chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received AREXVY; Underdose; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 36-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 15-NOV-2023, the patient received Arexvy. On 15-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Underdose). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received AREXVY). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178358:2nd patient US-GSK-US2023AMR178395:3rd patient US-GSK-US2023AMR178431:7th patient US-GSK-US2023173296:1st patient US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178469:13th patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178450:10th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178585:21st patient US-GSK-US2023AMR178588:22nd patient US-GSK-US2023AMR178594:23rd patient
Age: 27.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received AREXVY; underage; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 13-NOV-2023, the patient received Arexvy. On 13-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received AREXVY). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR178466:12th patient US-GSK-US2023AMR178358:2nd patient US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178395:3rd patient US-GSK-US2023AMR178431:7th patient US-GSK-US2023173296:1st patient US-GSK-US2023AMR178469:13th patient US-GSK-US2023AMR178450:10th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178585:21st patient US-GSK-US2023AMR178588:22nd patient US-GSK-US2023AMR178594:23rd patient
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received AREXVY; Underage; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 36-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 17-NOV-2023, the patient received Arexvy. On 17-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received AREXVY). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178358:2ndpatient US-GSK-US2023AMR178395:3rd patient US-GSK-US2023AMR178431:7th patient US-GSK-US2023173296:1st patient US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178469:13th patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178450:10th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178585:21st patient US-GSK-US2023AMR178588:22nd patient US-GSK-US2023AMR178594:23rd patient
Age: 39.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received Arexvy; Underage; This non-serious prospective pregnancy case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 39-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 26-OCT-2023, the patient received Arexvy. On 26-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received Arexvy). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023173296:1nd  PATIENT US-GSK-US2023AMR178395:3rd patient US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178450:10th patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023AMR178469:13th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178585:21th patient US-GSK-US2023AMR178588:22th patient US-GSK-US2023AMR178594:23th patient US-GSK-US2023AMR178431:2nd patient
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received AREXVY; Underage; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 36-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 10-NOV-2023, the patient received Arexvy. On 10-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received AREXVY). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR178431:10th patient US-GSK-US2023173296:10th patient US-GSK-US2023AMR178424:10th patient US-GSK-US2023AMR178358:10th patient US-GSK-US2023AMR178415:10th patient US-GSK-US2023AMR178412:10th patient US-GSK-US2023AMR178395:10 th patient US-GSK-US2023AMR178435:10th patient US-GSK-US2023AMR178444:10th patient US-GSK-US2023AMR178489:10th patient US-GSK-US2023AMR178565: US-GSK-US2023AMR178469:10th patient US-GSK-US2023AMR178458:10th patient US-GSK-US2023AMR178567: US-GSK-US2023AMR178513:10th patient US-GSK-US2023AMR178466:10th patient US-GSK-US2023AMR178481:10th patient US-GSK-US2023AMR178585:10th patient US-GSK-US2023AMR178578:10th patient US-GSK-US2023AMR178594:10th patient US-GSK-US2023AMR178588:10th patient US-GSK-US2023AMR178583:10th patient
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received Arexvy; Underage; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 07-NOV-2023, the patient received Arexvy. On 07-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received Arexvy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178395:3rd  patient US-GSK-US2023173296:1st  patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178358:2nd patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178450:10th patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023AMR178469:13th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178585:21 st patient US-GSK-US2023AMR178588:22 nd patient US-GSK-US2023AMR178594:23rd patient
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received AREXVY; underage; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 07-NOV-2023, the patient received Arexvy. On 07-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received AREXVY). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178358:2nd  patient US-GSK-US2023AMR178395:3rd patient US-GSK-US2023173296:1st patient US-GSK-US2023AMR178415:5th  patient US-GSK-US2023AMR178431:7th patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178450:10th patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023AMR178469:13th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178585:21st patient US-GSK-US2023AMR178588:22nd patient US-GSK-US2023AMR178594:23rd patient US-GSK-US2023AMR178578:6th patient
Age: 27.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received Arexvy; Underage; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 30-OCT-2023, the patient received Arexvy. On 30-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received Arexvy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR178395:3rd patient US-GSK-US2023AMR178358:2nd patient US-GSK-US2023173296:1st patient US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178431:7th patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178450:10th patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023AMR178469:13th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178585:21th patient US-GSK-US2023AMR178588:22ned patient US-GSK-US2023AMR178594:23rd patient
Age: 30.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received Arexvy; underage; This non-serious prospective pregnancy case was reported by a other health professional 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 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 30-NOV-2023, the patient received Arexvy. On 30-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received Arexvy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR178358:2nd patient US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178395:3rd patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023173296:1st patient US-GSK-US2023AMR178431:7th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178469:13th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178585:21th patient US-GSK-US2023AMR178588:22nd patient US-GSK-US2023AMR178594:23rd patient US-GSK-US2023AMR178450:10th patient
Age: 30.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received Arexvy; Underage; This non-serious prospective pregnancy case was reported by a other health professional 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 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 09-NOV-2023, the patient received Arexvy. On 09-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received Arexvy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR178358:2nd patient US-GSK-US2023173296:1st patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178431:7th patient US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178395:3rd patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178450:10th patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023AMR178469:13th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178585:21th patient US-GSK-US2023AMR178588:22nd patient US-GSK-US2023AMR178594:23rd patient
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Patient said she recieved Spikevax on 12/13/2023 at pharmacy and developed hives all over her trunk, legs, and arms on 12/14/23.  She has had no other reactions to any vaccines, but this is the first Moderna vaccine she has had.  She has sought medical care and is in stable condition.
Age: 0.5
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient received product, Wrong product administered
Clinical narrative: her 6-month-old grandchild received her 5-year-old grandchild's PROQUAD on accident at the pediatrician's office; No additional AE; This spontaneous report was received from a consumer (the patient's grandparent) regarding a 6-month-old infant of unspecified gender. Information regarding medical history, concurrent conditions and concomitant medications was not reported.   On an unspecified date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) as prophylaxis, on accident, at the pediatrician's office; as that vaccine was supposed to be administered to a 5-year-old patient (information captured in MARRS #: 2311USA010794). The patient was supposed to receive a "polio vaccine" (reporter did not confirm brand name or manufacturer for vaccine) instead (no more details regarding the vaccination were provided). It was attempted to collect further information from consumer; but consumer hung up phone and did not provide any further details. No additional adverse event (AE) was reported (no adverse event).; Sender Comments: Keywords : MUL
Age: 5.0
Sex: U
Vaccine: IPV, MMRV
Symptoms: No adverse event, Wrong patient received product
Clinical narrative: her 5-year-old grandchild received the 6-month-old's "POLIO VACCINE"; No additional AE; This spontaneous report was received from a consumer (the patient's grandparent) regarding a 5-year-old child of unspecified gender. Information regarding medical history, concurrent conditions and concomitant medications was not reported.   On an unspecified date, the patient was vaccinated with a "polio vaccine" (reporter did not confirm brand name or manufacturer for vaccine) that was supposed to be administered to a 6-month-old patient (information captured in #: 2311USA010736), instead of receiving the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) vaccine as prophylaxis (no more details regarding the vaccination were provided). It was attempted to collect further information from consumer; but consumer hung up phone and did not provide any further details. No additional adverse event (AE) was reported (no adverse event).; Sender Comments: Keywords : MUL
Age: 0.33
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; Inappropriate schedule of vaccine administered; This spontaneous report has been received from an other health care professional via medical records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2311USA002536), concerning an 1-year-old female patient.  The patient's medical history, concomitant medications, and concurrent conditions were not provided.  On 24-OCT-2003, the patient was vaccinated with a first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, units, frequency, route of administration, lot#, and expiration date were not reported) for prophylaxis. On 14-SEP-2004, the patient was vaccinated with a second dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, units, frequency, route of administration, lot#, and expiration date were not reported) for prophylaxis (Inappropriate schedule of product administration). On 11-NOV-2005, the patient was vaccinated with the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, units, frequency, route of administration, lot#, and expiration date were not reported) for prophylaxis (Inappropriate schedule of product administration).; Sender's Comments:  US-009507513-2311USA002536:original case
Age: 36.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pharmacist reports that a patient received the 1st dose on Feb. 15th, 2019, and the 2nd dose on an unspecified day in April 2019, but never received the third dose in the series.; No symptoms or issues reported/No further AE details.; This spontaneous report was received from a pharmacist and refers to a 40-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 15-FEB-2019, the patient was vaccinated with the first dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unspecified date in April 2019, the patient received the second dose of the vaccine, but never received the third dose in the series. Pharmacist was planning to give the patient the 3rd dose on 15-DEC-2023 (also reported as today) (Inappropriate schedule of product administration). No symptoms or issues were reported (No adverse event).
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Breast feeding, Faeces discoloured, Haematochezia, Pain
Clinical narrative: She notices visible specs of blood in her stool; 3-5 days after receiving the vaccine her daughter experienced pain and her bowel movements started to change color; Bowel movement started to change color, she advised it went from normal yellow to bright green; it could be from dairy allergy since she is breast feeding; This spontaneous report was received from a patient's mother and refers to a 2 month old female patient. The patient did no report pertinent medical history, nor drug reactions or allergies. Concomitant medications included vitamin D drops and unspecified probiotics.    On 05-DEC-2023, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), (strength, lot #, expiration date not provided) given orally as prophylaxis.      On approximately 08-DEC-2023 (reported as 3 - 5 days after receiving the vaccine), the patient experienced pain and her bowel movements started to change color, which went from normal yellow to bright green (faeces discoloured). On 15-DEC-2023, the patient had visible specs of blood in her stool (haematochezia). It was reported that she might had blood in her stool before this date, but the patient's mother was uncertain. The patient's mother sought medical attention for her daughter, and the health care professional (HCP) advised her that this event could be from a dairy allergy (milk allergy since unspecified date in 2023), since the patient was being breastfed; however, she did not experience the event until receiving the vaccine. No treatment was given for any event. At the reporting time, the patient had not recovered from pain, faeces discoloured and haematochezia. The outcome of dairy allergy was unknown.  Causality assessment between all the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.  Upon internal review, the event of haematochezia was determined to be medically significant.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Lymphadenopathy
Clinical narrative: Chills, sweats, body aches, swollen lymph nodes in neck, sore throat, extreme fatigue, headache
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: Chills, sweats, body aches, swollen lymph nodes in neck, sore throat, extreme fatigue, headache
Age: 53.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Neuralgia, Pain in jaw, Toothache
Clinical narrative: About an hour after the injections, the right side of my jaw started hurting (around a 2 to 3 on the pain scale). The pain subsided then about 6 hours after injection I took a drink of cool water and it caused a very painful spike in my upper and lower right side teeth (around an 8 or 9). It felt like intense nerve pain for a few seconds, only on the right side. This pain occurs every time I take a drink of cool/cold or warm/hot liquid. It still hurts 41 hours after the injections.
Age: 82.0
Sex: M
Vaccine: COVID19, FLUA4, RSV
Symptoms: Back pain, Mobility decreased
Clinical narrative: Patients wife reported that on 12/21 her husband had back pain and on 12/23 he was unable to move his legs.  She is taking him  to the ER on 12/23.
Age: 84.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: It?s been 3 days since my shingles shot. My shot doesn?t hurt today but about 6 inches below where I got the shot is red and sore. It?s a large red circle. Should I be concerned.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Ear pain, Eye pain, Facial pain, Headache
Clinical narrative: body aches in face, eyes, ears, headache, joint pain in arms, hands, wrists, knees, elbows, neck, nausea
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Pain
Clinical narrative: body aches in face, eyes, ears, headache, joint pain in arms, hands, wrists, knees, elbows, neck, nausea
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chest pain, Computerised tomogram head, Computerised tomogram neck
Clinical narrative: CHRONIC AND CONSTANT HEAD PAIN, MUSCLE FATIGUE AND WEAKNESS, SEVERE JOINT PAIN, NAUSEA, CHEST PAIN; ALL SYMPTOMS/EVENTS HAVE BEEN ONGOING AND INCREASED WITH EACH VACCINATION TO THE POINT OF DEBILITATION
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count, Headache, Immunology test, Magnetic resonance imaging head, Magnetic resonance imaging neck
Clinical narrative: CHRONIC AND CONSTANT HEAD PAIN, MUSCLE FATIGUE AND WEAKNESS, SEVERE JOINT PAIN, NAUSEA, CHEST PAIN; ALL SYMPTOMS/EVENTS HAVE BEEN ONGOING AND INCREASED WITH EACH VACCINATION TO THE POINT OF DEBILITATION
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle fatigue, Muscular weakness, Nausea, Scan with contrast
Clinical narrative: CHRONIC AND CONSTANT HEAD PAIN, MUSCLE FATIGUE AND WEAKNESS, SEVERE JOINT PAIN, NAUSEA, CHEST PAIN; ALL SYMPTOMS/EVENTS HAVE BEEN ONGOING AND INCREASED WITH EACH VACCINATION TO THE POINT OF DEBILITATION
Age: 66.0
Sex: F
Vaccine: RV1
Symptoms: Fatigue, Headache, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Swelling/tenderness in lymph node under left arm (injection site left arm); also normal reaction (low grade fever for ~ 4 hrs, headache (~ 1 day) and fatigue.  Pain in lymph nose greater 2nd day, after other symptoms went away.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Induration, Mass, Pyrexia, Skin warm
Clinical narrative: Patient describes hardened lump that is warm to the touch and red in appearance, growing in size over a few days that is now (12/23/2023) the size of a "softball". Patient also experienced  a transient fever overnight on the night of vaccination.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Patient describes hardened lump that is warm to the touch and red in appearance, growing in size over a few days that is now (12/23/2023) the size of a "softball". Patient also experienced  a transient fever overnight on the night of vaccination.
Age: 40.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered
Clinical narrative: Pt presented for vaccination with COVID and flu vaccines. Upon reviewing history in chart with patient and confirming with patient, it was agreed by this nurse and the patient that he was due for flu and COVID vaccines. Vaccines were administered and when this nurse went to chart the flu vaccine, a pop up warning appeared stating that flu vaccine was not indicated at this time. Upon closer review, pt had received flu vaccine on 9/8/23. Pt was completing his 15 min observation for COVID vaccine, so this nurse informed pt that he was not due for flu vaccine since he had received one in Sept. Once he was reminded of this dose, he remembered it. Pt was informed that it was not expected that he would not have any worse side effects than he would other wise and that the  initial infant schedule is two doses 4 weeks apart of this same vaccine. Pt stated he understood and did not have any questions.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Lymphadenopathy, Malaise
Clinical narrative: 23-24 formulation (XBB.1.5); light headache started approximately 2 hours post-injection; arm soreness increased over time since 2 hours post-vaccination, with a 2 cm red mark around the injection site appearing by morning. Headache worsened upon waking the next day with general malaise, fatigue, and mild body aches, especially on the right side of the body. Swollen lymph nodes also observed upon waking the day after vaccination.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: 23-24 formulation (XBB.1.5); light headache started approximately 2 hours post-injection; arm soreness increased over time since 2 hours post-vaccination, with a 2 cm red mark around the injection site appearing by morning. Headache worsened upon waking the next day with general malaise, fatigue, and mild body aches, especially on the right side of the body. Swollen lymph nodes also observed upon waking the day after vaccination.
Age: 59.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: RSV (Arexvy) is recommended for patients who are 60 years and older. Patient who received vaccine on 12/20/23, she is 59 1/2 years old and does not qualify for vaccine without a prescription from her primary care. Patient received the vaccine even though she is not 60 years old.
Age: 62.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received Fluzone High Dose incidentally rather than receiving Fluzone Quad. No adverse reaction at time of injection.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site erythema, Injection site nodule, Injection site warmth, Pain in extremity
Clinical narrative: THERE WAS A RAISED KNOT AND REDNESS/BRUISING AT THE INJECTION SITE (~SIZE OF HALF DOLLAR), STILL WARM TO THE TOUCH (2 WEEKS POST VACCINE), PATIENT SAID HER ARM WAS STILL SORE TOO.
Age: 51.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Pain, Rash
Clinical narrative: patient broke out in a rash starting from neck and extending down through arms
Age: 26.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site hypersensitivity, Injection site infection, Injection site mass
Clinical narrative: Received vaccine at 32 weeks gestation (EDD 2/13/2024), developed minor redness and swelling at injection site on date of injection. On the following day, a lump formed at injection site with redness and painful to the touch. The next day, lump doubled in size and  redness persists with substantial pain to the touch. Lump warm to touch on Day 2 following vaccination, low grade fever suggestive of infection or allergic reaction at site.
Age: 26.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Received vaccine at 32 weeks gestation (EDD 2/13/2024), developed minor redness and swelling at injection site on date of injection. On the following day, a lump formed at injection site with redness and painful to the touch. The next day, lump doubled in size and  redness persists with substantial pain to the touch. Lump warm to touch on Day 2 following vaccination, low grade fever suggestive of infection or allergic reaction at site.
Age: 31.0
Sex: F
Vaccine: PNC20
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Flu like symptoms and large swollen red spot around injection site
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: redness, swelling, heat surrounding injection site; patient did not take any OTC meds or use ice packs; patient reported to pharmacy on 12/23/23 (6 days  later) and it was still red.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt reports having a raised bump at the injection site, describes it being as large as a coke can. Says it's hot and itchy as well. She reports this started the next morning after getting the RSV vaccine, and is still on-going . She has been taking benadryl and cool compresses which have both been helping.
Age: 83.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Aphasia, Choking, Cough, Dysphagia, Dysphonia
Clinical narrative: Patient reported experiencing fatigue for the first 3 days after the vaccine, and said she also had pain, redness, and swelling at the injection site as well as a headache. She reports having trouble breathing as well as coughing, "strangling" on food and fluids, and having a swollen throat. The vaccines were given on 12/5/23, and as of 12/22/23, she still seems to have a swollen/hoarse throat, reporting that she is still not able to swallow properly or speak above a whisper and is worried about the risk of aspirating. She also says the arm that she received her RSV shot (the left arm) is still sore. On a visit with her doctor on 12/12/23, she was prescribed prednisone to help reduce the inflammation in her arm.
Age: 83.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Dyspnoea, Fatigue, Headache, Inflammation, Injection site erythema
Clinical narrative: Patient reported experiencing fatigue for the first 3 days after the vaccine, and said she also had pain, redness, and swelling at the injection site as well as a headache. She reports having trouble breathing as well as coughing, "strangling" on food and fluids, and having a swollen throat. The vaccines were given on 12/5/23, and as of 12/22/23, she still seems to have a swollen/hoarse throat, reporting that she is still not able to swallow properly or speak above a whisper and is worried about the risk of aspirating. She also says the arm that she received her RSV shot (the left arm) is still sore. On a visit with her doctor on 12/12/23, she was prescribed prednisone to help reduce the inflammation in her arm.
Age: 83.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Pharyngeal swelling
Clinical narrative: Patient reported experiencing fatigue for the first 3 days after the vaccine, and said she also had pain, redness, and swelling at the injection site as well as a headache. She reports having trouble breathing as well as coughing, "strangling" on food and fluids, and having a swollen throat. The vaccines were given on 12/5/23, and as of 12/22/23, she still seems to have a swollen/hoarse throat, reporting that she is still not able to swallow properly or speak above a whisper and is worried about the risk of aspirating. She also says the arm that she received her RSV shot (the left arm) is still sore. On a visit with her doctor on 12/12/23, she was prescribed prednisone to help reduce the inflammation in her arm.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: Urticaria covering face, trunk, limbs, hands, feet, with angioedema  of lips, fingers, toes, eyelids. No identifiable trigger. Well managed with 180mg fexofenadine q AM, discontinued after 23 days with no recurrence of hives.
Age: 68.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Chills, Headache, Productive cough, Respiratory tract congestion
Clinical narrative: Chest Congestion/Phlegm in Throat, Headache, Chills for one month
Age: 32.0
Sex: M
Vaccine: MMR
Symptoms: Full blood count, Headache, Lymphadenopathy, Metabolic function test, Pyrexia
Clinical narrative: Patient has been having headaches and swollen posterior cervical lymph nodes. He had a fever for 1 day on 12/18/2023.
Age: 66.0
Sex: M
Vaccine: FLUA4
Symptoms: Asthenia, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Guillain-Barre syndrome, severe weakness not involving respiratory compromise, IVIG, plasmapheresis
Age: 66.0
Sex: M
Vaccine: FLUA4
Symptoms: Plasmapheresis, Serology test
Clinical narrative: Guillain-Barre syndrome, severe weakness not involving respiratory compromise, IVIG, plasmapheresis
Age: 49.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no side effects reported. vaccine was given to patient who was not eligible for administration due to age limitations
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Discomfort, Dyspnoea exertional, Exercise tolerance decreased, Feeling cold
Clinical narrative: 65 yrs. male who presents to urgent care with a complaint of left lower lateral rib pain and dyspnea on exertion. Left lower rib pain woke him up from sleep around 4AM, felt better when got out of bed, but still having pain currently. Has had this discomfort throughout the week, but more acute last night, feels like an ache. Endorses dyspnea while running over the past week, had to stop run early yesterday. Runs 3 miles 4-5 times per week. Was getting dyspneic 1 mile in. Feels cold, but no chills or fever. No hx of heart or lung issues. No dyspnea currently.  Non-smoker. No leg swelling. No recent long car rides or flights. No hx of VTE. No family history of clotting disorder. No lightheadedness or dizziness. Received updated  covid-19 vaccination on 10/12/23.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Musculoskeletal chest pain, Pulmonary embolism, Sleep disorder
Clinical narrative: 65 yrs. male who presents to urgent care with a complaint of left lower lateral rib pain and dyspnea on exertion. Left lower rib pain woke him up from sleep around 4AM, felt better when got out of bed, but still having pain currently. Has had this discomfort throughout the week, but more acute last night, feels like an ache. Endorses dyspnea while running over the past week, had to stop run early yesterday. Runs 3 miles 4-5 times per week. Was getting dyspneic 1 mile in. Feels cold, but no chills or fever. No hx of heart or lung issues. No dyspnea currently.  Non-smoker. No leg swelling. No recent long car rides or flights. No hx of VTE. No family history of clotting disorder. No lightheadedness or dizziness. Received updated  covid-19 vaccination on 10/12/23.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Pt developed diffuse urticaria, various locations from head to toe 2 weeks after covid-19 vaccination. Continue to have daily urticaria. No other new medications, lotions, detergents, vaccinations.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria chronic
Clinical narrative: I?ve developed chronic urticaria I believe brought on by vaccines.  I?ve had all 5 shots.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears / tinnitus
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Patient complained about having a red circle around the injection site with no swelling or pain in the area. Pt reported a sore arm and no fever. Did not initiate any tx since it?s not severe, painful, or febrile.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, HPV9
Symptoms: Blood glucose normal, Loss of consciousness, Presyncope
Clinical narrative: As soon as the nurse was finished giving the shot to my daughter, she fell forward and passed out. I just happened to be standing in front of her so i laid her on her back. I thought it was just anxiety and she freaked herself out. But then her body locked up and it looked like she had a seizure-like event. she started shaking and her body was jerking. Her lips were pale but then she got color back. A few minutes later her body locked up again and she had another seizure-like event. Once again her lips were pale and after a few minutes color started coming back to her face. She was sitting up and talking to me and the nurse even gave her a drink and a snack. After a few minutes she told me she was going to pass out and, once again, her body locked and she had her 3rd seizure-like event. The nurses elevated her legs and she laid there for 10-15 minutes until the nurses and doctor allowed her to stand up and leave.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, HPV9
Symptoms: Dyskinesia, Fall, Loss of consciousness, Pallor, Seizure like phenomena
Clinical narrative: As soon as the nurse was finished giving the shot to my daughter, she fell forward and passed out. I just happened to be standing in front of her so i laid her on her back. I thought it was just anxiety and she freaked herself out. But then her body locked up and it looked like she had a seizure-like event. she started shaking and her body was jerking. Her lips were pale but then she got color back. A few minutes later her body locked up again and she had another seizure-like event. Once again her lips were pale and after a few minutes color started coming back to her face. She was sitting up and talking to me and the nurse even gave her a drink and a snack. After a few minutes she told me she was going to pass out and, once again, her body locked and she had her 3rd seizure-like event. The nurses elevated her legs and she laid there for 10-15 minutes until the nurses and doctor allowed her to stand up and leave.