chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arterial spasm, Balance disorder, Bell's palsy, Blood test normal, Computerised tomogram normal
Clinical narrative: Oct. 02, 2021 -6 hours after injection: extreme brain fog (couldn't speak or write), whole left side (face, arm, hand, leg, foot) went numb and weak, lips tingled, headaches, fatigue, dizziness, off balance, pain in right groin and top of right calf behind knee, lymph nodes under arms hurt. all symptoms ongoing. Dec. 28, 2021 carotids hurting and twitching, all other symptoms ongoing. February 16, 2022 heart racing at rest (palpations) on and off. all previous symptoms ongoing.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysgraphia, Electroencephalogram normal, Electromyogram normal, Fatigue
Clinical narrative: Oct. 02, 2021 -6 hours after injection: extreme brain fog (couldn't speak or write), whole left side (face, arm, hand, leg, foot) went numb and weak, lips tingled, headaches, fatigue, dizziness, off balance, pain in right groin and top of right calf behind knee, lymph nodes under arms hurt. all symptoms ongoing. Dec. 28, 2021 carotids hurting and twitching, all other symptoms ongoing. February 16, 2022 heart racing at rest (palpations) on and off. all previous symptoms ongoing.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Groin pain, Headache, Hemiparesis, Hypoaesthesia
Clinical narrative: Oct. 02, 2021 -6 hours after injection: extreme brain fog (couldn't speak or write), whole left side (face, arm, hand, leg, foot) went numb and weak, lips tingled, headaches, fatigue, dizziness, off balance, pain in right groin and top of right calf behind knee, lymph nodes under arms hurt. all symptoms ongoing. Dec. 28, 2021 carotids hurting and twitching, all other symptoms ongoing. February 16, 2022 heart racing at rest (palpations) on and off. all previous symptoms ongoing.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Magnetic resonance imaging head, Neurological examination, Neuropathy peripheral, Pain
Clinical narrative: Oct. 02, 2021 -6 hours after injection: extreme brain fog (couldn't speak or write), whole left side (face, arm, hand, leg, foot) went numb and weak, lips tingled, headaches, fatigue, dizziness, off balance, pain in right groin and top of right calf behind knee, lymph nodes under arms hurt. all symptoms ongoing. Dec. 28, 2021 carotids hurting and twitching, all other symptoms ongoing. February 16, 2022 heart racing at rest (palpations) on and off. all previous symptoms ongoing.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Palpitations, Paraesthesia oral, Speech disorder, Thyroid function test
Clinical narrative: Oct. 02, 2021 -6 hours after injection: extreme brain fog (couldn't speak or write), whole left side (face, arm, hand, leg, foot) went numb and weak, lips tingled, headaches, fatigue, dizziness, off balance, pain in right groin and top of right calf behind knee, lymph nodes under arms hurt. all symptoms ongoing. Dec. 28, 2021 carotids hurting and twitching, all other symptoms ongoing. February 16, 2022 heart racing at rest (palpations) on and off. all previous symptoms ongoing.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler, Vitamin B12
Clinical narrative: Oct. 02, 2021 -6 hours after injection: extreme brain fog (couldn't speak or write), whole left side (face, arm, hand, leg, foot) went numb and weak, lips tingled, headaches, fatigue, dizziness, off balance, pain in right groin and top of right calf behind knee, lymph nodes under arms hurt. all symptoms ongoing. Dec. 28, 2021 carotids hurting and twitching, all other symptoms ongoing. February 16, 2022 heart racing at rest (palpations) on and off. all previous symptoms ongoing.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: pt presents to hospital with increasing dyspnea; O2 supplementation; positive test for COVID; AHRF due to COVID; given decadron, vitamins C, D, and zinc; code blue called and ACLS initiated; despite several rounds of ACLS, unable to revive pt
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Cardio-respiratory arrest, Dyspnoea, Life support
Clinical narrative: pt presents to hospital with increasing dyspnea; O2 supplementation; positive test for COVID; AHRF due to COVID; given decadron, vitamins C, D, and zinc; code blue called and ACLS initiated; despite several rounds of ACLS, unable to revive pt
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: pt presents to hospital with increasing dyspnea; O2 supplementation; positive test for COVID; AHRF due to COVID; given decadron, vitamins C, D, and zinc; code blue called and ACLS initiated; despite several rounds of ACLS, unable to revive pt
Age: 91.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: pt brought to ED with cough and weakness; found to be positive for COVID; given Decadron, ABX, O2 supplementation; transferred to ICU; intubated with mechanical ventilation; experienced A Fib with RVR; DNR; pt worsened with a decrease in renal function and leukocytosis; family desired to transition pt to comfort measures; pt passed away in the hospital
Age: 91.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Atrial fibrillation, COVID-19, Cough, Death
Clinical narrative: pt brought to ED with cough and weakness; found to be positive for COVID; given Decadron, ABX, O2 supplementation; transferred to ICU; intubated with mechanical ventilation; experienced A Fib with RVR; DNR; pt worsened with a decrease in renal function and leukocytosis; family desired to transition pt to comfort measures; pt passed away in the hospital
Age: 91.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, Intensive care, Leukocytosis, Mechanical ventilation, Renal impairment
Clinical narrative: pt brought to ED with cough and weakness; found to be positive for COVID; given Decadron, ABX, O2 supplementation; transferred to ICU; intubated with mechanical ventilation; experienced A Fib with RVR; DNR; pt worsened with a decrease in renal function and leukocytosis; family desired to transition pt to comfort measures; pt passed away in the hospital
Age: 91.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: pt brought to ED with cough and weakness; found to be positive for COVID; given Decadron, ABX, O2 supplementation; transferred to ICU; intubated with mechanical ventilation; experienced A Fib with RVR; DNR; pt worsened with a decrease in renal function and leukocytosis; family desired to transition pt to comfort measures; pt passed away in the hospital
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: Hospitalized with hypercapnic respiratory failure intubated multiple times. Dexamethasone and remdesivir pt with fungal lung infection along with COVID 19 pneumonia.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Endotracheal intubation, Pneumonia fungal, Respiratory failure
Clinical narrative: Hospitalized with hypercapnic respiratory failure intubated multiple times. Dexamethasone and remdesivir pt with fungal lung infection along with COVID 19 pneumonia.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Electrocardiogram, Haemodynamic instability, Laboratory test, Palpitations
Clinical narrative: patient with palpitations, had intermittent non-sustained episodes of SVT lasting seconds and spontaneously resolving without any hemodynamic instability noted on 3/9/22 at ED, unknown underlying cause, admitted for monitoring given symptomatic
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Supraventricular tachycardia, Urine analysis
Clinical narrative: patient with palpitations, had intermittent non-sustained episodes of SVT lasting seconds and spontaneously resolving without any hemodynamic instability noted on 3/9/22 at ED, unknown underlying cause, admitted for monitoring given symptomatic
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Agitation, Blood glucose increased, Computerised tomogram head abnormal, Gastrostomy
Clinical narrative: Patient was functioning normally before receiving vaccine per nursing home staff and patient's wife. Able to walk and eat/drink, speak, and communicate at his usual baseline. Two days after receiving his vaccine he developed an inability to speak and change in behavior. Patient was evaluated in the ER for altered mental status and was noted to be agitated. Head CT done, provider recommended head/neck/carotid CTA but not done at this facility. Patient was admitted to Hospital and treated for metabolic encephalopathy. PEG tube replaced (had previously after stroke in October 2021) and patient was given an insulin drip per wife. Writer did not obtain records from admitting facility. Patient was hospitalized from 2/20/22 to 3/8/22. Patient remains worsened from baseline per wife and nursing home staff. This situation came to my attention when he was seen in the ER today (3/9/22) for high blood sugar levels in the 900s and has now been admitted to the hospital.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test normal, Mental status changes, Metabolic encephalopathy, Speech disorder
Clinical narrative: Patient was functioning normally before receiving vaccine per nursing home staff and patient's wife. Able to walk and eat/drink, speak, and communicate at his usual baseline. Two days after receiving his vaccine he developed an inability to speak and change in behavior. Patient was evaluated in the ER for altered mental status and was noted to be agitated. Head CT done, provider recommended head/neck/carotid CTA but not done at this facility. Patient was admitted to Hospital and treated for metabolic encephalopathy. PEG tube replaced (had previously after stroke in October 2021) and patient was given an insulin drip per wife. Writer did not obtain records from admitting facility. Patient was hospitalized from 2/20/22 to 3/8/22. Patient remains worsened from baseline per wife and nursing home staff. This situation came to my attention when he was seen in the ER today (3/9/22) for high blood sugar levels in the 900s and has now been admitted to the hospital.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling, prickling, and numbness.  GBS symptoms.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Malaise, Tachycardia
Clinical narrative: Generalized malaise, tachycardia and flushed cheeks
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: left arm pain since vaccination 12/31/19.pain mostly just at night while sleeping. hurts more If puts left arm over chest; Information was received from Food and Drug Administration on 04-FEB-2022.  This spontaneous report was received from healthcare professional/staff member and refers to a 12-year-old female patient. Her chronic or long-standing health conditions included atrioventricular (AV) block first degree, chronic urinary tract infection (UTI), anisometropia, myopia, amblyopia of left eye, tuberculosis (TB) positive with treatment and being adopted at age 4.  On 31-DEC-2019 at 14:00, she was vaccinated with a first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered intramuscularly into left arm, lot # R025728, expiration date 18-JUN-2021 (dose was not reported) for prophylaxis. Vaccination facility was reported as doctor's office, urgent care or hospital. It was reported that the patient was not pregnant at the time of vaccination. On the same day (reported as "since vaccination"), the patient experienced left arm pain mostly just at night while sleeping. The patient stated that it hurt more if she puts left arm over chest. On 13-JAN-2020, the patient visited doctor or other healthcare professional office with her mom as a result of adverse event. Outcome of pain in left arm was unknown.  Causality assessment was not provided.  The agency considered report as non-serious.  Follow-up information was received from the registered nurse on 24-FEB-2022. The reporter stated that without the patient's name and date of birth they cannot provide any information. Additional information is not expected.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; they accidently gave a VARlVAX that had expired the previous day; This spontaneous report was received from a nurse and refers to a 12-month-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-JAN-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #T002842, expiration date: 23-JAN-2022, administered subcutaneously (strength was not provided) for prophylaxis (expired product administered) with sterile diluent lot # T014299, expiration date: 28-NOV-2022. The products had no temperature excursions. The patient had no known side effects (no adverse event).
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report was received from a Medical Assistant referring to a 13 month old patient (gender not specified). The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported.   On 13-DEC-2021, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # U024221; expiration date: 04-OCT-2023) for prophylaxis which was improperly stored. It was mentioned that the temperature was 39.55 degrees Farhenheit for a time frame of 10 hours. There were no previous temperature excursion. No adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE information provided; expired VAQTA; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 13-JAN-2022, the patient was vaccinated with expired hepatitis a vaccine, inactivated(VAQTA) (1 ml, lot # T014590, expiration date was reported and internal validation established as 15-APR-2021, strength and route were not provided) for prophylaxis (expired product administered).The product had been properly stored and there were no excursions on the product.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; expired dose of GARDASIL 9 was administered to a patient; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 19-JAN-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # S010729; expiration date 01-DEC-2021; strength, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). It was confirmed that the expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) did not experience a temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired dose of GARDASIL 9 was administered to a patient; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 18-JAN-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # S010729; expiration date 01-DEC-2021; strength, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). It was confirmed that the expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) did not experience a temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired dose of GARDASIL 9 was administered; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 20-JAN-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # S010729; expiration date 01-DEC-2021; strength, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). It was confirmed that the expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) did not experience a temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; administration of expired vaccine; This spontaneous report was received from registered nurse and refers to 78-year-old female patient. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.   On 11-FEB-2022, the patient was vaccinated with expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), dose: 1 (unit not provided), lot# T009744, expiration date: 28-JAN-2022 (route of administration was not provided) for prophylaxis (expired product administered). The reporter confirmed Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not involved in any prior temperature excursions and had been stored per the recommended storage range until administration. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional information; Expired dose of PQOQUAD was administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 17-FEB-2022, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), 0.5 milliliter, (Lot# T028297 and expiration date 16-FEB-2022) (exact dose, frequency, route of administration were not reported) as prophylaxis. (expired product administered). There was no previous temperature excursion. No additional adverse event reported, no further information provided.
Sex: F
Vaccine: HPV9
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: there is a female patient in her 60's at their office that the vaccine is being considered for due to "very stubborn" hand warts.; there is a female patient in her 60's at their office that the vaccine is being considered for due to "very stubborn" hand warts.; there is a female patient in her 60's at their office that the vaccine is being considered for due to "very stubborn" hand warts.; This spontaneous report as received from a physician via medical assistant refers to female patient who would be "in her 60's" at the time of report. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was considered to start therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, expiration date and lot number unknown) (Circumstance or information capable of leading to medication error, inappropriate age at vaccine administration) of "very stubborn" warts on the hands (off-label use on unapproved indication), as the physician has read a few articles about the off label use of GARDASIL 9 in the treatment of warts on the hands.   The reporter confirmed that at the time of this report, the vaccine has not been administered to the patient.  This is one of two reports received from the same reporter.; Sender's Comments:  US-09507513-2202USA004993:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Refused a dose of Rotateq for a patient and the patient missed the dose; No further adverse event reported, no further information; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were not reported.   On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) Lot# 1742434, expiration date : 16-MAR-2023 (exact dose, frequency, anatomical site were not reported) as prophylaxis. The parent of patient refused a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for a patient (product dose omission issue). No additional adverse event reported, no further information provided
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  The blow vaccines (stored hepatitis b vaccine (recombinant)(RECOMBIVAX HB) and rotavirus vaccine, live, oral, pentavalent(ROTATEQ)) experienced a temperature excursion on 29-DEC-2021. On 06-JAN-2022, the patient was vaccinated with improper stored hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (lot# T032918, expiration date 12-NOV-2022, once, dose, route and strength were not provided) and rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot# 1742430, expiration date 16-SEP-2022, once, orally, dose and strength were not provided) for prophylaxis. The vaccine administered experienced temperature excursions of 35.9 Degree Fahrenheit for 20 minutes (product storage error). There was no previous temperature excursion. No additional adverse event reported.; Sender's Comments:  US-009507513-2202USA007167:
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; administered ROTATEQ and RECOMBIVAX HB after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 29-DEC-2021, hepatitis b vaccine (recombinant) (RECOMBIVAX HB) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion with 35.9 Fahrenheit degrees for 0 hours 20 minutes 0 seconds. There was no previous temperature excursion.  On 04-JAN-2022, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (once, lot # 1742430, expiration date 16-SEP-2022; strength was not reported) orally and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (once, lot # T032918, expiration date 12-NOV-2022; strength, route and anatomical location were not reported), both for prophylaxis (product storage error). No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA007167: US-009507513-2202USA006998: US-009507513-2202USA007571: US-009507513-2202USA007032: US-009507513-2202USA007028:
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: Shingles; zoster related-conditions; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   On or about 06-OCT-2011, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for the long-term prevention of shingles and zoster related-conditions.   On an unknown date, the patient was treated by a family nurse practitioner for shingles and other zoster-related conditions (ill-defined disorder).  The outcome of the shingles and other zoster-related conditions (ill-defined disorder) was unknown and the casuality assessment between the aforementioned events and the vaccination with a dose of zoster vaccine live (ZOSTAVAX) was reported as related.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: Shingles; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications.   On or about 11-SEP-2012, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for the long-term prevention of shingles and zoster related-conditions.   On an unknown date, the patient was treated by a physician for shingles and other zoster-related conditions (ill-defined disorder).  The outcome of the shingles and other zoster-related conditions (ill-defined disorder) was unknown and the casuality assessment between the aforementioned events and the vaccination with a dose of zoster vaccine live (ZOSTAVAX) was reported as related.  Follow-up information received from pharmacy records on 24-FEB-2022 indicated that the patient was vaccinated on 11-SEP-2012 with a dose of zoster vaccine live (ZOSTAVAX) at a pharmacy. Later, on 02-OCT-2012, the patient was also vaccinated with a dose of influenza vaccine inact sag 3v(FLUVIRIN) multidose vial, 0.5 ml (lot number, dosage and route of administration not provided).
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; administered ROTATEQ and RECOMBIVAX HB after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 29-DEC-2021, hepatitis b vaccine (recombinant) (RECOMBIVAX HB) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion with 35.9 Fahrenheit degrees for 0 hours 20 minutes 0 seconds. There was no previous temperature excursion.  On 03-JAN-2022, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (once, lot # 1742430, expiration date 16-SEP-2022; strength was not reported) orally and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (once, lot # T032918, expiration date 12-NOV-2022; strength was not reported), both for prophylaxis (product storage error). No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA007167: US-009507513-2202USA007118: US-009507513-2202USA006998: US-009507513-2202USA007028: US-009507513-2202USA007032:
Sex: F
Vaccine: HEP, HEPA
Symptoms: Fibromyalgia
Clinical narrative: set off fibromyalgia; This spontaneous report was received from a nurse and refers to a female patient (daughter) of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown) or hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as "the hepatitis vaccine", the type was not specified) for prophylaxis (route of administration, dose, lot number and expiration date were not provided).  On an unknown date, the patient experienced fibromyalgia. She had a reaction to the hepatitis vaccine, that led to her withdrawing from college for a semester.  The outcome of fibromyalgia was reported as not recovered/not resolved. The reporter considered fibromyalgia to be related to hepatitis a vaccine, inactivated (manufacturer unknown) and hepatitis b vaccine (recombinant) (manufacturer unknown).
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE information provided; via the intramuscular route rather than the subcutaneous route; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 04-MAR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml via the intramuscular route rather than the subcutaneous route (lot #U027947, expiration date 08-SEP-2023; anatomical location not reported) for prophylaxis (incorrect route of product administration). No additional adverse event (AE) information provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE; a patient was administered VARIVAX by intramuscular route; This spontaneous report was received from registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported.  On 03-MAR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL by intramuscular route (lot #U025205, expiration date 13-AUG-2023; anatomical location not reported) for prophylaxis (incorrect route of product administration). The administered vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) 0.5 mL (lot# and expiration date were not provided). No additional adverse event (AE).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE.; an expired dose of PROQUAD that was administered; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.      On 04-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, lot # T028297, expiry date 16-FEB-2022 (route of administration and vaccination site were not reported) for prophylaxis. No adverse event was reported.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Excessive granulation tissue, Injection site movement impairment, Injury, Laboratory test
Clinical narrative: Vaccination site necrosis; fever; feverish chill; her arm ended up with erythema; red and tight and went up to the elbow; This spontaneous report was received from a consumer refers to a 59 year-old female patient concerning herself. The patient's concurrent conditions included lipoedema, asthma, hypertension, fibromyalgia and arthritis. The patient was allergic to codeine.      On 15-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and with influenza vaccine in the same arm (dose, route, lot number and expiration date were not reported). Concomitant therapies included ketorolac tromethamine (TORADOL), hydroxyzine hydrochloride, antibiotics and ketorolac tromethamine.     In September 2020, the patient experienced vaccine necrotic tissue (vaccination site necrosis). She was sick and got a "105 fever", feverish chill and her arm ended up with erythema where it got red and tight and went up to the elbow (injection site movement impairment). The patient received pain medications, antibiotics and wound care from 12-NOV-2020 to 04-JAN-2021, and she took seven trips there over a course of seven weeks. The patient had to take the "gunk" out and said it was trauma. At the end, she had a large patch of granulation, and it's sunken in. A laboratories from primary care physician and rheumatologist were performed, but the results were not reported.  The outcome of the events was reported as not recovered/not resolved.     The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).  Upon internal review, the event of vaccination site necrosis was considered to be medically significant.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Malaise, Pyrexia, Skin indentation, Skin tightness, Vaccination site necrosis
Clinical narrative: Vaccination site necrosis; fever; feverish chill; her arm ended up with erythema; red and tight and went up to the elbow; This spontaneous report was received from a consumer refers to a 59 year-old female patient concerning herself. The patient's concurrent conditions included lipoedema, asthma, hypertension, fibromyalgia and arthritis. The patient was allergic to codeine.      On 15-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and with influenza vaccine in the same arm (dose, route, lot number and expiration date were not reported). Concomitant therapies included ketorolac tromethamine (TORADOL), hydroxyzine hydrochloride, antibiotics and ketorolac tromethamine.     In September 2020, the patient experienced vaccine necrotic tissue (vaccination site necrosis). She was sick and got a "105 fever", feverish chill and her arm ended up with erythema where it got red and tight and went up to the elbow (injection site movement impairment). The patient received pain medications, antibiotics and wound care from 12-NOV-2020 to 04-JAN-2021, and she took seven trips there over a course of seven weeks. The patient had to take the "gunk" out and said it was trauma. At the end, she had a large patch of granulation, and it's sunken in. A laboratories from primary care physician and rheumatologist were performed, but the results were not reported.  The outcome of the events was reported as not recovered/not resolved.     The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).  Upon internal review, the event of vaccination site necrosis was considered to be medically significant.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Wound treatment
Clinical narrative: Vaccination site necrosis; fever; feverish chill; her arm ended up with erythema; red and tight and went up to the elbow; This spontaneous report was received from a consumer refers to a 59 year-old female patient concerning herself. The patient's concurrent conditions included lipoedema, asthma, hypertension, fibromyalgia and arthritis. The patient was allergic to codeine.      On 15-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and with influenza vaccine in the same arm (dose, route, lot number and expiration date were not reported). Concomitant therapies included ketorolac tromethamine (TORADOL), hydroxyzine hydrochloride, antibiotics and ketorolac tromethamine.     In September 2020, the patient experienced vaccine necrotic tissue (vaccination site necrosis). She was sick and got a "105 fever", feverish chill and her arm ended up with erythema where it got red and tight and went up to the elbow (injection site movement impairment). The patient received pain medications, antibiotics and wound care from 12-NOV-2020 to 04-JAN-2021, and she took seven trips there over a course of seven weeks. The patient had to take the "gunk" out and said it was trauma. At the end, she had a large patch of granulation, and it's sunken in. A laboratories from primary care physician and rheumatologist were performed, but the results were not reported.  The outcome of the events was reported as not recovered/not resolved.     The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).  Upon internal review, the event of vaccination site necrosis was considered to be medically significant.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Wrong product administered
Clinical narrative: Patient who received Prevnar 13 instead of Pneumovax 23; This spontaneous report was received from a nurse concerning  a 58 year old male patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.     On an unknown date, the patient was vaccinated with pneumococcal vaccine conj 13v (crm197)(PREVNAR 13) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) instead of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) (wrong product administered).
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Itchy skin; This case was reported by a consumer via patient support programs and described the occurrence of itchy skin in a 75-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included hypertension (the patient was diagnosed with hypertension 10 years before the date of reporting).   On an unknown date, the patient received Shingles vaccine. In February 2022, between 7 and 9 months after receiving Shingles vaccine, the patient experienced itchy skin. On an unknown date, the outcome of the itchy skin was not recovered/not resolved.   The reporter considered the itchy skin to be unrelated to Shingles vaccine.  Additional details were reported as follows: The reporter was patient's spouse. The patient had shingles vaccine about 8 months ago but it was not through this program (P-55319505) and not sure if it was GlaxoSmithKline product. The patient had been itchy from the shingles on his whole body for two weeks now. The reporter consented to follow-up. The reporter declined to consent to follow-up with HCP (Health Care Professional).
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: arm blew up where shot was; arm Bright red; arm hot; arm hurt; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of injection site swelling (received 1st dose of shingles vaccine on an unknown date and presented with injection site erythema, injection site warmth and pain in arm. For tolerance to 1st dose, refer case US2022AMR014088).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site swelling, injection site erythema, injection site warmth and pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth and pain in arm were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth and pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR014088  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that after receiving 2nd dose of Shingles vaccine, his/her arm blew up where the shot was given, it was bright red and hot and the arm hurt for 3 weeks. The patient experienced same reactions with the 1st dose but he second time they were not as bad. The follow-up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR014088:Different dose
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Decreased appetite, Dizziness, Myalgia, Vertigo
Clinical narrative: Myalgia; no appetite; Vertigo; Dizziness; Bed bound; This case was reported by a pharmacist via sales rep and described the occurrence of myalgia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) for prophylaxis.   In October 2020, the patient received Shingrix and FLUAD. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced myalgia, appetite lost, vertigo, dizziness and bedridden. On an unknown date, the outcome of the myalgia, appetite lost, vertigo, dizziness and bedridden were unknown.   It was unknown if the reporter considered the myalgia, appetite lost, vertigo, dizziness and bedridden to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and Fluad approximately in October 2020 and less than 2 years after vaccination, experienced myalgia, no appetite, vertigo, dizziness and was bed bound. It was unknown if the reporter considered the myalgia, appetite lost, vertigo, dizziness and bedridden to be related to Fluad.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose administrated; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 42-year-old male patient who received HBV (Engerix B) (batch number 9p9b5, expiry date 7th February 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd March 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 3rd March 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 inadvertently administered expired dose of Engerix-B on the day of reporting, which led to expired vaccine used. No further events were reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up
Sex: U
Vaccine: DTAP, DTAPIPV, HEP, MENB, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B) for prophylaxis.   On 3rd March 2022, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and Menveo. On an unknown date, the patient received Boostrix. On 3rd March 2022, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device and Engerix B. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Menveo, Boostrix, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device and Engerix B, 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 age at vaccination was not applicable for this report. Medical office support reporting vaccines administered after temperature excursion of 26 Fahrenheit for an undetermined length of time for Bexsero, Menveo, Boostrix, Infanrix, Kinrix, Engerix-B, which led to incorrect storage of drug. Health care professional (HCP) did not had pertinent adverse event information available at time of call but gave permission for safety team to follow up. Possible multiple patients were involved. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only received adjuvant portion; only received adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter (CPT) reported that patient had only received the adjuvant suspension portion of the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was seeking medical guidance. Outside phone number GSK Medical Information given for future reference and warm transfer provided. Consented to follow up was provided. .