chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: received a dose of Boostrix at 28 weeks; received a dose of Boostrix at 37 weeks; then mistakenly received another dose at 37 weeks; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9429J, expiry date 19-MAR-2027) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 27-JAN-2025, the patient received the 2nd dose of Boostrix. On an unknown date, the patient received the 1st dose of Boostrix. On 27-JAN-2025, an unknown time after receiving Boostrix and Boostrix, the patient experienced extra dose administered (Verbatim: then mistakenly received another dose at 37 weeks). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: received a dose of Boostrix at 28 weeks) and vaccine exposure during pregnancy (Verbatim: received a dose of Boostrix at 37 weeks). The outcome of the vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were unknown.   Pregnancy exposure: Gestation time at first exposure (Boostrix): 37 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Gestation time at first exposure (Boostrix): 28 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   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: 28-JAN-2025 The nurse reported that they had a pregnant who received a dose of Boostrix at 28 weeks and then mistakenly received another dose at 37 weeks, which led to extra dose administered and vaccine exposure during pregnancy. The Vaccine Administration Facility was the same as Primary Reporter
Age: 0.25
Sex: F
Vaccine: RVX
Symptoms: Product preparation issue
Clinical narrative: only the diluent portion of Rotarix was given by mistake to a patient; only the diluent portion of Rotarix was given by mistake to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 14-week-old female patient who received Rotavirus vaccine for prophylaxis.   On 17-DEC-2024, the patient received Rotavirus vaccine. On 17-DEC-2024, an unknown time after receiving Rotavirus vaccine, the patient experienced inappropriate preparation of medication (Verbatim: only the diluent portion of Rotarix was given by mistake to a patient) and inappropriate dose of drug administered (Verbatim: only the diluent portion of Rotarix was given by mistake to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of drug administered were unknown.   Additional Information: GSK Receipt Date: 28-JAN-2025 Reporter called on 28th January 2025 to report on 17th December 2024, only the diluent portion of Rotarix had been given by mistake to a patient, which led to Inappropriate preparation of medication and Inappropriate dose of drug administered.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Malaise, Nasopharyngitis, Rhinorrhoea, Sneezing
Clinical narrative: cold-like symptoms; coughing; sneezing; runny nose; feeling sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-OCT-2022, the patient received the 1st dose of Shingrix. On 28-OCT-2022, less than a day after receiving Shingrix, the patient experienced feeling unwell (Verbatim: feeling sick). On an unknown date, the patient experienced cold symptoms (Verbatim: cold-like symptoms), cough (Verbatim: coughing), sneezing (Verbatim: sneezing) and runny nose (Verbatim: runny nose). The patient was treated with phenoxymethylpenicillin (Penicillin). The outcome of the feeling unwell, cold symptoms, cough, sneezing and runny nose were not resolved.   It was unknown if the reporter considered the feeling unwell, cold symptoms, cough, sneezing and runny nose to be related to Shingrix.     It was unknown if the company considered the feeling unwell, cold symptoms, cough, sneezing and runny nose to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-JAN-2025 The reporter reported that a patient received Shingrix and on that same day she started feeling sick.  She did not get dose 2.  She has had cold-like symptoms, coughing sneezing, and runny nose.  Patient had penicillin twice and 3 rounds of antibiotics and states she has not gotten better since.  She had not recovered.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: only gave the adjuvant diluent to the patient; only gave the adjuvant diluent to the patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 4NG3F, expiry date 06-DEC-2025) for prophylaxis.   On 28-JAN-2025, the patient received the 1st dose of Shingrix. On 28-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: only gave the adjuvant diluent to the patient) and inappropriate preparation of medication (Verbatim: only gave the adjuvant diluent to the patient). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 29-JAN-2025 The nurse practitioner explained that a first dose of Shingrix vaccine was administered but they only gave the adjuvant diluent to the patient which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The vaccine administration facility was the same as primary reporter.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd dose of vaccine late; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (Received 1st dose of vaccine in October 2022).   On 31-AUG-2024, the patient received the 2nd dose of Shingrix. On 31-AUG-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Patient received 2nd dose of vaccine late). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 30-JAN-2025 Reporter called to ask if a male patient had received a first dose in October 2022 and second dose in august 2024, whether he would be ok with this schedule or if they need to revaccinate. Patient received 2nd dose of vaccine late, which led to Drug dose administration interval too long.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the administration of 2 doses of Twinrix at less than the recommended interval.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 60-year-old male patient who received HAB (Twinrix) (batch number D4774, expiry date 12-SEP-2025) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX).   On 15-OCT-2024, the patient received the 2nd dose of Twinrix. On 15-OCT-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: the administration of 2 doses of Twinrix at less than the recommended interval.). The outcome of the drug dose administration interval too short 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-JAN-2025 The reporter request data about the administration of 2 doses of Twinrix at less than the recommended interval which led to drug dose administration interval too short. The provided data about vaccine, patient and even, consenting to receive follow-up. Vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hadn't received the 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16-SEP-2022, batch no XM22G with expiry date 31-AUG-2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: hadn't received the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-FEB-2025 The pharmacist called to informed that till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. This case had been linked to the case US2025017228, reported by the same reporter.; Sender's Comments:  US-GSK-US2025017228:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received dose 1 on February 8, 2024 and has not received dose 2 yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received 1st dose  on February 8, 2024 batch number 542E3).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received dose 1 on February 8, 2024 and has not received dose 2 yet). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 11-FEB-2025 The reporter reported that a patient had inquired about a Shingrix injection.  The patient had received dose 1 on February 8, 2024, and had not received dose 2 yet. The reporter did not consent to follow-up Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 42.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3rd dose of Twinrix in less than the 6 months period from the second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 42-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (2nd dose received on an unknown date) and Twinrix (1st dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: 3rd dose of Twinrix in less than the 6 months period from the second dose). The outcome of the drug dose administration interval too short 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-FEB-2025 Nurse called to report that a patient received 3 doses of Twinrix, but the 3dr dose was too close in less than 6 months from the second dose, which led shortening of vaccine schedule. The reporter asked was this dose valid. She has in her stock Engerix-B and Havrix, a dose of each one would be enough to complete the series. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: RSV
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 62-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number X2FT9, expiry date 02-FEB-2025) for prophylaxis.   On 09-FEB-2025, the patient received Arexvy. On 09-FEB-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: expired vaccine used). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 14-FEB-2025 Pharmacist called to report a male patient was administered an expired dose of an Arexvy vaccine.  Pharmacist asked if there is any advice recommendation on this topic. Patient received expired dose of Arexvy vaccine, which led to expired vaccine used.
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired drug used in a patient who received MMR (Priorix) (batch number BL452, expiry date 17-DEC-2024) for prophylaxis.   On 17-FEB-2025, the patient received Priorix. On 17-FEB-2025, an unknown time after receiving Priorix, the patient experienced expired drug used (Verbatim: expired dose administered). The outcome of the expired drug 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: 18-FEB-2025 Other HCP stated that their facility gave an expired dose of Priorix, which led to expired vaccine used. Reporter asked if this still be viable for the patient or should they get another dose. Patient had already been notified. HCP stated she cannot share the patient's information.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: had a reaction in the Moderna vaccine and the sister ended up in the hospital with cellulitis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CELLULITIS (had a reaction in the Moderna vaccine and the sister ended up in the hospital with cellulitis) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (had a reaction in the Moderna vaccine and the sister ended up in the hospital with cellulitis) (seriousness criterion hospitalization). At the time of the report, CELLULITIS (had a reaction in the Moderna vaccine and the sister ended up in the hospital with cellulitis) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported.   The reporter stated that, her sister had a reaction in the Moderna vaccine and ended up in the hospital with cellulitis, so they wanted to check the patient's genetics.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Feb-2025: Live follow-up received contains no new information.; Reporter's Comments: Temporal relationship between product administration and occurrence of Cellulitis remained unknown as there were no dates provided. Due to lack of information at this moment, causal relationship cannot be excluded and the event is assessed as related to the suspect product. The benefit-risk relationship of the product is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: We used Pfizer when we took the Covid shots and the boosters/Covid after Pfizer Shots; We used Pfizer when we took the Covid shots and the boosters/Covid after Pfizer Shots; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 76-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "We used Pfizer when we took the Covid shots and the boosters/Covid after Pfizer Shots". The events "we used pfizer when we took the covid shots and the boosters/covid after pfizer shots" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: the reporter stated, "We used Pfizer when we took the Covid shots and the boosters." Later on in the call, after they were provided with the voucher information, the reporter said, "We did this the other day for my husband, can you believe that's two people in one family have it now?". The reporter indicated Dr. (redacted) was their doctor; however, Dr. (redacted) is also in the same office and may have been the one who sent the prescription of Paxlovid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500018818 Same reporter, product, event; different patient;
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: COVID twice; COVID twice; COVID twice; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: E61686) and on 04Aug2021 as dose 2, single (Lot number: EW078) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "COVID twice".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500038522 same reporter/patient, different dose/AE;US-PFIZER INC-202500038523 same reporter/patient ,different drug/AE;
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Computerised tomogram, Deep vein thrombosis, Inappropriate schedule of product administration, Seizure
Clinical narrative: COVID twice; COVID twice; COVID twice; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: E61686) and on 04Aug2021 as dose 2, single (Lot number: EW078) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "COVID twice".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500038522 same reporter/patient, different dose/AE;US-PFIZER INC-202500038523 same reporter/patient ,different drug/AE;
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: COVID twice; COVID twice; COVID twice; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: E61686) and on 04Aug2021 as dose 2, single (Lot number: EW078) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "COVID twice".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500038522 same reporter/patient, different dose/AE;US-PFIZER INC-202500038523 same reporter/patient ,different drug/AE;
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling on the arm at the site of injection; redness and swelling on the arm at the site of injection; pain; This is a spontaneous report received from a Pharmacist from medical information team.  A 54-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 04Feb2025 as dose number unknown, single (Lot number: LG5577, Expiration Date: 30Apr2026), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Feb2025, outcome "not recovered"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset Feb2025, outcome "unknown" and all described as "redness and swelling on the arm at the site of injection".  Additional information: the patient was experiencing redness and swelling on the arm at the site of injection after administration of PREVNAR 20 last 04Feb2025. The patient was still experiencing pain after 2 weeks.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; he came positive for COVID, this was the second time he had COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient in his 70's 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "he came positive for COVID, this was the second time he had COVID". The clinical course was reported as follows: The patient's wife took her husband to the emergency room where he came positive for COVID, so they sent a medication to the pharmacy. She also reported since the vaccine came out; he always used Pfizer. The patient was previously given nirmatrelvir, ritonavir (PAXLOVID). The event "he came positive for covid, this was the second time he had covid" required emergency room visit. The patient underwent the laboratory tests and procedures as aforementioned. Therapeutic measures were taken as a result of covid-19, drug ineffective.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain crisis; This is a spontaneous report received from a Consumer or other non HCP.  A 30-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (hospitalization), outcome "unknown", described as "pain crisis". The patient took the Pfizer COVID vaccine and was hospitalized that night with a pain crisis. Therapeutic measures were taken as a result of pain including Ibuprofen 800 mg 3x day as needed for pain and Oxycodone 10-325 mg, every 4-6 hour as needed for pain.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 63-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Feb2025, outcome "unknown" and all described as "COVID-19". The clinical course was reported as follows: The patient had the Pfizer, the first Pfizer, then the patient had the booster, and then had another booster. The patient did not get the vaccine this year and actually got COVID 10 days ago.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received 2 doses of Shingrix back in 2021/2022 (before age 50) and it was not caught until after administration of a 3rd dose on 12/5/24. Patient had no adverse reaction to 3rd dose. Reporting because vaccination is outside of recommended vaccine schedule.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Extra dose administered
Clinical narrative: Patient was given a duplicate does of RSV. Patient had already received first dose of the RSV vaccine on 12/5/2024.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Decreased appetite, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: 10 cm circumference circle red mark at vaccine site given in error  not in muscle. Mild fever that night, next day pan increase and hard raised swelling at injection site ( have photos)  that progressively became worse and still appears on day three.  Day two fever between 99 and 100. 7 depending on when Tylenol was administered. Overall body aches and sick feeling.  Still had some appetite but too achy to shower until third day. Fever gone 3rd day, arm circle darker and still sore more than previously with any vaccine.  No fever but not feeling normal yet.  Concern because pharmacist administered vaccine intradermally and low on arm and if this may have caused my stronger than usual reaction.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: 10 cm circumference circle red mark at vaccine site given in error  not in muscle. Mild fever that night, next day pan increase and hard raised swelling at injection site ( have photos)  that progressively became worse and still appears on day three.  Day two fever between 99 and 100. 7 depending on when Tylenol was administered. Overall body aches and sick feeling.  Still had some appetite but too achy to shower until third day. Fever gone 3rd day, arm circle darker and still sore more than previously with any vaccine.  No fever but not feeling normal yet.  Concern because pharmacist administered vaccine intradermally and low on arm and if this may have caused my stronger than usual reaction.
Age: 10.0
Sex: M
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: Patient was given Hep A instead of Hep B
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received vaccine and had previously received vaccine 12/04/2023
Age: 53.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: duplicate vaccination (first time was 09/04/2024). This was not recorded in our system until after the appointment. No adverse reaction has been noticed so far, but we will continue to monitor.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Crying, Diarrhoea, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Abnormal swelling in the injection sites that occured weeks after injection (started on 2/16 and was the size of a half dollar red and hot to touch) , extreme crying from time of vaccine to current date, diarreah from 2/6 in the pm to current, red freckled rash from 2/8- 2/18
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Abnormal swelling in the injection sites that occured weeks after injection (started on 2/16 and was the size of a half dollar red and hot to touch) , extreme crying from time of vaccine to current date, diarreah from 2/6 in the pm to current, red freckled rash from 2/8- 2/18
Age: 5.0
Sex: F
Vaccine: HEPA, IPV, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient was given TDAP when due for DTAP. Mom notified of administration of incorrect vaccine and verbalizes understanding. Will administer DTAP at 6 year well child check.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Febrile convulsion, Influenza A virus test positive, Pyrexia
Clinical narrative: onset of high fever 2/15/25 febrile seizure 2/17/25, tested positive for influenza A
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Abdominal pain
Clinical narrative: Abdominal pain approx 15 mins after receiving vaccine.
Age: 18.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None reported.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Pneumonia, Pyrexia, Respiratory tract congestion
Clinical narrative: cough fever congestion.
Vaccine: COVID19, COVID19
Symptoms: Illness, Malaise
Clinical narrative: I am sick and suffering and haven't been well ever since I received your vaccine; I am sick and suffering and haven't been well ever since I received your vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  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. Vaccination history included: Pfizer vaccine for covid (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "I am sick and suffering and haven't been well ever since I received your vaccine", "I am sick and suffering and haven't been well ever since I received your vaccine". The following information was reported: ILLNESS (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "I am sick and suffering and haven't been well ever since I received your vaccine". Additional information: The patient had Pfizer vaccine for covid. Two of them. And the patient was sick and suffering and hadn't been well ever since the patient received Pfizer vaccine. The patient stated "I have lost everything - my health, my quality of life, my job". The patient was an ultrasound technologist. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500040022 Same patient/ product/AEs, different dose;
Age: 63.0
Sex: M
Vaccine: IPV
Symptoms: Blood test, Injection site pain, Injection site paraesthesia, Magnetic resonance imaging, Metagenomic analysis
Clinical narrative: After I go the shot, my should was painful where the injection was and then after the pain went away is started to fill tingling and it would come on and off. And this happens everyday. I went back to my doctor and he sent me to a neurologist at Clinic and i got a MRI, Blood test MNG and put me on steroids and it is still on going and its now spreading towards my neck. And now they do not know whats going on.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin abnormal, Folliculitis
Clinical narrative: developed folliculitis under her scalp; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 79-year-old 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: FOLLICULITIS (non-serious), outcome "not recovered", described as "developed folliculitis under her scalp". Therapeutic measures were taken as a result of folliculitis.  Additional information: Caller stated she sent an email asking for information about side effects with the first Pfizer covid vaccines and got an email back telling her to call.  She got the first three Pfizer covid vaccines and had developed folliculitis under her scalp.  It was painful and was taking her time away. She had seen 35 dermatologists and 2 neurologists and none of the treatments they had given her, even the shots, have worked.  She then went to the clinic and no one seems to be able to help her.  She contacted the FDA and they told her they have 32 (or 33, she was not sure if she was counted or not because she reported it to them) reports of folliculitis with the Pfizer covid vaccine.  She wanted to know if we have had reports of this.  She was sure it was related to the covid vaccine and since the doctors don't know if it was related, she wanted to find out from Pfizer. She had not gotten any of the other vaccines as she was sure it is related to the vaccine. She wanted to get proof to show to her doctor that this could be related to the vaccine.  Response: Reviewed previous interaction and spoke from attached document and PI: adverse reactions, section 6, folliculitis not listed. After an extended conversation about what information safety has vs the FDA and where she could access information, informed her she could have her doctor call us and we can to further research to see if there have been reports.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Folliculitis
Clinical narrative: developed folliculitis under her scalp; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 79-year-old 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: FOLLICULITIS (non-serious), outcome "not recovered", described as "developed folliculitis under her scalp". Therapeutic measures were taken as a result of folliculitis.  Additional information: Caller stated she sent an email asking for information about side effects with the first Pfizer covid vaccines and got an email back telling her to call.  She got the first three Pfizer covid vaccines and had developed folliculitis under her scalp.  It was painful and was taking her time away. She had seen 35 dermatologists and 2 neurologists and none of the treatments they had given her, even the shots, have worked.  She then went to the clinic and no one seems to be able to help her.  She contacted the FDA and they told her they have 32 (or 33, she was not sure if she was counted or not because she reported it to them) reports of folliculitis with the Pfizer covid vaccine.  She wanted to know if we have had reports of this.  She was sure it was related to the covid vaccine and since the doctors don't know if it was related, she wanted to find out from Pfizer. She had not gotten any of the other vaccines as she was sure it is related to the vaccine. She wanted to get proof to show to her doctor that this could be related to the vaccine.  Response: Reviewed previous interaction and spoke from attached document and PI: adverse reactions, section 6, folliculitis not listed. After an extended conversation about what information safety has vs the FDA and where she could access information, informed her she could have her doctor call us and we can to further research to see if there have been reports.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy, Folliculitis
Clinical narrative: developed folliculitis under her scalp; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 79-year-old 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: FOLLICULITIS (non-serious), outcome "not recovered", described as "developed folliculitis under her scalp". Therapeutic measures were taken as a result of folliculitis.  Additional information: Caller stated she sent an email asking for information about side effects with the first Pfizer covid vaccines and got an email back telling her to call.  She got the first three Pfizer covid vaccines and had developed folliculitis under her scalp.  It was painful and was taking her time away. She had seen 35 dermatologists and 2 neurologists and none of the treatments they had given her, even the shots, have worked.  She then went to the clinic and no one seems to be able to help her.  She contacted the FDA and they told her they have 32 (or 33, she was not sure if she was counted or not because she reported it to them) reports of folliculitis with the Pfizer covid vaccine.  She wanted to know if we have had reports of this.  She was sure it was related to the covid vaccine and since the doctors don't know if it was related, she wanted to find out from Pfizer. She had not gotten any of the other vaccines as she was sure it is related to the vaccine. She wanted to get proof to show to her doctor that this could be related to the vaccine.  Response: Reviewed previous interaction and spoke from attached document and PI: adverse reactions, section 6, folliculitis not listed. After an extended conversation about what information safety has vs the FDA and where she could access information, informed her she could have her doctor call us and we can to further research to see if there have been reports.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy both times; This is a spontaneous report received from a Nurse.  A 72-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Comirnaty (2024-2025 formula) (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Bells palsy both times". The following information was reported: BELL'S PALSY (hospitalization, disability, medically significant), outcome "unknown", described as "Bells Palsy both times". The patient was hospitalized for bell's palsy (hospitalization duration: 1 day(s)). The event "bells palsy both times" required physician office visit and emergency room visit.  Clinical course: The patient did not receive any other vaccines on the same date as the Pfizer vaccine and the patient was taking any other medications within 2 weeks prior to the event onset and did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: A possibly contributory role of BNT162b2 omicron (kp.2) in triggering the onset of the event BELL'S PALSY might not be fully excluded given known adverse event profile of the suspect vaccine.  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.
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Sep2024 as dose 1, single (Lot number: LM2212) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "cataracts are forming over the last few years" (ongoing); "Penicillin allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "tetracycline allergy" (unspecified if ongoing); "latex allergy" (unspecified if ongoing); "allergies" (unspecified if ongoing); "deaf/profound hearing loss" (ongoing), notes: 50+ years; "Wore oticon 380P hearing aids" (ongoing). Concomitant medication(s) included: LEVOXYL taken for thyroid disorder; CLARITIN [CLARITHROMYCIN]. Vaccination history included: BNT162b2 (Dose 2; Lot: EP6955), administration date: 27Mar2021, for covid-19 immunization, reaction(s): "sore arm"; BNT162b2 (Dose 3; lot: EW0162), administration date: 19Apr2021, for covid-19 immunization, reaction(s): "sore arm"; bivalent (Dose 4; lot: GH9703), administration date: 12Oct2022, for covid-19 immunization, reaction(s): "sore arm"; comirnaty (Dose 5; lot: HD9876), administration date: 04Oct2023, for covid-19 immunization, reaction(s): "sore arm"; Biontech (Dose 1; lot: FL3198), administration date: Apr2020, for covid-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The patient did not receive any other vaccines on the same date as Pfizer vaccine. The patient did not receive any other vaccine within 4 weeks prior to the first administration of the suspect vaccine. Patient reported that cataracts were forming before COVID vaccine and, therefore, cataract was not suspected due to Pfizer vaccine.   No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500040762 same patient/product/event; different dose;US-PFIZER INC-202500040763 same patient/product/event; different dose;US-PFIZER INC-202500040764 same patient/product/event; different dose;US-PFIZER INC-202500040765 same patient/product/event; different dose;US-PFIZER INC-202500040766 same patient/product/event; different dose;
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Cervix carcinoma
Clinical narrative: cervical cancer; cervical dysplasia; This spontaneous report was received from a consumer (patient's mother) and refers to a currently 35-year-old female patient.   The patient's medical history, concurrent conditions or concomitant therapies were not reported.   On an unknown date, as a child, the patient was vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) suspension for injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient ended up with cervical cancer or cervical dysplasia.   At the reporting time, the outcome of the events was unknown.   Causality assessment was not provided.  Upon internal review, the event of cervical cancer was determined to be medically significant.   Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: HIBV, HIBV, HIBV, HIBV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: extra dose administered; extra dose administered; Inappropriate schedule of vaccine; This spontaneous report was received from a lawyer and refers to a 12-year-old female patient who was involved in a litigation process regarding quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (case). All details regarding the patient's medical history, concurrent conditions and concomitant therapies were captured in case.   On 12-APR-2005, at the age of 1 month, the patient was vaccinated with the first dose Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (reported as Haemophilus Influenza Type B [Hb]) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) administered for prophylaxis.  On 14-JUN-2005, the patient was vaccinated with the third dose Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) administered for prophylaxis (inappropriate schedule of product administration).  On 16-AUG-2005, the patient was vaccinated with the second dose Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) administered for prophylaxis (extra dose administered).  On 27-JUN-2006, the patient was vaccinated with the third dose Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) administered for prophylaxis (extra dose administered).  This was one of several reports regarding the same patient.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Received First Dose Heplisav-B, and Has Not Received Second Dose Yet; Initial report received on 04-Feb-2025.  A pharmacist reported that a 33-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 27-Jul-2024 but has not received his second dose yet.  No medical history or concomitant medications were reported.  On 27-Jul-2024, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (NDC number 43528-003-05; expiration date and lot number not available) intramuscularly in the left arm.   As of the date of report, 04-Feb-2025, 192 days after having received the first dose of HEPLISAV-B, the patient has not yet received his second dose. No side effects were reported.  No other information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash was reported as worsened; This non-serious case was reported by a consumer via sales rep and described the occurrence of rash in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received a 1st dose on 21st October 2024 in left arm and had Injection site pain, refer case US2024131039).   On 21-JAN-2025, the patient received the 2nd dose of Shingrix (left deltoid). On 23-JAN-2025, 2 days after receiving Shingrix, the patient experienced rash (Verbatim: Rash was reported as worsened). The outcome of the rash was not resolved.   The reporter considered the rash to be related to Shingrix.     The company considered the rash to be related to Shingrix.   Linked case(s) involving the same patient: US2024131039   Additional Information: GSK Receipt Date: 23-JAN-2025 Patient was the reporter. Rash was reported as worsened. Patient received a subsequent dose of vaccine. For tolerance to 1st dose, refer case US2024131039.; Sender's Comments:  US-GSK-US2024131039:Same patient