chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive for COVID-19; Positive for COVID-19; MARKETING PROGRAM NAME NOT AVALIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4499107-00.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, single (Batch/Lot number: unknown), on 01Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 31May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years, all intramuscular for covid-19 immunization; adalimumab (HUMIRA), (Lot number: 1164825) at unk, citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was unknown.  The reporter considered "positive for covid-19" related to BNT162b2.  Clinical course:The reporter's causality for the event(s) of POSITIVE FOR COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19,Vaccination failure.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19/ Covid For 2nd Time; COVID-19/ Covid For 2nd Time; This is a solicited report received from contactable reporter(s) (Consumer). The reporter is the patient. Other Case identifier(s): 22K-163-4222940-00.  A 41-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, all intramuscular for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for ankylosing spondylitis. 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) all with onset Dec2021, outcome "recovering" and all described as "COVID-19/ Covid For 2nd Time". The patient underwent the following laboratory tests: SARS-CoV-2 test: (unspecified date) Positive; (Dec2021) Positive. The action taken for adalimumab was unknown.  Additional information: It was unknown if patient was enrolled in a covid-19 vaccine Trial. In Mar2021, patient received first dose covid-19 vaccine manufactured by Pfizer. On an unknown date, patient received second dose covid-19 vaccine manufactured by Pfizer. On an unknown date, patient received booster dose covid-19 vaccine manufactured by Johnson and Johnson. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of COVID/ COVID for 2nd time was no reasonable possibility.  The reporter's assessment of the causal relationship of "covid-19/ covid for 2nd time" with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 38.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4499921-00 (AbbVie).  A 39-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), on 11Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 11Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The action taken for adalimumab was unknown. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of COVID was not provided. Causality: COVID-19 vaccine: Causality as per reporter (Drug/Vaccine): Possible.  The reporter considered "covid" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankylosing spondylitis, Dizziness, Feeling abnormal
Clinical narrative: Foggy feeling in head; Ankylosing spondylitis; Dizziness; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4499673-00 (AbbVie).  A 58-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown), on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 05Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Nov2021, outcome "unknown"; ANKYLOSING SPONDYLITIS (medically significant) with onset 03Aug2022, outcome "not recovered"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Foggy feeling in head". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "ankylosing spondylitis", "dizziness" and "foggy feeling in head" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event ankylosing spondylitis and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Discomfort
Clinical narrative: discomfort; chest pain; feeling weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-000002784. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 03Jan2022 as dose number unknown, 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: CHEST PAIN (non-serious) with onset 2022, outcome "unknown"; DISCOMFORT (non-serious) with onset 2022, outcome "unknown"; ASTHENIA (non-serious) with onset 2022, outcome "unknown", described as "feeling weak". Additional information: The reporter reported on 28Jul2022. Indication not reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: FLUX
Symptoms: Cardiac arrest
Clinical narrative: went into cardiac arrest 45 minutes after receiving the flu shot; Initial information received on 09-Aug-2022 regarding an unsolicited valid  serious case received from a consumer/non-health care professional.This case is a courtesy case received from: Merck.  This case involves an unknown age female patient who went into cardiac arrest 45 minutes after receiving the flu shot ,while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2018, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported at an unknown dose via unknown route in unknown administration site for immunization.  In 2018, the patient went into cardiac arrest 45 minutes after receiving the flu shot (cardiac arrest) (latency: 45 minutes ) following the administration of INFLUENZA VACCINE.   Action taken :not applicable  It was not reported if the patient received a corrective treatment for the event .  Outcome: unknown; Sender's Comments: Sanofi company comment dated 12-Aug-2022: This case involves female patient of an unknown age who was vaccinated with influenza (unknown manufacturer) and experienced cardiac arrest. The time to onset is compatible (same day) with the role of the vaccine. The clinical course was not provided. Furthermore, information regarding condition at the time of vaccination, the role of medical history, concomitants, and laboratory data excluding other predisposing etiologies would be needed for a complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed. .
Sex: U
Vaccine: DTAPIPV
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: medication was given to an infant- with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves Infant with unknown age and gender patient who experienced medication was given to an infant- with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE Suspension for injection (strength, dose, route,lot number not reported) in unknown administration site for immunization.  On an unknown date the patient reported medication was given to an infant- with no reported adverse event (off label use) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event off label use.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Inflammation, Peripheral swelling, Sjogren's syndrome, Ultrasound Doppler abnormal
Clinical narrative: Inflammation and swelling the leg was observed pcp ordered ultrasound and results showed  DVT on right leg. Following investigation for causes of DVT patient was diagnosed with sjogren's syndrome.  No history of DVT or any autoimmune diseases in the past for patient and relatives. No other risk factors for DVT was found
Sex: M
Vaccine: TD
Symptoms: Injection site mass
Clinical narrative: had a lump at the injection site; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age male patient who had a lump at the injection site while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength: unknown) lot number not reported in unknown administration site as Immunization.Lot number is requested.  On an unknown date the patient had a lump at the injection site (vaccination site mass) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.He had the injection site for four months.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (had a lump at the injection site).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event had a lump at the injection site.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration
Clinical narrative: Patient was administered YF-VAX intramuscularly rather than subcutaneously with no reported adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered YELLOW FEVER VACCINE [YF-VAX] intramuscularly rather than subcutaneously with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect YELLOW FEVER VACCINE (strength, formulation, route, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of was administered yf-vax intramuscularly rather than subcutaneously with no reported adverse event (incorrect route of product administration) (latency: unknown).  Action taken: not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: IPV
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: temperature excursion involving punctured IPOL that was administered post excursion; due to being administered post excursion; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adolescent male patient who reported temperature excursion involving punctured ipol that was administered post excursion and due to being administered post excursion while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 08-Aug-2022, the patient received a  0.5 ml 1X dose of suspect IPV (VERO) (lot V1A121M; expiry date: 15-feb-2024) via intramuscular route in the deltoid nos (Deltoid (Caller did not know which arm)) for prophylactic vaccination..  On an unknown date the patient reported temperature excursion involving punctured ipol that was administered post excursion (product storage error) and On 08-AUG-2022, the patient reported due to being administered post excursion (poor quality product administered) following the administration of IPV (VERO).  Action taken: not applicable.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event product storage error and was Unknown for the event poor quality product administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Extra dose administered
Clinical narrative: dministered IPOL to a child that has already received the IPOL vaccine; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Child patient unknown gender who experienced dministered ipol to a child that has already received the ipol vaccine while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect IPV (VERO) (strength, dose, formulation, route, lot number :not reported) for immunization.  On an unknown date the patient reported administered ipol to a child that has already received the ipol vaccine (extra dose administered) (unknown latency) following the administration of IPV (VERO).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event extra dose administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: set of twins to receive ACT-HIB 2-days past the expiration date with no reported adverse events; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who experienced set of twins to receive act-hib 2-days past the expiration date with no reported adverse events while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation.  On 08-AUG-2022 , the patient received a  0.5ml dose of suspect HIB (PRP/T) VACCINE once (lot UJ522AA; expiry date: 06-aug-2022) via intramuscular route in the right thigh for immunization.  On 08-AUG-2022 the patient reported set of twins to receive act-hib 2-days past the expiration date with no reported adverse events (expired product administered) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  Action taken: not applicable.   It time of reporting, the outcome was Unknown for the event expired product administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01227624:
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: MENACTRA booster shot 23 days early than intended with no adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 19 years old male patient who experienced menactra booster shot 23 days early than intended with no adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) for Prophylactic vaccination.  On an unknown date, the patient received a  0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength, formulation, lot number not reported)  via intramuscular route in unknown administration site for immunization.  On an unknown date the patient reported menactra booster shot 23 days early than intended with no adverse event (inappropriate schedule of product administration) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event inappropriate schedule of product administration.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient being administered IPOL after it exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; patient received the IPOL after it was not suitable for use with no reported adverse event; Initial information received on 10-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient who was being administered ipol (IPV (VERO) ) after it exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event and patient received the ipol after it was not suitable for use with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 19-Jul-2022, the patient received a dose of 0.5 ml of  suspect IPV (VERO) (formulation, strength: unknown) lot U1C572M, expiration date:17-Jun-2023, via subcutaneous route in the right deltoid as Immunization   The patient was being administered ipol after it exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event (product storage error) (unknown latency) following the administration of IPV (VERO).  On 19-JUL-2022 the patient received the ipol after it was not suitable for use with no reported adverse event (poor quality product administered) same day following the administration of IPV (VERO).  Action taken was not applicable.  Corrective treatment: None.  At time of reporting, the outcome was Unknown for all.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot but got it anyway/suspected vaccination failure; I had the shot but got it anyway; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 1-AUG-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient had the Shingles shot but got shingles anyway. Additional Supportive Information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for shingles were unknown. The follow up would not be possible as contact details were not provided.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Shingles outbreak; red rash; itchy rash; painful rash; pain at injection site; redness at injection site; arthralgia; myalgia; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2022, the patient received the 1st dose of Shingrix. On 29th July 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site erythema, arthralgia and myalgia. On 7th August 2022, the patient experienced shingles, red rash, itchy rash and painful rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles, red rash, itchy rash and painful rash were not recovered/not resolved and the outcome of the injection site pain, injection site erythema, arthralgia and myalgia were recovered/resolved.   It was unknown if the reporter considered the shingles, injection site pain, injection site erythema, arthralgia, myalgia, red rash, itchy rash and painful rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comments: The caller was the patient.  The patient received first dose of Shingrix and experienced arthralgia, myalgia, and pain and redness at the injection site the day after receiving dose. The patient had rash that runs from their right side around to their back, near their bra line.  The patient reported that rash was red, itchy, and painful.  The patient was being prescribed Valtrex, for treatment of Shingles.  The patient experienced no Shingles outbreaks prior. The reporter consented to follow up. Additional Supportive Information: 10 days after receiving Shingrix, the patient experienced shingles, red rash, itchy rash and painful rash.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Shingles outbreak; red rash; itchy rash; painful rash; pain at injection site; redness at injection site; arthralgia; myalgia; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2022, the patient received the 1st dose of Shingrix. On 29th July 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site erythema, arthralgia and myalgia. On 7th August 2022, the patient experienced shingles, red rash, itchy rash and painful rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles, red rash, itchy rash and painful rash were not recovered/not resolved and the outcome of the injection site pain, injection site erythema, arthralgia and myalgia were recovered/resolved.   It was unknown if the reporter considered the shingles, injection site pain, injection site erythema, arthralgia, myalgia, red rash, itchy rash and painful rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comments: The caller was the patient.  The patient received first dose of Shingrix and experienced arthralgia, myalgia, and pain and redness at the injection site the day after receiving dose. The patient had rash that runs from their right side around to their back, near their bra line.  The patient reported that rash was red, itchy, and painful.  The patient was being prescribed Valtrex, for treatment of Shingles.  The patient experienced no Shingles outbreaks prior. The reporter consented to follow up. Additional Supportive Information: 10 days after receiving Shingrix, the patient experienced shingles, red rash, itchy rash and painful rash.
Age: 10.0
Sex: U
Vaccine: HPV9, TDAP
Symptoms: Dizziness, Injection site swelling
Clinical narrative: dizzy; injection site had been significantly swollen since the vaccine administration; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 10 years old of an unknown gender patient who experienced dizzy and injection site had been significantly swollen since the vaccine administration , after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Patient has no known drug allergies.   On 22-Feb-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported and a dose of suspect GARDASIL 9 not produced by Sanofi Pasteur (lot 1691180 and expiration date:15-Nov-2022) at an unknown dose once via unknown route in unknown administration site for immunization.  On 24-Feb-2021 (latency: 2 days )the patient developed a non-serious event of dizzy (dizziness) and injection site had been significantly swollen since the vaccine administration (vaccination site swelling) following the administration. On 09Mar2021 the dizziness and the swelling were improving.  It was reported that "The patient had received a TdaP vaccine (Adacel by Sanofi) during the same visit, and is on several anxiolytic medications (see AE Details). Patient has no known drug allergies"  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events  Outcome: Recovering / Resolving for both events
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Act-hib was expired by two days and administered with no reported adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reporter stated that HIB (PRP/T) VACCINE [ACT-HIB]was expired by two days and administered with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE (strength, formulation, frequency, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of act-hib was expired by two days and administered with no reported adverse event (expired product administered) (latency: same day) following the administration of HIB (PRP/T) VACCINE.  Action taken : not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine administered with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who administered expired vaccine with no reported adverse event, while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunization; and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunization.  On 08-Aug-2022, the patient received a dose of suspect HIB (PRP/T) VACCINE( lot UJ522AA and expiration date: 06-Aug-2022) at a dose of 0.50 ml via intramuscular route in the left thigh for immunization.  On 08-Aug-2022 (Latency: same day),the patient developed a non-serious event of expired vaccine administered with no reported adverse event (expired product administered) following the administration of HIB (PRP/T) VACCINE.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Reported area around vaccine site, red, swollen oblong rash, circular around site; appears lumpy and hard in certain areas and warm to touch; very little to no pain when pressed.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Vaccination site rash
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Reported area around vaccine site, red, swollen oblong rash, circular around site; appears lumpy and hard in certain areas and warm to touch; very little to no pain when pressed.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect reconstitution.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Myalgia, Pain, Testicular cyst
Clinical narrative: After getting second shingrix vaccine I experienced severe muscle and joint pain, then a small cyst on my testicles grew rapidly causing severe pain. I went to my urologist, Dr who started treatment with antibiotics. The cyst seems to keep growing and is very painful.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine increased, Chills, Diarrhoea, Fatigue, Feeling cold
Clinical narrative: I am a breast cancer patient that has recently experienced kidney damage from my 2nd Moderna booster vaccine.  I finished chemo mid January this year and continued keytruda immunotherapy every 3 weeks until August 15, 2022.  I had surgery 2/15/2022 and 21 days of radiation therapy in the month of April.  On July 11th I had my normal keytruda infusion and my blood panel was normal as usual.  On July 15th I had my Moderna booster vaccine.  I suffered for 3 weeks with cold chills most every day, extreme fatigue, some diarrhea and urgency to urinate.  On August 15th, I had my blood panel done by my oncologist and my Creatinine went from a normal .51 mg/dl (from July 11, 2022) to 5.27 mg/dl on August 8, 2022.  This alarmed my oncologist and he put me on prednisone 20 mg 3 times a day.  I went back on August 16, 2022 for a recheck and it is now 1.87 mg/dl. He has reduced my dose to 20 mg twice a day and I will go back in 2 weeks for another recheck. Thankfully I feel I am out of danger, but my concern is if I wasn't being seen by an oncologist, I could have ended up in the hospital or worse.  I just wanted to make sure this was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Micturition urgency, Renal disorder
Clinical narrative: I am a breast cancer patient that has recently experienced kidney damage from my 2nd Moderna booster vaccine.  I finished chemo mid January this year and continued keytruda immunotherapy every 3 weeks until August 15, 2022.  I had surgery 2/15/2022 and 21 days of radiation therapy in the month of April.  On July 11th I had my normal keytruda infusion and my blood panel was normal as usual.  On July 15th I had my Moderna booster vaccine.  I suffered for 3 weeks with cold chills most every day, extreme fatigue, some diarrhea and urgency to urinate.  On August 15th, I had my blood panel done by my oncologist and my Creatinine went from a normal .51 mg/dl (from July 11, 2022) to 5.27 mg/dl on August 8, 2022.  This alarmed my oncologist and he put me on prednisone 20 mg 3 times a day.  I went back on August 16, 2022 for a recheck and it is now 1.87 mg/dl. He has reduced my dose to 20 mg twice a day and I will go back in 2 weeks for another recheck. Thankfully I feel I am out of danger, but my concern is if I wasn't being seen by an oncologist, I could have ended up in the hospital or worse.  I just wanted to make sure this was reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID-19 vaccine breakthrough case. Dose 1 Pfizer 3/22/2021 EN6200. Dose 2 Pfizer 4/13/2021 ER8733.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I did not have a reaction to the COVID-19 vaccine. I ended up getting COVID-19. When I reported it, they said that's an adverse reaction.
Age: 45.0
Sex: M
Vaccine: UNK
Symptoms: Joint swelling, Mass, Pyrexia, Rash, Viral test negative
Clinical narrative: Started with a rash and swelling behind both knees but more pronounced in the right knee for both the rash and swelling. Days 6-8 I ran  a fever of 101.5 which eventually broke.  The rash is now mostly if not completely gone 18 days after the shot.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling abnormal, Feeling hot, Headache
Clinical narrative: 9 hours after injection: Uncontrollable shivers followed by feelings of unbearable ?dry? warmth?.  No sweating, just feeling on fire HOT.   This continued for 24 hours.  Headache? all over started around hour 24.  Fever of 102.5 started about hour 24.  Body aches, stiffness, cough all started around hour 30.  Hour 46? fever has broken, but headache & body aches still present.  Rotated/stacked 1000 mg acetaminophen q8 hrs and 800 mg ibuprofen q6 hrs
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: 9 hours after injection: Uncontrollable shivers followed by feelings of unbearable ?dry? warmth?.  No sweating, just feeling on fire HOT.   This continued for 24 hours.  Headache? all over started around hour 24.  Fever of 102.5 started about hour 24.  Body aches, stiffness, cough all started around hour 30.  Hour 46? fever has broken, but headache & body aches still present.  Rotated/stacked 1000 mg acetaminophen q8 hrs and 800 mg ibuprofen q6 hrs
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Back pain, Blood creatine phosphokinase increased, COVID-19, Myositis
Clinical narrative: Patient was initially presented on 1/5/2022 with  a chief complaint of bilateral thigh and lower back pain.  Patient tested positive for covid however asymptomatic with infection.  Patient reported that she was previously diagnosed to have myositis of unspecified etiology and was treated with steroid and Dilaudid. Patient was subsequently admitted for elevated CK due to rhabdomyolysis. Total CK level started to trend down and subsequently normalized.  Patient was also treated with IV fluid .  Patient was prescribed tapering dose of prednisone, Lyrica, Zanaflex and Norco for pain control.  Patient remained stable and was discharged at stable condition.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhabdomyolysis, SARS-CoV-2 test positive
Clinical narrative: Patient was initially presented on 1/5/2022 with  a chief complaint of bilateral thigh and lower back pain.  Patient tested positive for covid however asymptomatic with infection.  Patient reported that she was previously diagnosed to have myositis of unspecified etiology and was treated with steroid and Dilaudid. Patient was subsequently admitted for elevated CK due to rhabdomyolysis. Total CK level started to trend down and subsequently normalized.  Patient was also treated with IV fluid .  Patient was prescribed tapering dose of prednisone, Lyrica, Zanaflex and Norco for pain control.  Patient remained stable and was discharged at stable condition.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case. Moderna 7/22/21 040C21A, 8/18/21 002F21A, and boosted 2/9/22 084J21A
Age: 31.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Blood glucose normal, Cold sweat, Electrocardiogram normal, Pallor, Syncope
Clinical narrative: 5 min after vaccine administration employee became pale , clammy and fainted.  3 mins later he was awake, oriented and alert.  He answered questions appropriately.  BP 67/42 and O2 Sat 97 %.  EMS arrived at 12:10 , EKG done Blood Glucose 124.  At 12:18 BP 118/75  O2 Sat 100 %.  Employee states he is feeling well.   Employee stated after that he has a history of fainting only with blood draws.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling cold, Feeling hot, Headache, Insomnia
Clinical narrative: Took Janssen shot back in 05/15/2021, got the shot around 10am and by 11pm all the feelings of covid were present. Took pfizer at 11:30 on 08/16/2022, something happened. By 9pm that same night all symptoms of covid had been present. Throughout both nights,  there was lack of sleep, muscle spasms, headache, night sweats, fever, cold chills, and feeling of burning up. Both times told no one had issues with each shot. Yet in these 2 cases, both times felt as if covid had taken over. Even though negative for covid.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Muscle spasms, Night sweats, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Took Janssen shot back in 05/15/2021, got the shot around 10am and by 11pm all the feelings of covid were present. Took pfizer at 11:30 on 08/16/2022, something happened. By 9pm that same night all symptoms of covid had been present. Throughout both nights,  there was lack of sleep, muscle spasms, headache, night sweats, fever, cold chills, and feeling of burning up. Both times told no one had issues with each shot. Yet in these 2 cases, both times felt as if covid had taken over. Even though negative for covid.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Paraesthesia, X-ray
Clinical narrative: prednisone x 5 days unable to lift arm (shoulder to hand) L L hand tingles/numb at times left deltoid
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, COVID-19, Chest X-ray abnormal, Dyspnoea, Full blood count abnormal
Clinical narrative: on 11/ 21 patient presented to the ER for COVID-19 symptoms and was discharged home x-rays with pneumonia was empirically placed on steroids, REMDESIVIR with breathing treatment he required oxygen supplementation escalated to high-flow oxygen supplementation. on 11/23 he returned with worstening SOB.   Initially, CRP severely elevated to 29.6 trended down.   Id started patient on  Baricitinib.  Patient responded well to treatment CRP trended down.  CBC revealing thrombocytosis likely due to COVID-19 infection and pneumonia.  CBC blood work is being in 1 week to monitor the platelet count.  Patient has been updated even though this may be due to COVID-19 infection it is what the while to rule out other life-threatening medical condition.  He was discharged in stable condition and room air.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Lung disorder, Lung opacity, Malaise, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: on 11/ 21 patient presented to the ER for COVID-19 symptoms and was discharged home x-rays with pneumonia was empirically placed on steroids, REMDESIVIR with breathing treatment he required oxygen supplementation escalated to high-flow oxygen supplementation. on 11/23 he returned with worstening SOB.   Initially, CRP severely elevated to 29.6 trended down.   Id started patient on  Baricitinib.  Patient responded well to treatment CRP trended down.  CBC revealing thrombocytosis likely due to COVID-19 infection and pneumonia.  CBC blood work is being in 1 week to monitor the platelet count.  Patient has been updated even though this may be due to COVID-19 infection it is what the while to rule out other life-threatening medical condition.  He was discharged in stable condition and room air.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombocytosis
Clinical narrative: on 11/ 21 patient presented to the ER for COVID-19 symptoms and was discharged home x-rays with pneumonia was empirically placed on steroids, REMDESIVIR with breathing treatment he required oxygen supplementation escalated to high-flow oxygen supplementation. on 11/23 he returned with worstening SOB.   Initially, CRP severely elevated to 29.6 trended down.   Id started patient on  Baricitinib.  Patient responded well to treatment CRP trended down.  CBC revealing thrombocytosis likely due to COVID-19 infection and pneumonia.  CBC blood work is being in 1 week to monitor the platelet count.  Patient has been updated even though this may be due to COVID-19 infection it is what the while to rule out other life-threatening medical condition.  He was discharged in stable condition and room air.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case COVID-19 after fully vaccinated (2 doses mRNA).