chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: received an adult dose of Engerix B; pediatric patient received an adult dose of Engerix B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 3-month-old male patient who received HBV (Engerix B adult) (batch number NT9X3, expiry date 09-SEP-2024) for prophylaxis.   On 08-JAN-2024, the patient received Engerix B adult. On 08-JAN-2024, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: received an adult dose of Engerix B) and adult product administered to child (Verbatim: pediatric patient received an adult dose of Engerix B). The outcome of the overdose and adult product administered to child 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: 19-JAN-2024 The medical assistant reported that pediatric patient received an adult dose of Engerix B, which led to overdose and adult product administered to child. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Injection site mass
Clinical narrative: Wrong route of administration/ Boostrix vaccine given subcutaneously; has a lump under the skin at the injection site; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site lump in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 17-JAN-2024, the patient received Boostrix (subcutaneous). In JAN-2024, an unknown time after receiving Boostrix, the patient experienced injection site lump (Verbatim: has a lump under the skin at the injection site). On 17-JAN-2024, the patient experienced intramuscular formulation administered by other route (Verbatim: Wrong route of administration/ Boostrix vaccine given subcutaneously). The outcome of the injection site lump and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site lump to be related to Boostrix.     It was unknown if the company considered the injection site lump to be related to Boostrix.   Additional Information: GSK receipt date: 19-JAN-2024 The GlaxoSmithKline field representative reported that a practice manager called and emailed him to let him know that a patient received Boostrix vaccine SC (subcutaneously) not IM (intramuscularly), which led to an intramuscular formulation administered by other route, and the patient also had a lump under the skin at the injection site. No patient demographics, lot or expiry information provided, and product also not verified. No further information provided. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Hair colour changes
Clinical narrative: Hair turned barbie pink; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of hair color changes in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, several days after receiving Arexvy, the patient experienced hair color changes (Verbatim: Hair turned barbie pink). The outcome of the hair color changes was unknown.   It was unknown if the reporter considered the hair color changes to be related to Arexvy.     It was unknown if the company considered the hair color changes to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-Jan-2024 The reporter reported that the patient received Arexvy vaccine and went to get her hair dyed to blonde and within few days her hair turned Barbie pink.  The stylist could not figure it out and patient stated that the vaccine was the only thing she got differently.  The patient mentioned that she spoke to someone in GlaxoSmithKline and they informed it could happen as per prescribing information and needs to be a counselling point. The reporter consented to follow up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Needle issue, Underdose
Clinical narrative: patient only received approximately half of the dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-JAN-2024, the patient received Shingrix. On 19-JAN-2024, an unknown time after receiving Shingrix, the patient experienced underdose (Verbatim: patient only received approximately half of the dose). The outcome of the underdose was unknown.   Additional Information: GSK Receipt Date: 19-JAN-2024 A healthcare professional (HCP) reported that due to an issue with the needle, a patient only received approximately half of the dose of Shingrix, which led to under dose. No further information was known. The reporter consented to follow up.
Age: 30.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: Arexvy was administered to a pregnant patient; 30 years old patient received arexvy; Arexvy was administered to a pregnant patient instead of the Pfizer RSV vaccine; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 30-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number FN2FD, expiry date 24-FEB-2025) for prophylaxis.   On 19-JAN-2024, the patient received Arexvy. On 19-JAN-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 30 years old patient received arexvy) and wrong vaccine administered (Verbatim: Arexvy was administered to a pregnant patient instead of the Pfizer RSV vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy was administered to a pregnant patient). The outcome of the vaccine exposure during pregnancy, inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 19-JAN-2024 The pharmacist reported that a dose of Arexvy was administered to a pregnant patient, instead of the Pfizer RSV vaccine, which led to vaccine exposure during pregnancy, inappropriate age at vaccine administration and wrong vaccine administered. The reporter consent to follow up.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: administration of Flulaval to patient post excursion 22C x 74 hours; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 81-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2023-2024 season) (batch number 2XT9D, expiry date 30-JUN-2024) for prophylaxis.   On 15-JAN-2024, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: administration of Flulaval to patient post excursion 22C x 74 hours). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-JAN-2024 The patient received Flulaval vaccine post excursion to 22 degree C for 74 hours, which led to incorrect storage of drug. The reporter consented to follow up. This was 1 of the 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024009515:Different patient US-GSK-US2024009520:Different patient US-GSK-US2024009518:Different patient US-GSK-US2024009517:Different patient
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: administration of Flulaval to patient post excursion 22C x 74 hours; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 66-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2023-2024 season) (batch number 2XT9D, expiry date 30-JUN-2024) for prophylaxis.   On 15-JAN-2024, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: administration of Flulaval to patient post excursion 22C x 74 hours). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-JAN-2024 The reporter reported that the patient received Flulaval vaccine post excursion to 22 degree C for 74 hours on 15-JAN-2024, which led to an incorrect storage of drug. The reporter consented to follow up. This case was 1 of 5 linked cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2024009515:Different patient US-GSK-US2024009520:Different patient US-GSK-US2024009516:Different patient US-GSK-US2024009517:Different patient
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: administration of Flulaval to patient post excursion 22C x 74 hours; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 73-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2023-2024 season) (batch number 2XT9D, expiry date 30-JUN-2024) for prophylaxis.   On 15-JAN-2024, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: administration of Flulaval to patient post excursion 22C x 74 hours). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-JAN-2024 The patient received Flulaval vaccine post excursion to 22 degree C for 74 hours, which led to incorrect storage of drug.  The reporter consented to follow up. This was 1 of the 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024009515:Different patient US-GSK-US2024009516:Different patient US-GSK-US2024009517:Different patient US-GSK-US2024009518:Different patient
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: hasn't received a second 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 64-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose about 6 months ago).   On an unknown date, the patient did not received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: hasn't received a second 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: 19-JAN-2024 The pharmacist called to report a patient received a first dose of Twinrix about 6 months ago and had not received a second dose yet. The reporter consented to the follow up via email. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Age: 65.0
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: administration of only the diluent to a patient; administration of only the diluent to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 65-year-old patient who received RSVPreF3 adjuvanted (Arexvy) (batch number sj559, expiry date 01-AUG-2025) for prophylaxis.   On 19-JAN-2024, the patient received the 1st dose of Arexvy. On 19-JAN-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: administration of only the diluent to a patient) and inappropriate dose of vaccine administered (Verbatim: administration of only the diluent to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-JAN-2024 A pharmacist inquired about Arexvy and what information was available about the administration of only the diluent to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist did not wish to give all the information and abandoned the call.  The vaccine administration facility was the same as primary reporter. During the call, the healthcare professional (HCP) waved off the registry of information if it was not present in the data base and they did not wish to present any more information as they were short on time. They did not provide all of the information for an initial filing of an adverse event and place the call on hold until it had to be ended. The reporter did not consent to follow-up.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: the administration of a dose after the expiration date; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 49-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7ZD7L, expiry date 09-DEC-2023) for prophylaxis.   On 06-JAN-2024, the patient received Boostrix. On 06-JAN-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: the administration of a dose after the expiration date). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 19-JAN-2024 A reporter contacted GlaxoSmithKline via phone for inquiring about Boostrix and what information is available about administration of a dose after the expiration date. Partial information about vaccine, patient and event was provided. The patient received expired dose of vaccine which led to expired vaccine used. The Vaccine Administration Facility is the same as PrimaryReporter The reporter consented to follow up.
Age: 22.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 22 year old received Engerix B pediatric; 22 year old received Engerix B pediatric; 22 year old received Engerix B pediatric; 22 year old received Engerix B pediatric; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 22-year-old female patient who received HBV (Engerix B pediatric) (batch number N73FA) and (batch number ZP72S) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis.   On 31-JUL-2023, the patient received the 2nd dose of Engerix B pediatric. On 28-JUN-2023, the patient received the 1st dose of Engerix B pediatric. On 28-JUN-2023, not applicable after receiving Engerix B pediatric and an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: 22 year old received Engerix B pediatric) and adult use of a child product (Verbatim: 22 year old received Engerix B pediatric). On 31-JUL-2023, the patient experienced accidental underdose (Verbatim: 22 year old received Engerix B pediatric) and adult use of a child product (Verbatim: 22 year old received Engerix B pediatric). The outcome of the accidental underdose, adult use of a child product, accidental underdose and adult use of a child product 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: 23-JAN-2024 The reporter stated that a 22 year old patient was inadvertently administered Engerix pediatric doses which led to accidental underdose and adult use of a child product. The reporter mentioned the patient tried to go back to the pharmacy who administered the doses to get the correct doses but pharmacy turned the patient away due to legal issues. The Patient's Doctor advised to contact public health on how to proceed. The Registered Nurse stated they called GlaxoSmithKline for guidance. The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Menveo was given instead of Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 61-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA950A, expiry date 31-JUL-2024) for prophylaxis.   On 15-JAN-2024, the patient received Menveo. On 15-JAN-2024, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: Menveo was given instead of Shingrix). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 23-JAN-2024 The registered nurse reported that a Menveo was administered by mistake to a 61 year old female. The intended vaccine was Shingrix which led to wrong vaccine administered which led to wrong vaccine administered. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Death, Multiple sclerosis, Wheelchair user
Clinical narrative: Death; MS; Wheelchair-bound; This solicited report received from a consumer via PPSCVM000196: Janssen social media Account and concerned multiple patients. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced MS (multiple sclerosis), (dose number in series 1) and wheelchair-bound and died (dose number in series 1). On an unspecified date, the patient died from an unknown cause of death (dose number in series 1). It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not reported for MS and wheelchair-bound; and action taken with covid-19 vaccine ad26.cov2.s was not applicable for death. The outcome of MS and wheelchair-bound was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and death, MS, and wheelchair-bound was not related. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: Death.  The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: NATURE OF EVENT. Therefore, this event(s) is considered not related.  Multiple sclerosis. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered not related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She had COVID Disease and positive home tests 3 times: First time was DEC2021 and it lasted 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (She had COVID Disease and positive home tests 3 times: First time was DEC2021 and it lasted 2 weeks) in a 49-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Vaccination: J&J COVID-19 Vaccine (First dose and Batch/Lot: Unknown) on 08-Apr-2021. Past adverse reactions to the above products included No adverse effect with J&J COVID-19 Vaccine. Concurrent medical conditions included Lupus erythematosus (For many years), Blood pressure high (For many years. She states that she was not on any medications for HBP for 5 years prior to COVID-19 vaccination and her BP was under control.), Rheumatoid arthritis and Anxiety.    On 30-Oct-2021, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In December 2021, the patient experienced COVID-19 (She had COVID Disease and positive home tests 3 times: First time was DEC2021 and it lasted 2 weeks). At the time of the report, COVID-19 (She had COVID Disease and positive home tests 3 times: First time was DEC2021 and it lasted 2 weeks) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Patient was taking anxiety medication. Treatment information was not reported.   This case was linked to MOD-2024-758242 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2024: Live follow-up received and added references.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she only had a little sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (she only had a little sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A and 018F21A) for COVID-19 prophylaxis.     It was clear that patient had no relevant medical history conditions, allergy, concomitant diseases and risk factor. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (she only had a little sore arm). At the time of the report, PAIN IN EXTREMITY (she only had a little sore arm) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2024-758522 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Blood iron decreased, Neutrophil count, Neutrophil count decreased, White blood cell count
Clinical narrative: White blood cell count has plummeted; Iron and percent of saturation went down into the low range; Neutrophils went from mid 1500s to about mid 500s; This spontaneous case was reported by a patient and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (White blood cell count has plummeted), BLOOD IRON DECREASED (Iron and percent of saturation went down into the low range) and NEUTROPHIL COUNT DECREASED (Neutrophils went from mid 1500s to about mid 500s) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (It lasted 3 days.) in August 2022. Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (017HZZA) on 13-Nov-2022; for Product used for unknown indication: Flu Vaccine in January 2024, Pfizer vaccine and Pfizer vaccine. Past adverse reactions to the above products included No adverse event with Flu Vaccine, Moderna covid-19 vaccine, Pfizer vaccine and Pfizer vaccine.    On 20-Jan-2024, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Jan-2024, the patient experienced WHITE BLOOD CELL COUNT DECREASED (White blood cell count has plummeted), BLOOD IRON DECREASED (Iron and percent of saturation went down into the low range) and NEUTROPHIL COUNT DECREASED (Neutrophils went from mid 1500s to about mid 500s). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (White blood cell count has plummeted), BLOOD IRON DECREASED (Iron and percent of saturation went down into the low range) and NEUTROPHIL COUNT DECREASED (Neutrophils went from mid 1500s to about mid 500s) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2024, Blood iron: went down into the low range. On 22-Jan-2024, Neutrophil count: 1500s to about mid 500s. On 22-Jan-2024, White blood cell count: blood cell count has plummeted, it is the high 3s and went down to 2.4.         No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-758232 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-758232:Husband case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count decreased
Clinical narrative: White blood cell count has plummeted; Iron and percent of saturation went down into the low range; Neutrophils went from mid 1500s to about mid 500s; This spontaneous case was reported by a patient and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (White blood cell count has plummeted), BLOOD IRON DECREASED (Iron and percent of saturation went down into the low range) and NEUTROPHIL COUNT DECREASED (Neutrophils went from mid 1500s to about mid 500s) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (It lasted 3 days.) in August 2022. Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (017HZZA) on 13-Nov-2022; for Product used for unknown indication: Flu Vaccine in January 2024, Pfizer vaccine and Pfizer vaccine. Past adverse reactions to the above products included No adverse event with Flu Vaccine, Moderna covid-19 vaccine, Pfizer vaccine and Pfizer vaccine.    On 20-Jan-2024, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Jan-2024, the patient experienced WHITE BLOOD CELL COUNT DECREASED (White blood cell count has plummeted), BLOOD IRON DECREASED (Iron and percent of saturation went down into the low range) and NEUTROPHIL COUNT DECREASED (Neutrophils went from mid 1500s to about mid 500s). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (White blood cell count has plummeted), BLOOD IRON DECREASED (Iron and percent of saturation went down into the low range) and NEUTROPHIL COUNT DECREASED (Neutrophils went from mid 1500s to about mid 500s) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2024, Blood iron: went down into the low range. On 22-Jan-2024, Neutrophil count: 1500s to about mid 500s. On 22-Jan-2024, White blood cell count: blood cell count has plummeted, it is the high 3s and went down to 2.4.         No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-758232 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-758232:Husband case
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood iron, Blood iron decreased, Neutrophil count, Neutrophil count decreased, White blood cell count decreased
Clinical narrative: his White Blood Cell Count went from 6 to mid 3s," "his neutrophils went down, they dropped,"; his Iron and percent of saturation went down into the low range.; his neutrophils went down, they dropped; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (his White Blood Cell Count went from 6 to mid 3s," "his neutrophils went down, they dropped,"), BLOOD IRON DECREASED (his Iron and percent of saturation went down into the low range.) and NEUTROPHIL COUNT DECREASED (his neutrophils went down, they dropped) in a 67-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (her husband had covid in August 2022 on his birthday It lasted 3 days.) in August 2022. Previously administered products included for COVID-19 prophylaxis: Moderna (Dose 3 and booster) on 13-Nov-2022; for Product used for unknown indication: FLU in January 2024, Pfizer (Dose2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with FLU, Moderna, Pfizer and Pfizer.    On 20-Jan-2024, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Jan-2024, the patient experienced WHITE BLOOD CELL COUNT DECREASED (his White Blood Cell Count went from 6 to mid 3s," "his neutrophils went down, they dropped,"), BLOOD IRON DECREASED (his Iron and percent of saturation went down into the low range.) and NEUTROPHIL COUNT DECREASED (his neutrophils went down, they dropped). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (his White Blood Cell Count went from 6 to mid 3s," "his neutrophils went down, they dropped,"), BLOOD IRON DECREASED (his Iron and percent of saturation went down into the low range.) and NEUTROPHIL COUNT DECREASED (his neutrophils went down, they dropped) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2024, Blood iron: decreased. On 22-Jan-2024, Neutrophil count: went down, they dropped. On 22-Jan-2024, White blood cell count decreased: went from 6 to mid 3s.         No concomitant medication was reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-758228 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-758228:Wife case
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site nodule
Clinical narrative: After this dose she came back with a "Moderna arm." It is red and feels "nodule-ey."; After this dose she came back with a "Moderna arm." It is red and feels "nodule-ey."; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE NODULE (After this dose she came back with a "Moderna arm." It is red and feels "nodule-ey.") and VACCINATION SITE ERYTHEMA (After this dose she came back with a "Moderna arm." It is red and feels "nodule-ey.") in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 203G23A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (0.5mL dose and lot number 017H22A) on 05-Nov-2022; for Product used for unknown indication: Pfizer vaccine (0.3ml dose and lot number EL0447) on 19-Jun-2023. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) and Pfizer vaccine.    On 22-Jan-2024, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In January 2024, the patient experienced VACCINATION SITE NODULE (After this dose she came back with a "Moderna arm." It is red and feels "nodule-ey.") and VACCINATION SITE ERYTHEMA (After this dose she came back with a "Moderna arm." It is red and feels "nodule-ey."). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; HYDROCORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE NODULE (After this dose she came back with a "Moderna arm." It is red and feels "nodule-ey.") and VACCINATION SITE ERYTHEMA (After this dose she came back with a "Moderna arm." It is red and feels "nodule-ey.") had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: Patient calling to report an adverse event to Spikevax (2023-2024 Formula) that she received in December. She stated that her eyes are sensitive, she is sensitive to light, all in her eyes.; This spontaneous case was reported by a patient and describes the occurrence of PHOTOPHOBIA (Patient calling to report an adverse event to Spikevax (2023-2024 Formula) that she received in December. She stated that her eyes are sensitive, she is sensitive to light, all in her eyes.) in a 59-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 7387) for COVID-19 prophylaxis.     Patient did not report any medical history or condition.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, Lot-037B21A) on 06-Apr-2021, Moderna COVID-19 Vaccine (Dose 2, Lot-014C21A) on 04-May-2021, Moderna COVID-19 Vaccine (Dose 3, Lot- 012H21B) on 27-Nov-2021, Moderna COVID-19 Vaccine (Dose 4, Lot-056M21A) on 05-May-2022, Spikevax Bivalent (Dose 5 and Lot-030G22B) on 19-Oct-2022; for Product used for unknown indication: Flu shot (Flu shot was received 2 months before) in 2023. Past adverse reactions to the above products included No adverse event with Flu shot, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Spikevax Bivalent.    On 12-Dec-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PHOTOPHOBIA (Patient calling to report an adverse event to Spikevax (2023-2024 Formula) that she received in December. She stated that her eyes are sensitive, she is sensitive to light, all in her eyes.). At the time of the report, PHOTOPHOBIA (Patient calling to report an adverse event to Spikevax (2023-2024 Formula) that she received in December. She stated that her eyes are sensitive, she is sensitive to light, all in her eyes.) outcome was unknown.            The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Age: 53.0
Sex: U
Vaccine: COVID19-2, PNC20, VARZOS
Symptoms: Dyspnoea, Pain
Clinical narrative: patient experience body aches,, shortness of breath.  She took her asthma inhaler for shortness of breath and tylenol for pain. Did not went to doctor. patient said she experience pain and SOB because she received moderna instead of Pfizer. she does not know what allergies she has to moderna components of vaccines.
Age: 83.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Dizziness, Fatigue, Hypertension, Nausea
Clinical narrative: Weakness, nausea, fatigue, dizziness and high blood pressure starting 1/27/24
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Barium double contrast, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Presented with intussusception to ER 1/26, 7 days after Rotateq. Confirmed by ultrasound and reduced by pediatric surgeon via air enema.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Blood test, CSF protein increased, Chronic inflammatory demyelinating polyradiculoneuropathy, Electromyogram abnormal
Clinical narrative: 3 weeks after the 2nd vaccine I started to develop numbness, tingling and very intense, sharpe shooting pains to both hands and feet.  Additionally I started to have weakness in my upper and lower extremities and issues with balance as well. Was seen by PCP, then Neurology  and Rheumatology-Rheu w/u basically neg Neuro w/u showed some findings on EMG's c/w weakness and only other finding was increased protein in Lumbar Puncture  c/w Chronic Inflammatory Demyelinating  Polyneuropathy accordping to my Neurologist.  Iwas suggested I have IVIG  Infusions.  Had approximately 15 infusions with NO POSITIVE results-and that's where I'm at now.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Magnetic resonance imaging spinal, Muscular weakness, Pain
Clinical narrative: 3 weeks after the 2nd vaccine I started to develop numbness, tingling and very intense, sharpe shooting pains to both hands and feet.  Additionally I started to have weakness in my upper and lower extremities and issues with balance as well. Was seen by PCP, then Neurology  and Rheumatology-Rheu w/u basically neg Neuro w/u showed some findings on EMG's c/w weakness and only other finding was increased protein in Lumbar Puncture  c/w Chronic Inflammatory Demyelinating  Polyneuropathy accordping to my Neurologist.  Iwas suggested I have IVIG  Infusions.  Had approximately 15 infusions with NO POSITIVE results-and that's where I'm at now.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: 3 weeks after the 2nd vaccine I started to develop numbness, tingling and very intense, sharpe shooting pains to both hands and feet.  Additionally I started to have weakness in my upper and lower extremities and issues with balance as well. Was seen by PCP, then Neurology  and Rheumatology-Rheu w/u basically neg Neuro w/u showed some findings on EMG's c/w weakness and only other finding was increased protein in Lumbar Puncture  c/w Chronic Inflammatory Demyelinating  Polyneuropathy accordping to my Neurologist.  Iwas suggested I have IVIG  Infusions.  Had approximately 15 infusions with NO POSITIVE results-and that's where I'm at now.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruising
Age: 36.0
Sex: F
Vaccine: ADEN_4_7, FLU4, PNC20
Symptoms: Erythema, Fatigue, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Had fever 101.9F on Saturday, no longer febrile.  Bilateral arms are red, itchy, pain, warm to the touch.  Admits fatigue. Denies throat swelling, tongue swelling, shortness of breath, rash on the rest of the body.  Has tried icing, advil 600-800mg, stretching.  Advised to start zyrtec.
Age: 36.0
Sex: F
Vaccine: ADEN_4_7, FLU4, PNC20
Symptoms: Skin warm
Clinical narrative: Had fever 101.9F on Saturday, no longer febrile.  Bilateral arms are red, itchy, pain, warm to the touch.  Admits fatigue. Denies throat swelling, tongue swelling, shortness of breath, rash on the rest of the body.  Has tried icing, advil 600-800mg, stretching.  Advised to start zyrtec.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU4, PNC20, VARZOS
Symptoms: Rash
Clinical narrative: On 1/18/24, patient received Prevnar 20, Shingrix (2nd dose), Fluzone HD, and Spikevax at the pharmacy. On 1/28/24, patient returned to the pharmacy and stated she was experiencing an allergic reaction to the vaccines she received. Patient presented with a rash on both of her arms (visible across each arm at the time of consultation) and some of her back (not visible at the time of consultation - covered by shirt). Patient requested a recommendation to help with the rash. Patient stated the rash developed on 1/20/24. She stated the rash was not itchy, and she denied any other potential causes of the rash (ie changes in detergent, body wash, etc.). I recommended the patient take Benadryl, and I advised the patient to seek urgent/emergency care if condition worsens/spreads or signs/symptoms of anaphylaxis develop (difficulty breathing, facial swelling, swelling of the tongue).
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy
Clinical narrative: Child had headache, lethargy, 99 degree temp.  onset around 10am next day following vaccine booster at 3:30pm.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain
Clinical narrative: Pain in bellybutton area; This non-serious case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had a history of shingles near her bellybutton).   In DEC-2023, the patient received the 1st dose of Shingrix (left arm). In DEC-2023, 1 day after receiving Shingrix, the patient experienced abdominal pain (Verbatim: Pain in bellybutton area). The outcome of the abdominal pain was resolved.   It was unknown if the reporter considered the abdominal pain to be related to Shingrix.     It was unknown if the company considered the abdominal pain to be related to Shingrix.   Additional Information: GSK receipt date: 19-JAN-2024 The patient self-reported this case for herself. The patient received 1st dose of Shingrix and the day after she got the vaccine, had a lot of pain in bellybutton area. The reporter did not consent to follow up. This case had been linked with US2024AMR009746, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR009746:MALE PATIENT
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Sore arm, having aches; Sore arm, having aches; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. Other Case identifier: 02536561 (Merck).  A female patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: 33130BA) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, single; lot number: EN6200), administration date: 26Feb2021, for COVID-19 immunisation; BNT162b2 (dose 1, single; lot number: EN6203), administration date: 19Mar2021, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN (non-serious), outcome "unknown" and all described as "Sore arm, having aches". Additional information: The patient reported that she had vaccinated for COVID-19 on 03Dec2023 with Pfizer (33130BA). The patient adverse issue and side effect related to the vaccines includes a sore arm, having aches.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400010949 same patient and vaccine; different dose and event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm, having aches; Sore arm, having aches; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. Other Case identifier: 02536561 (Merck).  A female patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: 33130BA) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, single; lot number: EN6200), administration date: 26Feb2021, for COVID-19 immunisation; BNT162b2 (dose 1, single; lot number: EN6203), administration date: 19Mar2021, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN (non-serious), outcome "unknown" and all described as "Sore arm, having aches". Additional information: The patient reported that she had vaccinated for COVID-19 on 03Dec2023 with Pfizer (33130BA). The patient adverse issue and side effect related to the vaccines includes a sore arm, having aches.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400010949 same patient and vaccine; different dose and event;
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE/PQC; HCP called to report inadvertent administration of PROQUAD to an adult patient. Patient was scheduled to receive only MMR-II on 18JAN2024 but was instead given only PROQUAD.; This spontaneous report has been received from a pharmacist and refers to an adult patient of unknown age and gender.  The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 18-JAN-2024, the patient was supposed to receive only measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine, but was instead given only measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (wrong product administered). Vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) had an indication of prophylaxis (strength, dosage regimen, vaccination scheme, previous vaccination history, lot #, expiry date, anatomical site of administration and route of administration were not provided). No additional adverse events were reported for this patient.