chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 12 months old patient of unknown gender. the patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.   On 10-MAR-2021, the patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route were not provided; lot number was T025945 and expiration date was 30-JUL-2022) 0.5 ml and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (strength and route were not provided; lot number was S039319 and expiration date was 04-DEC-2021) 0.5 ml involved in temperature excursions for prophylaxis (product storage error). No additional adverse event was reported (no adverse event).  The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion from -10 degree Celsius to 8 degree Celsius (-1.6 degree Celsius) for 1 hour 36 minutes 0 seconds. The administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (stored in freezer) experienced the temperature excursion from -50 degree Celsius to +8 degree Celsius (-1.6 degree Celsius) for 1 hour 36 minutes 0 seconds. There was no previous temperature excursion. The event of temperature excursion was detected by a data logger.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX was administered to a patient prior to discovering the temperature excursion/improperly stored VARIVAX administered to a patient/temperature excursion involving their VARIVAX vaccines; This spontaneous report as received from a nurse practitioner refers to a 13-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-MAr-2021, the varicella virus vaccine live (oka/merck) (VARIVAX) experienced temperature excursion of 31.8 degrees Fahrenheit for 5 hours and 30 minutes. On 16-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, subcutaneously, frequency reported as "x1", lot # T022314, expiration date 30-JUN-2022 (anatomical location was not reported) for prophylaxis. During the temperature evaluation it was reported that the varicella virus vaccine live (oka/merck) (VARIVAX) was administered to a patient prior to discovering the temperature excursion. There was no previous temperature excursion reported. The digital data logger was involved.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal haemorrhage, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test
Clinical narrative: GI bleed; received dose 2 on 22Feb2021 10:15; received dose 2 on 22Feb2021 10:15; This is a spontaneous report from a contactable consumer. A 73-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 10:15 at 73-year-old (Lot Number: EN6201) as single dose for covid-19 immunization; apixaban (ELIQUIS), via an unspecified route of administration from 22Feb2021 06:00 (Batch/Lot number was not reported), at unspecified dose for cerebrovascular accident prophylaxis. Facility type vaccine was hospital. Medical history included atrial fibrillation and diverticulum. No covid prior vaccination. No known allergies. The patient's concomitant medications were not reported. The patient previous received the first dose of the vaccine (lot number: EN5318) on 05Feb2021 12:00 at Left arm for covid-19 immunization. No other vaccine in four weeks. At 11:45 am (an hour and a half later) on 22Feb2021. The patient was admitted to the hospital via the Emergency room for a gastrointestinal bleed. The patient had taken the Eliquis at 6 am that morning. The patient was hospitalized for GI bleed from 22Feb2021 to 26Feb2021 for 4 days. The patient underwent lab tests and procedures which included Nasal Swab sars-cov-2 test: negative on 22Feb2021. The action taken in response to the event for apixaban was unknown. The outcome of the event GI bleed was recovered. Treatment of Kcentra Infusion and 2 units of blood transfusion received. Additional information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-026613), license party for apixaban also included: BMS's assessment (event GI bleed was serious).; Sender's Comments: This patient had developed gastrointestinal haemorrhage after receiving apixaban therapy. Based on the anticoagulant nature of apixaban, its role in the bleeding event is considered possible.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via patient support programs and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 9th March 2021, the patient received Shingles vaccine. On 9th March 2021, less than a day after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The patient reported case for himself. The age at vaccination was not reported. The  patient experienced shingles after vaccination The reporter did not consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: ringing in my ears got extremely loud again; This case was reported by a consumer and described the occurrence of ringing in ears in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tinnitus (tinnitus and working with an audiologist for the past year).   On 15th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a day after receiving Shingrix, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was unknown.   It was unknown if the reporter considered the ringing in ears to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and all of progress in reducing the volume of my tinnitus evaporated.  The ringing in ears got extremely loud again, within a day and had stayed loud for the past 3 months.  The patient had to start over on tinnitus therapy. The patient was very hesitant to get the second shingles vaccine shot and would not be able to stand the tinnitus if it gets any louder.  The reporter asked was the first shot effective enough on its own.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: She gets sick; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a 62-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, reference case US2021AMR064841) and Shingrix with an associated reaction of pyrexia (2nd dose received on an unknown date, reference case US2021AMR064854).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported. The patient got sick after the flu shot. The consent to follow-up was requested.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR064841:Same reporter. US-GLAXOSMITHKLINE-US2021AMR064854:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Pain in extremity
Clinical narrative: Joint pain; Pain in my hands/ pain; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of arthritis (1st dose received on an unknown date, for tolerance refer case US2021AMR066228).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced joint pain and pain in hand. On an unknown date, the outcome of the joint pain and pain in hand were unknown.   The reporter considered the joint pain and pain in hand to be unrelated to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient had arthritis and did some strenuous exercise before getting shingrix vaccine. The patient had joint pain and asked if she could safely take advil or Tylenol after Shingrix dose. The patient did not believe that the pain was related to vaccine. She had pain in hands and was from yardwork. The patient just did not want to compromise the effectiveness of Shingrix shot. No further information was provided. The consented to follow up was unknown.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR066228:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Dry skin, Scratch, Skin exfoliation
Clinical narrative: dry scales to my back "scratch- like" periodically! / skin scales / S/ effect. I experienced; dry scales to my back "scratch- like" periodically!; dry scales to my back "scratch- like" periodically!; This case was reported by a consumer via interactive digital media and described the occurrence of scales in a adult 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 scales, dry skin and scratch. On an unknown date, the outcome of the scales, dry skin and scratch were unknown.   It was unknown if the reporter considered the scales, dry skin and scratch to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. Age at vaccination was not reported. The age group was selected as an adult. Patient experienced dry scales to back "scratch- like" periodically. No pain was reported. Reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Bursitis, Dizziness, Inflammation, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of bursitis in a 59-year-old female patient who received Herpes zoster Shingles vaccine for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of dizziness (the shingles shot was a horrible first dose in October, refer case US2021AMR067287). In January 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced bursitis, dizziness, limbs stiffness, inflammation, and pain in arm. The patient was treated with paracetamol (TYLENOL) and non-drug therapy (Ice Pack (No Medication)). Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the bursitis, limbs stiffness, inflammation and pain in arm were not recovered/not resolved and the outcome of the dizziness was recovered/resolved. It was unknown if the reporter considered the bursitis, dizziness, limbs stiffness, inflammation, and pain in arm to be related to Shingles vaccine. Additional details were reported as follows: Age at vaccination not reported. Patient got 2nd shot of shingles vaccine. Patient stated that post vaccination felt dizzy as a but dizzy like that for 2 days. Patent also stated she was scared to walk, from time to time she felt dizzy in the head.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR067287: Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of bursitis in a 59-year-old female patient who received Herpes zoster Shingles vaccine for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of dizziness (the shingles shot was a horrible first dose in October, refer case US2021AMR067287). In January 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced bursitis, dizziness, limbs stiffness, inflammation, and pain in arm. The patient was treated with paracetamol (TYLENOL) and non-drug therapy (Ice Pack (No Medication)). Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the bursitis, limbs stiffness, inflammation and pain in arm were not recovered/not resolved and the outcome of the dizziness was recovered/resolved. It was unknown if the reporter considered the bursitis, dizziness, limbs stiffness, inflammation, and pain in arm to be related to Shingles vaccine. Additional details were reported as follows: Age at vaccination not reported. Patient got 2nd shot of shingles vaccine. Patient stated that post vaccination felt dizzy as a but dizzy like that for 2 days. Patent also stated she was scared to walk, from time to time she felt dizzy in the head.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR067287: Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had his shots and got shingles a year later/Suspected vaccination failure; had his shots and got shingles a year later; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year 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's wife. The age at vaccination was not reported. The reporter stated that, her husband had shingles a year later administration of shingles shots. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles and laboratory confirmation for shingles were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Diplegia, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of paralysis of arms in a male patient who received Herpes zoster (Shingle's vaccine).    On an unknown date, the patient received Shingle's vaccine. On an unknown date, unknown after receiving Shingle's vaccine, the patient experienced paralysis of arms (serious criteria disability and GSK medically significant), anxiety and activities of daily living impaired. On an unknown date, the outcome of the paralysis of arms was recovered/resolved and the outcome of the anxiety and activities of daily living impaired were unknown.   It was unknown if the reporter considered the paralysis of arms, anxiety and activities of daily living impaired to be related to Shingle's vaccine.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The reporter stated that, after shingles shot, her husband's arm paralyzed for over a week, and it was frightening. The reporter had to help the patient for everything from showering to dressing to bathroom. The reporter stated that, did some research and lysine kept you from getting shingles. The reporter stated that never again would they get vaccines, or flu shots or all these crazy shots.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took the shots a couple of months before, he came down with them/suspected vaccination failure; took the shots a couple of months before he came down with them.; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The case was reported by the patient for himself. The patient took the Shingles shots a couple of months before, he came down with them. This case was considered as suspected vaccination failure since details regarding time to onset and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had shingles after having the vaccine / still get shingles but not as severe; This case was reported by a consumer 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 chickenpox (as a child).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient had shingles after having the vaccine and still get shingles but not as severe.  This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: I got my second shingles shot two months ago. I still have pain in my arm periodically; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient received 2nd shot two months ago from the reporting date and still had pain in her/his arm periodically and he/she wish someone could tell her/him the reason of this experience. The reporter mentioned that, he/she put off having the shot for years and this happened. The reporter thought about not getting a Covid shot. The follow-up would not possible as no contact details were available.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Pain, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; outbreak of Shingles; pain; rash on the back; two dses were given only one month apart / Dse #1-Feb. 2020 & Dse #2-March 2020; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 2nd dose of Shingrix. In February 2020, the patient received the 1st dose of Shingrix. In March 2020, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too short. In March 2021, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and rash. On an unknown date, the outcome of the vaccination failure, shingles, pain, rash and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by medical assistant. The age at vaccination was not reported. The patient stated to the reporter that the two doses were given only one month apart, which led to shortening of vaccination schedule. Approximately one year after receiving the 2nd doses of Shingrix, the patient experienced an outbreak of shingles and initial symptoms were pain, followed by a rash on the back. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain
Clinical narrative: Had the original vaccine / After / gave me 1st of 2 part new vaccine, got shingles; rib cage pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received original vaccine on an unknown date and got awful case of shingles 5 years later).   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 and rib pain. Shingles vaccine was discontinued. On an unknown date, the outcome of the shingles was unknown and the outcome of the rib pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles and rib pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of 2 parts new vaccine and got shingles almost right away. The patient still has rib cage pain occasionally. The patient was not going to take 2nd dose in series.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Skin discolouration
Clinical narrative: Her arm gets a rash / big red rash; Her arm gets / white  spots around the rash; This case was reported by a consumer and described the occurrence of red rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced red rash and skin discoloration. On an unknown date, the outcome of the red rash and skin discoloration were recovered/resolved.   It was unknown if the reporter considered the red rash and skin discoloration to be related to Shingrix.  Additional details was reported as follows: The case was reported by patient herself. The patient received Shingrix and after vaccination her arm gets a big red rash as well as white spots around the rash. The case is linked with US2021067588, by same reporter. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021067588:Same reporter. US-GLAXOSMITHKLINE-US2021067596:FU1 deleted
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had shingles shot then after my 2 / developed 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 COVID-19 VACCINE for prophylaxis.   Concomitant products included COVID-19 VACCINE.   On an unknown date, the patient received Shingles vaccine and the 2nd dose of COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient. The age at vaccination was not reported. The patient reported that preventing was a lie. The patient had shingles shot then after 2 COVID shots, the patient developed the shingles which the patient thought that the patient was having a heart attack. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. It was unknown if the reporter considered the shingles to be related to Covid vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure/Have had the 2 shots for shingles and still have outbreaks of it!; Have had the 2 shots for shingles and still have outbreaks of it!; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the 2 shots for shingles and had outbreaks of Shingles. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation test were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shingles after getting the vaccine./ Suspected Vaccination failure; got the shingles after getting the vaccine.; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter reported for himself or herself. The age at vaccination was not reported. The patient had shingles after shingles vaccine. 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: Malaise, Vaccine positive rechallenge
Clinical narrative: Pretty sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, refer case US2021AMR069301).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The reporter reported for himself/herself. The age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The patient got sick after 2nd shot of Shingles vaccine. The reporter had a feeling how he or she was going to feel after his or her 2nd COVID vaccine next week. For the tolerence of dose 1 refer case US2021AMR069301, reported by same reporter for same patient; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR069301:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer and described the occurrence of Suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported but was captured as an adult as per vaccine indication. The patient had Shingles after vaccination. This case was considered as suspected vaccination failure as completion of primary vaccination schedule, time to onset and laboratory confirmation test were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Suspected vaccination failure/First vaccine yrs ago / 2 part vaccine / Shingles now; My body is a mess with shingles now. Buttocs and back; First vaccine yrs ago / Turned 65 / 2 part; This case was reported by a consumer and described the occurrence of Suspected vaccination failure in a 65-year-old 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 and drug dose administration interval too long. On an unknown date, the outcome of the vaccination failure, shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose. The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient had f1st vaccine years ago and when turned to 65 years the physician  pushed  into getting the 2 part vaccine. The patient's body was a mess with shingles, buttocs and back. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation test were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Blood glucose normal, Dizziness
Clinical narrative: Got dizzy and off balance; off balance; This case was reported by a consumer and described the occurrence of dizziness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes, cardiac disorder nos and drug allergy (patient had allergy to some shots).   On 22nd March 2021, the patient received Shingrix. In March 2021, several hours after receiving Shingrix, the patient experienced dizziness and balance disorder. On an unknown date, the outcome of the dizziness and balance disorder were not recovered/not resolved.   It was unknown if the reporter considered the dizziness and balance disorder to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient had allergy to some shots, something in delivery system used or preservatives. The patient was diabetic cardiac patient. The patient's blood sugar was fine. On day before reporting the patient got the Shingrix vaccine. The patient experienced dizzy and off balance a few hours later vaccination. The again on day of reporting patient experienced dizzy and off balance. The reporter requesting consent to follow up.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: diagnosed with shingles; rash on the back of the / head; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th February 2021, the patient received the 1st dose of Shingrix (intramuscular). On 2nd March 2021, 3 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were recovered/resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and formulation unknown. The patient reported that 3 to 4 days after his injection, he was in a barber shop getting his haircut when the barber noted a rash on the back of the patient's head. The patient went to the emergency room for a few hours and was diagnosed with shingles. The shingles symptoms were improved. The patient did not consent to follow-up. Emergency room visit required.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Lip blister
Clinical narrative: blister Shingles on my right hand between the thumb and the finger; blistering on my lips; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient had Shingles 3 times in the past but not in the last 5 years).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced shingles and lip blister. On an unknown date, the outcome of the shingles and lip blister were recovered/resolved.   It was unknown if the reporter considered the shingles and lip blister to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The age at vaccination was not reported. The patient stated she had her 1st dose of Shingrix vaccine a few months ago in her left arm.  The patient had blistering on lips and a one blister Shingles on right hand between the thumb and the finger. The patient stated she knew it was a shingles blister on the hand because she had Shingles 3 times in the past but not in the last 5 years and it was in the same spot.  The patient stated it happened within 24 hours of the vaccine. The blister on the hand was gone after 10 days. It was small blister compared to the blister she had in the hand before that was very severe. The reporter did not consent to follow-up.
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Oropharyngeal pain, Product administered to patient of inappropriate age
Clinical narrative: dry cough; sore throat; Caller is less than 50 years old; This case was reported by a consumer via call center representative and described the occurrence of dry cough in a 41-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ulcerative colitis. Concomitant products included prednisone.   On 19th March 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 19th March 2021, less than a day after receiving Shingrix, the patient experienced dry cough, sore throat and inappropriate age at vaccine administration. On an unknown date, the outcome of the dry cough and sore throat were recovering/resolving and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the dry cough and sore throat to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for herself. The patient received immunosuppressive medication prednisone as concomitant medication. The patient received vaccine at the age of 41 years which led to inappropriate age at vaccine administration. The patient reported dry cough and sore throat within 12 hours of receiving first dose of Shingrix. The reporter consented to follow up.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Dehydration, Disorientation, Headache, Influenza like illness
Clinical narrative: severely dehydrated; cramping lower abdomen; flu like symptoms; intense vomiting; headache; fever; nausea; disoriented; cramping; A spontaneous report was received from a consumer who was also an 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe dehydration/Dehydration, cramping in lower abdomen/ abdominal pain lower, fever/pyrexia, nausea, headache, disorientation, flu like symptoms/ Influenza like illness, intense vomiting/ vomiting and cramping/ muscle spasms.  Patient's medical history was not provided, and concomitant medicines were not reported.   On 25 Jan 2021, the same day as the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Patient reported that she initially had an "extreme reaction" with severe, flu-like symptoms, headache, fever, disorientation, nausea and dehydration.  She reported that she had a fever within three hours of receiving the vaccination. She stated that she suffered extreme vomiting for three and a half weeks along with ongoing headache, fever and cramping.  On an unknown date, she was in the hospital, or ER, where she received medication for nausea and intravenous medication for dehydration (unknown if hospitalized}.  She reported eight hours of pain/cramping in her lower abdomen, and again, stated that she was severely dehydrated.  (The duration of hospitalization or ER visit was not reported).  At the time of reporting, she said that her symptoms were ongoing, however, much less severe.   Treatment included was nausea medication (patient did not remember the drug's name), intravenous (IV) medication for dehydration, IV antibiotics and dicycloverine.   Action taken with mRNA-1273 was not reported.  The outcomes of the events,  dehydration, cramping in lower abdomen, fever, nausea, headache, disorientation, flu like symptoms, intense vomiting and cramping, were considered recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Pyrexia, Vomiting
Clinical narrative: severely dehydrated; cramping lower abdomen; flu like symptoms; intense vomiting; headache; fever; nausea; disoriented; cramping; A spontaneous report was received from a consumer who was also an 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe dehydration/Dehydration, cramping in lower abdomen/ abdominal pain lower, fever/pyrexia, nausea, headache, disorientation, flu like symptoms/ Influenza like illness, intense vomiting/ vomiting and cramping/ muscle spasms.  Patient's medical history was not provided, and concomitant medicines were not reported.   On 25 Jan 2021, the same day as the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Patient reported that she initially had an "extreme reaction" with severe, flu-like symptoms, headache, fever, disorientation, nausea and dehydration.  She reported that she had a fever within three hours of receiving the vaccination. She stated that she suffered extreme vomiting for three and a half weeks along with ongoing headache, fever and cramping.  On an unknown date, she was in the hospital, or ER, where she received medication for nausea and intravenous medication for dehydration (unknown if hospitalized}.  She reported eight hours of pain/cramping in her lower abdomen, and again, stated that she was severely dehydrated.  (The duration of hospitalization or ER visit was not reported).  At the time of reporting, she said that her symptoms were ongoing, however, much less severe.   Treatment included was nausea medication (patient did not remember the drug's name), intravenous (IV) medication for dehydration, IV antibiotics and dicycloverine.   Action taken with mRNA-1273 was not reported.  The outcomes of the events,  dehydration, cramping in lower abdomen, fever, nausea, headache, disorientation, flu like symptoms, intense vomiting and cramping, were considered recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away; A spontaneous report was received from a Healthcare Professional concerning a 57-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed away/death.  The patient's medical history was not provided. However, the patient had some serious chronic health condition. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: LOT: 011L20A Exp: 03July2021) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. He did not experience any symptoms right away and nothing within the next 15 mins under observation.  On 22 Jan 2021, the patient passed away.   Treatment details was not reported.  Action taken with mRNA-1273 in response to the event passed away, was not applicable.   On 22 Jan 2021, the patient died. It was unknown if an autopsy was performed.; Reporter's Comments: Very limited information regarding the event of death has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Passed away
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Haematochezia, Myalgia, Nausea
Clinical narrative: I had the black stool, there was blood; Stomach upset; muscle ache; Fatigue; Nausea; A spontaneous report was received from a Reporter like Consumer concerning a 67 Year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscle ache, had the black stool there was blood/ Haematochezia, nausea, stomach upset, fatigue were reported.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 12 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch:024M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021 , The patient experienced the events muscle ache, had the black stool, there was blood , nausea, stomach upset, fatigue were reported. Event i had the black stool, there was blood was considered medically significant.  Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event haematochezia was unknown and for other event it was resolved on 13 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, visual, Pain in extremity
Clinical narrative: saw a ghost while being totally awake; Arm hurt; A spontaneous report was received from a Consumer concerning a 72-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm hurt, saw a ghost while being totally awake.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient experienced the events arm hurt. on 17 JAN 2021 saw a ghost while being totally awake. The event saw a ghost while being totally awake was considered to be medically significant.  Treatment details included For the symptoms: Acetaminophen., Other: drops for his eyes for the glaucoma., FMarasco 03Feb2021  Action taken with mRNA-1273 in response to the events was not reported.   On 15 Jan 2021 the outcome of events arm hurt was resolved.  On 17 Jan  the outcome of events include, saw a ghost while being totally awake was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events  a causal relationship cannot be excluded