chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: The expired Jynneos vaccine was administered to the patient, intradermally; The expired Jynneos vaccine was administered to the patient, intradermally; Case reference number US-BN-2023-000055 is a spontaneous case report initially received from other health care professional via Communications (reference number: USBAV23-0056) on 11-Jan-2023 and concerns an adult patient of unknown gender.  The patient's medical history and concomitant medication details were not provided.  On 27-Dec-2022, the patient was vaccinated with the first dose of expired Jynneos vaccine (batch number: FDP00014; expiration date: 19-Dec-2022), at an unknown dose or site of administration, intradermally, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection').    At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 11-Jan-2023 included the local BN case ID.  This case is linked to cases US-BN-2023-000050, US-BN-2023-000051, US-BN-2023-000052, US-BN-2023-000053 and US-BN-2023-000054 (same reporter).; Reporter's Comments: An adult patient was vaccinated with the first dose of expired Jynneos vaccine intradermally. Intradermal injection and expired product administered are listed by convention. No associated adverse events have been reported. Intradermal injection and expired product administered have been considered not related to the suspect product. The case is non-serious.; Sender's Comments: An adult patient was vaccinated with the first dose of expired Jynneos vaccine intradermally. Intradermal injection and expired product administered are listed by convention. No associated adverse events have been reported. Intradermal injection and expired product administered have been considered not related to the suspect product. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, Product administration error
Clinical narrative: An expired Jynneos vaccine was accidently administered to a patient; An expired Jynneos vaccine was accidently administered to a patient; Case reference number US-BN-2023-000104 is a spontaneous case report initially received from a health care professional via Communications (reference number: USBAV23-0124) on 20-Jan-2023 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On 13-Jan-2023, the patient was vaccinated with the first dose of expired Jynneos vaccine (batch number: FDP00014; refrigerator expiration date: 05-Jan-2023), at a dose of 0.5 mL, subcutaneously, at an unknown site of administration, for unknown indication (explicitly coded as 'expired vaccine used' and 'product administration error'). As reported, the patent received vaccine 64 days after the vaccine was moved from freezer to refrigerator and eight days after the refrigerator expiration date.   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 20-Jan-2023 included the local case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with the first dose of expired Jynneos vaccine on 13-Jan-2023 and expiration date was 05-Jan-2023, for unknown indication, which is considered as expired product administered and product administration error. No associated adverse events were reported. Expired product administered and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired product administered and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the first dose of expired Jynneos vaccine on 13-Jan-2023 and expiration date was 05-Jan-2023, for unknown indication, which is considered as expired product administered and product administration error. No associated adverse events were reported. Expired product administered and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired product administered and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: First Jynneos dose on 30-Nov-2022, missed the second dose; Case reference number US-BN-2023-000132 is a spontaneous case report initially received from other health care professional via Communications (reference number: USBAV23-0138) on 24-Jan-2023 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 30-Nov-2022, the patient was vaccinated with the first dose of Jynneos vaccine (batch number: unknown), at an unknown dose, route or site of administration, for indication reported as monkeypox.  As reported, the patient missed the second dose (explicitly coded as 'incomplete course of vaccination').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine.  Additional information received from Bavarian Nordic on 24-Jan-2023 included the local BN case ID.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos vaccine, at an unknown dose, route or site of administration, for indication reported as monkeypox. Reportedly, the patient missed the second dose, which is considered as incomplete course of vaccination. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos vaccine, at an unknown dose, route or site of administration, for indication reported as monkeypox. Reportedly, the patient missed the second dose, which is considered as incomplete course of vaccination. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Gave a monkeypox vaccine that was expired; Case reference number US-BN-2023-000188 is a spontaneous case report initially received from a nurse via Communications (reference number: USBAV23-0200) on 03-Feb-2023 and concerns an elderly male patient.  The patient's medical history and concomitant medication details were not provided.  On 30-Jan-2023, the patient was vaccinated with the first dose of expired Jynneos vaccine (batch number: FDP00014; expiration date: 27-Jan-2023), at a dose of 0.5 mL, administered subcutaneously, at an unknown site of administration, for monkeypox prophylaxis (explicitly coded as 'expired vaccine used').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 03-Feb-2023 included the local case ID.; Reporter's Comments: An elderly male patient was vaccinated with the first dose of expired Jynneos vaccine (expiration date: 27-Jan-2023), at a dose of 0.5 mL, administered subcutaneously, at an unknown site of administration, for monkeypox prophylaxis, which is considered as expired vaccine used. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired product administered has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An elderly male patient was vaccinated with the first dose of expired Jynneos vaccine (expiration date: 27-Jan-2023), at a dose of 0.5 mL, administered subcutaneously, at an unknown site of administration, for monkeypox prophylaxis, which is considered as expired vaccine used. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired product administered has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Got very sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 10-Feb-2023 Reporter's Comment: This case was reported by a patient's sister via interactive digital media. The reporter wants to have it (vaccine) but she was scared because her sister (patient) had it and got very sick from the side effects. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Fine motor skill dysfunction, Muscular weakness
Clinical narrative: Decrease in hand grasp, change in hand grip and ability to squeeze, decrease in right hand fine motor skills; Arm weakness increased over 72 hours; This case was reported by a other health professional via sales rep and described the occurrence of fine motor skill dysfunction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included nerve damage (In 2020 right-sided or right upper extremity nerve damage).   On an unknown date, the patient received Shingrix. On an unknown date, 4 hrs after receiving Shingrix, the patient experienced fine motor skill dysfunction and weakness of arms. On an unknown date, the outcome of the fine motor skill dysfunction was not recovered/not resolved and the outcome of the weakness of arms was unknown.   It was unknown if the reporter considered the fine motor skill dysfunction and weakness of arms to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-FEB-2023 Reporter's Comment: The physician assistant reported that he recently gave a Shingrix vaccine to the patient into left deltoid. The patient stated that approximately 4 hours after injection her right arm she noted a decrease in her hand grasp.  The patient stated that the right arm weakness increased over 72 hours where she noted a change in her hand grip and her ability to squeeze. At the time of reporting, the patient had a decrease in right hand fine motor skills. The patient was questioning whether this was related to her an injection she received on Friday while in office. The reporter was not able to find this was some sort of a side effect but reporter reaching out to GlaxoSmithKline to see if this was a possibility and also ruling out that this was some form of a stroke.  The reporter had placed her in occupational therapy, but reporter did not feel this was a reaction unless GlaxoSmithKline tell reporter some other information that reporter need to know. The reporter agreed to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in March 2022, 2nd dose not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2022).   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: 10-Feb-2023 Reporter's Comments: The consumer did not remember the exact date of her 1st dose of Shingrix or where the injection was administered.  The consumer reported that she did not receive her 2nd dose of Shingrix yet and it has been almost a year since the first dose.  The reporter consented 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. The reporting system provided corresponded to the first dose of Shingrix as the second dose was not administered yet.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Hvrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 71-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 8th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 8th 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: 10-FEB-2023 Reporter's Comments: The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.  Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Patient received dose from  refrigerator with an issue; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 62-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number B4C44, expiry date 10th November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th February 2023, the patient received Boostrix (intramuscular) and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, 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: 10-FEB-2023 Reporter's Comment: The reporter consented to follow up. Additional supportive information: The patient received a Boostrixin left arm, taken from medical refrigerators and discovered that the refrigerators had an issue, which led to incorrect storage of drug.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 6 months-old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th February 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 10th February 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 10-FEB-2023 Reporter's Comments: The reporter consented to follow-up. Additional Supportive Information: The patient was administered Kinrix vaccine at inappropriate age, which led inappropriate age at vaccine administration.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received HAV (Havrix 720) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th February 2023, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 10th February 2023, unknown after receiving Havrix 720 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: 10-FEB-2023 Reporter's Comment: The reporter consent to follow up via postal. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Swelling
Clinical narrative: Swelling below elbow; Pockets of bubbling; This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a elderly male patient who received Herpes zoster (Shingrix) (batch number xg7rf, expiry date 21st May 2024) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced local swelling and blister. On an unknown date, the outcome of the local swelling and blister were unknown.   It was unknown if the reporter considered the local swelling and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-FEB-2023 Reporter's Comment: The reporter reported that the patient woke up with the pockets of bubbling and swelling below elbow. The reporter did consent to follow up.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 18Nov2022, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose (1 ml) in unknown deltoid via intramuscular route (batch number: N4GA4 and expiry date 2nd January 2023) on 18th November 2022).   On an unknown date, the patient did not receive the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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:10-Feb-2023. Reporter's Comment: The vaccine administration facility (for 1st dose) was the same as primary reporter. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Engerix B vaccine, which led to incomplete course of vaccination. The VAERS details were reported for 1st dose.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: presented shingles in 3 different occasions/ suspected vaccination failure; shingles in 3 ocassions; This case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 13-FEB-2023 and 15-FEB-2023 Reporter's Comments: The patient completed Shingrix series, then presented shingles in 3 different occasions. The nurse inquired about the possibility of giving a third dose of Shingrix to a patient with a complete series of Shingrix vaccination. The nurse gave information regarding the patient but did not have information about the vaccine. The nurse reported that third dose was not yet administered. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Not specified), and other pre-existing medical conditions included: Patient was not pregnant at the time of reporting. Patient had no relevant medical history and concurrent conditions. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808609, expiry: unknown) dose was not reported, 1 total, administered on 19-MAR-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 31 years old. Concomitant medications included fluoxetine, and norethisterone.  It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received non-company suspect vaccine included: Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin, and route of admin were not reported, batch number: FF2590, expiry: unknown) dose was not reported, administered on 24-OCT-2021 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination with Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2). The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of admin, and route of admin were not reported, batch number: AS7145B, expiry: unknown) dose was not reported, administered on 10-SEP-2022 15:15 to left arm for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 3).  On an unspecified date, the patient experienced covid-19 infection (suspected covid-19 infection) (dose number in series 3) for which patient received non-company suspect drug included: Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose and frequency were not reported from 01-FEB-2023 to 06-FEB-2023 for covid-19 treatment. On 10-FEB-2023, at 18:30, the patient experienced rebound covid-19. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, and elasomeran was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore injection site arms; felt slightly fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued). At the time of the report, VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.   It was reported that, the patient received Moderna vaccination and had no side effects to the Moderna vaccine except sore injection site arms and felt slightly fatigued. "Just like with a Flu shot". Arm was sore for a day.   No treatment details were reported.  This case contains information for the 2nd of 05 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-710705 Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710705:1 out of 5 siblings
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore injection site arms; felt slightly fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued). At the time of the report, VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued) had resolved.            No concomitant medications were reported.   It was reported that, the patient received Moderna vaccination and had no side effects to the Moderna vaccine except sore injection site arms and felt slightly fatigued. "Just like with a Flu shot". Arm was sore for a day.   No treatment details were reported.  This case contains information for the 4th of 05 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-710705.   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710705:1 out of 5 siblings
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neurological symptom, Post-acute COVID-19 syndrome
Clinical narrative: she still has long COVID; she has different symptoms than her husband; neurological; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (she still has long COVID) and NEUROLOGICAL SYMPTOM (she has different symptoms than her husband; neurological) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included COVID-19 (Had COVID in 2020 prior to the COVID vaccines; was hospitalized for COVID virus.) since 2020.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (she still has long COVID) and NEUROLOGICAL SYMPTOM (she has different symptoms than her husband; neurological). At the time of the report, POST-ACUTE COVID-19 SYNDROME (she still has long COVID) had not resolved and NEUROLOGICAL SYMPTOM (she has different symptoms than her husband; neurological) outcome was unknown.            Concomitant medication of the patient was not reported.  The patient reported that she was a home health aide and a dental assistant in the past. The patient had COVID prior to receiving vaccines; then had COVID vaccines but developed long COVID. She also mentioned that her husband got COVID first and then she got COVID.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-710816.   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2023: As per follow-up document, event description was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710816:Husband case
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Myocardial infarction, Vaccination site reaction
Clinical narrative: Heart Attack / trauma; mysterious ring around the site that has grown larger and larger; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack / trauma) in a 50-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. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cerebral palsy.    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. In 2021, the patient experienced VACCINATION SITE REACTION (mysterious ring around the site that has grown larger and larger). On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart Attack / trauma) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart Attack / trauma) and VACCINATION SITE REACTION (mysterious ring around the site that has grown larger and larger) outcome was unknown.            No concomitant information was reported. Patient with cerebral palsy received COVID-19 vaccine. Patient had a mysterious ring around the site that had grown larger and larger and patient ignored it until October 31. Patient had a heart attack and had stints placed in heart. Patient blame Moderna and Moderna's vaccine. Patient can take action against Moderna for the trauma as patient have been through.  Company comment: This spontaneous case concerns a 50-year-old female patient, with no relevant medical history reported, who experienced the unexpected serious (Medically significant) AESI of Myocardial infarction that occurred in the context of mRNA-1273 Bivalent BA.4/BA.5 vaccine in COVID-19 vaccination series. Latency could not be assessed as the date of vaccination and onset date of event was not available. Patient experienced heart attack and had to have stents placed. No further information on risk factors, relevant medical history, clinical course, investigations and details of treatment received were provided. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5  vaccine is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose 1 on 01-DEC-2020  and dose 2 on 21-MAR-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 01-DEC-2020  and dose 2 on 21-MAR-2021) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma, Cardiovascular disease, unspecified, Latex allergy, Drug allergy (morphine sulfate allergy), Drug allergy (compazine allergy) and Drug allergy (beta blockers allergy).   On 01-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 01-DEC-2020  and dose 2 on 21-MAR-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 21-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 01-DEC-2020  and dose 2 on 21-MAR-2021) outcome was unknown. At the time of the report, 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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 01-DEC-2020  and dose 2 on 21-MAR-2021).    Patient took 5th dose of Moderna bivalent vaccine on 12-Oct-2022 in the left arm.  Patient experienced rebound of COVID-19 after Paxlovid on 13-Feb-2023, symptoms included fever, cough, congestion, headaches.   The patient was also taking Theophylline, Gabapentin, Aspirin, Nexium, Ibuprofen, Zyrtec and Metoprolol.  Treatment information was not provided.   Device date was reported as 15 Feb 2023.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022; product storage error; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-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 21-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022), PRODUCT STORAGE ERROR (product storage error) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022) and PRODUCT STORAGE ERROR (product storage error).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications were reported.  It was reported that the excursion took place on 15-Dec-2022 through 27-Dec-2022. Maximum temperature reached was 46.5 , cumulative duration of excursion was 19.3 hours.  HCP reported that they gave 16 doses of the vaccines between the 15-Dec-2022 and 21-Dec-2022 and then following that the vaccines were marked to not use. There were no reports of side effects had been reported to them. No treatment details were reported.
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Peripheral coldness, Vaccination site pain
Clinical narrative: He also had Chills; He started having random cold finger tips and toes; He had pain on the injection site; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL COLDNESS (He started having random cold finger tips and toes), CHILLS (He also had Chills) and VACCINATION SITE PAIN (He had pain on the injection site) in a 30-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Hypothyroidism (About 5 years ago patient was slightly Hypothyroid).    On 09-Jan-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced VACCINATION SITE PAIN (He had pain on the injection site). On 10-Jan-2023, the patient experienced PERIPHERAL COLDNESS (He started having random cold finger tips and toes). On 10-Jan-2023 at 4:00 AM, the patient experienced CHILLS (He also had Chills). On 10-Jan-2023 at 6:00 AM, CHILLS (He also had Chills) had resolved. At the time of the report, PERIPHERAL COLDNESS (He started having random cold finger tips and toes) had not resolved and VACCINATION SITE PAIN (He had pain on the injection site) 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.   About 5 years ago doctor told patient that he was slightly Hypothyroid. He never prescribed anything for it. It did not show up on the subsequent lab works for 5 years. No concomitant medications were provided. The patient received first primary monovalent dose on 14-Apr-2021 with lot number 043B21A. Second primary monovalent dose on 12-May-2021 with Lot number 035C21A. First monovalent booster dose on 07-Jan-2022 with lot number 070H21A. Patient did not had any side effects with all three doses. On 10-Jan-2023 patient started having random cold finger tips and toes. The issue went away on 11-Jan-2023. But it came back on Feb-2023. He states that when his fingertips were cold, he measured 12F difference between the cold tip of his fingers and the base of the fingers. When fingertips were cold, there was no discoloration. The finger looks normal. In addition, he had pain on the injection site Left arm on 9-Jan-2023 and 10-Jan-2023, then it went away. After the Bivalent booster, his doctor ordered lab works on Feb-2023. Everything was normal except that he was hypothyroid. He had an appointment to visit the doctor again this week to discuss that. He was concerned about the cold fingertips and toes.  No treatment medication was provided.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore injection site arms; felt slightly fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 001B21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu Shot and Flu Shot. Past adverse reactions to the above products included Fatigue with Flu Shot; and Vaccination site pain with Flu Shot.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued). At the time of the report, VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   The patient reports that she and her siblings each received 5 Moderna vaccinations and that they love Moderna The patient then goes on to say that she and her siblings had no side effects to the Moderna vaccine except they had sore injection site arms and felt slightly fatigued. Just like with a Flu Shot. Arm was sore for a day.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-710705 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710705:1 out of 5 siblings
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Fatigue, Vaccination site pain
Clinical narrative: sore injection site arms; felt slightly fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 001B21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu Shot and Flu Shot. Past adverse reactions to the above products included Fatigue with Flu Shot; and Vaccination site pain with Flu Shot.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued). At the time of the report, VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   The patient reports that she and her siblings each received 5 Moderna vaccinations and that they love Moderna The patient then goes on to say that she and her siblings had no side effects to the Moderna vaccine except they had sore injection site arms and felt slightly fatigued. Just like with a Flu Shot. Arm was sore for a day.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-710705 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710705:1 out of 5 siblings
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore injection site arms; felt slightly fatigued; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 001B21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu Vaccine and Flu Vaccine. Past adverse reactions to the above products included Fatigue with Flu Vaccine; and Vaccination site pain with Flu Vaccine.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and fifth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued). At the time of the report, VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) and mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   The patient reports that she and her siblings each received 5 Moderna vaccinations and that they love Moderna The patient then goes on to say that she and her siblings had no side effects to the Moderna vaccine except they had sore injection site arms and felt slightly fatigued. Just like with a Flu Shot. Arm was sore for a day.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-710705 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710705:1 out of 5 siblings