chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient, at above date and time, received a second dose of Moderna COVID 19 vaccine. The vaccine was administered only 4 days after the patient's first shot. By time clinic staff realized it was too early for the patients second dose the shot had already been administered. It is unknown whether or not the patient intended to receive vaccine on the incorrect date, but he was notified  by clinic staff and instructed to contact emergency help in the case of severe or unmanageable symptoms.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Headache, Myalgia, Neck pain
Clinical narrative: Day 3 of Headache, chest pain, shortness of breath, heart pounding, muscle pain, and neck pain
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Day 3 of Headache, chest pain, shortness of breath, heart pounding, muscle pain, and neck pain
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Thrombosis, Ultrasound scan abnormal
Clinical narrative: Blood clots, right leg, diagnosed with ultrasound. Pain, swelling, redness of right foot and leg.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Muscle strain, Nausea, Pelvic pain
Clinical narrative: Severe low back pain, pelvic pain lasting 1 week so far. nausea and chills started 5 days after 2nd shot, still have on day 7.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Pain, Presyncope
Clinical narrative: body pain; almost fainted; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old unknown gender patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 13:15 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included cyclobenzaprine hydrochloride (FLEXERIL) and etodolac (MANUFACTURER UNKNOWN) for unknown indications taken on unknown date and unknown if still ongoing. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient also received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 29Apr2021 at 08:30 the patient woke up with body pain, went to the bathroom and when stood up from the toilet, almost fainted. The patient was given alcohol to smell and did not entirely faint. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event body pain and almost fainted was resolved on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: MMR
Symptoms: Product use in unapproved indication
Clinical narrative: received an MMR vaccine in hopes that if they contract COVID-19; This spontaneous report was received from a patient of unknown age and gender referring to himself or herself. Information about medical historyand concomitant therapies was not provided.      On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) on the advice of the patient's physician in hopes that if the patient contract coronavirus disease 2019 (COVID-19) the patient may possibly have an attenuated response to that disease based on a current plausible medical theory (product use in unapproved indication).
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received either two or three doses of GARDASIL 9 "approximately 5 years ago," with the "second dose in 2015/in April 2021 administered another dose of GARDASIL 9; No additional adverse events or product quality complaints were reported.; and in April 2021 administered another dose of GARDASIL 9; This spontaneous report was received from a consumer regarding to her sister, a female patient of unknown age. The patient's medical history, drug reactions or allergies and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route, anatomical location , lot # and expiration date were not provided).   On an unspecified date in 2015 (conflicting information also reported as approximately 5 years ago), the patient received the second dose according to the sister's medical record, receiving "either two or three doses" of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route, anatomical location , lot # and expiration date were not provided).    On an unspecified date in April 2021, the patient received another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis. No additional adverse events or product quality complaints were reported.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Injection site induration, Injection site irritation, Injection site mass, Injection site pain
Clinical narrative: Golf ball sized lump at the injection site; Golf ball sized lump at the injection site that was hard; Golf ball sized lump at the injection site irritated; Golf ball sized lump at the injection site slightly sore; Golf ball sized lump at the injection site warm to the touch; persisted for 3-4 days with a low grade fever (-99 F); This spontaneous report was received from a 24 years old female patient via company representative referring to herself. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.    Approximately on 31-JUL-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis.  On the same day (31-JUL-2021), golf ball sized lump at the injection site that was hard, irritated, and slightly sore and warm to the touch, persisted for 3-4 days with a low grade fever (~99 Fahrenheit degrees (F)). Approximately on 06-AUG-2021 (reported as on day 6), kind of looked like a light bruise. No evidence of any other rash or anything resembling chicken pox anywhere else on the patient's body. Information about treatment given for the event, lab diagnostics/studies and medical attention was unknown. No product quality complaint (PQC) was reported. The outcome of all events was unknown.  The causality between all events and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Golf ball sized lump at the injection site; Golf ball sized lump at the injection site that was hard; Golf ball sized lump at the injection site irritated; Golf ball sized lump at the injection site slightly sore; Golf ball sized lump at the injection site warm to the touch; persisted for 3-4 days with a low grade fever (-99 F); This spontaneous report was received from a 24 years old female patient via company representative referring to herself. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.    Approximately on 31-JUL-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis.  On the same day (31-JUL-2021), golf ball sized lump at the injection site that was hard, irritated, and slightly sore and warm to the touch, persisted for 3-4 days with a low grade fever (~99 Fahrenheit degrees (F)). Approximately on 06-AUG-2021 (reported as on day 6), kind of looked like a light bruise. No evidence of any other rash or anything resembling chicken pox anywhere else on the patient's body. Information about treatment given for the event, lab diagnostics/studies and medical attention was unknown. No product quality complaint (PQC) was reported. The outcome of all events was unknown.  The causality between all events and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No additional AEs; M-M-R II was reconstituted with the incorrect diluent and administered; This spontaneous report was received from a healthcare business professional (office manager), referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided.     On 16-AUG-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status of rHA (recombinant human albumin)) (M-M-R II) (1 time dose, lot # S035356, expiration date 05-NOV-2021; strength and route were unknown) for prophylaxis. Caller confirmed that the diluent (suspect, strength, dose, frequency, route, lot# and expiration date were unknown) that was used to reconstitute measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  was the diluent used to reconstitute meningococcal vaccine A/C/Y/W conj (CRM197) (MENVEO) vaccine (product preparation issue). No additional adverse events. The reporter inquired if the patient needs to be revaccinated after measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was administered using the incorrect diluent.
Sex: U
Vaccine: HPV4, MENB
Symptoms: Syncope
Clinical narrative: fainted; This spontaneous report as received from a health professional via Pfizer (manufacturer control # 202101076767) refers to an approximately 16 or 17 years old patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.     On an unknown date in 2017, in the same visit, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis and meningococcal vaccine b rfhbpa/fhbpb (TRUMENBA) (dose, route of administration, anatomical location, lot # and expiration date were not reported).  In in 2017, after receiving meningococcal vaccine b rfhbpa/fhbpb (TRUMENBA), the patient fainted. The outcome of fainted was unknown.  Causality assessment was not provided.  Upon internal review, the event of fainted was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's were reported; reporting a temperature excursion for VARIVAX/ have been administered to several patients since the escursion; This spontaneous report has been received from an office manager and refers to patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 04-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose or frequency 1 (units not provided) (route of administration, vaccine scheme, anatomical site of vaccination were not reported; lot number T010313 has been verified to be valid, expiration date reported and established as 24-MAR-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 11.3 Fahrenheit degrees (°F) during a time frame of 15 minutes. It was reported that the vaccine was exposed to the following previous temperature excursions: 14 Fahrenheit degrees to 46 Fahrenheit degrees (46 F) for 1 hour, 14 Fahrenheit degrees to 46 Fahrenheit degrees (32.36 F) for 1 hour and 14 Fahrenheit degrees to 46 Fahrenheit degrees (21.38 F) for 37 minutes. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006642: US-009507513-2108USA006643: US-009507513-2108USA006644: US-009507513-2108USA006645: US-009507513-2108USA006646: US-009507513-2108USA006647: US-009507513-2108USA006641: US-009507513-2108USA006640: US-009507513-2108USA006639: US-009507513-2108USA006638: US-009507513-2108USA006637:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's were reported; reporting a temperature excursion for VARIVAX/ have been administered to several patients since the escursion; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 09-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose or frequency 1 (units not provided) (route of administration, vaccine scheme, anatomical site of vaccination were not reported; lot number T041685 has been verified to be valid, expiration date reported and established as 10-DEC-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 11.3 Fahrenheit degrees (°F) during a time frame of 15 minutes. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006576:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's were reported; reporting a temperature excursion for VARIVAX/ have been administered to several patients since the escursion; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 16-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose or frequency 1 (units not provided) (route of administration, vaccine scheme, anatomical site of vaccination were not reported; lot number T041685 has been verified to be valid, expiration date reported and established as 10-DEC-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 11.3 Fahrenheit degrees (°F) during a time frame of 15 minutes. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006576:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's were reported; reporting a temperature excursion for VARIVAX/ have been administered to several patients since the escursion; This spontaneous report has been received from an office manager and refers to patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 18-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose or frequency 1 (units not provided) (route of administration, vaccine scheme, anatomical site of vaccination were not reported; lot number T010313 has been verified to be valid, expiration date reported and established as 24-MAR-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 11.3 Fahrenheit degrees (°F) during a time frame of 15 minutes. It was reported that the vaccine was exposed to the following previous temperature excursions: 14 Fahrenheit degrees to 46 Fahrenheit degrees (46 F) for 1 hour, 14 Fahrenheit degrees to 46 Fahrenheit degrees (32.36 F) for 1 hour and 14 Fahrenheit degrees to 46 Fahrenheit degrees (21.38 F) for 37 minutes. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006576:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's were reported; reporting a temperature excursion for VARIVAX/ have been administered to several patients since the escursion; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 18-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose or frequency 1 (units not provided) (route of administration, vaccine scheme, anatomical site of vaccination were not reported; lot number T041685 has been verified to be valid, expiration date reported and established as 10-DEC-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 11.3 Fahrenheit degrees (°F) during a time frame of 15 minutes. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006576:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's were reported; reporting a temperature excursion for VARIVAX/ have been administered to several patients since the escursion; This spontaneous report has been received from an office manager and refers to patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 18-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose or frequency 1 (units not provided) (route of administration, vaccine scheme, anatomical site of vaccination were not reported; lot number T041685 has been verified to be valid, expiration date reported and established as 10-DEC-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 11.3 Fahrenheit degrees (°F) during a time frame of 15 minutes. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006576:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's were reported; reporting a temperature excursion for VARIVAX/ have been administered to several patients since the escursion; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 06-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose or frequency 1 (units not provided) (route of administration, vaccine scheme, anatomical site of vaccination were not reported; lot number T041685 has been verified to be valid, expiration date reported and established as 10-DEC-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 11.3 Fahrenheit degrees (°F) during a time frame of 15 minutes. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006576:
Sex: F
Vaccine: HPV4
Symptoms: Product confusion
Clinical narrative: potential product confusion; Information has been received from the patient reporting on herself. The patient's age, pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  In November 2015, the patient received a dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), lot # K010574, expiration date 08-APR-2017, for prophylaxis (dosage and route information were not provided). The consumer reported a potential product information (no further information provided). It was also stated that the she was informed that she received the correct vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: area is still very hot to the touch; This case was reported by a consumer via interactive digital media and described the occurrence of injection site warmth in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2021, the patient received the 1st dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced injection site warmth. On an unknown date, the outcome of the injection site warmth was not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself or herself. The age at vaccination was not reported. The patient had his/her first dose of Shingrix on Friday and the area was still very hot to the touch.  The patient asked if it was normal?
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist 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 stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patient's information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist 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 stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patient's information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist 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 stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patient's information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist 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 stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patient's information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist 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 stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patient's information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist 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 stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patient's information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist 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 stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patient's information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist 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 stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patient's information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist 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 stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patient's information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Asthenia, Decreased appetite, Herpes zoster, Mobility decreased
Clinical narrative: Shingles; Thought I was gonna die; so weak couldn't get in and out of bed; fever 102; pain through my whole body; no appetite; This case was reported by a consumer via and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles, impending doom, weakness, fever, appetite absent and general body pain. On an unknown date, the outcome of the shingles, impending doom, weakness, fever, appetite absent and general body pain were recovered/resolved.   It was unknown if the reporter considered the shingles, impending doom, weakness, fever, appetite absent and general body pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported the case. The patient got shingles which was not bad at all. The patient got most awful reaction. The patient thought he/she was going to died. The patient was so weak and could not get in and out of bed. The patient had fever and body temperature was recorded as 102 degree F. The patient experienced no appetite for 3 days and had pain through whole body unlike anything he/she experienced. The patient had the same reaction with the booster dose, refer case US2021AMR179531.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179531:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Shingles; Thought I was gonna die; so weak couldn't get in and out of bed; fever 102; pain through my whole body; no appetite; This case was reported by a consumer via and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles, impending doom, weakness, fever, appetite absent and general body pain. On an unknown date, the outcome of the shingles, impending doom, weakness, fever, appetite absent and general body pain were recovered/resolved.   It was unknown if the reporter considered the shingles, impending doom, weakness, fever, appetite absent and general body pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported the case. The patient got shingles which was not bad at all. The patient got most awful reaction. The patient thought he/she was going to died. The patient was so weak and could not get in and out of bed. The patient had fever and body temperature was recorded as 102 degree F. The patient experienced no appetite for 3 days and had pain through whole body unlike anything he/she experienced. The patient had the same reaction with the booster dose, refer case US2021AMR179531.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179531:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; 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.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for himself/herself.  The age at vaccination was not reported. After receiving Shingles vaccine, the patient got a bad case of shingles from the vaccine. It was told to the patient that, it sometimes happened. 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 completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR180544:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hurt; This case was reported by a consumer and described the occurrence of pain 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 pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient got vaccinated against shingles and it hurted for few days. The patient felt protected and felt good.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: since then with the Shot I've had them 3 more times /suspected vaccination failure; 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.   The patient's past medical history included shingles (had the shingles several years ago).   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 reporter was the patient. The age at vaccination was not reported. The reporter stated that, had shingles several years ago before the shot and since then with the shot had them 3 more times, the shot did not work. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got my shots- after I got shingles /suspected vaccination failure; 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.   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. Rechallenge with Shingles vaccine was unknown. 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 reporter was the patient. The age at vaccination was not reported. The reporter stated that, got shots and after got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Herpes zoster, Vaccination failure
Clinical narrative: had both shots / shingles /suspected vaccination failure; shingles; pain over my head; pain in right ear; 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), shingles, headache and ear pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the headache and ear pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, headache and ear pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had both shots and got the shingles really bad. Been almost 2 years ago and still had a lot of pain all over head and right ear. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.