chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Gaze palsy, Loss of consciousness, Nausea, Pain, Pyrexia
Clinical narrative: Seizure: while walking, felt weak, nausea, blurred vision, and lost consciousness with observed "jerking movements" of limbs by partner who says she was unresponsive with eyes rolled back into her head. Prior to this reported having aura. In the hours leading up to this, had fever, body aches, chills, nausea. Has history of seizures in childhood and felt this was similar.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Unresponsive to stimuli, Vision blurred
Clinical narrative: Seizure: while walking, felt weak, nausea, blurred vision, and lost consciousness with observed "jerking movements" of limbs by partner who says she was unresponsive with eyes rolled back into her head. Prior to this reported having aura. In the hours leading up to this, had fever, body aches, chills, nausea. Has history of seizures in childhood and felt this was similar.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistant reporting that a patient was administered VARIVAX after a temperature excursion.; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.  On 25-MAY-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U029496 has been verified to be a valid lot number, expiry date 21-SEP-2023) (strength, dose, frequency, route of administration, anatomical location and vaccination scheme were not provided).  The vaccine was stored at a temperature of 8.3 Fahrenheit (F) for the time frame of 0 hours 15 minutes and 0 seconds. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.  As of 07-JUN-2022, no further information is available.; Sender's Comments:  US-009507513-2206USA000990: US-009507513-2206USA000886:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Skin lesion, Tongue discomfort
Clinical narrative: blisters behind my knees and on my shoulders; some type of lesion under my arms, my waste, upper thighs and groin area; painful burning sensation on my tongue and the roof of my mouth; painful burning sensation on my tongue and the roof of my mouth; painful burning sensation on my tongue and the roof of my mouth; painful burning sensation on my tongue and the roof of my mouth; I also broke out into a rash; This spontaneous case was reported by a patient and describes the occurrence of BLISTER (blisters behind my knees and on my shoulders), SKIN LESION (some type of lesion under my arms, my waste, upper thighs and groin area), GLOSSODYNIA (painful burning sensation on my tongue and the roof of my mouth), TONGUE DISCOMFORT (painful burning sensation on my tongue and the roof of my mouth) and ORAL PAIN (painful burning sensation on my tongue and the roof of my mouth) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: J&J (first dose). Past adverse reactions to the above products included No adverse event with J&J.    On 05-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2022, the patient experienced BLISTER (blisters behind my knees and on my shoulders), SKIN LESION (some type of lesion under my arms, my waste, upper thighs and groin area), GLOSSODYNIA (painful burning sensation on my tongue and the roof of my mouth), TONGUE DISCOMFORT (painful burning sensation on my tongue and the roof of my mouth), ORAL PAIN (painful burning sensation on my tongue and the roof of my mouth), ORAL DISCOMFORT (painful burning sensation on my tongue and the roof of my mouth) and RASH (I also broke out into a rash). At the time of the report, BLISTER (blisters behind my knees and on my shoulders), SKIN LESION (some type of lesion under my arms, my waste, upper thighs and groin area), GLOSSODYNIA (painful burning sensation on my tongue and the roof of my mouth), TONGUE DISCOMFORT (painful burning sensation on my tongue and the roof of my mouth), ORAL PAIN (painful burning sensation on my tongue and the roof of my mouth), ORAL DISCOMFORT (painful burning sensation on my tongue and the roof of my mouth) and RASH (I also broke out into a rash) had not resolved.            Patient had the JJ shot first and then the Moderna booster shot.  No concomitant medication were provided.  It was reported that patient broke out into blisters behind knees and on shoulders. Patient also broke out into a rash and some type of lesion under arms, waist, upper thighs and groin area. Along with that patient started to experience a painful burning sensation on tongue and the roof of mouth.  Patient had done research on line and found similar experiences as well as have visited the dermatologist on two occasions.  Patient cannot get rid of events after being put on steroids, both pills and topical.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID BREAKTHROUGH CASE
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chills, Dry mouth, Feeling abnormal, Hyperhidrosis
Clinical narrative: made her feel like she got the flu; it also make her glands swelled for some reason; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (made her feel like she got the flu) and LYMPHADENOPATHY (it also make her glands swelled for some reason) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005c21a and 005c21a) for COVID-19 prophylaxis.     The patient's past medical history included Cancer surgery in 2019. Concurrent medical conditions included Abdominal tumor (Patient has 3 tumors on her stomach) since 2019, Diabetic, Hypertension, Acid reflux (oesophageal) (acid reflux medication), Cholesterol (cholesterol medication), Drug allergy (Aspirin), Penicillin allergy, Drug allergy (codeine), Allergy (Glascol), Drug allergy (ultram), Drug allergy (all of the cholesterol drugs except for the one the patient took) and Drug allergy (some other eye drug).   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-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 INFLUENZA (made her feel like she got the flu) and LYMPHADENOPATHY (it also make her glands swelled for some reason). At the time of the report, INFLUENZA (made her feel like she got the flu) and LYMPHADENOPATHY (it also make her glands swelled for some reason) outcome was unknown.            The Patient's concomitant medications included high blood pressure medication, diabetes medication, acid reflux medication and cholesterol medication.  Patient reported had been in remission for years. The patient  never had been diagnosed with/ tested positive for COVID 19. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine were reported as none. Acute illness at the time of vaccination and up to one month before was reported as none.  Treatment information was not reported.   This case was linked to MOD-2022-595931 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Lymphadenopathy, Neck pain, Pain, Suspected COVID-19
Clinical narrative: made her feel like she got the flu; it also make her glands swelled for some reason; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (made her feel like she got the flu) and LYMPHADENOPATHY (it also make her glands swelled for some reason) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005c21a and 005c21a) for COVID-19 prophylaxis.     The patient's past medical history included Cancer surgery in 2019. Concurrent medical conditions included Abdominal tumor (Patient has 3 tumors on her stomach) since 2019, Diabetic, Hypertension, Acid reflux (oesophageal) (acid reflux medication), Cholesterol (cholesterol medication), Drug allergy (Aspirin), Penicillin allergy, Drug allergy (codeine), Allergy (Glascol), Drug allergy (ultram), Drug allergy (all of the cholesterol drugs except for the one the patient took) and Drug allergy (some other eye drug).   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-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 INFLUENZA (made her feel like she got the flu) and LYMPHADENOPATHY (it also make her glands swelled for some reason). At the time of the report, INFLUENZA (made her feel like she got the flu) and LYMPHADENOPATHY (it also make her glands swelled for some reason) outcome was unknown.            The Patient's concomitant medications included high blood pressure medication, diabetes medication, acid reflux medication and cholesterol medication.  Patient reported had been in remission for years. The patient  never had been diagnosed with/ tested positive for COVID 19. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine were reported as none. Acute illness at the time of vaccination and up to one month before was reported as none.  Treatment information was not reported.   This case was linked to MOD-2022-595931 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: made her feel like she got the flu; it also make her glands swelled for some reason; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (made her feel like she got the flu) and LYMPHADENOPATHY (it also make her glands swelled for some reason) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005c21a and 005c21a) for COVID-19 prophylaxis.     The patient's past medical history included Cancer surgery in 2019. Concurrent medical conditions included Abdominal tumor (Patient has 3 tumors on her stomach) since 2019, Diabetic, Hypertension, Acid reflux (oesophageal) (acid reflux medication), Cholesterol (cholesterol medication), Drug allergy (Aspirin), Penicillin allergy, Drug allergy (codeine), Allergy (Glascol), Drug allergy (ultram), Drug allergy (all of the cholesterol drugs except for the one the patient took) and Drug allergy (some other eye drug).   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-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 INFLUENZA (made her feel like she got the flu) and LYMPHADENOPATHY (it also make her glands swelled for some reason). At the time of the report, INFLUENZA (made her feel like she got the flu) and LYMPHADENOPATHY (it also make her glands swelled for some reason) outcome was unknown.            The Patient's concomitant medications included high blood pressure medication, diabetes medication, acid reflux medication and cholesterol medication.  Patient reported had been in remission for years. The patient  never had been diagnosed with/ tested positive for COVID 19. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine were reported as none. Acute illness at the time of vaccination and up to one month before was reported as none.  Treatment information was not reported.   This case was linked to MOD-2022-595931 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza, Lymphadenopathy
Clinical narrative: made her feel like she got the flu; it also make her glands swelled for some reason; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (made her feel like she got the flu) and LYMPHADENOPATHY (it also make her glands swelled for some reason) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005c21a and 005c21a) for COVID-19 prophylaxis.     The patient's past medical history included Cancer surgery in 2019. Concurrent medical conditions included Abdominal tumor (Patient has 3 tumors on her stomach) since 2019, Diabetic, Hypertension, Acid reflux (oesophageal) (acid reflux medication), Cholesterol (cholesterol medication), Drug allergy (Aspirin), Penicillin allergy, Drug allergy (codeine), Allergy (Glascol), Drug allergy (ultram), Drug allergy (all of the cholesterol drugs except for the one the patient took) and Drug allergy (some other eye drug).   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-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 INFLUENZA (made her feel like she got the flu) and LYMPHADENOPATHY (it also make her glands swelled for some reason). At the time of the report, INFLUENZA (made her feel like she got the flu) and LYMPHADENOPATHY (it also make her glands swelled for some reason) outcome was unknown.            The Patient's concomitant medications included high blood pressure medication, diabetes medication, acid reflux medication and cholesterol medication.  Patient reported had been in remission for years. The patient  never had been diagnosed with/ tested positive for COVID 19. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine were reported as none. Acute illness at the time of vaccination and up to one month before was reported as none.  Treatment information was not reported.   This case was linked to MOD-2022-595931 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastric disorder, Inappropriate schedule of product administration, Memory impairment
Clinical narrative: Was having no pain at all.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 07Feb2021 as dose 2 , single (Lot number: EN6201) at the age of 77 years, on 09Nov2021 as dose 3 (booster), single (Lot number: FD3527) and on 27Jun2022 as dose 4 (booster), single (Lot number: KM9992) for covid-19 immunisation. The patient's relevant medical history included: "pain" (unspecified if ongoing), notes: in order to control her pain for almost 10 years.; "She takes her blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement; HYDROCHLOROTHIAZIDE; NUCYNTA taken for pain; SAVELLA taken for pain; EPHEDRINE taken for pain; AMITRIPTYLINE taken for pain; ORPHENADRINE; TYLENOL; CODEINE. Past drug history included: Levaquin, reaction(s): "affected her nervous system". Vaccination history included: BNT162b2 (Dose 1, SINGLE; lot number: EN5318), administration date: 29Jan2021, when the patient was 77-year-old, for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Was having no pain at all.".  Additional information: After the second dose the patient felt no pain at all. The patient received second booster dose and someone told her that the vaccine might have boosted her immune system. Three days after her second shot, the patient mentioned that she forgot to take the several medicines for her nervous system which the was before the shot and all of the sudden the patient felt well and had no pain. Now the patient has been a year without pain.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Was having no pain at all.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 07Feb2021 as dose 2 , single (Lot number: EN6201) at the age of 77 years, on 09Nov2021 as dose 3 (booster), single (Lot number: FD3527) and on 27Jun2022 as dose 4 (booster), single (Lot number: KM9992) for covid-19 immunisation. The patient's relevant medical history included: "pain" (unspecified if ongoing), notes: in order to control her pain for almost 10 years.; "She takes her blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement; HYDROCHLOROTHIAZIDE; NUCYNTA taken for pain; SAVELLA taken for pain; EPHEDRINE taken for pain; AMITRIPTYLINE taken for pain; ORPHENADRINE; TYLENOL; CODEINE. Past drug history included: Levaquin, reaction(s): "affected her nervous system". Vaccination history included: BNT162b2 (Dose 1, SINGLE; lot number: EN5318), administration date: 29Jan2021, when the patient was 77-year-old, for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Was having no pain at all.".  Additional information: After the second dose the patient felt no pain at all. The patient received second booster dose and someone told her that the vaccine might have boosted her immune system. Three days after her second shot, the patient mentioned that she forgot to take the several medicines for her nervous system which the was before the shot and all of the sudden the patient felt well and had no pain. Now the patient has been a year without pain.
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; ROTATEQ was administered after a temperature excursion; This spontaneous report as received from a registered nurse refers to a 3 month old female patient. On 25-MAY-2022, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# 1742083 exp date 22-SEP-2022) orally after a temperature excursion. The vaccine was stored below recommended temperature at 35 F for one month, however the doses remaining stable. No intervention or repeated doses were required. On the same date, the patient was also vaccinated with the first dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP). There was no adverse event.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion VARIVAX has been administered; This spontaneous report was received from a medical assistant referring to a 15-month-old female patient. The patient's illness at vaccination and pre-existing allergies, birth defects and medical conditions were reported as none. The birth weight was 7 lbs and 11.8 oz. The patient had one sister and one brother. Concomitant therapies included sterile diluent (manufacturer unknown) and HIB vaccine conj (tet tox) (HIBERIX).  On 31-MAY-2022, the patient was vaccinated with the second dose of temperature excursion varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U029496, expiration date: 21-SEP-2023) 0.5 ml subcutaneously at left thigh for prophylaxis (product storage error) at a private doctor's office. No adverse event was reported (no adverse event). The vaccine was purchased with public funds. The vaccine was used according to the instruction leaflet. The vaccine was in freezer and available for return/evaluation.  The vaccine underwent a temperature excursion of 5.5 Celsius degree for 5 hours and 6 minutes (vaccine was moved to refrigerator to deforest freezer at 07:49, returned to freezer at 12:55, min temperature in fridge: 4.46 Celsius degree, max temperature in fridge: 5.55 Celsius degree, the excursion occurred as a result of digital data logger).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007524: US-009507513-2206USA007508: US-009507513-2206USA007509: US-009507513-2206USA007510: US-009507513-2206USA007511: US-009507513-2206USA007512: US-009507513-2206USA007513:
Sex: F
Vaccine: HPV4
Symptoms: Palpitations, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: postural orthostatic tachycardia syndrome (POTS); dysautonomia; Autoimmune disease; chronic fatigue syndrome (CFS); migraines; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a teenager female patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 27-DEC-2017, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (Lot #, expiration date, dose, route of administration and anatomical location of vaccine were not provided) for preventing cervical cancer. On an unspecified date, within the first three months, she began to experience dizziness, headaches, and fatigue. Plaintiff and her mother did not think much about the symptoms, although the symptoms persisted for the next several months. On 13-NOV-2018, she was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). After the second dose, her symptoms dramatically worsened.  In early 2019, Plaintiff began having trouble walking up the stairs at their house and she would complain about her increased heart rate. Her mother assumed it was simply from exertion. As the months progressed, so did her injuries which now included: chronic fatigue, dizziness, migraines, faintness, and heart palpitations. The patient saw several doctors to determine what might be triggering her symptoms. During this time, she began to have intensified migraines, for which her doctors prescribed her medication. In March 2021, Plaintiff's cardiologist diagnosed her with postural orthostatic tachycardia syndrome (POTS) and dysautonomia. As a result of her post-Gardasil symptoms, patient could not engage in normal activities that a teenager would enjoy or participate in the activities she used to enjoy. Additionally, based upon her chronic and severe post-Gardasil symptoms, patient had been diagnosed with various medical conditions, including, but not limited to, POTs, dysautonomia, Chronic fatigue syndrome (CFS) and autonomic dysfunction. The patient contends that patient human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating injuries, including but not limited to POTS, dysautonomia, CFS, migraines, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or otherwise linked to her Gardasil-induced autoimmune disorder. Autoimmune Disease and Other Related Injuries and had resulted in her suffering from severe, debilitating, disabling and painful chronic injuries.  The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  Upon internal review the event of Autoimmune Disease was considered as medically significant
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion VARIVAX has been administered; This spontaneous report was received from a medical assistant referring to a 4-year-old female patient. The patient's illness at vaccination was otitis media. The pre-existing allergies, birth defects and medical conditions were reported as none. The birth weight was 9 lbs and 2.5 oz. The patient had 2 sisters. Concomitant therapies included sterile diluent (manufacturer unknown), diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX) and measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II).    On 01-JUN-2022, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U029496, expiration date: 21-SEP-2023) (The vaccine underwent a temperature excursion of 5.5 Celsius degree for 5 hours and 6 minutes on 26-MAY-2022 (vaccine was moved to refrigerator to deforest freezer at 07:49, returned to freezer at 12:55, min temperature in fridge: 4.46 Celsius degree, max temperature in fridge: 5.55 Celsius degree, the excursion did not occur as a result of digital data logger)) (Product storage error) 0.5 ml subcutaneously at right thigh for prophylaxis (product storage error) at a private doctor's office. No adverse event was reported (no adverse event).The vaccine was purchased with public funds. The vaccine was used according to the instruction leaflet. The vaccine was in freezer and available for return/evaluation.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001254: US-009507513-2206USA007509: US-009507513-2206USA007510: US-009507513-2206USA007511: US-009507513-2206USA007512: US-009507513-2206USA007513: US-009507513-2206USA007524:
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion VARIVAX has been administered; This spontaneous report was received from a medical assistant referring to a 2-year-old (also reported as 22 months) female patient. The patient's illness at vaccination were reported as none. The pre-existing allergies, birth defects and medical conditions included optic nerve hypoplasia. The birth weight was 8 lbs and 3 oz. The patient had one brother. Concomitant therapy included sterile diluent (manufacturer unknown), hepatitis a vaccine inact (HAVRIX), hib vaccine conj (tet tox) (HIBERIX) and diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (INFANRIX).    On 01-JUN-2022, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U029496, expiration date: 21-SEP-2023) (The vaccine underwent a temperature excursion of 5.5 Celsius degree for 5 hours and 6 minutes on 26-MAY-2022 (vaccine was moved to refrigerator to deforest freezer at 07:49, returned to freezer at 12:55, min temperature in fridge: 4.46 Celsius degree, max temperature in fridge: 5.55 Celsius degree, the excursion occurred as a result of digital data logger)) 0.5 ml subcutaneously at left thigh for prophylaxis at a private doctor's office (Product storage error). No adverse event was reported (no adverse event). The vaccine was purchased with public funds. The vaccine was used according to the instruction leaflet. The vaccine was in freezer and available for return/evaluation.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001254: US-009507513-2206USA007524: US-009507513-2206USA007508: US-009507513-2206USA007510: US-009507513-2206USA007511: US-009507513-2206USA007512: US-009507513-2206USA007513:
Age: 1.33
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion VARIVAX has been administered; This spontaneous report was received from a medical assistant referring to a 16-month-old (also reported as 14-month old) female patient. The patient's illness at vaccination and pre-existing allergies, birth defects and medical conditions were reported as none. The birth weight was 9 lbs. The patient had 1 sister. Concomitant therapy included sterile diluent (manufacturer unknown) and hib vaccine conj (tet tox) (HIBERIX).    On 26-MAY-2022, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U025790 (also reported as U02590), expiration date: 19-AUG-2023) (The vaccine underwent a temperature excursion of 5.5 Celsius degree for 5 hours and 6 minutes on 26-MAY-2022 (vaccine was moved to refrigerator to deforest freezer at 07:49, returned to freezer at 12:55, min temperature in fridge: 4.46 Celsius degree, max temperature in fridge: 5.55 Celsius degree, the excursion occurred as a result of digital data logger)) 0.5 ml subcutaneously at right thigh for prophylaxis (product storage error) at a private doctor's office. No adverse event was reported (no adverse event). The vaccine was used according to the instruction leaflet. The vaccine was no longer in office and no longer available for return or evaluation.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007524:MSD US-009507513-2206USA007508:MSD US-009507513-2206USA007509:MSD US-009507513-2206USA007511:MSD US-009507513-2206USA007512:MSD US-009507513-2206USA007513:MSD US-009507513-2206USA001254:MSD
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion VARIVAX has been administered; This spontaneous report was received from a medical assistant referring to a 4-year-old male patient. The patient's illness at vaccination and pre-existing allergies, birth defects and medical conditions were reported as none. The birth weight was 7 lbs 10 oz. The patient had no siblings. Concomitant therapy included sterile diluent (manufacturer unknown), diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX) and measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II).    On 01-JUN-2022, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U029496, expiration date: 21-SEP-2023) (The vaccine underwent a temperature excursion of 5.5 Celsius degree for 5 hours and 6 minutes on 26-MAY-2022 (vaccine was moved to refrigerator to deforest freezer at 07:49, returned to freezer at 12:55, min temperature in fridge: 4.46 Celsius degree, max temperature in fridge: 5.55 Celsius degree, the excursion occurred as a result of digital data logger)) 0.5 ml subcutaneously at right thigh for prophylaxis (product storage error) at a private doctor's office. No adverse event was reported (no adverse event). The vaccine was used according to the instruction leaflet. The vaccine was in freezer and available for return/evaluation.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007524: US-009507513-2206USA007508: US-009507513-2206USA007509: US-009507513-2206USA007510: US-009507513-2206USA007512: US-009507513-2206USA007513: US-009507513-2206USA001254:
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; temperature excursion VARIVAX has been administered; This spontaneous report was received from a medical assistant referring to a 15-month-old male patient. The patient's illness at vaccination was reported as none. The patient was allergy to peanuts, strawberries, tomatoes, lactose. The birth weight was 8 lbs and 12 oz. The patient had 1 sister and 1 brother. Concomitant therapy included sterile diluent (manufacturer unknown) and hib vaccine conj (tet tox) (HIBERIX).    On 26-MAY-2022, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U025790, expiration date: 19-AUG-2023) (The vaccine underwent a temperature excursion of 5.5 Celsius degree for 5 hours and 6 minutes on 26-MAY-2022 (vaccine was moved to refrigerator to deforest freezer at 07:49, returned to freezer at 12:55, min temperature in fridge: 4.46 Celsius degree, max temperature in fridge: 5.55 Celsius degree, the excursion occurred as a result of digital data logger)) 0.5 ml subcutaneously at right thigh for prophylaxis (product storage error) at a private doctor's office. The vaccine was purchased with public funds. No adverse event was reported (no adverse event). The vaccine was no longer in office and no longer available for return or evaluation.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007524: US-009507513-2206USA007508: US-009507513-2206USA007509: US-009507513-2206USA007510: US-009507513-2206USA007511: US-009507513-2206USA007513: US-009507513-2206USA001254:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion VARIVAX has been administered; This spontaneous report was received from a medical assistant referring to a 4-year-old female patient. The patient's illness at vaccination and pre-existing allergies, birth defects and medical conditions were reported as none. The birth weight was 7 lbs and 9.3 oz. The patient had 1 sister and 1 brother. Concomitant therapy included sterile diluent (manufacturer unknown), diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX) and measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II).   On 01-JUN-2022, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U029496, expiration date: 21-SEP-2023) (The vaccine underwent a temperature excursion of 5.5 Celsius degree for 5 hours and 6 minutes on 26-MAY-2022 (vaccine was moved to refrigerator to deforest freezer at 07:49, returned to freezer at 12:55, min temperature in fridge: 4.46 Celsius degree, max temperature in fridge: 5.55 Celsius degree, the excursion occurred as a result of digital data logger)) 0.5 ml subcutaneously at left thigh for prophylaxis (product storage error) at a private doctor's office. No adverse event was reported (no adverse event). The vaccine was used according to the instruction leaflet. The vaccine was in freezer and available for return/evaluation.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007524:MSD US-009507513-2206USA007508:MSD US-009507513-2206USA007509:MSD US-009507513-2206USA007510:MSD US-009507513-2206USA007511:MSD US-009507513-2206USA007512:MSD US-009507513-2206USA001254:MSD
Sex: U
Vaccine: MMRV
Symptoms: Stomatitis
Clinical narrative: Developed sores in mouth; This spontaneous report was received from a medical assistant referring to a 12-month-old patient of unknown gender. The medical history, historical drugs, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (formulation, strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient developed sores in mouth. At the time of reporting, the outcome of the event was not known.  The causal relationship between sores in mouth and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001254: US-009507513-2206USA007508: US-009507513-2206USA007509: US-009507513-2206USA007510: US-009507513-2206USA007511: US-009507513-2206USA007512: US-009507513-2206USA007513:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC.; Improperly stored for VARIVAX, Temperature: 4C, Time frame: 108 Hours; This spontaneous report was received from a medical assistant referring to a 16-month-old patient of unknown gender.  The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not provided.   On 27-JUN-2022, the patient was vaccinated with one dose of an improperly stored of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (strength, route of administration, anatomical injection site and frequency were not reported); lot number W002599 has been verified to be a valid lot number with expiration date on 24-JAN-2024 that underwent a temperature excursion of 4 Celsius degrees for 108 hours (product storage error). There was no previous temperature excursion. No additional adverse events were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of Moderna COVID-19 vaccine 12 hours after the initial vial puncture, and not after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of Moderna COVID-19 vaccine 12 hours after the initial vial puncture, and not after the published expiration date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 045L21A, 040A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of Moderna COVID-19 vaccine 12 hours after the initial vial puncture, and not after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of Moderna COVID-19 vaccine 12 hours after the initial vial puncture, and not after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  This patient had not reported symptoms.  No additional doses and medications have been administered in response.  Upon follow up, reportedly, agent clarified that patient's concerns were regarding the administration of Moderna COVID-19 vaccine 12 hours after the initial vial puncture, and not after the published expiration date.  No additional treatments have been administered in response.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2022: Live significant follow up information received: Event verbatim and narrative updated.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Discomfort, Feeling abnormal, Pain, Pain of skin
Clinical narrative: Thirsty; Ached (from second shot); This spontaneous case was reported by a patient and describes the occurrence of THIRST (Thirsty) and PAIN (Ached (from second shot)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (it was started 20 years ago. The condition was worsening at the time of reporting), Drug allergy (patient lip swell up), Drug allergy and Allergy to NSAIDs.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. In 2021, the patient experienced THIRST (Thirsty) and PAIN (Ached (from second shot)). At the time of the report, THIRST (Thirsty) and PAIN (Ached (from second shot)) had resolved.            It was unknown that patient ever had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient had received 3 vaccines in her deltoid muscle (upper arm). No concomitant medication information provided. Treatment was unknown at the time of reporting.   This case was linked to MOD-2022-597467 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Scratch, Thirst, Urticaria
Clinical narrative: Thirsty; Ached (from second shot); This spontaneous case was reported by a patient and describes the occurrence of THIRST (Thirsty) and PAIN (Ached (from second shot)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (it was started 20 years ago. The condition was worsening at the time of reporting), Drug allergy (patient lip swell up), Drug allergy and Allergy to NSAIDs.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. In 2021, the patient experienced THIRST (Thirsty) and PAIN (Ached (from second shot)). At the time of the report, THIRST (Thirsty) and PAIN (Ached (from second shot)) had resolved.            It was unknown that patient ever had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient had received 3 vaccines in her deltoid muscle (upper arm). No concomitant medication information provided. Treatment was unknown at the time of reporting.   This case was linked to MOD-2022-597467 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Thirst
Clinical narrative: Thirsty; Ached (from second shot); This spontaneous case was reported by a patient and describes the occurrence of THIRST (Thirsty) and PAIN (Ached (from second shot)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (it was started 20 years ago. The condition was worsening at the time of reporting), Drug allergy (patient lip swell up), Drug allergy and Allergy to NSAIDs.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. In 2021, the patient experienced THIRST (Thirsty) and PAIN (Ached (from second shot)). At the time of the report, THIRST (Thirsty) and PAIN (Ached (from second shot)) had resolved.            It was unknown that patient ever had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient had received 3 vaccines in her deltoid muscle (upper arm). No concomitant medication information provided. Treatment was unknown at the time of reporting.   This case was linked to MOD-2022-597467 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient had received 1st dose on 27 Jul 2021 and 2nd dose on 20 Oct 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 1st dose on 27 Jul 2021 and 2nd dose on 20 Oct 2021) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023D21A, 011F21A and 042S21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 2 diabetes mellitus since 23-Dec-2019 and Thyroid disorder (Thyroid) since 23-Dec-2019. Concomitant products included METFORMIN from 01-Dec-2021 to an unknown date and DILTIAZEM for an unknown indication.   On 27-Jul-2021 at 3:12 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Oct-2021 at 12:34 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 06-May-2022 at 11:17 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 20-Oct-2021 at 12:34 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 1st dose on 27 Jul 2021 and 2nd dose on 20 Oct 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 1st dose on 27 Jul 2021 and 2nd dose on 20 Oct 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2022: Live Significant follow-up received and included Reporter details, patients details, medical history & concomitant medications added.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dyspepsia, Gastrooesophageal reflux disease
Clinical narrative: Gastrointestinal distress, upset stomach, acid reflux, heartburn, diarrhea
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site erythema, Administration site pain, Administration site swelling, Back pain, C-reactive protein increased
Clinical narrative: Localized pain, redness, swelling at administration site. Severe and intractable lumbar pain requiring treatment at Emergency Room on 7/2/2022. CRP 25.76 mg/L. Radiography/MRI performed - findings of anterolisthesis L4/L5 and zygapophyseal tenosynvitis w/ mild surrounding inflammatory changes. Interventions included  management, oral corticosteroid, referral to neurosurgeon.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Magnetic resonance imaging spinal abnormal, Spinal X-ray abnormal, Spondylolisthesis, Tenosynovitis
Clinical narrative: Localized pain, redness, swelling at administration site. Severe and intractable lumbar pain requiring treatment at Emergency Room on 7/2/2022. CRP 25.76 mg/L. Radiography/MRI performed - findings of anterolisthesis L4/L5 and zygapophyseal tenosynvitis w/ mild surrounding inflammatory changes. Interventions included  management, oral corticosteroid, referral to neurosurgeon.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Feeling of body temperature change, Headache, Hypersomnia, Malaise
Clinical narrative: Been sick all day fever at 100° sleeping constantly. Body aches, stuffed up nose that I can't breath through, eyes burn, headache, cold and hot flashes off and on.  Nausea.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nausea, Pain, Pyrexia
Clinical narrative: Been sick all day fever at 100° sleeping constantly. Body aches, stuffed up nose that I can't breath through, eyes burn, headache, cold and hot flashes off and on.  Nausea.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Body rash, hives.  Currently taking over the counter antihistamines.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Computerised tomogram thorax normal, Electrocardiogram abnormal, Extrasystoles, Troponin normal
Clinical narrative: He developed a dysrhythmia - Bigeminy as noted on EKG
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dizziness, Dyspnoea, Headache
Clinical narrative: sob, ha, sore throat, dizziness, dry cough, body aches
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, SARS-CoV-2 test positive
Clinical narrative: sob, ha, sore throat, dizziness, dry cough, body aches