chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Biopsy kidney, Blood creatine, Blood creatinine, IgA nephropathy, Protein total
Clinical narrative: IgA nephropathy; This is a literature report.   Inclusion of patients with kidney disease in COVID vaccine trials remains low. It is important to report association of disease exacerbation so that patients may undergo post vaccination monitoring. The authors hereby present a case of worsening IgA nephropathy temporarily associated with COVID vaccination. A 63-year-old female with past medical history of hypertension, psoriatic arthritis presented to the hospital with gross hematuria for 6 weeks starting 3 days after 2nd dose of Pfizer COVID vaccine. Her PCP had sent her to ER 5 days after onset of hematuria as had noted a creatinine (Cr) of 1.6 with 3+ protein and greater than 20 RBCs on urinalysis suspicious for nephritic syndrome. On review she had serum Cr of 0.5 about 4 months ago with no proteinuria or hematuria before. In the ER she was given antibiotics for urinary tract infection and outpatient referral for nephrology. She could not make the outpatient appointment and with continued gross hematuria for a month, she presented to the ER again where she was noted to have Cr of 10 mg/dl and urine protein:cr ratio of 7.3gm/gm. Renal imaging including CT urogram was normal. Renal biopsy showed IgA nephropathy, M1S0E0T1C1 with a fibrocellular crescent and acute tubular necrosis likely secondary to lyzed red cells in setting of multiple RBC casts in the tubules. She was put on 250 mg Solumedrol for 3 doses followed by 1 mg/kg of Prednisone with eventual downtrend in Cr to 4.5 in 15 days.  There have been 2 cases reported in literature with known IgA nephropathy who developed gross hematuria post COVID 19 vaccination. SARS- COV 2 vaccines use nucleoside modified purified mRNA which does elicit higher neutralizing antibody titre and strong cluster of differentiation response leading to production of several proinflammatory cytokines. Thus, there is a concern that vaccines might exacerbate immune mediated glomerular diseases. IgA1 is involved in the pathogenesis of IgA nephropathy and patients with IgA nephropathy have higher than normal IgA1 response to other vaccines like influenza. Also while studying the antibody response to COVID 19 illness patients with IgA nephropathy are known to express higher IgA response compared to IgG and IgM along with reports of concurrent worsening of the glomerulonephritis. Nephrologists should closely follow patients with IgA nephropathy to establish the frequency of disease activation post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101562750 Same article/drug/ event; different patient.
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell count, Urine protein/creatinine ratio, Urogram
Clinical narrative: IgA nephropathy; This is a literature report.   Inclusion of patients with kidney disease in COVID vaccine trials remains low. It is important to report association of disease exacerbation so that patients may undergo post vaccination monitoring. The authors hereby present a case of worsening IgA nephropathy temporarily associated with COVID vaccination. A 63-year-old female with past medical history of hypertension, psoriatic arthritis presented to the hospital with gross hematuria for 6 weeks starting 3 days after 2nd dose of Pfizer COVID vaccine. Her PCP had sent her to ER 5 days after onset of hematuria as had noted a creatinine (Cr) of 1.6 with 3+ protein and greater than 20 RBCs on urinalysis suspicious for nephritic syndrome. On review she had serum Cr of 0.5 about 4 months ago with no proteinuria or hematuria before. In the ER she was given antibiotics for urinary tract infection and outpatient referral for nephrology. She could not make the outpatient appointment and with continued gross hematuria for a month, she presented to the ER again where she was noted to have Cr of 10 mg/dl and urine protein:cr ratio of 7.3gm/gm. Renal imaging including CT urogram was normal. Renal biopsy showed IgA nephropathy, M1S0E0T1C1 with a fibrocellular crescent and acute tubular necrosis likely secondary to lyzed red cells in setting of multiple RBC casts in the tubules. She was put on 250 mg Solumedrol for 3 doses followed by 1 mg/kg of Prednisone with eventual downtrend in Cr to 4.5 in 15 days.  There have been 2 cases reported in literature with known IgA nephropathy who developed gross hematuria post COVID 19 vaccination. SARS- COV 2 vaccines use nucleoside modified purified mRNA which does elicit higher neutralizing antibody titre and strong cluster of differentiation response leading to production of several proinflammatory cytokines. Thus, there is a concern that vaccines might exacerbate immune mediated glomerular diseases. IgA1 is involved in the pathogenesis of IgA nephropathy and patients with IgA nephropathy have higher than normal IgA1 response to other vaccines like influenza. Also while studying the antibody response to COVID 19 illness patients with IgA nephropathy are known to express higher IgA response compared to IgG and IgM along with reports of concurrent worsening of the glomerulonephritis. Nephrologists should closely follow patients with IgA nephropathy to establish the frequency of disease activation post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101562750 Same article/drug/ event; different patient.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immunisation, Interchange of vaccine products, Off label use, Tachycardia
Clinical narrative: Off-label use; Booster dose; Interchange of vaccine products; Tachycardia; dizziness; This is a spontaneous report from a contactable Other-HCP. This 27-year-old female Other-HCP (patient) reported for herself. A 27-year-old non-pregnant female patient (not pregnant at the time of vaccination) received third dose (booster) of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: FG3527, Expiry date: not reported) via an unspecified route of administration, on 05Nov2021 (27-year-old at the time of vaccination) as dose 3 (booster), single for COVID-19 immunization at pharmacy or drug store. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. Patient did not have any allergies. The patient previously took first dose of Moderna (MODERNA COVID-19 VACCINE, unknown formulation, Lot Number: 011L20A, Expiry date: not reported) via an unspecified route of administration, on 15Jan2021 (27-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization and took second dose of Moderna (MODERNA COVID-19 VACCINE, unknown formulation, Lot Number: 031L20A, Expiry date: not reported) via an unspecified route of administration, on 12Feb2021 (27-year-old at the time of vaccination) as dose 2, single for COVID-19 immunization. On 05Nov2021, the patient takes booster dose and experienced tachycardia and dizziness. Events leads to emergency room and physician office visit. It was reported that patient developed tachycardia and dizziness occurring 5 to 6 minutes after receiving Pfizer vaccine. Symptom onset was sudden. Peak symptoms occurred for around one minute, and slowly decreased in severity over the course of 3 hours. The patient did not any receive treatment for the events. On an unspecified date, the patient recovered from the events tachycardia and dizziness and outcome of the other events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lip swelling, Paraesthesia, Pruritus
Clinical narrative: slight swelling along the upper lip line and below the philtrum; numbness; tingling; itching; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient) reported for herself. A 59-years-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EL8982, Expiration date: 31May2021) via an unspecified route of administration, administered in left arm on 15Jan2021 at 11:00 am (age at vaccination was 59 years) as dose 1, single for COVID-19 immunization. The patient's medical history included diabetic, obesity, blood pressure high and sleep apnea (uses CPAP (Continuous positive airway pressure) machine for sleep). The patient did not have any family medical history relevant to adverse events. The patient did not receive any concomitant medications. There was no history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The facility where the most recent COVID-19 vaccine was administered was drive through clinic. The vaccine was not administered at Military facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of the Pfizer COVID-19 vaccine on 15Jan2021 and she experienced mild symptoms. On 15Jan2021, 30 mins after getting the shot, the patient experienced numbness, tingling, itching and slight swelling along the upper lip line and below the philtrum. It lasted for 30 mins and resolved on its own the same day with no treatment. The patient wanted to know what would be considered a severe adverse effect. The patient wanted to know if she could get the second dose of the vaccine. The patient wanted to know if she was still eligible to get the 2nd dose. The adverse events did not require a visit to Emergency Room or Physician Office. No treatment was received for the events. No relevant tests were done. The outcome of the events was resolved on 15Jan2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: slightly worse migraine; This is a spontaneous report from a contactable consumer. An adult female patient received the second dose of COVID-19 vaccine (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included ongoing chronic migraines since the age of 9-years-old. Concomitant medications were not reported. The patient previously received the first dose of COVID-19 vaccine (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) on an unknown date for COVID-19 immunization. On 09Nov2021, the patient had slightly worse migraines.  The patient had one episode in afternoon on 09Nov2021 as well as one on 10Nov2021. The patient had been vaccinated for a while (not further specified) and the past month the migraines have been slightly worse. The patient reported feeling much better on 11Nov2021.  The clinical outcome of the slightly worse migraines was recovering.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Death, Immunisation
Clinical narrative: patient may have died due to the Pfizer Booster dose of the covid vaccine; Booster; This is a spontaneous report from Pfizer from a contactable consumer. A male patient of an unspecified age received third booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: Unknown, Expiry date: unknown), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first and second dose of bnt162b2 via an unspecified route of administration on an unspecified date both as a single dose for COVID-19 immunization. On an unknown date it was reported that patient may have died due to the Pfizer Booster dose of the covid vaccine. Cardiologist that may have died was alleged to social media and he would not put too much credibility on that and states the cardiologist did die and the reporter did internet research, and he had no verification from the vaccine, but it was a claim they are after. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2 was not provided and will be request during follow-up. ; Reported Cause(s) of Death: patient may have died due to the Pfizer Booster dose of the covid vaccine
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I had no problem with this vaccination a littl sore but I got it.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the right arm on 09Sep2021 at 11:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation.The patient's medical history and known allergies were reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the right arm on 18Aug2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On an unknown date(also reported as 08Aug2021), the patient was a little sore, but he got it and reported that he had no problem with this vaccination. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event little sore was unknown at the time of this report.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Some difficulty breathing; Hives on face neck and back; This is a spontaneous report from a contactable consumer (patient herself, as reported) via COVID-19 Vaccine portal. A 6-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 13Nov2021 at 13:00 at the age of 6 years old (Batch/Lot Number: Fx5618, Expiration date: unknown) as dose 1, single for COVID-19 immunization. The vaccination facility type was a school/student health clinic. The patient was not pregnant at the time of vaccination. The patient had no medical history and had no known allergies. Concomitant medication included influenza vaccine (FLU) administered in the arm, taken for immunization on 13Nov2021. The patient had no covid prior vaccination and was not tested for covid post vaccination. On 13Nov2021 at 17:00, the patient experienced some difficulty breathing and hives on face neck and back. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of some difficulty breathing and hives on face neck and back, which included diphenhydramine hydrochloride (BENADRYL). The patient had recovered from both the events on an unspecified date.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes, Oral herpes, SARS-CoV-2 test
Clinical narrative: Within 2 weeks, this triggered a genital herpes outbreak; Since then a genital and/or oral herpes outbreak has occurred at least every 2 months; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on Mar2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included genital herpes and oral herpes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in 2021, within 2 weeks of receiving Pfizer COVID-19 vaccination, that triggered a genital herpes outbreak, and since then a genital and/or oral herpes outbreak had occurred at least every 2 months. The patient thought this would be of material interest regarding adverse events. She had never had outbreaks since her initial one 20 years ago. The patient thought Pfizer should know about this correlation with their vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent nasal swab and the result was negative. Therapeutic measures were taken as a result of reported events which was unspecified. The clinical outcome of the event genital herpes outbreak and oral herpes outbreak was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Immunisation, Near death experience, Syncope, Vomiting
Clinical narrative: Fainted after booster.; Chills after booster; Throwing up after booster; Booster; Caller states booster almost killed him.; This is a spontaneous report from a contactable consumer (patient).   A 46-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FF8841), via an unspecified route of administration, administered in left shoulder, on 15Oct2021 (at age of 46-year-old) as dose 3 (booster), single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9766), on 08Mar2021 and second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6203), on 29Mar2021, both were received via an unspecified route of administration, administered in left shoulder (at age of 45-year-old) as dose 1 and dose 2, single for covid-19 immunization. On 15Oct2021, the patient had booster; on 16Oct2021, the patient experienced throwing up after booster; on 18Oct2021, the patient had fainted after booster, chills after booster. Caller also stated that booster almost killed him on an unknown date in Oct2021. Events fainted after booster, chills after booster, throwing up after booster, caller states booster almost killed him resulted in physician office visit. On 17Oct2021, the outcome of the event throwing up after booster was recovered. On 18Oct2021, the outcome of events fainted after booster, chills after booster were recovered. The outcome of events booster almost killed him and booster were unknown.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Headache, Influenza, Malaise, Pyrexia
Clinical narrative: Drug ineffective; "I am not well either I have COVID or I don't know"; Not well at all; Terrible headaches; Fever; Flu; This is a spontaneous report from a contactable pharmacist (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), for dose 1, single; dose 2, single; and dose 3 (booster), single - all via an unspecified route of administration on an unspecified date (lot number was not reported) for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included RSV vaccine administered on 03Nov2021. The patient reported that he/she is a pharmacist and had a question. He/she received an RSV vaccine from a trial on 03Nov2021. Then, she got his/her 3rd shot for Pfizer booster on an unspecified date (reported as Tuesday). On an unspecified date, he/she was not well like at all. He/she had been having terrible headaches and fever. The patient was showing with this because he/she didn't feel like this with the first two vaccines, so he/she said that it was an interaction with the RSV trial vaccine which was also Pfizer and the booster. The patient reported that the clinician told him/her that it was ok and just wait for a couple of days which he/she did, but he/she was not well either he/she have COVID or he/she don't know. The patient reiterated that he/she was not well, he/she had flu. He/she have interaction with the vaccines or he/she don't know. 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: Based on available information a contributory role of BNT162B2 to the reported events suspected COVID-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.  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: U
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Drug ineffective; "I am not well either I have COVID or I don't know"; Not well at all; Terrible headaches; Fever; Flu; This is a spontaneous report from a contactable pharmacist (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), for dose 1, single; dose 2, single; and dose 3 (booster), single - all via an unspecified route of administration on an unspecified date (lot number was not reported) for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included RSV vaccine administered on 03Nov2021. The patient reported that he/she is a pharmacist and had a question. He/she received an RSV vaccine from a trial on 03Nov2021. Then, she got his/her 3rd shot for Pfizer booster on an unspecified date (reported as Tuesday). On an unspecified date, he/she was not well like at all. He/she had been having terrible headaches and fever. The patient was showing with this because he/she didn't feel like this with the first two vaccines, so he/she said that it was an interaction with the RSV trial vaccine which was also Pfizer and the booster. The patient reported that the clinician told him/her that it was ok and just wait for a couple of days which he/she did, but he/she was not well either he/she have COVID or he/she don't know. The patient reiterated that he/she was not well, he/she had flu. He/she have interaction with the vaccines or he/she don't know. 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: Based on available information a contributory role of BNT162B2 to the reported events suspected COVID-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.  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: U
Vaccine: COVID19, COVID19
Symptoms: Drug interaction, Headache, Influenza, Malaise, Pyrexia
Clinical narrative: Drug ineffective; "I am not well either I have COVID or I don't know"; Not well at all; Terrible headaches; Fever; Flu; This is a spontaneous report from a contactable pharmacist (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), for dose 1, single; dose 2, single; and dose 3 (booster), single - all via an unspecified route of administration on an unspecified date (lot number was not reported) for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included RSV vaccine administered on 03Nov2021. The patient reported that he/she is a pharmacist and had a question. He/she received an RSV vaccine from a trial on 03Nov2021. Then, she got his/her 3rd shot for Pfizer booster on an unspecified date (reported as Tuesday). On an unspecified date, he/she was not well like at all. He/she had been having terrible headaches and fever. The patient was showing with this because he/she didn't feel like this with the first two vaccines, so he/she said that it was an interaction with the RSV trial vaccine which was also Pfizer and the booster. The patient reported that the clinician told him/her that it was ok and just wait for a couple of days which he/she did, but he/she was not well either he/she have COVID or he/she don't know. The patient reiterated that he/she was not well, he/she had flu. He/she have interaction with the vaccines or he/she don't know. 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: Based on available information a contributory role of BNT162B2 to the reported events suspected COVID-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Feeling cold, Feeling hot, Flushing
Clinical narrative: his heart rate it was just like 130 so it's bit elevated; he have been checking his temperature and its low grade; he is just feeling cold; he is kind of really warm; kind of red just like red; like blushing earlier; I have my son earlier get his first dose of the COVID vaccine. He is only seven; This is a spontaneous report from a contactable consumer (parent). A 7-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: FK5127, Expiry Date: Not Reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced his heart rate it was just like 130 so it's bit elevated, he have been checking his temperature and its low grade, he is just feeling cold, he is kind of really warm, kind of red just like red, like blushing earlier, and I have my son earlier get his first dose of the COVID vaccine. He is only seven. The reporter just wanted to check with them to know because the reporter has his son earlier got his first dose of the COVID vaccine. He was only seven so that was around 11'o clock that morning and right then it was 7 or almost 8'o clock, then few hours he had been checking his temperature and it was low grade like 98.8 is the higher, 99.6, 99.5 but he kept on complaining that he was just feeling cold like that was like two blanket like it was cold there where they were at (City name) he took blankets and he stated he was kind of really warm and kind of red like blushing earlier just like red. Although the reporter thought it was maybe because he just feeling warm inside but he just feeling cold. The reporter questioned was that normal. When paraphrased the concern. The reporter stated the patient temperature about 99.8 was the highest, 99.6, 99.5 but kind of like low grade the reporter meant it did even reach 100 so far but he should complain for cold like really cold. Yes, and it was kind of reddish earlier but it kind of disappeared, but the reporter does not know it was just because of the reaction or and his heart rate it was just like 130. It was supposed to be like 110 Right? Normal 70 to 110. So, it was bit elevated. On an unspecified date, the patient underwent lab tests and procedures which included body temperature: 99.8, body temperature: 99.6, body temperature :100, body temperature: 98.8, body temperature: 99.5, and heart rate: 130: elevated. The outcome for all the reported event was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: his heart rate it was just like 130 so it's bit elevated; he have been checking his temperature and its low grade; he is just feeling cold; he is kind of really warm; kind of red just like red; like blushing earlier; I have my son earlier get his first dose of the COVID vaccine. He is only seven; This is a spontaneous report from a contactable consumer (parent). A 7-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: FK5127, Expiry Date: Not Reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced his heart rate it was just like 130 so it's bit elevated, he have been checking his temperature and its low grade, he is just feeling cold, he is kind of really warm, kind of red just like red, like blushing earlier, and I have my son earlier get his first dose of the COVID vaccine. He is only seven. The reporter just wanted to check with them to know because the reporter has his son earlier got his first dose of the COVID vaccine. He was only seven so that was around 11'o clock that morning and right then it was 7 or almost 8'o clock, then few hours he had been checking his temperature and it was low grade like 98.8 is the higher, 99.6, 99.5 but he kept on complaining that he was just feeling cold like that was like two blanket like it was cold there where they were at (City name) he took blankets and he stated he was kind of really warm and kind of red like blushing earlier just like red. Although the reporter thought it was maybe because he just feeling warm inside but he just feeling cold. The reporter questioned was that normal. When paraphrased the concern. The reporter stated the patient temperature about 99.8 was the highest, 99.6, 99.5 but kind of like low grade the reporter meant it did even reach 100 so far but he should complain for cold like really cold. Yes, and it was kind of reddish earlier but it kind of disappeared, but the reporter does not know it was just because of the reaction or and his heart rate it was just like 130. It was supposed to be like 110 Right? Normal 70 to 110. So, it was bit elevated. On an unspecified date, the patient underwent lab tests and procedures which included body temperature: 99.8, body temperature: 99.6, body temperature :100, body temperature: 98.8, body temperature: 99.5, and heart rate: 130: elevated. The outcome for all the reported event was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Joint instability, Pain in extremity
Clinical narrative: Nerve pain shooting from knee down lower legs; Causing knees to buckle; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2593) via an unspecified route of administration in the left arm on 04Nov2021 at 10:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 14Jan2021 (at the age of 73-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 04Feb2021 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 06Nov2021 at 05:00, the patient experienced nerve pain shooting from knee down lower legs causing the knees to buckle. The events resulted in emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nerve pain shooting from knee down lower legs causing knees to buckle was unknown at the time of this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphoedema
Clinical narrative: The patient received the third/booster dose of BNT162b2; Left axillae lymphedema; This is a spontaneous report from a contactable physician. A 74-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included hypersensitivity lung disease (HLD), hypertension (HTN), hypothyroidism, osteopenia and penicillin (PCN) allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date; both as single doses for COVID-19 immunisation. On an unknown date, the patient experienced left axillae lymphedema. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left axillae lymphedema was resolved on an unknown date.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Constipation, Eye pain, Headache, Hot flush, Insomnia
Clinical narrative: Rotating cold and hot flashes; Inability to sleep for 2 nights; Body aches; Heart palpitations; Extreme pain in eye sockets; Constipation; Night sweats; Headache all day and night; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old patient of unknown gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PAA173696) via an unspecified route of administration in the left arm on 06Nov2021 at 12:00 (at the age of 34-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received influenza vaccine (FLU) on 16Oct2021, within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3U1558A) via an unspecified route of administration in the left arm on 16Oct2021 at 08:00 (at the age of 34-year-old), as a single dose for COVID-19 immunisation. On 06Nov2021 at 15:00, the patient experienced rotating cold and hot flashes, inability to sleep for 2 nights, body aches, heart palpitations, extreme pain in eye sockets, constipation, night sweats and headache all day and night, since the second dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rotating cold and hot flashes, inability to sleep for 2 nights, body aches, heart palpitations, extreme pain in eye sockets, constipation, night sweats and headache all day and night was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Night sweats, Pain, Palpitations
Clinical narrative: Rotating cold and hot flashes; Inability to sleep for 2 nights; Body aches; Heart palpitations; Extreme pain in eye sockets; Constipation; Night sweats; Headache all day and night; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old patient of unknown gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PAA173696) via an unspecified route of administration in the left arm on 06Nov2021 at 12:00 (at the age of 34-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received influenza vaccine (FLU) on 16Oct2021, within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3U1558A) via an unspecified route of administration in the left arm on 16Oct2021 at 08:00 (at the age of 34-year-old), as a single dose for COVID-19 immunisation. On 06Nov2021 at 15:00, the patient experienced rotating cold and hot flashes, inability to sleep for 2 nights, body aches, heart palpitations, extreme pain in eye sockets, constipation, night sweats and headache all day and night, since the second dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rotating cold and hot flashes, inability to sleep for 2 nights, body aches, heart palpitations, extreme pain in eye sockets, constipation, night sweats and headache all day and night was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Muscle twitching, Paraesthesia
Clinical narrative: Numbness, tingling and twitching in my face, which spread throughout my body; Numbness, tingling and twitching in my face, which spread throughout my body; Numbness, tingling and twitching in my face, which spread throughout my body/ primarily twitching; Cramping throughout my body; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 25Jul2021 at 12:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included armodafinil (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously took cefaclor (CECLOR) for an unknown indication and experienced drug allergy. On 03Aug2021 at 14:45, the patient experienced numbness, tingling and twitching in his face, which had spread throughout his body. It started approximately 2 weeks after receiving the vaccine. At that point it was primarily twitching and cramping throughout his body. He had been seen by 3 neurologists now and they still did not have a diagnosis (at the time of this report). His next neurology follow-up was on 18Nov2021. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events numbness, tingling and twitching in his face, which spread throughout his body/ primarily twitching and cramping throughout his body was not resolved at the time of this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Bladder pain, Blood urine present, Groin pain, Immunisation
Clinical narrative: Blood in urine; Pain in the bladder; Pain in the bladder, groin; Pain in the bladder, groin, lower abdomen; Pain in the bladder, groin, lower abdomen, or pelvis; The patient received the third/booster dose of BNT162b2; Patient was administered booster dose with BNT162B2 and  received  initial complete immunisation with non-Pfizer vaccine.; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis C. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included dietary supplements (unspecified) for unknown indication from an unknown date and unknown if ongoing. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and doxycycline (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of COVID-19 vaccine (NOVAVAX; Lot Number: 28004) via an unspecified route of administration in the right arm on 20Apr2021 and the second dose of COVID-19 vaccine (NOVAVAX; Lot Number: 28004) via an unspecified route of administration in the left arm on 11May2021; both as single doses for COVID-19 immunisation. On 13Nov2021, the patient experienced blood in urine, also pain in the bladder, groin, lower abdomen, or pelvis. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events blood in urine, pain in the bladder, groin, lower abdomen, or pelvis was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pelvic pain
Clinical narrative: Blood in urine; Pain in the bladder; Pain in the bladder, groin; Pain in the bladder, groin, lower abdomen; Pain in the bladder, groin, lower abdomen, or pelvis; The patient received the third/booster dose of BNT162b2; Patient was administered booster dose with BNT162B2 and  received  initial complete immunisation with non-Pfizer vaccine.; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis C. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included dietary supplements (unspecified) for unknown indication from an unknown date and unknown if ongoing. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and doxycycline (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of COVID-19 vaccine (NOVAVAX; Lot Number: 28004) via an unspecified route of administration in the right arm on 20Apr2021 and the second dose of COVID-19 vaccine (NOVAVAX; Lot Number: 28004) via an unspecified route of administration in the left arm on 11May2021; both as single doses for COVID-19 immunisation. On 13Nov2021, the patient experienced blood in urine, also pain in the bladder, groin, lower abdomen, or pelvis. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events blood in urine, pain in the bladder, groin, lower abdomen, or pelvis was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.