chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic
Clinical narrative: warmth at injection site; pain at injection site; redness at injection site; Itchy rash; Tiredness/she felt exhausted; hurting joints; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ankylosing spondylitis (diagnosed in her mid 20's), covid-19 (positive for Covid after receiving her Covid vaccine) and shingles (diagnosed on 01-AUG-2024 on her buttocks and upper thigh and completely resolved.). Previously administered products included Covid-19 vaccine (received on 10-OCT-2024).   On 30-APR-2025, the patient received the 2nd dose of Shingrix (left arm). On 19-DEC-2024, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid) .5 ml. On 19-DEC-2024, not applicable after receiving Shingrix and less than a day after receiving Shingrix, the patient experienced joint pain (Verbatim: hurting joints). On 01-MAY-2025, the patient experienced tiredness (Verbatim: Tiredness/she felt exhausted). On 02-MAY-2025, the patient experienced injection site warmth (Verbatim: warmth at injection site), injection site pain (Verbatim: pain at injection site), injection site erythema (Verbatim: redness at injection site) and itchy rash (Verbatim: Itchy rash). The patient was treated with clobetasol propionate (Clobetasol). The outcome of the injection site warmth, injection site pain, injection site erythema, itchy rash and joint pain were not resolved and the outcome of the tiredness was resolving.   It was unknown if the reporter considered the injection site warmth, injection site pain, injection site erythema, itchy rash and tiredness to be related to Shingrix and Shingrix. It was unknown if the reporter considered the joint pain to be related to Shingrix.     It was unknown if the company considered the injection site warmth, injection site pain, injection site erythema, itchy rash and tiredness to be related to Shingrix and Shingrix. It was unknown if the company considered the joint pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-MAY-2025 The patient self-reported this case. The patient received her first Shingrix vaccine in an unknown arm and her second Shingrix vaccine and she felt exhausted and tired which still has not completely resolved, but she was feeling a little better and also had pain at the injection site, it was red and warm to the touch. The patient had a rash that had traveled to her elbow and to the crease of her arm from the injection site and the rash was itchy. The patient had some Clobetasol Ointment left over from when she had shingles that she used on the rash and it seemed to help. The patient had take no meds for this disease, but did say her joints have hurt more since receiving the Shingrix vaccines and the patient will reach out to her HCP for next steps about the rash on her arm.
Vaccine: VARZOS
Symptoms: Mammogram, Mobility decreased, Therapeutic response unexpected, X-ray
Clinical narrative: couldn't even move my arm; when the patient got Shingles shot the next day that pain and burning went away; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (that was really hurting and burning under my arm).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced mobility decreased (Verbatim: couldn't even move my arm) and unexpected therapeutic effect (Verbatim: when the patient got Shingles shot the next day that pain and burning went away). The outcome of the mobility decreased was not reported and the outcome of the unexpected therapeutic effect was not applicable.   It was unknown if the reporter considered the mobility decreased to be related to Shingles vaccine.     It was unknown if the company considered the mobility decreased to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAY-2025 This case was reported by a patient via interactive digital media The patient thought that he/she had shingles that was really hurting and burning under my arm and the patient never broke out, but when the patient got Shingles shot the next day that pain and burning went away, which led to unexpected therapeutic benefit. The doctor kept saying it wasn't shingles because the patient didn't break out, but when  got the shot that awful pain went away and hasn't come back and couldn't even move my arm without burning sharp pains. The patient had a mammograms and x-rays for muscle strains that we thought it was but I know it was shingles because it was all the symptoms of Shingles The patient had his/her second one now and highly recommend the vaccine on this one and for Pneumonia and said don't do the flu and definitely not the Covid but the patient did do Shingles and the RSV and Pnumonia one
Vaccine: RVX
Symptoms: Headache
Clinical narrative: having headaches every day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced headache (Verbatim: having headaches every day). The outcome of the headache was not resolved.   It was unknown if the reporter considered the headache to be related to RSV vaccine.     It was unknown if the company considered the headache to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 09-MAY-2025 This case was reported by a patient via interactive digital media. Reporter stated that vaccine my protect but left them having headaches everyday and also  stated that miserable going on a second year.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; suffering death with them right now; Extra dose administered; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: suffering death with them right now) (serious criteria life threatening) and extra dose administered (Verbatim: Extra dose administered). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAY-2025 This case was reported by a consumer via interactive digital media. The reporter reported that her husband was suffering death with them right now and had 3 shots. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1, 2 & 3). Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine(Dose 1, 2 & 3).
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; got shingles 3 times; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles 3 times). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAY-2025 This case was reported by a patient via interactive digital media. The patient took the both shingles vaccine and got shingles 3 times. This last time it was really bad, it burned like crazy. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Age: 48.0
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: Suspected vaccination failure; ot shingles again at 49; got the vaccine at 48; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 49-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got a a mild case of shingles at the age of 47 years old).   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: ot shingles again at 49) and inappropriate age at vaccine administration (Verbatim: got the vaccine at 48). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved and the outcome of the inappropriate age at vaccine administration was not applicable.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAY-2025 This case was reported by a patient via interactive digital media.  Patient stated he/she got the vaccine at the age of 48-years old, which led to an inappropriate age at vaccine administration and got shingles again at the age of 49-years-old and so far, patient was 50-years of age and was shingles free. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria ((insufficient information provided about  primary vaccination schedule,  time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Arm hurts; a lil nauseous; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (received 1st shot on an unknown date, had nausea, For tolerance to 1st dose, refer case US2025AMR058820).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm hurts) and nausea (Verbatim: a lil nauseous). Rechallenge with Shingles vaccine was positive. The outcome of the pain in arm and nausea were not reported.   It was unknown if the reporter considered the pain in arm and nausea to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and nausea to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2025AMR058820   Additional Information: GSK Receipt Date: 10-MAY-2025 This case was reported by a patient via interactive digital media. The patient said that first shot made him/her really sick and just got the second shot and the arm hurts and a lil nauseous but not as bad as the first one by far This case is linked with US2025AMR058820, reported by same reporter.; Sender's Comments:  US-GSK-US2025AMR058820:Original Case : US2025AMR058760
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had shingles 3 times even after the shot; 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) and shingles (Verbatim: I had shingles 3 times even after the shot). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAY-2025 This case was reported by a patient via interactive digital media. The patient had shingles 3 times even after the shot. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shinglex vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Penile blister
Clinical narrative: I have blisters on my penis; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of penile blister in a male 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 penile blister (Verbatim: I have blisters on my penis). The outcome of the penile blister was not reported.   It was unknown if the reporter considered the penile blister to be related to Shingles vaccine.     It was unknown if the company considered the penile blister to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that he had blisters on his penis what do the patient do.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: patient received Engerix-B on 7-APR-2025 and later it was realized that it expired 28-MAR-2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received HBV (Engerix B pediatric) (batch number 553j7, expiry date 28-MAR-2025) for prophylaxis.   On 07-APR-2025, the patient received Engerix B pediatric. On 07-APR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced expired vaccine used (Verbatim: patient received Engerix-B on 7-APR-2025 and later it was realized that it expired 28-MAR-2025). The outcome of the expired vaccine used was not applicable.   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 :05-MAY-2025 Pharmacist reported that a 17-year-old patient received Engerix-B on 7-APR-2025 and later it was realized that it expired 28-MAR-2025, which led to Expired vaccine used. The reporter Consented to follow up.
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: adult patient was given the Priorix vaccine IM instead of SC; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 47-year-old male patient who received MMR (Priorix) for prophylaxis.   On 23-APR-2025, the patient received Priorix. On 23-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: adult patient was given the Priorix vaccine IM instead of SC). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   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: 05-MAY-2025 A pharmacist reported that an adult patient was given the Priorix vaccine IM instead of SC, which led to subcutaneous injection formulation administered by another route. The pharmacist asked if the dose was valid.  The pharmacist did not provided information about Priorix dose. The reporter Consented to follow up.
Age: 41.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Engerix-B Interchangeability with Heplisav; This non-serious case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 41-year-old male patient who received HBV (Engerix B) (batch number 3X937, expiry date 07-DEC-2025) for prophylaxis.   Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for prophylaxis.   On 05-MAY-2025, the patient received the 2nd dose of Engerix B. On 03-APR-2025, the patient received Heplisav b. On 05-MAY-2025, an unknown time after receiving Engerix B, the patient experienced interchange of vaccine products (Verbatim: Engerix-B Interchangeability with Heplisav). The outcome of the interchange of vaccine products was not applicable.   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: 05-MAY-2025 Nurse reported that a patient received Heplisav on April 3rd 2025 and on the day of reporting Engerix B was administered to this patient, which led to interchange of vaccine products. The nurse asked how to proceed with the vaccination in order to complete the Hep B series.
Sex: M
Vaccine: DTAPHEPBIP, IPV
Symptoms: Incorrect dose administered
Clinical narrative: Extra dose of IPV component; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 9359N, expiry date 10-OCT-2027) for prophylaxis.   Co-suspect products included Polio vaccine inact (Ipv) (batch number X1D141M, expiry date 31-OCT-2026) for prophylaxis.   On 05-MAY-2025, the patient received the 1st dose of Pediarix and the 1st dose of Ipv. On 05-MAY-2025, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: Extra dose of IPV component). The outcome of the overdose was not applicable.   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: 05-MAY-2025 A registered nurse requested safety data about the administration of both Pediarix and a monovalent IPV vaccine on 05-MAY-2025. The monovalent IPV vaccine was confirmed to not be a GSK product. Patient received Pediarix and monovalent IPV vaccine on the same day, which led to overdose.
Age: 58.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shorter than recommended interval between 2nd and 3rd dose; Longer than recommended interval between 1st and 2nd dose; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 58-year-old male patient who received HAB (Twinrix) (batch number EF773, expiry date 09-SEP-2018) for prophylaxis.   Co-suspect products included HAB (Twinrix) (batch number EF773, expiry date 09-SEP-2018), (batch number EF77N, expiry date 09-SEP-2018) and (batch number HZ9Z9, expiry date 03-MAR-2017) for prophylaxis.   Previously administered products included Twinrix (received 1st dose twinrix on 1st January 2015 with batch number HZ9Z9 and expiry date 3rd March 2017).   In APR-2017, the patient received the 3rd dose of Twinrix. On 01-JAN-2017, the patient received the 2nd dose of Twinrix. On 01-JAN-2017, not applicable after receiving Twinrix, 731 days after receiving Twinrix and an unknown time after starting Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Longer than recommended interval between 1st and 2nd dose). In APR-2017, the patient experienced drug dose administration interval too short (Verbatim: Shorter than recommended interval between 2nd and 3rd dose). The outcome of the drug dose administration interval too short and drug dose administration interval too long were not applicable.   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: 05-MAY-2025 The physician called to request data regarding the possibility of a schedule variation being used.  The patient had received the first dose in January 2015, with lot number HZ9Z9 and expiration date 03rd March 2017.  The second dose was administered in January 2017, with lot number EF773 and expiration date 09th September 2018, and the third dose was given in April 2017, with the same lot number EF773 and expiration date 09th September 2018.  The physician had only inquired about the shorter than recommended interval between the second and third doses but did not ask about the longer than recommended interval between the first two doses. The interval between the second and third dose was shorter than recommended, which led to Drug dose administration interval too short. The interval between the first and second dose was longer than recommended, which led to Drug dose administration interval too long.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient not knowing that, the expiration date was 4/4 of 25/ I might just gave it to her like maybe 20 minutes ago; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 24-year-old female patient who received HBV (Engerix B) (batch number 79S54, expiry date 04-APR-2025) for prophylaxis.   On 12-MAY-2025, the patient received the 1st dose of Engerix B. On 12-MAY-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Patient not knowing that, the expiration date was 4/4 of 25/ I might just gave it to her like maybe 20 minutes ago). The outcome of the expired vaccine used was not applicable.   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: 12-MAY-2025 The certified medical assistant called to report she had given the vaccine to a patient without knowing or realizing that the expiration date was 4th April 2025 which led expired vaccine used. She believed she had administered it approximately 20 minutes prior to the call. She wanted to confirm whether the patient needed to repeat the first dose, as it was a Hepatitis B vaccine. She stated that the patient had just received the first of the three-dose series.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: KINRIX over age administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   Previously administered products included Dtap (received 3 doses on an unknown date) and IPV (received 2 doses on an unknown date).   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: KINRIX over age administration). The outcome of the inappropriate age at vaccine administration was not applicable.   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-MAY-2025 The nurse reported that 7 year old male patient received Kinrix by error, which led to inappropriate age at vaccine administration.  Patient already has 3 valid Dtaps and 2 IPVs.
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient experienced arm pain after receiving the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043838) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events.   The reporter checked to see if Spikevax lot 2043838 had any quality issues or concerns.  No treatment medication was reported.  This case contains information for the 3rd patient out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2025-786107 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2025: Live Follow up received that contains non-significant information: Reference added. On 07-May-2025: Live Follow up received that contains non-significant information: Reference added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-786107:Master case
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient experienced arm pain after receiving the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043838) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events.   The reporter checked to see if Spikevax lot 2043838 had any quality issues or concerns.  No treatment medication was reported.  This case contains information for the 4th patient out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2025-786107 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2025: Live Follow up received that contains non-significant information: Reference added. On 07-May-2025: Live Follow up received that contains non-significant information: Reference added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-786107:Master case
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient experienced arm pain after receiving the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043838) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events.   The reporter checked to see if Spikevax lot 2043838 had any quality issues or concerns.  No treatment medication was reported.  This case contains information for the 5th patient out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2025-786107 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2025: Live Follow up received that contains non-significant information: Reference added. On 07-May-2025: Live Follow up received that contains non-significant information: Reference added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-786107:Master case
Vaccine: COVID19
Symptoms: Device breakage
Clinical narrative: A broken flange was observed; The initial case was missing the following minimum criteria: product complaint only. Upon receipt of follow-up information on 08May2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Nurse from product quality group.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Lot number: LP1776, Expiration Date: 26Apr2025) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "A broken flange was observed". Additional information: NDC Number: 00069243210. A broken flange was observed during the evaluation of the returned complaint sample.  The reporter considered "a broken flange was observed" not related to BNT162b2 omicron (kp.2). Causality for "a broken flange was observed" was determined associated to device constituent of BNT162b2 omicron (kp.2) (malfunction).
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Post-acute COVID-19 syndrome, Pulmonary thrombosis
Clinical narrative: 2 blood cloths in my lung; breathing issues; long term Covid; No energy; fatigue; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "2 blood cloths in my lung"; DYSPNOEA (non-serious), outcome "unknown", described as "breathing issues"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long term Covid"; ASTHENIA (non-serious), outcome "unknown", described as "No energy"; FATIGUE (non-serious), outcome "unknown".  Clinical information: Patient asked, Why did Pfizer Covid vaccine give patient long term Covid fatigue diagnosed by reg doctor and specialist. Patient's life was ruined. No energy and breathing issues was on the world till given new 2023 vaccine in IICU (Intermediate Intensive Care Unit), within a day or so had 2 blood cloths in patient's lung and breathing issues.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain in extremity
Clinical narrative: sick; her arm gets very sored.; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV25-00307 (Novavax).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown. single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm gets very sored.". Additional information: Consumer states that possibly they will tweak it for the fall. She states usually it is 36 hours or 2 days that she doesn't feel good. Last time it was 5 days that she couldn't get off of the couch, she was really sick. Pfizer makes her verysick and her arm gets very sored. She gets other vaccines and she doesn't get sick.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Musculoskeletal disorder, Neuropathy peripheral, Peripheral swelling
Clinical narrative: After about a week, patient had swelling in right hand, neuropathy, and was unable to use her hand for about a week. Patient also reported neuropathy in feet that made it extremely difficult to walk.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Bell's palsy, Facial paralysis, Neck pain, Paraesthesia
Clinical narrative: Per patient mother, patient had tingling sensation in right arm, pain to back of neck, and right-side face drooping. ER visit was advised to mother by PCP for further evaluation. Per mom, provider dx patient with Bells Palsy due to adverse effect from vaccine received at PCP visit. Treatments and other outcomes have not yet been provided.
Age: 63.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: Writer gave vaccine to patient before visit starting. Writer gave vaccines to patient, then  15 minutes passed for patient to wait if there was reaction. Writer did not suspect patient having reaction nor did patient mention any symptoms.
Age: 43.0
Sex: F
Vaccine: HEP, PNC13, VARCEL
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Redness with itching on back side of right arm where MMR injection given, spreading down arm within 24 hours of vaccination, with patient scratching rash and applying a steroidal type of cream on rash, and taking one dose of Benadryl, within 24 hours of rash. Patient reports rash, itching and redness as decreasing as of 48 hours post vaccination
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: MMR accidentally given to patient instead of meningitis vaccine. no reaction. patient given correct vaccine 5/15/25
Age: 1.58
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: today, I see 1 cm circular mass left thigh, tender, but initially by report, presented as a large circular raised swelling.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC20
Symptoms: Albuminocytological dissociation present, Areflexia, Asthenia, CSF protein increased, CSF white blood cell count negative
Clinical narrative: Patient presented with inability to walk starting approximately 3 days after vaccination progressing over next 3 weeks. Admitted 5/14/25 and diagnosed with Guillain-Barre-Syndrome on 5/15/25. Diagnosis based on bilateral lower extremity predominant symmetric flaccid weakness, areflexia in lower extremities with hyporeflexia in upper extremities, diffuse spinal root enhancement on post-contrast T1 weighted MRI of the total spine, nerve conduction studies demonstrating primary demyelinating with secondary axon loss sensorimotor polyneuropathy, and albuminocytologic dissociation with CSF protein of 323mg/dL and 0WBC/hpf. Film array and culture are negative.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC20
Symptoms: Culture negative, Demyelinating polyneuropathy, Diffusion-weighted brain MRI, Gait inability, Guillain-Barre syndrome
Clinical narrative: Patient presented with inability to walk starting approximately 3 days after vaccination progressing over next 3 weeks. Admitted 5/14/25 and diagnosed with Guillain-Barre-Syndrome on 5/15/25. Diagnosis based on bilateral lower extremity predominant symmetric flaccid weakness, areflexia in lower extremities with hyporeflexia in upper extremities, diffuse spinal root enhancement on post-contrast T1 weighted MRI of the total spine, nerve conduction studies demonstrating primary demyelinating with secondary axon loss sensorimotor polyneuropathy, and albuminocytologic dissociation with CSF protein of 323mg/dL and 0WBC/hpf. Film array and culture are negative.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC20
Symptoms: Hyporeflexia, Hypotonia, Laboratory test normal, Magnetic resonance imaging abnormal, Nerve conduction studies abnormal
Clinical narrative: Patient presented with inability to walk starting approximately 3 days after vaccination progressing over next 3 weeks. Admitted 5/14/25 and diagnosed with Guillain-Barre-Syndrome on 5/15/25. Diagnosis based on bilateral lower extremity predominant symmetric flaccid weakness, areflexia in lower extremities with hyporeflexia in upper extremities, diffuse spinal root enhancement on post-contrast T1 weighted MRI of the total spine, nerve conduction studies demonstrating primary demyelinating with secondary axon loss sensorimotor polyneuropathy, and albuminocytologic dissociation with CSF protein of 323mg/dL and 0WBC/hpf. Film array and culture are negative.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC20
Symptoms: Peripheral sensorimotor neuropathy
Clinical narrative: Patient presented with inability to walk starting approximately 3 days after vaccination progressing over next 3 weeks. Admitted 5/14/25 and diagnosed with Guillain-Barre-Syndrome on 5/15/25. Diagnosis based on bilateral lower extremity predominant symmetric flaccid weakness, areflexia in lower extremities with hyporeflexia in upper extremities, diffuse spinal root enhancement on post-contrast T1 weighted MRI of the total spine, nerve conduction studies demonstrating primary demyelinating with secondary axon loss sensorimotor polyneuropathy, and albuminocytologic dissociation with CSF protein of 323mg/dL and 0WBC/hpf. Film array and culture are negative.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Discomfort, Urticaria
Clinical narrative: Occurring 17 hours after administration, the patient broke out in full-body hives. No lip swelling or difficulty breathing. Hives did not start at any specific injection site, they started on the neck.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Circumstance or information capable of leading to medication error, Fear of injection, Gait disturbance, Injection site pain, Injection site rash
Clinical narrative: During the time of the vaccinations given my child saw the needle got a little scared so I began to hold his hands while soothing him. The M.A who administered the shots straddles his feet to clean injection shot and then gave 1 dose in left thigh(DTP) . Then unstraddled his legs and came over to his left side and began another shot (hep a). While standing on the side of me he accidentally poked my belly and administered me part of the dosage(upon feeling what I felt I looked down and he then was inside my sons thigh with same needle that was in me. He then pulled needle (a little of the medicine that was left van out the syringe. He bandaged both me and my son up. I asked what was I just injected with he said he did not know. I asked office how to report such an event,as I was not trying to get anyone in trouble but needed to report what had happened in case something happens. Once home I noticed soreness on my own stomach and hive had began to form on my way home from the appointment. I took two benedryls. Checked my sons sight and he had multiple bumps around the injection sight on the right thigh where he had been stuck with an used needle. And by nights end complained of his leg hurting and not being able or wanting to walk. I took pictures of both. The next day my own sight was reder in color and swoll. Skin irritated
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Multiple use of single-use product, Underdose, Wrong technique in product usage process
Clinical narrative: During the time of the vaccinations given my child saw the needle got a little scared so I began to hold his hands while soothing him. The M.A who administered the shots straddles his feet to clean injection shot and then gave 1 dose in left thigh(DTP) . Then unstraddled his legs and came over to his left side and began another shot (hep a). While standing on the side of me he accidentally poked my belly and administered me part of the dosage(upon feeling what I felt I looked down and he then was inside my sons thigh with same needle that was in me. He then pulled needle (a little of the medicine that was left van out the syringe. He bandaged both me and my son up. I asked what was I just injected with he said he did not know. I asked office how to report such an event,as I was not trying to get anyone in trouble but needed to report what had happened in case something happens. Once home I noticed soreness on my own stomach and hive had began to form on my way home from the appointment. I took two benedryls. Checked my sons sight and he had multiple bumps around the injection sight on the right thigh where he had been stuck with an used needle. And by nights end complained of his leg hurting and not being able or wanting to walk. I took pictures of both. The next day my own sight was reder in color and swoll. Skin irritated
Age: 0.75
Sex: M
Vaccine: FLU3
Symptoms: Rash maculo-papular
Clinical narrative: generalized maculopapular rash
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Limb mass, Peripheral swelling, Pruritus
Clinical narrative: Mom reports leg is red and swollen compared to other leg. She does feel a hard bump under the skin. The leg is itchy. Mom has provided cold compresses and Benadryl with good affect. Patient will be coming to the office for evaluation
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event patient given wrong vaccine.
Age: 61.0
Sex: M
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Received PCV21 05/09/25 ~ Two days later, developed red, itchy painful rash to area under injection site. Appear more linear, raised erythematous. Approximately 10cm x 6cm. No open sores or lesions. Appears consistent with cellulitis. Treat with cephalexin 500 mg qid x 10 days.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Right arm swelling pain/itch redness induration warmth -> Benadryl & topical steroid given -> still redness -> antibiotic -> did not full scrip after as advised
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Skin warm
Clinical narrative: Right arm swelling pain/itch redness induration warmth -> Benadryl & topical steroid given -> still redness -> antibiotic -> did not full scrip after as advised
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Nausea, Seizure, Syncope, Tremor
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Blood test, Brain fog, Computerised tomogram, Diarrhoea
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Systemic: venous damage per pt-Medium, Systemic: Hypertension-Mild, Additional Details: pt reported md has diagnosed him with "long covid" associated with vaccine-venous damage , Other Vaccines:  VaccineTypeBrand: Flulaval; Manufacturer: ; LotNumber: 2724l; Route: im; BodySite: arm; Dose: ; VaxDate: 10/11/2024
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disturbance in attention, Dyspnoea, Fatigue, Heart rate increased, Impaired work ability
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Systemic: venous damage per pt-Medium, Systemic: Hypertension-Mild, Additional Details: pt reported md has diagnosed him with "long covid" associated with vaccine-venous damage , Other Vaccines:  VaccineTypeBrand: Flulaval; Manufacturer: ; LotNumber: 2724l; Route: im; BodySite: arm; Dose: ; VaxDate: 10/11/2024