chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose of Shingrix in 2019 but never received the 2nd dose; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in 2019).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received first dose of Shingrix in 2019 but never received the 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2023 The reporter stated patient received his first dose of shingrix in 2019 but never received the second dose which led to incomplete course of vaccination. Th reporter wants to know what advice patient should be given and how long patient can wait to receive the second dose. The vaccine administration facility was the same as primary reporter for the 1st dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: need to restart series or just give 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: need to restart series or just give 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 4-Oct-2023 The pharmacist called and they wanted to know how to proceed with series. The reporter asked that did they need to restart series or just give 2nd dose. The reporter had no details regarding patient or product. The reporter consented to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: female patient was accidentally given 2 doses of Arexvy on 04Oct2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7942H, expiry date 02-MAR-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 04-OCT-2023, the patient received Arexvy. On 04-OCT-2023, an unknown time after receiving Arexvy, the patient experienced overdose (Verbatim: female patient was accidentally given 2 doses of Arexvy on 04Oct2023).  The outcome of the overdose was unknown.   Additional Information: GSK receipt date: 4-Oct-2023 The pharmacist reported no symptoms. The reporter declined to provide patient's date of birth. The reporter consented to follow-up via email. The patient was accidentally given 2 doses of Arexvy on the day of reporting, which led to overdose.
Age: 58.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: dose of Twinrix expired on 9/22/2023 and was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 58-year-old male patient who received HAB (Twinrix adult) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 04-OCT-2023, the patient received Twinrix adult. On 04-OCT-2023, an unknown time after receiving Twinrix adult, the patient experienced expired vaccine used (Verbatim: dose of Twinrix expired on 9/22/2023 and was administered to a patient).  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: 4-Oct-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via mail. The patient received an expired dose of Twinrx, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrix was administered after being exposed to -21.7 degree C; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Shingrix was administered after being exposed to -21.7 degree C).The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 04-OCT-2023 The reporter was clinical office manager. The reporter called to report that Shingrix was administered after being exposed to -21.7 degree C, which led to incorrect storage of vaccine. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 21 October 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Not received 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-OCT-2023 The pharmacist stated that a patient received the first dose of Shingrix. It did not appear that the patient had yet received the 2nd dose as the Healthcare professional was looking for recommendations on how to proceed. The reporter consented to follow up via postal. The vaccine administration facility is the same as primary reporter for 1st dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: she got the flu after a flu shot/ suspected vaccination failure; flu after a flu shot; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 77-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced vaccination failure (Verbatim: she got the flu after a flu shot/ suspected vaccination failure) (serious criteria GSK medically significant) and influenza (Verbatim: husband got the flu after a flu shot).  The outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine.     It was unknown if the company considered the vaccination failure and influenza to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 05-OCT-2023 The reporter stated that she got the flu after a flu shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter did not consent to follow-up. The case is linked with US2023137025, by same reporter.; Sender's Comments:  US-GSK-US2023137025:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Illness, Mobility decreased, Nausea, Pyrexia
Clinical narrative: she had fever; chills; nausea; felt sick for 24 hours, had to stay in bed; felt sick for 24 hours, had to stay in bed; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: felt sick for 24 hours, had to stay in bed), fever (Verbatim: she had fever), chills (Verbatim: chills), nausea (Verbatim: nausea) and bedridden (Verbatim: felt sick for 24 hours, had to stay in bed).The outcome of the sickness was resolved (duration 24 hrs) and the outcome of the fever, chills, nausea and bedridden were resolved.   It was unknown if the reporter considered the sickness, fever, chills, nausea and bedridden to be related to Shingrix.  It was unknown if the company considered the sickness, fever, chills, nausea and bedridden to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-OCT-2023 The reporter stated that she received Shingrix in early April 2023.  She stated that she was sick for 24 hours after and had to stay in bed.  She also mentioned that she had fever, chills and nausea that only lasted a few days.  She would be getting dose 2 before the 6 month window ended. The reporter did not consent to follow-up.
Age: 30.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: patient was inadvertently administered an expired Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 30-year-old female patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 05-OCT-2023, the patient received Twinrix. On 05-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: patient was inadvertently administered an expired Twinrix).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: 05-OCT-2023 The reporter called to inquire if this dose was valid. The reporter reported that a patient was inadvertently administered an expired Twinrix, which led to expired vaccine used. The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: INJURED; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced injured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injured was not reported. This report was non-serious. This case, from the same reporter is linked to 20231022451.
Sex: F
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: she got some side effects; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (she got some side effects) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (she got some side effects). At the time of the report, IMMUNISATION REACTION (she got some side effects) outcome was unknown.            No concomitant drug was reported.  Patient had no reaction on the previous vaccines she received but after getting Spikevax, she got some side effects.  No treatment drug was reported.
Sex: M
Vaccine: UNK
Symptoms: Blindness unilateral, Eye disorder, Herpes zoster
Clinical narrative: Chicken Pox virus reactivated by Moderna shot a developed Shingles; Chicken Pox virus reactivated by Moderna shot a developed Shingles; This spontaneous case was reported by a non-health professional and describes the occurrence of HERPES ZOSTER (Chicken Pox virus reactivated by Moderna shot a developed Shingles) and VARICELLA (Chicken Pox virus reactivated by Moderna shot a developed Shingles) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Chicken Pox virus reactivated by Moderna shot a developed Shingles) and VARICELLA (Chicken Pox virus reactivated by Moderna shot a developed Shingles). At the time of the report, HERPES ZOSTER (Chicken Pox virus reactivated by Moderna shot a developed Shingles) and VARICELLA (Chicken Pox virus reactivated by Moderna shot a developed Shingles) outcome was unknown.            Concomitant medication information was not reported.  The patient experienced an eye stroke making him blind in the left eye and developed micro emboli from the Pfizer shot.  Treatment information was not reported.  The patient's next door neighbor suffered Bell's palsy.   This case was linked to US-MODERNATX, INC.-MOD-2023-745092, US-MODERNATX, INC.-MOD-2023-745094 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745092:Same Report US-MODERNATX, INC.-MOD-2023-745094:Same Report
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 53-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) 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 medication information was provided.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient stated that in total 5 of them caught COVID-19 after cruise.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742650, US-MODERNATX, INC.-MOD-2023-742698.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2023: Upon on internal review 12-Oct-2023, significant correction was done to retain and process this case in the database as previously this case was incorrectly deleted. Hence deletion action item closed for this case and now case processed as valid case.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742650:Same reporter, Different Patient US-MODERNATX, INC.-MOD-2023-742698:Same reporter, Different Patient
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Deafness unilateral
Clinical narrative: hearing loss in the left ear; diagnosed with covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEAFNESS UNILATERAL (hearing loss in the left ear) in an 83-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 28-Jun-2023, the patient experienced COVID-19 (diagnosed with covid). In July 2023, the patient experienced DEAFNESS UNILATERAL (hearing loss in the left ear) (seriousness criterion medically significant). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. In August 2023, DEAFNESS UNILATERAL (hearing loss in the left ear) had resolved. At the time of the report, COVID-19 (diagnosed with covid) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had hearing loss in the left ear 2 weeks after covid diagnosis but came back 3 weeks later. Company comment This spontaneous case concerns an 83-year-old male patient with no medical history reported, who experienced the unexpected, serious (medically significant), event of deafness unilateral and the non-serious event of COVID-19, in the context of a dose of SPIKEVAX NOS. The vaccination date was not provided, thus, exact latency between vaccination and onset of the events could not be assessed. It was reported that the patient had hearing loss in the left ear 2 weeks after COVID-19 diagnosis, but came back 3 weeks later. He was treated with Paxlovid. No further clinical information was provided for review. The events deafness unilateral and COVID-19 could be associated with each other. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-742650, US-MODERNATX, INC.-MOD-2023-742692 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742650: US-MODERNATX, INC.-MOD-2023-742692:Same reporter, Different Patient
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Pain, Panic attack, Pyrexia
Clinical narrative: body ache; flu like symptoms; panic attack; felt sick; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), INFLUENZA LIKE ILLNESS (flu like symptoms), PANIC ATTACK (panic attack), ILLNESS (felt sick) and PYREXIA (fever) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In March 2021, the patient experienced PAIN (body ache), INFLUENZA LIKE ILLNESS (flu like symptoms), PANIC ATTACK (panic attack), ILLNESS (felt sick) and PYREXIA (fever). In March 2021, PAIN (body ache), INFLUENZA LIKE ILLNESS (flu like symptoms) and PYREXIA (fever) had resolved. At the time of the report, PANIC ATTACK (panic attack) and ILLNESS (felt sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Sex: F
Vaccine: UNK
Symptoms: Post concussion syndrome
Clinical narrative: post concussion syndrome; This spontaneous case was reported by a consumer and describes the occurrence of POST CONCUSSION SYNDROME (post concussion syndrome) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In June 2023, the patient experienced POST CONCUSSION SYNDROME (post concussion syndrome). At the time of the report, POST CONCUSSION SYNDROME (post concussion syndrome) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  The patient has received Moderna Covid-19 vaccines in the past before she suffered a concussion in June-2023 as the result of an accident with post-concussion syndrome that continues.  Treatment medication use information was not provided by reporter.
Age: 75.0
Sex: M
Vaccine: UNK
Symptoms: COVID-19, Fatigue, Headache, No reaction on previous exposure to drug, Pain
Clinical narrative: The patient has achiness; fatigue; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (The patient has achiness), FATIGUE (fatigue) and HEADACHE (headache) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. A43834B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (The patient has achiness), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, PAIN (The patient has achiness), FATIGUE (fatigue) and HEADACHE (headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reportedly, the patient received his first Moderna COVID-19 vaccine on 15-Jan-2021 with lot number 026L20A. Patient received in his left arm. The patient had no adverse reactions or side effects to 1st dose.  The patient received his second Moderna COVID-19 vaccine on 02-Feb-2021 with lot number 029K20A. Patient received in his left arm. The patient had no adverse reactions or side effects to 2nd dose.  The patient received his first booster dose of Moderna COVID-19 vaccine on 24-Aug-2021 with lot number 002F21A. Patient received in his left arm. The patient had no adverse reactions or side effects to first booster dose.  The patient received his second booster dose of Moderna COVID-19 vaccine on 03-Mar-2022 with lot number 045L21A. Patient received in his left arm. The patient had no adverse reactions or side effects to second booster dose.  The patient received his third booster dose of Moderna COVID-19 vaccine on 07-Sep-2022 with lot number AS7144B. Patient received in his left arm. The patient had no adverse reactions or side effects to third booster dose.  In Feb-2023 the patient had a very mild case of COVID-19, the patient tested positive and had the sniffles for one day.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-744675 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744675:Case for Bivalent dose
Age: 75.0
Sex: M
Vaccine: UNK
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: The patient has achiness; fatigue; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (The patient has achiness), FATIGUE (fatigue) and HEADACHE (headache) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. A43834B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (The patient has achiness), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, PAIN (The patient has achiness), FATIGUE (fatigue) and HEADACHE (headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reportedly, the patient received his first Moderna COVID-19 vaccine on 15-Jan-2021 with lot number 026L20A. Patient received in his left arm. The patient had no adverse reactions or side effects to 1st dose.  The patient received his second Moderna COVID-19 vaccine on 02-Feb-2021 with lot number 029K20A. Patient received in his left arm. The patient had no adverse reactions or side effects to 2nd dose.  The patient received his first booster dose of Moderna COVID-19 vaccine on 24-Aug-2021 with lot number 002F21A. Patient received in his left arm. The patient had no adverse reactions or side effects to first booster dose.  The patient received his second booster dose of Moderna COVID-19 vaccine on 03-Mar-2022 with lot number 045L21A. Patient received in his left arm. The patient had no adverse reactions or side effects to second booster dose.  The patient received his third booster dose of Moderna COVID-19 vaccine on 07-Sep-2022 with lot number AS7144B. Patient received in his left arm. The patient had no adverse reactions or side effects to third booster dose.  In Feb-2023 the patient had a very mild case of COVID-19, the patient tested positive and had the sniffles for one day.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-744675 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744675:Case for Bivalent dose
Sex: U
Vaccine: UNK
Symptoms: Chest pain, Heart rate increased, Influenza like illness
Clinical narrative: pain on the left side of my chest; feel like I have the flu; fast heart rate; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (pain on the left side of my chest), INFLUENZA LIKE ILLNESS (feel like I have the flu) and HEART RATE INCREASED (fast heart rate) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 07-Oct-2023, the patient experienced CHEST PAIN (pain on the left side of my chest), INFLUENZA LIKE ILLNESS (feel like I have the flu) and HEART RATE INCREASED (fast heart rate). At the time of the report, CHEST PAIN (pain on the left side of my chest), INFLUENZA LIKE ILLNESS (feel like I have the flu) and HEART RATE INCREASED (fast heart rate) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: At rest 60-99.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.  Patient got vaccinated with latest vaccine. In the morning patient woke up with pain on the left side of chest and had fast heart rate. The pain was like a 4 to 5 and heart rate at rest was 60 to 99.   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2023: Live follow-up received with NNI
Sex: U
Vaccine: UNK
Symptoms: Adverse drug reaction, COVID-19, Feeling abnormal, Headache, Injection site pain
Clinical narrative: tested positive for COVID; sore at the injection spot; Had a small fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID), INJECTION SITE PAIN (sore at the injection spot) and PYREXIA (Had a small fever) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID), INJECTION SITE PAIN (sore at the injection spot) and PYREXIA (Had a small fever). At the time of the report, COVID-19 (tested positive for COVID), INJECTION SITE PAIN (sore at the injection spot) and PYREXIA (Had a small fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.  Patient received the latest Moderna Spikevax. The next day patient felt horrible. Had a small fever, headache and achy. After that, felt fine, just sore at the injection spot. 8 days later patient felt run down and tested positive for COVID, had congestion, headache and fever. Continued to test positive for the next 7 days. The side effects of Covid were less than the vaccine itself.   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2023: Live follow-up received. Reference numbers were added.
Sex: U
Vaccine: UNK
Symptoms: Pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; sore at the injection spot; Had a small fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID), INJECTION SITE PAIN (sore at the injection spot) and PYREXIA (Had a small fever) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID), INJECTION SITE PAIN (sore at the injection spot) and PYREXIA (Had a small fever). At the time of the report, COVID-19 (tested positive for COVID), INJECTION SITE PAIN (sore at the injection spot) and PYREXIA (Had a small fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.  Patient received the latest Moderna Spikevax. The next day patient felt horrible. Had a small fever, headache and achy. After that, felt fine, just sore at the injection spot. 8 days later patient felt run down and tested positive for COVID, had congestion, headache and fever. Continued to test positive for the next 7 days. The side effects of Covid were less than the vaccine itself.   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2023: Live follow-up received. Reference numbers were added.
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Covid-like symptoms; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-like symptoms) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-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 an unknown date, the patient experienced COVID-19 (Covid-like symptoms). At the time of the report, COVID-19 (Covid-like symptoms) 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.   Concomitant medication was not provided.  Patient reported that he had 2 primary doses and then bivalent shot. He said that he had Covid-like symptoms after.  Treatment information was not reported.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Neck pain
Clinical narrative: headache that won't go away just kind of a dull headache. Sort of on the back of my neck on one spot. It hurts.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache that won't go away just kind of a dull headache. Sort of on the back of my neck on one spot. It hurts.) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Patient was healthy.  Previously administered products included for Product used for unknown indication: Flu Shot (13 or 14 SEP2023) in September 2023. Past adverse reactions to the above products included No adverse effect with Flu Shot.    On 27-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced HEADACHE (headache that won't go away just kind of a dull headache. Sort of on the back of my neck on one spot. It hurts.). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache that won't go away just kind of a dull headache. Sort of on the back of my neck on one spot. It hurts.) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient had headache that won't go away just kind of a dull headache on the back of neck on one spot. It hurts. She has tried taking ibuprofen for about five days and while on Ibuprofen, it went away, but the minute it wears off, the symptoms are back. So, then she tried Tylenol and it's the same thing. About 5 days after vaccination, she started having a dull headache. She did not have any local arm reaction or anything else.   Reporter did not allow further contact
Age: 16.0
Sex: M
Vaccine: HEP, MENB
Symptoms: No adverse event
Clinical narrative: no adverse reaction to vaccine occurred at time of administration or after administration. 0845 on 9/27/2023 minor patient was scheduled to receive Bexsero. Nurse pulled and administered Engerix-B peds to pt (R) deltoid. Upon completion, error was noted to both pt and father. The use of Engerix B peds was then explained to both pt and father. No adverse reaction noted. Bexsero IM to (R) deltoid administered.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza virus test negative, Malaise, Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: Lowgrade fever , rash , malaise within 24hrs of vaccines
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Streptococcus test negative
Clinical narrative: Lowgrade fever , rash , malaise within 24hrs of vaccines
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Disorientation, Headache, Incontinence, Insomnia, Malaise
Clinical narrative: She awoke at 2 AM with fever, arm swelling and pain. At 4 AM she went to get Tylenol in other room. I was asleep. Called me for help. She was disoriented and said she didn't feel well. While I was helping her back to bed, she collapsed and had a seizure (non grand mal) for 5 minutes with vomiting and incontinence. She could have hit her head on marble floor if I was not present. Post ictal  she had insomnia, continued arm pain and swelling, and headache.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Peripheral swelling, Postictal state, Pyrexia, Seizure
Clinical narrative: She awoke at 2 AM with fever, arm swelling and pain. At 4 AM she went to get Tylenol in other room. I was asleep. Called me for help. She was disoriented and said she didn't feel well. While I was helping her back to bed, she collapsed and had a seizure (non grand mal) for 5 minutes with vomiting and incontinence. She could have hit her head on marble floor if I was not present. Post ictal  she had insomnia, continued arm pain and swelling, and headache.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Syncope, Vomiting
Clinical narrative: She awoke at 2 AM with fever, arm swelling and pain. At 4 AM she went to get Tylenol in other room. I was asleep. Called me for help. She was disoriented and said she didn't feel well. While I was helping her back to bed, she collapsed and had a seizure (non grand mal) for 5 minutes with vomiting and incontinence. She could have hit her head on marble floor if I was not present. Post ictal  she had insomnia, continued arm pain and swelling, and headache.
Age: 36.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Exposure during pregnancy, Eyelid margin crusting, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Patient is a 6 1/2 weeks pregnant. She came in to get her covid and flu vaccine. She called to say that 5 hours after receiving the vaccine she started noticing her left eye (which was the side that she received her vaccines) was watering. This morning she woke up to some crustiness in her eye and her eye was red. She said it looked like conjunctivitis. For now patient was advised to monitor. Told patient if it gets worse or if vision becomes blurry to get it checked out. Also if it doesn't go away in a couple days she should get it checked out.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt was scheduled to receive the flu vaccine. The pt received the COVID Spike Vax accidently in addition to the flu vaccine. The pt had received the Spike vax vaccine the night before.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt was scheduled for Flu vaccine, but accidently received both the COVID Spike Vax vaccine and the flu vaccine. Pt had already received the Spike Vax vaccine the night before.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Cannot lift up his right arm, painful. Advised to apply warm compresses, go to urgent care if symptoms worsen
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: PATIENT CALLED ON 10/12/23 TO REPORT A REACTION TO THE FLUZONE HD VACCINE THAT SHE RECIEVED ON 10/10/23. REACTION STARTED ON 10/11/23 - INJECTION SITE RASH AND AREA IS WARM TO TOUCH.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Peripheral swelling
Clinical narrative: Patient states his left foot and lower left leg was a little swollen, red, and numb
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given influenza vaccine for ages 65+ but she is only 63. She had no adverse effects per phone conversation on 10/12/2023.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Vaccine clinic vaccinator administered Fluarix vaccine to client instead of COVID-19 Moderna vaccine.  Client previously had flu vaccine 1 month ago.  Consulted with Health Officer, and provided reassurance and information to client.
Age: 79.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient noted bruising in her left arm at injection site and reddness and swelling in her lower left arm (about the size of an orange).  The red area is also warm.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PT REPORTED TO WINDOW ON 10/11, HAVING SHOTS ON 10/7.  PT REPORTS DECREASED SORENESS, BUT INCREASED REDNESS, WARMTH, AND SWELLING LOCALIZED TO INJECTION SITE. NO FEVER, NO RADIATION OF PAIN.  ADVISED PT TO ALERT PCP FOR FURTHER ACTION.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Wrong product administered
Clinical narrative: Pt was provided with wrong vaccine. Pt was supposed to receive updated covid booster. Pt was checked on via phone twice after administration she reported symptoms of mild fatigue but, still presented to receive a covid vaccine that evening. Denied any other concerns.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired pneumovax-23 shot on 10/11/23.  No adverse reactions was reported or noted from patient.   Patient was contact and a new pneumovax-23 shot was administered for patient on 10/12/2023.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance
Clinical narrative: patient states she received the vaccine at approximately 3pm on 10/11/23. in the early am of 10/12/23 her reaction started of dizziness. she states she cannot walk well and feels like she has to lay down most of the day.  this is the spikevax vaccine
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient   was given. third dose
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: swollen ankles and feet
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Palpitations, Paraesthesia
Clinical narrative: Pt c/o tingling in bilateral hands and heart racing resolved within 5 minutes of the initial response; no complaints of any other symptoms; pt observed for 30 minutes Vitals Obtained: initial vitals B/P 140/72 HR=100-107, R=22, 02 sat 99-100 on Room air  Final Vitals: HR=67 02 sat 98% on Room Air
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, No reaction on previous exposure to drug, Syncope
Clinical narrative: Pharmacy technician administer vaccine and when applying Band-Aid, patient lost consciousness. Tech immediately notified pharmacist and patient regained consciousness within 30 seconds. Pharmacist offered water and candy in case of low blood sugar. Patient remained seated and fainted again 5 minutes later. Patient was closely monitored for about 10 more minutes before the parents decided to leave pharmacy. Patient does not have a history of fainting and has received several Pfizer COVID vaccinations in the past without issue.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Biopsy bladder abnormal, Bladder discomfort, Bladder pain, Blood urine present, Cystitis noninfective
Clinical narrative: Onset of follicular cystitis Severe inflammation and physical changes of bladder, urethra, extreme vulvar pain and initiation of many medications, two surgeries, 3 months out on disability. Chronic discomfort, very sensitive bladder (re foods, hydraton etc), frequent UTIs sometimes with blood in urine). Considerable pain during flare ups which require strong pain meds. Ongoing for nearly 2 yrs.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Cystoscopy abnormal, Disability, Follicular cystitis, Pain, Surgery
Clinical narrative: Onset of follicular cystitis Severe inflammation and physical changes of bladder, urethra, extreme vulvar pain and initiation of many medications, two surgeries, 3 months out on disability. Chronic discomfort, very sensitive bladder (re foods, hydraton etc), frequent UTIs sometimes with blood in urine). Considerable pain during flare ups which require strong pain meds. Ongoing for nearly 2 yrs.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Urethral disorder, Urinary bladder haemorrhage, Urinary tract infection, Vulvovaginal pain
Clinical narrative: Onset of follicular cystitis Severe inflammation and physical changes of bladder, urethra, extreme vulvar pain and initiation of many medications, two surgeries, 3 months out on disability. Chronic discomfort, very sensitive bladder (re foods, hydraton etc), frequent UTIs sometimes with blood in urine). Considerable pain during flare ups which require strong pain meds. Ongoing for nearly 2 yrs.
Age: 22.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Visual impairment
Clinical narrative: A student  complaining that he started having vision problems the night of receiving flu and COVID shots on 9/25/23.  He has already been checked out in the ER and by an eye doctor. Outcome unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient states that arm is still sore.
Age: 57.0
Sex: M
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient received fluad at the age of 57 when it is not recommended.  No signs/symptoms at that moment.
Age: 38.0
Sex: F
Vaccine: FLUA4
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting/diarrhea
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Accident at work, Accidental exposure to product, Full blood count, HIV test, Hepatitis B virus test
Clinical narrative: Pharmacist was stuck accidentally after the covid vaccine was given to the pt. Pharmacist flushed open puncture wound out several times. Notified otherp pharmacist on duty, reported incident to HR, and manager
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatitis C virus test, Metabolic function test, Occupational exposure to product, Wound
Clinical narrative: Pharmacist was stuck accidentally after the covid vaccine was given to the pt. Pharmacist flushed open puncture wound out several times. Notified otherp pharmacist on duty, reported incident to HR, and manager
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 101.3
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Dyspnoea, Loss of consciousness, Snoring
Clinical narrative: Vaccine was administered to patient and a few moments later the patient stated she felt lightheaded. She then lost consciousness and began to make a snoring sound as if she had difficulty breathing/wasn't breathing well. I caught her in her chair and immediately told my technician to call EMS in case of anaphylaxis, and I grabbed an epi-pen. However, the patient then came back to consciousness and was breathing normally. She stated she felt lightheaded still but was getting better. She also stated she had no difficulty breathing and airway clear. She was monitored for 15-30 minutes nearby the pharmacy and paramedics showed up, but patient denied treatment. She told them what had happened and stated she was feeling better, but just wanted to sit for a bit. Patient contacted her husband to pick her up so she did not have to drive.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Blood blister, Muscle strain, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: About 24 hours after receiving the vaccine, I experienced extreme pain and stiffness in the back of my neck and my left should blade/upper back. It was a throbbing pain and shooting pain if I moved at all. I was unable to use my neck muscles at all without feeling strain and extreme pain. I also noticed blood blisters on the front of my collarbone/neck later that night. I have been in pain for 48 hours and have taken pain medications all  day and heating pads and nothing seems to help.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain
Clinical narrative: About 24 hours after receiving the vaccine, I experienced extreme pain and stiffness in the back of my neck and my left should blade/upper back. It was a throbbing pain and shooting pain if I moved at all. I was unable to use my neck muscles at all without feeling strain and extreme pain. I also noticed blood blisters on the front of my collarbone/neck later that night. I have been in pain for 48 hours and have taken pain medications all  day and heating pads and nothing seems to help.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pallor, Skin reaction
Clinical narrative: Delayed reaction (noticed at 10:00 am on October 12 by patient).  An approximately 6 cm circular area of localized redness, mild pain, and increased warmth developed around the injection site.  Skin was flat with no hives, no itching, and no areas of abnormal firmness.  Patient was afebrile and denied any other symptoms.  Skin within the reddened area would blanch with fingertip pressure and quickly reperfused.  Pain was reported as a "1" on a 1 to 10 scale, described as aching with no radiation.  No treatment requested by patient or rendered.  Though the evening, no worsening of pain, redness, or development of new signs/symptoms reported by the patient.