chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: mistakenly given the alternative vaccine Arexvy instead of Abrysvo; pregnant women were mistakenly given the alternative vaccine Arexvy; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of wrong vaccine administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and vaccine exposure during pregnancy (Verbatim: pregnant women were mistakenly given the alternative vaccine Arexvy). The outcome of the wrong vaccine administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, both were administered to 128 pregnant women and 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 128 pregnant women and 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The pregnant patient received Arexvy vaccine instead of alternative Abrysvo vaccine, which led to vaccine exposure during pregnancy and to wrong vaccine administered. The follow up would not possible as no contact details were available. This case was 1 of 128 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR020844:master case
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: mistakenly given the alternative vaccine Arexvy instead of Abrysvo; pregnant women were mistakenly given the alternative vaccine Arexvy; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of wrong vaccine administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and vaccine exposure during pregnancy (Verbatim: pregnant women were mistakenly given the alternative vaccine Arexvy ). The outcome of the wrong vaccine administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, both were administered to 128 pregnant women and 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 128 pregnant women and 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The pregnant patient received Arexvy vaccine instead of alternative Abrysvo vaccine, which led to vaccine exposure during pregnancy and to wrong vaccine administered. The follow up would not possible as no contact details were available. This case was 1 of 128 linked cases reported by the same reporter.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: mistakenly given the alternative vaccine Arexvy instead of Abrysvo; pregnant women were mistakenly given the alternative vaccine Arexvy; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of wrong vaccine administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and vaccine exposure during pregnancy (Verbatim: pregnant women were mistakenly given the alternative vaccine Arexvy). The outcome of the wrong vaccine administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, both were administered to 128 pregnant women and 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 128 pregnant women and 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The pregnant patient received Arexvy vaccine instead of alternative Abrysvo vaccine, which led to vaccine exposure during pregnancy and to wrong vaccine administered. The follow up would not possible as no contact details were available. This case was 1 of 128 linked cases reported by the same reporter.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: mistakenly given the alternative vaccine Arexvy instead of Abrysvo; pregnant women were mistakenly given the alternative vaccine Arexvy; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of wrong vaccine administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and vaccine exposure during pregnancy (Verbatim: pregnant women were mistakenly given the alternative vaccine Arexvy ). The outcome of the wrong vaccine administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, both were administered to 128 pregnant women and 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 128 pregnant women and 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The pregnant patient received Arexvy vaccine instead of alternative Abrysvo vaccine, which led to vaccine exposure during pregnancy and to wrong vaccine administered. The follow up would not possible as no contact details were available. This case was 1 of 128 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR020844:
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: mistakenly given the alternative vaccine Arexvy instead of Abrysvo; pregnant women were mistakenly given the alternative vaccine Arexvy; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of wrong vaccine administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and vaccine exposure during pregnancy (Verbatim: pregnant women were mistakenly given the alternative vaccine Arexvy). The outcome of the wrong vaccine administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, both were administered to 128 pregnant women and 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 128 pregnant women and 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The pregnant patient received Arexvy vaccine instead of alternative Abrysvo vaccine, which led to vaccine exposure during pregnancy and to wrong vaccine administered. The follow up would not possible as no contact details were available. This case was 1 of 128 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR020844:
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: mistakenly given the alternative vaccine; mistakenly given the alternative vaccine; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: mistakenly given the alternative vaccine) and wrong vaccine administered (Verbatim: mistakenly given the alternative vaccine). The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, both were administered to 128 pregnant women and 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 128 pregnant women and 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The pregnant patient received Arexvy vaccine instead of alternative Abrysvo vaccine, which led to vaccine exposure during pregnancy and to wrong vaccine administered. The follow up would not possible as no contact details were available. This case was 1 of 128 linked cases reported by the same reporter.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Pregnant women were mistakenly given the alternative vaccine Arexvy; Pregnant women were mistakenly given the alternative vaccine Arexvy; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Pregnant women were mistakenly given the alternative vaccine Arexvy) and wrong vaccine administered (Verbatim: Pregnant women were mistakenly given the alternative vaccine Arexvy). The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, both were administered to 128 pregnant women and 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 128 pregnant women and 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The pregnant patient received Arexvy vaccine instead of alternative Abrysvo vaccine, which led to vaccine exposure during pregnancy and to wrong vaccine administered. The follow up would not possible as no contact details were available. This case was 1 of 128 linked cases reported by the same reporter.
Age: 80.0
Sex: F
Vaccine: FLUA4
Symptoms: Electrocardiogram, Injection site swelling, Pulmonary function test, X-ray limb
Clinical narrative: severe swelling at injection site
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Rash
Clinical narrative: Rash on Stomach and Chest x 3 days
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Pregnant women were mistakenly given the alternative vaccine Arexvy; Pregnant women were mistakenly given the alternative vaccine Arexvy; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Pregnant women were mistakenly given the alternative vaccine Arexvy) and wrong vaccine administered (Verbatim: Pregnant women were mistakenly given the alternative vaccine Arexvy). The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, both were administered to 128 pregnant women and 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The United States centers for disease control was urging healthcare providers to be more careful and issued a report stated that 128 pregnant women and 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The pregnant patient received Arexvy vaccine instead of alternative Abrysvo vaccine, which led to vaccine exposure during pregnancy and to wrong vaccine administered. The follow up would not possible as no contact details were available. This case was 1 of 128 linked cases reported by the same reporter.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Pregnant women were mistakenly given the alternative vaccine Arexvy; Pregnant women were mistakenly given the alternative vaccine Arexvy; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Pregnant women were mistakenly given the alternative vaccine Arexvy) and wrong vaccine administered (Verbatim: Pregnant women were mistakenly given the alternative vaccine Arexvy). The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, both were administered to 128 pregnant women and 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 128 pregnant women and 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The pregnant patient received Arexvy vaccine instead of alternative Abrysvo vaccine, which led to vaccine exposure during pregnancy and to wrong vaccine administered. The follow up would not possible as no contact details were available. This case was 1 of 128 linked cases reported by the same reporter
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo; Wrong vaccine administered; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and wrong vaccine administered (Verbatim: Wrong vaccine administered). The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, both were administered to 128 pregnant women and 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 128 pregnant women and 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The pregnant patient received Arexvy vaccine instead of alternative Abrysvo vaccine, which led to vaccine exposure during pregnancy and to wrong vaccine administered. The follow up would not possible as no contact details were available. This case was 1 of 128 linked cases reported by the same reporter.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Bone pain, Fatigue, Headache, Night sweats, Pain
Clinical narrative: 02/18/24 at 4:18 am awakened with bone pain and h/a this progressed to night sweats, fatigue and body aches with jt swelling. He continued to have a headache that week. On 2/21/24 developed red bumps on arms and legs with swelling of feet and hands. Swelling and jt pains some better on 2/28/24. Bumps continued with warmth to bumps.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Peripheral swelling, Rash, Rash erythematous, Skin warm, Sleep disorder
Clinical narrative: 02/18/24 at 4:18 am awakened with bone pain and h/a this progressed to night sweats, fatigue and body aches with jt swelling. He continued to have a headache that week. On 2/21/24 developed red bumps on arms and legs with swelling of feet and hands. Swelling and jt pains some better on 2/28/24. Bumps continued with warmth to bumps.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: 02/18/24 at 4:18 am awakened with bone pain and h/a this progressed to night sweats, fatigue and body aches with jt swelling. He continued to have a headache that week. On 2/21/24 developed red bumps on arms and legs with swelling of feet and hands. Swelling and jt pains some better on 2/28/24. Bumps continued with warmth to bumps.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: Pt was given undiluted covid pfizer 6mth- 4yr  and received the entire vial, pt received 3 doses essentially. Contacted pts mom she reports no fever, no swelling, no redness, no trouble eating or drinking and that the pt is acting normal. No concerns.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Pain, Pain in extremity, Swelling
Clinical narrative: Swelling; arm pain with movement starting 2 days after injection
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Expired vaccine
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain, Muscle injury, X-ray limb normal
Clinical narrative: Immediate, sharp pain upon injection. Unresolved shoulder pain that has persisted since. Primary care doctor consulted and likely injury to shoulder muscle (according to patient, imaging showed no damage to shoulder joint)
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Rash pruritic, Vomiting
Clinical narrative: Patient developed a rash and was very itchy.  Also had nausea and vomiting.  Patient still itching 10 days later.
Age: 4.0
Sex: M
Vaccine: HEPA, MMR, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Double dose of MMR given. No symtoms nor any reactions. Mother was called and informed, of it. She states pt was fine no reactions at all. Next day also called to monitor if any symptoms. No symptos at all per (mother)
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Localized swelling, mass and lump in right upper shoulder 3 x 3.5 inches.
Age: 50.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Similar reaction on previous exposure to drug
Clinical narrative: Reported Symptoms: Narrative: Other Relevant HX: Patient stated that he had a similar reaction following the administration of his anthrax vaccine. Patient also stated that he had similar reaction to hydrocodone in the past, as well. Other:
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Left arm erythema, swelling and itching
Age: 50.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Similar reaction on previous exposure to drug
Clinical narrative: Reported Symptoms:  Narrative:  Other Relevant HX:  Patient stated that he had a similar reaction following the administration of his anthrax vaccine. Patient also stated that he had similar reaction to hydrocodone in the past, as well. Other:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Pain, Pyrexia
Clinical narrative: Reported Symptoms: 10000424:ACHE; 10016558:FEVER; 10021706:INDIGESTION; 10033371:PAIN; Narrative: Patient experienced fever, generalized aches and pains and indigestion following covid-19 vaccine. Other Relevant HX: n/a Other: aches/pains; indigestion
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Malaise, Mobility decreased, Pulmonary embolism
Clinical narrative: Reported Symptoms: 10025482:MALAISE; 10037377:PULMONARY EMBOLISM; Narrative: Patient received COVID booster dose on 12/11/23. Went to ER on 12/25/23 and found to have PE's. States that had not been feeling well since administration of COVID vaccine. Other Relevant HX: # Recent AKI on Stage CKD-IIIA # Hypertension # Obesity. BMI 38. # Coronary artery disease. s/p stents. # PAD - s/p stents bilateral lower extremities. # Ischemic cardiomyopathy # GERD # Anxiety disorder. # Major depression Other: PE, malaise
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Reported Symptoms: 10064366:EXTRA DOSE ADMINISTERED; Narrative: Patient presented to PCP clinic 12/20/2023 to receive b12 injection, while there requested his covid vaccine as well. RN administered the vaccine then went to note on his vaccine card. At this time she realized she had given him the vaccine 2 months prior on 10/16/23 per the vaccine card but had not documented it on patient's chart. Information entered and patient monitored. No issues noted at the time of report. Report submitted due to vaccine administered outside of guidelines. Other Relevant HX: Other: Duplicate administration
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Angioedema, Laryngeal oedema, Laryngoscopy abnormal, Lip swelling, Swelling face
Clinical narrative: Reported Symptoms:  10002424:ANGIOEDEMA;   Narrative: Patient is a 72 year old with PMH of tobacco use with multiple pulmonary nodules, carpal tunnel syndrome, hyperlipidemia, HTN on lisinopril, lumbar spinal stenosis, choledocholithiasis in spring 2023 s/p ERCP, and chronic sinusitis who presented to the ED with lip and left cheek and jaw swelling after receiving rsv vaccine on 12/6 and on home lisinopril.  On the evening of 12/7, patient noted that his left cheek and jaw line had some swelling. He went to bed, and when he woke up the next morning he noticed interval increase in the swelling. He then went to work at his auto body shop where his secretary noticed that his lip was also swelling. She encouraged him to present to the ED, which he did.  In the ED his VS were wnl. He was treated with diphenhydramine 25 mg iv push, methylprednisolone 125 iv push, and famotidine 20 mg iv push. ENT evaluated the patient and performed laryngoscopy which revealed mild post-cricoid edema. Lisinopril was discontinued upon discharge and RSV vaccine was entered as adr as well as lisinopril. Patient was discharged home on cetirizine, famotidine, and methylprednisolone for the angioedema. Other Relevant HX; Other:
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dysstasia, Groin pain, Hallucination
Clinical narrative: Reported Symptoms: 10018735: GROIN PAIN; 10019077:HALLUCINATIONS; 10047862:WEAKNESS; 10050218:DIFFICULTY IN STANDINGS; Narrative: Other Relevant HX: Other: WEAKNESS, GROIN PAIN, UNABLE TO STAND
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Reported Symptoms: 10016558:FEVER; 10047700:VOMITING; Narrative: Other Relevant HX: Other: VOMITING; FEVER
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Reported Symptoms: 10016558:FEVER; Narrative: Patient received Moderna vaccine at previous facility Immunization Series Date Facility Reaction Info COVID-19 (MODERNA), MRNA, LNP-5, 2 12/01/2021 No Site COVID-19 (MODERNA), MRNA, LNP-5, 1 11/03/2021 Unable to find documentation in progress notes related to reaction. She has since transferred care to another location. At primary care appointment 12/14/23 she reported to Nurse fever with previous COVID vaccination. No additional information related to reaction available at this time. Other Relevant HX: Patient received Moderna vaccine at previous facility Immunization Series Date Facility Reaction Info COVID-19 (MODERNA), MRNA, LNP-5, 2 12/01/2021 No Site COVID-19 (MODERNA), MRNA, LNP-5, 1 11/03/2021 Unable to find documentation in progress notes related to reaction. She has since transferred care to another location. At primary care appointment 12/14/23 she reported to Nurse fever with previous COVID vaccination. No additional information related to reaction available at this time. Other:
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Reported Symptoms: 10042674:SWELLING; Narrative: On 9/6/23, a reaction of swelling to the COVID Vaccine was entered. No further details documented. No history of COVID vaccination at the medical center. Other Relevant HX: Other: SWELLING
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angina pectoris, Dyspnoea, Erythema, Fatigue, Malaise
Clinical narrative: Reported Symptoms: 10000424:ACHE; 10002391:ANGINAL PAIN; 10016558:FEVER; 10040604:SHORTNESS OF BREATH; 10043890:TIREDNESS; Narrative: Patient came to medical facility for evaluation. Arm redness and swelling, body aches, malaise status post COVID-vaccine booster on 9/6/23. Pt was advised to take acetaminophen/ibuprofen. Pt thought he was dying and declined future covid vaccines. Pt with BH history Other Relevant HX: Other: SOB, tired, body aches
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain, Peripheral swelling, Pyrexia
Clinical narrative: Reported Symptoms: 10000424:ACHE; 10002391:ANGINAL PAIN; 10016558:FEVER; 10040604:SHORTNESS OF BREATH; 10043890:TIREDNESS; Narrative: Patient came to medical facility for evaluation. Arm redness and swelling, body aches, malaise status post COVID-vaccine booster on 9/6/23. Pt was advised to take acetaminophen/ibuprofen. Pt thought he was dying and declined future covid vaccines. Pt with BH history Other Relevant HX: Other: SOB, tired, body aches
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction
Clinical narrative: Reported Symptoms: 10022095:INJECTION SITE REACTION; Narrative:  Other Relevant HX:  Other:  injection site reaction left arm
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: Reported Symptoms: 10002118:ANAPHYLAXIS; Narrative: Personal history of anaphylaxis reaction to influenza vaccine on 09/18/2023 Other Relevant HX: Other: ANAPHYLAXIS
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Reported Symptoms: 10033556:PALPITATION; Narrative: a 24 year old male patient with PMH of anxiety, depression, migraine, palpitations/SVT with report of experiencing palpitations after receiving COVID-19 Moderna vaccine. There is no documentation surrounding events of ADR per chart review. Pt does have history of palpitations and SVT that may be due to anxiety but not clear of etiology. Pt also has history of experiencing palpitations after taking cefazolin. Unclear if ADR is due to vaccine. Information about vaccines given and who administered it is limited. Other Relevant HX: Other: PALPITATIONS
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Pain, Visual impairment
Clinical narrative: Reported Symptoms: 10000424:ACHE; 10012727:DIARRHEA; 10033371:PAIN; 10047508:VISION ABNORMAL; 10047862:WEAKNESS; Narrative: On August 15, 2023, attending physician reported the patient had a historical ADR of Pfizer Covid - 19 vaccine induced Visual Disturbance, Diarrhea, Weakness, Generalized Aches and Pains classified as severe rxn year 2021. no other detailed information provided. No administration facility, who administered the vaccine or detailed information regarding the vaccine itself was provided. Other Relevant HX: Other: VISUAL DISTURBANCE; DIARRHEA; GENERALIZED ACHES AND PAINS; WEAKNESS
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: Other Relevant HX: Other: ANAPHYLAXIS
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Anterior chamber reformation, Arterial disorder, Atelectasis, Blood creatinine increased
Clinical narrative: Reported Symptoms: 10043607:THROMBOSIS; Narrative: Patient is a 76 year old male with PMH significant for GERD HLD, IFG, CKD 3, Gout, and OA who was admitted to hospital on 5/14/21 due to SOB. He states that since receiving the 2nd Pfizer vaccine in mid-Feb 2021, he has been having shortness of breath. He was seen in PCP clinic on 5/10/21 and plan for outpatient PFTs and stress echo. Labs at the time showed d dimer of 3.77 and he was called in for stat chest CTA which showed bilateral PE, no saddle embolus, no right heart strain. US of LE negative for DVT. He states that he drove previous week, approximately 70 miles back and forth. He denies recent surgeries, prior VTE, or family history of VTE. Other Relevant HX: prior to event: denies any long distance travel, sedentary lifestyle, recent surgeries, prior VTE, or family history of VTE Other: THROMBOSIS
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Dyspnoea exertional, Fibrin D dimer increased, Full blood count normal, Metabolic function test normal
Clinical narrative: Reported Symptoms: 10043607:THROMBOSIS; Narrative: Patient is a 76 year old male with PMH significant for GERD HLD, IFG, CKD 3, Gout, and OA who was admitted to hospital on 5/14/21 due to SOB. He states that since receiving the 2nd Pfizer vaccine in mid-Feb 2021, he has been having shortness of breath. He was seen in PCP clinic on 5/10/21 and plan for outpatient PFTs and stress echo. Labs at the time showed d dimer of 3.77 and he was called in for stat chest CTA which showed bilateral PE, no saddle embolus, no right heart strain. US of LE negative for DVT. He states that he drove previous week, approximately 70 miles back and forth. He denies recent surgeries, prior VTE, or family history of VTE. Other Relevant HX: prior to event: denies any long distance travel, sedentary lifestyle, recent surgeries, prior VTE, or family history of VTE Other: THROMBOSIS
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, Ultrasound Doppler normal
Clinical narrative: Reported Symptoms: 10043607:THROMBOSIS; Narrative: Patient is a 76 year old male with PMH significant for GERD HLD, IFG, CKD 3, Gout, and OA who was admitted to hospital on 5/14/21 due to SOB. He states that since receiving the 2nd Pfizer vaccine in mid-Feb 2021, he has been having shortness of breath. He was seen in PCP clinic on 5/10/21 and plan for outpatient PFTs and stress echo. Labs at the time showed d dimer of 3.77 and he was called in for stat chest CTA which showed bilateral PE, no saddle embolus, no right heart strain. US of LE negative for DVT. He states that he drove previous week, approximately 70 miles back and forth. He denies recent surgeries, prior VTE, or family history of VTE. Other Relevant HX: prior to event: denies any long distance travel, sedentary lifestyle, recent surgeries, prior VTE, or family history of VTE Other: THROMBOSIS
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Reported symptoms: 10037844:RASH; 10046735:URTICARIA; Narrative: Other Relevant HX: Other: RASH, URTICARIA
Sex: M
Vaccine: FLU4
Symptoms: Transient ischaemic attack
Clinical narrative: Reported Symptoms:  10044391:TRANSIENT ISCHEMIC ATTACKS;  Narrative:  Other Relevant HX:  Other:  TRANSIENT ISCHEMIC ATTACK
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Pruritus, Urticaria
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; 10013963:DYSPNEA; 10037007:PRURITUS; 10046735:URTICARIA; Narrative: Patient received the COVID-19 vaccine at an outside facility three years ago and when transferring care to our facility reported history of anaphylactic reaction to the COVID-19 vaccine from pfizer. Patient did receive other COVID-19 vaccines from other manufacturers thereafter. Other Relevant HX: Other: ANAPHYLAXIS; URTICARIA; PRURITUS; DYSPNEA
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Headache, Throat irritation
Clinical narrative: Reported Symptoms: 10019211:HEADACHE; 10043521:THROAT IRRITATION; Narrative: Other Relevant HX: Other: Throat irritation
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Reported Symptoms: 10013573:DIZZINESS; Narrative: A 59yo male with PMH which included Hyperlipidemia, Mild Cognitive Disorder, GERD, TBI, Nicotine Dependence, Pre- Diabetes, Parasthesia, Cervicalgia, Pain of R. shoulder, R. Arm. low Back. Difficulty walking, Epidemoid Cyst, OA of Knees, Liver cyst, and Pain of LT. ankle Joint. On August 30, 2023, staff RN reported the patient had a historical ADR of Influenza vaccine induced dizziness. No other detailed information regarding the vaccine was provided. Other Relevant HX: Other: DIZZINESS
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tachycardia
Clinical narrative: Reported Symptoms: 10043071:TACHYCARDIA; Narrative: This adverse event happened at an outside facility so there is very limited information available. Other Relevant HX: Other: TACHYCARDIA
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: Reported Symptoms: 10006791:BURNING SENSATION SKIN; Narrative: A 60yo male with PMH of Displacement of Lumbar Intervertebral Disc without Myelopathy, Hyperlipidemia, DM, Morbid Obesity, Total L. Hip Joint replacement, OA, HTN, Allergic Rhinitis, GERD, Chronic PTSD, Splenectomy, Hypersomnia w/sleep Apnea and Migraine. A historical ADR of Covid-19 vaccine induced burning sensation "felt was reported by staff R.N. on September 9, 2023. No other detailed information regarding the vaccine was provided. except the last was Moderna while the first two Covid - 19 vaccines received were Pfizer;s Patient's vaccine record showed last Covid - 19 vaccine was received on January 7, 2022, The first two were received on Feb 9, 2021 and March 2, 2021. Other Relevant HX: Other: BURNING SENSATION
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Patient received high-dose influenza vaccine on 09/13/2023. Patient walked into vaccine clinic on 09/18/2023 with redness on arm that was larger than two quarters and believed it was due to the influenza vaccine. PACT nurse created a note alerting PCP. PCP documented ADR in patient's chart. Other Relevant HX: Patient walked into vaccine clinic on 09/18/2023 with redness on arm that was larger than two quarters and believed it was due to the influenza vaccine. PACT nurse created a noted alerting PCP. PCP documented ADR in patient's chart. Other: RASH
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Reported Symptoms: 10038198:REDNESS; 10042674:SWELLING; Narrative: States L deltoid area sore for 13-14 after vaccination and was red/raised; now resolved with minimal soreness but still present. Other Relevant HX: Other: redness/swelling
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Reported Symptoms:  10043517:THROAT CONSTRICTION;   Narrative:  A 53yo female with PMH of  Ankle Surgery, multiple DVT, PE, Migraines, Chronic pain, Cervicalgia, Asthma and Chronic PTSD.  On September 7, 2023, NP reported the patient had a historical ADR of Covid-19 vaccine induced airway constriction. No other specific information regarding the vaccine ( i.e. manufacturer, lot# expiration date etc) or when and who administered the vaccine, was not provided  However the patient's immunization record indicated , he had received Covid - 19 ( Pfizer) MRNA, Lnp-5 pf 30,cg/0.3ml dose on April 2, 2021, August 2021 and April 23, 2022.  Covid- 19 vaccination  Other Relevant HX:  Other: AIRWAY CONSTRICTION
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Rash
Clinical narrative: Reported Symptoms: 10016256:FATIGUE; 10037844:RASH; Narrative: Other Relevant HX: Other: FATIGUE
Age: 94.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Asthenia, Fall, Haemorrhage, Head injury, Pain
Clinical narrative: Reported Symptoms: 10013573:DIZZINESS; 10016178:FALLING DOWN; 10047862:WEAKNESS; Narrative: 10/24 Pt presents to ED "per patient yesterday had a flu shot and COVID shot. He is stood up and went to the vanity and suddenly he fell down. He did not lose his consciousness as per patient. He fell backward and start bleeding. He was feeling somewhat weak. As per patient it happened last time last year when had similar COVID and flu shot. At that time he fell down he came to the ER. Last time he did not hit his head, at present still feeling somewhat weak and tired." Was hospitalized for 2 days for observation. Unknown vaccine details. Other Relevant HX: h/o weakness and falls after vaccines Other: generalized weakness with fall
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Reported Symptoms:  10046735:URTICARIA;  Narrative: RN reported the historical ADR as 2 episodes of oral hives which occurred years ago immediately after having flu shots. Other Relevant HX; Other: URTICARIA
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Myalgia, Pyrexia, Rash
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10013963:DYSPNEA; 10016558:FEVER; 10019211:HEADACHE; 10028922:MUSCLE PAIN; 10028411:MYALGIA; 10037844:RASH; Narrative: Other Relevant HX: Other: RASH; FEVER; DYSPNEA; MUSCLE PAIN; HEADACHE
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Reported Symptoms: 10028322:MUSCLE PAIN; Narrative: 74 year old patient who previously received 2 covid modern vaccines (5/21/21; 4/23/21) reports unwilling to get 3rd vaccine due to experiencing muscle pains after the last covid shot. No pertinent drug interactions. Other Relevant HX: Other: MUSCLE PAIN