chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: tingling in my toes, tingling in my Rt arm.; numbness in my toes; burning sensation in the Right arm; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix. In May 2022, 8 hrs after receiving Shingrix, the patient experienced tingling of extremity, numbness in toes and burning sensation. The patient was treated with methylprednisolone (Medrol). On an unknown date, the outcome of the tingling of extremity and burning sensation were not recovered/not resolved and the outcome of the numbness in toes was recovered/resolved.   The reporter considered the tingling of extremity, numbness in toes and burning sensation to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-MAY-2022 Reporter's comment: The patient self reported the case. One week prior to the reporting patient received 1st dose of vaccine and 8 hours after patient developed numbness and tingling in her toes. Now 10 days later patient continue to have on and off tingling in right arm. The numbness was gone on her toes. Asked was this normal. The patient took a Medrol dose pack and the toe numbness went away but now having tingling and burning sensation in right arm. The patient felt it was related to the vaccine because the symptoms started 8 hours after receiving the vaccine.  The patient was fine before then.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, COVID-19, Deafness unilateral, Hypoacusis, Magnetic resonance imaging head normal
Clinical narrative: I have permanent hearing loss in my right ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 41-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEAFNESS UNILATERAL (medically significant), outcome "unknown", described as "I have permanent hearing loss in my right ear". Customer Verbatim: I have permanent hearing loss in my right ear after Pfizer vaccine doses and tinnitus 24/7 since Pfizer booster. I think Pfizer should pay for my hearing aid. I'm otherwise 41 years old and healthy. Disgusting.  Forwarded as an Adverse Event by the on 25May2022. Reporter provided verification of contact address on 24May2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: I have permanent hearing loss in my right ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 41-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEAFNESS UNILATERAL (medically significant), outcome "unknown", described as "I have permanent hearing loss in my right ear". Customer Verbatim: I have permanent hearing loss in my right ear after Pfizer vaccine doses and tinnitus 24/7 since Pfizer booster. I think Pfizer should pay for my hearing aid. I'm otherwise 41 years old and healthy. Disgusting.  Forwarded as an Adverse Event by the on 25May2022. Reporter provided verification of contact address on 24May2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness unilateral
Clinical narrative: I have permanent hearing loss in my right ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 41-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEAFNESS UNILATERAL (medically significant), outcome "unknown", described as "I have permanent hearing loss in my right ear". Customer Verbatim: I have permanent hearing loss in my right ear after Pfizer vaccine doses and tinnitus 24/7 since Pfizer booster. I think Pfizer should pay for my hearing aid. I'm otherwise 41 years old and healthy. Disgusting.  Forwarded as an Adverse Event by the on 25May2022. Reporter provided verification of contact address on 24May2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Audiogram, COVID-19, Magnetic resonance imaging, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I have permanent hearing loss in my right ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 41-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEAFNESS UNILATERAL (medically significant), outcome "unknown", described as "I have permanent hearing loss in my right ear". Customer Verbatim: I have permanent hearing loss in my right ear after Pfizer vaccine doses and tinnitus 24/7 since Pfizer booster. I think Pfizer should pay for my hearing aid. I'm otherwise 41 years old and healthy. Disgusting.  Forwarded as an Adverse Event by the on 25May2022. Reporter provided verification of contact address on 24May2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Fatigue, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: Er8730), in right arm, on 19Apr2021 as dose 2, single (Lot number: Ew0170), in right arm, on 30Oct2021 as dose 3 (booster), single (Lot number: Ff2589), in right arm and on 30Apr2022 as dose 4 (booster), single (Lot number: Fk9893) at the age of 51 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Known allergies: Tree nits" (unspecified if ongoing), notes: Known allergies: Tree nits. The patient's concomitant medications were not reported, also reported as unknown if the  patient took any other medications/products within 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14May2022, outcome "unknown" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Positive; (21May2022) Negative; (23May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid(treatment start date: 14May2022, treatment stop date: 18May2022). Clinical course was reported as, the patient was COVID positive on 14May2022. Began taking Paxlovid 14May2022 and ended on 18May2022. The patient felt better and tested COVID negative on 21May2022. COVID symptoms returned and felt horrible and tested COVID positive on 23May2022. (name withheld) tests, the patient had PCR on 23May2022 and confirmed positive Paxlovid rebound case. Patient was not recovered from symptoms and treatment received for symptoms included 6 day dose of Methylprednisolone & antibiotics zp. Other medical history was reported as none.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: Er8730), in right arm, on 19Apr2021 as dose 2, single (Lot number: Ew0170), in right arm, on 30Oct2021 as dose 3 (booster), single (Lot number: Ff2589), in right arm and on 30Apr2022 as dose 4 (booster), single (Lot number: Fk9893) at the age of 51 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Known allergies: Tree nits" (unspecified if ongoing), notes: Known allergies: Tree nits. The patient's concomitant medications were not reported, also reported as unknown if the  patient took any other medications/products within 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14May2022, outcome "unknown" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Positive; (21May2022) Negative; (23May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid(treatment start date: 14May2022, treatment stop date: 18May2022). Clinical course was reported as, the patient was COVID positive on 14May2022. Began taking Paxlovid 14May2022 and ended on 18May2022. The patient felt better and tested COVID negative on 21May2022. COVID symptoms returned and felt horrible and tested COVID positive on 23May2022. (name withheld) tests, the patient had PCR on 23May2022 and confirmed positive Paxlovid rebound case. Patient was not recovered from symptoms and treatment received for symptoms included 6 day dose of Methylprednisolone & antibiotics zp. Other medical history was reported as none.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: PFIZER DOSE WAS STORED AT AN INAPPROPRIATE TEMPERATURE
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PFIZER DOSE WAS STORED AT AN INAPPROPRIATE TEMPERATURE
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via Pfizer (other manufacturer) concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, fibromyalgia, asthma, idiopathic anaphylaxis, systemic cold urticaria, and drug allergy (Nsaids), and other pre-existing medical conditions included: The patient was not pregnant. The patient was taking any other medications or products within 2 weeks of starting COVID-19 treatment. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose,1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. The patient additionally received booster dose of non-company suspect vaccine elasomeran (moderna vaccine) (spikevax) (Dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 20-NOV-2021 for prophylactic vaccination. Concomitant medications included adalimumab, doxepin, hydroxychloroquine phosphate, and methotrexate. On 07-MAY-2022, covid symptoms first appeared ((confirmed covid-19 infection (Dose number in series 2) and confirmed clinical vaccination failure (Dose number in series 1)). On 09-MAY-2022, after receiving a positive PCR test and she was placed on Paxlovid and it was finished on 13-MAY-2022. The patient was pretty much symptom free except for occasion bouts of tiredness and an occasional cough. The last necessary dose of cough medicine was taken by her was on 14-MAY-2022. On 18-MAY-2022, 12 days after first symptoms her cough started to come back. After a telehealth appointment on 19-MAY-2022, her doctor put her on Penicillin, as he said it was either a secondary infection or what will eventually be considered long Covid and not once did he mentioned the post Paxlovid rebound. And physician told her if it continues into next week, he will do a chest X-ray. The patient talked to a second medical professional and she informed the patient of it and felt that was what was going on. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran (spikevax) was not applicable. The patient had not recovered from confirmed covid-19 infection and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0: 20220557265-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTRATION OF EXPIRED AND IMPROPERLY STORED VACCINE; This spontaneous report received from a physician concerned a 39 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 08-SEP-2022) .5 ml, administered on 10-DEC-2021 for prophylactic vaccination. Age at time of vaccination 39 years old. No concomitant medications were reported. On 10-DEC-2021, the patient experienced administration of expired and improperly stored vaccine. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired and improperly stored vaccine and incorrect product storage was not reported. This report was non-serious. This report was associated with product quality complaint: 90000233203. This case, from the same reporter is linked to 20220558497, 20220558436, 20220558479, 20220558482, 20220558498 and 20220558469.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTRATION OF EXPIRED AND IMPROPERLY STORED VACCINE; This spontaneous report received from a physician concerned a 39 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 08-SEP-2022) .5 ml, administered on 10-DEC-2021 for prophylactic vaccination. Age at time of vaccination 39 years old. No concomitant medications were reported. On 10-DEC-2021, the patient experienced administration of expired and improperly stored vaccine. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired and improperly stored vaccine and incorrect product storage was not reported. This report was non-serious. This report was associated with product quality complaint: 90000233203. This case, from the same reporter is linked to 20220558497, 20220558436, 20220558479, 20220558482, 20220558498 and 20220558469.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via Pfizer (other manufacturer) concerned a 40 year old male. Initial information was processed along with the additional information received on 31-MAY-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy, and other pre-existing medical conditions included: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 1805018, expiry: unknown) dose was not reported, 1 total, administered on left arm on 20-MAR-2021 for prophylactic vaccination. Age at the time of vaccination was 39 years. No concomitant medications were reported. The patient additionally received booster dose of non-company suspect vaccine Spikevax (elasomeran) (dose 1 of dose number in series 2) (form of administration and route of administration was not reported, batch number: 033F21A and expiry: unknown) 1 total, dose was not reported, administered on left arm on 31-OCT-2021 for prophylactic vaccination. The patient received another dose of Spikevax (elasomeran) (dose 2 of dose number in series 2) (form of administration, route of administration and batch number were not reported and expiry: unknown) dose was not reported, 1 total, administered on left arm on 06-MAY-2022 for prophylactic vaccination. On 10-MAY-2022, tested positive for Covid and was prescribed Paxlovid (confirmed clinical vaccination failure) (dose number in series 1). The patient began taking Paxlovid (batch number: FY0461) on 10-MAY-2022 and completed the 5-day treatment on 15-MAY-2022 for Covid-19 treatment. The patient took full course of pills and felt better each day. He took several home antigen tests and each one showed a positive result (confirmed Covid-19 infection) (dose number in series 2) but with a fading positive line. On 20-MAY-2022, the patient felt the symptoms returning and he took another test and found the positive line thick and clear which indicated that his viral load had increased since getting off Paxlovid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality compliant: 90000233604.; Sender's Comments: V0: 20220558520-  covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via Pfizer (other manufacturer) concerned a 40 year old male. Initial information was processed along with the additional information received on 31-MAY-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy, and other pre-existing medical conditions included: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 1805018, expiry: unknown) dose was not reported, 1 total, administered on left arm on 20-MAR-2021 for prophylactic vaccination. Age at the time of vaccination was 39 years. No concomitant medications were reported. The patient additionally received booster dose of non-company suspect vaccine Spikevax (elasomeran) (dose 1 of dose number in series 2) (form of administration and route of administration was not reported, batch number: 033F21A and expiry: unknown) 1 total, dose was not reported, administered on left arm on 31-OCT-2021 for prophylactic vaccination. The patient received another dose of Spikevax (elasomeran) (dose 2 of dose number in series 2) (form of administration, route of administration and batch number were not reported and expiry: unknown) dose was not reported, 1 total, administered on left arm on 06-MAY-2022 for prophylactic vaccination. On 10-MAY-2022, tested positive for Covid and was prescribed Paxlovid (confirmed clinical vaccination failure) (dose number in series 1). The patient began taking Paxlovid (batch number: FY0461) on 10-MAY-2022 and completed the 5-day treatment on 15-MAY-2022 for Covid-19 treatment. The patient took full course of pills and felt better each day. He took several home antigen tests and each one showed a positive result (confirmed Covid-19 infection) (dose number in series 2) but with a fading positive line. On 20-MAY-2022, the patient felt the symptoms returning and he took another test and found the positive line thick and clear which indicated that his viral load had increased since getting off Paxlovid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality compliant: 90000233604.; Sender's Comments: V0: 20220558520-  covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 39 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing), notes: on immunosuppressant Stelara; "COVID-19" (unspecified if ongoing), notes: Paxlovid treatment started that day, and took the full dose on schedule. Concomitant medication(s) included: PENTASA, start date: Feb2018; GABAPENTIN, start date: Apr2022; ALBUTEROL SULFATE HFA, start date: Apr2022, stop date: 20May2022; WIXELA INHUB, start date: Mar2022, stop date: 20May2022; FLUOXETINE, start date: Sep2021; STELARA, in Oct2021 as 90 mg. Vaccination history included: BNT162b2 (Dose number: 3, Vaccine lot number: FW0177, Vaccine location: Left arm), administration date: 23Aug2021, when the patient was 39-year-old, for COVID-19 Immunization; BNT162b2 (Dose number: 2, Vaccine lot number: ER8737, Vaccine location: Left arm), administration date: 07Apr2021, when the patient was 39-year-old, for COVID-19 immunization; BNT162b2 (Dose number: 1, Vaccine lot number: FP7534, Vaccine location: Left arm), administration date: 15Mar2021, when the patient was 38-year-old, for COVID-19 immunization. The following information was reported: RHINORRHOEA (non-serious) with onset 16May2022, outcome "unknown", described as "runny nose"; COUGH (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Apr2022) Positive; (16May2022) Positive; (18May2022) Positive; (10May2022) negative; (11May2022) negative; (18May2022) Positive. Additional information: Covid Positive tests on 04May and then again on 16May , with negative tests in between on 10May and 11 may. Patient tested positive (antigen) for Covid the first time on 4May2022, got a prescription for Paxlovid that day, and took the full dose on schedule. Patient tested negative (antigen) on both 10May and 11May and had limited remaining symptoms. Patient woke up with a bad runny nose and cough again on 16May and tested positive again immediately on two different antigen tests. Patient also tested positive on a PCR on 18May. Patient was initially told by her PCP not to do another round of Paxlovid, but when her cough got worse and into her chest Patient was prescribed a second round of Paxlovid beginning 20May. Additionally, her son developed Covid symptoms on 17May and tested positive (PCR) on 18May. Patient assume he caught it from her rebound covid, but he could have caught it elsewhere. patient had no known allergies.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 39 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing), notes: on immunosuppressant Stelara; "COVID-19" (unspecified if ongoing), notes: Paxlovid treatment started that day, and took the full dose on schedule. Concomitant medication(s) included: PENTASA, start date: Feb2018; GABAPENTIN, start date: Apr2022; ALBUTEROL SULFATE HFA, start date: Apr2022, stop date: 20May2022; WIXELA INHUB, start date: Mar2022, stop date: 20May2022; FLUOXETINE, start date: Sep2021; STELARA, in Oct2021 as 90 mg. Vaccination history included: BNT162b2 (Dose number: 3, Vaccine lot number: FW0177, Vaccine location: Left arm), administration date: 23Aug2021, when the patient was 39-year-old, for COVID-19 Immunization; BNT162b2 (Dose number: 2, Vaccine lot number: ER8737, Vaccine location: Left arm), administration date: 07Apr2021, when the patient was 39-year-old, for COVID-19 immunization; BNT162b2 (Dose number: 1, Vaccine lot number: FP7534, Vaccine location: Left arm), administration date: 15Mar2021, when the patient was 38-year-old, for COVID-19 immunization. The following information was reported: RHINORRHOEA (non-serious) with onset 16May2022, outcome "unknown", described as "runny nose"; COUGH (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Apr2022) Positive; (16May2022) Positive; (18May2022) Positive; (10May2022) negative; (11May2022) negative; (18May2022) Positive. Additional information: Covid Positive tests on 04May and then again on 16May , with negative tests in between on 10May and 11 may. Patient tested positive (antigen) for Covid the first time on 4May2022, got a prescription for Paxlovid that day, and took the full dose on schedule. Patient tested negative (antigen) on both 10May and 11May and had limited remaining symptoms. Patient woke up with a bad runny nose and cough again on 16May and tested positive again immediately on two different antigen tests. Patient also tested positive on a PCR on 18May. Patient was initially told by her PCP not to do another round of Paxlovid, but when her cough got worse and into her chest Patient was prescribed a second round of Paxlovid beginning 20May. Additionally, her son developed Covid symptoms on 17May and tested positive (PCR) on 18May. Patient assume he caught it from her rebound covid, but he could have caught it elsewhere. patient had no known allergies.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac function test, Chest discomfort, Dizziness, Polymerase chain reaction
Clinical narrative: 23May2022: qRT-PCR, Nasal Swab: Positive; 23May2022: qRT-PCR, Nasal Swab: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 at 18:00 as dose 1, single (Lot number: EL9261), in right arm, on 15Feb2021 at 18:00 as dose 2, single (Lot number: EL9261), in right arm and on 19Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "allergy to Poultry" (unspecified if ongoing), notes: allergy to Poultry. The patient's concomitant medications were not reported. Past drug history included: Naproxen, reaction(s): "allergy". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 23May2022, outcome "unknown" and all described as "23May2022: qRT-PCR, Nasal Swab: Positive". The event "23may2022: qrt-pcr, nasal swab: positive" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Positive, notes: Nasal Swab. Clinical Course: Facility type vaccine: Pharmacy or Drug Store. Adverse event: Within 3 months of receiving the 2nd/3rd dose of the vaccine he had multiple episodes (4) of a sudden onset of chest tightness and feeling of being light-headed and dizzy. The chest tightness would subside after about 30 minutes and the feeling of being light headed could last 1-6 hours. If treatment of adverse event, a series of cardiac tests and blood work. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 23May2022: qRT-PCR, Nasal Swab: Positive; 23May2022: qRT-PCR, Nasal Swab: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 at 18:00 as dose 1, single (Lot number: EL9261), in right arm, on 15Feb2021 at 18:00 as dose 2, single (Lot number: EL9261), in right arm and on 19Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "allergy to Poultry" (unspecified if ongoing), notes: allergy to Poultry. The patient's concomitant medications were not reported. Past drug history included: Naproxen, reaction(s): "allergy". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 23May2022, outcome "unknown" and all described as "23May2022: qRT-PCR, Nasal Swab: Positive". The event "23may2022: qrt-pcr, nasal swab: positive" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Positive, notes: Nasal Swab. Clinical Course: Facility type vaccine: Pharmacy or Drug Store. Adverse event: Within 3 months of receiving the 2nd/3rd dose of the vaccine he had multiple episodes (4) of a sudden onset of chest tightness and feeling of being light-headed and dizzy. The chest tightness would subside after about 30 minutes and the feeling of being light headed could last 1-6 hours. If treatment of adverse event, a series of cardiac tests and blood work. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 26.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Laboratory test
Clinical narrative: Shingles; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (Shingles) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.            No concomitant medication information provided. Patient wanted to know in case shingles was linked with Moderna vaccine. Further it was reported that it had allegedly caused some people to get shingles within 2 months after receiving any of the vaccines. No treatment information provided.
Age: 26.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (Shingles) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.            No concomitant medication information provided. Patient wanted to know in case shingles was linked with Moderna vaccine. Further it was reported that it had allegedly caused some people to get shingles within 2 months after receiving any of the vaccines. No treatment information provided.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Loss of personal independence in daily activities, Pruritus, Skin discolouration, Skin disorder
Clinical narrative: all my body turned red and itchy; all my body turned red and itchy; there are black spot all over my body right now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), in Jan2022 as dose 1, single (Lot number: pf330308D) at the age of 27 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PRURITUS (disability), ERYTHEMA (disability) all with onset 02Jan2022 at 17:00, outcome "not recovered" and all described as "all my body turned red and itchy"; PIGMENTATION DISORDER (disability) with onset 02Jan2022 at 17:00, outcome "not recovered", described as "there are black spot all over my body right now". The events "all my body turned red and itchy" and "there are black spot all over my body right now" required physician office visit. Therapeutic measures were taken as a result of pruritus, erythema. Therapeutic measures were not taken as a result of pigmentation disorder. Clinical information included patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. no prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. No known allergies. pharmacy a few hours later all my body turned red and itchy. Patient can't even take a shower or sleep the next day runner to doc at urgent care not far from me and they give me a steroid shot but it does work for a few and later at the night my skin problem has began .last time i went to get a new job and they can't hire me because of my skin .there are black spot all over my body right now i can't take a shower. Patient wish to send some photo of my skin that can explain what  talkin about.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pigmentation disorder, Pruritus
Clinical narrative: all my body turned red and itchy; all my body turned red and itchy; there are black spot all over my body right now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), in Jan2022 as dose 1, single (Lot number: pf330308D) at the age of 27 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PRURITUS (disability), ERYTHEMA (disability) all with onset 02Jan2022 at 17:00, outcome "not recovered" and all described as "all my body turned red and itchy"; PIGMENTATION DISORDER (disability) with onset 02Jan2022 at 17:00, outcome "not recovered", described as "there are black spot all over my body right now". The events "all my body turned red and itchy" and "there are black spot all over my body right now" required physician office visit. Therapeutic measures were taken as a result of pruritus, erythema. Therapeutic measures were not taken as a result of pigmentation disorder. Clinical information included patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. no prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. No known allergies. pharmacy a few hours later all my body turned red and itchy. Patient can't even take a shower or sleep the next day runner to doc at urgent care not far from me and they give me a steroid shot but it does work for a few and later at the night my skin problem has began .last time i went to get a new job and they can't hire me because of my skin .there are black spot all over my body right now i can't take a shower. Patient wish to send some photo of my skin that can explain what  talkin about.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Jan2021 at 12:00 as dose 1, single (Lot number: 029L20A), in left arm and on 18Feb2021 at 12:00 as dose 2, single (Lot number: 016M20A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: rebound positive, rapid test after paxlovid series; Negative, notes: return of symptoms and positive test after full remission and negative test. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient received covid 19 treatment with anti-viral product, brand pfizer, treatment start date 14may2022, treatment stop date 19may2022. The patient had Cough, Sore throat. Rebound positive rapid test after paxlovid series. Rebound COVID, return of symptoms and positive test after full remission and negative test.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Jan2021 at 12:00 as dose 1, single (Lot number: 029L20A), in left arm and on 18Feb2021 at 12:00 as dose 2, single (Lot number: 016M20A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: rebound positive, rapid test after paxlovid series; Negative, notes: return of symptoms and positive test after full remission and negative test. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient received covid 19 treatment with anti-viral product, brand pfizer, treatment start date 14may2022, treatment stop date 19may2022. The patient had Cough, Sore throat. Rebound positive rapid test after paxlovid series. Rebound COVID, return of symptoms and positive test after full remission and negative test.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Moderna Lot: 046L21A. Other medical history: No chronic health conditions.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Moderna Lot: 046L21A. Other medical history: No chronic health conditions.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2022 at 09:30 as dose 4 (booster), single (Lot number: FK9895) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Feb2021 as dose 1, single (Lot number: 013A21A), in left arm, on 24Mar2021 as dose 2, single (Lot number: 016B21A), in left arm and on 02Nov2021 as dose 3 (booster), single (Lot number: 039905), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Dose:4 Pfizer/Dose:3, 2, 1 Moderna" (not ongoing), notes: Dose:4 Pfizer/Dose:3, 2, 1 Moderna. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: May2020; CALCIUM, start date: Jan2012; VITAMIN B COMPLEX, start date: Jan2021; VITAMIN B12 [CYANOCOBALAMIN], start date: Jan2018; VITAMIN D [COLECALCIFEROL], start date: Jan2012. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Positive, notes: Positive rapid antigen test at home; (22May2022) Positive, notes: Covid test was again positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was also reported that patient also received Paxlovid from 11May2022 to 16May2022 of lot number FX8140 for the indication of treatment of Covid-19.  Clinical course: Recurrent Covid symptoms very similar to the previous ones onset 5 days after completing full course of Paxlovid and with a positive home antigen test the next day (6 days from finishing Paxlovid).  Both initial and recurrent symptoms have been mild and persist to the date of this report. They include sore throat, congestion, rhinorrhea, myalgias, headache, fatigue and poor appetite. Initial diagnosis of Covid was on 10May22 with a positive rapid antigen test at home. Initial symptoms prior to first test started on 9May2022.Symptoms had seemingly resolved by about 19May did not repeat antigen test at that time. Symptoms recurred 2 days later and Covid test was again positive the next day on 22May2022.