chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Malaise
Clinical narrative: Feeling really bad/Feeling super crappy; Chills; Sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling bad 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 feeling bad (Verbatim: Feeling really bad/Feeling super crappy), chills (Verbatim: Chills) and sickness (Verbatim: Sick). The outcome of the feeling bad was resolved and the outcome of the chills and sickness were unknown.   It was unknown if the reporter considered the feeling bad, chills and sickness to be related to Shingrix.     It was unknown if the company considered the feeling bad, chills and sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-JUL-2024 The reporter was a friend of the patient. The age of the patient was between 55 years and 75 years old. The patient got sick after receiving the Shingrix vaccine.  The patient reported chills and feeling super crappy. The patient felt really bad after receiving the Shingrix vaccine, but it was short lived. This was 1 of 4 linked cases by the same reporter for different patients.; Sender's Comments:  US-GSK-US2024095868:Same reporter/Male patient US-GSK-US2024095870:Same reporter/Female patient US-GSK-US2024AMR096058:Same reporter/Female patient US-GSK-US2024AMR096059:Same reporter/Female patient
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Underdose
Clinical narrative: only got half dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 4-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 29-JUL-2024, the patient received Kinrix. On 29-JUL-2024, an unknown time after receiving Kinrix, the patient experienced accidental underdose (Verbatim: only got half dose). The outcome of the accidental underdose 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: 30-JUL-2024 4 year old patient went to get vaccinated, when Kinrix was applied the boy moved and the needle came out and they decided not to inject him again, he only got half dose which led to Accidental underdose.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Wrong technique in product usage process
Clinical narrative: Half of adult dose administered to pediatric patient; Half of adult dose administered to pediatric patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 17-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   In JUL-2024, the patient received Engerix B adult. In JUL-2024, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Half of adult dose administered to pediatric patient) and wrong technique in drug usage process (Verbatim: Half of adult dose administered to pediatric patient). The outcome of the adult product administered to child and wrong technique in drug usage process 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: 30-JUL-2024 The pharmacist called and reported that a week ago the patient received half of an adult dose of Engerix B, which led to adult product administered to child and wrong technique in drug usage process. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: infant was administered Kinrix; infant was administered Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 23-JUL-2024, the patient received Kinrix. On 23-JUL-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: infant was administered Kinrix) and inappropriate age at vaccine administration (Verbatim: infant was administered Kinrix). The outcome of the wrong vaccine administered was unknown and the outcome of the inappropriate age at vaccine administration was not reported.   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: 30-JUL-2024 Healthcare professional was the reporter.  Called to report that an infant was administered Kinrix which led to wrong Vaccine Administered and inappropriate age at vaccine administration. No further information is known including lot number.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: a dose of Priorix was given intramuscularly instead of subcutaneously; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 1-year-old male patient who received MMR (Priorix) (batch number 9594A, expiry date 01-DEC-2024) for prophylaxis.   On 29-JUL-2024, the patient received Priorix (intramuscular). On 29-JUL-2024, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: a dose of Priorix was given intramuscularly instead of subcutaneously). The outcome of the subcutaneous injection formulation administered by other route 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: 30-JUL-2024 According to the other health professional (practice manager), a dose of Priorix was given IM (intramuscularly) instead of SQ (subcutaneously), which led to subcutaneous injection formulation administered by other route. The reporter reported that, a nurse gave a dose of Priorix and he/she needed to find out if the vaccine needs to be re given or if there was going to be any efficacy with that injection. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: liquid conjugate portion of Menveo was likely administered to two patients as they found two doses; liquid conjugate portion of Menveo was likely administered to two patients as they found two doses; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: liquid conjugate portion of Menveo was likely administered to two patients as they found two doses) and inappropriate dose of vaccine administered (Verbatim: liquid conjugate portion of Menveo was likely administered to two patients as they found two doses). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 31-JUL-2024 An office coordinator reported that the liquid conjugate portion of Menveo was likely administered to two patients as they found two doses where it was missing and only the lyophilized portion remained which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter stated she was still investigating to find out who may have received the conjugate portion doses and she had no details at time of reporting but stated if she can find any details she would provide them in follow-up from safety.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Reports that there was approximately 15 months between receiving dose 1 and dose 2 of suspect vaccine.; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 453S4, expiry date 19-MAR-2022) for prophylaxis.   Previously administered products included Shingrix (on 10th February 2020 received 1st dose with batch number 453S4 and expiry date 19 March 2022).   On 26-MAY-2021, the patient received the 2nd dose of Shingrix. On 26-MAY-2021, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Reports that there was approximately 15 months between receiving dose 1 and dose 2 of suspect vaccine.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 31-JUL-2024 The patient self-reported. She stated that there was approximately 15 months between receiving dose 1 and dose 2 of suspect vaccine.  The reporter would like follow up to be done with administering pharmacy and she feels that the Adverse Event was due to not being given an appointment for the second dose. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule. This case was linked with case US2024095889 with same reporter.; Sender's Comments:  US-GSK-US2024095889:Same reporter/Different patient
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Vaccine was given after the expiration date; 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 22-year-old female patient who received MMR (Priorix) (batch number CB979, expiry date 13-MAY-2024) for prophylaxis.   On 31-JUL-2024, the patient received Priorix. On 31-JUL-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Vaccine was given after the expiration date). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-JUL-2024 Vaccine was given after the expiration date Consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: system was telling her that the patient received an invalid dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (on an unknown date received 1st dose).   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 incomplete dose administered (Verbatim: system was telling her that the patient received an invalid dose). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt date: 31-JUL-2024 A pharmacist reported that system was telling her that the patient received an invalid dose, and also the patient did not remember whether if received that second dose.  The reporter wanted to know was there any recommendation about this, pharmacist did not know if this was a system error, or so, but needs further assistance in this situation.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Muscle spasms, Nausea
Clinical narrative: she had terrible cramps in her legs/The leg cramps were really bad.'; she felt nauseous and had a headache.; she felt nauseous and had a headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of leg cramps in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (history of two episodes of shingles (first case was mild, second case was worse).   In MAY-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, between 1 and 3 months after receiving Shingrix, the patient experienced leg cramps (Verbatim: she had terrible cramps in her legs/The leg cramps were really bad.'), headache (Verbatim: she felt nauseous and had a headache.) and nausea (Verbatim: she felt nauseous and had a headache). The outcome of the leg cramps, headache and nausea were resolved (duration 1 day).   The reporter considered the leg cramps, headache and nausea to be related to Shingrix.     The company considered the leg cramps, headache and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-JUL-2024 The patient self-reported this case. The patient received 1st dose of Shingrix vaccine and she had terrible cramps in her legs with both legs and calves like she never had before and the leg cramps were really bad. The leg cramps were so bad that she had to lay down and also she felt nauseous and had a headache.  These events resolved after one day. She stated that her doctor said that her reaction to Shingrix was very unusual and her doctor was letting her decide if she would get 2nd dose or not. The reporter did not consent to follow-up.
Age: 18.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Interchange of vaccine products
Clinical narrative: second dose was Menquadfi advised them not to get the Menveo vaccine,received Menveo vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis.   Previously administered products included Meningococcal vaccine A (received 1st dose on 31-OCT-2017).   On 31-JUL-2024, the patient received Menveo. On 20-JUL-2023, the patient received the 2nd dose of Menquadfi. On 31-JUL-2024, an unknown time after receiving Menveo, the patient experienced interchange of vaccine products (Verbatim: second dose was Menquadfi advised them not to get the Menveo vaccine,received Menveo vaccine). The outcome of the interchange of vaccine products was unknown.   Additional Information: GSK Receipt Date: 01-AUG-2024 The reporter reported that the patients school asked that they received a Meningococcal A and B vaccine before attending.  According to the patients charts, the patient received a Meningococcal A vaccine (no brand name on chart) and the patient's got second dose which was Menquadfi. The healthcare professional (HCP) advised them not to get the Menveo vaccine, but the patient went to a pharmacy and received the Menveo vaccine against doctors recommendations. The patient received a dose of Menquadfi and Menveo, which led to interchange of vaccine products. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: patient that had their shingrix 2nd dose 3 years after 1st dose because of covid.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose).   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 social problem (Verbatim: patient that had their shingrix 2nd dose 3 years after 1st dose because of covid.). The outcome of the social problem was unknown.   Additional Information: GSK receipt date: 25-MAY-2024 The patient that had their shingrix 2nd dose 3 years after 1st dose because of covid, which led to social problem.  The reporter asked if that acceptable for coverage. Did not consent to follow-up.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: underdose; Maladministration of Pediatric Dose on an Adult Patient - Inappropriate Dose Administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HBV (Engerix B) (batch number 4ZN3H, expiry date 28-FEB-2025) for prophylaxis.   Previously administered products included Pediarix (on an unknown date received initial dose for hep b like the 3 doses) and Pediarix (on 24th August 2004, receive additional dose, 4th dose).   On 01-AUG-2024, the patient received Engerix B. On 01-AUG-2024, an unknown time after receiving Engerix B, the patient experienced underdose (Verbatim: underdose) and adult use of a child product (Verbatim: Maladministration of Pediatric Dose on an Adult Patient - Inappropriate Dose Administered). The outcome of the underdose was not reported and the outcome of the adult use of a child product 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: 01-AUG-2024 Medical Assistant reports that a female patient came today and needed a booster of Hep B (second dose), she received a pediatric dose instead of an adult dose, which led to underdose and adult use of child product. She requested for advise on this situation.  The Vaccine Administration Facility was the same as Primary Reporter. The patient had an initial dose for hep b like the 3 doses (Pediarix) that you need to get when you are younger and she had an additional dose which would be her 4th dose (HCP believed that these doses were Pediarix), which complete her series, but she had some blood work done and they said that she need to basically re do the hep b series again for kind of like a booster.  Her first dose of the new series of Hep B was a Engerix-B pediatric formulation. Consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received the first dose of Shingrix on 2021 and I'm inquiring if do we need to restart the series or just give the second 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 the 1st dose in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received the first dose of Shingrix on 2021 and I'm inquiring if do we need to restart the series or just give the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-AUG-2024 The patient was more than 50 years old. The pharmacist reported that they had a patient who last received the first dose of Shingrix in 2021 and was inquiring if do they need to restart the series or just give the second dose. The reporter was not sure if patient was considered immunocompromised or not. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered the 1st dose of Bexsero on June 29th and it expired on March 31, 2024; 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 female patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   On 29-JUN-2024, the patient received the 1st dose of Bexsero. On 29-JUN-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: administered the 1st dose of Bexsero on June 29th and it expired on March 31, 2024). 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: 01-AUG-2024 Operations Manager states they administered the 1st dose of Bexsero on June 29th and it expired on March 31, 2024, which led to expired vaccine used. Consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received first dose of Shingrix on 29Mar2021 and did not receive second dose until 31May2024; 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 elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 29 March 2021 received 1st dose).   On 31-MAY-2024, the patient received the 2nd dose of Shingrix. On 31-MAY-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received first dose of Shingrix on 29Mar2021 and did not receive second dose until 31May2024). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 01-AUG-2024 The pharmacist reported female patient received first dose of Shingrix on 29th March 2021 and did not receive second dose until 31st May 2024, which led go lengthening of vaccination schedule. The patient's pharmacist recommended an additional dose for this patient but at the time of reporting, an additional dose has not been administered. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Deep vein thrombosis; This solicited report received from a consumer via PPSCVM000808: Janssen for XARELTO concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported (dose series 1), administered on 08-APR-2021 for covid-19 prophylaxis. Batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced deep vein thrombosis (dose series 1). Patient was then prescribed Xarelto. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deep vein thrombosis was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and deep vein thrombosis was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0;  Deep vein thrombosis; The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Have had every vaccine available to me in a timely manner and first time covid positive. Had a Moderna vaccine 2 weeks prior to infection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Have had every vaccine available to me in a timely manner and first time covid positive. Had a Moderna vaccine 2 weeks prior to infection) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (received last fall). Past adverse reactions to the above products included No adverse effect with PFIZER BIONTECH COVID-19 VACCINE.    In June 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In June 2024, the patient experienced COVID-19 (Have had every vaccine available to me in a timely manner and first time covid positive. Had a Moderna vaccine 2 weeks prior to infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral use) from 29-Jun-2024 to 03-Jul-2024 for COVID-19 treatment, at a dose of 2 x day and IBUPROFEN (ADVIL [IBUPROFEN]) for Inflammation, at a dose of 2 per day during infection only. At the time of the report, COVID-19 (Have had every vaccine available to me in a timely manner and first time covid positive. Had a Moderna vaccine 2 weeks prior to infection) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2024, SARS-CoV-2 test: Positive.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported. The patient had the Moderna vaccine 2 weeks prior to the infection and had Pfizer vaccine last fall. The patient was not taking any other medications within 2 weeks prior to the event onset.  For the first time, the patient became COVID positive. The patient began Paxlovid with symptoms on day 1 of positive test, no symptoms there on day 5, followed by 2 negative tests, on day 10, again patient got COVID positive, had stronger symptoms, fatigue (for 6 more days until negative), still had congestion and fatigue and the patient was surprised by rebound severity.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Pyrexia
Clinical narrative: Extreme dizzy spells; had "103 temperature" after the 2nd shot; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Extreme dizzy spells) and PYREXIA (had "103 temperature" after the 2nd shot) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 013A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced DIZZINESS (Extreme dizzy spells) and PYREXIA (had "103 temperature" after the 2nd shot). At the time of the report, DIZZINESS (Extreme dizzy spells) and PYREXIA (had "103 temperature" after the 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 103 temperature after the 2nd shot.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. No effects from 1st shot according to patient. Patient stated that about a week to 10 days (within a week) after second vaccination he was out for running (patient stated that he was a runner) and was about a mile or so out and experienced extreme dizzy spells.  He stated that he was in great shape at current age of 72 years and doctors ran tests and were unable to find anything wrong and everything came back negative (lab test).  Patient stated that after second vaccination he almost died and that it put him in bed for a day and he had 103 temperatures after the second shot. No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Aortic aneurysm repair, Aortic valve replacement, Cardiac pacemaker insertion
Clinical narrative: valve and root replacement and a pacemaker was installed; valve and root replacement and a pacemaker was installed; valve and root replacement and a pacemaker was installed; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC PACEMAKER INSERTION (valve and root replacement and a pacemaker was installed), AORTIC ANEURYSM REPAIR (valve and root replacement and a pacemaker was installed) and AORTIC VALVE REPLACEMENT (valve and root replacement and a pacemaker was installed) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC PACEMAKER INSERTION (valve and root replacement and a pacemaker was installed), AORTIC ANEURYSM REPAIR (valve and root replacement and a pacemaker was installed) and AORTIC VALVE REPLACEMENT (valve and root replacement and a pacemaker was installed). At the time of the report, CARDIAC PACEMAKER INSERTION (valve and root replacement and a pacemaker was installed), AORTIC ANEURYSM REPAIR (valve and root replacement and a pacemaker was installed) and AORTIC VALVE REPLACEMENT (valve and root replacement and a pacemaker was installed) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.  It was unknown if patient had allergy, concomitant diseases and risk factor.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2024: Live non-significant follow-up received; reference number added.
Sex: M
Vaccine: COVID19
Symptoms: Tooth loss
Clinical narrative: losing his teeth since he got the Moderna shot; This spontaneous case was reported by a patient and describes the occurrence of TOOTH LOSS (losing his teeth since he got the Moderna shot) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) 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. On an unknown date, the patient experienced TOOTH LOSS (losing his teeth since he got the Moderna shot). At the time of the report, TOOTH LOSS (losing his teeth since he got the Moderna shot) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. It was reported that patient received Moderna vaccine a couple year ago and since then patient started to lose his teeth. It was also reported that before vaccination some teeth were missed for patient. Prior to vaccination patient had near about 15 teeth but post vaccination patient had only seven teeth left. No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2024: Live follow-up received, and follow-up information included no new information.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Cutaneous lymphoma
Clinical narrative: skin lymphoma/worsened; This is a spontaneous report and received from Consumer or other non HCPs from medical information team, Program ID.  A 74-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Jan2024 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, anatomical location: Regular dose, in arm; Time administered: Doesn't remember, probably late morning), administration date: 23Feb2021, when the patient was 71-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, anatomical location: Regular dose, in arm; Time administered: Doesn't remember, probably late morning), administration date: 16Mar2021, when the patient was 71-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, anatomical location: Regular dose, in arm; Time administered: Doesn't remember, probably late morning), administration date: 29Oct2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, anatomical location: Regular dose, in arm; Time administered: Doesn't remember, probably late morning), administration date: 15Apr2022, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, anatomical location: Regular dose, in arm; Time administered: Doesn't remember, probably late morning), administration date: 12Nov2022, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "skin lymphoma". The following information was reported: CUTANEOUS LYMPHOMA (medically significant), outcome "not recovered", described as "skin lymphoma/worsened". The event "skin lymphoma/worsened" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: Unknown results, notes: Working on biopsy, has two takes on biopsy, and working on a third. Clinical course: When patient was asked if patient had experienced skin lymphoma as an after effect of the Covid vaccines, patient answered that she is pretty sure she have it and have had 6 Pfizer vaccines. She has a condition that may be related to the vaccines. Clarified the condition patient has dermatologist thinks is skin lymphoma. Started last summer (unspecified), then progressed, trying to work on it now, pathologist is doing round three for biopsy and physical picture, trying to nail a diagnosis, but think that is what it is. Confirmed started after having Pfizer COVID vaccines, thinks occurred after receiving 5th dose of Pfizer COVID vaccine.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder, Melanocytic naevus, Precancerous skin lesion
Clinical narrative: moles are pre-cancerous; More than 20 moles have been taken out. More moles continue to come up.; immune system was against him; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single for covid-19 immunisation. The patient's relevant medical history included: "platelet disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 omi xbb.1.5 (DOSE 1, SINGLE (Comirnaty and/or Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula))), for Covid-19 immunization, reaction(s): "Mole of skin".  The following information was reported: PRECANCEROUS SKIN LESION (medically significant), outcome "unknown", described as "moles are pre-cancerous"; MELANOCYTIC NAEVUS (non-serious), outcome "unknown", described as "More than 20 moles have been taken out. More moles continue to come up."; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "immune system was against him".  Clinical course: The caller was called on half of her son who has a platelet disorder. She wanted to know if Zavzpret would have any platelet related reaction if her son takes it. The caller had another inquiry regarding her son who had a platelet disorder. Her son mentioned that he got two shots of the Pfizer Covid-19 vaccine and said that all problems started after that his immune system was against him. More than 20 moles have been taken out. More moles continue to come up. She said that these moles are pre-cancerous. She wanted to know any information about this. No information found on blood diseases, cancer, or mole development with the Pfizer Covid-19 vaccine.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Vaccination site bruising
Clinical narrative: Adverse reaction to the RSV immunization/Bruise mark about 3 inches long; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 29Jul2024 as dose number unknown, 0.5 ml, single (Lot number: Unknown) at the age of 70 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset 05Aug2024, outcome "unknown", described as "Adverse reaction to the RSV immunization/Bruise mark about 3 inches long". Therapeutic measures were not taken as a result of vaccination site bruising. Additional information: the patient had an adverse reaction to the RSV immunization. She had a bruise mark about 3 inches long and that was not under it until today (at the time of report). The patient had no vaccinations four weeks prior.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Had COVID 3 times; Had COVID 3 times; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) 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 relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had COVID 3 times". Clinical Course: Patient stated, He had the vaccination each one that come on and all the boosters. Patient never taken the Paxlovid, was in line in the (withheld) trying to get the Paxlovid. Patient had not consumed the medication, was trying to get the Pax though, but have to see how much it will cost now, got the discount card. Patient was trying to talk to the pharmacist, because patient was trying to pick up the medication right now.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Death, Interchange of vaccine products
Clinical narrative: Death; Interchange of vaccine products; Safety information originally reported under manufacturer case PV202300039938 has been nullified and re-entered under this new manufacturer report number 202400232373.  This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Dose 1, single, lot number unknown), for COVID-19 immunisation. The following information was reported: DEATH (death), outcome "fatal"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. On an unspecified date (post 1 week of vaccination), the patient died from an unknown cause of death (dose number in series 2). The reporter seated that "My brother died a week after he got a booster. His first vaccine was J&J, booster was Pfizer". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Follow-up (07Aug2024): This is a follow-up report to notify that the case 202400232373 and PV202300039938 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202400232373.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: resident passed away in his sleep; Safety information originally reported under manufacturer case PV202200075864 has been nullified and re-entered under this new manufacturer report number 202400232531.  This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An 80-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cerebrovascular accident" (unspecified if ongoing), notes: History of MI (Myocardial infarction), Dementia, COPD, Penicillins; "Myocardial infarction" (unspecified if ongoing), notes: History of MI (Myocardial infarction), Dementia, COPD, Penicillins; "Dementia" (unspecified if ongoing), notes: History of MI (Myocardial infarction), Dementia, COPD, Penicillins; "Chronic obstructive pulmonary disease" (unspecified if ongoing), notes: History of MI (Myocardial infarction), Dementia, COPD, Penicillins; "History/Allergies: Penicillins" (unspecified if ongoing), notes: History of MI (Myocardial infarction), Dementia, COPD, Penicillins. Concomitant medication(s) included: REMERON; MEMANTINE; PLAVIX; CARVEDILOL; ACETYLSALICYLIC ACID; TRAZODONE. Vaccination history included: Covid-19 vaccine (Dose Number: 01, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 02, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 03, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 04, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DEATH (death, medically significant) with onset 10Sep2022, outcome "fatal", described as "resident passed away in his sleep". The patient date of death was 10Sep2022. The reported cause of death was unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: Removed events Off label use and Incorrect dose administered.  Follow-up (07Aug2024): This is a follow-up report to notify that the case PV202200075864 and 202400232531 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202400232531.; Reported Cause(s) of Death: resident passed away in his sleep
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: kills people; Safety information originally reported under manufacturer case PV202300004826 has been nullified and re-entered under this new manufacturer report number 202400232549.  This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "kills people". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The reporter said Pfizer is evil, terrorist and it kills people.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (07Aug2024): This is a follow-up report to notify that the case 202400232549 and PV202300004826 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202400232549.; Reported Cause(s) of Death: kills people
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 21 year old dropping dead; Safety information originally reported under manufacturer case PV202300012864 has been nullified and re-entered under this new manufacturer report number 202400232556.  This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A 21-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "21 year old dropping dead". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: It was reported that caller was asking on how Pfizer measures the success of the Pfizer covid 19 vaccine because the Pfizer vaccine killed less than the Moderna and the Johnson and Johnson. Caller also mentioned about the 21 year old dropping dead; that Pfizer was murdering people.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (07Aug2024): This is a follow-up report to notify that the case PV202300012864 and 202400232556 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202400232556.; Reported Cause(s) of Death: 21 year old dropping dead