chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AE/No PQC.; HCP called stating that a male 16 year old patient was inadvertently given the adult formulation 1mL dose of RECOMBIVAX HB "last week". No further information provided. No other AE/No PQC. 1 mL RECOMBIVAX - last week  male 00006-4094-02; This spontaneous report was received from a Physician and refers to a 16-year-old male patient.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.   On an unknown date in July 2025 (reported as last week), the patient was inadvertently vaccinated with an adult formulation of Hepatitis B Vaccine (Recombinant) 10MCG/1.0ML Injection, at a dose of 1mL, prefilled syringe, administered as prophylaxis (route of administration, anatomical site of injection, lot number and expiration date were not reported) (Accidental overdose). No additional adverse event was reported for the patient.   No further information provided.
Age: 28.0
Sex: M
Vaccine: PNC21
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; the CAPVAXIVE was exposed to a minimum temperature of 0C and a maximum of 9C. Capvaxive was administered to a patient on 07/03/2025; This spontaneous report was received from a Physician Assistant (medical assistant) and refers to a 28-year-old male patient.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.   From 27-JUN-2025 through 09-JUN-2025, a temperature excursion occurred for Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE). On 03-JUL-2025, the patient was vaccinated with an improperly stored dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), Injection, prefilled syringe, strength: 168 mcg/ml, 0.5 ml, once, administered as prophylaxis (lot number Z002626 has been verified to be valid for Pneumococcal 21-valent Conjugate Vaccine [CAPVAXIVE], expiration date not reported but upon internal validation was established as 04-SEP-2026; anatomical site of injection, route of administration and vaccination scheme frequency were not provided).  The reporter stated that the administered vaccine was exposed to a minimum temperature of 0 degree Celsius (C) and a maximum of 9 degree C (Product storage error), but was unable to confirm the exact dates of the excursions and indicated that is unknown if there were any previous excursions. The reporter confirmed the patient did not report any adverse issues or side effects from the administrated dose (No adverse event).  This is one of three reports from the same reporter.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: an adult who received a pediatric dose of Hep B vaccine/ she only had half a dose; an adult who received a pediatric dose of Hep B vaccine/Unapproved age; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 35-year-old female patient who received HBV (Engerix B pediatric) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis.   On 30-JUN-2025, the patient received Engerix B pediatric. On 30-JUN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: an adult who received a pediatric dose of Hep B vaccine/ she only had half a dose) and adult use of a child product (Verbatim: an adult who received a pediatric dose of Hep B vaccine/Unapproved age). The outcome of the underdose and adult use of a child product 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: 30-JUN-2025 Nurse had a patient, an adult who received a pediatric dose of Hep B vaccine, which led to an adult use of a child product and underdose. Nurse questioned what was and what they do because she only had half a dose. Did they have to came her back for a second pediatric dose to equal to 1 ml.
Vaccine: YF
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received a booster dose of YF-vax prior to the 10-year interval., with no reported adverse event; Initial information received on 08-Jul-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves unknown gender child patient who received a booster dose of Yellow Fever Vaccine - Us [Yf-Vax] prior to the 10-year interval, with no reported adverse event.   This case was linked to US-SA-2025SA194574  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Yellow Fever Vaccine - US, Solution for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site due to upcoming travel requirement (immunization) prior to the 10-year interval, with no reported adverse event (inappropriate schedule of product administration) (latency same day).  Information regarding batch number corresponding to the one at time of event occurrence was requested.  Reportedly, a family of 5 came in to get YF-vax due to upcoming travel requirements; that the family told the Pharmacy that they had not gotten a YF-vax before; that it was not until after administration the pharmacy was alerted that 2-of the family members had had the vaccine 6-years prior.  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA194574:
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: permanent neuropathy issues; This serious case was reported by a consumer via interactive digital media and described the occurrence of neuropathy in a female 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 neuropathy (Verbatim: permanent neuropathy issues) (serious criteria GSK medically significant). The outcome of the neuropathy was not reported.   The reporter considered the neuropathy to be related to Shingles vaccine.     The company considered the neuropathy to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-JUL-2025 This case was reported by a patient via interactive digital media. The reporter said that probably not as bad as the permanent neuropathy issues his/her daughter have gotten from taking Shingles vaccine. This case is linked with US2025AMR088680, reported by same reporter.; Sender's Comments: A case of Neuropathy peripheral, an unknown time after receiving Shingles vaccine, in a female subject. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. US-GSK-US2025AMR088680:Same reporter
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: Permanent neuropathy issues many others have gotten from taking it; This serious case was reported by a consumer via interactive digital media and described the occurrence of neuropathy 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 neuropathy (Verbatim: Permanent neuropathy issues many others have gotten from taking it) (serious criteria GSK medically significant). The outcome of the neuropathy was not reported.   The reporter considered the neuropathy to be related to Shingles vaccine.     The company considered the neuropathy to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-JUL-2025 This case was reported by a patient via interactive digital media. The reporter said that probably not as bad as the permanent neuropathy issues many others have gotten from taking Shingles vaccine. This case is linked with US2025AMR085363, reported by same reporter.; Sender's Comments: A case of Neuropathy peripheral, an unknown time after receiving Shingles vaccine, in a female subject. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. US-GSK-US2025AMR085363:Same reporter
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Condition aggravated, Gait inability, Injection site pain, Injection site swelling
Clinical narrative: Back pain; excruciating sciatica pain; Leg pain; I can't even walk due to the pain; Injection site pain; Injection site warmth; Injection site swelling; I can't even walk due to the pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number EK225, expiry date 03-OCT-2027) for prophylaxis.   Concurrent medical conditions included sciatic nerve injury. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix), gabapentin and ibuprofen sodium (Ibuprofen).   On 27-JUN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. In JUN-2025, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain), injection site warmth (Verbatim: Injection site warmth), injection site swelling (Verbatim: Injection site swelling), pain (Verbatim: I can't even walk due to the pain) and unable to walk (Verbatim: I can't even walk due to the pain). On 28-JUN-2025, the patient experienced back pain (Verbatim: Back pain), sciatica aggravated (Verbatim: excruciating sciatica pain) and leg pain (Verbatim: Leg pain). Rechallenge with Shingrix was positive. The outcome of the injection site pain, injection site warmth, injection site swelling, pain, back pain, sciatica aggravated, leg pain and unable to walk were not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site swelling, pain, back pain, sciatica aggravated, leg pain and unable to walk to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site warmth, injection site swelling, pain, back pain, sciatica aggravated, leg pain and unable to walk to be related to Shingrix.   Linked case(s) involving the same patient: US2025AMR082131   Additional Information: GSK Receipt Date: 30-JUN-2025 The reporter was the patient.  The patient reports that she received the 2nd dose of Shingrix vaccine at a local pharmacy and were administered in the left arm.  The patient reports that she has sciatic nerve issues and gets treatment with a chiropractor and her condition was under control.  The patient states she had just left the chiropractor office when she went to get the 2nd dose of Shingrix. The patient reports that on Saturday June 28th 2025 in the morning she had excruciating sciatica pain on her back and right leg. The patient reports with the 1st dose she had pain and swollen of the injection site.  She reports that with the second dose she has the same but also it was warm. The patient reports could not even walk due to the pain.  The patient reports she has applied ice and has taken Ibuprofen for the pain.   No additional event was reported.; Sender's Comments:  US-GSK-US2025AMR082131:Same patient/Dose 1
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity, Sciatica, Vaccine positive rechallenge
Clinical narrative: Back pain; excruciating sciatica pain; Leg pain; I can't even walk due to the pain; Injection site pain; Injection site warmth; Injection site swelling; I can't even walk due to the pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number EK225, expiry date 03-OCT-2027) for prophylaxis.   Concurrent medical conditions included sciatic nerve injury. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix), gabapentin and ibuprofen sodium (Ibuprofen).   On 27-JUN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. In JUN-2025, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain), injection site warmth (Verbatim: Injection site warmth), injection site swelling (Verbatim: Injection site swelling), pain (Verbatim: I can't even walk due to the pain) and unable to walk (Verbatim: I can't even walk due to the pain). On 28-JUN-2025, the patient experienced back pain (Verbatim: Back pain), sciatica aggravated (Verbatim: excruciating sciatica pain) and leg pain (Verbatim: Leg pain). Rechallenge with Shingrix was positive. The outcome of the injection site pain, injection site warmth, injection site swelling, pain, back pain, sciatica aggravated, leg pain and unable to walk were not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site swelling, pain, back pain, sciatica aggravated, leg pain and unable to walk to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site warmth, injection site swelling, pain, back pain, sciatica aggravated, leg pain and unable to walk to be related to Shingrix.   Linked case(s) involving the same patient: US2025AMR082131   Additional Information: GSK Receipt Date: 30-JUN-2025 The reporter was the patient.  The patient reports that she received the 2nd dose of Shingrix vaccine at a local pharmacy and were administered in the left arm.  The patient reports that she has sciatic nerve issues and gets treatment with a chiropractor and her condition was under control.  The patient states she had just left the chiropractor office when she went to get the 2nd dose of Shingrix. The patient reports that on Saturday June 28th 2025 in the morning she had excruciating sciatica pain on her back and right leg. The patient reports with the 1st dose she had pain and swollen of the injection site.  She reports that with the second dose she has the same but also it was warm. The patient reports could not even walk due to the pain.  The patient reports she has applied ice and has taken Ibuprofen for the pain.   No additional event was reported.; Sender's Comments:  US-GSK-US2025AMR082131:Same patient/Dose 1
Vaccine: RVX
Symptoms: Cough, Dyspnoea, Fatigue, Paranasal sinus hypersecretion, Respiratory syncytial virus infection
Clinical narrative: Cough; Sinus drainage; Hard time getting my breath; fatigued; Suspected vaccination failure; RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included asthma.   On an unknown date, the patient received RSV vaccine. In MAY-2025, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: RSV). On an unknown date, the patient experienced cough (Verbatim: Cough), postnasal drip (Verbatim: Sinus drainage), difficulty breathing (Verbatim: Hard time getting my breath) and fatigue (Verbatim: fatigued). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection, cough, postnasal drip, difficulty breathing and fatigue were not resolved.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, cough, postnasal drip, difficulty breathing and fatigue to be related to RSV vaccine.     The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection, cough, postnasal drip, difficulty breathing and fatigue to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 24-JUN-2025 The patient had the RSV vaccine after the first of the year and about one month ago the patient was pretty sure about got respiratory syncytial virus infection because everyone around seemed to have it.  The patient have asthma and still coughing and lots of sinus drainage.  Hard time getting breath and so fatigued.  At first thought it was really bad allergies but got worse.  Still hoping anyway now would be back to normal. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming respiratory syncytial virus infection 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 details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming respiratory syncytial virus infection) is considered unrelated to GSK's RSV vaccine.
Vaccine: RVX
Symptoms: Vaccination failure
Clinical narrative: Cough; Sinus drainage; Hard time getting my breath; fatigued; Suspected vaccination failure; RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included asthma.   On an unknown date, the patient received RSV vaccine. In MAY-2025, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: RSV). On an unknown date, the patient experienced cough (Verbatim: Cough), postnasal drip (Verbatim: Sinus drainage), difficulty breathing (Verbatim: Hard time getting my breath) and fatigue (Verbatim: fatigued). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection, cough, postnasal drip, difficulty breathing and fatigue were not resolved.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, cough, postnasal drip, difficulty breathing and fatigue to be related to RSV vaccine.     The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection, cough, postnasal drip, difficulty breathing and fatigue to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 24-JUN-2025 The patient had the RSV vaccine after the first of the year and about one month ago the patient was pretty sure about got respiratory syncytial virus infection because everyone around seemed to have it.  The patient have asthma and still coughing and lots of sinus drainage.  Hard time getting breath and so fatigued.  At first thought it was really bad allergies but got worse.  Still hoping anyway now would be back to normal. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming respiratory syncytial virus infection 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 details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming respiratory syncytial virus infection) is considered unrelated to GSK's RSV vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles on face and near my eye; 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. In JUL-2025, 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 facial herpes zoster (Verbatim: shingles on face and near my eye). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was not resolved.   It was unknown if the reporter considered the vaccination failure and facial herpes zoster 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 facial herpes zoster to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 05-JUL-2025 This case was reported by a patient via interactive digital media. Patient finished the two shot series in late spring and was diagnosed this week with shingles, stated that I'm sitting here in July with shingles on my face and near my eye.  Patient was questioning the value of the vaccine. 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 details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine (Dose 1 & 2).
Age: 71.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: he got the 3rd one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 71-year-old male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received 1st dose of vaccine on 23rd February 1999) and Havrix (received 2nd dose of vaccine on 12th October1999).   On 01-OCT-2024, the patient received the 3rd dose of Havrix. On 01-OCT-2024, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: he got the 3rd one). The outcome of the extra dose administered 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: 30-JUN-2025 Pharmacist just need to check and saw if this patient needs another vaccination. Patient had 2 (doses) in 1999, an another one (dose) last year, was typically a 2-shot series. But patient got the 3rd one which led to extra dose administered. Pharmacist questioned that if he needs a 4th dose.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Intramuscular Administration of Priorix (Inappropriate Route of Administration); 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 64-year-old female patient who received MMR (Priorix) (batch number 2N795, expiry date 13-SEP-2026) for prophylaxis.   On 01-JUL-2025, the patient received the 1st dose of Priorix (intramuscular). On 01-JUL-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Intramuscular Administration of Priorix (Inappropriate Route of Administration)). 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: 01-JUL-2025 The pharmacist called to ask for information/advise about the administration of Priorix intramuscularly instead of subcutaneously which led to subcutaneous injection formulation administered by other route. Vaccination date, vaccine detail and patient demographics were obtained in this call (only no patient initials provided from the Pharmacist end). No further information was obtained in this call. The vaccine administration facility was the same as primary reporter.
Age: 0.75
Sex: M
Vaccine: PNC20
Symptoms: Lethargy, Syncope
Clinical narrative: Prolonged Syncope; The baby was lethargic; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 08Jul2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Physician from medical information team.  A 9-month-old male patient received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) at the age of 9 months for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant, life threatening), outcome "unknown", described as "Prolonged Syncope"; LETHARGY (life threatening), outcome "unknown", described as "The baby was lethargic".  Clinical course: The pediatrician called regarding a 9-month baby, healthy, no allergies (referred a "perfectly fine") who was administered PCV 20. The pediatrician initially reported that the baby almost died right after giving the vaccine in their office and that they almost lost the baby. She mentioned that this is so very serious. This vaccine is causing problems and lots of reactions. She does not know if she should give this vaccine anymore. On 08Jul2025, the same pediatrician reported that the baby had a reaction that is not outlined in the PI. As soon as PCV 20 was administered, the baby went to sleep almost immediately, they thought they had lost him. They tried to wake him up, took about half an hour to know what's going on. The baby was lethargic, almost called the Emergency Services. The pediatrician stated that this is not normal. It was an instant reaction to the vaccine. The pediatrician is aware that the PI reported drowsiness, however she would referred it as Prolonged Syncope. The pediatrician also reported that she has seen other local reactions (redness, 1-inch knots that take 2-4 weeks) that she didn't see with PCV 13. The pediatrician wanted to know if she should continue to give the vaccine and if there are any more reports.  The information on the batch/lot number for pneumococcal 20- valent conjugate vaccine (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Based on the close temporal relationship, the association between the events syncope and lethargy with PREVNAR 20 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Death, Thrombosis
Clinical narrative: Died in sleep; started getting blood clots; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, 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: DEATH (death, medically significant), outcome "fatal", described as "Died in sleep"; THROMBOSIS (medically significant), outcome "unknown", described as "started getting blood clots". The patient date of death was unknown. Reported cause of death: "Died in sleep". It was not reported if an autopsy was performed.  Clinical course: The patient got the vaccine for COVID-19 from Pfizer. The patient started getting blood clots and she died in her sleep.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: Died in sleep
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19 pneumonia, Drug ineffective
Clinical narrative: gets pneumonia from getting sick/fever of 102/getting financial assistance for the medication Paxlovid; gets pneumonia from getting sick/fever of 102/getting financial assistance for the medication Paxlovid; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 PNEUMONIA (medically significant), outcome "unknown" and all described as "gets pneumonia from getting sick/fever of 102/getting financial assistance for the medication Paxlovid". The patient underwent the following laboratory tests and procedures: Body temperature: 102. Therapeutic measures were taken as a result of drug ineffective, covid-19 pneumonia. The patient did state that they had Pfizer, she said it was the booster shot while on the line about getting financial assistance for the medication Paxlovid. She did state that she gets pneumonia from getting sick, that she has that as well and she has a fever of 102.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness at the injection site and swollen; Redness at the injection site and swollen; This is a spontaneous report received from a Physician from a sales representative.  A 64-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 01Jul2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 02Jul2025, outcome "not recovered" and all described as "Redness at the injection site and swollen". It was unknown if therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Pain at the injection where she has lost full movement of moving her arm all the way up and down; Pain at the injection where she has lost full movement of moving her arm all the way up and down; This is a spontaneous report received from an Other HCP from a sales representative.  A 59-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), INJECTED LIMB MOBILITY DECREASED (non-serious) all with onset Jul2025, latency 2 weeks after the suspect product(s) administration, outcome "not recovered" and all described as "Pain at the injection where she has lost full movement of moving her arm all the way up and down". Therapeutic measures were not taken as a result of vaccination site pain, injected limb mobility decreased.  Additional information: The patient didn't receive any other vaccines on the same date as the vaccine reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the vaccine reported. It was unknown if the patient was taking any other medications within 2 weeks of the event starting. Pain at the injection where the patient has lost full movement of moving her arm all the way up and down. This was 2 weeks later from vaccine administered. The reporter classified the event as non-serious.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity
Clinical narrative: pain in both legs for 3 plus weeks; This is a spontaneous report received from a Physician from a sales representative.  A 73-year-old female patient received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), on 17Jun2025 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years for immunisation. The patient's relevant medical history included: "Smoker" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Jun2025, outcome "recovering", described as "pain in both legs for 3 plus weeks". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s) for which you are reporting. It was unknown if the patient received any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. The patient was not taking any other medications within 2 weeks of the event starting.  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Immunisation reaction, Swelling
Clinical narrative: he swelled up like a balloon; bad Allergic Reaction to a Pfizer (Flu) Vaccine; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on (09Jul2025) , this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP, Program ID: 005570.  A 90-year-old male patient received pneumococcal 20 val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: HP73b4). The patient's relevant medical history included: "Deaf" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome unknown, described as "he swelled up like a balloon" HYPERSENSITIVITY (non-serious), outcome "unknown", described as bad Allergic Reaction to a Pfizer (Flu) Vaccine.  Additional information: The patient stated he was 90 years old and deaf. He had a bad reaction and got the questionnaire all filled out and is trying to find out an email he can send the completed form back to Pfizer. He needed an email to send this 7 page completed form. He was in a nursing home, and it has Pfizer all over the envelope and he is not sure they will release this to the mail man. Is there a customer relations email to send this to. The nursing home gave him this and he swelled up like a balloon and he thinks they tried to take him out. He put down everything he could. 3 months later they told him it was a pneumonia shot, told him the HP73b4. He is trying to get Pfizer interested in this crazy thing. He has trouble getting 7 page completed questionnaire in mail to reach us.  wanted to back up with email. Gave him a mystery chemical and they wouldn't tell him what it was until 3 months later and gave this number. There was no consent form, and it was all underhanded and not properly handled. Can this call handler talk to head of privacy branch and come up with an email. He tried to get this in the mail, but he really needs an email to send as backup. This is for proper purpose. It was a Pfizer product they started with and something happened to it, they did something and did not  think Pfizer is responsible. He blew up like a balloon for 2 weeks. He has had 200 shots in his life and had a military career and was in 3rd world countries and never had a reaction in his life. They tried to take him out and he wanted to get the information to Pfizer. The patient stated he was a lawyer and federal judge. He is very hard of hearing so if we send him an email address he can have this taken care of in 5 minutes. Clarifies he was hard of hearing before the shot; it had nothing to do with Pfizer at all. Email works because he can read but over telephone, he is unreliable. PSCC Communication: Informed caller his request would be filed and that call handler does not have an email to provide.
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I don't trust it because I was very sick after taking vaccines.; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, 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 "I don't trust it because I was very sick after taking vaccines.".  Additional information: Causality reported as not known.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: YF
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2-family members received a booster dos of YF-vax prior to the 10- year interval, with no reported adverse event; Initial information received on 09-Jul-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves Child patient with unknown gender who received a booster dos of Yellow Fever Vaccine - US [YF-VAX] prior to the 10- year interval, with no reported adverse event.  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 dose of suspect Yellow Fever Vaccine - US, Solution for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization and 2-family members received a booster dos of yf-vax prior to the 10- year interval, with no reported adverse event (inappropriate schedule of product administration).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, she was asking if there were any precautions they need to take for this situation.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA194542:
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Loss of consciousness, Malaise, Vomiting
Clinical narrative: Grandmother called in today 7/11/25 and reported that yesterday around 5:30 client had passed out on a car ride. She received her second dose of Trumenba around 2:30 on 7/10/25.  Grandmother reports they were driving down the highway and client reported she didn't feel good and then she passed out on the grandmother's arm. Grandmother reports she called the clients name and no response. States the episode didn't last very long and she came too. Her eyes were open and continued to complain of not feeling well. Report they went to get her something to drink and she then vomited x1.  After emesis continued to complain of being tired and not feeling good. Reports client is fine today and no complaints.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident passed away on 7/10/2025
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC20, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No advance effect reported or observed, patient accidently received 2 hepatitis B vaccines. One hepatitis B vaccine and Pediarix which also contains hepatitis B component.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Diarrhoea, Discomfort, Facial pain, Haemorrhage
Clinical narrative: with first shot missed three days of work for chills, shivering, throwing up, diarrhea . After 2nd shot missed 5 days of work for the same symptoms and about a week after second shot patient's face started breaking out and it is still going and no doctor new what to do till now. it itches it bleeds it burns it hurts in addition to that it makes patient feel uncomfortable and insecure and he guarantee he lost his job for it even though he cant prove it. In summery this adverse reaction changes patient's life. He fills up work applications and when they look at his face they don't give him the job- sad.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Impaired work ability, Pruritus, Rash, Skin burning sensation, Vomiting
Clinical narrative: with first shot missed three days of work for chills, shivering, throwing up, diarrhea . After 2nd shot missed 5 days of work for the same symptoms and about a week after second shot patient's face started breaking out and it is still going and no doctor new what to do till now. it itches it bleeds it burns it hurts in addition to that it makes patient feel uncomfortable and insecure and he guarantee he lost his job for it even though he cant prove it. In summery this adverse reaction changes patient's life. He fills up work applications and when they look at his face they don't give him the job- sad.
Age: 13.0
Sex: M
Vaccine: DTAP, HEP, HEPA, HPV9, MNQ, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave patient vaccine, and tolerated well.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: PATIENT COMPLAINED OF PAIN IN RIGHT ARM THAT IS DESCRIBED AS CONTINOUS TINGLING WITH PAIN WITH NO RELIEF. SYMPTOMS START APPROXIMATELY  2 MONTHS AFTER RECEVING VACCINE. PATIENT FOLLOWED UP WITH PROVIDER WHO COMPLETED ASSESMENT WITH SCAN WHICH PROVED INCONCLUSIVE. PROVIDER INQUIRRED ABOUT VACCINE HISTORY IN WHICH PREVNAR 20 WAS THE LAST VACCINE ADMINISTERED TO PATIENT.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dysmenorrhoea, Polymenorrhoea
Clinical narrative: Period started 2 weeks early after having regular periods for 12 months. Period is accompanied by severe debilitating cramps and child has never had cramps since starting menstruatio
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain, Chills, Dry mouth, Headache, Heart rate increased
Clinical narrative: Patient started experiencing the following symptoms after receiving the vaccine. These symptoms included fever, chills, sweats, elevated heart rate, nausea, sore throat, headache, abdominal pain, vomiting, rash on chest, loss of appetite, dry mouth, sore throat, restlessness, insomnia and headache.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Hyperhidrosis, Insomnia, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient started experiencing the following symptoms after receiving the vaccine. These symptoms included fever, chills, sweats, elevated heart rate, nausea, sore throat, headache, abdominal pain, vomiting, rash on chest, loss of appetite, dry mouth, sore throat, restlessness, insomnia and headache.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Rash, Restlessness, Vomiting
Clinical narrative: Patient started experiencing the following symptoms after receiving the vaccine. These symptoms included fever, chills, sweats, elevated heart rate, nausea, sore throat, headache, abdominal pain, vomiting, rash on chest, loss of appetite, dry mouth, sore throat, restlessness, insomnia and headache.
Age: 38.0
Sex: M
Vaccine: HEP, IPV, MMR, TD, VARCEL
Symptoms: Arthralgia, Discomfort
Clinical narrative: The patient reported experiencing a constant aching and heavy sensation in the left shoulder blade area since receiving vaccines on June 30, 2025. They did not seek medical attention for this concern, believing the sensation was a normal reaction after vaccination. The patient stated that they have not experienced any headaches, dizziness, fainting, or swelling of the tongue, lips, or throat. Additionally, the patient mentioned, "I work for X, and I use my back because I change tires, batteries, and provide gas."
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Autoimmune disorder, Dizziness, Dyspnoea
Clinical narrative: Rash fevers shortness of breath dizzines auto immune disorder
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test abnormal, Pyrexia, Rash
Clinical narrative: Rash fevers shortness of breath dizzines auto immune disorder
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, PNC20
Symptoms: Crying, Inappropriate schedule of product administration
Clinical narrative: Patient received Infanrix dose too early. Patient's mom contacted the clinic around 1646 in the afternoon stating that patient was non-stop crying throughout the day and was not able to settle down after receiving vaccines. Patient was at daycare after the immunizations and was told that the patient was basically inconsolable all afternoon, daycare was able to calm her down slightly by turning on the TV. Patient was heard crying in the background during the call. She was given protocol recommendations and patient's mom states that she would rather give patient ibuprofen to see if she settles down and mother stated that she would take the patient in if she was not able to settle down.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope, Tremor
Clinical narrative: Per MD Mom reported 5 mins  patient fainted for 4-5 seconds and then begin to shake. MD and medical staff immediatly call. Vitals take , water , ice packs and graham crackers  Mom stated that patient hadn't eaten at all  and was nervous about the shots.  Md assessed patient . Patient remembered everything before and after this happened, and was back to baseline within a few minutes.  MD Continue to monitor patient in the office for the next 20 minutes, and provided warning signs and ED precautions.  Also placed referral for neurologist out of extra precaution due to episode of shaking
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Post vaccine admin, pt was given water and instructed to lay down per caution. A few minutes later pt c/o "stomach hurting" and vomitted shortly after.  Vitals obtained and were normal.