chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Pain, Pruritus
Clinical narrative: Suspected vaccination failure; Got shingles now; blistering was seriously painful; blistering was seriously painful; Burning; Itching; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got shingles now), blister (Verbatim: blistering was seriously painful), pain (Verbatim: blistering was seriously painful), burning sensation (Verbatim: Burning) and pruritus (Verbatim: Itching). The patient was treated with aloe vera. The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved and the outcome of the blister was resolved and the outcome of the burning sensation and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, blister, pain, burning sensation and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, blister, pain, burning sensation and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-FEB-2024  The case was received from the patient via (social media) interactive digital media.   The patient reported he/she now got the shingles. The patient had blistering which was seriously painful and now they had dried up but the pain was persisting in a lesser degree. The burning and itching still kept the patient from any kind of normal rest. The doctors gave him/her the medicines which did nothing. The patient used aloe Vera which helped as much as anything he/she tried. The reporter stated he/she also knows the people to whom vaccination did not worked. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; Got shingles now; blistering was seriously painful; blistering was seriously painful; Burning; Itching; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got shingles now), blister (Verbatim: blistering was seriously painful), pain (Verbatim: blistering was seriously painful), burning sensation (Verbatim: Burning) and pruritus (Verbatim: Itching). The patient was treated with aloe vera. The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved and the outcome of the blister was resolved and the outcome of the burning sensation and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, blister, pain, burning sensation and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, blister, pain, burning sensation and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-FEB-2024  The case was received from the patient via (social media) interactive digital media.   The patient reported he/she now got the shingles. The patient had blistering which was seriously painful and now they had dried up but the pain was persisting in a lesser degree. The burning and itching still kept the patient from any kind of normal rest. The doctors gave him/her the medicines which did nothing. The patient used aloe Vera which helped as much as anything he/she tried. The reporter stated he/she also knows the people to whom vaccination did not worked. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-FEB-2024 This case was reported the patient via (social media) interactive digital media. The reporter asked not to  buy into it I know too many people that got the shingles shot and still got shingles. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: some got the shot and still get shingles/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: some got the shot and still get shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-FEB-2024   The case was received from the patient via interactive digital media.   The reporter stated some got the shingles shot and still get the shingles and never were completely rid of them. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: patient received both doses of Shingrix and still presented with Shingles/ suspected vaccination failure; Shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: patient received both doses of Shingrix and still presented with Shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 16-Feb-2024 The reporter reported that he was concerned because he had a patient who had received both doses of Shingrix and still presented in his office with Shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter consented to follow up.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Formication, Paraesthesia, Pruritus
Clinical narrative: itching all over his hands, arms, legs and back; burning on hands and body, mostly on back; feels like thousands of needles poking; sensation of a bug or parasite crawling; This non-serious case was reported by a consumer via patient support programs and described the occurrence of pruritus in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included acetylsalicylic acid (Aspirin) and rosuvastatin calcium (Crestor).   On 01-FEB-2024, the patient received the 1st dose of Shingrix (intramuscular). On 04-FEB-2024, 3 days after receiving Shingrix, the patient experienced tingling (Verbatim: feels like thousands of needles poking) and formication (Verbatim: sensation of a bug or parasite crawling). On 05-FEB-2024, the patient experienced pruritus (Verbatim: itching all over his hands, arms, legs and back) and burning sensation (Verbatim: burning on hands and body, mostly on back). Shingrix was discontinued. The outcome of the pruritus was not resolved and the outcome of the burning sensation, tingling and formication were unknown.   It was unknown if the reporter considered the pruritus, burning sensation, tingling and formication to be related to Shingrix.     It was unknown if the company considered the pruritus, burning sensation, tingling and formication to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-FEB-2024   The patient self reported this case. The patient received Shingrix and three to four days later he began itching all over his hands, arms, legs and back, accompanied by burning, the sensation of a bug or parasite crawling, felt like thousands of needles poking him. The patient wanted to know how long itching would last.  The patient's doctor recommended against taking the 2nd dose of Shingrix, as he was afraid patient would have an anaphylactic reaction.
Sex: U
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 25 children under age 2 received a vaccination; This non-serious case was reported by a consumer and described the occurrence of inappropriate age at vaccine administration in a 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 inappropriate age at vaccine administration (Verbatim: 25 children under age 2 received a vaccination). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 14-FEB-2024 The reporter stated this winter there were two vaccines available to ward off respiratory syncytial virus, which was particularly dangerous to older adults and infants one of them was Abrysvo, made by Pfizer which was approved for pregnant women, and neither was for young children. The distinction was apparently slipped by some clinicians and pharmacists and at least 25 children under age 2 received a vaccination, the Centers for Disease Control and Prevention has warned. Evidence from animal testing strongly suggested that Arexvy might exacerbate Respiratory syncytial (R.S.V.) infection in children younger than 2, rather than mitigate it, according to the Food and Drug administration. The reporter stated that she was flummoxed that young children received R.S.V. vaccines. Because they were not approved for children, pediatrician's offices, which typically administer vaccines, should not have had any in stock. The consent to follow up requested. This case was linked with US2024AMR020844 and US2024AMR020864, same reporter.; Sender's Comments:  US-GSK-US2024AMR020844:same reporter US-GSK-US2024AMR020864:same reporter
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Premature labour, Product use issue, Wrong product administered
Clinical narrative: pregnant daughter received Arexvy; premature labor a few hours later; tried to locate Pfizer's R.S.V. vaccine/her daughter received Arexvy instead; This non-serious prospective pregnancy case was reported by a consumer and described the occurrence of premature labor in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In SEP-2023, the patient received Arexvy. In SEP-2023, several hours after receiving Arexvy, the patient experienced premature labor (Verbatim: premature labor a few hours later) and wrong vaccine administered (Verbatim: tried to locate Pfizer's R.S.V. vaccine/her daughter received Arexvy instead). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant daughter received Arexvy). The outcome of the premature labor was not reported and the outcome of the wrong vaccine administered and vaccine exposure during pregnancy were unknown.   The reporter considered the premature labor to be related to Arexvy.     The company considered the premature labor to be related to Arexvy.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 14-FEB-2024 The former kindergarten teacher said she tried to locate Pfizer's RSV vaccine in several pharmacies for her pregnant daughter. In mid-September, on the very last day that her daughter was eligible to receive the shot, she found a drugstore that said it stocked the vaccine, but her daughter received Arexvy instead, which led to wrong vaccine administered and vaccine exposure during pregnancy. The reporter stated, we are all human, but there had got to be more checks and balances than this. The reporter believed the shot led to her daughter's (patient's) premature labor a few hours later. The errors were reported to a database called the Vaccine Adverse Event Reporting System.  Those administered the vaccines might have been confused in part by the similarity of the two names, experts said. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR020863:same reporter US-GSK-US2024AMR020844:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Throat irritation
Clinical narrative: patient experienced scratchy throat; swollen lymph nodesnodes on left side of patients neck; This non-serious case was reported by a physician via call center representative and described the occurrence of scratchy throat in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included swollen lymph nodes (in armpit area).   On 17-JAN-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, 3 weeks after receiving Shingrix, the patient experienced scratchy throat (Verbatim: patient experienced scratchy throat) and swollen lymph nodes (Verbatim: swollen lymph nodesnodes on left side of patients neck). The outcome of the scratchy throat and swollen lymph nodes were not reported.   It was unknown if the reporter considered the scratchy throat and swollen lymph nodes to be related to Shingrix.     It was unknown if the company considered the scratchy throat and swollen lymph nodes to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-FEB-2024 3 weeks after shot was given the patient experienced scratchy throat followed by swollen lymph nodes on left side of patients neck and approximately. On 15th January 2024 has swollen lymph nodes in armpit area that doctor thought could be possibility infected, so much so that she prescribed an antibiotic as a course of treatment. The reporter consented to follow up.
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: adults are receiving Infanrix rather than Boostrix; adults are receiving Infanrix rather than Boostrix; This non-serious case was reported by a physician via sales rep and described the occurrence of wrong vaccine administered in a adult patient who received DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: adults are receiving Infanrix rather than Boostrix) and adult use of a child product (Verbatim: adults are receiving Infanrix rather than Boostrix). The outcome of the wrong vaccine administered and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-FEB-2024 The physician reported that they inquired about the age indications of Boostrix and Infanrix. The reporter reported that they noted during the call that they had reviewed documents in which adults were receiving Infanrix rather than Boostrix, which led to wrong vaccine administered and adult use of a child product. The agent taking the call did not transfer to the Health Authority to report the adverse event.  There was no indication made by the caller that a health safety information/adverse event report had been filed.  No other information was gathered from the caller. The caller was not given the opportunity during the call to report the adverse event and adverse event was discovered during a quality assurance audit of the call.  The caller had not been able to advise if they wish to remain anonymous as such, had indicated them to remain anonymous.  There was no information provided regarding dates of administration or subjective or objective patient outcomes. The reporter did not consent to follow-up.
Sex: U
Vaccine: DTAPHEPBIP, DTAPHEPBIP, DTAPHEPBIP
Symptoms: Hepatitis B antibody negative
Clinical narrative: no protective titers; This non-serious case was reported by a other health professional via call center representative and described the occurrence of hepatitis b antibody negative in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Pediarix, the 2nd dose of Pediarix and the 1st dose of Pediarix. On an unknown date, an unknown time after receiving Pediarix, Pediarix and Pediarix, the patient experienced hepatitis b antibody negative (Verbatim: no protective titers). The outcome of the hepatitis b antibody negative was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-FEB-2024 Reporter requested the information on infant who had received a full series of hepatitis b via Pediarix, but as teens, show no protective titers. The reporter consented to follow-up.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered
Clinical narrative: received the Hep B in the Engerix dose and then in the Pediarix dose on the same day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number A32BB, expiry date 10-AUG-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 5M93R, expiry date 05-APR-2024) for prophylaxis.   On 14-FEB-2024, the patient received Pediarix (left thigh) and Engerix B (left thigh). On 14-FEB-2024, an unknown time after receiving Pediarix and Engerix B, the patient experienced accidental overdose (Verbatim: received the Hep B in the Engerix dose and then in the Pediarix dose on the same day). The outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-FEB-2024 The reporter was the Medical Assistant. The reporter reported that the patient was inadvertently administered a double dose of Hepatitis B vaccine. The patient received the Hepatitis B in the Engerix dose and then in the Pediarix dose, which led to accidental overdose. The reporter did not consent to follow up.
Age: 85.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: inadvertently administered 2 doses of Arexvy to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 85-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2KJ34, expiry date 03-JUL-2025) for prophylaxis.   Concomitant products included RSV vaccine prot. subunit PreF3 (Arexvy).   On 14-DEC-2023, the patient received the 2nd dose of Arexvy. On 14-DEC-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: inadvertently administered 2 doses of Arexvy to a patient). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 14-FEB-2024 The pharmacist stated that they inadvertently administered 2 doses of Arexvy vaccine (1st dose on 17-NOV-2023) to a patient, which led to an extra dose administered. The HCP (health care professional) stated that the patient has not had any issues. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product preparation error
Clinical narrative: removed needle from stopper after injecting adjuvant into antigen vial/ vaccine was not administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intercepted product preparation error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted product preparation error (Verbatim: removed needle from stopper after injecting adjuvant into antigen vial/ vaccine was not administered). The outcome of the intercepted product preparation error was unknown.   Additional Information: GSK Receipt Date: 15-FEB-2024 The phlebotomists called to request a replacement for a dose of Shingrix. Stated that she removed the needle from stopper after injecting adjuvant into antigen vial. HCP (health care professional) then reconstituted the liquid and punctured the vial stopper a second time. Further stated when she tried to withdraw reconstituted liquid the dose was sprayed out of the original puncture spot. This in turn cause the dose to be less than a complete dose of vaccine and vaccine was not administered to the patient, which led to an intercepted product preparation error. The PI instructions was reviewed with health care professional. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Immunodeficiency, Inappropriate schedule of product administration
Clinical narrative: Patient never received Shingrix second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2020).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient never received Shingrix second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-Feb-2024 The reporter reported that the patient was an immunocompetent which never received second dose of Shingrix vaccine. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: a patient received 3 doses of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 274YD, expiry date 15-SEP-2025) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17-MAR-2020, Batch no: J352N and Expiration Date: 11-DEC-2021) and Shingrix (1st dose received on 11-JUL-2020, Batch no: GH455 and Expiration Date: 29-JAN-2022).   On 05-SEP-2023, the patient received the 3rd dose of Shingrix. On 05-SEP-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: a patient received 3 doses of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 19-FEB-2024 The pharmacist reported that a patient received 3 doses of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness; Swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: Redness) and swelling (Verbatim: Swelling). The outcome of the erythema and swelling were unknown.   It was unknown if the reporter considered the erythema and swelling to be related to Shingrix.     It was unknown if the company considered the erythema and swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-FEB-2024 Customer reported developing swelling and redness after receiving the Shingrix vaccine. Customer reported the redness was 5 inches in diameter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: she experienced pain and redness at injection site; she experienced pain and redness at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-OCT-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: she experienced pain and redness at injection site) and injection site pain (Verbatim: she experienced pain and redness at injection site). The patient was treated with menthol (Ice). The outcome of the injection site erythema and injection site pain were resolved (duration 1 week).   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site erythema and injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-FEB-2024 Consumer was the reporter who stated that she had her first dose of Shingrix administered on 10-OCT-2023 and she experienced pain and redness at injection site that lasted approximately one week.  The consumer stated that she iced the area and the pain and redness got better.  No further information was known.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Bone scan, Chronic spontaneous urticaria
Clinical narrative: Patient was diagnosed with idiopathic chronic urticaria via biopsy in 2021; This spontaneous case was reported by a patient and describes the occurrence of CHRONIC SPONTANEOUS URTICARIA (Patient was diagnosed with idiopathic chronic urticaria via biopsy in 2021) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Chronic idiopathic urticaria since 15-Jun-2021.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced CHRONIC SPONTANEOUS URTICARIA (Patient was diagnosed with idiopathic chronic urticaria via biopsy in 2021). At the time of the report, CHRONIC SPONTANEOUS URTICARIA (Patient was diagnosed with idiopathic chronic urticaria via biopsy in 2021) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: Diagnosis of idiopathic chronic urticaria. On an unknown date, Bone scan: Diagnosed with osteoporosis.         The concomitant medication was not reported by reporter. It was reported that on 19-JAN-2022 and 22-DEC-2022, received a Pfizer Covid shot. She had not received any more Covid vaccines since then.  It was also reported that the hives persisted since 01-MAR-2021 and have been getting worse. Patient had been treated by several different kinds of doctors including dermatologists and allergists. Patient was diagnosed with idiopathic chronic urticaria via biopsy in 2021. Patient never had any relief from the hives and had them from scalp to her knees, Patient described hives as itchy and burning and getting worse.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Caller calls to know if one of the symptoms his husband has had for the past year is related to our vaccines.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Caller calls to know if one of the symptoms his husband has had for the past year is related to our vaccines.) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Caller calls to know if one of the symptoms his husband has had for the past year is related to our vaccines.). At the time of the report, IMMUNISATION REACTION (Caller calls to know if one of the symptoms his husband has had for the past year is related to our vaccines.) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-595633 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-595633:Same reporte different patient (Husband case)
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Having a reaction with redness, bumps, itching that's not getting better and is painful; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), in Feb2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "dermatomyositis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAPULE (non-serious) with onset Feb2024, outcome "not recovered", described as "Having a reaction with redness, bumps, itching that's not getting better and is painful". Additional information: the reporter stated they had a patient that had a history of dermatomyositis, and she received the vaccine weeks prior to the report.  The patient was having right after the vaccination, symptoms like redness, bumps, and itching that was not getting better and was painful.   The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 at 16:00 as dose 1, single (Lot number: ER8727) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression", start date: 1994 (ongoing); "eczema", start date: 2019 (ongoing); "high cholesterol", start date: 1998 (ongoing). Concomitant medication(s) included: WELLBUTRIN oral taken for depression (ongoing); CRESTOR oral taken for blood cholesterol increased (ongoing); KETOCONAZOLE topical taken for eczema (ongoing). The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400015149 same patient, different dose number and event;
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 22Apr2021 at 13:40 as dose 2, single (Lot number: EW0175) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "depression", start date: 1994 (ongoing); "high cholesterol", start date: 1998 (ongoing); "eczema", start date: 2019 (ongoing). Concomitant medication(s) included: WELLBUTRIN oral taken for depression (ongoing); CRESTOR oral taken for blood cholesterol increased (ongoing); KETOCONAZOLE topical taken for eczema (ongoing). Vaccination history included: BNT162b2 (first dose, at 16:00, lot#ER8727, via intramuscular route at left arm), administration date: 01Apr2021, for COVID-19 immunization, reaction(s): "fever". The following information was reported: PYREXIA (non-serious) with onset 23Apr2021 at 11:00, outcome "recovered", described as "Fever". Therapeutic measures were not taken as a result of pyrexia.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400015149 same patient, different dose number and event;
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 02Dec2021 at 15:40 as dose 3, single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "depression", start date: 1994 (ongoing); "eczema", start date: 2019 (ongoing); "high cholesterol", start date: 1998 (ongoing). Concomitant medication(s) included: WELLBUTRIN oral taken for depression (ongoing); CRESTOR oral taken for blood cholesterol increased (ongoing); KETOCONAZOLE topical taken for eczema (ongoing). Vaccination history included: BNT162b2 (first dose, at 16:00, lot#ER8727, via intramuscular route at left arm), administration date: 01Apr2021, for COVID-19 vaccination, reaction(s): "fever"; BNT162b2 (second dose, at 13:40, lot#EW0175, via intramuscular route at left arm), administration date: 22Apr2021, for COVID-19 immunization, reaction(s): "fever". The following information was reported: PYREXIA (non-serious) with onset 03Dec2021, outcome "recovered", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400015149 same patient, different dose number and event;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Feb2023 at 11:00 as dose 4, single (Lot number: GJ3270) at the age of 65 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "depression", start date: 1994 (ongoing); "high cholesterol", start date: 1998 (ongoing); "eczema", start date: 2019 (ongoing). Concomitant medication(s) included: WELLBUTRIN oral taken for depression (ongoing); CRESTOR oral taken for blood cholesterol increased (ongoing); KETOCONAZOLE topical (ongoing). Vaccination history included: BNT162b2 (first dose, at 16:00, lot#ER8727, via intramuscular route at left arm), administration date: 01Apr2021, for COVID-19 immunization, reaction(s): "fever"; BNT162b2 (second dose, at 13:40, lot#EW0175, via intramuscular route at left arm), administration date: 22Apr2021, for COVID-19 immunization, reaction(s): "fever"; BNT162b2 (third dose, at 15:40, via intramuscular route at left arm), administration date: 02Dec2021, for COVID-19 immunization, reaction(s): "fever". The following information was reported: PYREXIA (non-serious) with onset 16Feb2023 at 16:00, outcome "recovered", described as "Fever". Therapeutic measures were not taken as a result of pyrexia.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400015149 same patient, different dose number and event.;
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pyrexia, Tinnitus
Clinical narrative: Tinnitus/Ringing in the ear; high fever; chills; general weakness; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Lot number: FJ1611) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, intramuscular in left arm at 12:30, lot number EN6208), administration date: 12Mar2021, when the patient was 50-year-old, for COVID-19 immunisation; BNT162b2 (Dose 2, single, intramuscular in left arm at 14:00, lot number ER8733), administration date: 02Apr2021, when the patient was 50-year-old, for COVID-19 immunisation, reaction(s): "high fever", "general weakness", "chills". The following information was reported: TINNITUS (non-serious) with onset Dec2021, outcome "not recovered", described as "Tinnitus/Ringing in the ear"; CHILLS (non-serious) with onset Dec2021, outcome "recovered"; ASTHENIA (non-serious) with onset Dec2021, outcome "recovered", described as "general weakness"; PYREXIA (non-serious) with onset Dec2021, outcome "recovered", described as "high fever".  Additional information: the patient had strong reaction to dose 2 and dose 3 with high fever, chills and general weakness for about 2 days post injection. After recovering from the third dose, he noticed that he had a persisting ringing in the ear (tinnitus) which had not gone away.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400007536 same patient, different events after different doses of the vaccine;
Age: 21.0
Sex: U
Vaccine: TDAP
Symptoms: Encephalopathy
Clinical narrative: cp signs that encephalopathy; Initial information received on 15-Feb-2024 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp (patient).   This case involves a 21 years old patient of an unknown gender who had received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] booster and cp signs that encephalopathy.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a Booster unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Prophylactic vaccination (immunization).   On an unknown date the patient developed encephalopathy (unknown latency). These events were assessed as medically significant.   Action taken: not applicable.   It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the outcome was Unknown for the event.; Sender's Comments: Sanofi company comment dated on 20-Feb-2024: This case involves a 21 years old patient of an unknown gender who had received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] booster and cp signs that encephalopathy. Further information regarding tolerance, past medical or family history, current condition and concomitant medication for the reported event is needed to fully assess this case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 67.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Pt was hospitalized 12/31/23 with paralysis. Pt later diagnosed with Guillain-Barre syndrome. At first they thought it was his MS, but then the drs decided it was Guillan-Barre syndrome. Wife said he was in the hospital for a month and then was moved to rehab and he is still there.
Age: 56.0
Sex: F
Vaccine: YF
Symptoms: Syringe issue, Underdose
Clinical narrative: During administration of vaccination, small amount of the vaccine leaked from syringe (2-3 drops) .  Contacted facility's Travel Department for advise.  Told to have patient return within 24 hours or 28 days to re vaccinate half dose to patient.  Patient rescheduled 3/22/2024 for vaccination at Clinic.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: swelling at injection site, vomiting, confusion, fever
Age: 65.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Asthenia, Blood test, Chills, Headache, Vomiting
Clinical narrative: headache, vomiting, chills, weakness
Age: 13.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK, UNK, UNK, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received additional varicella vaccine on same day due to administration of both varicella and proquad on the same day. At this time, there is no reported adverse health impact.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody positive, Laboratory test, Microscopic polyangiitis
Clinical narrative: Diagnosed with Microscopic Polyangiitis.  No prior issues with any immuno disorders and no prior issues with the vasculitis experiences as a result.  Initially treated with methotrexate but changed to Hydroxychloroquine due to concerns with liver function.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: patient had a rash on left side of face (cheek)
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site inflammation, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Members left arm developed a rash; red, inflamed, and warmed to the touch. Measuring about 8mm across. Technician performed visual inspection to ensure rash was localized to left upper extremity.  Member states she has also been experiencing headaches which is uncommon for her. Member informed to keep eye on site and be aware of fevers. Instructed to go to ER/Clinic in symptoms persist.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia
Clinical narrative: Extreme speech aphasia
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin abnormal, Malignant melanoma, Melanocytic naevus
Clinical narrative: In June 2023, I noticed one of my moles start changing color and the shape looked asymmetrical.  I was seen by a dermatologist and diagnosed with melanoma upon confirming with biopsy results of the site. I don t have a family history of melanoma. The spot is not sun exposed.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Pain in left arm and shoulder
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Feeling hot, Periorbital swelling
Clinical narrative: Patient states they got red and felt hot like a fever, got puffy eyes that lasted the whole day.
Age: 7.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Swelling, Urticaria
Clinical narrative: Severe hives and swelling, pain at injection site
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Developed erythema at site of injections on Right Deltoid after vaccine administration on 1/22/2024. Developed pain and edema at the site over 3 weeks. Treated with Bactrim 10 day course for cellulitis of Right arm.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC15, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was supposed to receive MMR and Varicella individually. Patient was administered a individual dose of Varicella and then was given ProQuad instead of an individual dose of MMR. Patient effectively was given two doses of varicella
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Irritability, Loss of personal independence in daily activities
Clinical narrative: On 02/21/2024, doctor spoke to dad who reported that on 10/17/2023, patient had fever, fussy, tired, decreased appetite. On 10/18/2023, fever, vomiting 1-2, and loose stool. Stayed home from school on 10/17/2023 and 10/18/2023. Back to school on 10/19/2023.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: On 02/21/2024, doctor spoke to dad who reported that on 10/17/2023, patient had fever, fussy, tired, decreased appetite. On 10/18/2023, fever, vomiting 1-2, and loose stool. Stayed home from school on 10/17/2023 and 10/18/2023. Back to school on 10/19/2023.
Age: 52.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 0