a little calmer. She stated she will keep sipping water and rest as much as she can. She stated if she did get worse she may not be able to call anybody. Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, SARS-CoV-2 test, Tinnitus
Clinical narrative: Left arm 6 months later still stuck,  ears ringing. Tinnitus now very bad; Left arm 6 months later still stuck,  ears ringing. Tinnitus now very bad; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, dose number unknown, via an unspecified route of administration, administered in left arm on 12Mar2021 07:00, at 70 years of age, (Batch/Lot Number: Ew0150) as single dose for COVID-19 immunization. Medical history included allergy to sulfa drugs from an unknown date. The patient was not diagnosed with COVID-19 prior vaccination. Concomitant medication included estrogens conjugated (PREMARIN) taken for an unspecified indication, since an unknown date. The patient didn't receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient reported that on 12Mar2021 08:00 she experienced left arm stuck, ears ringing, tinnitus. These events were assessed serious as disabling/incapacitating. On 31Aug2021 the patient underwent SARS-CoV-2 test (nasal swab) which was negative. It was reported that 6 months later the left arm was still stuck, ears were still ringing and tinnitus was now very bad. No treatment was administered for the events. At the time of the report the event had not resolved yet.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: his wife was vaccinated but still got CoVid; his wife was vaccinated but still got Covid; This is a spontaneous report from a program via a non-contactable other, HCP reported for a female patient. A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as unknown, a single dose for COVID-19 immunization. The reporter stated the patient was vaccinated but still got COVID on an unspecified date. The reporter went on to express wishes that hopes everyone from Pfizer gets COVID and wondered how we could sleep with ourselves for inventing such a terrible vaccine and went on with some profanities and hung up. The patient underwent lab test and procedure included COVID with result still got covid on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained. Sender's Comments: As there is limited information in the case provided, the causal association between the event Covid 19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Cerebrovascular accident, Myocardial infarction
Clinical narrative: stroke; heart attack; he has a lot of heart problems; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose and First dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced stroke, heart attack, he has a lot of heart problems. Clinical course was reported as patient was 69-year-old patients who wants to know when he and his wife will get their booster shot. He has a lot of heart problems. he had a stroke and a couple of heart attack. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.