chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Got and adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Got and adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Got and adverse reaction). At the time of the report, VACCINATION COMPLICATION (Got and adverse reaction) outcome was unknown.            No concomitant medications were reported. No treatment information were reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: 0.25mL administered at the second dose of primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (0.25mL administered at the second dose of primary series) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 30-Dec-2021, the patient experienced UNDERDOSE (0.25mL administered at the second dose of primary series). On 30-Dec-2021, UNDERDOSE (0.25mL administered at the second dose of primary series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: neck swelling side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (neck swelling side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 SWELLING (neck swelling side effects). At the time of the report, SWELLING (neck swelling side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Road traffic accident
Clinical narrative: terrible car accident just after having the shots; This spontaneous case was reported by a consumer and describes the occurrence of ROAD TRAFFIC ACCIDENT (terrible car accident just after having the shots) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiovascular disease, unspecified (Cardiovascular disease), Small intestine carcinoma (cancer in the small intestines), Diabetes and Cancer (unspecified).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ROAD TRAFFIC ACCIDENT (terrible car accident just after having the shots). At the time of the report, ROAD TRAFFIC ACCIDENT (terrible car accident just after having the shots) outcome was unknown.            The patient had been taking a lot unspecified medicines for her maintenance medication.   The Moderna Booster shot was scheduled for the patient on 03-Jan-2022.  No treatment information was provided by the reporter.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest discomfort, Dyspnoea
Clinical narrative: heart has a lot of problems,; is like somebody is siting in his chest,; has troubling breathing.; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart has a lot of problems,), CHEST DISCOMFORT (is like somebody is siting in his chest,) and DYSPNOEA (has troubling breathing.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced CARDIAC DISORDER (heart has a lot of problems,), CHEST DISCOMFORT (is like somebody is siting in his chest,) and DYSPNOEA (has troubling breathing.). At the time of the report, CARDIAC DISORDER (heart has a lot of problems,), CHEST DISCOMFORT (is like somebody is siting in his chest,) and DYSPNOEA (has troubling breathing.) had not resolved.            No Concomitant product use was reported.  The patient received the Moderna booster and since the booster, the patient's heart had a lot of problems, and was like somebody was sitting in their chest, and had troubling breathing. Reportedly, it had been 10 days since the Booster.  No treatment information was provided.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A lot number with beyond used date of 31-Dec-2021 and one dose was given out of this lot; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A lot number with beyond used date of 31-Dec-2021 and one dose was given out of this lot) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A lot number with beyond used date of 31-Dec-2021 and one dose was given out of this lot). On 02-Jan-2022, EXPIRED PRODUCT ADMINISTERED (A lot number with beyond used date of 31-Dec-2021 and one dose was given out of this lot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Number of doses/vials: 1 dose was given; date the vial was initially stored in the refrigerator was 01-Dec-2021 and the vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Lichen planus
Clinical narrative: she developed Lichen Planus after she received the second dose; This spontaneous case was reported by a physician and describes the occurrence of LICHEN PLANUS (she developed Lichen Planus after she received the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LICHEN PLANUS (she developed Lichen Planus after she received the second dose). At the time of the report, LICHEN PLANUS (she developed Lichen Planus after she received the second dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment mediations were reported.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (experienced rash and hives all day after the booster shot that are itchy and red), ERYTHEMA (experienced rash and hives all day after the booster shot that are itchy and red), PRURITUS (experienced rash and hives all day after the booster shot that are itchy and red) and RASH (experienced rash and hives all day after the booster shot that are itchy and red) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (experienced rash and hives all day after the booster shot that are itchy and red), ERYTHEMA (experienced rash and hives all day after the booster shot that are itchy and red), PRURITUS (experienced rash and hives all day after the booster shot that are itchy and red) and RASH (experienced rash and hives all day after the booster shot that are itchy and red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK, as necessary. At the time of the report, URTICARIA (experienced rash and hives all day after the booster shot that are itchy and red), ERYTHEMA (experienced rash and hives all day after the booster shot that are itchy and red), PRURITUS (experienced rash and hives all day after the booster shot that are itchy and red) and RASH (experienced rash and hives all day after the booster shot that are itchy and red) had not resolved. Patient experienced the symptoms all day after the booster shot and the symptoms had flared up recently only in the evening. No concomitant medication were reported.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test negative, Vaccination site erythema
Clinical narrative: Redness around my vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness around my vaccination site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Previously administered products included for Product used for unknown indication: FLU on 03-Mar-2021. Past adverse reactions to the above products included No adverse event with FLU. Concomitant products included FLUTICASONE for Asthma, METOPROLOL, LOSARTAN and AMLODIPINE for Blood pressure, RIVAROXABAN for Paroxysmal atrial fibrillation, ALLOPURINOL, DOXAZOSIN, FISH OIL, OMEPRAZOLE, CYANOCOBALAMIN (VITAMIN B 12 LICHTENSTEIN) and MULTIVITAMIN & MINERAL for an unknown indication, CHOLECALCIFEROL.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 30-Nov-2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. In February 2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around my vaccination site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness around my vaccination site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 antibody test negative: negative (Negative) NEGATIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-402836, MOD-2021-402912 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: got their  ass kick pretty good, first couple of days,; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (got their  ass kick pretty good, first couple of days,) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced VACCINATION COMPLICATION (got their  ass kick pretty good, first couple of days,). At the time of the report, VACCINATION COMPLICATION (got their  ass kick pretty good, first couple of days,) outcome was unknown.            No Concomitant Drug details were reported.  No Treatment information was provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Experienced 2 strokes after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Experienced 2 strokes after vaccination) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Experienced 2 strokes after vaccination) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 14 days due to CEREBROVASCULAR ACCIDENT. The patient was treated with Surgery (Brain surgery) for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (Experienced 2 strokes after vaccination) outcome was unknown.            No concomitant medication was given. No treatment medication was given.   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Follow up received and contains no new information.; Sender's Comments: This case concerns a 57-year-old, male patient with no relevant medical history, who experienced the unexpected event of Cerebrovascular Accident. The event occurred at unspecified interval after the second dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Headache, Vaccination site mass, Vaccination site pain
Clinical narrative: Headache; lump at injection site; pain at injection site; Administration of an expired dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose), HEADACHE (Headache), VACCINATION SITE MASS (lump at injection site) and VACCINATION SITE PAIN (pain at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose). On an unknown date, the patient experienced HEADACHE (Headache), VACCINATION SITE MASS (lump at injection site) and VACCINATION SITE PAIN (pain at injection site). On 28-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose) had resolved. At the time of the report, HEADACHE (Headache), VACCINATION SITE MASS (lump at injection site) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.            Patient is on immunotherapy drugs.  No treatment information was provided.
Sex: F
Vaccine: MMR
Symptoms: Varicella
Clinical narrative: This spontaneous report was received from a consumer referring to herself as a child White female patient. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, route of administration, lot/batch # and expiration date were not reported) as prophylaxis. The patient reported that the vaccine she was gave was not good, but she never caught measles or mumps and only had 2 pock marks from chickenpox. The outcome of varicella was unknown. The reporter did not provide a causal assessment between varicella and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown).
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 18-Dec-2021 regarding an unsolicited valid Social Media non-serious case received  from a consumer/non-hcp.  This case involves a of unknown age and gender patient who experienced flu while receiving vaccine INFLUENZA VACCINE.   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 lot number not reported in unknown administration site for immunization.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported " after quitting vaccines I stopped getting the flu they're supposed to prevent ."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: got the flu; shot is not as effective; Initial information received on 21-Dec-2021 regarding an unsolicited valid Social Media serious case received from a patient.  This case involves unknown demographics patient who got the flu while receiving vaccine influenza vaccine.  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 (dose, formulation, strength, expiry date and lot number not reported via unknown route in unknown administration site) as prophylactic vaccination (Flu).  It seems the shot is not as effective (vaccination failure) several people that got flu shot got the flu (influenza). Not so great Several. Have gotten flu and they had shot; (unknown onset date and latency)  It was unknown if there were lab data/results available  Action taken with influenza vaccine was 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.  Seriousness criteria: medically significant for influenza and its symptom vaccination failure; Sender's Comments: Sanofi company comment dated 03-Jan-2022: This case involves unknown demographics patient who got the flu while receiving vaccine influenza vaccine. Case will be reevaluated post further update on concurrent condition during vaccination, underlying disease, laboratory investigations excluding alternative etiologies for the reported event, concomitant drug/ vaccine, which will preclude a comprehensive assessment of this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLU3
Symptoms: Illness
Clinical narrative: sick; Initial information received from on 25-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced sick while receiving vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].   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 USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  Action taken with INFLUENZA VACCINE TRIVALENT (FLUZONE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Unknown for the event sick.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: always gets the flu within a few days of the shot; Initial information received on 24-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a non-Healthcare Professional.  This case involves an unknown age female patient who always gets the flu within a few days of the shot while receiving vaccine INFLUENZA VACCINE.  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 (dose, formulation, strength, expiry date and lot number not reported via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "always gets the flu within a few days of the shot" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Never had the flu shot and never had the flu. The GF (girlfriend) is forced to get it at work and automatically schedules time off as she always gets the flu within a few days of the shot. She actually writes her prediction on the calendar."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (always gets the flu within a few days of the shot).  At time of reporting, the outcome was Unknown for the event always gets the flu within a few days of the shot.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 27-Dec-2021 regarding an unsolicited valid non-serious social media case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who experienced flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (with an unknown formulation, strength) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE..  It was reported" Never had the flu till I had a flu shot in 1970. Never again. It is unknown if patient's physician provided consent to be contacted It is unknown if the patient experienced any additional symptoms/events."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: Pharmacist received prescription to administer ACT-HIB to patient that is over 5 years of age - with no adverse event; Initial information received on 20-Dec-2021 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age female patient whose pharmacist received prescription to administer act-hib to patient that is over 5 years of age - with no adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].     The patient's past medical history included Paroxysmal nocturnal haemoglobinuria. The patient's past medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot number not reported, formulation not reported via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event, "pharmacist received prescription to administer act-hib to patient that is over 5 years of age - with no adverse event" (product prescribing error) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  It was reported, "Pharmacist states they received a prescription from a provider to administer the ACT-HIB vaccine to a patient. However the prescription is for an adult, and the pharmacist states they know the vaccine PI states 2 months through 5 years for the age range. The consumer has paroxysmal nocturnal hemoglobin urea and the ActHib was ordered for her but they haven't given it as yet. Consumer came back in today to get it but has left at the moment. Pharmacist has spoken with the doctor and is waiting for the script but will probably administer the injection."  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Pharmacist received prescription to administer ACT-HIB to patient that is over 5 years of age - with no adverse event).  At time of reporting, the outcome was Unknown for the event pharmacist received prescription to administer act-hib to patient that is over 5 years of age - with no 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: 15.0
Sex: M
Vaccine: IPV
Symptoms: Chest pain, Headache
Clinical narrative: complaining of intermittent chest pain and headache; complaining of intermittent chest pain and headache; Initial information received on 22-Dec-2021 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 15 years old male patient who was complaining of intermittent chest pain and headache, while receiving vaccine IPV (VERO) [IPOL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Prophylactic vaccination.  On 20-Dec-2021, the patient received a dose of suspect IPV (VERO) (lot U1A452M, expiry date:20-Feb-2023) via intramuscular route in unknown administration site for prophylactic vaccination.  On 22-DEC-2021 the patient developed a non-serious event "complaining of intermittent chest pain and headache" (chest pain) 2 days following the administration of IPV (VERO). On 22-DEC-2021 the patient developed a non-serious event "complaining of intermittent chest pain and headache" (headache) 2 days following the administration of IPV (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  It was not reported if the patient received a corrective treatment for the events (complaining of intermittent chest pain and headache, complaining of intermittent chest pain and headache).  At time of reporting, the outcome was Unknown for the event complaining of intermittent chest pain and headache and was Unknown for the event complaining of intermittent chest pain and headache.; Sender's Comments:  00908756:associated case
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: as they were administering the vaccine half of the product leaked out with no reported adverse event; needle broke off the syringe at the tip with no reported adverse event; Initial information received on 22-Dec-2021 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 77 years old male patient who experienced as they were administering the vaccine half of the product leaked out with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Dec-2021, the patient received 0.7mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJ766AA, expiry date: 30-Jun-2022  via intramuscular route in upper shoulder right administration site (formulation and strength not reported) as prophylactic vaccination. First time product used : Yes   On 22-DEC-2021 the patient developed a non-serious event "needle broke off the syringe at the tip with no reported adverse event "(needle issue) (latency same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On 22-DEC-2021 the patient developed a non-serious event "as they were administering the vaccine half of the product leaked out with no reported adverse event" (product leakage) (latency same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "Caller states that as she was administering the product the needle broke off the syringe at the tip. Caller states that more than half the product leaked out and at least three drops splashed onto the HCP's (healthcare professional) glasses"  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the events (needle broke off the syringe at the tip with no reported adverse event, as they were administering the vaccine half of the product leaked out with no reported adverse event).  At time of reporting, the outcome was Unknown for the event needle broke off the syringe at the tip with no reported adverse event and was Unknown for the event as they were administering the vaccine half of the product leaked out with no reported adverse event.
Sex: U
Vaccine: MNQ, TYP
Symptoms: No adverse event, Product storage error
Clinical narrative: Placed in the freezer mistakenly with no reported adverse event; Initial information received on 23-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a patient of unknown demographics who received vaccines TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] and placed in the freezer mistakenly 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 dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (with an unknown dose, route, frequency, formulation, strength) lot u6936aa in unknown administration site.  On an unknown date, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (with an unknown dose, route, frequency, formulation, strength) lot 1a671m in unknown administration site.  On an unknown date the patient developed a non-serious event "placed in the freezer mistakenly with no reported adverse event" (product storage error) (unknown latency) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and TYPHOID VI POLYSACCHARIDE VACCINE.  It was reported" Caller is requesting a temperature excursion for the following: menquadfi and Typhim Vi. Cause: Placed in the freezer mistakenly. Lowest Temp: frozen -5F Time exposed to temp: 15 hours Opened or Unopened products: unopened."  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) and TYPHOID VACCINE (TYPHIM VI) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Placed in the freezer mistakenly with no reported adverse event).  At time of reporting, the outcome was Unknown for the event placed in the freezer mistakenly 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: FLU4, FLUR4
Symptoms: Product storage error
Clinical narrative: temperature excursion occurred for a total of 86 hours and 30 minutes because the refrigerator was unplugged with no reported adverse event; Initial information received on 27-Dec-2021 regarding an unsolicited valid non-serious case received from a patient.  This case involves an unknown demographics patient who experienced (product temperature excursion issue), temperature excursion occurred for a total of 86 hours and 30 minutes because the refrigerator was unplugged with no reported adverse event while receiving vaccines INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and while treated with TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient started taking TUBERSOL (TUBERCULIN TEST) (dose, formulation and strength not reported via unknown route in unknown administration site; lot - C5804AA, expiry: 03-Feb-2023, 17-Mar-2023) for Tuberculin test. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot UJ724AA, expiry: 30-Jun-2022 and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJ759AD, expiry: 30-Jun-2022 via unknown route in unknown administration site (dose, formulation and strength not reported) as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "temperature excursion occurred for a total of 86 hours and 30 minutes because the refrigerator was unplugged with no reported adverse event" (product temperature excursion issue) (unknown latency) following the first dose intake of TUBERCULIN TEST, INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "Caller states that a temperature excursion occurred for a total of 86 hours and 30 minutes because the refrigerator was unplugged. The highest temperature reached was 70.0F(Fahrenheit). The products involved were unopened: FLUBLOK QUADRIVALENT, TUBERSOL, and FLUZONE HIGH-DOSE QUADRIVALENT. Caller asked for stability information for these products."  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV), TUBERCULIN TEST (TUBERSOL) and QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the event (temperature excursion occurred for a total of 86 hours and 30 minutes because the refrigerator was unplugged with no reported adverse event).  At time of reporting, the outcome was Unknown for the event temperature excursion occurred for a total of 86 hours and 30 minutes because the refrigerator was unplugged with no reported adverse event.
Age: 0.5
Sex: U
Vaccine: YF
Symptoms: Maternal exposure during breast feeding, No adverse event
Clinical narrative: This case involves a patient with unknown gender 6 month old who is currently breast feeding - with no reported adverse event while receiving vaccine YELLOW FEVER VACCINE [YF-VAX]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-Dec-2021, the patient received a dose of suspect YELLOW FEVER VACCINE - US lot number, expiry date and formulation was not reported via transmammary route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event "6 month old who is currently breast feeding - with no reported adverse event" (maternal exposure during breast feeding) (unknown latency) following the administration of YELLOW FEVER VACCINE. It was reported, "Nursing mother received YF vaccine on Dec 29, 2021". Action taken with YELLOW FEVER VACCINE (YF-VAX) was not applicable. It was not reported if the patient received a corrective treatment for the event (6 month old who is currently breast feeding - with no reported adverse event). At time of reporting, the outcome was Unknown for the event 6 month old who is currently breast feeding - with no reported adverse event.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory disorder, SARS-CoV-2 test negative
Clinical narrative: Febrile/respiratory illness, COVID antigen and PCR NEGATIVE.  Resolved after 1 week
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Complete cessation of menstruation. Prior to vaccine patient had regular, consistent menses. After vaccine, as of time of reporting menses has been absent for eight months.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Fatigue, Feeling cold, Headache
Clinical narrative: Vomiting day 2,  fever , body aches, headache. Fatigue .  Continued through day 3.  Day 4 in early AM.  Chest pain cold feeling. Taken to ER. diagnosis myocarditis. In ICU. 2 days.   Ongoing symptoms. Not recovered 100 %  yet
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Intensive care, Myocarditis, Pain, Pyrexia, Ultrasound scan
Clinical narrative: Vomiting day 2,  fever , body aches, headache. Fatigue .  Continued through day 3.  Day 4 in early AM.  Chest pain cold feeling. Taken to ER. diagnosis myocarditis. In ICU. 2 days.   Ongoing symptoms. Not recovered 100 %  yet
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting day 2,  fever , body aches, headache. Fatigue .  Continued through day 3.  Day 4 in early AM.  Chest pain cold feeling. Taken to ER. diagnosis myocarditis. In ICU. 2 days.   Ongoing symptoms. Not recovered 100 %  yet
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Bone contusion, COVID-19, Cough, Influenza A virus test negative
Clinical narrative: Tested positive for COVID-19. Initially went to see healthcare provider regarding an interesting rash on hands (small bumps/blisters) that started on 2021-12-20. Evening of 2021-12-21, developed a very small sore throat (ticklish). Tested positive with a rapid COVID-19 test. Developed a worsening cough and congestion over the next few days. Cough has persisted until 2021-01-02.  Lots of fluids, including warm water with honey and lemon. Used over-the-counter cough medicine the last few days. Cough has slightly lessened on 2021-01-03. As a result of constant coughing, ribs seem to be bruised and coughing can be painful.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza B virus test, Influenza virus test negative, Oropharyngeal pain, Rash, Respiratory syncytial virus test negative
Clinical narrative: Tested positive for COVID-19. Initially went to see healthcare provider regarding an interesting rash on hands (small bumps/blisters) that started on 2021-12-20. Evening of 2021-12-21, developed a very small sore throat (ticklish). Tested positive with a rapid COVID-19 test. Developed a worsening cough and congestion over the next few days. Cough has persisted until 2021-01-02.  Lots of fluids, including warm water with honey and lemon. Used over-the-counter cough medicine the last few days. Cough has slightly lessened on 2021-01-03. As a result of constant coughing, ribs seem to be bruised and coughing can be painful.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: Tested positive for COVID-19. Initially went to see healthcare provider regarding an interesting rash on hands (small bumps/blisters) that started on 2021-12-20. Evening of 2021-12-21, developed a very small sore throat (ticklish). Tested positive with a rapid COVID-19 test. Developed a worsening cough and congestion over the next few days. Cough has persisted until 2021-01-02.  Lots of fluids, including warm water with honey and lemon. Used over-the-counter cough medicine the last few days. Cough has slightly lessened on 2021-01-03. As a result of constant coughing, ribs seem to be bruised and coughing can be painful.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt was monitored after vaccine administration, after 20  minutes no adverse events were noted. Pt came in for TDap and mistakenly was given covid vaccine. I personally handled this patient at several instances, including adminsitering the vaccine. At both instances when addressing the fact that this was a  pfizer booster the pt acknowledged as though she understood. This vaccine was administered upon the form I was presented to give the vaccine as it was a covid vaccine form. I also checked database before administering the vaccine and it currently only shows the first 2 vaccines with the patient being eligible for the third. It was not till she left that she returned and mentioned she actually wanted the TDap vaccination. Pt was then given the correct shot. Pt had already recieved her booster, her most  recent dose was given on 09/02/21. There was no true adverse event here but there was an administration error.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram abnormal, Myocarditis
Clinical narrative: Suspected myocarditis after injection Currently having symptomatic 4:1 AV condition atrial fibrillation after vaccination pending further echocardiographic and holter evaluation and probable TEE- guided cardioversion
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Depressed level of consciousness, Fall, Pallor, Syncope
Clinical narrative: Pt received 1st pfizer covid vaccination. He was fine after I gave the immunization and then went to post immunization waiting area. Patient had family with but they went to cafe. I came back to pharmacy then patient fainted from chair and was caught by another patient sitting in the area. I came right outside as soon as this happened and pt was on ground. He felt clammy and looked pale. I asked him if he was awake and ok to assess situation if he was responsive and then he became alert and said he was ok. The pharmacy staff inside pharmacy was on phone with 911 but patient became alert and declined assistance from 911. we had him lay on floor for several minutes then got him into a chair and got him water. The family came back right after he fainted. Patient was ok after and store manager also filled out incident report for sams club. I advised before he left that he talk to his doctor before he would get the second dose of this vaccine to make sure they feel if he should receive second dose and to check if they want him to get this vaccine under dr supervision.
Age: 69.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLUA4
Symptoms: General physical health deterioration, Loss of consciousness, Memory impairment, Respiratory rate decreased
Clinical narrative: After she had both flu and Covid booster shots on the same day she had to rest for 2 days. After then her memory started to deteriorate. I took her to the ER on November27 where they did a battery of test and could find nothing wrong. Her condition continued to deteriorate over the next 3 weeks so I had her admitted to the Sarasota Memorial Hospital on Dec 17 . Again they could find nothing wrong and she was deteriorating rapidly She was moved to hospice on 27 Dec where she is now basically unconscious with very slow breathing.
Age: 69.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLUA4
Symptoms: Coma, Condition aggravated, Fatigue, Feeding disorder, Feeling abnormal
Clinical narrative: After she had both flu and Covid booster shots on the same day she had to rest for 2 days. After then her memory started to deteriorate. I took her to the ER on November27 where they did a battery of test and could find nothing wrong. Her condition continued to deteriorate over the next 3 weeks so I had her admitted to the Sarasota Memorial Hospital on Dec 17 . Again they could find nothing wrong and she was deteriorating rapidly She was moved to hospice on 27 Dec where she is now basically unconscious with very slow breathing.
Age: 69.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLUA4
Symptoms: Immunisation, Off label use, Product use issue, Thinking abnormal
Clinical narrative: After she had both flu and Covid booster shots on the same day she had to rest for 2 days. After then her memory started to deteriorate. I took her to the ER on November27 where they did a battery of test and could find nothing wrong. Her condition continued to deteriorate over the next 3 weeks so I had her admitted to the Sarasota Memorial Hospital on Dec 17 . Again they could find nothing wrong and she was deteriorating rapidly She was moved to hospice on 27 Dec where she is now basically unconscious with very slow breathing.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Pain, Peripheral swelling, Pruritus
Clinical narrative: Red swollen itchy ring on arm Headache Body aches
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Feeling abnormal, Vaccine positive rechallenge
Clinical narrative: Within a few days, I was having bone pain.  I have had this bone pain after the 1st and 2nd vaccines too.  I have NEVER had bone pain in my life ever. It's a strange feeling.    I still, 2 months later, sometimes wake up with bone pain, especially in my lower leg bones.   I wake up 1-2X a week with this pain.   I have no idea whether  it is causing lasting problems.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Eye pain, Headache, Nausea
Clinical narrative: Nausea, headache, stomach ache, fever, chills and sore eyes.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Nausea, headache, stomach ache, fever, chills and sore eyes.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fungal infection
Clinical narrative: I received my vaccination approximately a year ago. About a month later, I started having some kind of fungal reaction on about 50% of my body (groin, buttocks, head, back, legs and arms). 4 different doctors, but none have been able to diagnose my condition.