chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sinus disorder, Visual impairment
Clinical narrative: vision disturbances/vision problems; couldn't focus; feeling flu-ish under the weather; not feeling well; headaches; This spontaneous case was reported by a patient and describes the occurrence of VISUAL IMPAIRMENT (vision disturbances/vision problems), VISION BLURRED (couldn't focus), INFLUENZA LIKE ILLNESS (feeling flu-ish under the weather), MALAISE (not feeling well) and HEADACHE (headaches) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003b84h) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy, Thyroid disorder (was irradiated when he was in his 20s) and Type 2 diabetes mellitus (border line type 2 diabetic). Concomitant products included GABAPENTIN for Neuropathy, LEVOTHYROXINE SODIUM (SYNTHYROID) for Thyroid disorder.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (vision disturbances/vision problems), VISION BLURRED (couldn't focus), INFLUENZA LIKE ILLNESS (feeling flu-ish under the weather), MALAISE (not feeling well) and HEADACHE (headaches). At the time of the report, VISUAL IMPAIRMENT (vision disturbances/vision problems), VISION BLURRED (couldn't focus), INFLUENZA LIKE ILLNESS (feeling flu-ish under the weather), MALAISE (not feeling well) and HEADACHE (headaches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was stated that with the first two vaccines, patient had some vision problems, vision disturbances, could not focus, not feeling well, feeling flu-ish under the weather and headaches for a few days, but they went away. No treatment information was reported.   This case was linked to MOD-2022-672439, MOD-2021-161677 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Influenza like illness, Malaise, Vision blurred, Visual impairment
Clinical narrative: vision disturbances/vision problems; couldn't focus; feeling flu-ish under the weather; not feeling well; headaches; This spontaneous case was reported by a patient and describes the occurrence of VISUAL IMPAIRMENT (vision disturbances/vision problems), VISION BLURRED (couldn't focus), INFLUENZA LIKE ILLNESS (feeling flu-ish under the weather), MALAISE (not feeling well) and HEADACHE (headaches) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003b84h) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy, Thyroid disorder (was irradiated when he was in his 20s) and Type 2 diabetes mellitus (border line type 2 diabetic). Concomitant products included GABAPENTIN for Neuropathy, LEVOTHYROXINE SODIUM (SYNTHYROID) for Thyroid disorder.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (vision disturbances/vision problems), VISION BLURRED (couldn't focus), INFLUENZA LIKE ILLNESS (feeling flu-ish under the weather), MALAISE (not feeling well) and HEADACHE (headaches). At the time of the report, VISUAL IMPAIRMENT (vision disturbances/vision problems), VISION BLURRED (couldn't focus), INFLUENZA LIKE ILLNESS (feeling flu-ish under the weather), MALAISE (not feeling well) and HEADACHE (headaches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was stated that with the first two vaccines, patient had some vision problems, vision disturbances, could not focus, not feeling well, feeling flu-ish under the weather and headaches for a few days, but they went away. No treatment information was reported.   This case was linked to MOD-2022-672439, MOD-2021-161677 (Patient Link).
Age: 12.0
Sex: M
Vaccine: FLUA4, HPV9, FLUC3, HPV9
Symptoms: Syncope
Clinical narrative: Syncope; This spontaneous case was retrieved on 10-Nov-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2489803-1), reported by other healthcare professional and concerned a 12-year-old, male patient.  The patient's medical history and concomitant medications were not reported.   It was reported that on 24-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 'one', route of administration: intramuscular (IM), anatomical location: right arm (RA), indication: not reported). The batch number reported was 348362. The reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect product Fluad Quadrivalent. Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On the same date, the patient was vaccinated with non-company co-suspect Gardasil 9 (hpv vaccine vlp rl1 9v (yeast); dose: reported as 'two', route of administration: intramuscular (IM), anatomical location: left arm (LA), indication: not reported). The batch number reported was U038662.  On the same date, five and a half hours after receiving Flucelvax Quadrivalent and co-suspect Gardasil 9, the patient experienced syncope.   On 25-Oct-2022, the patient had an ordered electrocardiogram (EKG), however, the results were not provided.   At the time of initial reporting, the patient had not recovered from the event of syncope.   The reporter did not provide a causality assessment.  The event of syncope was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 12-year-old, male patient was vaccinated with the Flucelvax Quadrivalent and non-company co-suspect Gardasil 9 vaccine. Five and a half hours after vaccination, the patient experienced syncope. The patient had an ordered electrocardiogram (EKG), however, the results were not provided. The patient's medical history and concomitant medications were not reported. Causality was confounded by concurrent administration of co-suspect vaccine. Causal role of the suspect vaccine is assessed as possibly related, with the currently available information and plausible temporal relationship.; Sender's Comments: A 12-year-old, male patient was vaccinated with the Flucelvax Quadrivalent and non-company co-suspect Gardasil 9 vaccine. Five and a half hours after vaccination, the patient experienced syncope. The patient had an ordered electrocardiogram (EKG), however, the results were not provided. The patient's medical history and concomitant medications were not reported. Causality was confounded by concurrent administration of co-suspect vaccine. Causal role of the suspect vaccine is assessed as possibly related, with the currently available information and plausible temporal relationship.
Age: 12.0
Sex: M
Vaccine: FLUA4, HPV9, FLUC3, HPV9
Symptoms: Electrocardiogram, Syncope
Clinical narrative: Syncope; This spontaneous case was retrieved on 10-Nov-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2489803-1), reported by other healthcare professional and concerned a 12-year-old, male patient.  The patient's medical history and concomitant medications were not reported.   It was reported that on 24-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 'one', route of administration: intramuscular (IM), anatomical location: right arm (RA), indication: not reported). The batch number reported was 348362. The reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect product Fluad Quadrivalent. Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On the same date, the patient was vaccinated with non-company co-suspect Gardasil 9 (hpv vaccine vlp rl1 9v (yeast); dose: reported as 'two', route of administration: intramuscular (IM), anatomical location: left arm (LA), indication: not reported). The batch number reported was U038662.  On the same date, five and a half hours after receiving Flucelvax Quadrivalent and co-suspect Gardasil 9, the patient experienced syncope.   On 25-Oct-2022, the patient had an ordered electrocardiogram (EKG), however, the results were not provided.   At the time of initial reporting, the patient had not recovered from the event of syncope.   The reporter did not provide a causality assessment.  The event of syncope was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 12-year-old, male patient was vaccinated with the Flucelvax Quadrivalent and non-company co-suspect Gardasil 9 vaccine. Five and a half hours after vaccination, the patient experienced syncope. The patient had an ordered electrocardiogram (EKG), however, the results were not provided. The patient's medical history and concomitant medications were not reported. Causality was confounded by concurrent administration of co-suspect vaccine. Causal role of the suspect vaccine is assessed as possibly related, with the currently available information and plausible temporal relationship.; Sender's Comments: A 12-year-old, male patient was vaccinated with the Flucelvax Quadrivalent and non-company co-suspect Gardasil 9 vaccine. Five and a half hours after vaccination, the patient experienced syncope. The patient had an ordered electrocardiogram (EKG), however, the results were not provided. The patient's medical history and concomitant medications were not reported. Causality was confounded by concurrent administration of co-suspect vaccine. Causal role of the suspect vaccine is assessed as possibly related, with the currently available information and plausible temporal relationship.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, COVID-19, Inappropriate schedule of product administration, Malaise, Pruritus
Clinical narrative: few hours of lethargy the day after the second dose; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (few hours of lethargy the day after the second dose) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Pregnant (third child), Psoriasis and AFib. Previously administered products included for AFib: Pradaxa (blood thinner). Past adverse reactions to the above products included No adverse event with Pradaxa. Concurrent medical conditions included Blood pressure high.   In January 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced LETHARGY (few hours of lethargy the day after the second dose). At the time of the report, LETHARGY (few hours of lethargy the day after the second dose) outcome was unknown.            No concomitant medication was provided by the reporter.  It was reported that when patient was 24 and pregnant with third child, patient developed a patch Of psoriasis on the nape Of neck and an annoying patch in pubic area. Those two spots remained until patient was 74,at which time patient was put on a blood thinner (Pradaxa) due to AFib, Following the introduction to the blood thinner, overnight the psoriasis disappeared.   No treatment medication was provided by the reporter.   This case was linked to MOD-2022-662620 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Psoriasis, SARS-CoV-2 test, Sunburn
Clinical narrative: few hours of lethargy the day after the second dose; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (few hours of lethargy the day after the second dose) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Pregnant (third child), Psoriasis and AFib. Previously administered products included for AFib: Pradaxa (blood thinner). Past adverse reactions to the above products included No adverse event with Pradaxa. Concurrent medical conditions included Blood pressure high.   In January 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced LETHARGY (few hours of lethargy the day after the second dose). At the time of the report, LETHARGY (few hours of lethargy the day after the second dose) outcome was unknown.            No concomitant medication was provided by the reporter.  It was reported that when patient was 24 and pregnant with third child, patient developed a patch Of psoriasis on the nape Of neck and an annoying patch in pubic area. Those two spots remained until patient was 74,at which time patient was put on a blood thinner (Pradaxa) due to AFib, Following the introduction to the blood thinner, overnight the psoriasis disappeared.   No treatment medication was provided by the reporter.   This case was linked to MOD-2022-662620 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy
Clinical narrative: few hours of lethargy the day after the second dose; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (few hours of lethargy the day after the second dose) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Pregnant (third child), Psoriasis and AFib. Previously administered products included for AFib: Pradaxa (blood thinner). Past adverse reactions to the above products included No adverse event with Pradaxa. Concurrent medical conditions included Blood pressure high.   In January 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced LETHARGY (few hours of lethargy the day after the second dose). At the time of the report, LETHARGY (few hours of lethargy the day after the second dose) outcome was unknown.            No concomitant medication was provided by the reporter.  It was reported that when patient was 24 and pregnant with third child, patient developed a patch Of psoriasis on the nape Of neck and an annoying patch in pubic area. Those two spots remained until patient was 74,at which time patient was put on a blood thinner (Pradaxa) due to AFib, Following the introduction to the blood thinner, overnight the psoriasis disappeared.   No treatment medication was provided by the reporter.   This case was linked to MOD-2022-662620 (Patient Link).
Age: 17.0
Sex: M
Vaccine: UNK, HEPA, MENB, MNQ
Symptoms: Back pain, Balance disorder, Musculoskeletal stiffness
Clinical narrative: After immunizations pt. experienced H/A to one side of head reversed x1 day Eats breakfast better decreased lethargy 1st part of day Intermittent exercises helps, nap after school. A little off balanced with tandem gait. TICS exacerbation, not Tourette's, after immunized Had not taken medication for Tics x 1 week prior to event
Age: 17.0
Sex: M
Vaccine: UNK, HEPA, MENB, MNQ
Symptoms: Condition aggravated, Gait disturbance, Headache, Hypersomnia, Lethargy
Clinical narrative: After immunizations pt. experienced H/A to one side of head reversed x1 day Eats breakfast better decreased lethargy 1st part of day Intermittent exercises helps, nap after school. A little off balanced with tandem gait. TICS exacerbation, not Tourette's, after immunized Had not taken medication for Tics x 1 week prior to event
Age: 17.0
Sex: M
Vaccine: UNK, HEPA, MENB, MNQ
Symptoms: Tic
Clinical narrative: After immunizations pt. experienced H/A to one side of head reversed x1 day Eats breakfast better decreased lethargy 1st part of day Intermittent exercises helps, nap after school. A little off balanced with tandem gait. TICS exacerbation, not Tourette's, after immunized Had not taken medication for Tics x 1 week prior to event
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood iron, Blood test abnormal, Haematocrit decreased, Haemoglobin decreased, Iron deficiency anaemia
Clinical narrative: felt like her back was broken; couldn't move because of the pain; couldn't move because of the pain; can´t walk more than a walk feels her legs are going to give up; very fatigued /feeling tired; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (felt like her back was broken), MOBILITY DECREASED (couldn't move because of the pain), PAIN (couldn't move because of the pain), LIMB DISCOMFORT (can´t walk more than a walk feels her legs are going to give up) and FATIGUE (very fatigued /feeling tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011LZ0A) for COVID-19 vaccination.     The patient's past medical history included Back surgery in 2002. Previously administered products included for Drug use for unknown indication: Flu shot (6 to 8 weeks before receiving the vaccine). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Migraine, Allergy to antibiotic (Bactrim), Allergy to antibiotic (Avelox), Allergy (all artificial sweaters), Hay fever and Chronic pain. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL SUCCINATE (TOPROL XL), ROSUVASTATIN CALCIUM (CRESTOR), LISINOPRIL and FISH OIL for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (felt like her back was broken), MOBILITY DECREASED (couldn't move because of the pain), PAIN (couldn't move because of the pain), LIMB DISCOMFORT (can´t walk more than a walk feels her legs are going to give up) and FATIGUE (very fatigued /feeling tired). The patient was treated with CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) at an unspecified dose and frequency and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (felt like her back was broken), MOBILITY DECREASED (couldn't move because of the pain), PAIN (couldn't move because of the pain), LIMB DISCOMFORT (can´t walk more than a walk feels her legs are going to give up) and FATIGUE (very fatigued /feeling tired) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had herb medication for migraine, iron levels medication. The patient never had COVID positive test or diagnosis.  The patient had office visit with her primary physician. The patient had B12 injections and vitamins, prenatal vitamins as it has everything in one pill, supplements, but they were not working.   This case was linked to MOD-2022-672566, MOD-2022-672565 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mean cell haemoglobin concentration decreased, Red blood cell count decreased, Serum ferritin decreased, Transferrin saturation decreased
Clinical narrative: felt like her back was broken; couldn't move because of the pain; couldn't move because of the pain; can´t walk more than a walk feels her legs are going to give up; very fatigued /feeling tired; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (felt like her back was broken), MOBILITY DECREASED (couldn't move because of the pain), PAIN (couldn't move because of the pain), LIMB DISCOMFORT (can´t walk more than a walk feels her legs are going to give up) and FATIGUE (very fatigued /feeling tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011LZ0A) for COVID-19 vaccination.     The patient's past medical history included Back surgery in 2002. Previously administered products included for Drug use for unknown indication: Flu shot (6 to 8 weeks before receiving the vaccine). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Migraine, Allergy to antibiotic (Bactrim), Allergy to antibiotic (Avelox), Allergy (all artificial sweaters), Hay fever and Chronic pain. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL SUCCINATE (TOPROL XL), ROSUVASTATIN CALCIUM (CRESTOR), LISINOPRIL and FISH OIL for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (felt like her back was broken), MOBILITY DECREASED (couldn't move because of the pain), PAIN (couldn't move because of the pain), LIMB DISCOMFORT (can´t walk more than a walk feels her legs are going to give up) and FATIGUE (very fatigued /feeling tired). The patient was treated with CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) at an unspecified dose and frequency and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (felt like her back was broken), MOBILITY DECREASED (couldn't move because of the pain), PAIN (couldn't move because of the pain), LIMB DISCOMFORT (can´t walk more than a walk feels her legs are going to give up) and FATIGUE (very fatigued /feeling tired) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had herb medication for migraine, iron levels medication. The patient never had COVID positive test or diagnosis.  The patient had office visit with her primary physician. The patient had B12 injections and vitamins, prenatal vitamins as it has everything in one pill, supplements, but they were not working.   This case was linked to MOD-2022-672566, MOD-2022-672565 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Limb discomfort, Mobility decreased, Musculoskeletal discomfort, Pain
Clinical narrative: felt like her back was broken; couldn't move because of the pain; couldn't move because of the pain; can´t walk more than a walk feels her legs are going to give up; very fatigued /feeling tired; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (felt like her back was broken), MOBILITY DECREASED (couldn't move because of the pain), PAIN (couldn't move because of the pain), LIMB DISCOMFORT (can´t walk more than a walk feels her legs are going to give up) and FATIGUE (very fatigued /feeling tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011LZ0A) for COVID-19 vaccination.     The patient's past medical history included Back surgery in 2002. Previously administered products included for Drug use for unknown indication: Flu shot (6 to 8 weeks before receiving the vaccine). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Migraine, Allergy to antibiotic (Bactrim), Allergy to antibiotic (Avelox), Allergy (all artificial sweaters), Hay fever and Chronic pain. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL SUCCINATE (TOPROL XL), ROSUVASTATIN CALCIUM (CRESTOR), LISINOPRIL and FISH OIL for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (felt like her back was broken), MOBILITY DECREASED (couldn't move because of the pain), PAIN (couldn't move because of the pain), LIMB DISCOMFORT (can´t walk more than a walk feels her legs are going to give up) and FATIGUE (very fatigued /feeling tired). The patient was treated with CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) at an unspecified dose and frequency and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (felt like her back was broken), MOBILITY DECREASED (couldn't move because of the pain), PAIN (couldn't move because of the pain), LIMB DISCOMFORT (can´t walk more than a walk feels her legs are going to give up) and FATIGUE (very fatigued /feeling tired) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had herb medication for migraine, iron levels medication. The patient never had COVID positive test or diagnosis.  The patient had office visit with her primary physician. The patient had B12 injections and vitamins, prenatal vitamins as it has everything in one pill, supplements, but they were not working.   This case was linked to MOD-2022-672566, MOD-2022-672565 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Blood test normal, Computerised tomogram head normal, Confusional state, Feeling abnormal, Memory impairment
Clinical narrative: Diagnosed with Transient Global Amnesia; Felt very confused; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 at 10:30 as dose 3 (booster), single (Lot number: GJ5342) at the age of 69 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 08Oct2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PANTOPRAZOLE; SONATA [ZALEPLON]. Vaccination history included: BNT162b2, administration date: 19Apr2022, when the patient was 68-year-old, for Covid-19 Immunization; Covid-19 vaccine, for Covid-19 Immunization. The following information was reported: TRANSIENT GLOBAL AMNESIA (non-serious) with onset 06Nov2022 at 10:30, outcome "recovering", described as "Diagnosed with Transient Global Amnesia"; CONFUSIONAL STATE (non-serious) with onset 06Nov2022 at 10:30, outcome "recovering", described as "Felt very confused". The events "diagnosed with transient global amnesia" and "felt very confused" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of transient global amnesia, confusional state.
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Transient global amnesia, Urine analysis normal
Clinical narrative: Diagnosed with Transient Global Amnesia; Felt very confused; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 at 10:30 as dose 3 (booster), single (Lot number: GJ5342) at the age of 69 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 08Oct2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PANTOPRAZOLE; SONATA [ZALEPLON]. Vaccination history included: BNT162b2, administration date: 19Apr2022, when the patient was 68-year-old, for Covid-19 Immunization; Covid-19 vaccine, for Covid-19 Immunization. The following information was reported: TRANSIENT GLOBAL AMNESIA (non-serious) with onset 06Nov2022 at 10:30, outcome "recovering", described as "Diagnosed with Transient Global Amnesia"; CONFUSIONAL STATE (non-serious) with onset 06Nov2022 at 10:30, outcome "recovering", described as "Felt very confused". The events "diagnosed with transient global amnesia" and "felt very confused" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of transient global amnesia, confusional state.
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Confusional state, Transient global amnesia
Clinical narrative: Diagnosed with Transient Global Amnesia; Felt very confused; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 at 10:30 as dose 3 (booster), single (Lot number: GJ5342) at the age of 69 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 08Oct2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PANTOPRAZOLE; SONATA [ZALEPLON]. Vaccination history included: BNT162b2, administration date: 19Apr2022, when the patient was 68-year-old, for Covid-19 Immunization; Covid-19 vaccine, for Covid-19 Immunization. The following information was reported: TRANSIENT GLOBAL AMNESIA (non-serious) with onset 06Nov2022 at 10:30, outcome "recovering", described as "Diagnosed with Transient Global Amnesia"; CONFUSIONAL STATE (non-serious) with onset 06Nov2022 at 10:30, outcome "recovering", described as "Felt very confused". The events "diagnosed with transient global amnesia" and "felt very confused" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of transient global amnesia, confusional state.
Age: 67.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Arthralgia, Blood test, Hypoaesthesia
Clinical narrative: painful swelling; skin warm to touch; Sharp sciatica pain in the right buttock, inner thigh, posterior thigh, and lower leg; abdominal cramping and pain; numbness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (painful swelling), SKIN WARM (skin warm to touch), SCIATICA (Sharp sciatica pain in the right buttock, inner thigh, posterior thigh, and lower leg), ABDOMINAL PAIN (abdominal cramping and pain) and HYPOAESTHESIA (numbness) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 09-Nov-2022, the patient experienced SWELLING (painful swelling), SKIN WARM (skin warm to touch), SCIATICA (Sharp sciatica pain in the right buttock, inner thigh, posterior thigh, and lower leg), ABDOMINAL PAIN (abdominal cramping and pain) and HYPOAESTHESIA (numbness). At the time of the report, SWELLING (painful swelling), SKIN WARM (skin warm to touch), SCIATICA (Sharp sciatica pain in the right buttock, inner thigh, posterior thigh, and lower leg), ABDOMINAL PAIN (abdominal cramping and pain) and HYPOAESTHESIA (numbness) had not resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided. It is unknown if the patient experienced any additional symptoms/events.
Age: 67.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Musculoskeletal pain, Pain in extremity, Skin warm, Swelling, Ultrasound scan
Clinical narrative: painful swelling; skin warm to touch; Sharp sciatica pain in the right buttock, inner thigh, posterior thigh, and lower leg; abdominal cramping and pain; numbness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (painful swelling), SKIN WARM (skin warm to touch), SCIATICA (Sharp sciatica pain in the right buttock, inner thigh, posterior thigh, and lower leg), ABDOMINAL PAIN (abdominal cramping and pain) and HYPOAESTHESIA (numbness) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 09-Nov-2022, the patient experienced SWELLING (painful swelling), SKIN WARM (skin warm to touch), SCIATICA (Sharp sciatica pain in the right buttock, inner thigh, posterior thigh, and lower leg), ABDOMINAL PAIN (abdominal cramping and pain) and HYPOAESTHESIA (numbness). At the time of the report, SWELLING (painful swelling), SKIN WARM (skin warm to touch), SCIATICA (Sharp sciatica pain in the right buttock, inner thigh, posterior thigh, and lower leg), ABDOMINAL PAIN (abdominal cramping and pain) and HYPOAESTHESIA (numbness) had not resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided. It is unknown if the patient experienced any additional symptoms/events.
Age: 67.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Abdominal pain, Hypoaesthesia, Sciatica, Skin warm, Swelling
Clinical narrative: painful swelling; skin warm to touch; Sharp sciatica pain in the right buttock, inner thigh, posterior thigh, and lower leg; abdominal cramping and pain; numbness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (painful swelling), SKIN WARM (skin warm to touch), SCIATICA (Sharp sciatica pain in the right buttock, inner thigh, posterior thigh, and lower leg), ABDOMINAL PAIN (abdominal cramping and pain) and HYPOAESTHESIA (numbness) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 09-Nov-2022, the patient experienced SWELLING (painful swelling), SKIN WARM (skin warm to touch), SCIATICA (Sharp sciatica pain in the right buttock, inner thigh, posterior thigh, and lower leg), ABDOMINAL PAIN (abdominal cramping and pain) and HYPOAESTHESIA (numbness). At the time of the report, SWELLING (painful swelling), SKIN WARM (skin warm to touch), SCIATICA (Sharp sciatica pain in the right buttock, inner thigh, posterior thigh, and lower leg), ABDOMINAL PAIN (abdominal cramping and pain) and HYPOAESTHESIA (numbness) had not resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided. It is unknown if the patient experienced any additional symptoms/events.
Age: 30.0
Sex: U
Vaccine: COVID19-2
Symptoms: Immediate post-injection reaction, Paraesthesia oral, Throat tightness
Clinical narrative: Patient reported back to the pharmacy experiencing tingling in their mouth and tightness  in their throat within 15 minutes of receiving the shot. Patient was given 25mg of Benadryl, water and candy and monitored for another 20 minutes. After about 15 to 20 minutes after receiving the Benadryl patient started feeling much better and felt comfortable leaving on their own accord. The pharmacist felt comfortable after examining and talking to the patient that an immediate concern had passed.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Migraine, Night sweats, Pyrexia
Clinical narrative: Migraine, fever, night sweats, chills, fatigue,   Lasted 2 days.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein increased, Dizziness, Fatigue, Magnetic resonance imaging
Clinical narrative: Pt. developed arthralgias in upper and lower extremities, fatigue, and dizziness the day following the covid vaccine. Due to intensity of symptoms and elevated crp (24)/esr(64). Pt was treated with Predinisone toper for several months. The joint pain improved over a few weeks but had persistant pain and weakness in right arm and dx with brachial neuritis based in exam/history and MRI.  Pt improved over 8 months with  steroids, PT, and hyperbaric oxygen.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Radiculitis brachial
Clinical narrative: Pt. developed arthralgias in upper and lower extremities, fatigue, and dizziness the day following the covid vaccine. Due to intensity of symptoms and elevated crp (24)/esr(64). Pt was treated with Predinisone toper for several months. The joint pain improved over a few weeks but had persistant pain and weakness in right arm and dx with brachial neuritis based in exam/history and MRI.  Pt improved over 8 months with  steroids, PT, and hyperbaric oxygen.
Age: 34.0
Sex: F
Vaccine: FLUR4
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rashes on left collar area and upper back, itchy, red. It has been a week now, not getting better.  I have had previous reactions to flu shot, so I thought it was my egg allergy so I got the flublok but still have the reaction.  Anti itch cream used to relieve itch. Typically I get a steroid pack, but I cannot now since I?m nursing.
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Pseudostroke
Clinical narrative: I have stroke like symptoms-left side; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team, Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "covid-19" (unspecified if ongoing), notes: Patient was vaccinated while patient was infected with covid-19. The patient's concomitant medications were not reported. The following information was reported: PSEUDOSTROKE (medically significant), outcome "unknown", described as "stroke like symptoms-left side". The patient underwent the following laboratory tests and procedures: Computerised tomogram: No stroke.  Clinical course: Patient was vaccinated while patient was infected with covid-19. As a result, patient had stroke like symptoms-left side. CAT scan revealved no stroke.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no adverse event; Customer reported that a patient received their first dose of ROTATEQ at 6 months of age outside the recommended PI.  No additional AE information no PQC.; This spontaneous report was received from a medical assistant referring to patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 10-OCT-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis at 6 months of age outside the recommended product label (strength, lot #, and expiry date were not provided) (product administered to patient of inappropriate age). No additional adverse event information was reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; patient received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 21-OCT-2022, the patient was vaccinated with following improperly stored vaccines: haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 1 dose, lot # U039951 with expiration date 22-JUN-2024, for prophylaxis (exact dose, route of administration and injection site were not provided); rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot # 1912561 was confirmed to be valid, with expiration date 10-DEC-2023, administered orally for prophylaxis (exact dose was not provided) (product storage error). The vaccines were improperly stored for 15 minutes in the temperature of 34.9 degrees Fahrenheit (F). It was unknown if data logger was used to capture the temperature excursion. There were no previous temperature excursions. No additional adverse events were reported (no adverse event).
Age: 0.33
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; HCP reporting an MMRII vaccine was accidentally administered to a 4 month old. No additional clarifying statements or details were provided. No additional AE. No PQC.; This spontaneous report was received from a Medical Assistant and refers to a 4  month old patient (gender not reported). The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 10-NOV-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, once., administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate age at vaccine administration).   At the reporting time, no adverse events were not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional clarifying statements or details were; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a medical assistant and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug allergies or previous drug reactions, and concomitant medications were not reported.  On 04-NOV-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, with a default oral route of administration (strength, dose, vaccination scheme frequency and anatomical site of application was not provided; lot number 1879858 that was verified to be valid with an expiration date reported and established as 21-OCT-2023) for prophylaxis (product storage error).   The administered dose of vaccine was stored at a temperature excursion of 47.83 degrees Fahrenheit (°F), during a time frame of 0 hours 10 minutes with 0 seconds.There was no previous temperature excursion.  No additional clarifying statements or details were provided (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; Initial Report Received on 28-Jun-2022 (Central Receipt Date: 01-Sep-2022)  A pregnant patient reported to the pregnancy registry that she, a 25-year-old patient (race and ethnicity not provided) with estimated due date of 05-Nov-2022, received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 28-Jun-2022, the patient received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) with route and site not reported from the pharmacy.   The pharmacy did not have the patient listed as pregnant in their charts. It is her first pregnancy.   The call was lost before the patient could provide her obstetrician contact information and confirm participation and consent to the pregnancy registry.   No additional information was reported. Consent for additional follow-up with the patient was not granted.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Given Dose of HEPLISAV-B That Had Been Out of Temperature Range for 11 Hours; Initial Report Received on 02-Sep-2022  A pharmacist reported that a female patient (age, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had been out of temperature range for 11 hours.  Medical history, concomitant medications, and allergies at the time of vaccination were unknown.  On 01-Sep-2022, the patient received the first dose of HEPLISAV-B (Lot # 938793; expiration date 07-Oct-2023, NDC # unknown) intramuscularly in the left deltoid. The HEPLISAV-B had been out of temperature range for 11 hours. The patient did not report any adverse effects/reactions.  No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Received HEPLISAV-B as 1st Dose and 2nd Dose Engerix; Initial Report Received on 02-Sep-2022  A pharmacist reported that a 61-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as a first dose and Engerix as a second dose.  Medical history, concomitant medications, and allergies at the time of vaccination were unknown.  On 01-Aug-2022, the patient received the first dose with HEPLISAV-B (Lot # 937232, expiration date 04-Mar-2023, NDC # 43528-003-05) intramuscularly in the left deltoid. The patient did not report any adverse effects.  On 01-Sep-2022, 32 days after having been vaccinated with HEPLISAV-B, the patient received Engerix as the second dose at a different pharmacy (details unknown).   No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Received HEPLISAV-B 1st Dose then Engerix as 2nd Dose; Initial Report Received on 02-Sep-2022  An advanced nurse practitioner reported that a female patient (age, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Engerix as the second dose.  Medical history, concomitant medications, and allergies at the time of vaccination were unknown.  On 21-Jul-2022, the patient received the first dose with HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site unknown).   On 20-Aug-2022, 31 days after having been vaccinated with HEPLISAV-B, the patient received Engerix as the second dose (no details provided).   No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.