chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: She had injection site swelling; She had injection site redness; injection site itchiness; low grade fever; chills; Headache; skin hardness; She had injection site pain for a few days; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-DEC-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. On 03-DEC-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: She had injection site pain for a few days) and skin induration (Verbatim: skin hardness). On 04-DEC-2023, the patient experienced injection site swelling (Verbatim: She had injection site swelling), injection site erythema (Verbatim: She had injection site redness), injection site itching (Verbatim: injection site itchiness), low grade fever (Verbatim: low grade fever), chills (Verbatim: chills) and headache (Verbatim: Headache). The patient was treated with paracetamol (Tylenol). On 05-DEC-2023, the outcome of the low grade fever, chills and headache were resolved (duration 1 day). On 06-DEC-2023, the outcome of the skin induration was resolved (duration 3 days). On 11-DEC-2023, the outcome of the injection site swelling, injection site erythema and injection site itching were resolved (duration 7 days). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, injection site itching, low grade fever, chills, headache and skin induration to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site swelling, injection site erythema, injection site itching, low grade fever, chills, headache and skin induration to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-DEC-2023 The patient reported after first dose of Shingrix at her pharmacy she had injection site pain for few days. Her skin was harden for about three days. A day after vaccination she had headache, chills and low grade fever which resolved after taking the Tylenol on 4th December 2023 and 5th December 2023. She also had injection site swelling, redness and itchiness that increase over the course of the week and then resolved. The patient had nothing else to report. The reporter consented a follow up with physician.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia, Skin induration
Clinical narrative: She had injection site swelling; She had injection site redness; injection site itchiness; low grade fever; chills; Headache; skin hardness; She had injection site pain for a few days; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-DEC-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. On 03-DEC-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: She had injection site pain for a few days) and skin induration (Verbatim: skin hardness). On 04-DEC-2023, the patient experienced injection site swelling (Verbatim: She had injection site swelling), injection site erythema (Verbatim: She had injection site redness), injection site itching (Verbatim: injection site itchiness), low grade fever (Verbatim: low grade fever), chills (Verbatim: chills) and headache (Verbatim: Headache). The patient was treated with paracetamol (Tylenol). On 05-DEC-2023, the outcome of the low grade fever, chills and headache were resolved (duration 1 day). On 06-DEC-2023, the outcome of the skin induration was resolved (duration 3 days). On 11-DEC-2023, the outcome of the injection site swelling, injection site erythema and injection site itching were resolved (duration 7 days). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, injection site itching, low grade fever, chills, headache and skin induration to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site swelling, injection site erythema, injection site itching, low grade fever, chills, headache and skin induration to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-DEC-2023 The patient reported after first dose of Shingrix at her pharmacy she had injection site pain for few days. Her skin was harden for about three days. A day after vaccination she had headache, chills and low grade fever which resolved after taking the Tylenol on 4th December 2023 and 5th December 2023. She also had injection site swelling, redness and itchiness that increase over the course of the week and then resolved. The patient had nothing else to report. The reporter consented a follow up with physician.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Administration of an expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 68-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2ZS9N, expiry date 24-SEP-2023) for prophylaxis.   On 12-DEC-2023, the patient received the 2nd dose of Boostrix. On 12-DEC-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Administration of an expired dose). 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: 12-DEC-2023 The healthcare professional contacted GSK via phone inquiring about Boostrix and what information was available about the administration of an expired dose, which led to expired vaccine used. They asked not information about them be recorded but accepted follow-up. Partial information about vaccine, event and patient provided. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received two doses of Shingrix two weeks apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient received two doses of Shingrix two weeks apart). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 13-DEC-2023 The pharmacist reported a patient received two doses of Shingrix two weeks apart.  2nd dose was administered at a different pharmacy than the RPH reporting.  The patient received 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule.  The reporter consented to follow up.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: female patient received an expired dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 02-FEB-2023, the patient received the 1st dose of Havrix. On 02-FEB-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: female patient received an expired dose of Havrix). 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: 13-DEC-2023 The Office Manager called in on reporter stated patient received expired dose of Havrix, which led to expired vaccine used. The reporter consented to follow-up via email.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Maladministration for Boostrix after expiration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (expiry date 09-DEC-2023) for prophylaxis.   On 12-DEC-2023, the patient received Boostrix. On 12-DEC-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Maladministration for Boostrix after expiration). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 13-Dec-2023 The reporter wanted to get more information on an expired Boostrix vaccine that was administered yesterday, which led to expired vaccine used. The reporter did not had details about vaccine injected or patient was involved. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient has not yet received the second dose of the vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20th February 2020).   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: Patient has not yet received the second dose of the vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-Dec-2023 The reporter was asked if patient need to restart the series. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: one dose of an expired dose of Havrix was administered to a a patient on Nov 20th 2023 Havrix was expired on Nov 19th 2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 47xg3, expiry date 19-NOV-2023) for prophylaxis.   On 20-NOV-2023, the patient received Havrix. On 20-NOV-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: one dose of an expired dose of Havrix was administered to a a patient on Nov 20th 2023 Havrix was expired on Nov 19th 2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 13-DEC-2023 Nurse reported that the patient received an expired Havrix vaccine, which led to expired vaccine used.  No patient details were available. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pruritus, Rash
Clinical narrative: Shingles; Burning; Itching; Rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blind (almost totally Blind) and heart disorder.   In NOV-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm). In NOV-2023, less than a month after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles), burning sensation (Verbatim: Burning), pruritus (Verbatim: Itching) and rash (Verbatim: Rash). The outcome of the shingles, burning sensation, pruritus and rash were not resolved.   It was unknown if the reporter considered the shingles, burning sensation, pruritus and rash to be related to Shingrix.     It was unknown if the company considered the shingles, burning sensation, pruritus and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-Dec-2023 The patient reported that he received Shingrix vaccine 5 weeks ago and he did not recall the exact date, lot and expiry date. The patient reports that the vaccine was provided at a local pharmacy.  The patient stated that the 2 weeks ago he developed Shingles. The patient reported that he had burning and itching and prescribed a cream to apply to the rash on his right leg.  The patient reported it was not recovered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Female patient, who is either 78 or 79 years of age, received her 1st dose of Shingrix in 2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 12-NOV-2020, the patient received the 1st dose of Shingrix.).   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: Female patient, who is either 78 or 79 years of age, received her 1st dose of Shingrix in 2020). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-DEC-2023 The pharmacist stated that a female patient, who was either 78 or 79 years of age, received her 1st dose of Shingrix in 2020, wants to know does she need to restart the series, which led to incomplete course of vaccination. The VAERS details reported for 1st dose. The reporter consented to follow up via mail.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: the administration of only the adjuvant.; the administration of only the adjuvant.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 3924D) for prophylaxis.   On 13-DEC-2023, the patient received the 2nd dose of Shingrix. On 13-DEC-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: the administration of only the adjuvant.) and inappropriate dose of vaccine administered (Verbatim: the administration of only the adjuvant.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 13-DEC-2023 The pharmacist contacted inquiring about Shingrix and asked for information was available about the administration of only the adjuvant.  Partial information about the event, vaccine and patient was provider. The Vaccine Administration Facility was the same as Primary Reporter. The patient only received adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Pediarix today; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 7L9PZ, expiry date 24-NOV-2023) for prophylaxis.   On 14-DEC-2023, the patient received Pediarix. On 14-DEC-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of Pediarix today). 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: 14-DEC-2023 The Medical Assistant called reporting that a patient received an expired dose of Pediarix day of reporting which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Shingrix reconstituted with the incorrect diluent.; the administration of a dose of Shingrix reconstituted with the incorrect diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number B9J49, expiry date 30-SEP-2025) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix reconstituted with the incorrect diluent.) and inappropriate dose of vaccine administered (Verbatim: the administration of a dose of Shingrix reconstituted with the incorrect diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date:14-DEC-2023 A pharmacist contacted to GlaxoSmithKline and enquired about Shingrix and what information was available about the administration of a dose of Shingrix reconstituted with the incorrect diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The health care professional was unsure of the patient and date of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I forgot to make an appointment for my second shot; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th February 2023).   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: I forgot to make an appointment for my second shot). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-Dec-2023 The reporter reported that the patient was forgot to make an appointment for her second dose. The patient wanted to know if she need to start over having the first dose or she can make arrangements for the second dose. The patient had an appointment on Sunday 17th December 2023 for her flu vaccine, so can she schedule to had her second dose done at the same time. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: administration of FluLaval instead of Fluzone; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 66-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number 9ZTD2, expiry date 30-JUN-2024) for prophylaxis.   On 06-DEC-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On 06-DEC-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced wrong vaccine administered (Verbatim: administration of FluLaval instead of Fluzone). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 15-DEC-2023 A nurse requested information about the administration of FluLaval instead of Fluzone and wished to know if there was any information available, which led to wrong vaccine administered. The adverse event was filed because of the administration of the unintended vaccine. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA762A, expiry date 30-NOV-2023) for prophylaxis.   In DEC-2023, the patient received Menveo. In DEC-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired vaccine administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 15-DEC-2023 The pharmacist reported on December 15th 2023 that during the week of reporting (not exact date provided), Menveo was administered to a patient (no data provided) and the dose had expired on November 30th 2023 which led to expired vaccine used. The reporter did not consent to follow up.
Age: 4.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Bexsero in patients younger than 10 years of age; who received Bexsero instead of HepB vaccine; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 14-DEC-2023, the patient received Bexsero. On 14-DEC-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Bexsero in patients younger than 10 years of age) and wrong vaccine administered (Verbatim: who received Bexsero instead of HepB vaccine). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-DEC-2023 The reporter reported that the administration of Bexsero to a 4 year-old patient who received Bexsero instead of HepB vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter asked for information about the use of Bexsero in patients younger than 10 years of age. The reporter did not provide information about the Bexsero dose given (lot number, exp date). The reporter consented to follow up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: a dose of Kinrix that had already expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   On 13-DEC-2023, the patient received Kinrix. On 13-DEC-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: a dose of Kinrix that had already expired). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-DEC-2023 The reporter called to inform that a patient received a dose of Kinrix that had already expired, which led to expired vaccine used. The reporter did not consent to follow-up.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired Boostrix dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 75-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7zd7l, expiry date 09-DEC-2023) for prophylaxis.   On 15-DEC-2023, the patient received Boostrix. On 15-DEC-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired Boostrix dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 15-Dec-2023 The patient received already expired Boostrix vaccine, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: HCP reports giving AREXVY vaccine to a pregnant woman; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: HCP reports giving AREXVY vaccine to a pregnant woman). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 18-DEC-2023 The reporter reported giving Arexvy vaccine to a pregnant woman. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient received one dose of Shingrix 4 years ago in 2019 and did not get a 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received one dose of Shingrix 4 years ago in 2019).   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: a patient received one dose of Shingrix 4 years ago in 2019 and did not get a 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-DEC-2023 The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: he had COVID about a month ago; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (he had COVID about a month ago) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2023, the patient experienced COVID-19 (he had COVID about a month ago). At the time of the report, COVID-19 (he had COVID about a month ago) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient only have had Moderna COVID shots. He had COVID about a month ago when he was in Europe. No treatment medication reported.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: The patient had Bell's Palsy 3 months ago and HCP told him to wait and not get another COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (The patient had Bell's Palsy 3 months ago and HCP told him to wait and not get another COVID-19 vaccine) in an adult male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2023, the patient experienced BELL'S PALSY (The patient had Bell's Palsy 3 months ago and HCP told him to wait and not get another COVID-19 vaccine) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (The patient had Bell's Palsy 3 months ago and HCP told him to wait and not get another COVID-19 vaccine) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       The concomitant medication was not reported by reporter.   The patient received a Moderna COVID-19 vaccine about 8 months ago.   Suspect product dosage text was given as unknown.  The treatment medication was not reported by reporter.  Company Comment: This is a Spontaneous case concerning an adult male patient with no medical history reported, who experienced the serious (per medically significant) unexpected AESI of Bell's palsy which occurred about 5 months after a dose of SPIKEVAX NOS for COVID-19 Vaccination.  No further clinical information or diagnostic tests results were disclosed for analysis. No concomitant medication or treatment information was reported. The benefit-risk relationship of SPIKEVAX NOS is not affected by this report.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test, Wrong product administered
Clinical narrative: she went to the pharmacy and requested Pfizer COVID-19 vaccine. They lied to her and administered Spikevax by Moderna on 19-Oct-2023; She was sick for 5 days; She states that 2 weeks after receiving Spikevax she had a cold and Positive COVID Disease; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (She was sick for 5 days), COVID-19 (She states that 2 weeks after receiving Spikevax she had a cold and Positive COVID Disease) and WRONG PRODUCT ADMINISTERED (she went to the pharmacy and requested Pfizer COVID-19 vaccine. They lied to her and administered Spikevax by Moderna on 19-Oct-2023) in a 62-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030366) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer Covid-19 vaccine (She states that all her previous COVID-19 shots were Pfizer and she never got COVID after Pfizer vaccination.). Past adverse reactions to the above products included No adverse event with Pfizer Covid-19 vaccine.    On 19-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In 2023, the patient experienced ILLNESS (She was sick for 5 days) and COVID-19 (She states that 2 weeks after receiving Spikevax she had a cold and Positive COVID Disease). On 19-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced WRONG PRODUCT ADMINISTERED (she went to the pharmacy and requested Pfizer COVID-19 vaccine. They lied to her and administered Spikevax by Moderna on 19-Oct-2023). In 2023, ILLNESS (She was sick for 5 days) had resolved. At the time of the report, COVID-19 (She states that 2 weeks after receiving Spikevax she had a cold and Positive COVID Disease) and WRONG PRODUCT ADMINISTERED (she went to the pharmacy and requested Pfizer COVID-19 vaccine. They lied to her and administered Spikevax by Moderna on 19-Oct-2023) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, SARS-CoV-2 test: Positive.         Concomitant product use was not provided by the reporter.  It was reported that she went to the pharmacy and requested Pfizer COVID-19 vaccine. They lied to her and administered Spikevax by Moderna on 19-Oct-2023. After 2 weeks receiving Spikevax she had a cold and Positive COVID Disease. She was sick for 5 days. She went to the hospital emergency room.  Treatment information was not provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: shoulders were still sore; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (shoulders were still sore) in a 72-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030340) for COVID-19 prophylaxis.     No relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 03-Nov-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In 2023, the patient experienced ARTHRALGIA (shoulders were still sore). At the time of the report, ARTHRALGIA (shoulders were still sore) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-754369 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-754369:Wife's case
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: shoulders are still sore; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ARTHRALGIA (shoulders are still sore) in an 80-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030340) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (shoulders are still sore). At the time of the report, ARTHRALGIA (shoulders are still sore) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (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.   This case was linked to US-MODERNATX, INC.-MOD-2023-754348 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-754348:Husband's case
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; He informed his son had his first dose of ROTATEQ today 12/20/23 and the nurse had the vaccine out of refrigeration in room temperature for about 1 hour and 30 minutes; This spontaneous report has been received from the patient's father, regarding his son, a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not provided.  On 20-DEC-2023, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (dose, vaccination scheme, frequency, anatomical location, lot number and expiration date were not provided). The nurse had the vaccine out of refrigeration in room temperature (no exact temperature) for about 1 hour and 30 minutes before administering to his son (product storage error). Previous temperature excursion was unknown.  No additional adverse event (AE).
Sex: F
Vaccine: RSV
Symptoms: Decreased appetite
Clinical narrative: Patient experienced a decrease in appetite; This is a spontaneous report received from a Physician from a sales representative.  An elderly female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DECREASED APPETITE (non-serious), outcome "unknown", described as "Patient experienced a decrease in appetite". It was unknown if therapeutic measures were taken as a result of decreased appetite. Additional information: No other vaccine received on same date, unknown if other vaccine in four weeks or other medications in two weeks.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: RSV
Symptoms: Gastrooesophageal reflux disease, Muscle spasms, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Fever; Reflux; Spasms in the left arm; Runny nose; Pain and tingling in the left arm; He has a pain down in the left arm and the left hand, specifically the ring and middle fingers/Pain and tingling in the left arm; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 92-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COVID", start date: Jul2022, stop date: 2022, notes: He got over it after 4 days and 4 nights in the hospital; "Pneumonia", start date: Jul2022, stop date: 2022, notes: He got over it after 4 days and 4 nights in the hospital; "long COVID", start date: 2022 (unspecified if ongoing), notes: 15 days later from hospitalization, he was diagnosed long COVID.; "Bacteria infection" (unspecified if ongoing), notes: After long COVID, bacteria infection that didn't go away with conventional treatments; "COPD" (unspecified if ongoing); "AFIB" (unspecified if ongoing), notes: He has been consulting his case with his cardiologist and neurologist.; "He got over it after 4 days and 4 nights in the hospital" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "not recovered", described as "He has a pain down in the left arm and the left hand, specifically the ring and middle fingers/Pain and tingling in the left arm"; PARAESTHESIA (non-serious) with onset 2023, outcome "not recovered", described as "Pain and tingling in the left arm"; RHINORRHOEA (non-serious) with onset 2023, outcome "not recovered", described as "Runny nose"; MUSCLE SPASMS (non-serious) with onset 2023, outcome "not recovered", described as "Spasms in the left arm"; PYREXIA (non-serious) with onset Nov2023, outcome "recovered" (Nov2023), described as "Fever"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset Nov2023, outcome "recovered" (Nov2023), described as "Reflux".  Additional information: The patient was still having really bad reactions after being on RSV vaccine. The patient took Abrysvo over 30 days ago. He was still experiencing pain and tingling in the left arm. He has a pain down in the left arm and the left hand, specifically the ring and middle fingers. He wanted to know how long these symptoms may last. He never had a problem with a vaccine before Abrysvo. Initially, he had a reflux and fever once but those symptoms went away a couple days after vaccination. He still has spasms in the left arm and a runny nose every morning. Question: He also wanted to know if Abrysvo contains the weakened virus.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.
Sex: M
Vaccine: RSV
Symptoms: Rhinorrhoea
Clinical narrative: Fever; Reflux; Spasms in the left arm; Runny nose; Pain and tingling in the left arm; He has a pain down in the left arm and the left hand, specifically the ring and middle fingers/Pain and tingling in the left arm; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 92-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COVID", start date: Jul2022, stop date: 2022, notes: He got over it after 4 days and 4 nights in the hospital; "Pneumonia", start date: Jul2022, stop date: 2022, notes: He got over it after 4 days and 4 nights in the hospital; "long COVID", start date: 2022 (unspecified if ongoing), notes: 15 days later from hospitalization, he was diagnosed long COVID.; "Bacteria infection" (unspecified if ongoing), notes: After long COVID, bacteria infection that didn't go away with conventional treatments; "COPD" (unspecified if ongoing); "AFIB" (unspecified if ongoing), notes: He has been consulting his case with his cardiologist and neurologist.; "He got over it after 4 days and 4 nights in the hospital" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "not recovered", described as "He has a pain down in the left arm and the left hand, specifically the ring and middle fingers/Pain and tingling in the left arm"; PARAESTHESIA (non-serious) with onset 2023, outcome "not recovered", described as "Pain and tingling in the left arm"; RHINORRHOEA (non-serious) with onset 2023, outcome "not recovered", described as "Runny nose"; MUSCLE SPASMS (non-serious) with onset 2023, outcome "not recovered", described as "Spasms in the left arm"; PYREXIA (non-serious) with onset Nov2023, outcome "recovered" (Nov2023), described as "Fever"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset Nov2023, outcome "recovered" (Nov2023), described as "Reflux".  Additional information: The patient was still having really bad reactions after being on RSV vaccine. The patient took Abrysvo over 30 days ago. He was still experiencing pain and tingling in the left arm. He has a pain down in the left arm and the left hand, specifically the ring and middle fingers. He wanted to know how long these symptoms may last. He never had a problem with a vaccine before Abrysvo. Initially, he had a reflux and fever once but those symptoms went away a couple days after vaccination. He still has spasms in the left arm and a runny nose every morning. Question: He also wanted to know if Abrysvo contains the weakened virus.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Amnesia, Confusional state, Coordination abnormal, Disorientation, Dizziness
Clinical narrative: feel mentally disoriented; loss of memory/ were trying to drive and became lost, couldn't remember where we were or how we got there; mental confusion/ couldn't add up numbers, remember places or people; Very fatigued; Headache; dizziness; lack of coordination; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 05Dec2023 at 15:45 as dose 1, single (Lot number: HM7645, Expiration Date: Feb2025, Batch number: PAA209777) at the age of 79 years, in left arm for immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "nocturna - uncontrolled urinating at night" (unspecified if ongoing); "sinus issues" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 06Dec2023 at 20:00, outcome "recovering"; FATIGUE (non-serious) with onset 06Dec2023 at 20:00, outcome "recovering", described as "Very fatigued"; DIZZINESS (non-serious) with onset 06Dec2023 at 20:00, outcome "recovering"; DISORIENTATION (non-serious) with onset 06Dec2023 at 20:00, outcome "recovering", described as "feel mentally disoriented"; COORDINATION ABNORMAL (non-serious) with onset 06Dec2023 at 20:00, outcome "recovering", described as "lack of coordination"; AMNESIA (non-serious) with onset 06Dec2023 at 20:00, outcome "recovering", described as "loss of memory/ were trying to drive and became lost, couldn't remember where we were or how we got there"; CONFUSIONAL STATE (non-serious) with onset 06Dec2023 at 20:00, outcome "recovering", described as "mental confusion/ couldn't add up numbers, remember places or people". Therapeutic measures were not taken as a result of disorientation, amnesia, confusional state, fatigue, headache, dizziness, coordination abnormal.  Additional information: The patient had no known allergy. No other vaccine same date, no other vaccine in four weeks, there was other medications in two weeks. Began to feel mentally disoriented. 2 days later she was trying to drive and became lost, couldn't remember where she were or how she got there. She had loss of memory and mental confusion. She couldn't add up numbers, remember places or people. She continued to be so disoriented that she had to lay down and rest. Very fatigued. Headache, dizziness, lack of coordination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300444503 same reporter/drug/event, different patients;
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache
Clinical narrative: feel mentally disoriented; loss of memory/ were trying to drive and became lost, couldn't remember where we were or how we got there; mental confusion/ couldn't add up numbers, remember places or people; Very fatigued; Headache; dizziness; lack of coordination; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 05Dec2023 at 15:45 as dose 1, single (Lot number: HM7645, Expiration Date: Feb2025, Batch number: PAA209777) at the age of 79 years, in left arm for immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "nocturna - uncontrolled urinating at night" (unspecified if ongoing); "sinus issues" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 06Dec2023 at 20:00, outcome "recovering"; FATIGUE (non-serious) with onset 06Dec2023 at 20:00, outcome "recovering", described as "Very fatigued"; DIZZINESS (non-serious) with onset 06Dec2023 at 20:00, outcome "recovering"; DISORIENTATION (non-serious) with onset 06Dec2023 at 20:00, outcome "recovering", described as "feel mentally disoriented"; COORDINATION ABNORMAL (non-serious) with onset 06Dec2023 at 20:00, outcome "recovering", described as "lack of coordination"; AMNESIA (non-serious) with onset 06Dec2023 at 20:00, outcome "recovering", described as "loss of memory/ were trying to drive and became lost, couldn't remember where we were or how we got there"; CONFUSIONAL STATE (non-serious) with onset 06Dec2023 at 20:00, outcome "recovering", described as "mental confusion/ couldn't add up numbers, remember places or people". Therapeutic measures were not taken as a result of disorientation, amnesia, confusional state, fatigue, headache, dizziness, coordination abnormal.  Additional information: The patient had no known allergy. No other vaccine same date, no other vaccine in four weeks, there was other medications in two weeks. Began to feel mentally disoriented. 2 days later she was trying to drive and became lost, couldn't remember where she were or how she got there. She had loss of memory and mental confusion. She couldn't add up numbers, remember places or people. She continued to be so disoriented that she had to lay down and rest. Very fatigued. Headache, dizziness, lack of coordination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300444503 same reporter/drug/event, different patients;