chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Dyspnoea, Feeling abnormal, Limb discomfort, Malaise
Clinical narrative: got sick the next day; she had nausea; diarrhea; she then had brain fog; heaviness in her legs; rash; just feeling terrible; she had shortness of breathe; This spontaneous report was received from a consumer concerning herself to a 59-years-old female patient. The patient's concurrent conditions included food allergy and seasonal allergy. Her medical history and concomitant therapies were not reported.     On 21-MAY-2021 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis or with varicella zoster vaccine rge (cho) (SHINGRIX) (dose, frequency, route of administration, lot # and expiration date were not reported), (patient was not sure about which onw vaccine she received).      Patient reported that on 22-MAY-2021 (also reported as the next date after got vaccine), she got sick (Malaise), had diarrhoea and nausea, which she thought was something she ate, then on an unspecified date in 2021, she had brain fog (Mental fatigue), heaviness in her legs (Limb discomfort), a rash and just was feeling terrible (feeling abnormal) which she took Benadryl for. Patient stated she was still not feeling a few weeks later where she had shortness of breathe (dyspnea) so she went to the emergency room ,and at the emergency room they did not know what was wrong, did different tests to make sure it was not heart, but was never admitted, therefore the patient was put on prednisone. She stated she was still feeling sick. She called her physician but there was nothing they could do and asked her how they could help her. Patient did not want to be on prednisone for a while.      The outcome of malaise, dyspnoea, feeling abnormal, rash, limb discomfort, mental fatigue, diarrhoea and nausea was not reported.   The events malaise, dyspnoea, feeling abnormal, rash, limb discomfort, mental fatigue, diarrhoea and nausea were considered to be related to Zoster Vaccine Live (ZOSTAVAX) or varicella zoster vaccine rge (cho) (SHINGRIX).    As of 23-SEP-2021, all telephone attempts trying to obtain additional information has been unsuccessful.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mental fatigue, Nausea, Rash
Clinical narrative: got sick the next day; she had nausea; diarrhea; she then had brain fog; heaviness in her legs; rash; just feeling terrible; she had shortness of breathe; This spontaneous report was received from a consumer concerning herself to a 59-years-old female patient. The patient's concurrent conditions included food allergy and seasonal allergy. Her medical history and concomitant therapies were not reported.     On 21-MAY-2021 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis or with varicella zoster vaccine rge (cho) (SHINGRIX) (dose, frequency, route of administration, lot # and expiration date were not reported), (patient was not sure about which onw vaccine she received).      Patient reported that on 22-MAY-2021 (also reported as the next date after got vaccine), she got sick (Malaise), had diarrhoea and nausea, which she thought was something she ate, then on an unspecified date in 2021, she had brain fog (Mental fatigue), heaviness in her legs (Limb discomfort), a rash and just was feeling terrible (feeling abnormal) which she took Benadryl for. Patient stated she was still not feeling a few weeks later where she had shortness of breathe (dyspnea) so she went to the emergency room ,and at the emergency room they did not know what was wrong, did different tests to make sure it was not heart, but was never admitted, therefore the patient was put on prednisone. She stated she was still feeling sick. She called her physician but there was nothing they could do and asked her how they could help her. Patient did not want to be on prednisone for a while.      The outcome of malaise, dyspnoea, feeling abnormal, rash, limb discomfort, mental fatigue, diarrhoea and nausea was not reported.   The events malaise, dyspnoea, feeling abnormal, rash, limb discomfort, mental fatigue, diarrhoea and nausea were considered to be related to Zoster Vaccine Live (ZOSTAVAX) or varicella zoster vaccine rge (cho) (SHINGRIX).    As of 23-SEP-2021, all telephone attempts trying to obtain additional information has been unsuccessful.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional adverse events reported; Caller reports that an expired dose of MMR II was administered to a patient today; This spontaneous report was received from a medical assistant concerning to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.      On 22-SEP-2021 the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S029457 and expiration date since it make match with the autopopulated expiration date: 19-SEP-2021 (dose, frequency, route of administration and indication were not provided).
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; Improper storage of product in use; This spontaneous report as received from a nurse referring to a 4 years old patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.    On 10-SEP-2021, the patient was vaccinated with a improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # U015682that has been verified to be valid for varicella virus vaccine live (oka/merck)  expiration date 18-MAY-2023 for prophylaxis, 1 dosage form (frequency, strength, and route of administration, were not reported). The vaccine was expose to a temperature of 4 Celsius degrees for 20 minutes during the transport in two occasions and also a previously temperature excursion of -10 to 8 Celsius degrees (4C) for  7 hours and 30 minutes  (product storage error). No additional adverse events were reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005910: US-009507513-2109USA005648: US-009507513-2109USA005742: US-009507513-2109USA005964: US-009507513-2109USA005891: US-009507513-2109USA005795: US-009507513-2109USA005662: US-009507513-2109USA005651: US-009507513-2109USA005648: US-009507513-2109USA005641: US-009507513-2109USA005639: US-009507513-2109USA005632: US-009507513-2109USA005628: US-009507513-2109USA005618:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager, referring 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 28-SEP-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliters (ml) intramuscularly (IM) as prophylaxis (dose number, anatomical site of vaccination and vaccine scheme were not provided; lot number 1602284 has been verified to be valid, expiration date reported and established as 26-SEP-2021) (expired product administered). No additional adverse events reported (no adverse event).
Age: 15.0
Sex: U
Vaccine: HEPA, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE's reported; She reported that GARD ASIL 9 and V AQT A were administered to a patient today that had undergone temperature excursion; This spontaneous report was received from a medical assistant referring to a 15-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On 29-SEP-2021, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) (lot number U003464 has been verified to be valid, expiration date reported and established as 02-MAY-2022) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number T039467 has been verified to be valid, expiration date reported and established as 20-MAY-2023) (doses, routes of administration, anatomical sites of vaccination, dose numbers and vaccine schemes were not reported). Both vaccines were administered as prophylaxis.   It was reported that the vaccines undergone a temperature excursion of 1.3 degrees Celsius (C) during a time frame of 15 hours and 43 minutes (product storage error). There was no previous temperature excursion, and no additional adverse events were reported (no adverse event).
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Adverse reaction
Clinical narrative: She had a reaction; This spontaneous report was received from a consumer, via Pfizer, and refers to her daughter, a 1-year-old female patient. No inforamation was reported regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (dose, route, lot number and expiration date were not reported) and had a reaction to the vaccine. The outcome of the event was unknown.  The event was related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; HCP called to report that an expired vaccine PNEUMOV AX 23 was administered to a patient today; This spontaneous report has been received from an office manager, concerning 70-year-old female patient. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions, and concomitant therapies was not provided  On 30-SEP-2021, reported as today, the patient was vaccinated with a expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) (lot number T017385 has been verified to be valid, expiration date reported and stablished as 01-SEP-2021) (dose number, dose, strength, vaccination scheme frequency, route and anatomical location of administration, lot number and expiration date were not reported) as prophylaxis (expired product administered). The reported wanted to know if the vaccine was still viable; no additional adverse event (AE) was reported.
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; a 14 month old patient received an expired dose of VARIVAX; This spontaneous report was received from an office manager via company representative and refers to a 14-month-old patient of an unknown gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided. On 30-SEP-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) first dose for prophylaxis (exact dose, route of administration and lot number were not provided) (expired vaccine used). No additional adverse event (AE) was reported.
Sex: M
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient who was under 65 and received a dose of p23 and needed another dose 5 years later, but they never received it; No additional information; This spontaneous report was received from a pharmacist, via a company representative, and refers to an Adult male patient (Age reported as "under 65").  No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On an unknown date, the patient received a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis.  It was stated that, the patient needed another dose 5 years later, but never received it. There was no adverse event reported and no product quality complaint was involved.
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Blister, Headache, Pyrexia
Clinical narrative: small blister all over body; fever; headaches; This spontaneous report has been received from a consumer via Pfizer, regarding a 35-year-old female patient. The patient's concurrent conditions, medical history, and concomitant medications were not provided.  On 01-SEP-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) as prophylaxis (dose, route of administration, anatomical location of vaccination, lot number and expiration date were not provided) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP vaccine) (dose, route of administration, anatomical location of vaccination, indication, lot number and expiration date were not provided). However, after the vaccines, on an unspecified date in 2021, the patient presented small blister all over body (blister), fever (pyrexia), and headaches (headache). Therefore, the primary care physician (PCP) prescribed medications (meds) (unspecified) and the events (also reported as symptoms from vaccines) were resolved on an unspecified date in 2021.  The causality assessment between both suspect vaccines and blister, pyrexia, and headaches were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: he broke out with shingles all over including the lower back, hair line, and head.; This spontaneous report as received from a currently 72 years old male patient via GlaxoSmithKline referring to himself. The patient's medical history included herpes zoster. Information about concurrent conditions and concomitant therapies was not provided.     On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On 23-JUL-2021, the patient was vaccinated with the first dose of varicella zoster vaccine rge (cho) (SHINGRIX).  In the months of July and August, the patient broke out with shingles all over including the lower back, hair line, and head. The patient stated that this episode was worse than ever. The patient called to inquire if it was safe for him to receive second dose of varicella zoster vaccine rge (cho) (SHINGRIX) and if it would have any benefit. The outcome of the event was unknown.       The causality between the event and zoster vaccine live (ZOSTAVAX) was not provided.
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: received PROQUAD vaccine that had undergone temperature excursion; No additional AE reported.; This spontaneous report was received from a nurse concerning a male patient of currently 4 years of age. No concurrent condition, medical history, or concomitant therapy was reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength and route were unknown; recombinant Human albumin; lot # U002539 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 24-JUL-2022) for prophylaxis following a temperature excursion (product storage error). Temperature were 13.8 Fahrenheit (F). The time frame was reported as 1 hour 48 minutes. There was no previous temperature excursion. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA001589: US-009507513-2110USA001664: US-009507513-2110USA001341: US-009507513-2110USA001533:
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: incorrect product storage; No additional AE event reported; This spontaneous report was received from a registered nurse and refers to a currently 4-year-old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number: U002539 with an expiration date: 24-JUL-2022 (exact dose, route and frequency were not reported) for prophylaxis. The vaccine had undergone temperature excursion at 13.8 Degrees Fahrenheit for 1 hour and 48 minutes (product storage error). No previous temperature excursion. No additional adverse event (AE) reported.  This is one of 5 reports from the same reporter.; Sender's Comments:  US-009507513-2110USA001533: US-009507513-2110USA001521: US-009507513-2110USA001341: US-009507513-2110USA001589:
Age: 19.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: No additional adverse events reported; VARIVAX was administered via intramuscular route versus subcutaneous route to a patient; This spontaneous report was received from a registered nurse, referring to a 19 year old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On 06-OCT-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter once, via intramuscular route instead of subcutaneous route (incorrect route of product administration), lot # U002400, with expiration date of 22-JAN-2023, for prophylaxis (anatomical location not reported). No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not get second dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This patient self-reported the case. The age at vaccination was not applicable for this report. The patient stated he/she did not get the 2nd dose of Shingrix within 6 months interval, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first Shingrix shot in Jan 2019, do they need to start over?; This case was reported by a other health professional via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, if the patient had 1st shot of Shingrix, do they need to start over with 2 shots or just need to get one more Shingrix dose. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: was given only the liquid portion; was given only the liquid portion; This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received the 1st dose of Menveo. On an unknown date, unknown after receiving Menveo, 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 patient was given only the liquid portion of Menveo at age 11 (age unit not provided), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up. This case has been linked to the case US2021AMR131344, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR131344:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Fatigue, Gait disturbance, Injection site pain
Clinical narrative: no appetite; fatigue; pain at the site; pain in my shoulders muscles and muscle legs were sore; painful pins and needles; attempted to walk and it was difficult.; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2021, the patient received the 1st dose of Shingrix. On 5th October 2021 05:00, 5 days after receiving Shingrix, the patient experienced localized muscle pain, pins and needles and walking difficulty. On an unknown date, the patient experienced injection site pain, appetite absent and fatigue. On an unknown date, the outcome of the injection site pain, appetite absent and fatigue were recovered/resolved and the outcome of the localized muscle pain, pins and needles and walking difficulty were unknown.   It was unknown if the reporter considered the injection site pain, localized muscle pain, appetite absent, fatigue, pins and needles and walking difficulty to be related to Shingrix.  Additional details provided were as follows: The patient self-reported the case. The age at vaccination was not reported. The patient received a dose of Shingrix vaccine and less than a week after receiving Shingrix, experienced typical pain in the shoulder muscles and at the site, no appetite, had fatigue which all seem to have subsided. On the evening of reporting about 5 PM, the patient had started to feel like his/her muscles in the legs were sore painful like pins and needles and he/she attempted to take a walk like she/he usually did but only could walk 1.8 miles and it was difficult. The patient was hoping not to develop Guillain-Barre.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: no appetite; fatigue; pain at the site; pain in my shoulders muscles and muscle legs were sore; painful pins and needles; attempted to walk and it was difficult.; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2021, the patient received the 1st dose of Shingrix. On 5th October 2021 05:00, 5 days after receiving Shingrix, the patient experienced localized muscle pain, pins and needles and walking difficulty. On an unknown date, the patient experienced injection site pain, appetite absent and fatigue. On an unknown date, the outcome of the injection site pain, appetite absent and fatigue were recovered/resolved and the outcome of the localized muscle pain, pins and needles and walking difficulty were unknown.   It was unknown if the reporter considered the injection site pain, localized muscle pain, appetite absent, fatigue, pins and needles and walking difficulty to be related to Shingrix.  Additional details provided were as follows: The patient self-reported the case. The age at vaccination was not reported. The patient received a dose of Shingrix vaccine and less than a week after receiving Shingrix, experienced typical pain in the shoulder muscles and at the site, no appetite, had fatigue which all seem to have subsided. On the evening of reporting about 5 PM, the patient had started to feel like his/her muscles in the legs were sore painful like pins and needles and he/she attempted to take a walk like she/he usually did but only could walk 1.8 miles and it was difficult. The patient was hoping not to develop Guillain-Barre.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm a little sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (had old one).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had first of new Shingles vaccine in last week from reporting date and stated that his/her arm was just a little sore on the next day. The patient could get 2nd dose in a couple months. The patient reported that it was expensive even with his/her insurance and worth it. The follow-up would not possible as no contact details were available.
Age: 59.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Lip dry, Peripheral swelling, Pruritus, Rash
Clinical narrative: dry lips; rash on arms and torso; swelling in limbs; overall itching; This case was reported by a pharmacist via call center representative and described the occurrence of lip dry in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 7742z, expiry date 25th March 2023) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On 14th September 2021, the patient received Shingrix (intramuscular) and INFLUENZA VACCINE. In September 2021, 2 weeks after receiving Shingrix, the patient experienced lip dry, rash, swelling of limb and generalized pruritus. On an unknown date, the outcome of the lip dry, rash, swelling of limb and generalized pruritus were unknown.   It was unknown if the reporter considered the lip dry, rash, swelling of limb and generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient received the Shingrix and a non-GSK flu vaccine on the same day and experienced dry lips, rash on arms and torso, swelling in limbs, and overall itching. The patient did not have any symptoms until 2 weeks after his vaccines. The reporter spoke per content and referred patient to healthcare professional. The reporter did not consent to follow-up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered with only the AS01B adjuvant of Shingrix.; administered with only the AS01B adjuvant of Shingrix.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 7C483, expiry date 14th November 2022) for prophylaxis.   On 16th September 2021, the patient received Shingrix. On 16th September 2021, 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 patient was administered with only the AS01B adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This is one of four cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021206994:same reporter US-GLAXOSMITHKLINE-US2021206993:same reporter US-GLAXOSMITHKLINE-US2021206990:same reporter
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered with only adjuvant; administered with only adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 7C483, expiry date 14th November 2022) for prophylaxis.   On 17th September 2021, the patient received Shingrix. On 17th September 2021, 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 patient was administered with only the AS01B adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This is one of four cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021206993:same reporter US-GLAXOSMITHKLINE-US2021206991:same reporter US-GLAXOSMITHKLINE-US2021206994:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose on 9/30/2020 and is on schedule for the 2nd dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 30th September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix and was on schedule for the 2nd dose. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up via mail or email.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late 2nd dose/2nd dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20th October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The 2nd dose of Shingrix had not administered to the patient till the time of reporting, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late second dose/had not been given a second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received around 7 months ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had not been given a 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. There was no specific date collected by reporter from the patient.  No other patient or vaccine information was available to reporter. The reporter declined follow-up since they were not aware if they would be available for follow-up due to them not working there all the time. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine /first dose around two years ago and has not received the second dose yet.; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received around two years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The physician reported inappropriate schedule of Shingrix vaccine. The patient had not received the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter emailed to ask if Shingrix series needs to be restarted if first dose of Shingrix given 2 years prior.  No information on the patient affected by inappropriate schedule of Shingrix vaccine. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine /has not received the second dose yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 1 year ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had not received the second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. At the time of reporting no patient or vaccine data was available. The reporter consented to follow up via email. This is one of five cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021207617:same reporter US-GLAXOSMITHKLINE-US2020173719:same reporter US-GLAXOSMITHKLINE-US2020100162:same reporter US-GLAXOSMITHKLINE-US2020072774:same reporter
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Medication error, SARS-CoV-2 test, Vaccination complication, Vaccination failure
Clinical narrative: MEDICATION ERROR; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION (BREAKTHROUGH); SEVERE REACTION TO JNJ VACCINE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was needed to take steroids. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry date: unknown) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. Concomitant medications included mrna 1273 for covid-19 vaccine.  On 05-OCT-2021, the patient experienced suspected clinical vaccination failure, suspected covid-19 infection (breakthrough) and severe reaction to JNJ vaccine. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On an unspecified date, the patient experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection (breakthrough), and the outcome of severe reaction to JNJ vaccine, suspected clinical vaccination failure and medication error was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000196555.; Sender's Comments: V0: 20211010258-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Platelet count decreased
Clinical narrative: DECREASED PLATELET COUNT; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: liver transplant, and concurrent conditions included: chemotherapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced decreased platelet count. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) Decreased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of decreased platelet count was not reported. This report was non-serious. This case, from the same reporter is linked to 20211011824.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Choking, Dysarthria, Dysphagia, Dysstasia, Impaired work ability
Clinical narrative: CHOKED ON DRINKS; DIFFICULTY SWALLOWING, EVEN LIQUIDS; BOUTS OF SLURRED SPEECH; MUSCLE CRAMPS; MAKING IT DIFFICULT TO STAND, BEING OFF BALANCE; DIFFICULT TO WORK; WEAK MUSCLES IN NECK AND SPINE; This spontaneous report received from a patient concerned of an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  After receiving the vaccine, the patient experienced deteriorating health. On an unspecified date, the patient had muscle cramps, being off balance, made it difficult to stand, as well as weakness in the muscles in her neck and around the spine. She also noted that lately, the muscle cramping was worse and she had bouts of slurred speech. She had difficulty swallowing, even liquids, noting she choked on her drinks. It was reported that it made difficult for her to work.  She had numerous healthcare professionals (HCPs), including rheumatologists and neurologists. On unspecified date she visited Emergency room  and Physician office for events difficulty swallowing even liquids, weak muscles in neck and spine, bouts of slurred speech, muscle cramps and making it difficult to stand. On unspecified date she had numerous tests done, including C-reactive protein test (CRP) and it was normal and a spinal tap was negative for meningitis. She felt that she was declining rapidly.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty swallowing, even liquids, weak muscles in neck and spine, bouts of slurred speech, muscle cramps, making it difficult to stand, being off balance, and difficult to work, and the outcome of choked on drinks was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211011611-COVID-19 VACCINE AD26.COV2.S-choked on drinks. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscular weakness
Clinical narrative: CHOKED ON DRINKS; DIFFICULTY SWALLOWING, EVEN LIQUIDS; BOUTS OF SLURRED SPEECH; MUSCLE CRAMPS; MAKING IT DIFFICULT TO STAND, BEING OFF BALANCE; DIFFICULT TO WORK; WEAK MUSCLES IN NECK AND SPINE; This spontaneous report received from a patient concerned of an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  After receiving the vaccine, the patient experienced deteriorating health. On an unspecified date, the patient had muscle cramps, being off balance, made it difficult to stand, as well as weakness in the muscles in her neck and around the spine. She also noted that lately, the muscle cramping was worse and she had bouts of slurred speech. She had difficulty swallowing, even liquids, noting she choked on her drinks. It was reported that it made difficult for her to work.  She had numerous healthcare professionals (HCPs), including rheumatologists and neurologists. On unspecified date she visited Emergency room  and Physician office for events difficulty swallowing even liquids, weak muscles in neck and spine, bouts of slurred speech, muscle cramps and making it difficult to stand. On unspecified date she had numerous tests done, including C-reactive protein test (CRP) and it was normal and a spinal tap was negative for meningitis. She felt that she was declining rapidly.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty swallowing, even liquids, weak muscles in neck and spine, bouts of slurred speech, muscle cramps, making it difficult to stand, being off balance, and difficult to work, and the outcome of choked on drinks was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211011611-COVID-19 VACCINE AD26.COV2.S-choked on drinks. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Monoplegia
Clinical narrative: SLIGHTLY PARALYZED ON INJECTION SIDE; NUMBNESS IN ARM AND HAND; This spontaneous report received from a patient via social media concerned a patient of unspecified age, sex, race and ethnicity The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. As per the report, the patient commented that "My first JJ Vaccine caused me to be slightly paralyzed on my injection side. Numbness in my arm and hand lasted 2 weeks, the para lasted about 2 hours" (dates not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slightly paralyzed on injection side, and numbness in arm and hand. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211014451-Covid-19 vaccine ad26.cov2.s -Slightly paralyzed on injection side. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEAD; This spontaneous report received from a consumer concerned a 24 year old female with an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, with frequency time 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, reporter said that after vaccination his cousin was dead. It was unknown, if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from an unknown cause of death. This report was serious (Death). This case, from the same reporter is linked to 20211014628 and 20211014652.; Sender's Comments: V0:20211014552-covid-19 vaccine ad26.cov2.s-dead. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH