chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Chest pain; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 15Jun2021 at 04:00 PM (age at vaccination: 35 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient did not have any known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 25May2021 at 05:00 PM (age at vaccination: 35 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 17Jun2021 at 08:00 AM, the patient experienced chest pain and difficulty breathing. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The patient was not received treatment for the events. Outcome of the events was not recovered.  The lot number for [BNT162B2], was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstrual disorder
Clinical narrative: Missed periods for three months; Headache for about 5 weeks; This is a spontaneous report from a contactable consumer (patient). A 47-year-old (Adult 18-64 Years) non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on 19Mar2021 (the day of vaccination), as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. The patient had no other medical history and no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration in left arm, on 19Mar2021 (at the age of 47-year-old), as dose 1, single for COVID-19 immunisation. There was no other vaccine in four weeks. There were no other medications in two weeks. The patient had no covid prior vaccination and not test covid post vaccination. On an unspecified date, consumer stated that she missed periods for three months after second dose of vaccine. She had no explanation for why she missed her period. Never missed in the past and returned in June. Headache for about 5 weeks after second dose. She didn't take pain relief before or after vaccine. Took pain relief about 3 weeks after second dose because headache was persistent. AE resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for AE included pain medications for headache, didn't work. Outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: She had flushing on the same side of her face on that she got the vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Right on 25Mar2021 08:30 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Mar2021 13:00 the patient experienced she had flushing on the same side of her face on that she got the vaccine. The outcome of the event flushing was recovering.  Information about lot/batch number not provided. Requested during follow up.
Age: 37.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient received Daptacel instead of Adacel with no reported adverse event; 37 year old patient received Daptacel instead of Adacel with no adverse event; Initial information was received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from other health care professional and consumer/non-healthcare professional via Medical information (under reference number - 00778953).  This case involves a 37-year-old female patient who was accidentally vaccinated with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL] with no adverse event (Wrong product administered) (Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 17-Sep-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination (Wrong product administered) (Product administered to patient of inappropriate age).  It was reported "caller asks when can the Adacel be given? Also, when would the patient get an Adacel booster?."  There were no laboratory data/results available.  It was case of an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency was on same day)  At the time of report, no adverse events were reported.  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. 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: F
Vaccine: FLUC3
Symptoms: Rash, Rash erythematous, Skin swelling, Skin warm
Clinical narrative: Red rash on arm, it is red, hot, and swollen; Red rash on arm, it is red, hot, and swollen; Red rash on arm, it is red, hot, and swollen; This spontaneous case was received on 15-Sep-2021 from non-health professional (consumer) via Med Communications (reference number: SEQW21-02335) and concerned an 18-year-old female patient.  The patient's concurrent conditions included celiac disease, eosinophilic esophagitis (EoE), and allergy to wheat, flour and chicken. The patient was not taking any concomitant medications.   On 12-Sep-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 308451 and expiry date 30-Jun-2022.   On the same day, after receiving Flucelvax Quadrivalent, the patient experienced red rash on her arm and it was red, hot and swollen. The patient did not receive any treatment for the events.   At the time of initial reporting on 15-Sep-2021, the patient had not recovered from the events.  The reporter assessed the case as non-serious.  Company comment: An 18-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same day, after receiving Flucelvax Quadrivalent, the patient experienced red rash on her arm and it was red, hot and swollen. Causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: An 18-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same day, after receiving Flucelvax Quadrivalent, the patient experienced red rash on her arm and it was red, hot and swollen. Causal role of the suspect vaccine is assessed as possibly related.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting and diarrhea; Nausea, vomiting and diarrhea; Nausea, vomiting and diarrhea; This spontaneous case was received on 17-Sep-2021 from other health professional (pharmacist) via Agency (reference number: SEQW21-02439) and concerned a 61-years-old female patient.   The patient's medical history was not reported. The patient's concomitant medication included Plavix (clopidogrel bisulfate), Hydrocodone (hydrocodone bitartrate), Lipitor (atorvastatin calcium), Protonix (pantoprazole sodium sesquihydrate), Losartan (losartan potassium), Amlodipine (amlodipine besilate), chlorthalidone (reported as Chlortalidone), Cymbalta (duloxetine hydrochloride) all used for an unreported indication.   On 10-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number was P100360857 and expiry date was reported as 30-Jun-2022.  On the same date after receiving Afluria Quadrivalent, the patient had severe nausea, vomiting and diarrhea.  On 12-Sep-2021, the patient recovered from the events of 'nausea', 'vomiting' and 'diarrhoea'.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company Comment: Events 'nausea', 'vomiting' and 'diarrhoea' are considered as related to Afluria Quadrivalent.; Sender's Comments: Events 'nausea', 'vomiting' and 'diarrhoea' are considered as related to Afluria Quadrivalent.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting and diarrhea; Nausea, vomiting and diarrhea; Nausea, vomiting and diarrhea; This spontaneous case was received on 17-Sep-2021 from pharmacist via Med Communications (reference number: SEQW21-02439) and concerned a 59-year-old, male patient.  The patient's medical history was not reported. The patient's concomitant medication included Hydrocodone (hydrocodone bitartrate), nifedipine, Cymbalta (duloxetine hydrochloride) and Losartan (losartan potassium), all used for unreported indication.  On 10-Sep-2021, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was P100360857 and expiry date was 30-Jun-2022.   On the same date, after receiving Afluria Quadrivalent, the patient had severe nausea, vomiting and diarrhea.  On 12-Sep-2021, the patient recovered from the events.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  This case is linked to the case 202103051 (the same reporter).  Company comment: Events nausea, vomiting and diarrhea are considered as related to Afluria Quadrivalent.; Sender's Comments: Events nausea, vomiting and diarrhea are considered as related to Afluria Quadrivalent.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's reported.; products experienced an excursion of ( 4C) for 20 minutes on 9/7; This spontaneous report was received from a registered nurse (also reported as medical assistant) referring to a 7-year old patient of unknown gender. The patient's pertinent medical history, drug allergies/reactions and concomitant medication were not provided.    Per reporter, varicella virus vaccine live (oka/merck) (VARIVAX) with lot# U015682, U002394, and U010400 experienced an excursion of minus 10 degree Celsius to 8 degree Celsius (4 degree Celsius) for 20 minutes on 07-SEP-2021 during transport and minus 10 degree Celsius to 8 degree Celsius (4 degree Celsius) for 20 minutes on 09-SEP-2021 during transport. On 15-SEP-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U010400, expiration date 01-APR-2023, dose: 1 (unit unknown); strength and route were unknown) for prophylaxis (product storage error). No additional adverse event and product quality complaint reported.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2109USA005628:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; an excursion of 4 Celsius degrees for 20 minutes during transport and 4 Celsius degrees for 20 minutes during transport/ administered on 09-SEP-2021; This spontaneous report was received from a registered nurse (also reported as medical assistant) and refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 07-SEP-2021 during transport, the varicella virus vaccine live (oka/merck) (VARIVAX) lot# U015682, expiration date: 18-MAY-2023, lot# U002394, expiration date: 22-JAN-2023 and lot # U010400, expiration date: 01-APR-2023 , experienced an excursion of (4 Celsius degree) for 20 minutes. On 09-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot# U015682, expiration date reported as 18-MAY-2023 (formulation, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). Administered dose of vaccine experienced the temperature excursion of -10 Celsius degree (C) to 8C ( 4C) for 20 minutes and -10C to 8C ( 4C) for 20 minutes. Previous temperature excursion: -10C to 8C ( 4C) for 7 hours and 30 minutes. No additional adverse event was reported (no adverse event).  This is one of the several reports from the same reporter concerning this vaccine.; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005618: US-009507513-2109USA005632: US-009507513-2109USA005744: US-009507513-2109USA005742: US-009507513-2109USA005776: US-009507513-2109USA005881: US-009507513-2109USA005945: US-009507513-2109USA005964:
Sex: U
Vaccine: VARZOS
Symptoms: Diplopia
Clinical narrative: Double vision; This case was reported by a consumer via media and described the occurrence of double vision in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced double vision. On an unknown date, the outcome of the double vision was unknown.   It was unknown if the reporter considered the double vision to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient developed double vision about 3 weeks after shingles vaccine. The patient asked was this a side effects. The follow-up would not possible as contact information was not available.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Fatigue
Clinical narrative: fatigued; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   The patient's past medical history included shingles (had 30 years ago on face and it was incredibly painful).   On an unknown date, the patient received the 1st dose of Shingles vaccine and PNEUMONIA VACCINE. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the fatigue to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the first shingle shot and pneumonia vaccine and was very fatigued the next day. It was unknown if the reporter considered the fatigue to be related to Pneumonia vaccine. For tolerance to 2nd dose, refer case US2021AMR200706.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR200706:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Mobility decreased, Pain, Pyrexia
Clinical narrative: have stayed in the bed all day; got my 1st one in August then went yesterday to get my second one, it; aching and hurts all over; fever; This case was reported by a consumer via interactive digital media and described the occurrence of generalized aching in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox when patient was kid). Concomitant products included SHINGLES VACCINE (NOS) (SHINGLES VACCINE).   On 19th September 2021, the patient received the 2nd dose of Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine and an unknown time after receiving SHINGLES VACCINE, the patient experienced generalized aching and fever. On 19th September 2021, the patient experienced drug dose administration interval too short. On 20th September 2021, the patient experienced mobility decreased. On an unknown date, the outcome of the generalized aching and fever were not recovered/not resolved and the outcome of the mobility decreased and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the generalized aching, fever and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the first shingle shot in august. The patient received second dose one month early, which led to shortening of vaccination schedule. The second shot did not hurt when patient got the vaccine but sometime during the night it started aching and hurts all over. The patient was running a fever and on the day of reporting patient stayed in the bed all day, hurting and running a fever. The patient would not ever get another one . The patient would better think twice before getting one.
Sex: U
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: Due to availability did not receive second dose; This case was reported by a consumer via (Shingrix  interactive digital media and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The repoprter stated that, due to availability and cost, did not receive 2nd dose of Shingrix.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Rash
Clinical narrative: shingles; rash was bad enough; did no get the 2nd shot; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles, rash and incomplete course of vaccination. On an unknown date, the outcome of the shingles, rash and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shot and was promised that the vaccine would not give him/her shingles, but it did. The patient also experienced bad rash. Till the time of reporting, the patient did not get the second shot, which led to incomplete course of vaccination. The patient thought that the single dose was enough. The follow-up would not possible as no contact details were available. This case had been linked with US2021AMR201148, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201148:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus, Lip swelling
Clinical narrative: itching in vaccine spot; swelling at lips; This case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th September 2021, the patient received Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced injection site itching and lip swelling. On an unknown date, the outcome of the injection site itching and lip swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching and lip swelling to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine six days ago and still experiencing itching in that spot, swelling at the lips for which he/she cannot find a logical excuse. The patient not eaten or drank anything different. The patient wanted to know could this be a side effect. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: under 50 years old; This case was reported by a consumer via (Shingrix ) interactive digital media and described the occurrence of inappropriate age at vaccine administration in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The reporter was the patient. The reporter stated that, received shingrix vaccine at the age of under 50 years old, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: passed away; This case was reported by a consumer via media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be related to Shingles vaccine.  Additional details were reported as follows: The patient was reporter's sister in law. The age at vaccination was not reported. The patient passed away from getting the Shingles shot during the night she received it. The follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Wrong technique in device usage process
Clinical narrative: HCP was not sure were the subcutaneous area of the patient ended; HCP mentioned they've used a 5/8 needle on the patient instead of a 1 inch needle; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 54-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 95K95, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season (subcutaneous) and Fluarix Tetra Pre-Filled Syringe Device. On 20th September 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route and wrong technique in device usage process. On an unknown date, the outcome of the intramuscular formulation administered by other route and wrong technique in device usage process were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that the patient with a very substantial deltoid was administered Fluarix vaccine with a 5/8 needle on the patient instead of a 1 inch needle, which led to wrong technique in device usage process. Health care professional was not sure were the subcutaneous area of the patient ended, which led to intramuscular formulation administered by other route. No adverse effects were reported at the time of the reporting. The reporter consented to follow up either by email or phone. No further details were provided. Note: The event intramuscular formulation administered by other route was captured conservatively considering vaccine been administered subcutaneously.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Gastrointestinal disorder, Headache, Immediate post-injection reaction
Clinical narrative: Fever; Shivering; Fatigue; Gastrointestinal symptoms; Headache; Malaise; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2021, the patient received the 1st dose of Shingrix. On 15th September 2021, immediately after receiving Shingrix, the patient experienced headache, malaise, fever, shivering, fatigue and gastrointestinal symptom nos. On an unknown date, the outcome of the headache, malaise, fever, shivering, fatigue and gastrointestinal symptom nos were unknown.   It was unknown if the reporter considered the headache, malaise, fever, shivering, fatigue and gastrointestinal symptom nos to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. This case was reported by the patient's father. The patient received dose of Shingrix vaccine and immediately began experiencing headache, malaise, fever, shivering, fatigue, and gastrointestinal symptoms. The reporter did not provide details regarding whether symptoms have resolved. The reporter declined to provide demographics for daughter/patient. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Fever; Shivering; Fatigue; Gastrointestinal symptoms; Headache; Malaise; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2021, the patient received the 1st dose of Shingrix. On 15th September 2021, immediately after receiving Shingrix, the patient experienced headache, malaise, fever, shivering, fatigue and gastrointestinal symptom nos. On an unknown date, the outcome of the headache, malaise, fever, shivering, fatigue and gastrointestinal symptom nos were unknown.   It was unknown if the reporter considered the headache, malaise, fever, shivering, fatigue and gastrointestinal symptom nos to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. This case was reported by the patient's father. The patient received dose of Shingrix vaccine and immediately began experiencing headache, malaise, fever, shivering, fatigue, and gastrointestinal symptoms. The reporter did not provide details regarding whether symptoms have resolved. The reporter declined to provide demographics for daughter/patient. The reporter did not consent to follow up.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered infanrix/, Date of birth Jul 28th 2009; administered infanrix/ Boostrix was the vaccine indicated; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th September 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: A health care professional administered Infanrix to a patient of age 12 years old, instead Boostrix was the vaccine indicated for the patient, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. This case was 1 of 7 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201377:same reporter US-GLAXOSMITHKLINE-US2021201373:same reporter US-GLAXOSMITHKLINE-US2021201375:same reporter US-GLAXOSMITHKLINE-US2021201376:same reporter US-GLAXOSMITHKLINE-US2021201380:same reporter US-GLAXOSMITHKLINE-US2021201379:same reporter
Age: 13.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered infanrix /, Date of birth Feb 13th 2008; administered infanrix, /Boostrix was the vaccine indicated; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 13-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th September 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: A health care professional administered infanrix to a patient of age 13 years old, instead Boostrix was the vaccine indicated for the patient, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. This case was 1 of 7 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201373:same reporter US-GLAXOSMITHKLINE-US2021201375:same reporter US-GLAXOSMITHKLINE-US2021201376:same reporter US-GLAXOSMITHKLINE-US2021201380:same reporter US-GLAXOSMITHKLINE-US2021201379:same reporter US-GLAXOSMITHKLINE-US2021201378:same reporter
Age: 13.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered infanrix/ Date of birth Mar 13th 2008; administered infanrix/ Boostrix was the vaccine indicated; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 13-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th September 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: A health care professional administered infanrix to a patient of age 13 years old, instead Boostrix was the vaccine indicated for the patient, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. This case was 1 of 7 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201378:same reporter US-GLAXOSMITHKLINE-US2021201377:same reporter US-GLAXOSMITHKLINE-US2021201373:same reporter US-GLAXOSMITHKLINE-US2021201375:same reporter US-GLAXOSMITHKLINE-US2021201376:same reporter US-GLAXOSMITHKLINE-US2021201380:same reporter
Sex: F
Vaccine: COVID19
Symptoms: Depression, Gastrooesophageal reflux disease, Hyperparathyroidism secondary, Hypertension, Hypothyroidism
Clinical narrative: GERD; hypertension; Hypothyroidism; Mayor depression disorder; Hyperparathyroidism secondary; Had pneumonia after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Had pneumonia after the vaccine), GASTROOESOPHAGEAL REFLUX DISEASE (GERD ), HYPERTENSION (hypertension ), HYPOTHYROIDISM (Hypothyroidism ), DEPRESSION (Mayor depression disorder ) and HYPERPARATHYROIDISM SECONDARY (Hyperparathyroidism secondary) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (GERD ) (seriousness criterion hospitalization), HYPERTENSION (hypertension ) (seriousness criterion hospitalization), HYPOTHYROIDISM (Hypothyroidism ) (seriousness criteria hospitalization and medically significant), DEPRESSION (Mayor depression disorder ) (seriousness criterion hospitalization) and HYPERPARATHYROIDISM SECONDARY (Hyperparathyroidism secondary) (seriousness criterion hospitalization). On an unknown date, the patient experienced PNEUMONIA (Had pneumonia after the vaccine) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Had pneumonia after the vaccine), GASTROOESOPHAGEAL REFLUX DISEASE (GERD ), HYPERTENSION (hypertension ), HYPOTHYROIDISM (Hypothyroidism ), DEPRESSION (Mayor depression disorder ) and HYPERPARATHYROIDISM SECONDARY (Hyperparathyroidism secondary) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.  Company comment: This case concerns a female patient of an unknown age with no previous relevant medical history, who experienced the unexpected event of pneumonia. The events occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was positive, as the events happened after the first dose and second dose have repeated. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-325636, MOD-2021-325515 (Patient Link).; Sender's Comments: This case concerns a female patient of an unknown age with no previous relevant medical history, who experienced the unexpected event of pneumonia. The events occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was positive, as the events happened after the first dose and second dose have repeated. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: GERD; hypertension; Hypothyroidism; Mayor depression disorder; Hyperparathyroidism secondary; Had pneumonia after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Had pneumonia after the vaccine), GASTROOESOPHAGEAL REFLUX DISEASE (GERD ), HYPERTENSION (hypertension ), HYPOTHYROIDISM (Hypothyroidism ), DEPRESSION (Mayor depression disorder ) and HYPERPARATHYROIDISM SECONDARY (Hyperparathyroidism secondary) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (GERD ) (seriousness criterion hospitalization), HYPERTENSION (hypertension ) (seriousness criterion hospitalization), HYPOTHYROIDISM (Hypothyroidism ) (seriousness criteria hospitalization and medically significant), DEPRESSION (Mayor depression disorder ) (seriousness criterion hospitalization) and HYPERPARATHYROIDISM SECONDARY (Hyperparathyroidism secondary) (seriousness criterion hospitalization). On an unknown date, the patient experienced PNEUMONIA (Had pneumonia after the vaccine) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Had pneumonia after the vaccine), GASTROOESOPHAGEAL REFLUX DISEASE (GERD ), HYPERTENSION (hypertension ), HYPOTHYROIDISM (Hypothyroidism ), DEPRESSION (Mayor depression disorder ) and HYPERPARATHYROIDISM SECONDARY (Hyperparathyroidism secondary) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.  Company comment: This case concerns a female patient of an unknown age with no previous relevant medical history, who experienced the unexpected event of pneumonia. The events occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was positive, as the events happened after the first dose and second dose have repeated. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-325636, MOD-2021-325515 (Patient Link).; Sender's Comments: This case concerns a female patient of an unknown age with no previous relevant medical history, who experienced the unexpected event of pneumonia. The events occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was positive, as the events happened after the first dose and second dose have repeated. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Muscle spasms, Muscular weakness, Pain, Pain in extremity
Clinical narrative: CONSTANT LEG CRAMPS; COMMON SIDE EFFECTS; CONSTANT PINCHES; SIDE OF THE ARM OF JAB STILL HURTS; LOST STRENGTH IN ARM (WAS NOT ABLE TO OPEN WATER BOTTLE AS USED TO BEFORE); This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have potential Guillain barre syndrome and blood clot situation before getting the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the patient experienced constant leg cramps. On APR-2021, the patient experienced common side effects. On APR-2021, the patient experienced constant pinches. On APR-2021, the patient experienced side of the arm of jab still hurts. On APR-2021, the patient experienced lost strength in arm (was not able to open water bottle as used to before). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from side of the arm of jab still hurts, and the outcome of common side effects, lost strength in arm (was not able to open water bottle as used to before), constant leg cramps and constant pinches was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death, Vaccination failure, Vaccine breakthrough infection
Clinical narrative: DEATH; BREAKTHROUGH INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a physician via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: hypertension, dyslipidemia, type 2 diabetes, and Chronic renal failure (CKD). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, 1 total administered on unspecified therapy start date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced breakthrough infection with Covid-19 vaccine ad26.cov2.s(suspected clinical vaccine failure), and died. On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breakthrough infection and suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: 20210949213-covid-19 vaccine ad26.cov2.s-Suspected Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has an 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  20210949213-covid-19 vaccine ad26.cov2.s-Death, breakthrough infection. This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage, Hypersensitivity, Paraesthesia
Clinical narrative: SUBCONJUNCTIVAL HEMORRHAGE; ALLERGIC REACTION; TINGLING SENSATION BACK TO LEFT KNEE; This spontaneous report received from a patient concerned a 59 year old female with unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: 1822809, and expiry: 07-MAR-2022) dose was not reported, 1 total administered at left arm on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced subconjunctival hemorrhage, allergic reaction, tingling sensation back to left knee. The patient had no immediate reaction following injection. The patient had developed once a red spot to the eye cornea and it was described as a subconjunctival hemorrhage. The patient denied any respiratory distress or immediate emergency and was aware about clotting issues with hemorrhage of eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the subconjunctival hemorrhage, allergic reaction and tingling sensation back to left knee was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210949991-covid-19 vaccine ad26.cov2.s -Subconjunctival hemorrhage. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).