chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Feeling exhausted; Still did not feel good; Lost range of motion in right arm; Shaking; Restless; Could not stop chilling; Achy all over; Fever; Injection hurt more than any other IM injection including but not limited to the influenza vaccine; had a terrible headache following vaccination; This spontaneous report was received from a nurse concerning a 61 year old female patient who experienced achy all over (pain),  lost range of motion in right arm (joint range of motion decreased),  shaking (tremor), still did not feel good (malaise),  had a terrible headache following vaccination (headache), could not stop chilling (chills), fever (pyrexia), injection hurt more than any other IM injection including but not limited to the influenza vaccine (injection site pain), restless (restlessness) and feeling exhausted (fatigue).  The patient's medical history included COVID 19. Concomitant medications were not reported.   On 03 JAN 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot 039K20-2A) intramuscularly in the right deltoid.  On 03 Jan 2021, the patient experienced injection hurt more than any other IM injection including but not limited to the influenza vaccine, a diminished range of motion in her right arm, which got worse through the night. Within two hours, after vaccination, she began to feel achy all over. She was chilling and shaking and stated that her pain level increased from one to seven and she was restless with the pain overnight. Her temperature went up to 102 degrees F, and day after receiving vaccine she used Tylenol which brought it down to 100, but she still did not feel good. All symptoms that she attributes to the vaccine started fast and she felt like she actually had COVID 19. She had terrible headache, following vaccination, and chills. When she was diagnosed with  COVID, could not taste or smell, and her sense of smell and taste is still touch and go, but she does not believe it was related to the vaccine. Symptoms are no longer ongoing.  Treatment for the events included Tylenol.   Action taken with  mRNA-1273 in response to the events was not applicable. Second dose was scheduled for 29 JAN 2021.   The events of achy all over (pain),  lost range of motion in right arm (joint range of motion decreased),  shaking (tremor), still did not feel good (malaise), had a terrible headache following vaccination (headache), could not stop chilling (chills), fever (pyrexia), injection hurt more than any other IM injection including but not limited to the influenza vaccine (injection site pain), restless (restlessness) and feeling exhausted (fatigue) were considered recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood glucose increased, Body temperature increased, Insomnia, Myalgia
Clinical narrative: Urine came out of me at its own will; Didn't sleep in all the night; Back pain; Temperature was 99.4; Body pain; Nauseous; Blood sugar was elevated over 400; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar was elevated over 400), URINARY INCONTINENCE (Urine came out of me at its own will), INSOMNIA (Didn't sleep in all the night), BACK PAIN (Back pain) and BODY TEMPERATURE INCREASED (Temperature was 99.4) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blind, Vertigo, Neuropathy, Hypertension and Diabetes mellitus.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar was elevated over 400). On 21-Jan-2021, the patient experienced URINARY INCONTINENCE (Urine came out of me at its own will), INSOMNIA (Didn't sleep in all the night), BACK PAIN (Back pain), BODY TEMPERATURE INCREASED (Temperature was 99.4), MYALGIA (Body pain) and NAUSEA (Nauseous). The patient was treated with OXYCODONE HYDROCHLORIDE (OXYCONTIN) for Back pain, at an unspecified dose and frequency. On 23-Jan-2021, BLOOD GLUCOSE INCREASED (Blood sugar was elevated over 400), URINARY INCONTINENCE (Urine came out of me at its own will), INSOMNIA (Didn't sleep in all the night), BACK PAIN (Back pain), BODY TEMPERATURE INCREASED (Temperature was 99.4), MYALGIA (Body pain) and NAUSEA (Nauseous) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Blood glucose increased: 400 (High) Over 400 for 8 hours. On 20-Jan-2021, Body temperature increased: 99.4 (abnormal) 99.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products used included trigeminal neuralgia medication, vertigo medication, neuropathy medication, high blood pressure medication, diabetes medication and stroke medication.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: Follow-up received and added Patient demographics, medical history, concomitant medications, stop date for events and treatment provided were reported. On 09-Jun-2021: follow up received and added patient doctor had not allowed him to have the second shot.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Urinary incontinence
Clinical narrative: Urine came out of me at its own will; Didn't sleep in all the night; Back pain; Temperature was 99.4; Body pain; Nauseous; Blood sugar was elevated over 400; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar was elevated over 400), URINARY INCONTINENCE (Urine came out of me at its own will), INSOMNIA (Didn't sleep in all the night), BACK PAIN (Back pain) and BODY TEMPERATURE INCREASED (Temperature was 99.4) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blind, Vertigo, Neuropathy, Hypertension and Diabetes mellitus.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar was elevated over 400). On 21-Jan-2021, the patient experienced URINARY INCONTINENCE (Urine came out of me at its own will), INSOMNIA (Didn't sleep in all the night), BACK PAIN (Back pain), BODY TEMPERATURE INCREASED (Temperature was 99.4), MYALGIA (Body pain) and NAUSEA (Nauseous). The patient was treated with OXYCODONE HYDROCHLORIDE (OXYCONTIN) for Back pain, at an unspecified dose and frequency. On 23-Jan-2021, BLOOD GLUCOSE INCREASED (Blood sugar was elevated over 400), URINARY INCONTINENCE (Urine came out of me at its own will), INSOMNIA (Didn't sleep in all the night), BACK PAIN (Back pain), BODY TEMPERATURE INCREASED (Temperature was 99.4), MYALGIA (Body pain) and NAUSEA (Nauseous) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Blood glucose increased: 400 (High) Over 400 for 8 hours. On 20-Jan-2021, Body temperature increased: 99.4 (abnormal) 99.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products used included trigeminal neuralgia medication, vertigo medication, neuropathy medication, high blood pressure medication, diabetes medication and stroke medication.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: Follow-up received and added Patient demographics, medical history, concomitant medications, stop date for events and treatment provided were reported. On 09-Jun-2021: follow up received and added patient doctor had not allowed him to have the second shot.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Incorrect route of product administration, Pain in extremity, Pyrexia
Clinical narrative: Soreness of the arm; Inappropriate route of vaccine administration(Implant); Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, INCORRECT ROUTE OF PRODUCT ADMINISTRATION, CHILLS, and PYREXIA in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY, INCORRECT ROUTE OF PRODUCT ADMINISTRATION, CHILLS, and PYREXIA. At the time of the report, PAIN IN EXTREMITY, INCORRECT ROUTE OF PRODUCT ADMINISTRATION, CHILLS, and PYREXIA outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided. Sender's Comments: This report refers to a case of Product administration error  for mRNA-1273, lot # unknown with associated AEs (Soreness of the arm, Chills, Fever). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Feeling cold, Headache, Heart rate
Clinical narrative: slept for 9 hours (which is not normal for me); muscle aches; temperature of 100.4 F (Fahrenheit); dizziness; injection site is pink and hurts so much I cannot lift my arm; injection site is pink and hurts so much I cannot lift my arm; heart rate is elevated; slight headache; Felt cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD, HYPERSOMNIA, MYALGIA, PYREXIA, and DIZZINESS in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mastectomy.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FEELING COLD (Felt cold). On 15-Jan-2021, the patient experienced HYPERSOMNIA, MYALGIA, PYREXIA, DIZZINESS, INJECTION SITE ERYTHEMA, INJECTION SITE PAIN, HEART RATE INCREASED, and HEADACHE. On 15-Jan-2021, DIZZINESS outcome was unknown. At the time of the report, FEELING COLD, HYPERSOMNIA, MYALGIA, PYREXIA, INJECTION SITE ERYTHEMA, INJECTION SITE PAIN, HEART RATE INCREASED, and HEADACHE outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 100.4 f. (Inconclusive) 100.4 F. On 15-Jan-2021, Heart rate: 92 normal (normal) 92.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypersomnia, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: slept for 9 hours (which is not normal for me); muscle aches; temperature of 100.4 F (Fahrenheit); dizziness; injection site is pink and hurts so much I cannot lift my arm; injection site is pink and hurts so much I cannot lift my arm; heart rate is elevated; slight headache; Felt cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD, HYPERSOMNIA, MYALGIA, PYREXIA, and DIZZINESS in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mastectomy.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FEELING COLD (Felt cold). On 15-Jan-2021, the patient experienced HYPERSOMNIA, MYALGIA, PYREXIA, DIZZINESS, INJECTION SITE ERYTHEMA, INJECTION SITE PAIN, HEART RATE INCREASED, and HEADACHE. On 15-Jan-2021, DIZZINESS outcome was unknown. At the time of the report, FEELING COLD, HYPERSOMNIA, MYALGIA, PYREXIA, INJECTION SITE ERYTHEMA, INJECTION SITE PAIN, HEART RATE INCREASED, and HEADACHE outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 100.4 f. (Inconclusive) 100.4 F. On 15-Jan-2021, Heart rate: 92 normal (normal) 92.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: slept for 9 hours (which is not normal for me); muscle aches; temperature of 100.4 F (Fahrenheit); dizziness; injection site is pink and hurts so much I cannot lift my arm; injection site is pink and hurts so much I cannot lift my arm; heart rate is elevated; slight headache; Felt cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD, HYPERSOMNIA, MYALGIA, PYREXIA, and DIZZINESS in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mastectomy.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FEELING COLD (Felt cold). On 15-Jan-2021, the patient experienced HYPERSOMNIA, MYALGIA, PYREXIA, DIZZINESS, INJECTION SITE ERYTHEMA, INJECTION SITE PAIN, HEART RATE INCREASED, and HEADACHE. On 15-Jan-2021, DIZZINESS outcome was unknown. At the time of the report, FEELING COLD, HYPERSOMNIA, MYALGIA, PYREXIA, INJECTION SITE ERYTHEMA, INJECTION SITE PAIN, HEART RATE INCREASED, and HEADACHE outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 100.4 f. (Inconclusive) 100.4 F. On 15-Jan-2021, Heart rate: 92 normal (normal) 92.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Administration site bruise, Vaccination site erythema, Vaccination site pain
Clinical narrative: Bruise 2" wide brown spot on the right of injection site; Redness next to the injection site; Injection site was aching a little; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA, and ADMINISTRATION SITE BRUISE in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction. Concomitant products included VITAMIN D.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN. On 05-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA. On 15-Jan-2021, the patient experienced ADMINISTRATION SITE BRUISE. On 06-Jan-2021, VACCINATION SITE PAIN had resolved. On 07-Jan-2021, VACCINATION SITE ERYTHEMA had resolved. At the time of the report, ADMINISTRATION SITE BRUISE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pain of skin, Pruritus
Clinical narrative: Skin is tender all over; Itchy; Skin was flushed; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING, PAIN OF SKIN, and PRURITUS in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced FLUSHING and PRURITUS. On 15-Jan-2021, the patient experienced PAIN OF SKIN. The patient was treated with BENADRYL on 14-Jan-2021 at a dose of 25 milligram. At the time of the report, FLUSHING, PAIN OF SKIN, and PRURITUS had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Treatment medications included Diphenhydramine.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Stomatitis, Tongue disorder
Clinical narrative: sores; few white dots on my tongue; left arm painful; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (sores), TONGUE DISORDER, and PAIN IN EXTREMITY (left arm painful) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced STOMATITIS (sores), TONGUE DISORDER, and PAIN IN EXTREMITY (left arm painful). On 07-Jan-2021, STOMATITIS (sores), TONGUE DISORDER, and PAIN IN EXTREMITY (left arm painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. She reports rinsing mouth with warm water and salt. She applied Abreva on the outer part of her lip. She rinsed with Listerine.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up was received on 20 may 2021  significant case included event start and stop date added and second dose taken. No further follow up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; inadvertently administering VARlVAX on 03AUG2021 after the product expired on 25JUN2021; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.     On 03-AUG-2021, the patient was inadvertently vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S019584 was confirmed to be valid, expiration date 25-JUN-2021, 1 dosage form (route of administration, anatomical location were not reported) for prophylaxis. No additional adverse effect was reported. The reporter confirmed that this product did not have any known temperature excursions.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives completely on her chest wall and neck; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives completely on her chest wall and neck) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (EUTHYROX) for Hypothyroidism.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced URTICARIA (Hives completely on her chest wall and neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY NIGHTTIME) (oral) for Urticaria, at a dose of 50 mg. On 08-Jan-2021, URTICARIA (Hives completely on her chest wall and neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Current condition and concomitant medication; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Headache, Heart rate
Clinical narrative: Heart rate increased from 98 to 114; Dizziness; Hyperhidrosis; Blood pressure increased; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of TACHYCARDIA (Heart rate increased from 98 to 114), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), BLOOD PRESSURE INCREASED (Blood pressure increased) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug hypersensitivity (allergy to sulfa) and Drug allergy (allergy to codeine). Concomitant products included SPIRONOLACTONE, NALTREXONE+BUPROPIN, PHENTERMINE, ROPINIROLE HYDROCHLORIDE (REQUIP), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), VITAMINS NOS (MULTIVITAMINUM) and IBUPROFEN for an unknown indication, SERTRALINE and trazadone.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced TACHYCARDIA (Heart rate increased from 98 to 114), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), BLOOD PRESSURE INCREASED (Blood pressure increased) and HEADACHE (Headache). At the time of the report, TACHYCARDIA (Heart rate increased from 98 to 114), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), BLOOD PRESSURE INCREASED (Blood pressure increased) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, Blood pressure measurement: 142/88 (High) elevated BP ranging from 138/72- 142/88. On 28-Dec-2020, Heart rate: 114 (High) elevated HR from 98-114  After sitting HR went down to 88.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Tachycardia
Clinical narrative: Heart rate increased from 98 to 114; Dizziness; Hyperhidrosis; Blood pressure increased; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of TACHYCARDIA (Heart rate increased from 98 to 114), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), BLOOD PRESSURE INCREASED (Blood pressure increased) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug hypersensitivity (allergy to sulfa) and Drug allergy (allergy to codeine). Concomitant products included SPIRONOLACTONE, NALTREXONE+BUPROPIN, PHENTERMINE, ROPINIROLE HYDROCHLORIDE (REQUIP), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), VITAMINS NOS (MULTIVITAMINUM) and IBUPROFEN for an unknown indication, SERTRALINE and trazadone.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced TACHYCARDIA (Heart rate increased from 98 to 114), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), BLOOD PRESSURE INCREASED (Blood pressure increased) and HEADACHE (Headache). At the time of the report, TACHYCARDIA (Heart rate increased from 98 to 114), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), BLOOD PRESSURE INCREASED (Blood pressure increased) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, Blood pressure measurement: 142/88 (High) elevated BP ranging from 138/72- 142/88. On 28-Dec-2020, Heart rate: 114 (High) elevated HR from 98-114  After sitting HR went down to 88.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3 doses; This case was reported by a other health professional via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 2 doses on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient accidentally received 3 doses of Shingrix, which led to extra dose administered. The reporter wanted to know if it was safe.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Incomplete course of vaccination, Neck pain, Pain in extremity
Clinical narrative: severe neck / pain for a month; severe / arm / pain for a month; severe / back pain for a month; had my first Shingrix shot Jan. 14th and was due for second one in July / How long past my time can I wait for second shot?; This case was reported by a consumer via media and described the occurrence of neck pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced neck pain, pain in arm, back pain and incomplete course of vaccination. On an unknown date, the outcome of the neck pain, pain in arm and back pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the neck pain, pain in arm and back pain to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported for 1st dose and was not applicable for 2nd dose. The patient had received 1st dose of Shingrix and experienced severe neck, arm and back pain for a month. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The patient enquired how long past time he/she could wait for second shot.
Sex: U
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: mixed menveo with diluant and not liquid part of menveo; mixed menveo with diluant and not liquid part of menveo; This case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional case details were provided as follows: The age at vaccination was not reported. Menveo was mixed with diluent and not liquid part of menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.. The reporter agreed to follow up. This case was 1 of 3 case reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR166884:same reporter US-GLAXOSMITHKLINE-US2021AMR166885:same reporter
Sex: U
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: mixed menveo with diluant and not liquid part of menveo; mixed menveo with diluant and not liquid part of menveo; This case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional case details were provided as follows: The age at vaccination was not reported. Menveo was mixed with diluent and not liquid part of Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter agreed to follow up. This case was 1 of 3 case reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR166851:same reporter US-GLAXOSMITHKLINE-US2021AMR166885:same reporter
Sex: U
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: mixed menveo with diluant and not liquid part of menveo; mixed menveo with diluant and not liquid part of menveo; This case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional case details were provided as follows: The age at vaccination was not reported. Menveo was mixed with diluent and not liquid part of menveo which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter agreed to follow up. This case was 1 of 3 case reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR166884:same reporter US-GLAXOSMITHKLINE-US2021AMR166851:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: After 7 weeks / arm still hurts; This case was reported by a other health professional via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided are as follows: The age at vaccination was not reported. The reporter reported that, the patient of him/her got the shingles shot in unknown arm and after 7 weeks their arm still hurts. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the Shot But I still got the Shingles/ suspected vaccination failure; got the Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated that he/she got the shingles shot but still got the Shingles and his/her physician said it would had been a lot worse, if had he/she not took the shot, so make sure you get the shot. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: got the two series shot. Got shingles again/ suspected vaccination failure; Got shingles again; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she never had chickenpox, so he/she skipped getting vaccinated and got shingles anyway. The patient received 2 series Shingles vaccine and got shingles again but not as severe. The patient stated vaccine worked. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine but still got / shingles/ suspected vaccination failure; got / shingles.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received vaccine but still got the horrible shingles. The patient stated that he/she paid but still got shingles. The follow-up would not possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shots. Still got shingles/ Suspected vaccination failure; Got shingles / mild case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received the Shingles shots and still got shingles. But relatively mild case. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; have the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The patient reported that, he or she had received the Shingles shot and still had the shingles.  So the patient stated that the shot did not work. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Someone who got both shots and still got a bad case/ Suspected vaccination failure; Got a bad case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got both shots and still got a bad case. The reporter stated that Shingles vaccine doesn't always work, but still a good idea to get. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: was administrated with Havrix after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old male patient who received HAV (Havrix) (batch number 7hj74, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th July 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was administrated with Havrix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 29 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: received the 1 dose / on 12/10/2020 / 1, 6-month doses were not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 10th December 2020 from batch number P4DJ5).   On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. The action taken with Engerix B Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: Age at vaccination was not applicable for this report. Health care professional was called to report that the patient received 1st dose of Engerix B and did not receive the 2nd dose, till the time of reporting. VAERS details was provided for the 1st dose of Engerix. The reporter consented to follow-up. This case is linked with case US2021164835, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164835:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: developed shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and after that developed shingles. The health care professional was not willing to provide patient's identifiers, dates, lot number nor expiration date. The reporter did not consent to follow up.