chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Found an extra diluent in the box and believe that one of the 3 patients from Jan 2023 until now received it/Non-approved diluent for reconstitution; Found an extra diluent in the box and believe that one of the 3 patients from Jan 2023 until now received it/Non-approved diluent for reconstitution; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA933A, expiry date 30-JUN-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Found an extra diluent in the box and believe that one of the 3 patients from Jan 2023 until now received it/Non-approved diluent for reconstitution) and inappropriate dose of vaccine administered (Verbatim: Found an extra diluent in the box and believe that one of the 3 patients from Jan 2023 until now received it/Non-approved diluent for reconstitution). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-Jan-2024 The reporter reported that when they opened the box of Menveo vaccine of 2 vials as they found an extra diluent in the box and believe that one of the 3 patients from January 2023 until now received it.  The reporter was not sure who it was among the 3 patients. Menveo reconstituted with another solution instead of the supplied CYW-135 liquid conjugate, which led to Wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This US2024011341 and US2024AMR015886 cases has been linked to the case reported by the same reporter. The reporter consented to follow up via phone.; Sender's Comments:  US-GSK-US2024011341:1 PATIENT US-GSK-US2024AMR015886:2 ND PATIENT
Age: 63.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Arthralgia, Headache, Injection site discolouration, Injection site infection, Injection site reaction
Clinical narrative: Pt. seen in our office on 1/22/24 and had been experiencing some unusual symptoms for three weeks. Pt. c/o tenderness and throbbing pain in  right arm, without fever. Also c/o neck pain radiating down the right arm and bruising at site. Pt. was started on Clindamycin for 7 days and Bethamethasone cream twice a day for 7 days. Torodal 60 mg inj given for pain. Pt. seen again on 2/2/24 with worsening symptoms in right arm and unable to lift due to pain. Her skin was black in color in a 2x2 cm size knot that is tender to palpate, no fever.
Age: 63.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Malaise, Necrotising fasciitis, Pain, Pain in extremity
Clinical narrative: Pt. seen in our office on 1/22/24 and had been experiencing some unusual symptoms for three weeks. Pt. c/o tenderness and throbbing pain in  right arm, without fever. Also c/o neck pain radiating down the right arm and bruising at site. Pt. was started on Clindamycin for 7 days and Bethamethasone cream twice a day for 7 days. Torodal 60 mg inj given for pain. Pt. seen again on 2/2/24 with worsening symptoms in right arm and unable to lift due to pain. Her skin was black in color in a 2x2 cm size knot that is tender to palpate, no fever.
Age: 63.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Injection site bruising, Neck pain, Nodule, Pain, Pain in extremity
Clinical narrative: Pt. seen in our office on 1/22/24 and had been experiencing some unusual symptoms for three weeks. Pt. c/o tenderness and throbbing pain in  right arm, without fever. Also c/o neck pain radiating down the right arm and bruising at site. Pt. was started on Clindamycin for 7 days and Bethamethasone cream twice a day for 7 days. Torodal 60 mg inj given for pain. Pt. seen again on 2/2/24 with worsening symptoms in right arm and unable to lift due to pain. Her skin was black in color in a 2x2 cm size knot that is tender to palpate, no fever.
Age: 63.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Skin discolouration, Tenderness
Clinical narrative: Pt. seen in our office on 1/22/24 and had been experiencing some unusual symptoms for three weeks. Pt. c/o tenderness and throbbing pain in  right arm, without fever. Also c/o neck pain radiating down the right arm and bruising at site. Pt. was started on Clindamycin for 7 days and Bethamethasone cream twice a day for 7 days. Torodal 60 mg inj given for pain. Pt. seen again on 2/2/24 with worsening symptoms in right arm and unable to lift due to pain. Her skin was black in color in a 2x2 cm size knot that is tender to palpate, no fever.
Age: 63.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Bacterial infection, Headache, Injection site infection, Malaise, Pain
Clinical narrative: Pt. seen in our office on 1/22/24 and had been experiencing some unusual symptoms for three weeks. Pt. c/o tenderness and throbbing pain in  right arm, without fever. Also c/o neck pain radiating down the right arm and bruising at site. Pt. was started on Clindamycin for 7 days and Bethamethasone cream twice a day for 7 days. Torodal 60 mg inj given for pain. Pt. seen again on 2/2/24 with worsening symptoms in right arm and unable to lift due to pain. Her skin was black in color in a 2x2 cm size knot that is tender to palpate, no fever.
Age: 63.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Pain in extremity, Product complaint, Skin discolouration, Wound
Clinical narrative: Pt. seen in our office on 1/22/24 and had been experiencing some unusual symptoms for three weeks. Pt. c/o tenderness and throbbing pain in  right arm, without fever. Also c/o neck pain radiating down the right arm and bruising at site. Pt. was started on Clindamycin for 7 days and Bethamethasone cream twice a day for 7 days. Torodal 60 mg inj given for pain. Pt. seen again on 2/2/24 with worsening symptoms in right arm and unable to lift due to pain. Her skin was black in color in a 2x2 cm size knot that is tender to palpate, no fever.
Sex: U
Vaccine: COVID19
Symptoms: Embolism
Clinical narrative: blood clot; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), in 2023 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: EMBOLISM (medically significant, life threatening) with onset 2023, outcome "unknown", described as "blood clot". The event "blood clot" required emergency room visit. Therapeutic measures were taken as a result of embolism. Clinical course: A year ago (2023), the patient battled a blood clot. The patient previously had received the Pfizer vaccine for Covid. The patient was ask about what vaccine s/he had received prior to the emergency hospital visit. The emergency doctor said the clot could be from that vaccine. Interestingly enough, the patient was given Eliquis to dissolve the clot. The patient stated that it almost cost his/her life.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: her child had a rash; This spontaneous report was received from a physician via company representative referring to a child patient. The patient's medical history, current conditions and concomitant medications were unknown. The patient's drug reactions/allergies were unknown.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, frequency, route of administration, lot number, expiration date and anatomical location were not reported) for prophylaxis. On the same day, the patient was vaccinated with several other unspecified vaccines (dose, frequency, route of administration, lot number, expiration date and anatomical location were not reported) for prophylaxis.  On 01-FEB-2024 (reported as today), the patient was due for the next hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose, but when the patient arrived to the clinic the parent declined to have the dose given today, and reported that on an unknown date (reported as after the last dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)), her child had a rash. It was unknown if the patient sought medical attention, and the treatment given for event was unknown. The outcome of rash was not reported. The causality between all suspect therapies and rash was not provided.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; PROQUAD administered after reconstitution with expired sterile diluent (expired product administered); This spontaneous report was received from a registered nurse and refers to a 6-year-old patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 31-JAN-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #W024972, (expiration date: 05-FEB-2024), administered subcutaneously for prophylaxis (strength, dose, scheme and anatomical site injection were not provided); and  sterile diluent (manufacture unknown) (formulation not reported, but upon internal review, established as solution for injection/infusion), 0.7 milligram lot # X004657, (expiry date: 26-JAN-2024)(strength, route of administration, and indication were not provided). On the same date, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was administered after reconstitution with expired sterile diluent (expired product administered). Additionally, it was informed that the patient did not experience adverse event (no adverse event).
Age: 7.0
Sex: U
Vaccine: HEPA, MMR
Symptoms: Expired product administered, Incorrect dose administered, No adverse event
Clinical narrative: No additional AE; expired MMR II was administered to a patient. Product expired 1/7/2024 and was administered 1/31/2024.; administered an adult dose of VAQTA on the same day 1/31/2024; This spontaneous report was received from a medical assistant referring to a 7-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 31-JAN-2024, the patient was vaccinated with expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (rHA) injection (0.5 mL, lot#: W017557, expiration date: 07-JAN-2024; route of administration and anatomical location were not reported) for prophylaxis (expired product administered) together with sterile diluent (strength, dose, lo#, and expiration date were not reported); and Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection (1 mL (adult dose), lot#: X006702, expiration date: 01-OCT-2024; route of administration and anatomical location were not reported) for prophylaxis (incorrect dose administered). The vaccines administered did not experience temperature excursion through date of administration. No additional adverse events (AE) were reported (no adverse event).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SYMPTOMATIC COVID-19 INFECTION; This spontaneous report received from a consumer via another company (Pfizer Inc.) on 11-JAN-2024 was received on 11-JAN-2024 and concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: hypothyroidism, and mild asthma. The patient experienced allergy when treated with benzylpenicillin. The patient received covid-19 vaccine ad26.cov2.s (Dose series:1)(suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. Non-company suspect vaccine included: elasomeran (Dose series:2) ( form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included guaifenesin, and ibuprofen. Age at the time of vaccination was not reported.  On 06-JAN-2024, the patient experienced symptomatic covid-19 infection (Dose series:2) and The patient still had mild symptoms that were continuing to improve. The patient was tested negative on 03-JAN-2024. Patient started feeling poorly again on 06-JAN-2024. The patient was tested on 08-JAN-2024 and had a positive test (dose series 2). Symptoms were not as severe but had new symptoms. The patient had headache, body ache, low-grade fever, cough, fatigue, cough and congestion as before with sore throat and earache this time as well and On an unspecified date, the patient experienced revaccination with different covid-19 vaccine  (Dose series:2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from symptomatic covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 Treatment was Paxlovid with treatment start date on 22Jan2024 and treatment stop date on 27Jan2024. Covid again on 01Feb2024 and the patient was recovering.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Glioblastoma
Clinical narrative: Glioblastoma of the brain; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2023-737352 (Moderna).  A 57-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2021, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: Apr2021, for COVID-19 immunization. The following information was reported: GLIOBLASTOMA (death) with onset 31Jul2022, outcome "fatal", described as "Glioblastoma of the brain". The patient date of death was 31Jul2022. Reported cause of death: "Glioblastoma of the brain". It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reported Cause(s) of Death: Glioblastoma of the brain
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I took the vaccines for covid and I still got covid no matter what; I took the vaccines for covid and I still got covid no matter what; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 89-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I took the vaccines for covid and I still got covid no matter what". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. Additional information: Patient states "l took the vaccines for covid and I still got covid no matter what".  The information on the batch/lot number for Bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: sore arms; soreness in the muscle; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): US-MODERNATX-MOC20230925000151 (MODERNA).  An elderly female patient received BNT162b2 (BNT162B2 NOS), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) and in 2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (2 Moderna COVID-19 Shots), administration date: 2021, for COVID-19 Vaccination; Moderna (Moderna COVID-19 booster), administration date: 2021, for COVID-19 Immunisation; Moderna (Moderna COVID-19 booster), administration date: 2022, for COVID-19 Immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arms"; MYALGIA (non-serious), outcome "unknown", described as "soreness in the muscle". Additional information: For previous ones only had sore arms and normal soreness in the muscle.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: Blood pressure keeps going up; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): US-MODERNATX-MOC20230912000033.  A 53-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "Blood pressure keeps going up".  Additional information: Eats healthy and works out this shouldn't be happening.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Illness
Clinical narrative: I've been sick for 2 days; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE), as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I've been sick for 2 days".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: punctured IPOL was administered that was not suitable for use with no reported adverse event; Initial information received on 29-Jan-2024 regarding an unsolicited valid non-serious case received from nurse.  This case involves a 4 years old male patient who was administered punctured IPV (VERO) [IPOL] that was not 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.  On 04-Dec-2023, the patient received 0.5 ml dose of punctured suspect IPV (VERO) (strength: standard; frequency: once) Suspension for injection of lot W1B511M and expiry: 08-Sep-2025 via intramuscular route in the right deltoid for immunization, that was not suitable for use with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly, nurse called back and added that the punctured IPOL she reported previously was administered to 50 patients. Nurse also asked for recommendations if the patients need revaccination. Product/s: Punctured IPOL Reason: Unknown Max/low temperature reached: 9.3 C for 13 mins 10 C.  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: 15.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Punctured ipol exposed to 9.3 C for 13 mins with no reported adverse event; inappropriate use due to administration of punctured ipol with no reported adverse event; Initial information received on 29-Jan-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an 15 years old female patient where reporter reported punctured IPV (vero) [IPOL] exposed to 9.3 c for 13 mins with no reported adverse event and inappropriate use due to administration of punctured ipol 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 measles vaccine, mumps vaccine, rubella vaccine (mmr), diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (tdap), varicella zoster vaccine (varicella vaccine) and hepatitis a vaccine (hepatitis a vaccine) for Immunisation.  On 02-Jan-2024, the patient received 0.5 ml dose of suspect IPV (vero) Suspension for injection (lot W1C751M and expiration date- 18-Nov-2025) via intramuscular route in the left deltoid (strength: not provided) for Immunisation (product storage error) and (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 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: 9.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Max/low temperature reached 9.3 C for 13 mins 10 C for 10 C was administered to patient with no reported adverse event; Initial information was received on 29-Jan-2024 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 9 years old female patient to whom max/low temperature reached: 9.3 c for 13 mins 10 c for 10 c was administered 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 influenza vaccine, hepatitis A vaccine, diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) and varicella zoster vaccine (varicella vaccine)for Prophylactic vaccination.  On 04-Jan-2024, the patient received a 0.5 ml, once dose of suspect IPV (VERO) (Suspension for injection) (lot W1C751M, expiry date: 18-Nov-2025, Strength: standard) via intramuscular route in the left deltoid for Immunisation and max/low temperature reached: 9.3 c for 13 mins 10 c for 10 c was administered to patients with no reported adverse event (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 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: 4.0
Sex: M
Vaccine: DTAP, IPV, UNK
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: accidentally administered PENTACEL instead of the IPV vaccine with no reported adverse event; DAPTACEL and PENTACEL vaccines are administered on same day with no reported adverse event; Initial information received on 30-Jan-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2024SA038117.  This case involves a 4 years old male patient who was accidentally administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] instead of the Poliomyelitis Vaccine (Inactivated) vaccine with no reported adverse event, diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] and pentacel vaccines are administered on same day 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 measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine (Varicella Vaccine) for Immunisation.  On an unknown date, patient was accidentally administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot number; strength; expiry date unknown) instead of the Poliomyelitis Vaccine (Inactivated) vaccine (lot number; strength; expiry date unknown) with no reported adverse event (wrong product administered) (latency: same day) and diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot number; strength; expiry date unknown) and pentacel vaccines are administered on same day with no reported adverse event (extra dose administered) (latency: same day). Information regarding batch number will be requested in this case.   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: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: MENQUADFI was exposed to temperature excursion with max/low temperature reached: 33 F Duration out of labelled range: 19 hrs and 15 mins and was administered post excursion with no reported adverse event; Initial information received on 31-Jan-2024 regarding an unsolicited valid non-serious case received from other health professional.  This case involves patient of unknown age and gender meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was exposed to temperature excursion with max/low temperature reached: 33 F duration out of labelled range: 19 hrs and 15 mins and was administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Jan-2024, the patient received a dose of 0.5 ml of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot: U79458BA; expiry date: Mar-2026); frequency: once; strength: standard via unknown route in an unknown administration site for Immunization which was exposed to temperature excursion with max/low temperature reached: 33 f duration out of labelled range: 19 hrs and 15 mins and was administered post excursion with no reported adverse event (poor quality product administered) (latency: same day).  It was reported, "Reason: Unknown; Human Error: Unknown Does extended stability data cover the excursion? No for MENQUADFI and yes for the rest of the vaccines."   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 medicatin error.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: really a lot of soreness at the injection site in their arms; Initial information was received on 31-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2024SA037976(CLUSTER).  This case involves an unknown age female patient who experienced really a lot of soreness at the injection site in their arms after receiving influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.7 ml, (once) total dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot number, expiry date: unknown, strength: standard) via intramuscular route in the deltoid nos for Influenza Immunization. The information on the batch number was requested.  On an unknown date the patient had really a lot of soreness at the injection site in their arms (vaccination site pain) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: MENQUADFI experienced a temperature excursion overnight, and then 1 dose of MENQUADFI was administered early this morning with no reported AE; Initial information received From United states on 01-Feb-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient who had received 1 dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] early this morning after a temperature excursion overnight with no reported adverse event.  The patient's past vaccination(s) included MENACTRA in 2018. The patient's past medical history, medical treatment(s) and family history were not provided.   On 01-Feb-2024, the patient received a Booster 0.5 ml dose of suspect A-C-Y-W135 (T Conj) Vaccine Solution for injection (lot U7903AB, strength: standard except for Fluzone High Dose Quadrivalent) via intramuscular route in the left deltoid as immunization and experienced a temperature excursion overnight, and then 1 dose of menquadfi was administered early this morning with no reported adverse event (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 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: VARZOS
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number T5T79, expiry date 24-NOV-2023) for prophylaxis.   On 25-JAN-2024, the patient received Shingrix. On 25-JAN-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Administration of an expired vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 30-JAN-2024 A nurse contacted GlaxoSmithKline via phone and inquiring about Shingrix and what information was available about the administration of Shingrix after the expiration date. The patient received expired dose of Shingrix, which led to expired vaccine used. The reporter gave partial information about the event, vaccine and consented to follow-up. The Vaccine Administration Facility was the same as Primary Reporter. The reporter granted the permission for consent to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: MASSIVE CLOT; This spontaneous report received from a health care professional by a Business partner (Pfizer Inc.) on 02-FEB-2024 was received on 02-FEB-2024 and concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and we are unable to perform follow up request for batch numbers. No concomitant medications were reported. On an unspecified date, the patient experienced massive clot. On an unspecified date, the patient died from massive clot (dose series 1). It was not reported if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: Thrombosis. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: MASSIVE CLOT
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal faeces, Ageusia, Anal pruritus, Anosmia, Arthralgia
Clinical narrative: Two days after, and continuing for 4 months (continuing and ongoing to today Feb, 2,2024) after Pfizer Covid 19 booster shot in my upper left arm on Oct 2, 2023, I am experiencing following reactions: 1) Extreme constant tiredness and 2) Severe arthritis symptoms (joint pain in all joints, especially in legs and knees, and 3) Constant itching on scalp, nose, eyelashes, eyebrows, and scrotum and anus 4) Pain at site of vaccine injection (when moving arm), and 5) Constant chronic extreme tiredness and fatigue and 6) Brain fog, and 7) Noticeable loss of smell and taste and 8) Daily intermittent dry cough and bad taste in mouth and bad chemical smell in breath and increased throat and nasal mucous in morning upon awakening, and 9) Much more frequent trips to bathroom (Urine quantity and number of trips has increased, with a noticeable bad chemical smell). Bowel movements normal, but have the same chemical smell. Note: Home Covid 19 tests taken right after symptoms began were negative. Went to my primary care physician and to my dermatologist recently pointing out my itching and increased arthritis symptoms. Dermatologist prescribed fungal and steroid ointments, but didnt cure. Primary care doctor prescribed increase in blood pressure medicine and sleep study, and to quit taking Prozac. (Awaiting results of sleep study that was just taken Feb 2, 2024). My neurologist on Jan18,2024 recommended Mediteranian diet and routine exercise.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Brain fog, Breath odour, Cough, Differential white blood cell count
Clinical narrative: Two days after, and continuing for 4 months (continuing and ongoing to today Feb, 2,2024) after Pfizer Covid 19 booster shot in my upper left arm on Oct 2, 2023, I am experiencing following reactions: 1) Extreme constant tiredness and 2) Severe arthritis symptoms (joint pain in all joints, especially in legs and knees, and 3) Constant itching on scalp, nose, eyelashes, eyebrows, and scrotum and anus 4) Pain at site of vaccine injection (when moving arm), and 5) Constant chronic extreme tiredness and fatigue and 6) Brain fog, and 7) Noticeable loss of smell and taste and 8) Daily intermittent dry cough and bad taste in mouth and bad chemical smell in breath and increased throat and nasal mucous in morning upon awakening, and 9) Much more frequent trips to bathroom (Urine quantity and number of trips has increased, with a noticeable bad chemical smell). Bowel movements normal, but have the same chemical smell. Note: Home Covid 19 tests taken right after symptoms began were negative. Went to my primary care physician and to my dermatologist recently pointing out my itching and increased arthritis symptoms. Dermatologist prescribed fungal and steroid ointments, but didnt cure. Primary care doctor prescribed increase in blood pressure medicine and sleep study, and to quit taking Prozac. (Awaiting results of sleep study that was just taken Feb 2, 2024). My neurologist on Jan18,2024 recommended Mediteranian diet and routine exercise.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Full blood count, Glycosylated haemoglobin, Injection site pain, Lipids
Clinical narrative: Two days after, and continuing for 4 months (continuing and ongoing to today Feb, 2,2024) after Pfizer Covid 19 booster shot in my upper left arm on Oct 2, 2023, I am experiencing following reactions: 1) Extreme constant tiredness and 2) Severe arthritis symptoms (joint pain in all joints, especially in legs and knees, and 3) Constant itching on scalp, nose, eyelashes, eyebrows, and scrotum and anus 4) Pain at site of vaccine injection (when moving arm), and 5) Constant chronic extreme tiredness and fatigue and 6) Brain fog, and 7) Noticeable loss of smell and taste and 8) Daily intermittent dry cough and bad taste in mouth and bad chemical smell in breath and increased throat and nasal mucous in morning upon awakening, and 9) Much more frequent trips to bathroom (Urine quantity and number of trips has increased, with a noticeable bad chemical smell). Bowel movements normal, but have the same chemical smell. Note: Home Covid 19 tests taken right after symptoms began were negative. Went to my primary care physician and to my dermatologist recently pointing out my itching and increased arthritis symptoms. Dermatologist prescribed fungal and steroid ointments, but didnt cure. Primary care doctor prescribed increase in blood pressure medicine and sleep study, and to quit taking Prozac. (Awaiting results of sleep study that was just taken Feb 2, 2024). My neurologist on Jan18,2024 recommended Mediteranian diet and routine exercise.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Nasal pruritus, Pain, Pain in extremity, Pollakiuria
Clinical narrative: Two days after, and continuing for 4 months (continuing and ongoing to today Feb, 2,2024) after Pfizer Covid 19 booster shot in my upper left arm on Oct 2, 2023, I am experiencing following reactions: 1) Extreme constant tiredness and 2) Severe arthritis symptoms (joint pain in all joints, especially in legs and knees, and 3) Constant itching on scalp, nose, eyelashes, eyebrows, and scrotum and anus 4) Pain at site of vaccine injection (when moving arm), and 5) Constant chronic extreme tiredness and fatigue and 6) Brain fog, and 7) Noticeable loss of smell and taste and 8) Daily intermittent dry cough and bad taste in mouth and bad chemical smell in breath and increased throat and nasal mucous in morning upon awakening, and 9) Much more frequent trips to bathroom (Urine quantity and number of trips has increased, with a noticeable bad chemical smell). Bowel movements normal, but have the same chemical smell. Note: Home Covid 19 tests taken right after symptoms began were negative. Went to my primary care physician and to my dermatologist recently pointing out my itching and increased arthritis symptoms. Dermatologist prescribed fungal and steroid ointments, but didnt cure. Primary care doctor prescribed increase in blood pressure medicine and sleep study, and to quit taking Prozac. (Awaiting results of sleep study that was just taken Feb 2, 2024). My neurologist on Jan18,2024 recommended Mediteranian diet and routine exercise.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pruritus genital, SARS-CoV-2 test negative, Secretion discharge, Sleep study
Clinical narrative: Two days after, and continuing for 4 months (continuing and ongoing to today Feb, 2,2024) after Pfizer Covid 19 booster shot in my upper left arm on Oct 2, 2023, I am experiencing following reactions: 1) Extreme constant tiredness and 2) Severe arthritis symptoms (joint pain in all joints, especially in legs and knees, and 3) Constant itching on scalp, nose, eyelashes, eyebrows, and scrotum and anus 4) Pain at site of vaccine injection (when moving arm), and 5) Constant chronic extreme tiredness and fatigue and 6) Brain fog, and 7) Noticeable loss of smell and taste and 8) Daily intermittent dry cough and bad taste in mouth and bad chemical smell in breath and increased throat and nasal mucous in morning upon awakening, and 9) Much more frequent trips to bathroom (Urine quantity and number of trips has increased, with a noticeable bad chemical smell). Bowel movements normal, but have the same chemical smell. Note: Home Covid 19 tests taken right after symptoms began were negative. Went to my primary care physician and to my dermatologist recently pointing out my itching and increased arthritis symptoms. Dermatologist prescribed fungal and steroid ointments, but didnt cure. Primary care doctor prescribed increase in blood pressure medicine and sleep study, and to quit taking Prozac. (Awaiting results of sleep study that was just taken Feb 2, 2024). My neurologist on Jan18,2024 recommended Mediteranian diet and routine exercise.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder, Urine odour abnormal
Clinical narrative: Two days after, and continuing for 4 months (continuing and ongoing to today Feb, 2,2024) after Pfizer Covid 19 booster shot in my upper left arm on Oct 2, 2023, I am experiencing following reactions: 1) Extreme constant tiredness and 2) Severe arthritis symptoms (joint pain in all joints, especially in legs and knees, and 3) Constant itching on scalp, nose, eyelashes, eyebrows, and scrotum and anus 4) Pain at site of vaccine injection (when moving arm), and 5) Constant chronic extreme tiredness and fatigue and 6) Brain fog, and 7) Noticeable loss of smell and taste and 8) Daily intermittent dry cough and bad taste in mouth and bad chemical smell in breath and increased throat and nasal mucous in morning upon awakening, and 9) Much more frequent trips to bathroom (Urine quantity and number of trips has increased, with a noticeable bad chemical smell). Bowel movements normal, but have the same chemical smell. Note: Home Covid 19 tests taken right after symptoms began were negative. Went to my primary care physician and to my dermatologist recently pointing out my itching and increased arthritis symptoms. Dermatologist prescribed fungal and steroid ointments, but didnt cure. Primary care doctor prescribed increase in blood pressure medicine and sleep study, and to quit taking Prozac. (Awaiting results of sleep study that was just taken Feb 2, 2024). My neurologist on Jan18,2024 recommended Mediteranian diet and routine exercise.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: Patient stated he experienced an increased bleeding event after the immunization which required him to be hospitalized.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Albumin globulin ratio normal, Alpha 1 globulin normal, Alpha 2 globulin normal, Amino acid level increased, Antineutrophil cytoplasmic antibody negative
Clinical narrative: 1. In late October, early November 2022: Started experiencing acute bilateral stinging/burning sensation to scalp, face, arms, torso, legs 24 hours/day, worse in the evenings, disrupting sleep. 2. Referred by PCP to neurosurgeon due to history of nerve root decompression at C5-6 and C6-7. Started gabapentin 300 mg at HS, ordered MRI. 3. 2/21/23: Saw neurologist, who ordered labs 4. 3/16/23: Neurosurgery f/u: stated MRI results were negative, increased gabapentin to 600 mg at HS, referred to rheumatologist for possible autoimmune neuropathy 5. 6/8/23: Rheumatologist ordered prednisone 40 mg daily x 2 weeks, then taper x 1 week (taper completed 7/1/23). Symptoms ceased completely, then returned on 7/7/23. 7/11/23: Rheumatologist gave Kenalog 80 mg IM & started Plaquinil PO. 10/11/23: Plaquinil stopped due to lack of improvement & (+) side effects.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Antinuclear antibody, Antinuclear antibody negative, Antinuclear antibody positive, Beta globulin normal, Biopsy skin normal
Clinical narrative: 1. In late October, early November 2022: Started experiencing acute bilateral stinging/burning sensation to scalp, face, arms, torso, legs 24 hours/day, worse in the evenings, disrupting sleep. 2. Referred by PCP to neurosurgeon due to history of nerve root decompression at C5-6 and C6-7. Started gabapentin 300 mg at HS, ordered MRI. 3. 2/21/23: Saw neurologist, who ordered labs 4. 3/16/23: Neurosurgery f/u: stated MRI results were negative, increased gabapentin to 600 mg at HS, referred to rheumatologist for possible autoimmune neuropathy 5. 6/8/23: Rheumatologist ordered prednisone 40 mg daily x 2 weeks, then taper x 1 week (taper completed 7/1/23). Symptoms ceased completely, then returned on 7/7/23. 7/11/23: Rheumatologist gave Kenalog 80 mg IM & started Plaquinil PO. 10/11/23: Plaquinil stopped due to lack of improvement & (+) side effects.