chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Arthralgia, Cardiovascular disorder, Discomfort, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; Numbness; heaviness; nearly paralyzing/paralysis; sensation of swelling with no circulation; sensation of swelling with no circulation; difficulty moving; Whole body aches like being in a car wreck; Random pain throughout body, toe, finger, jaw, heel, knee, etc.; Random pain throughout body, toe, finger, jaw, heel, knee, etc.; Random pain throughout body, toe, finger, jaw, heel, knee, etc.; feelings of being bloated; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient (currently 55-year-old) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 16Apr2021 12:00 (at the age of 54-years-old) (Batch/Lot Number: ER8731) as dose 1, single for COVID-19 immunization. Medical history included digestive disorders, gastroparesis, hiatal hernia, GERD, allergic to onions. The patient did not have COVID prior to vaccination. Concomitant medication included quetiapine; buspirone; and sertraline; all taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient previously took flu vaccines for immunization (unspecified date) and 100% of the time resulting in upper middle back pain lasting approximately 2-weeks. Because of this have not had a vaccine in at least 25-years. Wanted to help end the pandemic and decided to get the Covid-19 vaccine even though he expected to have an adverse event similar to his prior experiences. On 17Apr2021 15:00 (reported as 3:00 pm), the patient described the adverse event as far more serious than expected, nearly paralyzing him. Symptoms were consistent with Guillain-Barre syndrome. Numbness, heaviness, paralysis, sensation of swelling with no circulation, difficulty moving. Worsens if stagnate or over stimulated physically. Whole body aches like being in a car wreck. Random pain throughout body, toe, finger, jaw, heel, knee etc. Feeling of bloated and weighing 10-times normal weight. The events resulted in doctor or other healthcare professional office/clinic visit. The patient considered the events to be life-threatening illness (immediate risk of death from the event) and disability or permanent damage. The patient received gabapentin as treatment for the events. The patient has not recovered from the events.. The patient was not COVID tested post vaccination.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Movement disorder, Pain, Pain in extremity, Pain in jaw
Clinical narrative: Guillain-Barre syndrome; Numbness; heaviness; nearly paralyzing/paralysis; sensation of swelling with no circulation; sensation of swelling with no circulation; difficulty moving; Whole body aches like being in a car wreck; Random pain throughout body, toe, finger, jaw, heel, knee, etc.; Random pain throughout body, toe, finger, jaw, heel, knee, etc.; Random pain throughout body, toe, finger, jaw, heel, knee, etc.; feelings of being bloated; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient (currently 55-year-old) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 16Apr2021 12:00 (at the age of 54-years-old) (Batch/Lot Number: ER8731) as dose 1, single for COVID-19 immunization. Medical history included digestive disorders, gastroparesis, hiatal hernia, GERD, allergic to onions. The patient did not have COVID prior to vaccination. Concomitant medication included quetiapine; buspirone; and sertraline; all taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient previously took flu vaccines for immunization (unspecified date) and 100% of the time resulting in upper middle back pain lasting approximately 2-weeks. Because of this have not had a vaccine in at least 25-years. Wanted to help end the pandemic and decided to get the Covid-19 vaccine even though he expected to have an adverse event similar to his prior experiences. On 17Apr2021 15:00 (reported as 3:00 pm), the patient described the adverse event as far more serious than expected, nearly paralyzing him. Symptoms were consistent with Guillain-Barre syndrome. Numbness, heaviness, paralysis, sensation of swelling with no circulation, difficulty moving. Worsens if stagnate or over stimulated physically. Whole body aches like being in a car wreck. Random pain throughout body, toe, finger, jaw, heel, knee etc. Feeling of bloated and weighing 10-times normal weight. The events resulted in doctor or other healthcare professional office/clinic visit. The patient considered the events to be life-threatening illness (immediate risk of death from the event) and disability or permanent damage. The patient received gabapentin as treatment for the events. The patient has not recovered from the events.. The patient was not COVID tested post vaccination.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paralysis, Swelling
Clinical narrative: Guillain-Barre syndrome; Numbness; heaviness; nearly paralyzing/paralysis; sensation of swelling with no circulation; sensation of swelling with no circulation; difficulty moving; Whole body aches like being in a car wreck; Random pain throughout body, toe, finger, jaw, heel, knee, etc.; Random pain throughout body, toe, finger, jaw, heel, knee, etc.; Random pain throughout body, toe, finger, jaw, heel, knee, etc.; feelings of being bloated; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient (currently 55-year-old) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 16Apr2021 12:00 (at the age of 54-years-old) (Batch/Lot Number: ER8731) as dose 1, single for COVID-19 immunization. Medical history included digestive disorders, gastroparesis, hiatal hernia, GERD, allergic to onions. The patient did not have COVID prior to vaccination. Concomitant medication included quetiapine; buspirone; and sertraline; all taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient previously took flu vaccines for immunization (unspecified date) and 100% of the time resulting in upper middle back pain lasting approximately 2-weeks. Because of this have not had a vaccine in at least 25-years. Wanted to help end the pandemic and decided to get the Covid-19 vaccine even though he expected to have an adverse event similar to his prior experiences. On 17Apr2021 15:00 (reported as 3:00 pm), the patient described the adverse event as far more serious than expected, nearly paralyzing him. Symptoms were consistent with Guillain-Barre syndrome. Numbness, heaviness, paralysis, sensation of swelling with no circulation, difficulty moving. Worsens if stagnate or over stimulated physically. Whole body aches like being in a car wreck. Random pain throughout body, toe, finger, jaw, heel, knee etc. Feeling of bloated and weighing 10-times normal weight. The events resulted in doctor or other healthcare professional office/clinic visit. The patient considered the events to be life-threatening illness (immediate risk of death from the event) and disability or permanent damage. The patient received gabapentin as treatment for the events. The patient has not recovered from the events.. The patient was not COVID tested post vaccination.
Age: 78.0
Sex: M
Vaccine: COVID19, FLUA3, UNK
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Pain in shoulder; The patient received 2 vaccines (influenza and covid vaccines) in the same arm; One was too high/he did receive vaccine too high; This spontaneous case from the United States was retrieved on 27-Sep-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1697391-1), reported by other health professional and concerned a 78-year-old, male patient.   The patient's medical history and concomitant medications were not reported.  On 28-Oct-2021,the patient was vaccinated with non-company co-suspect Covid-19 vaccine (Moderna; dose: reported as three, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 004f21a.   On the same date, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as one, route of administration: intramuscular, anatomical location: left arm and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was 312832. It was reported that one of vaccines were administered too high (explicitly coded as 'Product administered at inappropriate site').    On the same date, after receiving Fluad Quadrivalent and non-company co-suspect Covid-19 vaccine, the patient had severe pain in shoulder and visited doctor who stated that the patient did receive vaccine too high and advise patient to report the incident.  On an unspecified date in 2021, the patient recovered from the event of 'shoulder pain'.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.  Company comment: Event 'shoulder pain' was considered as related to Fluad Quadrivalent, while the events of 'Product administration error' and 'Product administered at inappropriate site' were considered as not related to Fluad Quadrivalent.; Sender's Comments: Event 'shoulder pain' was considered as related to Fluad Quadrivalent, while the events of 'Product administration error' and 'Product administered at inappropriate site' were considered as not related to Fluad Quadrivalent.
Age: 78.0
Sex: M
Vaccine: COVID19, FLUA3, UNK
Symptoms: Arthralgia, Product administered at inappropriate site, Product administration error
Clinical narrative: Pain in shoulder; The patient received 2 vaccines (influenza and covid vaccines) in the same arm; One was too high/he did receive vaccine too high; This spontaneous case from the United States was retrieved on 27-Sep-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1697391-1), reported by other health professional and concerned a 78-year-old, male patient.   The patient's medical history and concomitant medications were not reported.  On 28-Oct-2021,the patient was vaccinated with non-company co-suspect Covid-19 vaccine (Moderna; dose: reported as three, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 004f21a.   On the same date, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as one, route of administration: intramuscular, anatomical location: left arm and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was 312832. It was reported that one of vaccines were administered too high (explicitly coded as 'Product administered at inappropriate site').    On the same date, after receiving Fluad Quadrivalent and non-company co-suspect Covid-19 vaccine, the patient had severe pain in shoulder and visited doctor who stated that the patient did receive vaccine too high and advise patient to report the incident.  On an unspecified date in 2021, the patient recovered from the event of 'shoulder pain'.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.  Company comment: Event 'shoulder pain' was considered as related to Fluad Quadrivalent, while the events of 'Product administration error' and 'Product administered at inappropriate site' were considered as not related to Fluad Quadrivalent.; Sender's Comments: Event 'shoulder pain' was considered as related to Fluad Quadrivalent, while the events of 'Product administration error' and 'Product administered at inappropriate site' were considered as not related to Fluad Quadrivalent.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: abdominal pain; nausea; bloating; back pain; chest pain; shortness of breath; This is a spontaneous report from a contactable consumer. This is the second of two report referred to same patient and second dose only. A 56-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in arm on 20Jan2021 (Batch/Lot Number: EL3249) as DOSE 2, SINGLE for covid-19 immunisation.Vaccine facility type: Hospital. The patient medical history and concomitant medications were not reported. Historical vaccine included on 29Dec2020 dose 1 anatomical site of injection: arm deltoid, intramuscular Batch/Lot number: EL1284. On 07Sep2021 patient experienced back pain on with outcome of recovering, chest pain with outcome of recovering, shortness of breath on with outcome of recovering. In addition on an unspecified date abdominal pain on with outcome of recovering, nausea with outcome of recovering, bloating with outcome of recovering. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Sep2021 and sars-cov-2 test: positive on 03Sep2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101168685 Same reporter/ patient/ product, different dose/AEs.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain, Back pain, Chest pain, Dyspnoea
Clinical narrative: abdominal pain; nausea; bloating; back pain; chest pain; shortness of breath; This is a spontaneous report from a contactable consumer. This is the second of two report referred to same patient and second dose only. A 56-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in arm on 20Jan2021 (Batch/Lot Number: EL3249) as DOSE 2, SINGLE for covid-19 immunisation.Vaccine facility type: Hospital. The patient medical history and concomitant medications were not reported. Historical vaccine included on 29Dec2020 dose 1 anatomical site of injection: arm deltoid, intramuscular Batch/Lot number: EL1284. On 07Sep2021 patient experienced back pain on with outcome of recovering, chest pain with outcome of recovering, shortness of breath on with outcome of recovering. In addition on an unspecified date abdominal pain on with outcome of recovering, nausea with outcome of recovering, bloating with outcome of recovering. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Sep2021 and sars-cov-2 test: positive on 03Sep2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101168685 Same reporter/ patient/ product, different dose/AEs.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, SARS-CoV-2 test
Clinical narrative: abdominal pain; nausea; bloating; back pain; chest pain; shortness of breath; This is a spontaneous report from a contactable consumer. This is the second of two report referred to same patient and second dose only. A 56-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in arm on 20Jan2021 (Batch/Lot Number: EL3249) as DOSE 2, SINGLE for covid-19 immunisation.Vaccine facility type: Hospital. The patient medical history and concomitant medications were not reported. Historical vaccine included on 29Dec2020 dose 1 anatomical site of injection: arm deltoid, intramuscular Batch/Lot number: EL1284. On 07Sep2021 patient experienced back pain on with outcome of recovering, chest pain with outcome of recovering, shortness of breath on with outcome of recovering. In addition on an unspecified date abdominal pain on with outcome of recovering, nausea with outcome of recovering, bloating with outcome of recovering. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Sep2021 and sars-cov-2 test: positive on 03Sep2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101168685 Same reporter/ patient/ product, different dose/AEs.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Agitation, Anxiety, Chills, Feeling cold, Feeling jittery
Clinical narrative: sweating; chills; felt really tired; felt feverish; This is a spontaneous report from a contactable consumer reported in response to Non-HCP letter sent. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203), via an unspecified route of administration on 24Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history was Pneumonia 5 YR booster; 15 days before Covid-19 shot. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM) 50 mg ongoing taken for thyroid. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 1, single on 03Feb2021Lot number EL3247 for covid-19 immunization and no side effect. The patient experienced on 24Feb2021 01:30, After 2nd dose, started having chills, took tylenol went back to bed. That morning Feb2021 just felt really tired. That evening 05:30 PM, Feb2021 felt feverish took another Tylenol just started sweating. Treatment provided after second dose tylenol extra strength for chills, Feverish. The outcome of event for chills, felt really tired, felt feverish was recovered on 2021 and rest all was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Pain, Pain in extremity, Pyrexia, Vaccination site pruritus
Clinical narrative: sweating; chills; felt really tired; felt feverish; This is a spontaneous report from a contactable consumer reported in response to Non-HCP letter sent. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203), via an unspecified route of administration on 24Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history was Pneumonia 5 YR booster; 15 days before Covid-19 shot. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM) 50 mg ongoing taken for thyroid. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 1, single on 03Feb2021Lot number EL3247 for covid-19 immunization and no side effect. The patient experienced on 24Feb2021 01:30, After 2nd dose, started having chills, took tylenol went back to bed. That morning Feb2021 just felt really tired. That evening 05:30 PM, Feb2021 felt feverish took another Tylenol just started sweating. Treatment provided after second dose tylenol extra strength for chills, Feverish. The outcome of event for chills, felt really tired, felt feverish was recovered on 2021 and rest all was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: sweating; chills; felt really tired; felt feverish; This is a spontaneous report from a contactable consumer reported in response to Non-HCP letter sent. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203), via an unspecified route of administration on 24Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history was Pneumonia 5 YR booster; 15 days before Covid-19 shot. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM) 50 mg ongoing taken for thyroid. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 1, single on 03Feb2021Lot number EL3247 for covid-19 immunization and no side effect. The patient experienced on 24Feb2021 01:30, After 2nd dose, started having chills, took tylenol went back to bed. That morning Feb2021 just felt really tired. That evening 05:30 PM, Feb2021 felt feverish took another Tylenol just started sweating. Treatment provided after second dose tylenol extra strength for chills, Feverish. The outcome of event for chills, felt really tired, felt feverish was recovered on 2021 and rest all was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Electric shock sensation, Paraesthesia, Urticaria
Clinical narrative: her lips were "tingling"; she had one hive appear where she received her shot but it disappeared within a minute; gastrointestinal issues such as diarrhea; terrible headache; Rash; non-severe allergic reactions; Itching; really sick a few days right after; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267, NDC number: Not Provided, expiry date: Unknown) via an unspecified route of administration on 16Mar2021 (age at vaccination was 37 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient normally takes Zyrtec for seasonal allergies but states she did not take it before her first dose of the vaccine because patient was worried about a potential reaction. The patient states that when she received her first dose, within 25 minutes on an unspecified date in Mar2021, her lips were "tingling" but states that went away after a minute. on an unspecified date in Mar2021, the patient then reports that 30 hours later she had one hive appear where she received her shot but it disappeared within a minute. The patient then reports that 48 hours later another hive appeared on the shoulder of the same arm that she received her shot in, but states that it also went away in a minute. on an unspecified date in 2021, she also had GI issues such as diarrhea for like five days afterwards and also had a "terrible headache" but states she was more so concerned about her symptoms with the lips and the hives. The patient knows that things such as rash, itching, and hives were reported after a dose of the vaccine on an unspecified date in 2021 and were considered to be non-severe allergic reactions. The patient called the third day after the shot as she was really sick a few days right after the shot. The report was non-serious. Outcome of the event her lips were "tingling" and Vaccination site urticaria was resolved on an unspecified date in Mar2021 and outcome was unknown for remaining events.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Headache, Hypersensitivity, Illness, Paraesthesia oral
Clinical narrative: her lips were "tingling"; she had one hive appear where she received her shot but it disappeared within a minute; gastrointestinal issues such as diarrhea; terrible headache; Rash; non-severe allergic reactions; Itching; really sick a few days right after; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267, NDC number: Not Provided, expiry date: Unknown) via an unspecified route of administration on 16Mar2021 (age at vaccination was 37 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient normally takes Zyrtec for seasonal allergies but states she did not take it before her first dose of the vaccine because patient was worried about a potential reaction. The patient states that when she received her first dose, within 25 minutes on an unspecified date in Mar2021, her lips were "tingling" but states that went away after a minute. on an unspecified date in Mar2021, the patient then reports that 30 hours later she had one hive appear where she received her shot but it disappeared within a minute. The patient then reports that 48 hours later another hive appeared on the shoulder of the same arm that she received her shot in, but states that it also went away in a minute. on an unspecified date in 2021, she also had GI issues such as diarrhea for like five days afterwards and also had a "terrible headache" but states she was more so concerned about her symptoms with the lips and the hives. The patient knows that things such as rash, itching, and hives were reported after a dose of the vaccine on an unspecified date in 2021 and were considered to be non-severe allergic reactions. The patient called the third day after the shot as she was really sick a few days right after the shot. The report was non-serious. Outcome of the event her lips were "tingling" and Vaccination site urticaria was resolved on an unspecified date in Mar2021 and outcome was unknown for remaining events.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Vaccination site urticaria
Clinical narrative: her lips were "tingling"; she had one hive appear where she received her shot but it disappeared within a minute; gastrointestinal issues such as diarrhea; terrible headache; Rash; non-severe allergic reactions; Itching; really sick a few days right after; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267, NDC number: Not Provided, expiry date: Unknown) via an unspecified route of administration on 16Mar2021 (age at vaccination was 37 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient normally takes Zyrtec for seasonal allergies but states she did not take it before her first dose of the vaccine because patient was worried about a potential reaction. The patient states that when she received her first dose, within 25 minutes on an unspecified date in Mar2021, her lips were "tingling" but states that went away after a minute. on an unspecified date in Mar2021, the patient then reports that 30 hours later she had one hive appear where she received her shot but it disappeared within a minute. The patient then reports that 48 hours later another hive appeared on the shoulder of the same arm that she received her shot in, but states that it also went away in a minute. on an unspecified date in 2021, she also had GI issues such as diarrhea for like five days afterwards and also had a "terrible headache" but states she was more so concerned about her symptoms with the lips and the hives. The patient knows that things such as rash, itching, and hives were reported after a dose of the vaccine on an unspecified date in 2021 and were considered to be non-severe allergic reactions. The patient called the third day after the shot as she was really sick a few days right after the shot. The report was non-serious. Outcome of the event her lips were "tingling" and Vaccination site urticaria was resolved on an unspecified date in Mar2021 and outcome was unknown for remaining events.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: cold sore break out; shingles; rash; severe pain in back; This is a spontaneous report from a contactable consumer (patient) via Regulatory Authority. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 15Jul2021, dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that about two weeks afterwards the vaccination, the patient had a cold sore break out. Then on 16Sep2021, the patient started having severe pain in back. On 18Sep2021, a rash was forming, and the patient went to the emergency room on 20Sep2021 to be told the patient have shingles. The patient filed a report to notify of this and asked any studies on the effect the mRNA was having on these other viruses.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Back pain, Herpes zoster, Oral herpes, Rash
Clinical narrative: cold sore break out; shingles; rash; severe pain in back; This is a spontaneous report from a contactable consumer (patient) via Regulatory Authority. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 15Jul2021, dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that about two weeks afterwards the vaccination, the patient had a cold sore break out. Then on 16Sep2021, the patient started having severe pain in back. On 18Sep2021, a rash was forming, and the patient went to the emergency room on 20Sep2021 to be told the patient have shingles. The patient filed a report to notify of this and asked any studies on the effect the mRNA was having on these other viruses.  Information on the lot/batch number has been requested.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test, C-reactive protein increased, Chest X-ray normal, Dyspnoea
Clinical narrative: high inflammation markers (CRP 88mg/L, ESR 53mm/hr); high inflammation markers (CRP 88mg/L, ESR 53mm/hr); Urinalysis results were normal except for transitional high Urobilinogen at 2.0 mg/dl; High fever of 102.7; Intense pain in upper left back near his shoulder blade; which made it hard to breath; pain continued for 6+ days; inflammation was due to vaccine; This is a spontaneous report from a contactable consumer (patient). A 13-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot number: not reported) via an unspecified route of administration, administered in Arm Left on 10Aug2021 15:00 (13-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took Tamiflu (TAMIFLU) and experienced seizure, hallucination and allergies. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was tested since vaccination. On 18Aug2021 at 12:00, the patient experienced intense pain in upper left back near his shoulder blade, which made it hard to breath, pain continued for 6+ days. On the first morning after symptoms started (19Aug2021), patient underwent chest x-ray to check his lungs, which were clear and visited the Pediatrician for evaluation. They waited a few days to suggest additional testing. On 20Aug2021, patient experienced high fever of 102.7 and was tested negative for COVID-19 [test: Nasal Swab- BinaxNOW-Negative]. On 24Aug2021, patient underwent urinalysis with results which were normal except for transitional high Urobilinogen at 2.0 mg/dL. On 25Aug2021, blood panel was mostly within normal range except for high inflammation markers (CRP 88mg/L, ESR 53mm/hr). On 02Sep2021, repeat blood panel showed that inflammation markers had dropped to just above normal (CRP 8mg/L, ESR 17mm/hr). Because inflammation markers dropped and pain had mostly dissipated (02Sep2021), the Pediatrician did not order any further testing. Her conclusion was that the inflammation [onset date: Aug2021] was due to vaccine. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken for the events using OTC pain relief, heating pad, chiropractor for pai. The outcome of the events were recovering.   The lot number for BNT162B2 was not provided and will be request during follow-up.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Inflammatory marker increased, Pyrexia, Red blood cell sedimentation rate increased, SARS-CoV-2 test negative
Clinical narrative: high inflammation markers (CRP 88mg/L, ESR 53mm/hr); high inflammation markers (CRP 88mg/L, ESR 53mm/hr); Urinalysis results were normal except for transitional high Urobilinogen at 2.0 mg/dl; High fever of 102.7; Intense pain in upper left back near his shoulder blade; which made it hard to breath; pain continued for 6+ days; inflammation was due to vaccine; This is a spontaneous report from a contactable consumer (patient). A 13-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot number: not reported) via an unspecified route of administration, administered in Arm Left on 10Aug2021 15:00 (13-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took Tamiflu (TAMIFLU) and experienced seizure, hallucination and allergies. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was tested since vaccination. On 18Aug2021 at 12:00, the patient experienced intense pain in upper left back near his shoulder blade, which made it hard to breath, pain continued for 6+ days. On the first morning after symptoms started (19Aug2021), patient underwent chest x-ray to check his lungs, which were clear and visited the Pediatrician for evaluation. They waited a few days to suggest additional testing. On 20Aug2021, patient experienced high fever of 102.7 and was tested negative for COVID-19 [test: Nasal Swab- BinaxNOW-Negative]. On 24Aug2021, patient underwent urinalysis with results which were normal except for transitional high Urobilinogen at 2.0 mg/dL. On 25Aug2021, blood panel was mostly within normal range except for high inflammation markers (CRP 88mg/L, ESR 53mm/hr). On 02Sep2021, repeat blood panel showed that inflammation markers had dropped to just above normal (CRP 8mg/L, ESR 17mm/hr). Because inflammation markers dropped and pain had mostly dissipated (02Sep2021), the Pediatrician did not order any further testing. Her conclusion was that the inflammation [onset date: Aug2021] was due to vaccine. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken for the events using OTC pain relief, heating pad, chiropractor for pai. The outcome of the events were recovering.   The lot number for BNT162B2 was not provided and will be request during follow-up.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urine analysis, Urobilinogen urine increased
Clinical narrative: high inflammation markers (CRP 88mg/L, ESR 53mm/hr); high inflammation markers (CRP 88mg/L, ESR 53mm/hr); Urinalysis results were normal except for transitional high Urobilinogen at 2.0 mg/dl; High fever of 102.7; Intense pain in upper left back near his shoulder blade; which made it hard to breath; pain continued for 6+ days; inflammation was due to vaccine; This is a spontaneous report from a contactable consumer (patient). A 13-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot number: not reported) via an unspecified route of administration, administered in Arm Left on 10Aug2021 15:00 (13-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took Tamiflu (TAMIFLU) and experienced seizure, hallucination and allergies. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was tested since vaccination. On 18Aug2021 at 12:00, the patient experienced intense pain in upper left back near his shoulder blade, which made it hard to breath, pain continued for 6+ days. On the first morning after symptoms started (19Aug2021), patient underwent chest x-ray to check his lungs, which were clear and visited the Pediatrician for evaluation. They waited a few days to suggest additional testing. On 20Aug2021, patient experienced high fever of 102.7 and was tested negative for COVID-19 [test: Nasal Swab- BinaxNOW-Negative]. On 24Aug2021, patient underwent urinalysis with results which were normal except for transitional high Urobilinogen at 2.0 mg/dL. On 25Aug2021, blood panel was mostly within normal range except for high inflammation markers (CRP 88mg/L, ESR 53mm/hr). On 02Sep2021, repeat blood panel showed that inflammation markers had dropped to just above normal (CRP 8mg/L, ESR 17mm/hr). Because inflammation markers dropped and pain had mostly dissipated (02Sep2021), the Pediatrician did not order any further testing. Her conclusion was that the inflammation [onset date: Aug2021] was due to vaccine. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken for the events using OTC pain relief, heating pad, chiropractor for pai. The outcome of the events were recovering.   The lot number for BNT162B2 was not provided and will be request during follow-up.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test, Body temperature, C-reactive protein, C-reactive protein increased
Clinical narrative: high inflammation markers (CRP 88mg/L, ESR 53mm/hr); high inflammation markers (CRP 88mg/L, ESR 53mm/hr); Urinalysis results were normal except for transitional high Urobilinogen at 2.0 mg/dl; High fever of 102.7; Intense pain in upper left back near his shoulder blade; which made it hard to breath; pain continued for 6+ days; inflammation was due to vaccine; This is a spontaneous report from a contactable consumer (patient). A 13-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot number: not reported) via an unspecified route of administration, administered in Arm Left on 10Aug2021 15:00 (13-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took Tamiflu (TAMIFLU) and experienced seizure, hallucination and allergies. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was tested since vaccination. On 18Aug2021 at 12:00, the patient experienced intense pain in upper left back near his shoulder blade, which made it hard to breath, pain continued for 6+ days. On the first morning after symptoms started (19Aug2021), patient underwent chest x-ray to check his lungs, which were clear and visited the Pediatrician for evaluation. They waited a few days to suggest additional testing. On 20Aug2021, patient experienced high fever of 102.7 and was tested negative for COVID-19 [test: Nasal Swab- BinaxNOW-Negative]. On 24Aug2021, patient underwent urinalysis with results which were normal except for transitional high Urobilinogen at 2.0 mg/dL. On 25Aug2021, blood panel was mostly within normal range except for high inflammation markers (CRP 88mg/L, ESR 53mm/hr). On 02Sep2021, repeat blood panel showed that inflammation markers had dropped to just above normal (CRP 8mg/L, ESR 17mm/hr). Because inflammation markers dropped and pain had mostly dissipated (02Sep2021), the Pediatrician did not order any further testing. Her conclusion was that the inflammation [onset date: Aug2021] was due to vaccine. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken for the events using OTC pain relief, heating pad, chiropractor for pai. The outcome of the events were recovering.   The lot number for BNT162B2 was not provided and will be request during follow-up.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Dyspnoea, Inflammation, Pain, Pyrexia
Clinical narrative: high inflammation markers (CRP 88mg/L, ESR 53mm/hr); high inflammation markers (CRP 88mg/L, ESR 53mm/hr); Urinalysis results were normal except for transitional high Urobilinogen at 2.0 mg/dl; High fever of 102.7; Intense pain in upper left back near his shoulder blade; which made it hard to breath; pain continued for 6+ days; inflammation was due to vaccine; This is a spontaneous report from a contactable consumer (patient). A 13-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot number: not reported) via an unspecified route of administration, administered in Arm Left on 10Aug2021 15:00 (13-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took Tamiflu (TAMIFLU) and experienced seizure, hallucination and allergies. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was tested since vaccination. On 18Aug2021 at 12:00, the patient experienced intense pain in upper left back near his shoulder blade, which made it hard to breath, pain continued for 6+ days. On the first morning after symptoms started (19Aug2021), patient underwent chest x-ray to check his lungs, which were clear and visited the Pediatrician for evaluation. They waited a few days to suggest additional testing. On 20Aug2021, patient experienced high fever of 102.7 and was tested negative for COVID-19 [test: Nasal Swab- BinaxNOW-Negative]. On 24Aug2021, patient underwent urinalysis with results which were normal except for transitional high Urobilinogen at 2.0 mg/dL. On 25Aug2021, blood panel was mostly within normal range except for high inflammation markers (CRP 88mg/L, ESR 53mm/hr). On 02Sep2021, repeat blood panel showed that inflammation markers had dropped to just above normal (CRP 8mg/L, ESR 17mm/hr). Because inflammation markers dropped and pain had mostly dissipated (02Sep2021), the Pediatrician did not order any further testing. Her conclusion was that the inflammation [onset date: Aug2021] was due to vaccine. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken for the events using OTC pain relief, heating pad, chiropractor for pai. The outcome of the events were recovering.   The lot number for BNT162B2 was not provided and will be request during follow-up.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate, Red blood cell sedimentation rate increased, SARS-CoV-2 test, Urine analysis, Urobilinogen urine increased
Clinical narrative: high inflammation markers (CRP 88mg/L, ESR 53mm/hr); high inflammation markers (CRP 88mg/L, ESR 53mm/hr); Urinalysis results were normal except for transitional high Urobilinogen at 2.0 mg/dl; High fever of 102.7; Intense pain in upper left back near his shoulder blade; which made it hard to breath; pain continued for 6+ days; inflammation was due to vaccine; This is a spontaneous report from a contactable consumer (patient). A 13-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot number: not reported) via an unspecified route of administration, administered in Arm Left on 10Aug2021 15:00 (13-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took Tamiflu (TAMIFLU) and experienced seizure, hallucination and allergies. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was tested since vaccination. On 18Aug2021 at 12:00, the patient experienced intense pain in upper left back near his shoulder blade, which made it hard to breath, pain continued for 6+ days. On the first morning after symptoms started (19Aug2021), patient underwent chest x-ray to check his lungs, which were clear and visited the Pediatrician for evaluation. They waited a few days to suggest additional testing. On 20Aug2021, patient experienced high fever of 102.7 and was tested negative for COVID-19 [test: Nasal Swab- BinaxNOW-Negative]. On 24Aug2021, patient underwent urinalysis with results which were normal except for transitional high Urobilinogen at 2.0 mg/dL. On 25Aug2021, blood panel was mostly within normal range except for high inflammation markers (CRP 88mg/L, ESR 53mm/hr). On 02Sep2021, repeat blood panel showed that inflammation markers had dropped to just above normal (CRP 8mg/L, ESR 17mm/hr). Because inflammation markers dropped and pain had mostly dissipated (02Sep2021), the Pediatrician did not order any further testing. Her conclusion was that the inflammation [onset date: Aug2021] was due to vaccine. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken for the events using OTC pain relief, heating pad, chiropractor for pai. The outcome of the events were recovering.   The lot number for BNT162B2 was not provided and will be request during follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: She developed a rash; She developed a rash and hives; The rash was so itchy,; Patient cry; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 06Mar2021 (age at vaccination 40 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On 06Mar2021 the patient experienced she developed a rash, she developed a rash and hives, the rash was so itchy, patient cry. Reporter stated, Patient had a really bad reaction to the first dose. Patient has not received her second dose of the covid vaccine yet. Patient is supposed to get her second dose of the covid vaccine tomorrow. Patient is not sure if she should get the second dose of the covid vaccine because her rash and hives were so bad. Reporter is calling for patient to help give her some guidance on whether or not she should get the second dose. It was not until the last couple of days that patients rash and hives have cleared up. Patient is reporter's co worker. She developed a rash and hives: Patient described the rash and hives together. Reporter does not know if these occurred separately. Reporter is going off of how patient described it to reporter. The rash was so itchy, that it made the patient cry. The rash and hives started to appear Saturday night or Sunday morning. Rash and hives resolved a couple of day ago. Patient told reporter that now the rash and hives are pretty much completely gone. Patient had a rash and hives for a full month. Patient visited physician office for event developed rash. The doctor told her to take Benadryl. Patient received treatment for developed a rash Even with Benadryl, the rash did not get better. The Benadryl did not work. Unknown NDC, lot number or expiration date for Benadryl. The outcome of event rash, hives was recovered rest of event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained