chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: diarrhea; numbess (to the skin) on chest left side; Chest tightness; muscle aches; fatigue; headache; shivering; Low grade fever; injection site (left arm) pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included drug hypersensitivity (sensitivity to corticosteroids).   On 8th February 2023, the patient received the 1st dose of Shingrix (intramuscular). On 8th February 2023, less than a day after receiving Shingrix, the patient experienced injection site pain. On 9th February 2023, the patient experienced numbness, chest tightness, muscle pain, fatigue, headache, shivering and low grade fever. On 11th February 2023, the patient experienced diarrhea. On an unknown date, the outcome of the injection site pain, numbness, chest tightness, muscle pain, fatigue, headache, shivering and low grade fever were not recovered/not resolved and the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the injection site pain, numbness, chest tightness, muscle pain, fatigue, headache, shivering, low grade fever and diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-FEB-2023 Reporter's Comment: The case was reported by the patient's husband. The patient received dose of Shingrix into left deltoid and experienced injection site pain (left arm). One day after vaccination, the patient experienced numbness on the left side of chest, muscle aches, fatigue, headache, shivering and low grade fever. 3 days after vaccination, the patient developed diarrhea. The patient saw her healthcare professional on 17th February 2023 and tested negative for Covid. The patient was offered steroid to treat the effects but declined due to a sensitivity to corticosteroids. Nothing else was reported. The reporter consented to follow up. Might follow up with HCP.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Myalgia, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: diarrhea; numbess (to the skin) on chest left side; Chest tightness; muscle aches; fatigue; headache; shivering; Low grade fever; injection site (left arm) pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included drug hypersensitivity (sensitivity to corticosteroids).   On 8th February 2023, the patient received the 1st dose of Shingrix (intramuscular). On 8th February 2023, less than a day after receiving Shingrix, the patient experienced injection site pain. On 9th February 2023, the patient experienced numbness, chest tightness, muscle pain, fatigue, headache, shivering and low grade fever. On 11th February 2023, the patient experienced diarrhea. On an unknown date, the outcome of the injection site pain, numbness, chest tightness, muscle pain, fatigue, headache, shivering and low grade fever were not recovered/not resolved and the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the injection site pain, numbness, chest tightness, muscle pain, fatigue, headache, shivering, low grade fever and diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-FEB-2023 Reporter's Comment: The case was reported by the patient's husband. The patient received dose of Shingrix into left deltoid and experienced injection site pain (left arm). One day after vaccination, the patient experienced numbness on the left side of chest, muscle aches, fatigue, headache, shivering and low grade fever. 3 days after vaccination, the patient developed diarrhea. The patient saw her healthcare professional on 17th February 2023 and tested negative for Covid. The patient was offered steroid to treat the effects but declined due to a sensitivity to corticosteroids. Nothing else was reported. The reporter consented to follow up. Might follow up with HCP.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose one month after 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) (batch number 73PP9, expiry date 30th May 2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 20th February 2023, the patient received the 2nd dose of Shingrix. On 20th February 2023, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt date: 20-Feb-2023. Reporter's Comment: Reporter did not provide full patient demographics or lot number and expiration date of dose one. The reporter did not consent to follow-up. Additional Supportive Information: Patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to drug dose administration interval too short.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix Administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 38-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 20th February 2023, unknown after receiving Havrix and Havrix 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: 20-FEB-2023 Reporter's Comment: The reporter was a clinic administrator. The reporter reported that the patient received Havrix vaccine which was expired on 30th January 2023. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, FLU4, HEPA, RV1, TDAP
Symptoms: Product storage error
Clinical narrative: Vaccines given after temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Tetra 2022-2023 season) for prophylaxis, flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, Fluarix Tetra 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Havrix, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Pediarix, Pediarix Pre-Filled Syringe Device and Boostrix. On an unknown date, unknown after receiving Infanrix, Infanrix Pre-Filled Syringe Device, Fluarix Tetra 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Havrix, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Pediarix, Pediarix Pre-Filled Syringe Device and Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 20-FEB-2023 Reporter's comment: The reporter calling about Infanrix, Fluarix Tetra 2022-2023 season, Kinrix, Havrix, Rotarix lyophilized formulation, Pediarix and Boostrix vaccines that had been exposed for 69 days at a temperature of 63 degree F.  She was looking for guidance as the vaccines had been administered to patients.  The vaccine administration facility was the same as primary reporter. The reporter did not have accurate lot numbers or expiration dates and it was not known at this time how many patients received the vaccines. The reporter consented to follow up via postal. Additional Supportive Information: The patients received Infanrix, Fluarix Tetra 2022-2023 season, Kinrix, Havrix, Rotarix lyophilized formulation, Pediarix and Boostrix vaccines that had been exposed for 69 days at a temperature of 63 degree F, which led to incorrect storage of drug.
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Pediarix given instead of Dtap vaccine; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number E9Y29, expiry date 26th October 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th February 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 17th February 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, 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: 20-FEB-2023 Reporter's Comments: The reporter wanted to know if there would be an expected adverse reaction and if the patient was going to be ok. The reporter consented to follow up. Additional Supportive Information: The patient was administered Pediarix instead of a Dtap vaccine, which led to wrong vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 3 years ago, has not received 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix 3 years ago).   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: 21-FEB-2023 Reporter's Comment: The pharmacist reported that the patient had no side effects.  However based off of the Centers for disease control and prevention guidance 'to administer as soon as possible' the reporter will be administering it. The reporter did not provided a specific date she will be administering that 2nd dose. The reporter did consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 68.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 68-year-old male patient who received HBV (Engerix B) (batch number N4GA4, expiry date 2nd January 2023) for prophylaxis.   On 21st February 2023, the patient received Engerix B. On 21st February 2023, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-Feb-2023  Reporter's comment: The medical assistant called to enquire if patient should be revaccinate as they inadvertently administered an expired Engerix dose to a patient in their facility.  The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Engerix, which led to expired vaccine used.
Age: 41.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Facial pain, Herpes zoster, Neck pain
Clinical narrative: Shingles two weeks after Shingrix; Pain on right side of his face, neck, upper back and shoulder; feeling pain on one side (side unknown) of his face; Feeling pain on neck; Feeling pain on upper back pain/ pain between neck and shoulder; Erupted into a rash/Rash on right side of his face, neck, upper back and shoulder; This case was reported by a nurse via sales rep and described the occurrence of shoulder pain in a 41-year-old male patient who received Herpes zoster (Shingrix) (batch number 5H29X, expiry date 6th July 2023) for prophylaxis.   Concurrent medical conditions included autoimmune disorder (have had autoimmune disorder). Concomitant products included adalimumab (Humira).   On 7th February 2023, the patient received the 1st dose of Shingrix. On 9th February 2023, 2 days after receiving Shingrix, the patient experienced shoulder pain, rash, facial pain, neck pain and upper back pain. On 14th February 2023, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex) and topical steroid nos (Topical Steroid). On an unknown date, the outcome of the shoulder pain, rash and shingles were recovering/resolving and the outcome of the facial pain, neck pain and upper back pain were unknown.   It was unknown if the reporter considered the shoulder pain, rash, shingles, facial pain, neck pain and upper back pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's Comment:Nurse reported that the patient was administered a dose of Shingrix and the rheumatologist at the clinic presribed the Shingrix because the patient was on Humira. The patient was monitored for 15 minutes after he received the vaccination, and the patient was fine. The patient developed the pain and rash in the right side of his face, neck, shoulder and between his neck and shoulder. On 10th February 2023,  the patient called the clinic about these adverse reactions. The patient's primary care provider applied topical steroid that did not help his symptoms and he was then referred to dermatologist.  On 13th February 2023, the patient was seen by the dermatologist in the clinic and on 14th February 2023 was confirmed to had an outbreak of Shingles, and provided education, and the patient was prescribed Valtrex (Valacyclovir) for the shingles by the dermatologist. The shingles was now resolving since it was two weeks after Shingrix was given. The dermatologist did recommend that the patient receive his second dose of Shingrix at the 14th February 2023 appointment, and the patient was scheduled to receive his second dose in April 2023. The patient consent to follow up with the health care professional was obtained.
Age: 41.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Shingles two weeks after Shingrix; Pain on right side of his face, neck, upper back and shoulder; feeling pain on one side (side unknown) of his face; Feeling pain on neck; Feeling pain on upper back pain/ pain between neck and shoulder; Erupted into a rash/Rash on right side of his face, neck, upper back and shoulder; This case was reported by a nurse via sales rep and described the occurrence of shoulder pain in a 41-year-old male patient who received Herpes zoster (Shingrix) (batch number 5H29X, expiry date 6th July 2023) for prophylaxis.   Concurrent medical conditions included autoimmune disorder (have had autoimmune disorder). Concomitant products included adalimumab (Humira).   On 7th February 2023, the patient received the 1st dose of Shingrix. On 9th February 2023, 2 days after receiving Shingrix, the patient experienced shoulder pain, rash, facial pain, neck pain and upper back pain. On 14th February 2023, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex) and topical steroid nos (Topical Steroid). On an unknown date, the outcome of the shoulder pain, rash and shingles were recovering/resolving and the outcome of the facial pain, neck pain and upper back pain were unknown.   It was unknown if the reporter considered the shoulder pain, rash, shingles, facial pain, neck pain and upper back pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's Comment:Nurse reported that the patient was administered a dose of Shingrix and the rheumatologist at the clinic presribed the Shingrix because the patient was on Humira. The patient was monitored for 15 minutes after he received the vaccination, and the patient was fine. The patient developed the pain and rash in the right side of his face, neck, shoulder and between his neck and shoulder. On 10th February 2023,  the patient called the clinic about these adverse reactions. The patient's primary care provider applied topical steroid that did not help his symptoms and he was then referred to dermatologist.  On 13th February 2023, the patient was seen by the dermatologist in the clinic and on 14th February 2023 was confirmed to had an outbreak of Shingles, and provided education, and the patient was prescribed Valtrex (Valacyclovir) for the shingles by the dermatologist. The shingles was now resolving since it was two weeks after Shingrix was given. The dermatologist did recommend that the patient receive his second dose of Shingrix at the 14th February 2023 appointment, and the patient was scheduled to receive his second dose in April 2023. The patient consent to follow up with the health care professional was obtained.
Age: 0.5
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received an expired vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old patient who received HBV (Engerix B pediatric) (batch number 53YL7, expiry date 22nd December 2022) for prophylaxis.   On 22nd February 2023, the patient received the 3rd dose of Engerix B pediatric. On 22nd February 2023, unknown after receiving Engerix B pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-FEB-2023 Reporter's Comments: The medical assistant had twins (male and female) who one of them probably received an expired Engerix-B vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received an expired Engerix-B, which led to expired vaccine used. This case was found as duplicate of case US2023029942. All the information from the case US2023029942 was merged into this case. The case US2023029942 was deleted and this case stand as case of record for this patient
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Itching all over body; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included eczema and mumps (she had mumps as a child).   In February 2023, the patient received the 1st dose of Shingrix. In February 2023, less than a day after receiving Shingrix, the patient experienced generalized pruritus. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the generalized pruritus was not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional Information: GSK Receipt Date: 22-FEB-2023 Reporter's Comment: The patient said that she got her Shingrix shot in the right arm sometimes last week. The patient said that she started to experience itching all over her body later on that same night.  The patient reported starting Benadryl for itching on 17th February 2023 The patient said that she had never had chicken pox or measles. The patient did not know the lot number/expiration date of the Shingrix vaccine she received. The reporter did not consent to follow-up.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Overdose
Clinical narrative: 19 year old received Engerix 1mL; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B) (batch number AX2D5, expiry date 7th December 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd February 2023, the patient received Engerix B 1 ml and Engerix B Pre-Filled Syringe Device. On 22nd February 2023, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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: 23-FEB-2023 Reporter's Comments: The reporter consented to follow up via email. Additional Supportive Information: The 19 year old patient received a 1 ml dose of Engerix-B, which led to overdose.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 38-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 1st February 2023, unknown after receiving Havrix and Havrix 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: 23-FEB-2023 Reporter comment: The reporter reported that, the expired dose of Havrix was administered to a patient. The reporter consented to follow up via email. Additional Supportive Information: The patient received an expired dose of Havrix vaccine which led to expired vaccine used.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose given to an adult; Pediatric dose given to an adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 50-year-old female patient who received HBV (Engerix B pediatric) (batch number EM9E4, expiry date 17th February 2025) for prophylaxis.   On 20th February 2023, the patient received the 1st dose of Engerix B pediatric. On 20th February 2023, 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: 24-Feb-2023 Reporter's comment: The reporter consented to follow-up by email. Additional supportive information: An adult patient received a pediatric dose of Engerix-B, which underdose and adult use of a child product.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: 22 year old was given a pediatric dose; 22 year old was given a pediatric dose; given an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 22-year-old female patient who received HBV (Engerix B pediatric) (batch number LM992, expiry date 13th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th February 2023, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 20th February 2023, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product, underdose and expired vaccine used. On an unknown date, the outcome of the adult use of a child product, underdose and expired vaccine used were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023031106   Additional Information: GSK Receipt Date: 24-FEB-2023 Reporter's Comments: The information for the adverse event was collected and reporter accepted to be escalated. The vaccine administration facility was the same as primary reporter reported. The reporter consented to follow up. Additional Supportive Information: The pharmacist reported that the patient inadvertently received a pediatric dose of Engerix-B that had also expired, which lead to underdose, adult use of a child product and expired vaccine used. This case was found as duplicate of case US2023031106. All the information from the case US2023031106 was merged into this case. The case US2023031106 was deleted and this case stand as case of record for this patient; Sender's Comments:  US-GSK-US2023031106:same reporter - FU1 - deleted
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Myalgia, Oropharyngeal pain
Clinical narrative: Sore throat; Muscle ache; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and MYALGIA (Muscle ache) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high (treated), Premature ventricular contractions (treated) and Allergy. Concomitant products included VERAPAMIL from 10-Sep-2020 to an unknown date, ATORVASTATIN from 10-Sep-2020 to an unknown date and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) from 09-Jan-2023 to an unknown date for an unknown indication.    On 12-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Feb-2023 at 7:00 AM, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and MYALGIA (Muscle ache). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-Feb-2023 to 14-Feb-2023 for COVID-19 treatment, at an unspecified dose and frequency. On 12-Feb-2023, OROPHARYNGEAL PAIN (Sore throat) and MYALGIA (Muscle ache) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient's race was reported. Patient took first dose of Moderna with batch number 012L20A on 12-Jan-2021 and location of injection was left arm. Patient took second dose of Moderna with batch number 010M20A on 09-Feb-2021 and location of injection was left arm. Patient took third dose of Moderna with batch number 035C21A on 28-OCT-2021 and location of injection was left arm. Patient took fourth dose of Moderna with batch number 033C21-2A on 20-MAR-2022 and location of injection was left arm.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Small fibre neuropathy
Clinical narrative: Small-Fiber Neuropathy; This literature-non-study case was reported in a literature article and describes the occurrence of SMALL FIBRE NEUROPATHY (Small-Fiber Neuropathy) in a 43-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SMALL FIBRE NEUROPATHY (Small-Fiber Neuropathy) (seriousness criterion medically significant). At the time of the report, SMALL FIBRE NEUROPATHY (Small-Fiber Neuropathy) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Patient had the small-fiber neuropathy after second dose of vaccination with mRNA-1273 SARS-CoV-2 vaccine.  Company comment: This is a literature non-study case concerning a 43-year-old, female patient with no reported medical history, who experienced the unexpected, serious (due to medically significant) event of small fiber neuropathy. The event occurred after the second dose of mRNA-1273 received on an unknown date. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme increased
Clinical narrative: liver enzymes being elevated; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME INCREASED (liver enzymes being elevated) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Rheumatoid arthritis (Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement), Penicillin allergy, Sulfonamide allergy (Allergy to Sulfa) and Allergy to NSAIDs (Allergy to Aspirin). Concomitant products included OMEPRAZOLE, PARACETAMOL (TYLENOL), METHYLPREDNISOLONE, COLECALCIFEROL, MENAQUINONE (D3 +K2) and CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (liver enzymes being elevated). At the time of the report, HEPATIC ENZYME INCREASED (liver enzymes being elevated) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: elevated.         It was reported that the patient would not take another booster of Moderna, due to uncertainty about liver enzymes being elevated caused by taking the Moderna COVID vaccine.  No treatment information was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Immune-mediated myositis
Clinical narrative: Refractory seronegative immune-mediated necrotizing myopathy; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE-MEDIATED MYOSITIS (Refractory seronegative immune-mediated necrotizing myopathy) in a 71-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE-MEDIATED MYOSITIS (Refractory seronegative immune-mediated necrotizing myopathy) (seriousness criterion medically significant). At the time of the report, IMMUNE-MEDIATED MYOSITIS (Refractory seronegative immune-mediated necrotizing myopathy) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported. Company comment: This is a literature non-study case concerning a 71-year-old female patient, with no medical history reported, who received the second dose of the mRNA-1273 vaccine and developed the unexpected and serious (medically significant) event of IMMUNE-MEDIATED MYOSITIS (reported as necrotizing myopathy). The onset date and the vaccination date were not reported; hence, latency could not be properly assessed. No details of previous doses were provided. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Received Moderna Dose on 4-OCT-2022 and 25-OCT-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Moderna Dose on 4-OCT-2022 and 25-OCT-2022) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Shellfish allergy.   On 04-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Oct-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Moderna Dose on 4-OCT-2022 and 25-OCT-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Moderna Dose on 4-OCT-2022 and 25-OCT-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Moderna Dose on 4-OCT-2022 and 25-OCT-2022).    No concomitant medication was reported.  The patient received first and second dose of Moderna vaccine (monovalent variant) on 24-MAR-2021 and 21-APR-2021 respectively.  No treatment medication was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients).    Concomitant medications were not reported.  This case is for 5th patient out of 17 patients reported. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713254 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Live Follow up received contains Patient details added. On 28-Feb-2023: Follow-up received contains no new information On 28-Feb-2023: Follow-up received contains no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713254:Patient 1 out 17 patients
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: he had Moderna and Pfizer vaccines and has learned information since that could jeopardize his and his wifes health.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (he had Moderna and Pfizer vaccines and has learned information since that could jeopardize his and his wifes health.) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (he had Moderna and Pfizer vaccines and has learned information since that could jeopardize his and his wifes health.). At the time of the report, IMMUNISATION REACTION (he had Moderna and Pfizer vaccines and has learned information since that could jeopardize his and his wifes health.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.     The patient received the initial booster dose of Moderna COVID-19 vaccine, Bivalent.  No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Intercepted medication error, Liquid product physical issue, No adverse event
Clinical narrative: Intercepted medication error; No adverse event; HCP just received shipment of Moderna COVID19 vaccine monovalent which doesn't look as translucent and a little more cloudy than the bivalent almost white looking. Caller mentioned that it doesn't expire until 03/31/23, it looks kind of weird; This spontaneous case was reported by a pharmacist and describes the occurrence of LIQUID PRODUCT PHYSICAL ISSUE (HCP just received shipment of Moderna COVID19 vaccine monovalent which doesn't look as translucent and a little more cloudy than the bivalent almost white looking. Caller mentioned that it doesn't expire until 03/31/23, it looks kind of weird), INTERCEPTED MEDICATION ERROR (Intercepted medication error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042C22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2023, the patient experienced LIQUID PRODUCT PHYSICAL ISSUE (HCP just received shipment of Moderna COVID19 vaccine monovalent which doesn't look as translucent and a little more cloudy than the bivalent almost white looking. Caller mentioned that it doesn't expire until 03/31/23, it looks kind of weird). On an unknown date, the patient experienced INTERCEPTED MEDICATION ERROR (Intercepted medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, LIQUID PRODUCT PHYSICAL ISSUE (HCP just received shipment of Moderna COVID19 vaccine monovalent which doesn't look as translucent and a little more cloudy than the bivalent almost white looking. Caller mentioned that it doesn't expire until 03/31/23, it looks kind of weird), INTERCEPTED MEDICATION ERROR (Intercepted medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for LIQUID PRODUCT PHYSICAL ISSUE (HCP just received shipment of Moderna COVID19 vaccine monovalent which doesn't look as translucent and a little more cloudy than the bivalent almost white looking. Caller mentioned that it doesn't expire until 03/31/23, it looks kind of weird) and INTERCEPTED MEDICATION ERROR (Intercepted medication error).    No concomitant medications was provided. It was repoted that, HCP stated that she first noticed that the product looked separated but after a while it didn't anymore. Dosage text was reported as unknown for suspect. No treatment medications was provided.   Reporter did not allow further contact
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered after manufacturer date of expiry; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 27-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 27-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry).    No concomitant medications were reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The vaccine had been frozen with no known temperature excursion before being thawed today for administration.   The vial was initially stored in the refrigerator on 27-Feb-2023 .  The vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 1.08
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; A Moderna bivalent 6 year and up vaccine was given to a 13 month old by mistake/This was suppose to be their first monovalent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (A Moderna bivalent 6 year and up vaccine was given to a 13 month old by mistake/This was suppose to be their first monovalent dose) and NO ADVERSE EVENT (No adverse event) in a 13-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     The patient was not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 28-Feb-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (A Moderna bivalent 6 year and up vaccine was given to a 13 month old by mistake/This was suppose to be their first monovalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A Moderna bivalent 6 year and up vaccine was given to a 13 month old by mistake/This was suppose to be their first monovalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A Moderna bivalent 6 year and up vaccine was given to a 13 month old by mistake/This was suppose to be their first monovalent dose).    Concomitant medication was not provided.   Treatment information was not provided.