chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Wrong technique in product usage process
Clinical narrative: vaccine on a 230 pound female,  used a 1 inch needle, not confident that it reached the muscle; Wrong Route of Administration; This case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in product usage process in a 62-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5723N, expiry date 19th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 6th April 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong technique in product usage process and inappropriate route of vaccination. On an unknown date, the outcome of the wrong technique in product usage process and inappropriate route of vaccination 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 Information: GSK Receipt Date: 8-Apr-2022 Reporter's comments The registered pharmacist administered Boostrix vaccine to the patient and used a 1 inch needle. The reporter was not confident that it reached the muscle and was wondering if he should repeat the dose. The consent to follow up was given via postal. Additional Supportive Information: The pharmacist administered Boostrix to a patient, and used 1 inch needle and reporter was not confident that it reached the muscle, which led to wrong technique in product usage process and inappropriate route of vaccination.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 8-Apr-2022 Reporter's comments: The patient received an expired dose of Engerix B. When asked regarding vaccination date, the healthcare professional reported not sure but she thought it happened in January. No details from patient or vaccine were available at the moment of the call. Pharmacist practically did not have any details regarding this situation and when asked about vaccination date that was she answered. No lot or expiration date available. The consent to follow up was given by email. Additional Supportive Information: The patient received expired dose of Engrix B, which led to expired vaccine used.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received a third dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2019) and Shingrix (received 2nd dose in March 2019).   On 29th March 2022, the patient received the 3rd dose of Shingrix (intramuscular). On 29th March 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: Additional Information: GSK Receipt Date: 08-Apr-2022 Reporter's Comments: Pharmacist reported a patient at the clinic received a third dose of Shingrix on the left arm, it was discovered after the third dose of Shingrix was given. The reporter consented to follow up. Additional Supportive Information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: HR up to 103; This case was reported by a pharmacist via call center representative and described the occurrence of heart rate increased in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 57LJ9, expiry date 14th April 2023) for prophylaxis.   On 5th April 2022, the patient received the 1st dose of Shingrix. In April 2022, 2 days after receiving Shingrix, the patient experienced heart rate increased. The patient was treated with clonazepam. On an unknown date, the outcome of the heart rate increased was recovered/resolved.   It was unknown if the reporter considered the heart rate increased to be related to Shingrix.  Additional Information: GSK Receipt Date: 08-APR-2022 Reporter's Comment:The reporter stated that the patient received in left arm.  2 days later, the patient was sitting at her desk and her apple watch showed her HR at 103.  She took her clonazepam and HR (Heart rate) went back down to normal.  She then asked if patient should get the second dose.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient was given a pediatric dose; Adult patient was given a pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On 8th April 2022, the patient received Engerix B pediatric. On 8th April 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 08-APR-2022 Reporter's Comments: Pharmacist reporting adult patient over the age of 20 years old was given a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. Health care professional (HCP) did not had any further adverse event details at this time.  HCP gave permission for safety to follow up. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles after series completion of Shingrix/Suspected vaccination failure; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On 8th April 2022, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the vaccination failure was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 08-APR-2022 Reporter's Comment: The reporter was reporting that patient getting shingles after series completion of Shingrix.  The reporter consented to follow up from safety team. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: administered Shingrix by subcutaneous route; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number Y537X, expiry date 19th May 2023) for prophylaxis.   On 6th April 2022, the patient received the 1st dose of Shingrix (subcutaneous). On 6th April 2022, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 08-APR-2022 Reporter's Comment: The reporter was pharmacy technician. The patient realized the error after reading over paperwork which noted vaccine should be administered intramuscularly. The reporter consented to follow up. Additional Supportive Information:The reporter reported that a nurse administered a dose of Shingrix to a patient in the right arm by subcutaneous route, which led to intramuscular formulation administered by other route.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Infanrix instead of Boostrix; 11 year old received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female 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 March 2022, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 15th March 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and adult use of a child product. On an unknown date, the outcome of the wrong vaccine administered and adult use of a child product 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 Information: GSK Receipt Date: 08-APR-2022 Reporter's Comment: The reporter consented to follow up. Additional Supportive Information:The reporter reported that a patient received Infanrix instead of Boostrix (dtap instead of tdap),which led to wrong vaccine administered and adult use of child product. The case had been linked to US2022051794,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022051794:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Surgery
Clinical narrative: ablation, was hospitalized; ablation, was hospitalized; This case was reported by a physician via sales rep and described the occurrence of hospitalization in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hospitalization (serious criteria hospitalization) and surgical procedure. On an unknown date, the outcome of the hospitalization and surgical procedure were unknown.   It was unknown if the reporter considered the hospitalization and surgical procedure to be related to Shingrix.     Additional Information: GSK receipt date: 08-Apr-2022 Reporter's comment: Field representative called on behalf of physician. The patient had an ablation after receiving a dose of Shingrix. The patient was hospitalized and duration of hospitalization was unknown. The patient had not yet received 2nd dose of Shingrix. The reporter was not able to provide any additional information.  The adverse event was filed with very limited information. The reporter requested that safety follow-up with physician regarding the event. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Dec2020, now wants 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's Comments: The reporter was pharmacy purchaser reporting on behalf of nurse.  The patient missed all of their follow-up appointments, but now the patient was interested in receiving second dose.  Health care professional (HCP) gave permission for follow-up The reporter consented to follow up  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Patients have shingles despite being fully vaccinated; Shingles; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.     Additional Information: GSK receipt date: 07-Apr-2022 Reporter's comment: The physician at her speaking event reported that as a physician she had seen many more patients had breakthrough shingles cases despite being fully vaccinated with Shingrix after having covid infection (unspecified number of patients, unknown date of birth of patients, and unknown gender).  The reporter did not provide any additional demographical information or contact information.  The health care professional was not currently practicing. Consent was not obtained, lot/expiry date not available. No further information was provided. Did not consent to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain, Chills, Pyrexia
Clinical narrative: Child with development of chills and "teeth chattering" along with abd pain and subjective fever last night about 2.5 hours after getting bexsero. No rash, no hives, no trouble breathing, no vomiting.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Faeces discoloured, Product administration error, Product use complaint
Clinical narrative: DIARRHEA; STOOL BECAME WHITE; TOOK 1 PILL OF BOTH IMODIUM MULTI SYMPTOM RELIEF AND IMODIUM AD AT THE SAME TIME; CAN'T SEE THE LOT NUMBER WITHOUT MY GLASSES. IT'S HARD TO SEE; This spontaneous report received from a patient concerned a male of an unspecified age, 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 (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, first dose administered on unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date, the patient experienced diarrhea (dose number in series 2). The patient received loperamide/simethicone (coated tablet, route of admin not reported, batch number: AJF051 expiry: 30-JUN-2023) dose and frequency were not reported from 13-JAN-2022 for diarrhea; and loperamide hydrochloride (coated tablet, route of admin, and batch number were not reported) dose and frequency were not reported from 13-JAN-2022 to 13-JAN-2022 for diarrhea. No concomitant medications were reported.  On 14-JAN-2022, the patient experienced stool became white (dose number in series 2). On JAN-2022, the patient cannot see the lot number without glasses and it was hard to see.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with loperamide/simethicone, and loperamide hydrochloride was not reported. The outcome of the stool became white, took 1 pill of both imodium multi symptom relief and imodium ad at the same time, can't see the lot number without my glasses. it's hard to see and diarrhea was not reported. This report was non-serious. This case, involving the same patient is linked to 20220401524. This report was associated with a product quality complaint: 10000935997.   Additional information was received from patient on 14-JAN-2022. The following information was updated and incorporated into the case narrative: concurrent condition of diarrhea was removed, new event added (diarrhea), suspect and past vaccines added (Janssen Covid-19 vaccine) as dose number in series 1 and 2, new due diligence for vaccine was scheduled.
Sex: U
Vaccine: COVID19
Symptoms: Multiple allergies
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient's allergies acted up. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome: not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous report received from a consumer, concerned a female of unspecified age. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose: not reported, on Apr 7, 2021, for immunization. Unable to perform follow-up to request batch/lot numbers. On Apr 8, 2021, patient experienced a fever 24 hours after vaccination. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of fever 24 hours after vaccination: not reported.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Pyrexia
Clinical narrative: BONES ARE HURTING; FEVER; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced fever, and bones are hurting. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and bones are hurting was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: AFTER VACCINATION, GOT LIKE SCIATIC PAIN IN LEG; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 01-APR-2021, the patient experienced after vaccination, got like sciatic pain in leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from after vaccination, got like sciatic pain in leg. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: A LITTLE BIT OF REACTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced a little bit of reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a little bit of reaction was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: GOT A  CLOT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex, race and ethnic origin. 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, and batch number: unknown, expiry: unknown) dose, one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, After two week post vaccination, the patient experienced got a clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got a clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220406137-covid-19 vaccine ad26.cov2.s-got a clot. 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). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHE; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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, and batch number were not reported) dose was not reported, administered on 11-APR-2021 15:00 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 11-APR-2021, the patient experienced body ache, fever, and headache. Laboratory data included: Body temperature (NR: not provided) 102.7 C. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of body ache and headache was not reported. This report was non-serious. This report was associated with product quality complaint: 90000224527. This case, involving the same patient is linked to 20210431635.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up request batch/lot numbers. On an unspecified date, patient experienced sore throat, and headache every single month (like a migraine). The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of sore throat, and headache every single month (like a migraine): not reported.
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report received from a consumer, concerned a male of unspecified age. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced an adverse reaction with the COVID-19 vaccine. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of adverse reaction with the COVID-19 vaccine: not reported.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced some residual, left over symptoms. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous report received from a consumer, concerned a female of unspecified age. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced severe headaches. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered from severe headaches.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose: not reported, on Apr 7, 2021, for immunization. Unable to perform follow-up to request batch/lot numbers. Apr 2021, patient experienced lightheadedness and tiredness. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered. This case, from the same reporter, linked to 20220407545.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Fatigue
Clinical narrative: This spontaneous report received from a consumer, concerned a female of unspecified age. Medical history, concurrent conditions, concomitant medications, weight and height not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch/lot number: not reported) dose: not reported, on Apr 7, 2021, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced lightheadedness/feeling worse and tired. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome: not reported. This case (same reporter) linked to 20220407428.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Hot flush
Clinical narrative: REAL BAD HOT FLASHES; BOOBS HURT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced real bad hot flashes, and boobs hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from real bad hot flashes, and the outcome of boobs hurt was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVES/ITCHING; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced hives/itching. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hives/itching. This report was non-serious. This case, involving the same patient is linked to 20210762228.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin.. 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, batch number and expiry were not reported) dose was not reported, 1 total was administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 01-MAY-2021, 30 days after vaccination, the patient experienced Guillain-Barre Syndrome. The patient reported, this ruined patients life and was not still learning how to walk again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Guillain-Barre Syndrome. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220408510-COVID-19 Vaccine Ad26.CoV2.S- GUILLAIN-BARRE SYNDROME. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of an unspecified age, sex, 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, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, following a shot of the vaccine, the patient experienced a reaction of blood clot. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220408511-Covid-19 vaccine ad26.cov2.s -blood clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Pain
Clinical narrative: INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination.  No adverse event reported after primary vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 13-APR-2021 for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered (dose number in series 2).  The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient experienced pain (dose number in series 2). On 14-APR-2021 at 09:00, the patient took Tylenol (paracetamol).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain, and the outcome of off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot number: unknown, expiry: unknown) dose: not reported, on Mar 2021, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient developed cramps in both legs and the calf area. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome: not reported.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This spontaneous report received from a patient, concerned a 74 year old female. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number: not reported) dose: not reported, on Mar 5, 2021 for immunization. The batch/lot number requested. May 2021, patient felt better than what she felt for the past 18 years. She noticed a difference in energy. The vaccine changed something. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome: not reported.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Feeling hot
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and  concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient got hot and had side effects. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered from got hot and side effects.
Sex: U
Vaccine: COVID19
Symptoms: Decreased immune responsiveness, SARS-CoV-2 test
Clinical narrative: ANTIGEN IMMUNITY WAS VERY LOW; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced antigen immunity was very low. Laboratory data (dates unspecified) included: COVID-19 antigen test (NR: not provided) very low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of antigen immunity was very low was not reported. This report was non-serious. This report was associated with product quality complaint: 90000224750. The suspected product quality complaint has been confirmed to be voided (this record does not contain a product quality complaint and is not considered a lack of effect) based on the evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: This spontaneous report received from a consumer, concerned a male of unspecified age. Medical history, height, weight, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch/lot number: not reported) dose, start therapy date; not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced concerning problems. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of concerning problems: not reported.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient started getting side effect. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of started getting side effect: not reported.
Sex: U
Vaccine: COVID19
Symptoms: Influenza, Nonspecific reaction
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced a bad reaction/bad flu. Treatment medications (dates unspecified) included: paracetamol. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. Patient recovering from bad flu; outcome of bad reaction: not reported. This case (same patient) linked to 20220412017.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LOT OF PAIN IN ARM; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight was 145 pounds, and height was not reported. The patient's pre-existing medical conditions included: The patient had no medical conditions or relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced lot of pain in arm. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lot of pain in arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Influenza
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose: not reported, administered on Apr 29, 2021, immunization. Unable to perform follow-up to request batch/lot numbers. May 2021, patient experienced flu symptoms and sickness. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered from flu symptoms and sickness.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the patient experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test abnormal
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose: not reported, on Mar 12, 2021, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced low antibodies. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of low antibodies: not reported.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: POSITIVE COVID-19; This spontaneous report received from a patient via a company representative concerned a patient of an unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced positive covid-19. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of positive covid-19 was not reported. This report was non-serious. This report was associated with a product quality complaint 90000224711. The suspected product quality complaint has been confirmed to be voided (did not meet  criteria as the report indicated medical adverse events for the patient, there was no product quality issue described in the information reported and did not meet the criteria for lack of effect for the vaccine) based on the evaluation/investigation performed.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced a lingering side effect. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered.