chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: a Pediatric vaccine, Engerix B was given to an adult; a Pediatric vaccine, Engerix B was given to an adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: a Pediatric vaccine, Engerix B was given to an adult) and adult use of a child product (Verbatim: a Pediatric vaccine, Engerix B was given to an adult).  The outcome of the underdose 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: 30-Aug-2023 Nurse stated that the call was dropped and no further information was available. Above information was all the reporter was able to obtain. Did not consent to follow-up. An adult patient received a dose of Engerix-B pediatric, which led to underdose and adult use of a child product.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect route of product administration, Miliaria, Paraesthesia, Pyrexia, Rash
Clinical narrative: arm broke out/ flat rash; solid red rash; itchy rash; tingly rash; Fever; SC injection by her pharmacist, instead of an IM injection; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included covid-19.   On 27-AUG-2023, the patient received Arexvy (subcutaneous, right arm). On 27-AUG-2023, an unknown time after receiving Arexvy, the patient experienced intramuscular formulation administered by other route (Verbatim: SC injection by her pharmacist, instead of an IM injection). On 28-AUG-2023, the patient experienced fever (Verbatim: Fever). On 29-AUG-2023, the patient experienced rash (Verbatim: arm broke out/ flat rash), red rash (Verbatim: solid red rash), itchy rash (Verbatim: itchy rash) and prickly heat (Verbatim: tingly rash).  The patient was treated with hydrocortisone (Cortaid) and benadryl (nos) (Benadryl). The outcome of the fever was resolved and the outcome of the rash, red rash, itchy rash and prickly heat were not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the fever, rash, red rash, itchy rash and prickly heat to be related to Arexvy.     It was unknown if the company considered the fever, rash, red rash, itchy rash and prickly heat to be related to Arexvy.   Additional Information: GSK receipt date: 30 Aug 2023  The patient reported that she received the Arexvy vaccine 3pm and had some fever, up to 99.4, that lasted over the next few days (specific time range not provided). 2 days after the vaccination, the patient her arm broke out one day before the reporting day, in a solid red, flat, itchy, tingly rash, that is 3 inches wide and 8 inches long, on her right arm.  The patient was using topical Cortaid and Benadryl, both over the counter medications, to treat the rash, and has not seen her physician.  All the patient provided about these events were reported.  The patient reported that the pharmacist told her it was being administered as a subcutaneous injection.  The reporter consented to follow-up with health care professional. The reporter consented to follow-up. This is 1 of 2 linked reported, reported by same reporter. The patient received a dose of Shingrix subcutaneously, which led to intramuscular formulation administered by other route.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: arm broke out/ flat rash; solid red rash; itchy rash; tingly rash; Fever; SC injection by her pharmacist, instead of an IM injection; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included covid-19.   On 27-AUG-2023, the patient received Arexvy (subcutaneous, right arm). On 27-AUG-2023, an unknown time after receiving Arexvy, the patient experienced intramuscular formulation administered by other route (Verbatim: SC injection by her pharmacist, instead of an IM injection). On 28-AUG-2023, the patient experienced fever (Verbatim: Fever). On 29-AUG-2023, the patient experienced rash (Verbatim: arm broke out/ flat rash), red rash (Verbatim: solid red rash), itchy rash (Verbatim: itchy rash) and prickly heat (Verbatim: tingly rash).  The patient was treated with hydrocortisone (Cortaid) and benadryl (nos) (Benadryl). The outcome of the fever was resolved and the outcome of the rash, red rash, itchy rash and prickly heat were not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the fever, rash, red rash, itchy rash and prickly heat to be related to Arexvy.     It was unknown if the company considered the fever, rash, red rash, itchy rash and prickly heat to be related to Arexvy.   Additional Information: GSK receipt date: 30 Aug 2023  The patient reported that she received the Arexvy vaccine 3pm and had some fever, up to 99.4, that lasted over the next few days (specific time range not provided). 2 days after the vaccination, the patient her arm broke out one day before the reporting day, in a solid red, flat, itchy, tingly rash, that is 3 inches wide and 8 inches long, on her right arm.  The patient was using topical Cortaid and Benadryl, both over the counter medications, to treat the rash, and has not seen her physician.  All the patient provided about these events were reported.  The patient reported that the pharmacist told her it was being administered as a subcutaneous injection.  The reporter consented to follow-up with health care professional. The reporter consented to follow-up. This is 1 of 2 linked reported, reported by same reporter. The patient received a dose of Shingrix subcutaneously, which led to intramuscular formulation administered by other route.
Age: 18.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Shingrix administered instead of Menveo; 18 year old received Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 18-year-old male patient who received Herpes zoster (Shingrix) (batch number 3ZX3E, expiry date 02-JUL-2025) for prophylaxis.   Additional patient notes included Patient was not immunocompromised..   On 14-AUG-2023, the patient received the 1st dose of Shingrix. On 14-AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Shingrix administered instead of Menveo) and inappropriate age at vaccine administration (Verbatim: 18 year old received Shingrix).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 31-AUG-2023 A 18-year-old was administered Shingrix instead of Menveo, which led to Wrong vaccine administered and Inappropriate age at vaccine administration. The reporter consented to follow up. This case was 1 of 2 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023119223:1st Report
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the patient had only 1 dose previously, and it was given on 09Dec2021; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th December 2021, batch number HM24H).   On an unknown date, the patient did nor received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: the patient had only 1 dose previously, and it was given on 09Dec2021).  The outcome of the inappropriate schedule of vaccine administered was unknown.   Additional Information: GSK receipt date 31 Aug 2023 The pharmacist stated she had a patient walk into the pharmacy yesterday day before reporting asking about getting another Shingrix dose.  As per state records, the patient had only 1 dose previously. At the time of reporting, no additional doses have been administered. The reporter consented to follow up via email.   Till the time of reporting the patient did not receive 2nd dose which led to incomplete course of vaccination.
Sex: F
Vaccine: RSV
Symptoms: Product complaint, Underdose
Clinical narrative: The defect was discovered after administration; white powder in the antigen vial/pqc filed; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7K545, expiry date 22-OCT-2024) for prophylaxis. This case was associated with a product complaint.   On 30-AUG-2023, the patient received Arexvy (intramuscular). On 30-AUG-2023, an unknown time after receiving Arexvy, the patient experienced underdose (Verbatim: white powder in the antigen vial/pqc filed). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: The defect was discovered after administration).  The outcome of the underdose and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt date: 31-AUG-2023 Pharmacist reported that a colleague had administered Arexvy to two patients and after the patients had left the pharmacy, the reporter noticed that retained white powder in the antigen vial.  The powder was described as partially pill-like and partially like powdered sugar.  They did not know which of two patients received the underdose.  The reporter I reviewed the reconstitution instructions, and received the following information prior to transferring the call to the medical information department for further instruction. All operations were performed appropriately before defect was discovered.  The defect was discovered after administration. The mixing was performed gently. The vial was held upside-down while being withdrawn. The product was administered. The health care professional was experienced in vaccine administration. The antigen component was the component in question. The health care professional was not able to email a picture. No liquid, only powder was left in the affected vial/s.  Yes the stopper was pierced in the circular area dedicated to perforation.  It was unknown if air was injected into vial. The reporter will call them back with wholesaler information for credit when they locate this information. The reporter consented to follow up. This is 1 of 2 linked report, reported by same reporter. The patient received Arexvy and later it was noticed that retained white powder in the antigen vial, which led to underdose.; Sender's Comments:  US-GSK-US2023119233:Same reporter
Sex: M
Vaccine: RSV
Symptoms: Product complaint, Underdose
Clinical narrative: Underdose; Product Complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 68-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7k545, expiry date 22-OCT-2024) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Arexvy (intramuscular). On an unknown date, an unknown time after receiving Arexvy, the patient experienced underdose (Verbatim: Underdose) and pharmaceutical product complaint (Verbatim: Product Complaint).  The outcome of the underdose and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt date: 31-AUG-2023 Pharmacist reported that a colleague had administered Arexvy to two patients and after the patients had left the pharmacy, the reporter noticed that retained white powder in the antigen vial.  The powder was described as partially pill-like and partially like powdered sugar.  They did not know which of two patients received the underdose.  The reporter reviewed the reconstitution instructions and received the following information prior to transferring the call to the medical information department for further instruction. The reporter stated that all operations were performed appropriately before defect was discovered. The defect was discovered after administration. The mixing was performed gently. The vial was held upside-down while being withdrawn. The product was administered. The health care professional was experienced in vaccine administration. The antigen component was the component in question. The health care professional was not able to email a picture. No liquid, only powder was left in the affected vial/s. Yes, the stopper was pierced in the circular area dedicated to perforation.  It was unknown if air was injected into vial. The reporter would call GSK back with wholesaler information for credit when they locate this information. The reporter consented to follow up. This is 1 of 2 linked report, reported by same reporter. The patient received Arexvy and later it was noticed that retained white powder in the antigen vial, which led to underdose.; Sender's Comments:  US-GSK-US2023119231:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: no second dose received; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date, received first dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim:  no second dose received).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 31-AUG-2023 The reporter was a patient who resides out of town. The reporter stated that she received first dose of Shingrix 1 or 2 years ago from the reporting day and no second dose was received. The reporter refused to provide any other information. The reporter referred to GSK. The reporter did not consent to follow up. The reporter reported that till the time of reporting the patient had not received the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: Diarrhea; Her arm hurt really bad; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-JUN-2023, the patient received the 1st dose of Shingrix (right arm). On 09-JUN-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Her arm hurt really bad). On an unknown date, the patient experienced diarrhea (Verbatim: Diarrhea).  The outcome of the pain in arm was resolved (duration 3 days) and the outcome of the diarrhea was not resolved.   It was unknown if the reporter considered the pain in arm and diarrhea to be related to Shingrix.     It was unknown if the company considered the pain in arm and diarrhea to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-AUG-2023 The patient was self-reported this case. The reporter reported that she received Shingrix vaccine and on same day she experienced arm hurt really bad for 3 days. The patient experienced diarrhea before receiving 2nd dose of Shingrix vaccine. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR122939:
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site warmth, Nerve injury, Paraesthesia, Pruritus
Clinical narrative: injection site on left arm felt warm; had pruritus right; experiencing a tingling sensation; Nerve damage; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling of warmth in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included cyanocobalamin + pyridoxine hydrochloride (Vitamin B12 And B6).   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, immediately after receiving Shingrix, the patient experienced feeling of warmth (Verbatim: injection site on left arm felt warm), pruritus (Verbatim: had pruritus right), tingling (Verbatim: experiencing a tingling sensation) and nerve damage (Verbatim: Nerve damage).  The outcome of the feeling of warmth, pruritus and tingling were not resolved and the outcome of the nerve damage was not reported.   It was unknown if the reporter considered the feeling of warmth, pruritus, tingling and nerve damage to be related to Shingrix.     It was unknown if the company considered the feeling of warmth, pruritus, tingling and nerve damage to be related to Shingrix.   Additional Information: GSK receipt date: 31-AUG-2023 The patient had her first dose of Shingrix approximately 2 months ago.   The patient reported that injection site on left arm felt warm and had pruritus right after injection of vaccine that was not resolved.   Also, reports that she was experiencing a tingling sensation down her left arm and up the left side of her neck that was not resolved.  The patient had been assessed by her physician for the adverse event (AE) symptoms.   The patient stated that she was diagnosed with possible nerve damage and was ordered Vitamin B12 and B6 supplements.   However, she was in a car at time of call and going under a tunnel.   Therefore, reporter inadvertently abandoned call and no other detail information available.   Call back to customer attempted by this agent with no answer.  Message left requesting a call back to GSK. The reporter abandoned call before physician's information was obtained. The patient gave permission to follow up with her physician.
Age: 38.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Shingrix vaccine on June 19, 2023 by error; wrong vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 38-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-JUN-2023, the patient received Shingrix. On 19-JUN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Shingrix vaccine on June 19, 2023 by error) and wrong vaccine administered (Verbatim: wrong vaccine administered).  The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK receipt date: 01-SEP-2023 The patient was sent to the pharmacy to receive another vaccine. Patient is not immunocompromised. The reporter was a pharmacist intern who stated a 38 years old male patient received first dose of Shingrix vaccine by error, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: Approximately one month ago, Patient experienced blindness 24 to 48 hours after injection/she went blind within 24-48 hours after vaccine; This serious case was reported by a consumer via sales rep and described the occurrence of blind in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced blind (Verbatim: Approximately one month ago, Patient experienced blindness 24 to 48 hours after injection/she went blind within 24-48 hours after vaccine) (serious criteria GSK medically significant).  The outcome of the blind was unknown.   It was unknown if the reporter considered the blind to be related to Shingrix.     It was unknown if the company considered the blind to be related to Shingrix.   Additional Information: GSK Receipt date: 01-SEP-2023 The reporter was sales representative and said that fell free to call her at any time. The reporter called and reported that approximately 1 month ago, patient went to first physician who provided Shingrix injection and reported to the second physician the patient followed up with that she went blind within 24 to 48 hours after vaccine. The reporter gathered information from second physician during visit and said she had to report this adverse event. Neither physician wanted their names mentioned and the first one did not want to report it, and the second physician was not a fan of Shingrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administered a dose of Engerix B that had expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) (batch number 4345R, expiry date 11-AUG-2023) for prophylaxis.   On 01-SEP-2023, the patient received Engerix B. On 01-SEP-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: administered a dose of Engerix B that had expired).  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: 01-SEP-2023 The medical assistant reported on September 1st 2023 that he administered a dose of Engerix B that had expired on August 11th 2023 which led to expired vaccine used. The reported enquired how to proceed. The reporter consented to follow up.  The vaccine administration facility is the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Shingrix that expired on 8/24/2023 was administered to a female patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a adult female patient who received Herpes zoster (Shingrix) (batch number 49N3S, expiry date 24-AUG-2023) for prophylaxis.   On 30-AUG-2023, the patient received the 1st dose of Shingrix. On 30-AUG-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Shingrix that expired on 8/24/2023 was administered to a female patient).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 01-Sept-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. The patient received an expired dose of Shingrix, which led to expired vaccine used.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: administration of a pediatric Engerix-B dose to an adult patient; administration of a pediatric Engerix-B dose to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 22-year-old male patient who received HBV (Engerix B pediatric) (batch number 9PG49, expiry date 28-DEC-2024) for prophylaxis.   On 05-SEP-2023, the patient received Engerix B pediatric. On 05-SEP-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: administration of a pediatric Engerix-B dose to an adult patient) and adult use of a child product (Verbatim: administration of a pediatric Engerix-B dose to an adult patient).The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 05-SEP-2023 The reporter was a medical assistant. The reporter reported that the administration of a pediatric Engerix-B dose to an adult patient, which led to underdose and adult use of a child product. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: administered an adult dose of Havrix; administered an adult dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 17-year-old female patient who received HAV (Havrix 1440) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   On 14-AUG-2023, the patient received the 1st dose of Havrix 1440. On 14-AUG-2023, an unknown time after receiving Havrix 1440, the patient experienced overdose (Verbatim: administered an adult dose of Havrix) and inappropriate age at vaccine administration (Verbatim: administered an adult dose of Havrix).The outcome of the overdose and inappropriate age at vaccine administration 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: 06-SEP-2023 The reporter reported that a 17-year-old patient was administered an adult dose of Havrix, which led to overdose and inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter. No PQC (product quality complaint) was reported. No additional adverse event was reported. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: received Bexsero instead of Menveo; This non-serious 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 Men B NVS (Bexsero) (batch number 5AR2D, expiry date 31-DEC-2025) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: received Bexsero instead of Menveo).The outcome of the wrong vaccine administered 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: 06-SEP-2023 The reporter called to ask for information regarding a patient who received Bexsero instead of Menveo, which led to wrong vaccine administered. The healthcare professional asked how to proceed with this patient. The reporter did not provide the date of administration. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac fibrillation
Clinical narrative: FIBRILLATION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex and ethnic origin The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) 1 total, dose and start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced fibrillation, for which the patient had heart shocked 3 times, but it only helped for a short while. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fibrillation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230906188- Fibrillation. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Nodule, Oedema, Osteoarthritis
Clinical narrative: She has a lump on one of her arms; eating up with osteo arthritis; Neuropathy in both legs since the shot; edema; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy in both legs since the shot) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy in both legs since the shot) (seriousness criterion medically significant) and OEDEMA (edema). On an unknown date, the patient experienced NODULE (She has a lump on one of her arms) and OSTEOARTHRITIS (eating up with osteo arthritis). The patient was treated with Surgery for Neuropathy peripheral. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy in both legs since the shot) and OEDEMA (edema) had not resolved and NODULE (She has a lump on one of her arms) and OSTEOARTHRITIS (eating up with osteo arthritis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient stated they did not have any previous history or conditions before receiving the vaccine. No concomitant medication was reported.  Patient stated she need help figuring out if Autoimmune disorder has been seen with the vaccine. She had 10 MRI. She has been to a Cardiologist, Brain specialist and foot doctor. She had edema ever since. She stated, she could feel it moving up. She had 5 surgery and 2 knee replacement. Patient also stated she has blood test that she can provide the result. No treatment information was reported. The patient had undergone a Hip replacement.  Company Comment: This is a spontaneous case concerning a 50 year-old, female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of neuropathy peripheral, which occurred the same day after the first dose of mRNA-1273 vaccine. The outcome was reported as not recovered. Additionally, non-serious events of osteoarthritis, oedema and nodule were reported in the case. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criteria hospitalization and medically significant). At the time of the report, THROMBOSIS (blood clots) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown.  It was reported that patient went into dialysis as a result of having blood clots from the vaccine. Company comment This spontaneous case concerns a patient of an unknown age and gender with no medical history reported, who experienced the unexpected, serious (medically significant and hospitalization), AESI of thrombosis and received a dose of mRNA-1273. The vaccination date and event onset date were not provided, thus, exact latency between vaccination and onset of the event could not be assessed. It was reported that patient went into dialysis as a result of having blood clots from the vaccine. No further clinical information was provided for review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: no adverse event; GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT TEMPERATURE EXCURSION ISSUE (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event) in a 14-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and PRODUCT TEMPERATURE EXCURSION ISSUE (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT TEMPERATURE EXCURSION ISSUE (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular use), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and PRODUCT TEMPERATURE EXCURSION ISSUE (GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE).    Concomitant medication was not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 86-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (2022) and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: when I caught Covid last year, I picked up the positive virus. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: The patient stated that he received two shots of the vaccine and two booster shots. The patient had COVID last year with the added immunity from the boosters. The patient stated that he was travelling internationally and it was the reason why he had COVID. when he caught Covid last year, he picked up the positive virus in his system within 5 days and he took Paxlovid prescribed and it wiped it out completely in 3 days and that was incredible.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID; got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID ", start date: Sep2022 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "got COVID". Reporter inquired if the updated COVID vaccine be effective against the new BA 2.86 COVID Variant. Patient was fully vaccinated, with latest being multi-variant Pfizer vaccine. Yet in July, got COVID. Patient had much worse symptoms than when had COVID last fall (Sep2022). If it was the new variant, it was brutal especially CNS symptoms of brain fog, tinnitus, visual spatial disorientation, and extreme fatigue.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Paraesthesia
Clinical narrative: the severe neck pain and shoulder pain started a few days, 2 or 3 days after the second shot.; the severe neck pain and shoulder pain started a few days, 2 or 3 days after the second shot.; started having tingling in feet, more like in the right foot.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), in 2022 as dose 2, single (Batch/Lot number: unknown), in right arm (reported as "right shoulder") for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical Location: first one was left shoulder), for Covid-19 immunization, reaction(s): "After first shot, 2 days after, started causing him severe neck pain and shoulder pain", "Can not do any exercising at all because of this pain. It has injured his lifestyle", "After first shot, 2 days after, started causing him severe neck pain and shoulder pain". The following information was reported: PARAESTHESIA (non-serious) with onset 2022, outcome "not recovered", described as "started having tingling in feet, more like in the right foot."; NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 2022, outcome "not recovered" and all described as "the severe neck pain and shoulder pain started a few days, 2 or 3 days after the second shot.". Therapeutic measures were not taken as a result of neck pain, arthralgia, paraesthesia.  Additional information: Severe neck pain and shoulder pain started within 2 or 3 days after the second shot. Does not actually remember particularly, when. At first, felt like, was having some little pains, thought he was going to be fine. Also, had another thing he noticed, started having tingling in feet, more like in the right foot. Tingling in feet started same time, after Covid shot. Treatment: No, doctor recommended muscle relaxer, said he would have to pick up medicine again and, if it continues will be looking to recommend some kind of chiropractic thing. Is not a big fan of taking things. Clarified, he took muscle relaxant, did not like how it made him feel, didn't fee like it was doing a whole lot.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral
Clinical narrative: Single sided deafness within days. Hearing has never returned; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Jan2023 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown), for COVID-19 immunization. The patient had no known allergy.  The following information was reported: DEAFNESS UNILATERAL (disability, medically significant) with onset 13Feb2023, outcome "not recovered", described as "Single sided deafness within days. Hearing has never returned". The event "single sided deafness within days. hearing has never returned" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of deafness unilateral including steroid injections and recently cochlear implant. No covid tested post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Single sided deafness within days. Hearing has never returned; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Jan2023 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown), for COVID-19 immunization. The patient had no known allergy.  The following information was reported: DEAFNESS UNILATERAL (disability, medically significant) with onset 13Feb2023, outcome "not recovered", described as "Single sided deafness within days. Hearing has never returned". The event "single sided deafness within days. hearing has never returned" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of deafness unilateral including steroid injections and recently cochlear implant. No covid tested post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: blotchy skin rash on her torso, face and arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 67 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE Lot No: EN6200), administration date: 23Feb2021, when the patient was 67-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 1, SINGLE Lot No: EL9265), administration date: 02Feb2021, when the patient was 67-year-old, for Covid-19 Immunization. The following information was reported: RASH MACULAR (non-serious) with onset Dec2021, outcome "recovered with sequelae", described as "blotchy skin rash on her torso, face and arms". Therapeutic measures were not taken as a result of rash macular.
Sex: U
Vaccine: COVID19
Symptoms: Acute kidney injury, Neoplasm malignant
Clinical narrative: died from cancer; kidneys shut down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (death), outcome "fatal", described as "died from cancer"; ACUTE KIDNEY INJURY (death), outcome "fatal", described as "kidneys shut down". The patient date of death was unknown. Reported cause of death: "died from cancer", "kidneys shut down". It was not reported if an autopsy was performed. Clinical course: As per reporter, he had lost 3 friends in the last 45 days, kidneys shut down. All 3 of them died from cancer.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200354728 same reporter, different patient/drug/event;; Reported Cause(s) of Death: died from cancer; kidneys shut down
Sex: U
Vaccine: COVID19
Symptoms: Acute kidney injury, Neoplasm malignant
Clinical narrative: died from cancer; kidneys shut down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (death), outcome "fatal", described as "died from cancer"; ACUTE KIDNEY INJURY (death), outcome "fatal", described as "kidneys shut down". The patient date of death was unknown. Reported cause of death: "died from cancer", "kidneys shut down". It was not reported if an autopsy was performed. Clinical course: As per reporter, he had lost 3 friends in the last 45 days, kidneys shut down. All 3 of them died from cancer.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200354728 Same reporter, different patient/drug/event;; Reported Cause(s) of Death: died from cancer; kidneys shut down
Sex: U
Vaccine: COVID19
Symptoms: Renal failure
Clinical narrative: His 35 year old attorney, both kidneys shut down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: RENAL FAILURE (medically significant), outcome "unknown", described as "His 35 year old attorney, both kidneys shut down". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.