chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.58
Sex: U
Vaccine: RAB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was administered with two 0.1 mL doses of IMOVAX RABIES vaccine intradermally with no adverse event; patient was administered with two 0.1 mL doses of IMOVAX RABIES vaccine intradermally with no adverse event; Initial information received on 05-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 months old patient of unknown gender who was administered with two 0.1 ml doses of rabies (HDC) vaccine [Imovax Rabies] intradermally with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the patient was administered with two 0.1 ml doses of rabies (HDC) vaccine (Powder and solvent for suspension for injection) (lot: V1D771M) (strength; expiry date unknown) intradermally with no adverse event (incorrect route of product administration) (incorrect dose administered) (latency: same day) via unknown route in unknown administration for post-exposure prophylaxis (Immunisation).  It was reported, "A nurse manager asks if the 0.1 mL intradermal dose of IMOVAX RABIES vaccine is equivalent to the 1 mL intramuscular dose, and if we do manufacture intradermal IMOVAX RABIES. Patient already received two intradermal doses of 0.1 mL in the ER, and they will be giving the patient two intramuscular 1 mL doses; caller asks if those two different routes and doses are interchangeable."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: someone in office gave dtap/ipv component without hib as mixture twice with no reported adverse event; Initial information was received on 06-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender of patient who reported that someone in office gave dtap/ipv component without hib as mixture twice with no reported adverse event after receiving diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)].  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 dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (Suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Immunization and someone in office gave dtap/ipv component without hib as mixture twice with no reported adverse event (product preparation error) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine. The information on batch number was requested.  It was reported that "Caller stated that someone in the office gave the dtap/ipv component without the hib as the mixture twice to two separate patients. Caller stated that are not sure who the patients are yet and are investigating, but she wants to know if when the patients are revaccinated, do they need to be given the entire PENTACEL vaccine."  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, ipv and HIB VACCINE (Pentacel (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for the event someone in office gave dtap/ipv component without hib as mixture twice with no reported adverse event.  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: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired lot for ACTHIB with no reported Adverse event; Initial information received on 06-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old and unknown gender patient who was administered an expired lot for 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.  On 15-Jul-2022, the patient received a dose 1 of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot number not reported via intramuscular route in unknown administration site, on 16-Sep-2022 also received a Dose 2 of the same vaccine, on 19-Nov-2022 also received a dose 3 of the same vaccine. On an unknown date patient also received a dose 4 Booster dose 0.5 ml of the same vaccine lot UJ787AA expiry date: 11-Aug-2023 via intramuscular route in the left thigh for immunization.  On an unknown date the patient administered an expired lot for acthib with no reported adverse event (expired product administered) on the same day following the administration of HIB (PRP/T) VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired lot for acthib with no reported adverse event.   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: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Ipol was exposed to 52.3F for 2 hours and 41 minutes with no reported adverse event; temperature excursion product administered to a patient with no reported adverse event; Initial information received on 07-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of an unknown gender and age and administered Ipv (Vero) [Ipol] was exposed to 52.3f for 2 hours and 41 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Ipv (Vero) Suspension for injection (strength: unknown, expiry date: 14-Feb-2025, lot W1A191M) via unknown route in unknown administration site as Immunization (poor quality product administered) (latency: same day) and was exposed to 52.3f for 2 hours and 41 minutes with no reported adverse event (product storage error) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Extra dose administered
Clinical narrative: 3rd HPV vaccine was given when it was not medically indicated. Patient received 2 HPV vaccines prior to the age of 15 years.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: VACCINE ADMINISTERED 11:15AM;  I RECEIVED NOTIFICATION AT 11:22AM THAT ALL MODERNA BIVALENT COVID19 VACCINE ADMINISTRATION WERE TO BE HALTED AND VACCINES TO BE DISCARDED.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Syringe issue
Clinical narrative: RN went to administer Heb B Vaccine, upon administration, noted that vaccine was leaking out of connector, RN attempted to tighten connection of needle and syringe, RN attempted to push more of med, more vaccine noted still leaking from needle. RN removed needle and syringe since majority of vaccine had leaked out of syringe. New syringe and set up obtained, different Hep B vaccination administered to pt. Pt remained in clinic for additional monitoring, no side effects noted, PCP notified.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site pain, Loss of consciousness, Syncope, Urticaria
Clinical narrative: Pt had syncopal episode as he stood after vaccine.  LOC transient.  His L arm was noted to be red/vasculitic (looked like a port wine stain) - in front of adminstration site and he stated it was painful to touch. Ice was applied over next 20 minutes on and off with improvement of vascular marking. Urticarial lesions appeared and it was still tender to palpation at the 30 minute mark. He was given 15 ml of Benadryl and more ice. At 60 minute mark, resolution of hives and no longer tender. Skin color at site returned to normal. Pt. sent home to redose benadryl at 6 hour mark.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Vasculitis
Clinical narrative: Pt had syncopal episode as he stood after vaccine.  LOC transient.  His L arm was noted to be red/vasculitic (looked like a port wine stain) - in front of adminstration site and he stated it was painful to touch. Ice was applied over next 20 minutes on and off with improvement of vascular marking. Urticarial lesions appeared and it was still tender to palpation at the 30 minute mark. He was given 15 ml of Benadryl and more ice. At 60 minute mark, resolution of hives and no longer tender. Skin color at site returned to normal. Pt. sent home to redose benadryl at 6 hour mark.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: Administered Vaccine after the terminated authorization of bivalent mRNA COVID-19
Age: 0.17
Sex: M
Vaccine: UNK, UNK
Symptoms: Pyrexia
Clinical narrative: Pt experenced a low grade fever roughly 24hrs after immunization which later progressed into a 103.5 degree fever and hospitalization.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: Patient was administered Moderna Bivalent at 9:33am . Later that day we were notified at 2:21pm. received email stating bivalent administration given today would be considered error due to no longer being authorized.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: Patient given Moderna Bivalent today at 10:50am, we were notified at 2:21pm that the Bivalent was no longer approved for use in the this country and anyone who had been administered a Bivalent Covid vaccine should have a VAERS report submitted.
Age: 57.0
Sex: F
Vaccine: MNQ
Symptoms: Decreased appetite
Clinical narrative: GAVE VACCINE OUTSIDE PATIENT'S RECOMMENDED AGE
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Fatigue, Hypotension
Clinical narrative: patient reported that she was fine the day of the vaccine but developed symptoms the following morning that included low blood pressure (87/40) , was weak and tired all day .  On the 2nd day following vaccine she felt back to normal.  No other local or systemic symptoms  noted.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea
Clinical narrative: The patient reached out to Dr. stating she had been feeling sick ever since she got her tdap vaccine. She reported sx of fatigue, chills, headaches and woke up nasueated Friday morning and woke up and vomitted Saturday morning. She reports her sx come intermittently and that sometimes she feels ok and sometimes not and wondered if this was normal.  She also mentions that her arm got a red swollen patch from the shot.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Skin discolouration, Vomiting
Clinical narrative: The patient reached out to Dr. stating she had been feeling sick ever since she got her tdap vaccine. She reported sx of fatigue, chills, headaches and woke up nasueated Friday morning and woke up and vomitted Saturday morning. She reports her sx come intermittently and that sometimes she feels ok and sometimes not and wondered if this was normal.  She also mentions that her arm got a red swollen patch from the shot.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Brain stem stroke, Cerebellar stroke
Clinical narrative: Multiple strokes.  Cellebellum and pons
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Lymphadenopathy, Peripheral swelling, Respiratory disorder, Skin discolouration
Clinical narrative: Patient reported swelling in arm and lymph node. Patient also had extensive bruising on the INSIDE of arm and on side of chest. Bright blue and purple bruising not at the injection sight but on the side of the body of the injection. She also reported red spots on side of abdomen and some slight discomfort breathing
Age: 73.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Atrial fibrillation, Brain natriuretic peptide increased, Chest X-ray abnormal, Echocardiogram abnormal, Ejection fraction normal
Clinical narrative: Atrial Fibrillation with rapid ventricular response, new onset-rate now controlled on Diltiazem however Afib persists. Only symptoms "felt loopy" Wife is a physician and heard Afib upon auscultation Hospitalized for 2 days at: Hospital
Age: 73.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Electrocardiogram abnormal, Feeling abnormal, Full blood count normal, Hepatomegaly, International normalised ratio increased
Clinical narrative: Atrial Fibrillation with rapid ventricular response, new onset-rate now controlled on Diltiazem however Afib persists. Only symptoms "felt loopy" Wife is a physician and heard Afib upon auscultation Hospitalized for 2 days at: Hospital
Age: 73.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Laboratory test normal, Left ventricular hypertrophy, Prothrombin time, Troponin normal
Clinical narrative: Atrial Fibrillation with rapid ventricular response, new onset-rate now controlled on Diltiazem however Afib persists. Only symptoms "felt loopy" Wife is a physician and heard Afib upon auscultation Hospitalized for 2 days at: Hospital
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Haematoma
Clinical narrative: Patient developed a small dime-sized hematoma on left arm shortly after receiving the Arexvy vaccine. She stated that it started smal and grew to the size of a dime over a span of an hour or two. She stated that she did not bump or scrap her arm at any point after the vaccine was given. Two smaller spots were also noted on her left forearm just above the first spot.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain, Pruritus, Rash
Clinical narrative: left lower leg & ankle redness, rashes with swollen, warm, itch and pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: left lower leg & ankle redness, rashes with swollen, warm, itch and pain.
Age: 13.0
Sex: F
Vaccine: MNQ, UNK, UNK, UNK, UNK, UNK
Symptoms: Dizziness
Clinical narrative: Client stated feeling lightheaded after vaccination. Client parent stated client had not eaten. Client lowered to the floor, legs placed on chair, and cool towel placed on client head by LVN. Client stated no longer feeling lightheaded. Client sat in chair. Client vital signs checked. Client blood pressure- 104/62, temperature- 97.3, pulse- 62, oxygen saturation- 98%, and respiration- 20. Client denies having any other symptoms prior to leaving post vaccination. Client parent stated that that they were going to eat. Client denies any distress prior to leaving post vaccination area.
Age: 71.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: pt stated she started feeling a little itchy the night of vaccines and then woke the next morning with a red, itchy rash mostly contained to her back. When she reported it she said it had basically gone away by 9/7/23
Age: 0.25
Sex: M
Vaccine: DTAPIPV, MENB, PNC13, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Unknown
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Cough, Pharyngeal swelling, Rash macular, Sneezing
Clinical narrative: 4 years On Moms way out of the office after vaccination ~5minutes patient returned with sneezing and red blotchy face No vomiting or increased WOB Pt given benadryl PO
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Rash macular, Sneezing
Clinical narrative: 4 years On Moms way out of the office after vaccination ~5minutes patient returned with sneezing and red blotchy face No vomiting or increased WOB Pt given benadryl PO
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE/PQC; the patient received 0.5 ml of VAQTA instead of 1 ml of VAQTA; This spontaneous report was received from a Medical Assistant referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 30-AUG-2023, the patient was vaccinated with a pediatric first dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter (strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis (incorrect dose administered). No additional adverse event was provided
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: administered on 16-MAR-2004; administered on 14-AUG-2003; administered on 22-MAY-2003; This spontaneous report was received from a health professional referring to a 5-month-old female patient.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP), hib vaccine, pneumococcal polysaccharide conjugate vaccine (7-valent (+) adsorbed) and polio vaccine inact (IPV).   On 23-NOV-2002, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On 22-MAY-2003, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (inappropriate schedule of product administration). On 14-AUG-2003, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (inappropriate schedule of product administration). On 16-MAR-2004, the patient was vaccinated with the fourth dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (extra dose administered).; Sender's Comments:  US-009507513-2306USA007890:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no further AE; GARDASIL 9 given during a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-AUG-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (lot# W029724, expiration date: 08-JAN-2025; strength, dose, and route were not provided) during a temperature excursion (TE) (product storage error). TEs were on 02-AUG-2023 and 04-AUG-2023. There was no further adverse event (AE).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2309USA002410: US-009507513-2309USA002283: US-009507513-2309USA002102: US-009507513-2309USA002460: US-009507513-2309USA002163:
Sex: U
Vaccine: PNC15
Symptoms: Product storage error
Clinical narrative: No further AE details; HCP called to report that a dose of VAXNEUVANCE that experienced a TE on 9/6/2023 that was Not Supported was administered to a patient on 9/7/2023. HCP gave permission to contact. No further AE details/ No PQC.   ?; This spontaneous report has been received form a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 06-SEP-2023, a dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (lot number: X011332, which was determined to be valid, with an expiration date on 01-JAN-2025) underwent a temperature excursion of -0.55 degrees Celsius for 5 hours, which was not supported.  On 07-SEP-2023, the patient was vaccinated with the improperly storage dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection, at a dose of 0.5 milliliters once as prophylaxis (strength, route and anatomical location of administration were not reported).  No previous temperature excursion was reported.  No additional adverse event was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    No concomitant medication was reported.   Suspect product dosage text was reported as unknown.  The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions.  No treatment medication was reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.  This case contains information for patient 5 out of 16.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master case
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Arrhythmia, Bradycardia, Dizziness, Electrocardiogram, Heart rate decreased
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS), Bradycardia, Dizzy Spells, heart arrhythmia, lightheaded, rapid heartbeats, slow heartbeats.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Heart rate increased, Postural orthostatic tachycardia syndrome
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS), Bradycardia, Dizzy Spells, heart arrhythmia, lightheaded, rapid heartbeats, slow heartbeats.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia
Clinical narrative: Joint soreness in left hand (knuckle joints).  Appeared suddenly yesterday morning and still sore today.   I do not have arthritis.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: 3 days after shot, experienced lightheadedness, vertigo, nausea x 5 hours. Slowly got better over next 3 hours.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.     In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported.  This case was reported for patient 13th out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master Case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor. No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case is reported for patient 14 out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor. No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case is reported for patient 11 out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master case
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 39 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EW0151), in left arm, on 30Apr2021 as dose 2, single (Lot number: EW0167), in left arm and on 04Nov2021 as dose 3 (booster), single (Lot number: FFT8026), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received bnt162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of "COVID 19 Treatment" included Paxlovid from 29Aug2023 to 02Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 70 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: En6203), in left arm, on 18Mar2021 as dose 2, single (Lot number: Ep7534), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: FF2588), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Kidney Disease" (unspecified if ongoing), notes: Other medical history: Kidney Disease; "Known allergies: Shell Fish (enzyme)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures included Paxlovid from 25Aug2023 to 30Aug2023 were taken as a result of vaccination failure, covid-19.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: Sterile Water for Injection as the diluent of ACT-HIB instead of the 0.4% Sodium Chloride with no adverse event; Initial information received on 07-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2-months-old male patient who had sterile water for injection as the diluent of HIB (PRP/T) vaccine [ACT-HIB] instead of the 0.4% sodium chloride with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine inact 3V (vero) (IPOL) for Immunisation.  On 29-Aug-2023, the patient received 0.5 mL dose 1 of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (Strength: Standard; Frequency: Once) (batch number: UJ837AA; expiry date: unknown) via intramuscular route in the left vastus lateralis for Immunization with sterile water for injection as the diluent instead of the 0.4% sodium chloride with no adverse event (product preparation error) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diuretic therapy, Echocardiogram abnormal, Electrocardiogram, Feeding disorder
Clinical narrative: Severe chest pain after echocardiogram found fluid building up around my heart, this Continued and worsened over the next three months becoming so severe and painful that I could not even get a hug from my Children.  I prayed nightly that god grant me just one more day.  I could not Eat, I was slowly dying and I was forced to get this vaccine. My financial situation is horrible right now, I was not supported by my employer through this situation as  I was promised, only pressured to return to work despite my declining health status and my financial situation worsening
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fluid retention, General physical health deterioration, Loss of personal independence in daily activities, Pericardial effusion
Clinical narrative: Severe chest pain after echocardiogram found fluid building up around my heart, this Continued and worsened over the next three months becoming so severe and painful that I could not even get a hug from my Children.  I prayed nightly that god grant me just one more day.  I could not Eat, I was slowly dying and I was forced to get this vaccine. My financial situation is horrible right now, I was not supported by my employer through this situation as  I was promised, only pressured to return to work despite my declining health status and my financial situation worsening
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My mother got vaccinated for shingles, and still got it the same year/ Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced vaccination failure (Verbatim: My mother got vaccinated for shingles, and still got it the same year/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     The company considered the vaccination failure and shingles to be possibly related to Shingrix.   Additional Information: GSK Receipt date: 05-SEP-2023 This case was reported by consumer via interactive digital media. The reporter reported that he's mother got vaccinated for shingles and still got shingles the same year. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory details were unknown at a time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles (Verbatim: shingles).  The outcome of the shingles was not reported.   The reporter considered the shingles to be possibly related to Shingrix.     The company considered the shingles to be possibly related to Shingrix.   Additional Information: GSK Receipt date: 05-SEP-2023 This case was reported by consumer via interactive digital media. The reporter was a patient and reported that she got a shingles a week after she got vaccinated for it. The reporter reported that she found out it took more than a week for it to work. The reporter reported that she did not get it too bad though.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: touched the injected arm and said why did that hurt; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) (batch number Z3H93, expiry date 07-JUL-2024) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced pain in arm (Verbatim: touched the injected arm and said why did that hurt).  The outcome of the pain in arm was resolved.   The reporter considered the pain in arm to be related to Shingrix and Shingrix.     The company considered the pain in arm to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 05-SEP-2023 and 07-SEP-2023 The reporter is the patient.  She said she had both of her Shingrix shots and she indicated that she did not had any side effects.  She even indicated that she forgot that had the shot until one time she accidentally touched the injected arm and said why did that hurt and remembered about the injection but patient was not sure if the incident happened after the 1st or 2nd shot. The patient states she did not even know that she had it done then she touched the injected arm and go, why did that hurt, oh it's because she got the Shingrix. The reporter did not consent to follow up. This case was linked with case US2023121053 with same reporter.; Sender's Comments:  US-GSK-US2023121053:Same reporter, different patient
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vaccine have been administered to patients post excursion with no reported adverse event; Initial information received on 06-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age female patient who have been administered Diphtheria-2/Tetanus/5 AC Pertussis vaccine [Adacel] 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 12-Jun-2023, the patient received an unknown dose of 0.5 ml (frequency: once) of suspect Diphtheria-2/Tetanus/5 AC Pertussis vaccine Suspension for injection of standard strength of lot 2CA24C1 and expiry: 20-Dec-2024 via unknown route in unknown administration site for immunization, post excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.   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.  Additional information was received on 06-Sep-2023 from Consumer. Patient details, date of administration, clinical course updated and text amended accordingly. Case has become non valid to valid.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin abnormal, Lichen planus, Skin discolouration
Clinical narrative: After my last shot in November 2021 I did not notice a black mark on my left side of scalp till July 2022 after receiving a haircut.  The black mark begin to grow and move across and down my scalp. I did know what or where it was from. It kept moving till  it reached my facial skin just past my left side hairline.  I went to one dermatologist and wasn?t satisfied so I found another and the appointment was like 5 months out in May of 2023 .  The Dermatologist did a biopsy and found it was Lichen Planus .   They did  not tell me the cause. I just found on a Website that Lichen Planus could result from the vaccine.
Age: 71.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Computerised tomogram, Magnetic resonance imaging, Transient ischaemic attack
Clinical narrative: Within hours of receiving the vaccine I was diagnosed with what appears to have been a TIA.  During my subsequent neurologist appointment  he noted in his report the association between my TIA and vaccine is noteworthy since result testing and reporting, unlike COVID vaccines, is not available.
Age: 71.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Dizziness, Dyspnoea, Fatigue, Laboratory test normal, Transient ischaemic attack
Clinical narrative: Within hours of receiving the vaccine I was diagnosed with what appears to have been a TIA.  During my subsequent neurologist appointment  he noted in his report the association between my TIA and vaccine is noteworthy since result testing and reporting, unlike COVID vaccines, is not available.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, COVID-19
Clinical narrative: Presented to ED after leaving AMA from another hospital in which she was being treated for Covid but felt she was not receiving proper care; dx with Covid PTA on 1/26/22; previously rec'd antibiotics and ivermectin at other hospital; TX: Zithromax, Rocephin, lovenox and zinc; REmained on room air for hospitalization
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Asthenia, Atrial fibrillation, Body temperature increased, C-reactive protein increased
Clinical narrative: Presented to ED with fatigue, sore throat, gen weakness & cough: + Covid in ED: CXR: opacity in RL base, concerning for PNA; initially on room air; TX: startedon maxipime, rocephin, 12/19 Vit C, Zithromax, decadron, lovenox,   zinc added 12/21 pt worsened overnight with increasing O2 requirements and elevated temp; CRP up to 5.17; remdesivir added; O2 @ 2 LPM via NC 12/22 O2 @ 4 LPM; discussed Toci tx but pt declined; prone positioning ad lib; 12/24 O2 @ 5 LPM; CRP trending down (peaked as 12.81) 12/27 afib with RVR; Cardizem started; O2 @ 6 LPM; 12/28 NSR, 4 lpm O2 12/31 off supplemental O2; remains on room air; doing well