chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Hypoaesthesia, Inappropriate schedule of product administration, Lymphadenopathy, Paraesthesia
Clinical narrative: Left eye isn't right; Didn't get second dose of Covid-19 vaccine as scheduled; Everything on the left side of body was going numb/Left nostril went numb/Left cheekbone really tight and numb/Left back side of neck went numb/Left shoulder and arm were numb; Tingling in fingers; Lymph nodes on left side of neck were swollen; Left shoulder and arm were numb; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: was not reported; Expiration Date: Jul2021) via an unspecified route of administration on 16Mar2021 18:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On 16Mar2021 the patient experienced everything on the left side of body was going numb, left nostril went numb, left cheekbone really tight and numb, left back side of neck went numb, left shoulder and arm were numb on 16Mar2021, tingling in fingers, lymph nodes on left side of neck were swollen. The patient experienced left eye isn't right and didn't get second dose of covid-19 vaccine as scheduled on an unspecified date. Caller reported that she was supposed to get her second dose of the Covid-19 vaccine on 06Apr2021 but she is waiting to get the second dose. Caller reported that her physician is going to run tests because her symptoms have been kind of bizarre. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Pharyngeal swelling, Swelling face
Clinical narrative: face and throat swelling and redness; face and throat swelling and redness; mild face swelling; lymph nodes swelling in armpits; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; Lot Number: ER8737 and expiration date was not reported), via an unspecified route administered in right arm on 31Mar2021 at 12:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. The patient had no known allergies to medications, food or other products. The patient's medical history included ductal carcinoma in situ (DCIS). The patient previously received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; Lot Number and expiration date were not reported), via an unspecified route of administration, date and dose for COVID-19 immunization. The patient was not pregnant. It was reported that no other vaccine was given in four weeks but patient had received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced mild face swelling and lymph nodes swelling in armpits on day 1 (01Apr2021) after vaccination. On day 2 and 3 after vaccination, the patient had only mild face swelling. On day 4 (04Apr2021), the patient experienced severe face and throat swelling and redness. The patient rushed to the emergency room (ER) but conditions reduced by 80% by the time of arrival at the ER. The patient took diphenhydramine (BENADRYL) tablets and the doctor prescribed an epinephrine autoinjector (EPIPEN) and told her to keep on hand. From day 5 to day 8, mild facial swelling still exits. On day 9 (09Apr2021), patient had just a trace of facial swelling. It seems like conditions were getting normal. The outcome of the event facial swelling was recovering at the reporting time. The outcome of lymph nodes swelling in armpits and severe face and throat swelling and redness was recovered at the reporting time on Apr2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: started the migraines, kicking it into overdrive; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included she is immunocompromised and is suffering from heart problems (both ongoing), had a hysterotomy 2 months before an unspecified date, ongoing auto-immune issues. Concomitant medications included had botulinum toxin type a (BOTOX) injections 2 weeks prior to her first injection; golimumab (SIMPONI) for auto-immune issues. Patient reported that she already had the injections of golimumab done. After receiving the first dose of Pfizer's COVID vaccine, it kicked her migraines to overdrive on an unspecified date. After her 1st injection, it started the migraines, kicking it into overdrive. Her migraine doctor started another medication and started another side medication on top of that. And she was still having migraines. Therapeutic measures were taken as a result of the event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Right sided Bell's Palsy Grade IV; This is a spontaneous report from a contactable physician. A 42-Year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) intramuscular, administered in left arm on 15Mar2021 (at the age of 41-years-old) as SINGLE DOSE, dose and second dose was intramuscular, administered in left arm on 05Apr2021 as SINGLE DOSE for covid-19 immunization. Medical history included covid-19 and ongoing allergies. Concomitant medication was Benadryl PRN for allergies. On 09Apr2021,the patient experienced right sided bell's palsy grade iv. The patient underwent lab tests and procedures which included sars-cov-2 test was pending on 09Apr2021 Covid test type post vaccination done by nasal swab. Therapeutic measures were taken as a result of right sided bell's palsy grade iv included Prednisone Taper and pain medication. The outcome of event was not recovered.  Information about the Lot/batch number has been requested. ; Sender's Comments: Considering a plausible temporal relationship, a possible contributory role of suspect vaccine BNT162B2 to the reported event facial paralysis cannot be completely 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site joint movement impairment, Vaccination site joint pain, Vaccination site swelling
Clinical narrative: Swelling under the armpit of arm; painful and prevents the arm from moving; painful and prevents the arm from moving; This is a spontaneous report of a contactable consumer (patient) by a Pfizer colleague through a program. A 58-Year-old female consumer received the doses 1 of bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in arm right, administered on 07Apr2021 at 14:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history includes Type 1 Diabetic, pressure (increased blood pressure) and allergic to penicillin. Concomitant medications were not reported. It was reported that on 08Apr2021 at 05:00 pm patient experienced swelling under the armpit of arm where vaccine was administered, and It was painful and prevents the arm from moving. The patient was not pregnant at the time of vaccination. The patient did not do a test Covid post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. Patient did not receive any other vaccine in four weeks. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Autism spectrum disorder, Cerebral palsy
Clinical narrative: cerepal palsy; autism; This is a spontaneous report from a contactable other healthcare professional (mother) reporting for her child. A 16-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient took Flu vaccine eight years ago, eyes glued shut and was hospitalized, reported sticky. She does not know the ingredients but mentioned preservatives. The patient concomitant medications were not reported. On an unspecified date, the reporter stated that her child had cerebral palsy and autism and was looking for information on adverse events. Outcome was unknown for the events.   Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events cerebral palsy and autism and the suspect drug.  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: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: (name) had a seizure within 5 minutes or less of the first dose.; This is a spontaneous report from a contactable consumer or other non-HCP. A 16-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8729) via an unspecified route of administration in Right Arm on 09Apr2021 00:30 as single dose for covid-19 immunization. Medical history included depression and seizure. The patient's concomitant medications were not reported. On 09Apr2021 00:30, the patient had a seizure within 5 minutes or less of the first dose. Therapeutic measures were taken as a result of had a seizure within 5 minutes or less of the first dose. The outcome of event was recovering.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Insomnia, Palpitations
Clinical narrative: Chest pain; Palpitations; Shortness of breath; Cant Sleep; This is a spontaneous report from a contactable consumer reporting for himself. A 48-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 21Mar2021 17:00 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation (Age at vaccination 48 years) .  Medical history included anxiety,Post traumatic stress disorder , hypertension , blood cholesterol increased. On 24Feb2021 the patient received the first dose of BNT162B2 vaccine. Concomitant medication included clonazepam (CLONAZEPAM) taken for anxiety, start and stop date were not reported.  The patient previously took penicillin b.   The patient experienced chest pain  , palpitations  , shortness of breath , cant sleep all on 23Mar2021 with outcome of not recovered.    Course of events. This past Sunday would be 3 weeks post receiving his vaccine. Since he got the vaccine, about 3 days later he experienced chest pain, palpitations, Shortness of breath. He checked his own Blood pressure and its not high and his pulse is normal also. He's not a doctor and he doesn't know if its anxiety, but he also cant sleep, he's been getting like 4 hours of sleep every night since this started.  No follow-up attempts are needed. No further information is expected. Lot information already received.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Malaise, Pain in extremity, Seizure
Clinical narrative: Seizure; Cough; Sore Right Arm; physical ability to do things has worsened, he is really tired, states she has no good words to describe it, but he is physically not able to do things after the two seizures; physical ability to do things has worsened, he is really tired, states she has no good words to describe it, but he is physically not able to do things after the two seizures; This is a spontaneous report from a contactable consumer (reporter's boyfriend). A 21-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 07Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. There were no medical history and concomitant medications reported. It was reported that, seizure (within the 15-minute wait time he experienced a seizure), cough, sore right arm, physical ability to do things has worsened, he is tired, states she has no good words to describe it, but he is physically not able to do things after the two seizures on 07Apr2021. No therapeutic measures were taken. The outcome of the event was unknown for seizure, for cough and physical ability to do things has worsened, he is really tired, states she has no good words to describe it, but he is physically not able to do things after the two seizures outcome of the event was not recovered/not resolved and for sore right arm outcome of the event was recovering/resolving.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Burning sensation, Dry throat, Dyspnoea
Clinical narrative: pain in her left shoulder; dry throat; sore throat and throat pain; feel severe pain on her arm; a burning sensation in all of her left arm combined with a tingling sensation and cramps,; a burning sensation in all of her left arm combined with a tingling sensation and cramps,; a burning sensation in all of her left arm combined with a tingling sensation and cramps,; fell generalized weakness; was not able to breath properly, her breathing was similar to an asthma attack; vomited; heart was beating like never before; feel severe pain on her arm that would not aloud her to move her arm; had a nervous breakdown; This is a spontaneous report received from a contactable consumer, the patient. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date in Apr2021 at 10 am SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Approximately on an unspecified date in Apr2021 from 4 pm the patient experienced to develop a lot of adverse reactions that increased over time: she presented pain in her left shoulder that did not allowed her to move properly, dry throat, sore throat and throat pain. She returned home to rest and overnight she started to feel severe pain on her arm that would not allowed her to move her arm, she put ice on her left arm which allowed her to sleep for a couple of hours, at midnight she started to experience a burning sensation in all of her left arm combined with a tingling sensation and cramps, this sensation extended through one of her legs and then the other one, she started to fell generalized weakness and was not able to breath properly, her breathing was similar to an asthma attack and she had to choose between speaking or breathing because she was unable to do both at the same time, she had to be send to the emergency room where she vomited, had a nervous breakdown and after a couple of hours was stabilized, she felt that her heart was "beating like never before", this worries her because she believes that she could go into a heart attack or have a stroke, today she only has pain in her arm. The Patient wants to know if she can take Advil to treat the adverse effects. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Mental disorder, Mobility decreased, Muscle spasms, Oropharyngeal pain
Clinical narrative: pain in her left shoulder; dry throat; sore throat and throat pain; feel severe pain on her arm; a burning sensation in all of her left arm combined with a tingling sensation and cramps,; a burning sensation in all of her left arm combined with a tingling sensation and cramps,; a burning sensation in all of her left arm combined with a tingling sensation and cramps,; fell generalized weakness; was not able to breath properly, her breathing was similar to an asthma attack; vomited; heart was beating like never before; feel severe pain on her arm that would not aloud her to move her arm; had a nervous breakdown; This is a spontaneous report received from a contactable consumer, the patient. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date in Apr2021 at 10 am SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Approximately on an unspecified date in Apr2021 from 4 pm the patient experienced to develop a lot of adverse reactions that increased over time: she presented pain in her left shoulder that did not allowed her to move properly, dry throat, sore throat and throat pain. She returned home to rest and overnight she started to feel severe pain on her arm that would not allowed her to move her arm, she put ice on her left arm which allowed her to sleep for a couple of hours, at midnight she started to experience a burning sensation in all of her left arm combined with a tingling sensation and cramps, this sensation extended through one of her legs and then the other one, she started to fell generalized weakness and was not able to breath properly, her breathing was similar to an asthma attack and she had to choose between speaking or breathing because she was unable to do both at the same time, she had to be send to the emergency room where she vomited, had a nervous breakdown and after a couple of hours was stabilized, she felt that her heart was "beating like never before", this worries her because she believes that she could go into a heart attack or have a stroke, today she only has pain in her arm. The Patient wants to know if she can take Advil to treat the adverse effects. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Vomiting
Clinical narrative: pain in her left shoulder; dry throat; sore throat and throat pain; feel severe pain on her arm; a burning sensation in all of her left arm combined with a tingling sensation and cramps,; a burning sensation in all of her left arm combined with a tingling sensation and cramps,; a burning sensation in all of her left arm combined with a tingling sensation and cramps,; fell generalized weakness; was not able to breath properly, her breathing was similar to an asthma attack; vomited; heart was beating like never before; feel severe pain on her arm that would not aloud her to move her arm; had a nervous breakdown; This is a spontaneous report received from a contactable consumer, the patient. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date in Apr2021 at 10 am SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Approximately on an unspecified date in Apr2021 from 4 pm the patient experienced to develop a lot of adverse reactions that increased over time: she presented pain in her left shoulder that did not allowed her to move properly, dry throat, sore throat and throat pain. She returned home to rest and overnight she started to feel severe pain on her arm that would not allowed her to move her arm, she put ice on her left arm which allowed her to sleep for a couple of hours, at midnight she started to experience a burning sensation in all of her left arm combined with a tingling sensation and cramps, this sensation extended through one of her legs and then the other one, she started to fell generalized weakness and was not able to breath properly, her breathing was similar to an asthma attack and she had to choose between speaking or breathing because she was unable to do both at the same time, she had to be send to the emergency room where she vomited, had a nervous breakdown and after a couple of hours was stabilized, she felt that her heart was "beating like never before", this worries her because she believes that she could go into a heart attack or have a stroke, today she only has pain in her arm. The Patient wants to know if she can take Advil to treat the adverse effects. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling hot, Headache
Clinical narrative: Injection site pain; Fatigue; Headache; Muscle pain; Chills; Low grade fever; Joint pain; Mild swelling at the injection site; Nausea; Feeling warmness; This is a spontaneous report from a contactable consumer.  A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included middle ear infection. Concomitant medication included ciprofloxacin taken for Middle ear infection.  It was reported that patient got the first shot about 2 weeks ago and is still having side effects. He stated he knows it should only last a day or two and he asked what he should. When probed for symptoms experienced, consumer stated on an unspecified date he had injection site pain, fatigue, headache, muscle pain, chills, joint pain, low grade fever, mild swelling at the injection site, nausea, feeling warmness. Patient also stated, For the first couple days he took Acetaminophen they said not to take anything but Acetaminophen and since then he had been taking Ibuprofen. Outcome of the events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site pain; Fatigue; Headache; Muscle pain; Chills; Low grade fever; Joint pain; Mild swelling at the injection site; Nausea; Feeling warmness; This is a spontaneous report from a contactable consumer.  A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included middle ear infection. Concomitant medication included ciprofloxacin taken for Middle ear infection.  It was reported that patient got the first shot about 2 weeks ago and is still having side effects. He stated he knows it should only last a day or two and he asked what he should. When probed for symptoms experienced, consumer stated on an unspecified date he had injection site pain, fatigue, headache, muscle pain, chills, joint pain, low grade fever, mild swelling at the injection site, nausea, feeling warmness. Patient also stated, For the first couple days he took Acetaminophen they said not to take anything but Acetaminophen and since then he had been taking Ibuprofen. Outcome of the events was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, COVID-19, Decreased appetite, Memory impairment, Pneumonia
Clinical narrative: Pneumonia; got Covid; doesn't have her appetite back; still kind of shaky/was trembling and shaking; lives with her niece and she found her in between china cabinet and fireplace and asked her how long she been there and she didn't know/going to the bathroom on herself and she doesn't recall that; This is a spontaneous report from a contactable consumer (reported for herself).  This 79-year-old female patient received her first dose of the BNT162B2 (Pfizer covid vaccine, Lot number: ER2613 expiry date: unknown) via an unspecified route at left arm as a single dose on 23Mar2021 11:00, for Covid-19 immunization. Medical history included diabetic, cholesterol, acid reflux; had a reaction to tetramycin: she had shortness of breath, sweating, and light headed-ness, 30 years prior to this report. She stated that it was a form of penicillin and they didn't have penicillin so they gave her something else. Concomitant medications included metformin(METFORMIN) for diabetic, fexofenadine hydrochloride (ALLEGRA) and ibandronate sodium (BONIVA). It was reported that she skipped Boniva, that she usually would take at the end of the month. On 25Mar2021, two days after first dose, she got covid and pneumonia . She visited emergency room and was admitted in the hospital from 26Mar2021 till 05Apr2021. The patient did not have her appetite back, felt still kind of shaky, and was trembling and shaking. She did not remember what happened on the 24Mar2021 and 25Mar2021. It was stated that she was improving but she was not back to par. she was not trembling. She stated that she was not fully recovered. She was scheduled for her second dose in 2 weeks on 13Apr2021. It was stated that she had got a list of concomitant medications she was taking (unspecified names) and she did not think any of them would have interacted with this and she was taking them way before she got the Covid shot, also stated that she did not think she had bad underlying issues. The patient had her blood sugar checked and was given her insulin because of Covid and something else. She did not receive any additional vaccines on same date of the Pfizer Suspect or prior vaccinations (within 4 weeks). The patient did not have any Antipyretic (around the date(s) of Vaccination). The patient was recovering from the event of Pneumonia. The outcome of the events of doesn't have her appetite back and shaky/was trembling and shaking was not recovered, however the outcome of the events of Covid and did not remember what happened on the 24Mar2021 and 25Mar2021 was unknown.  No further information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Pneumonia; got Covid; doesn't have her appetite back; still kind of shaky/was trembling and shaking; lives with her niece and she found her in between china cabinet and fireplace and asked her how long she been there and she didn't know/going to the bathroom on herself and she doesn't recall that; This is a spontaneous report from a contactable consumer (reported for herself).  This 79-year-old female patient received her first dose of the BNT162B2 (Pfizer covid vaccine, Lot number: ER2613 expiry date: unknown) via an unspecified route at left arm as a single dose on 23Mar2021 11:00, for Covid-19 immunization. Medical history included diabetic, cholesterol, acid reflux; had a reaction to tetramycin: she had shortness of breath, sweating, and light headed-ness, 30 years prior to this report. She stated that it was a form of penicillin and they didn't have penicillin so they gave her something else. Concomitant medications included metformin(METFORMIN) for diabetic, fexofenadine hydrochloride (ALLEGRA) and ibandronate sodium (BONIVA). It was reported that she skipped Boniva, that she usually would take at the end of the month. On 25Mar2021, two days after first dose, she got covid and pneumonia . She visited emergency room and was admitted in the hospital from 26Mar2021 till 05Apr2021. The patient did not have her appetite back, felt still kind of shaky, and was trembling and shaking. She did not remember what happened on the 24Mar2021 and 25Mar2021. It was stated that she was improving but she was not back to par. she was not trembling. She stated that she was not fully recovered. She was scheduled for her second dose in 2 weeks on 13Apr2021. It was stated that she had got a list of concomitant medications she was taking (unspecified names) and she did not think any of them would have interacted with this and she was taking them way before she got the Covid shot, also stated that she did not think she had bad underlying issues. The patient had her blood sugar checked and was given her insulin because of Covid and something else. She did not receive any additional vaccines on same date of the Pfizer Suspect or prior vaccinations (within 4 weeks). The patient did not have any Antipyretic (around the date(s) of Vaccination). The patient was recovering from the event of Pneumonia. The outcome of the events of doesn't have her appetite back and shaky/was trembling and shaking was not recovered, however the outcome of the events of Covid and did not remember what happened on the 24Mar2021 and 25Mar2021 was unknown.  No further information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Inflammation, Joint swelling
Clinical narrative: mild scleroderma flare up on skin; mild headache; tiredness; joint swelling and pain; joint swelling and pain; mild connective tissue inflammation; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old female (non pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8727), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 (at the age of 49-years-old) as SINGLE DOSE for covid-19 immunization. On an unspecified date medical history included scleroderma, scleroderma - symptoms of CREST syndrome(25+ years), food allergy to peanuts, shellfish. Concomitant medication(s) included loratadine (CLARITINE)and Multivitamin taken for an unspecified indication, on an unspecified date. On 23Mar2021, the patient experienced mild scleroderma flare up on skin, mild headache, tiredness, joint swelling and pain, joint swelling and pain and mild connective tissue inflammation. The outcome of the events were recovering.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Scleroderma
Clinical narrative: mild scleroderma flare up on skin; mild headache; tiredness; joint swelling and pain; joint swelling and pain; mild connective tissue inflammation; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old female (non pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8727), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 (at the age of 49-years-old) as SINGLE DOSE for covid-19 immunization. On an unspecified date medical history included scleroderma, scleroderma - symptoms of CREST syndrome(25+ years), food allergy to peanuts, shellfish. Concomitant medication(s) included loratadine (CLARITINE)and Multivitamin taken for an unspecified indication, on an unspecified date. On 23Mar2021, the patient experienced mild scleroderma flare up on skin, mild headache, tiredness, joint swelling and pain, joint swelling and pain and mild connective tissue inflammation. The outcome of the events were recovering.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood pressure measurement, Drooling, Heart rate, Oxygen saturation
Clinical narrative: Anaphylaxis; drooling; This is a spontaneous report from a non-contactable health care professional. A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EP7533, Expiration date: Not reported), via an unspecified route of administration on 08Apr2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that  patient had facial/throat swelling after the 15 min waiting period while driving home. No medical treatment, self-resolved with Benadryl at home, Differential Diagnosis: Anaphylaxis (dyspnea, stridor, drooling, tongue swelling). The patient underwent lab tests and procedures which includes patient Vital parameters results included: BP (138/89), HR (81), O2 (96%) at 11:45 am and BP (141/89), HR (68), O2 (97%) at 12:04.. Treatment included: Antihistamines, Epinephrine and IM steroids. Pre-treatment with Benadryl, Pepcid, and Zyrtec. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: The event anaphylaxis and drooling was considered related to suspect drug based on strong temporal association and known safety profile of the drug.   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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Lethargy, Oropharyngeal pain
Clinical narrative: Headache; body aches; light headedness; blurry vision; lethargic; sore throat the next morning; slight fever; fatigue; This is a spontaneous report from a non-contactable consumer or other non hcp. A 32-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included, covid 19 vaccination from an unknown date.The patient's concomitant medications were not reported. On 08Apr2021 patient had headache, body aches, light headedness, blurry vision, lethargic, sore throat the next morning, slight fever, fatigue resulted in prolongation of existing hospitalization (vaccine received during existing hospitalization). The patient did not test for COVID post vaccination and did not received any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vision blurred
Clinical narrative: Headache; body aches; light headedness; blurry vision; lethargic; sore throat the next morning; slight fever; fatigue; This is a spontaneous report from a non-contactable consumer or other non hcp. A 32-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included, covid 19 vaccination from an unknown date.The patient's concomitant medications were not reported. On 08Apr2021 patient had headache, body aches, light headedness, blurry vision, lethargic, sore throat the next morning, slight fever, fatigue resulted in prolongation of existing hospitalization (vaccine received during existing hospitalization). The patient did not test for COVID post vaccination and did not received any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; I tested positive for covid; This is a spontaneous report from a contactable consumer (patient herself) received from a Pfizer sponsored program.  A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Her second dose was scheduled for Sunday 11Apr2021, however she currently has Covid-19. The patient underwent lab tests which included a positive result for SARs-COV-2 test on an unspecified date. Patient would like to know how to reschedule her appointment for vaccine second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: developed Covid and had to be hospitalized; This is a spontaneous report from a contactable consumer. A 52-years-old male patient (husband) received first dose of BNT162B2 (BNT162B2), formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19Mar2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced developed covid and had to be hospitalized, (covid-19) on 26Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: developed covid after 7 days of first vaccine. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Erythema multiforme, Fatigue, Rash
Clinical narrative: Erythema multiforme; asthma attack/shortness of breath/cough; Rash started on legs on the 03Apr2021 late morning buy next day (04Apr2021) full body rash from shoulders to top of feet; extreme exhaustion; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER 8730), via an unspecified route of administration, administered in left arm on 02Apr2021 09:15 as single dose for covid-19 immunisation. Medical history included heart disease, high blood pressure, asthma, drug hypersensitivity and wasp stings. Concomitant medication(s) included amlodipine; aspirin and atorvastatin. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 09:45 late morning, the patient experienced rash started on legs by next day (04Apr2021) full body rash from shoulders to top of feet. Later on 03Apr2021, extreme exhaustion and dry cough that went into shortness of breath and asthma attack. Visit to ER and later sent to dermatologist. Possible Erythema multiforme. As of 09Apr2021 still have rash and exhaustion and dry cough. It was unknown whether patient received any treatment. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: 9 days after she got the results of testing positive; This is a spontaneous report from a Pfizer A 63-year-old female patient received the first dose of the BNT162B2 (Pfizer covid vaccine, lot number: unknown) via an unspecified route of administration injected in left arm in the muscle as a single dose on 23Mar2021 09:00, for Covid-19 immunization. The patient's medical history included cholesterol and concomitant medications included an unspecified cholesterol medication. On 31Mar2021 approximately 19:00, she was tested positive for covid. Her second dose was scheduled on 13Apr2021. There was no history of previous immunization and was not administered any additional vaccines on same date or prior vaccinations (within 4 weeks) of the Pfizer Suspect.  She did not went to any emergency room or physician's office visit, neither undergone any relevant test. She did not know if she was completely recovered.  She was ok, but it had only been 9 days after she got the results of testing positive. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Atrial septal defect, COVID-19, Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: he suffered a mini stroke 2 weeks after; congenital hole in his heart between the atrium; in which 2 days later he got the Covid virus; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a 42-years old male patient (husband) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date in Mar2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The pharmacist reported that on an unspecified date in Mar2021, two days after vaccination, the patient got the Covid virus due to an unknowing prior exposure and that once he got over the Covid virus. On 04Apr2021, he suffered a mini stroke two weeks after receiving the vaccine. She stated that while her husband was in the hospital, they found a congenital hole in his heart between the atrium which was the reason why he had a mini stroke. Her husband is scheduled to receive his second dose the next day and asked for any guidance on whether he should receive the vaccine at that time. She stated that she had spoken with his cardiologist, in which they believe it is best to hold off until after surgery to receive the second dose, just in case. Outcome was unknown for all the events.  Information on the lot/batch number has been requested.; Sender's Comments: Based on current information available, the event stroke and congenital atrial septal defect represented intercurrent condition in this patient unrelated to Bnt162b2. Covid19 was considered related. However, full immunity is only expected 1 week after the second dose.   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 RAs, Ethics Committees, and Investigators, as appropriate
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chills, Cough, Painful respiration, Pneumonia
Clinical narrative: Sudden onset of pneumonia and Afib; Sudden onset of pneumonia and Afib; fever; chills; cough; chest pain on breathing; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265) via an unspecified route of administration, administered into the left arm on 12Feb2021 (at the age of 72-years-old) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included rosuvastatin (ROSUVASTATIN) and timolol (TIMOLOL). Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3246) administered into the left arm on 22Jan2021 08:00 (at the age of 72-years-old) for COVID-19 immunisation. On 29Mar2021 01:00, patient had sudden onset of pneumonia and afib (atrial fibrillation), fever, chills, cough and chest pain on breathing. The patient was brought to the emergency room and was then hospitalized for 4 days due to the events reported. It was also reported that the patient was treated with antibiotics and heart medications. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 29Mar2021 and negative on 02Apr2021. Outcome of events was unknown.  Follow up attempts needed. Further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Sudden onset of pneumonia and Afib; Sudden onset of pneumonia and Afib; fever; chills; cough; chest pain on breathing; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265) via an unspecified route of administration, administered into the left arm on 12Feb2021 (at the age of 72-years-old) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included rosuvastatin (ROSUVASTATIN) and timolol (TIMOLOL). Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3246) administered into the left arm on 22Jan2021 08:00 (at the age of 72-years-old) for COVID-19 immunisation. On 29Mar2021 01:00, patient had sudden onset of pneumonia and afib (atrial fibrillation), fever, chills, cough and chest pain on breathing. The patient was brought to the emergency room and was then hospitalized for 4 days due to the events reported. It was also reported that the patient was treated with antibiotics and heart medications. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 29Mar2021 and negative on 02Apr2021. Outcome of events was unknown.  Follow up attempts needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: slightly elevated fever; nausea; vomiting; joint pain; muscle pain; This is a spontaneous report received from a Pfizer Sponsored Program received from a contactable female consumer (patient)   A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization.  The patient received first dose of BNT162B2 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. It was reported that 45 days since 2nd dose she still presented slightly elevated fever, nausea, vomiting, muscle and joint pain. At the time of the reporting the patient had not yet recovered from the events.   Information on the lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain, Hypoacusis
Clinical narrative: minor hearing loss; inner ear pains; stuffy ears; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) via an unspecified route of administration administered in the left arm on 09Apr2021 10:30 at a single dose for covid-19 immunization. Medical history included anxiety and, Meniere's disease. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient did not have covid prior vaccination. It has been two hours since the patient received the first shot, and she was experiencing minor hearing loss, inner ear pains, and stuffy ears all on 09Apr2021 12:30 PM. The outcome of the adverse events was unknown. The patient has not been covid-tested post-vaccination.   Information about the lot/batch number has been requested.