chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: off label use due to--inappropriate age for the product as per local labelling (with no reported adverse event); Initial information received on 31-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 years old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE and this condition is off label use due to--inappropriate age for the product as per local labelling (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 LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) both for Immunisation.  On 30-Sep-2022, the patient received 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test--0.5ml dose 5 of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (Strength: standard) (Frequency: once) (lot number: U7526AA) (expiry date: 07-sep-2024) via intramuscular route in the left deltoid for Immunization or TB skin test. and this condition is off label use due to--inappropriate age for the product as per local labelling (with no reported adverse event) (product administered to patient of inappropriate age) (latency: same day).   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 guidelines. 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: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: dose of acthib was given past the expiration date with no adverse event; Initial information was received on 01-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 15 months old female patient who stated dose of acthib was given past the expiration date with no adverse event after receiving haemophilus type B (HIB) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (Daptacel).  On 27-Jan-2023, the patient received 0.5 ml dose of suspect haemophilus type B (HIB) vaccine Powder and solvent for solution for injection (lot UJ584AAA, expiration date: 16-Oct-2022) (strength, frequency was unknown) via intramuscular route on left thigh for Immunization.  On 27-Jan-2023 the patient developed a non-serious event dose of acthib was given past the expiration date with no adverse event (expired product administered) same day following the administration of hib (prp/t) 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.  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: M
Vaccine: FLUC3
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case from was received on 31-Jan-2023 from other non-healthcare professional (patient's parent) via Communications (reference number: SEQW23-00423) with additional information received on 01-Feb-2023 via Med Communications (being processed together) and concerned a male patient of unreported age.   The patient's medical history and concomitant medication were not reported.  On an unspecified date in Jan-2020, the patient was vaccinated with Flucelvax Quadrivalent vaccine (influenza vaccine inact sag 4v; dose: 0.5ml, route of administration: intramuscular, anatomical location: not reported), for prevention of influenza. The batch number was not reported.  On an unspecified date in Jan-2020, unspecified time after receiving Flucelvax Quadrivalen, the patient experienced hives. As reported, the patient only symptom was hives and he was treated with Benadryl (Acrivastine). According to the reporter's (parent's) understanding, their doctor at that time did report that he had a reaction.  On an unspecified date in 2020, after about six weeks, the patient recovered from the event.   On an unspecifired date, the parents and their son moved to another state and had a new doctor who was concerned about him having another reaction. The parents were trying to find out what was in the flu shot to see what the patient may have reacted to before he gets his next set of vaccines.  The reporter assessed the event of hives as related to Flucelvax Quadrivalent. As reported, the patient reacted with hives for about six weeks and his only symptom was hives.  The case was assessed as non-serious.  Company comment: The events of hives is assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship.; Reporter's Comments: As reported, the patient reacted with hives for about six weeks and his only symptom was hives.; Sender's Comments: The events of hives is assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship.
Age: 66.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Rash
Clinical narrative: Swellin, itching, redness of the face that occurred 2 hours after the immunization
Age: 66.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swellin, itching, redness of the face that occurred 2 hours after the immunization
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bacterial test, Blood creatine phosphokinase normal, C-reactive protein normal, Electrocardiogram abnormal, Faecal calprotectin increased
Clinical narrative: My son received the vaccine on 01/02/2023 and started vomiting early morning of 01/04/2023. He had 2-3 more episodes of vomiting over the next few days and then the symptoms worsened severely on 01/10/2023 with multiple episodes of vomiting. Did not have diarrhea or fever. No runny nose or cough. Needed to be hospitalized from 01/11/2023 until 01/18/2023. His vomiting was resistant to all conventional treatments: Reglan, Zofran, Phenergan. He last vomited on 01/19/2023 and since then has been better. The doctors could not conclusively determine the cause of the vomiting. They were considering gastroparesis however could not perform the gastric emptying scan as my son would not tolerate eating a meal due to vomiting. They also considered cyclic vomiting syndrome but he did not have any previous attacks to clinically confirm this diagnosis. My son also started having severe calf pain in both legs and could not walk on 01/24/2023. We had to see his pediatrician the next day. Labs were normal. He eventually started walking and symptom free on 01/30/2023.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Full blood count normal, Gait disturbance, Lipase normal, Magnetic resonance imaging head normal, Metabolic function test
Clinical narrative: My son received the vaccine on 01/02/2023 and started vomiting early morning of 01/04/2023. He had 2-3 more episodes of vomiting over the next few days and then the symptoms worsened severely on 01/10/2023 with multiple episodes of vomiting. Did not have diarrhea or fever. No runny nose or cough. Needed to be hospitalized from 01/11/2023 until 01/18/2023. His vomiting was resistant to all conventional treatments: Reglan, Zofran, Phenergan. He last vomited on 01/19/2023 and since then has been better. The doctors could not conclusively determine the cause of the vomiting. They were considering gastroparesis however could not perform the gastric emptying scan as my son would not tolerate eating a meal due to vomiting. They also considered cyclic vomiting syndrome but he did not have any previous attacks to clinically confirm this diagnosis. My son also started having severe calf pain in both legs and could not walk on 01/24/2023. We had to see his pediatrician the next day. Labs were normal. He eventually started walking and symptom free on 01/30/2023.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Oesophagogastroduodenoscopy normal, Pain in extremity, Procalcitonin normal, Red blood cell sedimentation rate normal, Sinus bradycardia
Clinical narrative: My son received the vaccine on 01/02/2023 and started vomiting early morning of 01/04/2023. He had 2-3 more episodes of vomiting over the next few days and then the symptoms worsened severely on 01/10/2023 with multiple episodes of vomiting. Did not have diarrhea or fever. No runny nose or cough. Needed to be hospitalized from 01/11/2023 until 01/18/2023. His vomiting was resistant to all conventional treatments: Reglan, Zofran, Phenergan. He last vomited on 01/19/2023 and since then has been better. The doctors could not conclusively determine the cause of the vomiting. They were considering gastroparesis however could not perform the gastric emptying scan as my son would not tolerate eating a meal due to vomiting. They also considered cyclic vomiting syndrome but he did not have any previous attacks to clinically confirm this diagnosis. My son also started having severe calf pain in both legs and could not walk on 01/24/2023. We had to see his pediatrician the next day. Labs were normal. He eventually started walking and symptom free on 01/30/2023.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ultrasound abdomen normal, Urinary system X-ray, Vomiting, X-ray gastrointestinal tract normal
Clinical narrative: My son received the vaccine on 01/02/2023 and started vomiting early morning of 01/04/2023. He had 2-3 more episodes of vomiting over the next few days and then the symptoms worsened severely on 01/10/2023 with multiple episodes of vomiting. Did not have diarrhea or fever. No runny nose or cough. Needed to be hospitalized from 01/11/2023 until 01/18/2023. His vomiting was resistant to all conventional treatments: Reglan, Zofran, Phenergan. He last vomited on 01/19/2023 and since then has been better. The doctors could not conclusively determine the cause of the vomiting. They were considering gastroparesis however could not perform the gastric emptying scan as my son would not tolerate eating a meal due to vomiting. They also considered cyclic vomiting syndrome but he did not have any previous attacks to clinically confirm this diagnosis. My son also started having severe calf pain in both legs and could not walk on 01/24/2023. We had to see his pediatrician the next day. Labs were normal. He eventually started walking and symptom free on 01/30/2023.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Dyspnoea, Headache, Insomnia, Musculoskeletal stiffness
Clinical narrative: Severe muscle and joint pain, stiff neck, bad headache, difficulty with breathing and required double the dose of asthma medication (inhaler) at every 2 hours or less. Unable to stay asleep, and more urination than normal.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Urine output increased
Clinical narrative: Severe muscle and joint pain, stiff neck, bad headache, difficulty with breathing and required double the dose of asthma medication (inhaler) at every 2 hours or less. Unable to stay asleep, and more urination than normal.
Age: 21.0
Sex: M
Vaccine: TYP
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Pt reported to clinic with complaints of rash and itching to arms, legs, and back that started less than 24 hours after receiving typhoid immunization. He also reported redness to neck and face this morning that had faded by the time he reported to clinic. Pt was given Benadryl 25 mg PO x 6 capsules. Instructed to return to clinic if symptoms worsen. Typhoid vaccine added to list of allergies.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: diffuse hair loss; This case was reported by a consumer via call center representative and described the occurrence of hair loss in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingrix. In December 2022, between 1 and 3 months after receiving Shingrix, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was not recovered/not resolved.   It was unknown if the reporter considered the hair loss to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-Jan-2023 Reporter's Comments: This case was self reported by the patient. The patient received the dose of Shingrix vaccine in the left arm. The patient experienced diffuse hair loss.  The patient was still experiencing the hair loss.  The reporter did not consent to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Loss of consciousness, Pulmonary thrombosis, Thrombosis
Clinical narrative: BLOOD CLOT IN THE LEG; PASSED OUT; BLOOD CLOT IN LUNGS; This spontaneous report received from a consumer (parent) concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, administered on an unspecified date in 2022 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in JAN-2023, the patient experienced blood clot in the leg that went to his lungs (blood clot in lungs) and later, he had passed out and was taken to the hospital. In the hospital they performed laboratory tests and found blood clot in lungs for which they had done emergency surgery within a couple of hours and later many more laboratory tests were performed and found blood clot had started in his leg. The patient had taken thinners as treatment medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in the leg, passed out and blood clot in lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230200683 -blood clot in the leg. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  20230200683- passed out. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.  20230200683 -blood clot in lungs. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid; Vaccine does not work; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Covid) and VACCINATION FAILURE (Vaccine does not work) in a 4-decade-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced COVID-19 (Covid) and VACCINATION FAILURE (Vaccine does not work). At the time of the report, COVID-19 (Covid) and VACCINATION FAILURE (Vaccine does not work) outcome was unknown.            The patient was in 30s.  It was reported that patient not took any medication. No concomitant medications were reported. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-706221 (E2B Linked Report).; Reporter's Comments: This spontaneous case concerns a 4-decade-old female patient, with no medical reported who experienced the unexpected events of Covid-19 and vaccination failure approximately 3 months after a dose of  mRNA- 1273 bivalent vaccine. We have no information about primary schedule, events after them and outcome of the event. The benefit-risk relationship of mRNA-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706221:Husband case
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid-19) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19. Previously administered products included for COVID-19 prophylaxis: moderna covid-19 vaccine; for COVID-19 vaccination: COVID-19 Vaccine (booster 1) and COVID-19 Vaccine (booster 2). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine, COVID-19 Vaccine and moderna covid-19 vaccine.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2022, the patient experienced COVID-19 (covid-19). At the time of the report, COVID-19 (covid-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Patient had the vaccinations and two boosters already. Patient received her last booster, but it was the regular one. Patient had Covid before (date unknown) and then the second time in Nov-2022.   No treatment details were reported.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; We gave a patient 1 dose of Moderna Covid-19 vaccine Bivalent BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave a patient 1 dose of Moderna Covid-19 vaccine Bivalent BUD) and NO ADVERSE EVENT (No adverse event) in a 79-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave a patient 1 dose of Moderna Covid-19 vaccine Bivalent BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave a patient 1 dose of Moderna Covid-19 vaccine Bivalent BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave a patient 1 dose of Moderna Covid-19 vaccine Bivalent BUD).    Concomitant medication was not provided. Treatment medication information was not provided by the reporter
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got flu last week with flu shot only 1 day horrible day then I was alright; Initial information received on 30-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced i got flu last week with flu shot only 1 day horrible day then i was alright after receiving vaccine influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor 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 influenza vaccine produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed i got flu last week with flu shot only 1 day horrible day then i was alright (influenza) (unknown latency)   It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event  At time of reporting, the outcome was recovered for the event
Age: 1.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient was administered the diluent only, with no reported adverse event; only gave the diluent of PENTACEL, with no reported adverse event; Initial information received on 31-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 months old female "patient who was administered with the diluent only, with no reported adverse event" and "only gave the diluent of pentacel, with no reported adverse event" after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  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 VACCIN) for Immunization.  On 16-Nov-2022, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U7311AA) via unknown route in the left thigh (expiry date, strength, form: unknown) for prophylactic vaccination.  On an unknown date the patient was administered the diluent only, with no reported adverse event (single component of a two-component product administered) and only gave the diluent of pentacel, with no reported adverse event(product preparation error)  (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for both the events.   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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: U
Vaccine: FLUR3
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok was given to 6 months old patient with no reported adverse event; Initial information received on 31-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old and unknown gender patient where Flublok was given to 6 months old patient with no reported adverse event while receiving vaccine influenza quadrivalent recombinant vaccine [Flublok].  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrivalent recombinant vaccine in unknown administration site (dose, frequency, route, formulation, strength, lot/batch number and expiration date and indication: not provided) as immunization.  On an unknown date the Flublok was given to 6 months old patient with no reported adverse event (product administered to patient of inappropriate age) (unknown latency) following the administration of influenza quadrivalent recombinant vaccine.  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event inappropriate age at vaccine administration 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.; Sender's Comments:  01435784:
Age: 63.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2nd dose late; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received HAB (Twinrix) (batch number H3SG9, expiry date 3rd January 2025) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (on an unknown date received 1st dose).   On 26th January 2023, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 26th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's Comment: The nurse reported that the patient received a late 2nd dose of Twinrix as she received this dose more than 9 months after the 1st dose. At the moment of the call, the HCP called to request information about an alternative schedule for the vaccine, so 3rd dose was still not given. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 19-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered).    Concomitant medication was not provided.  It was reported that patient was administered with the Moderna vaccine which was beyond the 30 day beyond use date. The beyond use date of lot 023H22A was 15-Dec-2022.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2023: Upon internal review on 03-Feb-2023, significant correction was performed to update Suspect product start date,  dose, units, lot number, expiration date, event start date and narrative description. On 24-Jan-2023: Live Significant follow up ; Patient information updated, vaccinations details updated On 24-Jan-2023: Live Non-significant follow up On 27-Jan-2023: Follow-up received contains non significant information. Narrative was updated. On 01-Feb-2023: Follow-up  received, updated non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Dose of Moderna Covid-19 Vaccine (Monovalent) was administered post excursion; Dose of Moderna Covid-19 Vaccine (Monovalent) was administered post excursion; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose of Moderna Covid-19 Vaccine (Monovalent) was administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Dose of Moderna Covid-19 Vaccine (Monovalent) was administered post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose of Moderna Covid-19 Vaccine (Monovalent) was administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Dose of Moderna Covid-19 Vaccine (Monovalent) was administered post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose of Moderna Covid-19 Vaccine (Monovalent) was administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Dose of Moderna Covid-19 Vaccine (Monovalent) was administered post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: It made my tummy hurt
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Patient experienced chills, dizziness, lightheadedness, sweating, nausea. Patient lied down flat on chair bed with legs elevated. Water was given since patient asked for it. After 20 minutes, she felt much better and can walk on her own. She said she is fine and her relative will drive her home.
Age: 9.0
Sex: M
Vaccine: TYP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site swelling, Thrombosis
Clinical narrative: Site: Swelling at Injection Site-Mild, Additional Details: patient had a blood clot on 01/12/2023
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Patient stated the pain in her arm still exists from the vaccine
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 92.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Contracted COVID despite receiving COVID vaccination-pt states vaccination but she could not remember date.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Contracted COVID despite having vax-pt could not remember vax date.
Age: 37.0
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Contracted covid despite vax-pt could not remember vax date.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness, Syncope
Clinical narrative: DIZZINESS & FAINTING
Sex: M
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Got covid, was vax'd-pt doesn't remember date of vax
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 3/23/21, 4/20/21, 11/23/21. Positive on 2/2/23
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 3/3/21, 3/24/21, 12/3/21. Positive on 2/1/23.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Asthenia, COVID-19, Confusional state
Clinical narrative: 71-year-old female who presents to the emergency department by ambulance for weakness and tingling to hands and feet.  Patient was seen 1 week ago in the emergency department for abdominal pain and she was diagnosed with a UTI at that time, she was put on Keflex.  Her sister and her son had noticed that she is not taking her medication and 2 days ago they restarted her Keflex and she denies any urinary symptoms at this time.  Patient states that she has had some abdominal bloating, she is a former heavy drinker and stopped drinking around Christmas time.  In a prior note she has had these paresthesias to her hands and legs over the last week so this is not a new complaint.  Patient is a smoker and past surgical history is tonsillectomy.  She states that she has not walked in the last several days because of the paresthesias in her feet and she feels too weak to get out of the chair, she is only drinking Ensure for nutrition.  Her son lives out of town and he is here today very concerned that she is not able to take care of herself.  She is also had some intermittent confusion over the last several weeks. Associated Symptoms: cough, fatigue, weakness
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Ex-alcohol user, Fatigue, Gait disturbance, Impaired self-care
Clinical narrative: 71-year-old female who presents to the emergency department by ambulance for weakness and tingling to hands and feet.  Patient was seen 1 week ago in the emergency department for abdominal pain and she was diagnosed with a UTI at that time, she was put on Keflex.  Her sister and her son had noticed that she is not taking her medication and 2 days ago they restarted her Keflex and she denies any urinary symptoms at this time.  Patient states that she has had some abdominal bloating, she is a former heavy drinker and stopped drinking around Christmas time.  In a prior note she has had these paresthesias to her hands and legs over the last week so this is not a new complaint.  Patient is a smoker and past surgical history is tonsillectomy.  She states that she has not walked in the last several days because of the paresthesias in her feet and she feels too weak to get out of the chair, she is only drinking Ensure for nutrition.  Her son lives out of town and he is here today very concerned that she is not able to take care of herself.  She is also had some intermittent confusion over the last several weeks. Associated Symptoms: cough, fatigue, weakness
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Paraesthesia, SARS-CoV-2 test positive, Treatment noncompliance, Urinary tract infection
Clinical narrative: 71-year-old female who presents to the emergency department by ambulance for weakness and tingling to hands and feet.  Patient was seen 1 week ago in the emergency department for abdominal pain and she was diagnosed with a UTI at that time, she was put on Keflex.  Her sister and her son had noticed that she is not taking her medication and 2 days ago they restarted her Keflex and she denies any urinary symptoms at this time.  Patient states that she has had some abdominal bloating, she is a former heavy drinker and stopped drinking around Christmas time.  In a prior note she has had these paresthesias to her hands and legs over the last week so this is not a new complaint.  Patient is a smoker and past surgical history is tonsillectomy.  She states that she has not walked in the last several days because of the paresthesias in her feet and she feels too weak to get out of the chair, she is only drinking Ensure for nutrition.  Her son lives out of town and he is here today very concerned that she is not able to take care of herself.  She is also had some intermittent confusion over the last several weeks. Associated Symptoms: cough, fatigue, weakness
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: 71-year-old female who presents to the emergency department by ambulance for weakness and tingling to hands and feet.  Patient was seen 1 week ago in the emergency department for abdominal pain and she was diagnosed with a UTI at that time, she was put on Keflex.  Her sister and her son had noticed that she is not taking her medication and 2 days ago they restarted her Keflex and she denies any urinary symptoms at this time.  Patient states that she has had some abdominal bloating, she is a former heavy drinker and stopped drinking around Christmas time.  In a prior note she has had these paresthesias to her hands and legs over the last week so this is not a new complaint.  Patient is a smoker and past surgical history is tonsillectomy.  She states that she has not walked in the last several days because of the paresthesias in her feet and she feels too weak to get out of the chair, she is only drinking Ensure for nutrition.  Her son lives out of town and he is here today very concerned that she is not able to take care of herself.  She is also had some intermittent confusion over the last several weeks. Associated Symptoms: cough, fatigue, weakness
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Blood test, Cardiac function test, Feeling abnormal, Imaging procedure
Clinical narrative: Beginning 26 hours after his vaccine,  on 2/15/2021 around 3:30 pm he was at work and had to leave because he felt bad.  Somehow he drove home .  I am his wife and when I saw him try to exit his car in our driveway,  I thought it looked like a stroke.  I called the ER and drove  to the ER.   He could no longer speak any recognizable words.  We arrived just after 4:00 pm approx.   The Care crew of  professionals in the ER were there immediatley .  They worked with him for maybe an hour or so, while I was in the waiting room.   They brought me into see him who had almost totally recovered his speech. They were all so happy that we had arrived in time for there to be this meaningful recovery.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Transient ischaemic attack
Clinical narrative: Beginning 26 hours after his vaccine,  on 2/15/2021 around 3:30 pm he was at work and had to leave because he felt bad.  Somehow he drove home .  I am his wife and when I saw him try to exit his car in our driveway,  I thought it looked like a stroke.  I called the ER and drove  to the ER.   He could no longer speak any recognizable words.  We arrived just after 4:00 pm approx.   The Care crew of  professionals in the ER were there immediatley .  They worked with him for maybe an hour or so, while I was in the waiting room.   They brought me into see him who had almost totally recovered his speech. They were all so happy that we had arrived in time for there to be this meaningful recovery.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute kidney injury, Asthenia, COVID-19, COVID-19 pneumonia, Confusional state
Clinical narrative: Discharge Provider: MD Primary Care Provider: DO Admission Date: 1/30/2023 Discharge Date: Feb 1, 2023  PRESENTING PROBLEM: Acute kidney injury [N17.9] COVID [U07.1] Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: Patient is a 77 y.o. male with past medical history significant for nonischemic cardiomyopathy, afib, HTN, right AKA presented to the ED with generalized weakness and some confusion. His wife was diagnosed with COVID and he has been having a cough and subjective fever. Given his symptoms and inability to get adequate care by his wife due to her COVID and assistants were not traveling to the house with their COVID, he presented to the ER for further evaluation.   He remained stable and did not require supplemental oxygen for his COVID. Workup was negative for alternative diagnoses. He worked with PT/OT who had some limited assessment as his prosthesis was at home, but ultimately recommended SNF. After discussion with family he previously did not do well with SNF as they could not meet his needs and therefore they wanted him to return home when stable. His wife felt able to meet his needs at this time as she feels recovered from COVID. CM able to arrange transport, and he was discharged home in stable condition on 2/1/23.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Exposure to SARS-CoV-2, Laboratory test normal, Pyrexia
Clinical narrative: Discharge Provider: MD Primary Care Provider: DO Admission Date: 1/30/2023 Discharge Date: Feb 1, 2023  PRESENTING PROBLEM: Acute kidney injury [N17.9] COVID [U07.1] Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: Patient is a 77 y.o. male with past medical history significant for nonischemic cardiomyopathy, afib, HTN, right AKA presented to the ED with generalized weakness and some confusion. His wife was diagnosed with COVID and he has been having a cough and subjective fever. Given his symptoms and inability to get adequate care by his wife due to her COVID and assistants were not traveling to the house with their COVID, he presented to the ER for further evaluation.   He remained stable and did not require supplemental oxygen for his COVID. Workup was negative for alternative diagnoses. He worked with PT/OT who had some limited assessment as his prosthesis was at home, but ultimately recommended SNF. After discussion with family he previously did not do well with SNF as they could not meet his needs and therefore they wanted him to return home when stable. His wife felt able to meet his needs at this time as she feels recovered from COVID. CM able to arrange transport, and he was discharged home in stable condition on 2/1/23.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Injection site pain, SARS-CoV-2 test positive
Clinical narrative: I had a little tenderness at the injection site after receiving the vaccine for a few days. I was exposed to COVID-19 while visiting a friend in the hospital. The hospital had about 42 positive cases. I tested positive for COVID-19 on 10/25/2022. This was my third time having COVID-19 so I took over the counter medication. I did contact my doctor, but I was doing what I needed to do to get better. I didn't have as much fear this time because I knew what to expect.
Age: 52.0
Sex: F
Vaccine: COVID19, PNC15
Symptoms: Blood bicarbonate decreased, Blood glucose increased, Blood ketone body increased, Blood pH decreased, COVID-19
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: MD  Admission Date: 1/30/2023 Discharge Date: ?2/1/2023   PRESENTING PROBLEM: DKA, type 1, not at goal  Diabetic ketoacidosis without coma associated with type 1 diabetes mellitus COVID-19    HOSPITAL COURSE: Patient is a 53-year-old woman with complex past medical history including type 1 diabetes with insulin pump, combined heart failure, hypertension, atrial fibrillation, coronary artery disease status post stenting who presented with 2 weeks of upper respiratory infection symptoms and difficulty monitoring her blood sugars.  Patient's Dexcom meter malfunctioned and she did not have any more sensors at home.  She was unable to refill the sensors early.  She still continued to use her insulin pump, but was unable to check sugars at all because her home fingerstick glucometer was out of batteries.  She stated that life was busy lately and she did not have time to get batteries for the glucometer.  When she presented to the emergency department her blood glucose was 525, pH was 7.07, beta hydroxybutyrate greater than 9, and bicarbonate of 7. She was found to be COVID positive.  Patient was admitted to the intensive care unit for insulin drip.  She required electrolyte replacement on the drip and was also given IV fluids.  Patient was taken off the insulin drip and transitioned to subcutaneous Lantus 15 units in the early afternoon on 01/31.  Her blood sugars remained well controlled and by the following day she was feeling well. She was set up with a new glucometer and discharged on basal bolus insulin. She has an appointment with her endocrinologist next week and was encouraged to keep that appointment and to follow up with her PCP after discharge. The patient verbalized understanding of these instructions and discharged home in stable condition.