chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration, No adverse event, Wrong product administered
Clinical narrative: inadvertently administered ADACEL instead of the TB skin test with no reported adverse event; the route of administration was incorrect for Adacel as the vaccine was given intradermally with no reported adverse event; Initial information received on 10-Apr-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 years old male patient who was inadvertently administered diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] instead of the tuberculin test [Tubersol] and the route of administration was incorrect for adacel as the vaccine was given intradermally with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Apr-2024 the patient inadvertently administered diphtheria-2/tetanus/5 AC pertussis vaccine (lot 2CA61C1; expiry date: 06-Jun-2025; frequency: once; strength: standard) (Suspension for injection) via intradermal route in the left forearm for immunization instead of the tuberculin test (Solution for injection) with no reported adverse event (wrong product administered) (latency: same day) and the route of administration was incorrect for adacel as the vaccine was given intradermally with no reported adverse event (incorrect route of product administration) (latency: same day).   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.
Age: 0.33
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: attempting to give administer a dtap/ipv/hepa vaccine and she was supposed to give hep a, but she gave the patient act-hib and then she gave another dose of act-hib, so the patient got two doses of hib with no reported ae; attempting to give administer a dtap/ipv/hepa vaccine and she was supposed to give hep a, but she gave the patient act-hib and then she gave another dose of act-hib, so the patient got two doses of hib with no reported ae; Initial information received on 10-Apr-2024 (with live follow-up information received on same day) regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 4 months old male patient who was to be administered with Hepatitis A Vaccine, Diphtheria, Tetanus, AC Pertussis and IPV Vaccine and she was supposed to give Hepatitis A, but she gave the patient HIB (PRP/T) Vaccine [ACT-HIB] and then she gave another dose of HIB (PRP/T) Vaccine, so the patient got two doses of HIB (PRP/T) Vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine (Rotavirus Vaccine) and Pneumococcal Vaccine CONJ 20V (CRM197) (Pneumococcal Vaccine CONJ 20V (CRM197)); both for Prophylactic vaccination.  On 10-Apr-2024, the patient had received 0.5 ml (dose: 1) of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) (lot UJ982AA; expiration date and strength not reported) via unknown route in unknown administration site and on the same day the patient also received 0.5ml (dose: 2) of same vaccine (lot U039951; expiration date and strength not reported) via intramuscular route in the right thigh; both for Immunization instead of Hepatitis A Vaccine, Diphtheria, Tetanus, AC Pertussis and IPV Vaccine.  On 10-Apr-2024 it was reported that the patient was to be administered with Hepatitis A Vaccine, Diphtheria, Tetanus, AC Pertussis and IPV Vaccine and she was supposed to give Hepatitis A Vaccine, but she gave the patient HIB (PRP/T) Vaccine and then she gave another dose of HIB (PRP/T) Vaccine, so the patient got two doses of HIB (PRP/T) Vaccine with no reported adverse event (wrong product administered) (extra dose administered) (latency: same day).  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.
Age: 1.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient inadvertently was administered an expired dose of ActHib with no reported adverse event; Initial information received on 05-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 months old female patient who was inadvertently administered an expired dose of HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP); Pneumococcal Vaccine CONJ 7V (CRM197) (Prevnar); and Hepatitis A Vaccine (Hepatitis A); all for Prophylactic vaccination.  On 26-Mar-2024, the patient had inadvertently received an expired 0.5 ml (dose: 4) (total) of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) (lot UJ863AA, expiry date: 25-Mar-2024; strength not reported) via intramuscular route in the right thigh for Immunization with no reported adverse event (expired product administered) (Latency: same day).  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.
Age: 68.0
Sex: M
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired TYPHIM VI was administered yesterday with no reported adverse event; Initial information received on 10-Apr-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 68 years old male patient who was administered with expired Typhoid VI Polysaccharide Vaccine [Typhim VI] yersterday with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine INACT, Hepatitis B Vaccine RHBSAG (Yeast) (Twinrix) for Prophylactic vaccination.  On 09-Apr-2024, the patient had received expired 0.5 ml (Frequency = ONCE ) of suspect Typhoid VI Polysaccharide Vaccine (Solution for injection) (lot V1A331M, expiry date: 27-Feb-2024; strength not reported) via intramuscular route in the left deltoid for Immunization with no reported adverse event (expired product administered) (latency: same day).   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.
Sex: U
Vaccine: COVID19, FLUA4
Symptoms: COVID-19, Pain in extremity
Clinical narrative: Covid rebound, after I had a negative. I tested positive, was pu on Paxlovid. Tested negative after about a week/tested positive for a week after that.; Both arms were sore; This spontaneous case, initially received on 30-Mar-2024, was reported by a Non-Health Professional and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medications were not reported. The patient's historical vaccines included multiple Moderna COVID-19 vaccines received on 19-Feb-2021 (batch number: 010M20A), on 19-Mar-2021 (batch number: 040A21A), on 21-Aug-2021 (batch number: 3631A), on 08-Feb-2021 (batch number: 032H21A), on 21-Jun-2022 (batch number: 059A22D); and Pfizer COVID-19 vaccine received on 09-Sep-2022 (batch number: GH9694); all received for unknown indication.  Administration of company suspect drug(s):  On 13-Oct-2023, the patient received Fluad Quadrivalent for not reported indication, Route of administration: not reported, Anatomical Location: arm, Lot number: 371624.  Non-company suspect drugs: On 13-Oct-2023, the pateint received Moderna COVID-19 vaccine (Elasomeran) for not reported indication, Route of administration: not reported, Anatomical Location: arm, Lot number: 8057965.  Adverse reactions/events and outcomes: On an unknown date, the patient's both arms were sore.   On an unknown date, the patient experienced COVID-19 rebound after it had a negative. The patient tested positive and was put on Paxlovid. The patient tested negative about a week. The patient got sicker a day or two after that and tested positive for an entire week after that.   At the time of inital reporting, on 30-Mar-2024, the outcome of both events was unknown.   Non-drug treatment/Other action taken:  Fluad Quadrivalent action taken: Not Applicable  Repoter's assessment:  The reporter did not provide causality assessment.; Reporter's Comments: The event of pain in arm is assessed as possibly related to Fluad Quadrivalent due to anatomical plausability although temporal relationship is unclear. Due to lack of information and unclear temporal relationship, causality for COVID-19 is assessed as unassessable.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Perineal swelling, Periorbital swelling, Pharyngeal swelling, Swelling of eyelid, Swollen tongue
Clinical narrative: Severe swelling of eyelids and area around each eye, mild swelling of tongue, throat, and perineum
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dysstasia, Fall, Fatigue, Vertigo
Clinical narrative: Patient was immunized on Thursday, 3/7/24.  When he woke up at 7am on 3/8/24 the patient was very tired, weak, and experiencing vertigo.  He said he couldn't stand up and would fall down after standing.  He went to the hospital on 3/8/24.  He felt better by 3/9/24
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: This was an administration error. The patient has not experience an adverse event.  She was injected with the adjuvent suspension only.  The vaccine was not properly reconsituted with the antigen component.
Age: 51.0
Sex: F
Vaccine: FLU4, TDAP, VARCEL
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: Patient reported reaction after vaccines 4-12-24. States, no immediate reaction after vaccines given. Patient noticed itching on - Saturday morning at 900 am with swelling noted. Patient states more - swelling and redness, area felt hard to touch. Patient states "didn't want to do anyting to the arm, but to Ibuprofen." Patient advised to use cold packs to area and take Benadryl for itching. It no relief report to PCP for follow up - area hard and swollen 3-15-24 at TB reading.
Age: 84.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Cough
Clinical narrative: PATIENT REPORTS SEVERE COUGH
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: After administering the vaccine I realized it had expired 5 days earlier on 4/10/24. Placed a call to moderna and they said they will follow up with me in 3-5 business days after a Lot analysis
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Erythema, Exposure during pregnancy, Feeling abnormal, Feeling hot
Clinical narrative: Patient presented to the clinic for a TDAP booster, booster was approved by PCP as patient is 32 weeks pregnant. At the beginning of the visit patient informed this nurse that she has an allergy to dairy with a reaction of GI-Upset. Patient declined any reactions to previous vaccines on consent form, as well as multiple times during conversation. Vaccine verified by MA. Vaccine was administered at 3:50PM after disposing of needle, patient had a noted red mark around the size of a quarter on her left arm at immunization site. Patient stated that arm was stinging and painful, site was hot to the touch. Spoke with provider FNP, got approval to administer 25mg of Benadryl which was administered at 3:55. Patient had facial pallor and was visibly sweating. Patient stated that she felt "spacey and kind of lightheaded". Patients  blood pressure at this time (4:00pm) was 100/60 with a pulse of 110. Patient was provided with water and lung sounds and heart sounds were checked, lung sounds were clear and no abnormal heart beats were observed. No noted throat swelling. Patient's color returned and her face turned red, patient informed nurse that she felt very warm, and now had a headache. Patient s temperature was 98.1. Patient was provided with icepacks for comfort. Vitals at 4:15 were 113/73 with a pulse of 97,  swelling of her left arm increased in size to 10cmx11cm, ice pack was placed over immunization site. Patient informed this nurse at 4:19 that her mother stated she had previously had a reaction to a vaccine that had aluminum in it, that it had caused swelling in her arm. At 4:25 vitals were 126/78 with a pulse of 105. Patient stated that other than still feeling warm she was feeling better but still had the headache. Had patient standup, dizziness and lightheadedness did not return upon standing. Patient s vitals at 4:35 were 124/70 with a pulse of 80 temperature was 98.4. Lung sounds were clear, no abnormal heart beats observed during this assessment and no noted swelling in throat. Patient informed this nurse she also had a GI reaction to eggs during this time. Patient's husband brought her to clinic today, patient was provided with ER precautions and informed that we would reach out to her and check on her in the next couple days. Patient had no concerns at this time and felt comfortable leaving with her husband, Patient was walked to her vehicle by this nurse. Patient left clinic at 4:45. Vaccine: BOOSTRIX 0.5mL Lot: ET475 Exp: 05/08/26 Manufacture: GlaxoSmithKline Biologics.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hyperhidrosis, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Patient presented to the clinic for a TDAP booster, booster was approved by PCP as patient is 32 weeks pregnant. At the beginning of the visit patient informed this nurse that she has an allergy to dairy with a reaction of GI-Upset. Patient declined any reactions to previous vaccines on consent form, as well as multiple times during conversation. Vaccine verified by MA. Vaccine was administered at 3:50PM after disposing of needle, patient had a noted red mark around the size of a quarter on her left arm at immunization site. Patient stated that arm was stinging and painful, site was hot to the touch. Spoke with provider FNP, got approval to administer 25mg of Benadryl which was administered at 3:55. Patient had facial pallor and was visibly sweating. Patient stated that she felt "spacey and kind of lightheaded". Patients  blood pressure at this time (4:00pm) was 100/60 with a pulse of 110. Patient was provided with water and lung sounds and heart sounds were checked, lung sounds were clear and no abnormal heart beats were observed. No noted throat swelling. Patient's color returned and her face turned red, patient informed nurse that she felt very warm, and now had a headache. Patient s temperature was 98.1. Patient was provided with icepacks for comfort. Vitals at 4:15 were 113/73 with a pulse of 97,  swelling of her left arm increased in size to 10cmx11cm, ice pack was placed over immunization site. Patient informed this nurse at 4:19 that her mother stated she had previously had a reaction to a vaccine that had aluminum in it, that it had caused swelling in her arm. At 4:25 vitals were 126/78 with a pulse of 105. Patient stated that other than still feeling warm she was feeling better but still had the headache. Had patient standup, dizziness and lightheadedness did not return upon standing. Patient s vitals at 4:35 were 124/70 with a pulse of 80 temperature was 98.4. Lung sounds were clear, no abnormal heart beats observed during this assessment and no noted swelling in throat. Patient informed this nurse she also had a GI reaction to eggs during this time. Patient's husband brought her to clinic today, patient was provided with ER precautions and informed that we would reach out to her and check on her in the next couple days. Patient had no concerns at this time and felt comfortable leaving with her husband, Patient was walked to her vehicle by this nurse. Patient left clinic at 4:45. Vaccine: BOOSTRIX 0.5mL Lot: ET475 Exp: 05/08/26 Manufacture: GlaxoSmithKline Biologics.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pallor, Peripheral swelling
Clinical narrative: Patient presented to the clinic for a TDAP booster, booster was approved by PCP as patient is 32 weeks pregnant. At the beginning of the visit patient informed this nurse that she has an allergy to dairy with a reaction of GI-Upset. Patient declined any reactions to previous vaccines on consent form, as well as multiple times during conversation. Vaccine verified by MA. Vaccine was administered at 3:50PM after disposing of needle, patient had a noted red mark around the size of a quarter on her left arm at immunization site. Patient stated that arm was stinging and painful, site was hot to the touch. Spoke with provider FNP, got approval to administer 25mg of Benadryl which was administered at 3:55. Patient had facial pallor and was visibly sweating. Patient stated that she felt "spacey and kind of lightheaded". Patients  blood pressure at this time (4:00pm) was 100/60 with a pulse of 110. Patient was provided with water and lung sounds and heart sounds were checked, lung sounds were clear and no abnormal heart beats were observed. No noted throat swelling. Patient's color returned and her face turned red, patient informed nurse that she felt very warm, and now had a headache. Patient s temperature was 98.1. Patient was provided with icepacks for comfort. Vitals at 4:15 were 113/73 with a pulse of 97,  swelling of her left arm increased in size to 10cmx11cm, ice pack was placed over immunization site. Patient informed this nurse at 4:19 that her mother stated she had previously had a reaction to a vaccine that had aluminum in it, that it had caused swelling in her arm. At 4:25 vitals were 126/78 with a pulse of 105. Patient stated that other than still feeling warm she was feeling better but still had the headache. Had patient standup, dizziness and lightheadedness did not return upon standing. Patient s vitals at 4:35 were 124/70 with a pulse of 80 temperature was 98.4. Lung sounds were clear, no abnormal heart beats observed during this assessment and no noted swelling in throat. Patient informed this nurse she also had a GI reaction to eggs during this time. Patient's husband brought her to clinic today, patient was provided with ER precautions and informed that we would reach out to her and check on her in the next couple days. Patient had no concerns at this time and felt comfortable leaving with her husband, Patient was walked to her vehicle by this nurse. Patient left clinic at 4:45. Vaccine: BOOSTRIX 0.5mL Lot: ET475 Exp: 05/08/26 Manufacture: GlaxoSmithKline Biologics.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cellulitis
Clinical narrative: Patient got cellulitis. She did say she ran her arm through a hot shower and made it worse. Went to a walk in clinic who gave her a topical triamcinolone 0.1% cream to apply bid and keflex 500mg qid x7 days
Age: 23.0
Sex: F
Vaccine: COVID19, HPV9
Symptoms: Extra dose administered, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Gardasil given when not indicated. I had already received 3 doses (latest in 2020). Spikevax was supposed to be the only vaccine given. After realizing the gardasil error, I went ahead and proceeded to get the spikevax in the same arm. Gardasio injection site started to get slightly red and raised on 4/14 while the spikevax site was erythematous (approx 1.5" diameter) and sore. Both are slightly warm to the touch. I have not taken or done anything for the purpose of pain-reflief or other symptomatic treatment.
Age: 23.0
Sex: F
Vaccine: COVID19, HPV9
Symptoms: Wrong product administered
Clinical narrative: Gardasil given when not indicated. I had already received 3 doses (latest in 2020). Spikevax was supposed to be the only vaccine given. After realizing the gardasil error, I went ahead and proceeded to get the spikevax in the same arm. Gardasio injection site started to get slightly red and raised on 4/14 while the spikevax site was erythematous (approx 1.5" diameter) and sore. Both are slightly warm to the touch. I have not taken or done anything for the purpose of pain-reflief or other symptomatic treatment.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: fever and rash, Rx for Cephalexin 250mg/5ml take 2.7ml po BID x 10days
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No other AE; The caller said an adult patient received a pediatric dose of RECOMBIVAX HB on 2/29/2024. Confirmed no other AE occurred.; This spontaneous report was received from a medical assistant, referring to a patient of unknown gender and age (age group: adult). The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On 29-FEB-2024, the patient was vaccinated with hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) intramuscular injection, 1 dose, lot # was reported as w023682, but changed to W023682 per internal guidance, expiration date: 21-MAY-2025, administered for prophylaxis (strength and route were not provided). The adult patient received a pediatric dose of hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) on that day (underdose). It was confirmed that there was no other adverse event (AE) occurred (No adverse event). No product quality concern (PQC).
Age: 17.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 17 1/2 Year Old Was Given Heplisav-B; Initial report received on 16-Nov-2023  Additional information received on 29-Jan-2024 including concomitant medication and clarification of HEPLISAV-B dose given.  A physician and a registered nurse in the reported that a 17 1/2-year-old male patient (race and ethnicity not provided) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and allergies at the time of vaccination were not reported.   Concomitant medications included BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide).  On 31-Oct-2023, the 17 1/2-year-old patient received dose 1 of HEPLISAV-B (Lot # 943186, expiration date 30-Nov-2025, and NDC # 43520-003-05) intramuscularly in the right deltoid. No adverse side effects were reported.  No additional information was provided.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 Year Old Received Heplisav-B; Initial report received on 12-Mar-2024.  A pharmacist in the reported that a 4-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant medications at the time of vaccination were not reported. Allergies were unknown.  On 12-Mar-2024, the 4-year-old patient received a dose of HEPLISAV-B (Lot number, expiration date, NDC number, injection site, and route of administration were unknown). No adverse effects were reported.  There was no further information.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 35.0
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient Received First Dose With Heplisav-B, and Second Dose with Engerix; Initial report received on 25-Mar-2024.  A pharmacy intern in the reported that a 35-year-old male (race and ethnicity not provided) received the first dose with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then ENGERIX-B for the second dose.  Medical history, allergies, and concomitant medications at the time of vaccination were not reported.   On 23-Feb-2024, the patient received the first dose with HEPLISAV-B (Lot number 9Y3191, expiration date 21-Feb-2026, and NDC number 43528-003-05; administration route and injection site not reported).   On 23-Mar-2024, 30 days after having been vaccinated with HEPLISAV-B, the patient received the second dose with ENGERIX-B (Lot number, expiration date, NDC number, administration route, and injection site not reported). No adverse reactions were reported.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 13.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, IPV, VARCEL, FLU4, HEPA, HPV9, IPV, VARCEL
Symptoms: Cold sweat, Dizziness, Headache
Clinical narrative: 1051AM  Patient looked clammy, claimed her head hurts and was feeling dizzy. Had the patient laid down with her feet elevated. Vitals were OXY 99/PULSE 56. BP 102/62. Observed patient for 20 minutes and vitals were OXY 79/PULSE99 and BP was 107/66. Patient was given water to drink during observation by Imm. nurse and school nurse. After 20 minutes, patient felt better and opted to go back to class.
Age: 13.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, IPV, VARCEL, FLU4, HEPA, HPV9, IPV, VARCEL
Symptoms: Dizziness, Headache, Pallor
Clinical narrative: 1051AM  Patient looked clammy, claimed her head hurts and was feeling dizzy. Had the patient laid down with her feet elevated. Vitals were OXY 99/PULSE 56. BP 102/62. Observed patient for 20 minutes and vitals were OXY 79/PULSE99 and BP was 107/66. Patient was given water to drink during observation by Imm. nurse and school nurse. After 20 minutes, patient felt better and opted to go back to class.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired Product Used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number J52PN, expiry date 31-MAR-2024) for prophylaxis.   On 03-APR-2024, the patient received the 1st dose of Bexsero. On 03-APR-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: expired Product Used). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 04-APR-2024  The reporter was a physician's assistant. The reporter reported that the nurse administered the first of Bexsero vaccine to a patient which was already expired, which led expired vaccine used. The reporter reported that at the time of reporting, a repeat dose had not been administered. The vaccine administration facility was the same as primary reporter. The reporter consent the follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Achiness; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (1st dose received at the age of 55 years).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: Achiness). The outcome of the pain was resolved.   The reporter considered the pain to be related to Shingrix.     The company considered the pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR044160   Additional Information: GSK Receipt Date: 04-APR-2024 The patient was self-reported this case. The patient reported that she received 1st and 2nd dose of Shingrix vaccine about 3 to 4 years ago.  The patient experienced achiness after each dose, which resolved. The patient attributed the achiness to the vaccination.  No further information provided.  The reporter did not consent to follow-up.  This US2024AMR044160 case has been linked to the case reported by the same reporter for same patient. This US2024AMR043917 case has been linked to the case reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2024AMR043917:Same reporter/Different patient US-GSK-US2024AMR044160:Same patient/Dose 2
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Maladministration of Engerix-B After the Expiration Date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received HBV (Engerix B) (batch number X9FT7, expiry date 31-MAR-2024) for prophylaxis.   On 04-APR-2024, the patient received the 2nd dose of Engerix B. On 04-APR-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Maladministration of Engerix-B After the Expiration Date). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 04-APR-2024 The reporter was a medical assistant. The reporter reported that a patient received Engerix -B 2nd dose after the expiration date, which led to expired vaccine used. The reporter consent to follow up.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: an expired dose of Bexsero was given to a patient today, April 4, 2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   On 04-APR-2024, the patient received Bexsero. On 04-APR-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: an expired dose of Bexsero was given to a patient today, April 4, 2024). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-APR-2024 The reporter reported that an expired dose of Bexsero was given to a patient today, which led to expired vaccine used. No further details were provided on call. The reported consented to follow up.
Age: 14.0
Sex: M
Vaccine: IPV
Symptoms: Poor quality product administered
Clinical narrative: patient was administered with IPOL that was no longer suitable for use with no reported adverse event; Initial information received on 08-Apr-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 14 years old male patient who experienced patient was administered with IPV (Vero) [Ipol] that was no longer suitable for use with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine a/c/y/w conj (tet tox) (menquadfi); diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (boostrix); aesculus hippocastanum (varivax [aesculus hippocastanum]) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (tdap) for prophylactic vaccination.  On 08-Apr-2024, the patient received 0.5 ml dose of suspect IPV (VERO) Suspension for injection lot W1C751M via subcutaneous route in the right deltoid (strength and expiration date: not provided) for Immunisation (poor quality product administered) (latency- same day).  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 and Module of the 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.
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Biopsy skin abnormal, Blister, Dry skin, Eczema, Psoriasis
Clinical narrative: I received the Arexvy 120MCG/0.5ML injection on 10/20/2023. After this I started getting little red dots on my skin-on my back(thoracid area), neck, hands, decollete area. I went to my primary doctor who said i had psoriasis and was treated with topical steroid. This improved the areas that were red rash, broken skin, etc. But then other areas started to break out. I saw a dermatologist and had a biopsy with path results "spongiotic dermatitis". Again, treatment was topical steroid cream and vaseline. The rashes continued to recur after steroid treatment and clearing up and I had another biopsy in the last 6 weeks on my leg and same diagnosis. The rash is recurrent, painful and now I am getting blisters in the areas which are extremely painful. I have also tried zyrtec allergy med to see if it is an allergy. It does not help. All of my soaps/laundry detergents, etc. all vetted and are not causing this. We can only trace this back to this vaccination. I am still under treatment with my PCP and am looking for a dermatologist that has a specialty in this diagnosis because the rash continues to spread and it NOT getting better. It is covering my body.
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Rash, Rash macular, Rash papular, Skin wound
Clinical narrative: I received the Arexvy 120MCG/0.5ML injection on 10/20/2023. After this I started getting little red dots on my skin-on my back(thoracid area), neck, hands, decollete area. I went to my primary doctor who said i had psoriasis and was treated with topical steroid. This improved the areas that were red rash, broken skin, etc. But then other areas started to break out. I saw a dermatologist and had a biopsy with path results "spongiotic dermatitis". Again, treatment was topical steroid cream and vaseline. The rashes continued to recur after steroid treatment and clearing up and I had another biopsy in the last 6 weeks on my leg and same diagnosis. The rash is recurrent, painful and now I am getting blisters in the areas which are extremely painful. I have also tried zyrtec allergy med to see if it is an allergy. It does not help. All of my soaps/laundry detergents, etc. all vetted and are not causing this. We can only trace this back to this vaccination. I am still under treatment with my PCP and am looking for a dermatologist that has a specialty in this diagnosis because the rash continues to spread and it NOT getting better. It is covering my body.
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Biopsy, Biopsy skin abnormal, Eczema, Rash, Rash pruritic
Clinical narrative: I received the Arexvy 120MCG/0.5ML injection on 10/20/2023. After this I started getting little red dots on my skin-on my back(thoracid area), neck, hands, decollete area. I went to my primary doctor who said i had psoriasis and was treated with topical steroid. This improved the areas that were red rash, broken skin, etc. But then other areas started to break out. I saw a dermatologist and had a biopsy with path results "spongiotic dermatitis". Again, treatment was topical steroid cream and vaseline. The rashes continued to recur after steroid treatment and clearing up and I had another biopsy in the last 6 weeks on my leg and same diagnosis. The rash is recurrent, painful and now I am getting blisters in the areas which are extremely painful. I have also tried zyrtec allergy med to see if it is an allergy. It does not help. All of my soaps/laundry detergents, etc. all vetted and are not causing this. We can only trace this back to this vaccination. I am still under treatment with my PCP and am looking for a dermatologist that has a specialty in this diagnosis because the rash continues to spread and it NOT getting better. It is covering my body.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: PT RECEIVED PEDIATRIC VFC DOSE OF HEP B INSTEAD OF 317 ADULT DOSE OF HEP B VACCINE
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ageusia
Clinical narrative: LOSS OF TASTE - EATING
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: CARDIAC ARREST, DEATH
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Immunisation reaction, Laboratory test
Clinical narrative: MODERNA #1 4/8/2021 MODERNA #2 8/24/2021 BY JANUARY 2022 PATIENT NOTICED PALPITATIONS AS WELL AS SUSTAINED EPISODES OF A RAPID ONSET TACHYCARDIA.  HE WAS EXAMINED BY MULTIPLE DOCTORS AND FOUND TO HAVE VACCINE INDUCED HIGH-GRADE VENTRICULAR ECTOPY REQUIRING BETA-BLOCKERS.  CONDITION SLOWLY AND PARTIALLY IMPROVED WITH PROTOCOL BASE SPIKE PROTEIN DETOXIFICATION.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Tachycardia, Ventricular extrasystoles
Clinical narrative: MODERNA #1 4/8/2021 MODERNA #2 8/24/2021 BY JANUARY 2022 PATIENT NOTICED PALPITATIONS AS WELL AS SUSTAINED EPISODES OF A RAPID ONSET TACHYCARDIA.  HE WAS EXAMINED BY MULTIPLE DOCTORS AND FOUND TO HAVE VACCINE INDUCED HIGH-GRADE VENTRICULAR ECTOPY REQUIRING BETA-BLOCKERS.  CONDITION SLOWLY AND PARTIALLY IMPROVED WITH PROTOCOL BASE SPIKE PROTEIN DETOXIFICATION.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Hangnail, Hypoaesthesia, Nail operation, Raynaud's phenomenon
Clinical narrative: Both big toes swelled up and partial numbness. The right big toe swelled approx  50% bigger and became numb, the left big toe swelled approx 25% bigger and became numb. As of now, the right big toe is still approx 25% bigger with partial numbness, and the left is still 5-10% bigger with a small amount of numbness. 6 months after shots/ swelling started i had both big toe toenails removed permately to reduce excessive hangnail problems.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Febrile convulsion
Clinical narrative: The doctor stated that the patient had a febrile seizure after getting her 6months vaccine. This is reported to be her first episode and is currently doing well and stable. Patient went to ER. Patient was not hospitalized.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Patient came in for initial OB. She is a transfer of care. No records on file for her transfer during initial OB.  shots showed no influenza given.  Influenza vaccination provided during office visit 4/2/2024 Her records came in.  Influenza vaccination offered with previous OB provider on 10/09/2023. Patient received two doses of influenza during current pregnancy.  As of 4/16/2024 patient is 35 weeks and 3 days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Neck pain
Clinical narrative: Patient got vaccine on 4/5/24, on 4/6/24 patient had neck pain on the left side (same side as vaccine). this lasted for about 2-3 days and then started to improve. But, a day later or so neck pain started on her right side and continued down into her back. patient also reported haven knee and ankle pain around this time as well. patient is not sure if this is vaccine released but it all happened right after vaccine administration . **neck pain in right side still has not improved**
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: An errant dose of MMR was given to patient. RN reviewed records and per records patient needed MMR, however at previous visit an MMRV was given but coded as Varicella only causing this RN to give the errant dose of MMR.  Patient had no reaction to errant dose of MMR. Monitored patient for 15 minutes with no signs or symptoms.
Age: 38.0
Sex: U
Vaccine: UNK, UNK
Symptoms: Incorrect route of product administration, Injection site pain, Product administration error, Tuberculin test negative, Wrong product administered
Clinical narrative: Company is an end-to-end medical management company offering pre-hire, medical surveillance, return to work, fit for duty or wellness exams for employers. In this matter, company hired a clinic to conduct an exam. On April 9, 2024, the examinee brought forward to their employer and company, that the clinic openly disclosed their vaccine administration error in which Hepatitis B vaccine was given subcutaneously in the forearm instead of the PPD test. Company called the examinee on April 10, 2024 for a wellness call. Examinee stated site is still tender and will continue to monitor. April 11, 2024, company called examinee for a wellness call. Examinee stated site was still tender and their PPD site was negative. At this time company considers this matter closed. Should you have any questions, please feel free to contact. For questions regarding vaccine lot numbers, please contact company.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt received SpikeVax COVID vaccine at age 11.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Anion gap, Bacterial test negative, Basophil count normal, Basophil percentage, Blood albumin normal
Clinical narrative: Patient with mom,  seen in the clinic on 3/15/2024 for her wellness check . Patient received both Menquadfi and Bexsero that day.  parent reports that patient began experiencing leg pain and weakness the day after getting these two vaccines. After the third day of her legs hurting, parent took patient to the emergency department to be evaluated on 3/20/2024. Patient was given Ibuprofen 600 mg to take every 6 hours as needed for pain as well as Robaxin 500 mg to take four times daily as needed.  Patient was ruled out of not having a DVT , Gillian Barre syndrome, ligament injury or muscle strain or contusion. Patient came back to the clinic on 4/15/2024 to receive her second dose of Bexero and the immunization was withheld. Dr with our infectious disease department stated that patient should not receive anymore doses of the meningitis vaccines and should be listed as an allergy in her chart as well as reports to Vaers.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood bilirubin normal, Blood calcium decreased, Blood chloride normal, Blood creatine phosphokinase normal, Blood creatinine normal
Clinical narrative: Patient with mom,  seen in the clinic on 3/15/2024 for her wellness check . Patient received both Menquadfi and Bexsero that day.  parent reports that patient began experiencing leg pain and weakness the day after getting these two vaccines. After the third day of her legs hurting, parent took patient to the emergency department to be evaluated on 3/20/2024. Patient was given Ibuprofen 600 mg to take every 6 hours as needed for pain as well as Robaxin 500 mg to take four times daily as needed.  Patient was ruled out of not having a DVT , Gillian Barre syndrome, ligament injury or muscle strain or contusion. Patient came back to the clinic on 4/15/2024 to receive her second dose of Bexero and the immunization was withheld. Dr with our infectious disease department stated that patient should not receive anymore doses of the meningitis vaccines and should be listed as an allergy in her chart as well as reports to Vaers.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood glucose normal, Blood phosphorus, Blood potassium normal, Blood sodium normal, Blood urea normal
Clinical narrative: Patient with mom,  seen in the clinic on 3/15/2024 for her wellness check . Patient received both Menquadfi and Bexsero that day.  parent reports that patient began experiencing leg pain and weakness the day after getting these two vaccines. After the third day of her legs hurting, parent took patient to the emergency department to be evaluated on 3/20/2024. Patient was given Ibuprofen 600 mg to take every 6 hours as needed for pain as well as Robaxin 500 mg to take four times daily as needed.  Patient was ruled out of not having a DVT , Gillian Barre syndrome, ligament injury or muscle strain or contusion. Patient came back to the clinic on 4/15/2024 to receive her second dose of Bexero and the immunization was withheld. Dr with our infectious disease department stated that patient should not receive anymore doses of the meningitis vaccines and should be listed as an allergy in her chart as well as reports to Vaers.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood urine absent, C-reactive protein normal, Chromaturia, Eosinophil count, Eosinophil percentage
Clinical narrative: Patient with mom,  seen in the clinic on 3/15/2024 for her wellness check . Patient received both Menquadfi and Bexsero that day.  parent reports that patient began experiencing leg pain and weakness the day after getting these two vaccines. After the third day of her legs hurting, parent took patient to the emergency department to be evaluated on 3/20/2024. Patient was given Ibuprofen 600 mg to take every 6 hours as needed for pain as well as Robaxin 500 mg to take four times daily as needed.  Patient was ruled out of not having a DVT , Gillian Barre syndrome, ligament injury or muscle strain or contusion. Patient came back to the clinic on 4/15/2024 to receive her second dose of Bexero and the immunization was withheld. Dr with our infectious disease department stated that patient should not receive anymore doses of the meningitis vaccines and should be listed as an allergy in her chart as well as reports to Vaers.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Glucose urine absent, Haematocrit, Haemoglobin normal, Immature granulocyte count, Lymphocyte count normal
Clinical narrative: Patient with mom,  seen in the clinic on 3/15/2024 for her wellness check . Patient received both Menquadfi and Bexsero that day.  parent reports that patient began experiencing leg pain and weakness the day after getting these two vaccines. After the third day of her legs hurting, parent took patient to the emergency department to be evaluated on 3/20/2024. Patient was given Ibuprofen 600 mg to take every 6 hours as needed for pain as well as Robaxin 500 mg to take four times daily as needed.  Patient was ruled out of not having a DVT , Gillian Barre syndrome, ligament injury or muscle strain or contusion. Patient came back to the clinic on 4/15/2024 to receive her second dose of Bexero and the immunization was withheld. Dr with our infectious disease department stated that patient should not receive anymore doses of the meningitis vaccines and should be listed as an allergy in her chart as well as reports to Vaers.