chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Dyspnoea, Headache, Nausea
Clinical narrative: Diarrhea; Headache; queasiness; fever going up and down between 99-100.8; problem breathing; sore arm; Vomiting; injection site pain; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: 301558A) via an unspecified route of administration, administered in right arm on 05Oct2021 at approximately 11:00 (age at the time of vaccination was 55-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included covid-19 (he already had covid, he already gave blood to senior homes for people that did not have antibodies), obesity and overweight from unknown date and unknown if ongoing. Concomitant medications included vitamin D, Vitamin C and Zinc. No prior vaccination within four weeks. On 05Oct2021, from 7 pm he started experiencing diarrhea, headaches, queasiness, his fever goes up and down between 99-100, he had a problem breathing, he had to stand up and try to stretch to catch his breath, soreness of his injection arm and he vomited last night as well but hasn't since. He did a thermometer check and his temperature was 100.8. The lowest reading, he got last night was 99.3, and this morning it was back at 100. He had diarrhea two times late at night, and early in the morning. He just recently a little more. It was thicker than in the past. He had vomiting and injection site pain described as a throbbing pain in addition to the other reported side effects stated was like his body is acting like it is fighting the virus all over again. Patient asked are these side effects because he already had the virus, and it was overdriving his system making it like he had covid again. Patient took Tylenol for headache and queasiness and his breathing issue went away last night after using the restroom, stretching, and using nasal spray. The patient underwent lab tests and procedures which included body temperature resulting going up and down from 99 to 100.8 on an unspecified date (a fever going up and down from 99 to 100.8), body temperature resulting 100.4 and 100.8 on 05Oct2021. outcome of the events problem breathing, and vomiting was recovered on and unspecified date in Oct2021, outcome of fever was not recovered, diarrhea and headache was recovering and rest all events outcome was unknown at the time of reporting.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Diarrhea; Headache; queasiness; fever going up and down between 99-100.8; problem breathing; sore arm; Vomiting; injection site pain; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: 301558A) via an unspecified route of administration, administered in right arm on 05Oct2021 at approximately 11:00 (age at the time of vaccination was 55-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included covid-19 (he already had covid, he already gave blood to senior homes for people that did not have antibodies), obesity and overweight from unknown date and unknown if ongoing. Concomitant medications included vitamin D, Vitamin C and Zinc. No prior vaccination within four weeks. On 05Oct2021, from 7 pm he started experiencing diarrhea, headaches, queasiness, his fever goes up and down between 99-100, he had a problem breathing, he had to stand up and try to stretch to catch his breath, soreness of his injection arm and he vomited last night as well but hasn't since. He did a thermometer check and his temperature was 100.8. The lowest reading, he got last night was 99.3, and this morning it was back at 100. He had diarrhea two times late at night, and early in the morning. He just recently a little more. It was thicker than in the past. He had vomiting and injection site pain described as a throbbing pain in addition to the other reported side effects stated was like his body is acting like it is fighting the virus all over again. Patient asked are these side effects because he already had the virus, and it was overdriving his system making it like he had covid again. Patient took Tylenol for headache and queasiness and his breathing issue went away last night after using the restroom, stretching, and using nasal spray. The patient underwent lab tests and procedures which included body temperature resulting going up and down from 99 to 100.8 on an unspecified date (a fever going up and down from 99 to 100.8), body temperature resulting 100.4 and 100.8 on 05Oct2021. outcome of the events problem breathing, and vomiting was recovered on and unspecified date in Oct2021, outcome of fever was not recovered, diarrhea and headache was recovering and rest all events outcome was unknown at the time of reporting.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: lump underneath the arm pit; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173; Expiration Date: 30Nov2021), via an unspecified route of administration in right arm on 17Sep2021 at 19:44 (at the age of 52 years old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive any additional vaccines on same date of the Pfizer suspect. She noticed early last week on 26Sep2021 a lump underneath the arm pit. She was aware from her doctors office it might be a side effect, she had a virtual visits on 14Sep2021 before getting the shot and was told that one of side effects that has been reported. She explained that prior to this, she remembered she had a small bump under her arm from her deodorant that comes and goes, it was a little lump in a certain location. It was noticed that he little lump she had before the shot disappeared or moved locations, to center of her arm pit. The lump from her deodorant was the size of a dime but the new one was the size of nickel. She was calling because she was supposed to take the second shot today and was wondering should she hold off on this second dose. The one, the lump, that was there previously, it went away about 3 days after the shot. Both lumps were in the opposite side the shot was given, in the left arm. She stated that her doctor told her that the lump was normal and was experienced by that person but went away. On 21Oct2021 she is to go to the doctor related to this. No family medical history relevant to adverse events was provided and no relevant tests were performed. The adverse event resulted in a visit to the physician office. The outcome of event was unknown.  Follow-Up (12Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Blindness, Laboratory test, Nausea, Seizure
Clinical narrative: My eye sight kind of sort of dead; Seizures; tearing my left tendon; Nausea; Pain in ankle; This is a spontaneous report from a contactable consumer (patient). A 55-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: FE3592), via an unspecified route of administration, administered in Left arm on an unspecified date as dose 3, single for COVID-19 immunization. Medical history included asthma, where patient don't use the inhaler every day, and migraine from an unknown date and is Immunocompromised. Concomitant medications included oxcarbazepine; cefaclor; fluticasone; quetiapine fumarate (SEROQUEL) and amitriptyline hydrochloride (TRIPTA) all for an unspecified indication. Historical vaccine included first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, as single dose for COVID-19 immunization and the patient experienced seizures and had a bad reaction/wicked reaction on an unspecified date after the second dose. On an unspecified date, after the third dose, patient had reaction, patient experienced nausea and had pain in the ankle, also was ended up in tearing of left tendon, which lead to calling of ambulance. Patient had taken all of ondansetron and Oxycodone 5 mg was used in the emergency room and was sent out with prescription too. Patient was given Geodon (off label use). Also reported, that patient had seizures. Patient had bunch of lab tests, where results were unknown. The events nausea, pain in the ankle, tearing of left tendon resulted in emergency room visit. The outcome of the event arthralgia was recovering, while of other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Tendon rupture
Clinical narrative: My eye sight kind of sort of dead; Seizures; tearing my left tendon; Nausea; Pain in ankle; This is a spontaneous report from a contactable consumer (patient). A 55-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: FE3592), via an unspecified route of administration, administered in Left arm on an unspecified date as dose 3, single for COVID-19 immunization. Medical history included asthma, where patient don't use the inhaler every day, and migraine from an unknown date and is Immunocompromised. Concomitant medications included oxcarbazepine; cefaclor; fluticasone; quetiapine fumarate (SEROQUEL) and amitriptyline hydrochloride (TRIPTA) all for an unspecified indication. Historical vaccine included first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, as single dose for COVID-19 immunization and the patient experienced seizures and had a bad reaction/wicked reaction on an unspecified date after the second dose. On an unspecified date, after the third dose, patient had reaction, patient experienced nausea and had pain in the ankle, also was ended up in tearing of left tendon, which lead to calling of ambulance. Patient had taken all of ondansetron and Oxycodone 5 mg was used in the emergency room and was sent out with prescription too. Patient was given Geodon (off label use). Also reported, that patient had seizures. Patient had bunch of lab tests, where results were unknown. The events nausea, pain in the ankle, tearing of left tendon resulted in emergency room visit. The outcome of the event arthralgia was recovering, while of other events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Vaccination site paraesthesia
Clinical narrative: There was severe pain in the left arm for 48 hours; constant tingling in the left arm from the shot site down to my wrist; constant tingling in the left arm from the shot site down to my wrist; This is a spontaneous report from a contactable consumer reported for herself. A 59-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 27Sep2021 13:45 (Batch/Lot Number: FF8839) (at the age of 59-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation.  Medical history included Diabetes type 2 from an unknown date, neck surgery from 2007 to an unknown date.  There were no known allergies. The patient did not get covid prior vaccination. The patient did not get other vaccine in four weeks. There were no other medications in two weeks. There were no concomitant medications. Historical vaccine included the patient received first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 27Jan2021 (Batch/Lot No: EL1283) (at the age of 58 years old) as dose 1 single for Covid-19 immunization; The patient received second dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Batch/Lot No: EN5318) (at the age of 58 years old) as dose 2 single for Covid-19 immunization. On 27Sep2021 02:00 PM, there was severe pain in the left arm for 48 hours. Afterwards she had constant tingling in the left arm from the shot site down to her wrist. The events resulted in Disability or permanent damage. There was no treatment received. The outcome of the events was not resolved. The patient did not get covid tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact, Erythema, Hypersensitivity, Pain, Pruritus
Clinical narrative: allergic reaction; It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis; It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis; they started small and then grew up like a size of a golf ball, it's itchy and painful; It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis; It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis; red swollen and itchy like rash; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 07Oct2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included allergies. A couple of months ago she was rushed to the emergency room after eating pine nuts. They gave her some medicines and she had to stay there for couple of hours and then she went home. The patient's concomitant medications were not reported. The patient stated she took the Pfizer covid vaccine, and had an allergic reaction in Oct2021. She stated she had red and swollen, red swollen and itchy like rash like contact dermatitis, clarifying "It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis". She described it as putting your hands touching up plant and than they started small and then grew up like a size of a golf ball, it's itchy and painful, clarifying it just raised the swelling from the arm, 3 days later and was still itching. She stated that she took Benadryl last night (10Oct2021) but this morning (11Oct2021) three days later it was still itching. She also tried putting cold compressed arm. The patient stated she had an allergic reaction before and she stayed away from she was allergic to. She tried to stay away from things that aggravate her allergies.  The outcome of the events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin swelling
Clinical narrative: allergic reaction; It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis; It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis; they started small and then grew up like a size of a golf ball, it's itchy and painful; It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis; It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis; red swollen and itchy like rash; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 07Oct2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included allergies. A couple of months ago she was rushed to the emergency room after eating pine nuts. They gave her some medicines and she had to stay there for couple of hours and then she went home. The patient's concomitant medications were not reported. The patient stated she took the Pfizer covid vaccine, and had an allergic reaction in Oct2021. She stated she had red and swollen, red swollen and itchy like rash like contact dermatitis, clarifying "It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis". She described it as putting your hands touching up plant and than they started small and then grew up like a size of a golf ball, it's itchy and painful, clarifying it just raised the swelling from the arm, 3 days later and was still itching. She stated that she took Benadryl last night (10Oct2021) but this morning (11Oct2021) three days later it was still itching. She also tried putting cold compressed arm. The patient stated she had an allergic reaction before and she stayed away from she was allergic to. She tried to stay away from things that aggravate her allergies.  The outcome of the events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Parkinson's disease
Clinical narrative: One who went to the doctor and was now diagnosed with Parkinson's; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient's friend) reported that a patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient went to the doctor and was diagnosed with Parkinson's, all of a sudden on an unspecified date. Outcome of the event was unknown.  No follow-up attempts possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Hypersensitivity, Pain in extremity, Pruritus
Clinical narrative: Severe allergic reaction; Itchiness; Right arm was painful; Felt tired; Itchiness which was bumpy on her back; Almost like shingles; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program, Support. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 19Apr2021 (lot number: EW0169; expiration date: 31Aug2021) as dose 1, single for COVID-19 immunization. Medical history included allergy to and penicillin COVID-19 infection from Jan2019 (as reported). The patient's concomitant medications were not reported. In Apr2021 (between 6 to 9 days after the vaccination), the patient experienced itchiness which she described was "bumpy" on her back and "almost like shingles". The patient also felt tired and her right arm was painful. Due to this severe allergic reaction, she has not had the second dose of COVID vaccine yet. The patient is a flight attendant and her job was forcing her to be vaccinated, she was wondering if she can taken the vaccine because she had a severe reaction. The patient was also considering of getting vaccine from another company and wonder if its allowed. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: Severe allergic reaction; Itchiness; Right arm was painful; Felt tired; Itchiness which was bumpy on her back; Almost like shingles; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program, Support. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 19Apr2021 (lot number: EW0169; expiration date: 31Aug2021) as dose 1, single for COVID-19 immunization. Medical history included allergy to and penicillin COVID-19 infection from Jan2019 (as reported). The patient's concomitant medications were not reported. In Apr2021 (between 6 to 9 days after the vaccination), the patient experienced itchiness which she described was "bumpy" on her back and "almost like shingles". The patient also felt tired and her right arm was painful. Due to this severe allergic reaction, she has not had the second dose of COVID vaccine yet. The patient is a flight attendant and her job was forcing her to be vaccinated, she was wondering if she can taken the vaccine because she had a severe reaction. The patient was also considering of getting vaccine from another company and wonder if its allowed. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Diplopia, Dysphagia, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numbness in tongue, lips; Numbness in arms, legs and feet; heart palpitations; chest pressure; hard to swallow; double vision; This is a spontaneous report from a contactable other hcp (patient). This 29-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 24Sep2021 18:15 (Lot Number: FC3184) at age of 29-years-old as dose 2, single for COVID-19 immunization.  Medical history included COVID-19 (If COVID prior vaccination: Yes). There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0217), on 28Aug2021 09:00 AM at age of 29-years-old in Left arm for COVID-19 immunization, sumatriptan and experienced known allergies: Sumatriptan, topiramate and experienced known allergies: Topiramate, norco and experienced known allergies: Norco, metoclopramide hydrochloride (REGLAN) and experienced known allergies: Reglan. No other vaccine in four weeks. No other medications in two weeks. The patient experienced Numbness in tongue, lips, arms, legs and feet, Heart palpitations, Chest pressure, Hard to swallow, Double vision on 24Sep2021 18:45. The events resulted in Emergency room/department or urgent care. Treatment received for the events included IV fluids, Ativan, Steroid medication and Benadryl. The patient underwent lab tests and procedures which included Rapid Covid test Nasal Swab: negative on 30Sep2021. The outcome of the events was Recovered with Sequel in 2021.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Hypoaesthesia oral, Hypoaesthesia  Palpitation, Chest discomfort, Dysphagia, Diplopia and BNT162B2.  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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 test
Clinical narrative: Numbness in tongue, lips; Numbness in arms, legs and feet; heart palpitations; chest pressure; hard to swallow; double vision; This is a spontaneous report from a contactable other hcp (patient). This 29-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 24Sep2021 18:15 (Lot Number: FC3184) at age of 29-years-old as dose 2, single for COVID-19 immunization.  Medical history included COVID-19 (If COVID prior vaccination: Yes). There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0217), on 28Aug2021 09:00 AM at age of 29-years-old in Left arm for COVID-19 immunization, sumatriptan and experienced known allergies: Sumatriptan, topiramate and experienced known allergies: Topiramate, norco and experienced known allergies: Norco, metoclopramide hydrochloride (REGLAN) and experienced known allergies: Reglan. No other vaccine in four weeks. No other medications in two weeks. The patient experienced Numbness in tongue, lips, arms, legs and feet, Heart palpitations, Chest pressure, Hard to swallow, Double vision on 24Sep2021 18:45. The events resulted in Emergency room/department or urgent care. Treatment received for the events included IV fluids, Ativan, Steroid medication and Benadryl. The patient underwent lab tests and procedures which included Rapid Covid test Nasal Swab: negative on 30Sep2021. The outcome of the events was Recovered with Sequel in 2021.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Hypoaesthesia oral, Hypoaesthesia  Palpitation, Chest discomfort, Dysphagia, Diplopia and BNT162B2.  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
Symptoms: Myasthenia gravis
Clinical narrative: diagnosed with myasthenia gravis; This is a spontaneous report from a contactable consumer reported for a female patient in her 80s that who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Caller stated the person that also was diagnosed with myasthenia gravis was a friend of her cousin and her cousin went home to pick up the cousin's medications and met someone who worked with her and was telling the caller that it was really odd that this friend or her friend's sister came down four weeks ago and had her two vaccines and her age was in the low 80s and she did not know what vaccine this lady received but thought it was the Pfizer COVID vaccine but stated she has no other patient information and has no lots, expiry dates or NDC numbers for this patient's vaccine and did not know this person but the person is a friend of her cousin's. Stated the patient was diagnosed 4 weeks ago in Sep2021. Outcome of the event was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Rash, Urticaria
Clinical narrative: Rigors; Hives; Rash; This is a spontaneous report from a contactable nurse via a sales representative. This nurse reported for a 55-year-old male patient that who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization; started to receive immunoglobulin human normal (PANZYGA) via an unspecified route administration, from 21May2021 at unknown dose and frequency, then on 11Oct2021 at 08:45 am (lot number: L043A8251) at 10 g, for an unspecified indication. Medical history included CIDP. Concomitant medications were not reported. The patient previously received first single dose of BNT162B2 on an unspecified date for COVID-19 immunization. It was reported that patient had been receiving PANZYGA since 21May2021. Patient did not have any allergies to other IVIGs and had received other brands in the past. Patient received dosage this morning, 11Oct2021, approximately 08:45 am. Had a reaction, with rigors, hives and rash. It was at the tai end of his infusion (-95%). He was instructed to administer his epi-pen and then when RN got back to his home he was sent to Emergency Department via ambulance at 12:00 and discharged home at 14:30. The action taken to the events for immunoglobulin human normal was unknown. Outcome of the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Chills, Urticaria and Rash" and suspected vaccine BNT162B2 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: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Communication disorder, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: Stroke; Blood clot; currently is not communicating; may never walk  again or have a life; This is a spontaneous report from a contactable consumer (parent). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at 35 years old, dose 1 via an unspecified route of administration, administered in Arm Left on 02Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. There were no medical history and concomitant medications. No other vaccination (4 weeks prior). Patient currently was not communicating. Patient might never walk again or have a life because of the Pfizer vaccine. Patient after receiving the Pfizer vaccine suffered a stroke; he got a blood clot and 'separated' stroke (further not clarified) on September the 18th after receiving the vaccine. Patient was 'night ridden' to an ICU so there has been MRI's, CT scan, blood work with unknown results, but prior to the vaccine no." On 18Sep2021, patient was hospitalization, that's when he had the stroke. The patient was hospitalized for stroke and blood clot from 18Sep2021. The outcomes of events were unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Walking disability
Clinical narrative: Stroke; Blood clot; currently is not communicating; may never walk  again or have a life; This is a spontaneous report from a contactable consumer (parent). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at 35 years old, dose 1 via an unspecified route of administration, administered in Arm Left on 02Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. There were no medical history and concomitant medications. No other vaccination (4 weeks prior). Patient currently was not communicating. Patient might never walk again or have a life because of the Pfizer vaccine. Patient after receiving the Pfizer vaccine suffered a stroke; he got a blood clot and 'separated' stroke (further not clarified) on September the 18th after receiving the vaccine. Patient was 'night ridden' to an ICU so there has been MRI's, CT scan, blood work with unknown results, but prior to the vaccine no." On 18Sep2021, patient was hospitalization, that's when he had the stroke. The patient was hospitalized for stroke and blood clot from 18Sep2021. The outcomes of events were unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: diagnosed with Guillain-Barre Syndrome; This is a spontaneous report from a contactable consumer (patient). A 55 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose, via an unspecified route of administration on 02Mar2021 (Batch/Lot Number: ENN6202) (age at vaccination was 54 years old) as dose 2, single for covid-19 immunisation. Medical history included Chrohns, heart disease (2 stints following heart attack), covid-19 (Prior to vaccination). Concomitant medications included infliximab (REMICAID); fluticasone propionate (FLONASE); atorvastatin; colecalciferol (VITAMINE D); clarithromycin (CLARITAB). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL9269) on 02Feb2021 (age at vaccination was 54 years old) for covid-19 immunisation, Ceftriaxone Sodium, Tazobactam Sodium (BACTRUM T) and experienced allergy. There was no other vaccine in four weeks. The patient was diagnosed with guillain-barre syndrome on 20Sep2021. Event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for guillain-barre syndrome for 12 days. Treatment IVIG was received. The outcome of the event was unknown. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, SARS-CoV-2 test
Clinical narrative: diagnosed with Covid-19 last week; diagnosed with Covid-19 last week; super tired; This is a spontaneous report from a contactable nurse. This Nurse (patient's grandmother) reported for a 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. HCP also states that her 14 years old granddaughter received the Pfizer Covid-19 vaccine and was super tired and diagnosed with Covid-19 last week on Oct2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Oct2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: The possibility of occurrence of COVID -19 and Drug Ineffective cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness, Headache
Clinical narrative: Very weak; Arm at injection site is swollen, red and painful; Arm at injection site is swollen, red and painful; Arm at injection site is swollen, red and painful; Vomiting; Very intense headache; Cold chills; Hot sweat; Extremely dizzy when standing; Fever of 102.3; off label use; booster; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (Pfizer COVID 19), dose 3 via an unspecified route of administration, administered in left arm on 08Oct2021 12:45 (Batch/Lot number was not reported) as dose 3 (booster), single at the age of 42 years old for COVID-19 immunization. Medical history included fibromyalgia, rheumatoid arthritis, hypothyroidism, covid-19 in Mar2020, stroke in Mar2020, allergy to sylfa drugs. Concomitant medication included gabapentin within 2 weeks of vaccination. The patient previously dermoral and bactrim, both experienced allergy. Historic vaccine was bnt162b2 dose 1 administered in left arm on 04Mar2021 (lot En6199); dose 2 administered in left arm on 25Mar2021 (lot Ep7534), both as a single dose at the age of 42 years old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Oct2021 06:00, very intense headache, felt like a jackhammer going through head, cold chills, hot sweat, extremely dizzy when standing, fever of 102.3, vomiting, day 3 on 11Oct2021 finally able to keep food down still very weak and dizzy, arm at injection site was swollen.red..and painful. Had covid rapid test and it was negative, (had covid and a stroke in march of 2020, sever on vent for 2 weeks and hospital for 2 months). Event resulted in emergency room/department. Treatment received which included Iv zofran. The patient underwent lab tests and procedures which included body temperature: 102.3 on 09Oct2021, Nasal Swab Rapid test: negative on 09Oct2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovering. The lot number for bnt162b2, was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Immunisation, Off label use, Pyrexia, SARS-CoV-2 test
Clinical narrative: Very weak; Arm at injection site is swollen, red and painful; Arm at injection site is swollen, red and painful; Arm at injection site is swollen, red and painful; Vomiting; Very intense headache; Cold chills; Hot sweat; Extremely dizzy when standing; Fever of 102.3; off label use; booster; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (Pfizer COVID 19), dose 3 via an unspecified route of administration, administered in left arm on 08Oct2021 12:45 (Batch/Lot number was not reported) as dose 3 (booster), single at the age of 42 years old for COVID-19 immunization. Medical history included fibromyalgia, rheumatoid arthritis, hypothyroidism, covid-19 in Mar2020, stroke in Mar2020, allergy to sylfa drugs. Concomitant medication included gabapentin within 2 weeks of vaccination. The patient previously dermoral and bactrim, both experienced allergy. Historic vaccine was bnt162b2 dose 1 administered in left arm on 04Mar2021 (lot En6199); dose 2 administered in left arm on 25Mar2021 (lot Ep7534), both as a single dose at the age of 42 years old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Oct2021 06:00, very intense headache, felt like a jackhammer going through head, cold chills, hot sweat, extremely dizzy when standing, fever of 102.3, vomiting, day 3 on 11Oct2021 finally able to keep food down still very weak and dizzy, arm at injection site was swollen.red..and painful. Had covid rapid test and it was negative, (had covid and a stroke in march of 2020, sever on vent for 2 weeks and hospital for 2 months). Event resulted in emergency room/department. Treatment received which included Iv zofran. The patient underwent lab tests and procedures which included body temperature: 102.3 on 09Oct2021, Nasal Swab Rapid test: negative on 09Oct2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovering. The lot number for bnt162b2, was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: Very weak; Arm at injection site is swollen, red and painful; Arm at injection site is swollen, red and painful; Arm at injection site is swollen, red and painful; Vomiting; Very intense headache; Cold chills; Hot sweat; Extremely dizzy when standing; Fever of 102.3; off label use; booster; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (Pfizer COVID 19), dose 3 via an unspecified route of administration, administered in left arm on 08Oct2021 12:45 (Batch/Lot number was not reported) as dose 3 (booster), single at the age of 42 years old for COVID-19 immunization. Medical history included fibromyalgia, rheumatoid arthritis, hypothyroidism, covid-19 in Mar2020, stroke in Mar2020, allergy to sylfa drugs. Concomitant medication included gabapentin within 2 weeks of vaccination. The patient previously dermoral and bactrim, both experienced allergy. Historic vaccine was bnt162b2 dose 1 administered in left arm on 04Mar2021 (lot En6199); dose 2 administered in left arm on 25Mar2021 (lot Ep7534), both as a single dose at the age of 42 years old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Oct2021 06:00, very intense headache, felt like a jackhammer going through head, cold chills, hot sweat, extremely dizzy when standing, fever of 102.3, vomiting, day 3 on 11Oct2021 finally able to keep food down still very weak and dizzy, arm at injection site was swollen.red..and painful. Had covid rapid test and it was negative, (had covid and a stroke in march of 2020, sever on vent for 2 weeks and hospital for 2 months). Event resulted in emergency room/department. Treatment received which included Iv zofran. The patient underwent lab tests and procedures which included body temperature: 102.3 on 09Oct2021, Nasal Swab Rapid test: negative on 09Oct2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovering. The lot number for bnt162b2, was not provided and will be requested during follow up.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Dyspepsia
Clinical narrative: Heart burn; Abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 17-year-old non- pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at age of 17 years on 27Sep2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. No covid prior vaccination. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at age of 17 years on 09Sep2021 for COVID-19 Immunization. The patient experienced heart burn, abdominal pain, and more (as reported) in 2021. The events resulted in emergency room/department or urgent care and received treatment of antibiotics, blood work, pain medicine (in 2021). Covid test post vaccination was PCR via nasal swab on 27Sep2021 and negative. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Illness, Pneumonia
Clinical narrative: Now it feels like pneumonia; Fatigue; Then extremely ill with fever; Fever; Chills for a couple of weeks; I am having a lot of wheezing over a month later; This is a spontaneous report from a non-contactable other hcp (patient).  A 39-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 39 years old, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's medical history and concomitant medications were not reported. The patient did not receive other vaccine in four weeks of vaccination. Fatigue the day after, and then extremely ill with fever, and chills for a couple of weeks. Now it felt like pneumonia, and patient was having a lot of wheezing over a month later. Events resulted in emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results, fever. No treatment received. Outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Pneumonia.   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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Wheezing
Clinical narrative: Now it feels like pneumonia; Fatigue; Then extremely ill with fever; Fever; Chills for a couple of weeks; I am having a lot of wheezing over a month later; This is a spontaneous report from a non-contactable other hcp (patient).  A 39-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 39 years old, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's medical history and concomitant medications were not reported. The patient did not receive other vaccine in four weeks of vaccination. Fatigue the day after, and then extremely ill with fever, and chills for a couple of weeks. Now it felt like pneumonia, and patient was having a lot of wheezing over a month later. Events resulted in emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results, fever. No treatment received. Outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Pneumonia.   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