chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: use sterile diluent to reconstitute the lyophilized component of Menveo instead of the liquid conjugate component; use of different diluent for reconstitution and then administered to a patient; 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 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA986A, expiry date 31-OCT-2024) for prophylaxis.   On 03-JUN-2024, the patient received Menveo. On 03-JUN-2024, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: use sterile diluent to reconstitute the lyophilized component of Menveo instead of the liquid conjugate component) and inappropriate dose of vaccine administered (Verbatim: use of different diluent for reconstitution and then administered to a patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-JUN-2024. The HCP (health care professional) mentioned that one of the members of her staff used a sterile diluent to reconstitute the lyophilized component of Menveo instead of the liquid conjugate component and then this was administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The HCP asked when they could re-administer a properly reconstituted dose to this patient. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient did not recived 3rd 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 80-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose of Twinrix on an unknown date) and Twinrix (received 2nd dose of Twinrix on MAY-2023 13 months ago).   On an unknown date, the patient received the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient did not recived 3rd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 04-JUN-2024 Registered pharmacist (RPH) reported that the patient received the 2nd dose of Twinrix 13 months ago and called to inquire how to proceed with the series. The pharmacist informed that the patient that got two doses of Twinrix and they need to get a third dose. Till the time of reporting, the patient did not receive 3rd dose of Twinrix  vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow-up. The reporter did not want to provide any additional information and declined follow up.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Engerix-B; 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 36-year-old male patient who received HBV (Engerix B) (batch number N73FA, expiry date 31-MAY-2024) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 04-JUN-2024, the patient received Engerix B. On 04-JUN-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: received an expired dose of Engerix-B). 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: 04-JUN-2024 The other health professional (medical Assistant) explained that a patient received first dose of Hepatitis-B vaccine (Twinrix) on April 15th 2024 and then received an expired dose of Engerix-B, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Longer than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number EZ54G, expiry date 12-DEC-2025) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2016) and Zostavax (1st dose received in 2015).   On 05-JUN-2024, the patient received the 2nd dose of Shingrix. On 05-JUN-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Longer than recommended interval). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 05-JUN-2024 A pharmacist contacted GlaxoSmithKline to report that a 69 year old female patient whose initials are XX received their second dose of Shingrix on June 5th 2024, with the first dose being given in 2016. They also commented during the phone call that in 2015, the patient had received a dose of Zostavax, but did not elaborate. Only information about the administration after the maximum interval was solicited and provided. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) plus 7 days.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Vaccines administered with temperature excursions; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: Vaccines administered with temperature excursions). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 05-JUN-2024 Pharmacy technician stated that he had an excursion for Engerix B 10 mcg, the temperature got down to 35.2 Fahrenheit, 5 times each time for about 10 min. It was administered to patients, if they gave any doses in last 2 days then, yes but the reporter did not know how many patients received it  which led to incorrect storage of drug. The patient was at the pharmacy but this refrigerator was by itself for babies so the reporter just noticed today we had the excursions. No details when it was administered. The reporter was sure the charge nurse might know who got it in last couple of days. The reporter did not know how many patients were affected and the details, it was requested that if the nurse could call back and provide details, it would be greatly appreciated.
Age: 0.33
Sex: M
Vaccine: RVX
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: first dose was given at 17 week of age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received Rotavirus vaccine for prophylaxis.   Concomitant products included Rotavirus vaccine live oral 1v (Rotarix).   On 02-APR-2024, the patient received the 1st dose of Rotavirus vaccine. On 02-APR-2024, an unknown time after receiving Rotavirus vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: first dose was given at 17 week of age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt date: 06-JUN-2024 A nurse reported that a patient received yesterday the second dose of Rotarix and they realized that the first dose was given at 17 weeks of age which led to Inappropriate age at vaccine administration.
Age: 72.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently received Menveo instead of Menquadfi; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 72-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number L7373, expiry date 30-NOV-2024) for prophylaxis.   On 03-JUN-2024, the patient received Menveo. On 03-JUN-2024, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: inadvertently received Menveo instead of Menquadfi). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 06-JUN-2024 The registered pharmacists called stating a patient over 55 year old inadvertently received Menveo instead of Menquadfi on Monday administered by a new floater pharmacist which led to wrong vaccine administered. There was nothing on VAERS form indicating he was high risk.; Sender's Comments:  US-GSK-US2024070748:same reporter
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Guillain-Barre syndrome, Incomplete course of vaccination, Neurological symptom
Clinical narrative: developed Guillain-Barre Syndrome; Second Shingrix shot was not received; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE for prophylaxis.   On 11-SEP-2023, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In SEP-2023, the patient received COVID-19 VACCINE. On 16-OCT-2023, 35 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: developed Guillain-Barre Syndrome) (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Second Shingrix shot was not received). The outcome of the guillain barre syndrome and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     The company considered the guillain barre syndrome and incomplete course of vaccination to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 06-JUN-2024 The reporter was the wife of the patient who stated patient received Shingrix first shot and developed guillain-barre syndrome (GBS). At the end of September 2023 patient also received Covid-19 vaccination (Manufacturer not specified). The guillain-barre syndrome (GBS) was diagnosed while patient was hospitalized in between 24th October 2023 and 5th December2023.  According to the reporter, between 1 and 2 month after the Covid-19, the patient started having the first guillain-barre syndrome symptoms on 16 October 2023. The guillain-barre syndrome symptoms were not specified.  The second Shingrix shot was not received.  It was unknown if the reporter considered the guillain barre syndrome to be related to Covid-19.    Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments: Guillain-Barre syndrome and Incomplete course of vaccination are  unlisted events which are considered unrelated to GSK vaccine Shingrix dose I  and Shingrix dose II.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Laboratory test normal, Paraesthesia
Clinical narrative: pain at injection site; numbness and tingling from left arm going up shoulder to neck area.; numbness and tingling from left arm going up shoulder to neck area.; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of no adverse event (on an unknown date received 1st dose).   In MAR-2024, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site), tingling of extremity (Verbatim: numbness and tingling from left arm going up shoulder to neck area.) and numbness of upper extremities (Verbatim: numbness and tingling from left arm going up shoulder to neck area.). The outcome of the injection site pain was resolved and the outcome of the tingling of extremity and numbness of upper extremities were not resolved.   It was unknown if the reporter considered the injection site pain, tingling of extremity and numbness of upper extremities to be related to Shingrix.     It was unknown if the company considered the injection site pain, tingling of extremity and numbness of upper extremities to be related to Shingrix.   Additional Information: GSK Receipt date: 07-JUN-2024 The patient self-reported. He had his first Shingrix vaccine with no issues, then 3 months later he received dose 2.  He states he had pain at the injection site that lasted a few days and then he felt numbness and tingling that comes and goes.  The numbness/tingling started in left arm and it's radiating up his left shoulder and into neck area.  He went to HCP who referred him to neurology and all tests were negative.  He states he had not started the prescribed steroids he plans on starting them in a few days.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Immediate post-injection reaction, Incomplete course of vaccination, Rash, Skin warm
Clinical narrative: The blisters/bumps were warm and they hurt; blisters/bumps were warm; initially started out as a pimple-like; blistery patches and bumps all over her body; blistery patches and bumps all over her body; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sickle-cell anemia and multiple sclerosis. Additional patient notes included patient never had chickenpox.   On 13-OCT-2023, the patient received the 1st dose of Shingrix. On 13-OCT-2023, immediately after receiving Shingrix, the patient experienced pimples (Verbatim: initially started out as a pimple-like), blister (Verbatim: blistery patches and bumps all over her body) and generalized rash (Verbatim: blistery patches and bumps all over her body). On an unknown date, the patient experienced pain (Verbatim: The blisters/bumps were warm and they hurt) and feeling of warmth (Verbatim: blisters/bumps were warm). The outcome of the pain, feeling of warmth, pimples, blister and generalized rash were resolved.   It was unknown if the reporter considered the pain, feeling of warmth, pimples, blister and generalized rash to be related to Shingrix.     It was unknown if the company considered the pain, feeling of warmth, pimples, blister and generalized rash to be related to Shingrix.   Additional Information: GSK Receipt date: 07-JAN-2024 The patient self-reported.  She received the first dose of Shingrix on 13 October 2023, shortly after receiving the first dose, the patient developed blistery patches and bumps all over her body, which initially started out as a pimple-like. The blisters/bumps were warm and they hurt, this was a weekly cycle in which the blistery patches would go away then come back .  It took about 3 months for it to to all go away and the patient went to a dermatologist and it was never determined what the blistery patches were.  The patient stated that she also started on new antihypertensive medication (not specified) at the time she received the Shingrix vaccine.  The patient's doctor wanted to have the blistery patches resolve and determine was causing them before the patient received the second dose.  The patient never received the second dose of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: patient accidentally received a dose of Shingrix reconstituted with the incorrect diluent; patient accidentally received a dose of Shingrix reconstituted with the incorrect diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution 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 wrong solution used in drug reconstitution (Verbatim: patient accidentally received a dose of Shingrix reconstituted with the incorrect diluent) and inappropriate dose of vaccine administered (Verbatim: patient accidentally received 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: 07-JUN-2024 A pharmacist reported that a patient accidentally received a dose of Shingrix reconstituted with the incorrect diluent which led to Inappropriate dose of vaccine administered and Wrong solution used in drug reconstitution. During the phone call the healthcare professional stated that they did not know any details about the vaccine, vaccination or the patient and decline to receive follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not yet administered; 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 (1st dose received on 23 October 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: 2nd dose not yet administered). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-JUN-2024 A pharmacist called to informed had a lady who received a shingles vaccine and did not come back for the other. Reporter mentioned that the 1st dose was administered. Since then, the patient had not returned to get the 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administered the expired reconstituted Menveo; 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 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA926A, expiry date 31-MAY-2024) and (expiry date 2025) for prophylaxis.   On 07-JUN-2024, the patient received Menveo. On 07-JUN-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: administered the expired reconstituted Menveo). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 10-JUN-2024 A reporter reported that the Lyophilized component of Menveo was expired but the diluent component expires in year 2025.  HCP reported they administered the expired reconstituted Menveo to a patient on 07 Jun 2024 which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: developed redness and swelling near the injection site; developed redness and swelling near the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female 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 injection site swelling (Verbatim: developed redness and swelling near the injection site) and injection site erythema (Verbatim: developed redness and swelling near the injection site). The outcome of the injection site swelling and injection site erythema were resolved.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site swelling and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt date: 10-JUN-2024 A reporter was a friend of a patient who reported that her friend developed redness and swelling near the injection site of Shingrix after a dose.  Symptoms got worse on the 3rd day after the dose and was about 3 to 4 inches away from the injection site and the symptoms have resolved.
Sex: F
Vaccine: COVID19, FLUX, VARZOS
Symptoms: Feeling hot, Influenza like illness
Clinical narrative: felt feverish; flu-like symptom; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling hot in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis and Influenza vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix, COVID-19 vaccine and Influenza vaccine. On an unknown date, an unknown time after receiving Shingrix and an unknown time after receiving Influenza vaccine, the patient experienced feeling hot (Verbatim: felt feverish) and influenza-like symptoms (Verbatim: flu-like symptom). The outcome of the feeling hot and influenza-like symptoms were not reported.   It was unknown if the reporter considered the feeling hot and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the feeling hot and influenza-like symptoms to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR072356   Additional Information: GSK receipt date: 10-JUN-2024 The patient felt feverish and experienced flu-like symptoms after the first dose of Shingrix. That patient also received the Flu vaccine (manufacturer not specified) and the COVID vaccine at the same time as the Shingrix vaccine (first dose). Consented to follow up.; Sender's Comments:  US-GSK-US2024AMR072356:for Shingrix 2nd dose
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: she developed bilateral pulmonary embolisms after receiving her 2nd Moderna Covid Vaccine; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (she developed bilateral pulmonary embolisms after receiving her 2nd Moderna Covid Vaccine) in a female 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 second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (she developed bilateral pulmonary embolisms after receiving her 2nd Moderna Covid Vaccine) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (she developed bilateral pulmonary embolisms after receiving her 2nd Moderna Covid Vaccine) outcome was unknown.            No concomitant medications were reported. Treatment medications are not provided.; Reporter's Comments: This spontaneous case concerns a female patient of unknown age with no medical history information reported, who experienced the unexpected serious (medically significant) AESI of pulmonary embolism. The event occurred after the second dose of SPIKEVAX NOS. As reported, patient developed bilateral pulmonary embolisms after receiving her 2nd Moderna Covid Vaccine. No further information about the events was provided. The benefit-risk relationship of SPIKEVAX NOS is not affected by this report.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Insomnia, Overdose
Clinical narrative: Insomnia exacerbated; Given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml; This spontaneous case was reported by an other health care professional and describes the occurrence of INSOMNIA (Insomnia exacerbated) and OVERDOSE (Given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml) in a  child of an unknown age and gender exposed to mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch no. AU5556B) , while the mother received the product for COVID-19 immunisation.    CO-SUSPECT PRODUCT exposures included INFLUENZA VACCINE INACT SPLIT 4V (QUADRIVALENT INFLUENZA VACCINE).    Concurrent medical conditions included Insomnia.   On 09-Feb-2024, the mother received dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (unknown route) .5 milliliter and dose of INFLUENZA VACCINE INACT SPLIT 4V (QUADRIVALENT INFLUENZA VACCINE) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 09-Feb-2024, the child was diagnosed with INSOMNIA (Insomnia exacerbated) and OVERDOSE (Given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml). The delivery occurred on an unknown date, which was reported as Premature. For neonate 1, The outcome was reported as Pre-Term Birth NOS. At the time of the report, INSOMNIA (Insomnia exacerbated) and OVERDOSE (Given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml) outcome was unknown.        For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  It was not reported if the patient received a corrective treatment for the events.
Sex: F
Vaccine: COVID19, FLUX, RVX
Symptoms: Rash
Clinical narrative: a bad rash on her side that spread over most of her upper body and lasted for about four months; This spontaneous case was reported by a patient and describes the occurrence of RASH (a bad rash on her side that spread over most of her upper body and lasted for about four months) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect products included non-company products RSV VACCINE for an unknown indication and INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Concurrent medical conditions included Drug allergy (Tixocortol-21-Pivalate), Bronchiectasis and Allergy to chemicals (Gold Sodium Thiosulfate).   In 2023, the patient received dose of RSV VACCINE (unknown route) 1 dosage form. In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. In 2023, the patient experienced RASH (a bad rash on her side that spread over most of her upper body and lasted for about four months). At the time of the report, RASH (a bad rash on her side that spread over most of her upper body and lasted for about four months) had 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.   No concomitant medication was reported.  The patient got the Moderna COVID-19 Vaccine booster in early Oct 2023, and she got the flu shot at the same time. Two weeks later, per the doctor's instructions, the patient had the RSV vaccine. Four days after that, the patient got a bad rash on her side that spread over most of her upper body and lasted for about four months. Subsequently, the patient was tested for chemical & metallic substances, and it was determined that she was allergic to Tixocortol-21-Pivalate and Gold Sodium Thiosulfate. The patient's pulmonologist was advising her to get the newest booster for COVID-19 as she has Bronchiectasis.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2024: Live significant follow up received: Co-suspect added On 09-Jun-2024: Live non-significant follow-up received: Narrative updated On 09-Jun-2024: Live significant information added. Medical history updated. On 09-Jun-2024: Live non-significant follow-up received.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: pericarditis; This spontaneous case was reported by a patient and describes the occurrence of PERICARDITIS (pericarditis) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERICARDITIS (pericarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 01-Jun-2021 to 02-Jun-2021 due to PERICARDITIS. At the time of the report, PERICARDITIS (pericarditis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient was hospitalized on the 1st of June 2021 for 1 night and received treatment for pericarditis. but information about treatment not provided. Symptoms were the following: lot of pain in the upper body, not able to walk and diagnosed with pericarditis.   Company Comment: This is a spontaneous case concerning a 36-year-old, male patient with no reported medical history, who experienced the serious (due to medically significant and hospitalization) expected, event of Pericarditis, which occurred 11 days after the first dose of mRNA-1273 vaccine. Patient reported a lot of pain in the upper body, not able to walk and was diagnosed with pericarditis. He was hospitalized for one night and received treatment (without details). The outcome was reported as not recovered. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2024: Live non-significant follow-up received
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Rheumatoid arthritis: METHOTREXATE. Past adverse reactions to the above products included No adverse effect with METHOTREXATE. Concurrent medical conditions included Rheumatoid arthritis and Immunocompromised (Low immunity).    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. Reporter stated that medication reduces the effectiveness of the COVID vaccine. Patient also had several extra COVID shots and told her to get another one now because it had been over six months since her last one. As per patient, her last dose was October 2023 and it was about her 10th or 11th or maybe even 12 because of her low immunity. Patient had gotten extra shots. It was reported that patient did not experience any side effects and the only side effects, she ever had been the normal ones that people had, a sore arm and a headache for a day and a half or two days. Patient also stated that she did not have the shot in many months and never had COVID. She was extra, extra careful. Patient stated that her doctor does want her to get another one, another vaccine. Patient stated she does not want to get the Pfizer because she only had the Moderna and had just the limited reaction. It was reported that she has to stop the methotrexate for two weeks after she get the Moderna shot. The treatment medication was not reported by reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Nov2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (BOOSTER), unknown manufacturer), for COVID-19 immunization. No Known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid as treatment from 30May2024 to 04Jun2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: vaccine brand=Pfizer / BioNTech, vaccine brand other=Moderna; COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 as dose 1 (toppac); single (Lot number: HG4629) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: peanuts" (unspecified if ongoing); "known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, lot number=32030BD,, Anatomical location: Left arm), administration date: 02May2022, for COVID-19 immunization; moderna COVID-19 vaccine (DOSE 3 SINGLE, lot number=AS7163B, Anatomical location: Left arm), administration date: 04Oct2022, for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand=Pfizer / BioNTech, vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other vaccination and medication in 2 weeks. Paxlovid was given as treatment for COVID-19 from 30May2024 to 04Jun2024. Rebound COVID - tested positive again 5 days after completing Paxlovid treatment.
Sex: M
Vaccine: COVID19
Symptoms: Autism spectrum disorder
Clinical narrative: Autism; This is a spontaneous report and received from Consumer or other non HCPs.  A 22-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's family history included: "autism" (unspecified if ongoing), notes: runs in family, in general. The patient's concomitant medications were not reported. The following information was reported: AUTISM SPECTRUM DISORDER (medically significant), outcome "unknown", described as "Autism". Clinical course: Caller stated, he had adverse effect from Corona virus vaccine, has autism now. (PRIVACY) stated that all the time, he seems like he was very smart but, socially awkward. Felt like, since he got Covid vaccine, roughly 6 months ago it has affected him negatively in that sense. Clarified, was caller referring to Pfizer Covid vaccine. Reporter was head of janitorial staff at (privacy). Clarified, he has never worked as physician, pharmacist or nurse. Got his GED though.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Physician.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Jan2024 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: medical tape" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, stop date: 02Jun2024; TADALAFIL, stop date: 02Jun2024; OMEPRAZOLE; CITRUCEL; DOCUSATE SODIUM; POLYETHYLENE GLYCOL COMPOUND; MULTIVITAMINS [VITAMINS NOS]. Vaccination history included: pfizer / biontech (DOSE NUMBER UNKNOWN), administration date: 04Oct2022, when the patient was 70-year-old, for Covid-19 immunization; moderna (DOSE NUMBER UNKNOWN), administration date: 05Aug2023, when the patient was 71-year-old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID as COVID-19 treatment from 02Jun2024 to 06Jun2024.  The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event vaccination failure. This case will be reassessed upon receipt of additional information.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Hemophilia" (unspecified if ongoing); "gluten allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "possible sjogrens" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset May2024, outcome "recovered" (01Jun2024); DRUG INEFFECTIVE (medically significant) with onset May2024, outcome "recovered" (01Jun2024). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Covid tests, more rapidly showing positive; (01Jun2024) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 27May2024 to 31May2024.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Angiocardiogram, Arteriogram, Atrial fibrillation, Blood test, Cardiac stress test
Clinical narrative: A-Fib; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 23Jul2021 as dose 1, single (Lot number: EW0173) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "She has allergy asthma" (unspecified if ongoing); "She has allergy asthma. Like when get to next to a dog." (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: BREO ELLIPTA oral taken for hypersensitivity. The following information was reported: ATRIAL FIBRILLATION (hospitalization) with onset 15Dec2021, outcome "unknown", described as "A-Fib". The patient was hospitalized for atrial fibrillation (start date: 15Dec2021, discharge date: 16Dec2021, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: Angiocardiogram: Unknown results; Arteriogram: Unknown results; Blood test: Unknown results; Cardiac stress test: Unknown results; Chest X-ray: Unknown results; Computerised tomogram thorax: Unknown results; Echocardiogram: Unknown results; Lab  test: Unknown results; Scan myocardial perfusion: Unknown results; Stress echocardiogram: Unknown results; Ultrasound scan: Unknown results; Electrocardiogram: Unknown results. Therapeutic measures were taken as a result of atrial fibrillation. Clinical course: Reporter on the line called to report side effect Pfizer Covid 19 Vaccine that she got. She did not have an underlying condition before the vaccination. However, she has had A-Fib after the vaccination. She commented she does not know how old she was currently. Thinks she was maybe as clarified 56 years old when event started. It would be 2 years ago from whatever age she is today. Reporter clarified dates of experiencing A-Fib as the: 1st Time: A-Fib occurred on 15Dec2021, 2nd Time: A-Fib occurred on 27Nov2023, 3rd Time: A-Fib occurred on 10May2024. On all three occasions she was hospitalized for 2 days. She was hospitalized on the date the fast heart beat started. The second time she was hospitalized 27Nov2023 to 28Nov2023. The third time she was hospitalized 10May2024 to 11May2024. Treatment/ Intervention: Now, she was on three medications with no underlying conditions. This was why she was so upset. They could not find a point of what she has. Initially stated the first time she was sent home with Diltiazem 120mg capsule to take every night before sleep. She later clarified this was started after the second occurrence. She started this Nov2023. After the third occurrence of A-Fib since this was the third time and had has three episodes they added Eliquis 5mg tablet to take every day during the day. She was also put on Amiodarone 200mg tablet to take every day in the morning with the Eliquis. Had to do exercise where they make you walk on treadmill to make heartbeat accelerate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram thorax, Echocardiogram, Electrocardiogram, Laboratory test
Clinical narrative: A-Fib; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 23Jul2021 as dose 1, single (Lot number: EW0173) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "She has allergy asthma" (unspecified if ongoing); "She has allergy asthma. Like when get to next to a dog." (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: BREO ELLIPTA oral taken for hypersensitivity. The following information was reported: ATRIAL FIBRILLATION (hospitalization) with onset 15Dec2021, outcome "unknown", described as "A-Fib". The patient was hospitalized for atrial fibrillation (start date: 15Dec2021, discharge date: 16Dec2021, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: Angiocardiogram: Unknown results; Arteriogram: Unknown results; Blood test: Unknown results; Cardiac stress test: Unknown results; Chest X-ray: Unknown results; Computerised tomogram thorax: Unknown results; Echocardiogram: Unknown results; Lab  test: Unknown results; Scan myocardial perfusion: Unknown results; Stress echocardiogram: Unknown results; Ultrasound scan: Unknown results; Electrocardiogram: Unknown results. Therapeutic measures were taken as a result of atrial fibrillation. Clinical course: Reporter on the line called to report side effect Pfizer Covid 19 Vaccine that she got. She did not have an underlying condition before the vaccination. However, she has had A-Fib after the vaccination. She commented she does not know how old she was currently. Thinks she was maybe as clarified 56 years old when event started. It would be 2 years ago from whatever age she is today. Reporter clarified dates of experiencing A-Fib as the: 1st Time: A-Fib occurred on 15Dec2021, 2nd Time: A-Fib occurred on 27Nov2023, 3rd Time: A-Fib occurred on 10May2024. On all three occasions she was hospitalized for 2 days. She was hospitalized on the date the fast heart beat started. The second time she was hospitalized 27Nov2023 to 28Nov2023. The third time she was hospitalized 10May2024 to 11May2024. Treatment/ Intervention: Now, she was on three medications with no underlying conditions. This was why she was so upset. They could not find a point of what she has. Initially stated the first time she was sent home with Diltiazem 120mg capsule to take every night before sleep. She later clarified this was started after the second occurrence. She started this Nov2023. After the third occurrence of A-Fib since this was the third time and had has three episodes they added Eliquis 5mg tablet to take every day during the day. She was also put on Amiodarone 200mg tablet to take every day in the morning with the Eliquis. Had to do exercise where they make you walk on treadmill to make heartbeat accelerate.