chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash macular, Swelling face, Vaccination complication
Clinical narrative: faciaI swelling and blotches on her face.; faciaI swelling and blotches on her face.; This spontaneous report was received from a consumer via Pfizer and refers to a female patient of unknown age. The patient concurrent condition included "bad reaction to eggs". There was no information about the patient's concomitant therapies or medical history provided. On an unknown date in 1999, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported). On an unknown date in 1999, the patient had bad reaction to an measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine, that resulted in faciaI swelling and blotches on her face. The patient was admitted to the hospital on an unknown date. The outcome of swelling face and rash macular was unknown.  The reporter considered swelling face and rash macular to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy, Deafness, Facial paralysis, Herpes zoster
Clinical narrative: hearing loss; herpes zoster; Bell's palsy/facial paralysis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 12-APR-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose and route of administration were not reported) for routine health maintenance an for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as after receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes zoster, Bell's palsy, hearing loss and facial paralysis. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster, Bell's palsy, hearing loss and facial paralysis was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   The events of herpes zoster, Bell's palsy, hearing loss and facial paralysis were considered to be disabling. Upon internal review, the events of Bell's palsy/facial paralysis and hearing loss were considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Injection site pain, Pain
Clinical narrative: achiness; soreness at site of vaccination; shivering/ chills; headache; fever; vomiting; Diarrhea; This case was reported by a consumer via other manufacturer and described the occurrence of pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received in July 2020, refer case US2020AMR254715). Concurrent medical conditions included egg allergy.   In October 2020, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than 3 months after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain, injection site pain, shivering, headache, fever, vomiting and diarrhea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain, injection site pain, shivering, headache, fever, vomiting and diarrhea were unknown.   It was unknown if the reporter considered the pain, injection site pain, shivering, headache, fever, vomiting and diarrhea to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported, however could be 56 or 57 years. The patient received Shingrix vaccine and Flu vaccine on same day. The patient reported experienced every adverse reaction possible. The symptoms listed were achiness, soreness at site of vaccination, chills, shivering, headache, fever, vomiting, and diarrhea. The reporter consent to call her back.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR254715:same reporter, 1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: achiness; soreness at site of vaccination; shivering/ chills; headache; fever; vomiting; Diarrhea; This case was reported by a consumer via other manufacturer and described the occurrence of pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received in July 2020, refer case US2020AMR254715). Concurrent medical conditions included egg allergy.   In October 2020, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than 3 months after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain, injection site pain, shivering, headache, fever, vomiting and diarrhea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain, injection site pain, shivering, headache, fever, vomiting and diarrhea were unknown.   It was unknown if the reporter considered the pain, injection site pain, shivering, headache, fever, vomiting and diarrhea to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported, however could be 56 or 57 years. The patient received Shingrix vaccine and Flu vaccine on same day. The patient reported experienced every adverse reaction possible. The symptoms listed were achiness, soreness at site of vaccination, chills, shivering, headache, fever, vomiting, and diarrhea. The reporter consent to call her back.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR254715:same reporter, 1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Mobility decreased, Myalgia
Clinical narrative: I was having trouble moving my head and arms without pain that makes you want to cry; scratchy throat; tired; muscle pain not too bad but not great; severe headache /  having trouble moving my head / without pain that makes you want to cry; pain in both arms / trouble moving my/ arms / without pain that makes you want to cry; neck and pain; upset stomach; shaking; This case was reported by a consumer and described the occurrence of throat irritation in a 55-year-old female patient who received Herpes zoster SHINGRIX. Concurrent medical conditions included thyroid hormones decreased and multiple allergies. On 6th November 2020, the patient received the 1st dose of SHINGRIX .5 ug. On 14th November 2020, 8 days after receiving SHINGRIX, the patient experienced mobility decreased. In November 2020, the patient experienced throat irritation, tiredness, muscle pain, headache, pain in arm, neck pain, upset stomach and tremor. On an unknown date, the outcome of the throat irritation, tiredness, muscle pain, headache, pain in arm, neck pain, upset stomach, tremor and mobility decreased were recovered/resolved. The reporter considered the throat irritation, tiredness, muscle pain, headache, pain in arm, neck pain, upset stomach, tremor and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had multiple allergies and take medicines for low thyroid. Age at vaccination was not reported. Age group was captured as adult as per product indication. The patient received SHINGRIX on right arm. Reaction started with scratchy throat, tired and muscle pain not too bad but not great. It escalated during the week with severe headache, neck and pain in both arms, upset stomach. By Saturday night on 14th November 2021 the patient had trouble moving head and arms without pain that makes want to cry. It started to ease up Monday the 16th but the patient did call doctor. The patient continued to feel milder symptoms until the next Sunday.
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pain in extremity, Throat irritation, Tremor
Clinical narrative: I was having trouble moving my head and arms without pain that makes you want to cry; scratchy throat; tired; muscle pain not too bad but not great; severe headache /  having trouble moving my head / without pain that makes you want to cry; pain in both arms / trouble moving my/ arms / without pain that makes you want to cry; neck and pain; upset stomach; shaking; This case was reported by a consumer and described the occurrence of throat irritation in a 55-year-old female patient who received Herpes zoster SHINGRIX. Concurrent medical conditions included thyroid hormones decreased and multiple allergies. On 6th November 2020, the patient received the 1st dose of SHINGRIX .5 ug. On 14th November 2020, 8 days after receiving SHINGRIX, the patient experienced mobility decreased. In November 2020, the patient experienced throat irritation, tiredness, muscle pain, headache, pain in arm, neck pain, upset stomach and tremor. On an unknown date, the outcome of the throat irritation, tiredness, muscle pain, headache, pain in arm, neck pain, upset stomach, tremor and mobility decreased were recovered/resolved. The reporter considered the throat irritation, tiredness, muscle pain, headache, pain in arm, neck pain, upset stomach, tremor and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had multiple allergies and take medicines for low thyroid. Age at vaccination was not reported. Age group was captured as adult as per product indication. The patient received SHINGRIX on right arm. Reaction started with scratchy throat, tired and muscle pain not too bad but not great. It escalated during the week with severe headache, neck and pain in both arms, upset stomach. By Saturday night on 14th November 2021 the patient had trouble moving head and arms without pain that makes want to cry. It started to ease up Monday the 16th but the patient did call doctor. The patient continued to feel milder symptoms until the next Sunday.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: headache; soreness; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and pain. On an unknown date, the outcome of the headache and pain were unknown.   The reporter considered the headache and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported but captured as an adult as per vaccine indication. The patient was vaccinated with Shingrix and experienced headache and soreness. The patient was asked if to take Tylenol or Advil for headache and soreness.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; 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 (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, 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 Shingrix.  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 was vaccinated with 1st dose of Shingrix 5 months ago from reporting day since then patient had arm soreness. Till time of reporting arm soreness was not resolved. The patient's physician never heard of this happening. The patient was scheduled to get the 2nd shot on reporting day.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Nurse or PA said take Tylenol for pain. Tylenol did not work; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  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 reporter stated that the nurse or PA told patient to take Tylenol for pain and do not  take Advil. The patient stated Tylenol did not help and asked if the patient could take Advil.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Still have the red discoloration at the site of injection; This case was reported by a consumer and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group at vaccination was not reported but was captured as an adult as per vaccine indication. The patient received Shingrix and experienced red discoloration at the site of injection. Till the time of reporting symptom was not resolved. The patient was asked to take the 2nd shot on same injection site or not.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Polycystic ovaries
Clinical narrative: My friend's daughter/ got the vaccine / has Polycystic Ovarian Syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of polycystic ovarian syndrome in a 19-year-old female patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patient received HPV vaccine. On an unknown date, 7 years after receiving HPV vaccine, the patient experienced polycystic ovarian syndrome. On an unknown date, the outcome of the polycystic ovarian syndrome was not recovered/not resolved.   It was unknown if the reporter considered the polycystic ovarian syndrome to be related to HPV vaccine.  Additional information was provided as follows: The patient received HPV vaccine and experienced polycystic ovarian syndrome. The reporter mentioned that, HPV vaccine had been used to sterilize the girls and she wished, she could have known this 7 years ago. The case is linked with the case number- US2020AMR247399, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR247399:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: strong burning sensation where I have had the Shingles; This case was reported by a consumer and described the occurrence of burning sensation in face in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (on the face, around left nostril and upper lip left side for 8 years).   On 10th December 2020, the patient received the 1st dose of Shingrix. On 17th December 2020, 7 days after receiving Shingrix, the patient experienced burning sensation in face. On an unknown date, the outcome of the burning sensation in face was not recovered/not resolved.   It was unknown if the reporter considered the burning sensation in face to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The had shingles on my face for 8 years now around the left nostril and upper lip left side. The patient recently got the Shingrix vaccination a week ago from the time of reporting as approved by the physician and on the day of reporting the patient was having strong burning sensation where he/she had the shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Nausea, Pain
Clinical narrative: Chills; arm pain at site of inj; achy; nauseous; This case was reported by a consumer and described the occurrence of chills in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, pain in arm, pain and nausea. On an unknown date, the outcome of the chills, pain in arm, pain and nausea were unknown.   It was unknown if the reporter considered the chills, pain in arm, pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however it could be 63 or 64 years. The patient asked how long may typical non-dangerous side effect last from Shingrix vaccine. The patient had the first or 2nd Shingrix vaccine. The patient enquired how long might typical side effects last. The patient was experiencing side effects, was achy nauseous usually the side area from shots, chills and typical arm pain at site of injection.
Sex: U
Vaccine: VARZOS
Symptoms: Papule
Clinical narrative: Got a red papule; This case was reported by a consumer via interactive digital media and described the occurrence of papule in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced papule. On an unknown date, the outcome of the papule was unknown.   It was unknown if the reporter considered the papule to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient got a red papule with the second Shingrix vaccine. The patient asked if this was normal.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Sensory disturbance
Clinical narrative: unusual reaction to the first dose; odd sensation in the upper arm muscle / occasional numbness / most pronounced when my arm was on the steering wheel or / relatively stationary position; This case was reported by a consumer and described the occurrence of numbness of upper extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included penicillin allergy.   On 10th September 2020, the patient received Shingrix. In September 2020, less than a month after receiving Shingrix, the patient experienced numbness of upper extremities. On an unknown date, the patient experienced adverse reaction. On an unknown date, the outcome of the numbness of upper extremities was not recovered/not resolved and the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the numbness of upper extremities and adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient was still experiencing an odd sensation in the upper arm muscle. The occurrence of this occasional numbness had diminished, sometime since September 2020 but till the time of reporting, it was still reoccurred daily. At first it was most pronounced when her arm was on the steering wheel or in a relatively stationary position for extended lengths of time. The patient reported that, the Shingrix website had no information that she could find on long term side effects. The patient's concerns were that taking a 2nd dose might exaggerate this condition. The patient would like to know how effective in preventing shingles in one dose of Shingrix. She asked if she choose to take a second dose can could she have the injection in her other arm.  The patient also reported that, she had an unusual reaction to the first dose. She was asking how effective one dose of Shingrix was.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives; This case was reported by a consumer and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. Age group was captured as adult as per product indication. The reporter reported that are hives after Shingrix normal. Due to insufficient information hives was consider as event.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose, Paraesthesia, Syringe issue
Clinical narrative: tingly arm; suspect that only about half the dose was given; This case was reported by a pharmacist and described the occurrence of tingling of extremity in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 53X42, expiry date unknown) for prophylaxis.   On 27th December 2020, the patient received the 1st dose of Shingrix. On 27th December 2020, less than a day after receiving Shingrix, the patient experienced tingling of extremity and accidental underdose. On an unknown date, the outcome of the tingling of extremity and accidental underdose were unknown.   It was unknown if the reporter considered the tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The reporter was giving the Shingrix vaccine to the patient, and quite a lot of liquid squirted out the sides of the plastic part of the needle, which led to accidental underdose. The reporter suspected that only about half the dose was given. The patient's arm felt tingly. The reporter asked for recommendation to give another dose or to give half dose or to wait until the next dose was due or other. On 28th December 2020, the reporter called for information regarding the administration of less than the recommended dose of Shingrix to a patient. The patient received around half a dose of Shingrix due to a needle leakage. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020256888:FU1 deleted
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Peripheral swelling
Clinical narrative: developed a red patch from shot site developed a red patch / to under my arm; Was swollen on part of it; This case was reported by a consumer and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities and local swelling. On an unknown date, the outcome of the erythema of extremities and local swelling were unknown.   It was unknown if the reporter considered the erythema of extremities and local swelling to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had a shingle shot and developed a red patch from shot site to under the arm, it was swollen on part of it. The patient asked it there was anything to worry about. The patient would be due for the second shot soon and had signed up for COVID shot at the end of December.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: red patch from shingle shot site to under arm; This case was reported by a consumer and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had red patch from shingle shot site to under arm. The patient asked if there was anything to worry about.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Chills
Clinical narrative: temperature is 99.9; shoulder was sore/ Joint pain; chills; This case was reported by a consumer and described the occurrence of shoulder soreness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on unknown date).   On 23rd December 2020, the patient received the 2nd dose of Shingrix. On 23rd December 2020, less than a day after receiving Shingrix, the patient experienced shoulder soreness and chills. On 24th December 2020, the patient experienced fever. On an unknown date, the outcome of the shoulder soreness and chills were unknown and the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the shoulder soreness, chills and fever to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient received the Shingle vaccine a day before reporting. The patient's shoulder was sore on the same day and later had joint pain and chills. At the time of reporting the patient's temperature is 99.9 degrees F. The patient asked if this was a side effect of the vaccine.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: transient lower extremity weakness; This case was reported by a consumer and described the occurrence of lower extremities weakness of in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. In April 2020, 2 weeks after receiving Shingrix, the patient experienced lower extremities weakness of. On an unknown date, the outcome of the lower extremities weakness of was resolved with sequelae.   It was unknown if the reporter considered the lower extremities weakness of to be related to Shingrix.  Additional details were provided as follows: The reporter was inquiring because an acquaintance experienced this symptom two weeks out from the second inject of Shingrix. The event occurred around April 2020. The weakness was transient. The reporter asked if there were any reports of transient lower extremity weakness with Shingrix. The reporter personally did not believe if there was a correlation but wanted to see if it had been reported during trials and follow up. The patient was concerned now only because of the possibility of taking the COVID vaccine. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021003169:same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Skin reaction
Clinical narrative: Skin reaction; severe bruising; January 13th 2020 and therefore the second dose was not administered; This case was reported by a pharmacist and described the occurrence of skin reaction in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced skin reaction, contusion and incomplete course of vaccination. On an unknown date, the outcome of the skin reaction was recovered/resolved and the outcome of the contusion and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the skin reaction and contusion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced skin reaction with severe bruising. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a nurse and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. After receiving Shingrix, then in the waiting period for the 2nd vaccine, they developed shingles. The reporter asked, how long until they could have the second dose. The reporter did not consent to follow up. No additional information available and no permission for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise
Clinical narrative: kicked her butt; This case was reported by a pharmacist and described the occurrence of feeling unwell in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's pharmacy friend. The patient born about in 1966. The age at vaccination was not reported. The patient received Shingrix in year 2020. The reporter stated that the 2nd dose of Shingrix kicked the patient's butt. The reporter consented to follow up. No further information available but agreeable to contact by email. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020246485:same reporter US-GLAXOSMITHKLINE-US2020246486:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise
Clinical narrative: kicked his butt; This case was reported by a pharmacist and described the occurrence of feeling unwell in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's pharmacy friend. The patient born about in 1966. The age at vaccination was not reported. The patient received Shingrix in year 2020. The reporter stated that the 2nd dose of Shingrix kicked the patient's butt. The reporter consented to follow up. No further information was available but agreeable to contact by email. This was 1 of 3 linked cases reported by the same reporter. Sender's Comments:  US-GLAXOSMITHKLINE-US2020246486:same reporter US-GLAXOSMITHKLINE-US2020246482:same reporter
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: feeling wiped out two days; This case was reported by a consumer and described the occurrence of worn out in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th February 2020, the patient received the 1st dose of Shingrix. On 13th February 2020, 2 days after receiving Shingrix, the patient experienced worn out. On an unknown date, the outcome of the worn out was recovered/resolved.   It was unknown if the reporter considered the worn out to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and 2 days after expereinced feeling wiped out. The reporter reported that till the time of report felt fine. The reporter did not consent to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: severe muscles aches which lasted 3 weeks; This case was reported by a pharmacist and described the occurrence of myalgia in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number KY5T4, expiry date unknown) for prophylaxis.   On 22nd October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 22nd October 2020, less than a day after receiving Shingrix, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was recovered/resolved.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient had severe muscle aches. The reporter did not consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Flushing
Clinical narrative: flushing in her face / flushed; face is visibly red; face/ feels warm; . This case was reported by a consumer and described the occurrence of facial flushing in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th November 2020, the patient received the 2nd dose of Shingrix. On 29th November 2020, 1 days after receiving Shingrix, the patient experienced facial flushing, red face and feeling of warmth facial. On an unknown date, the outcome of the facial flushing, red face and feeling of warmth facial were not recovered/not resolved.   It was unknown if the reporter considered the facial flushing, red face and feeling of warmth facial to be related to Shingrix.  Additional details were provided as follows: Patient woke up with flushing in her face also her face was visibly red and it felt warm. Patient did not have a fever or high blood pressure Patient was not sure if that was due to Shingrix or just a coincidence. The reporter consented to follow up.
Age: 84.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Pain in extremity
Clinical narrative: had pain in both arms from the elbow to the shoulder / pain / comes and goes; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) for prophylaxis.   The patient's past medical history included breast operation and shingles.   On 16th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th October 2020, the patient received FLUAD (intramuscular). In November 2020, less than 2 months after receiving Shingrix, the patient experienced pain in arm. The patient was treated with ibuprofen (Advil), paracetamol (Tylenol), trolamine salicylate (Aspercreme) and biofreeze (nos) (Biofreeze). 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 Shingrix.  Additional details were provided as follows: On 10th October 2020, the patient received Fluad. The beginning of November 2020 she had pain in both arms from the elbow to the shoulder. The patient reported it was not a steady pain but comes and goes. The patient had used Advil, Tylenol, Aspercreme, and Biofreeze to help treat the pain.  The patient did not have lot number or expiration date information to provide. The reporter consented to follow up. It was unknown if the reporter considered the pain in arm to be related to fluad.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Heart rate increased, Illness
Clinical narrative: headache; Rapid heart beat; Arm soreness; chills; sick; Diarrhea; This case was reported by a consumer and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced sickness, diarrhea, headache, chills, heartbeats increased and pain in arm. On an unknown date, the outcome of the sickness, diarrhea, chills, heartbeats increased and pain in arm were recovered/resolved and the outcome of the headache was unknown.   It was unknown if the reporter considered the sickness, diarrhea, headache, chills, heartbeats increased and pain in arm to be related to Shingrix.  Addditional details were reported as follows: The age at vaccination was not reported. The patient received the dose of Shingrix and experienced some arm soreness for 4 days, rapid heart beat for 1.5 days, chills, diarrhea and felt sick for 4 days. The reporter consented to follow up. Date of birth was not provided. This case has been linked with case ID US2020246524, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020246524:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: headache; Rapid heart beat; Arm soreness; chills; sick; Diarrhea; This case was reported by a consumer and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced sickness, diarrhea, headache, chills, heartbeats increased and pain in arm. On an unknown date, the outcome of the sickness, diarrhea, chills, heartbeats increased and pain in arm were recovered/resolved and the outcome of the headache was unknown.   It was unknown if the reporter considered the sickness, diarrhea, headache, chills, heartbeats increased and pain in arm to be related to Shingrix.  Addditional details were reported as follows: The age at vaccination was not reported. The patient received the dose of Shingrix and experienced some arm soreness for 4 days, rapid heart beat for 1.5 days, chills, diarrhea and felt sick for 4 days. The reporter consented to follow up. Date of birth was not provided. This case has been linked with case ID US2020246524, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020246524:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Pain in extremity
Clinical narrative: headache; diarrhea; Arm soreness; This case was reported by a consumer and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced headache, diarrhea and pain in arm. On an unknown date, the outcome of the headache, diarrhea and pain in arm were unknown.   It was unknown if the reporter considered the headache, diarrhea and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Husband stated that his wife received the dose of Shingrix and she experienced headache, diarrhea and arm soreness. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020246522:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise
Clinical narrative: Tiredness; malaise; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu shot (received shot annually).   On 21st March 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, between 1 and 3 months after receiving Shingrix, the patient experienced tiredness and malaise. On an unknown date, the outcome of the tiredness and malaise were recovered/resolved.   It was unknown if the reporter considered the tiredness and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however it could be 50 or 51 years. Shingrix vaccine was given in the patient's left arm The patient reported that she experienced malaise and tiredness after receiving the vaccine. The patient stated that these side effects only lasted for a day and a half. The patient reported not having a fever. The reporter did not consent to follow up. For tolerance after 2nd dose refer case US2020AMR253323.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR253323:same reporter
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphonia, Hypersensitivity, Productive cough, Swollen tongue, Throat tightness
Clinical narrative: Allergic reaction or throat tightness; Allergic reaction or throat tightness; Swollen tongue; Increased phlegm; Loss of voice; This case was reported by a consumer and described the occurrence of allergic reaction in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th January 2020, the patient received the 2nd dose of Shingrix. On 5th January 2020, 2 hrs after receiving Shingrix, the patient experienced allergic reaction, throat tightness, swollen tongue, phlegm and loss of voice. The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the allergic reaction, throat tightness, swollen tongue, phlegm and loss of voice were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, throat tightness, swollen tongue, phlegm and loss of voice to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix vaccine at the pharmacy and about 2 hours later she had an allergic reaction or throat tightness, swollen tongue, increased phlegm and loss of voice. The patient did not go to emergency room, but was seen by her doctor on 6th January 2020 Monday or 7th January 2020 Tuesdays and was started on steroid and some other medication. It took a total of about 2.5 to 3 weeks for all the adverse events to resolve. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Nausea, Pyrexia
Clinical narrative: low grade fever; chills; MILD nausea; stomach upset / mild stomach discomfort; This case was reported by a physician and described the occurrence of low grade fever in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, 1 day after receiving Shingrix, the patient experienced nausea and upset stomach. On 27th August 2020, the patient experienced low grade fever and chills. On 28th August 2020, the outcome of the low grade fever and chills were recovered/resolved. On an unknown date, the outcome of the nausea and upset stomach were recovered/resolved.   It was unknown if the reporter considered the low grade fever, chills and nausea to be related to Shingrix. The reporter considered the upset stomach to be related to Shingrix.  Additional details were provided as follows: Immunololgist reported that patient received the Shingrix and within the first 24 hours he developed a low grade fever and chills that dissipated. It was reported that low grade fever and chills started within 5-6 hours after Shingrix administration. On next day 15 to 20 hours post injection patient experienced mild nausea, stomach upset, mild stomach discomfort which was lasted for a few hours and then resolved. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain, Pain in extremity
Clinical narrative: sore arm; flu like symptoms; tired; achy; This case was reported by a consumer and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, tiredness and general body pain. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, tiredness and general body pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, tiredness and general body pain to be related to Shingrix.  Additional details were provided as follows: Patient received the 1st dose of Shingrix and experienced a sore arm and flu like symptoms consisting of being tired and achy. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR253321:same reporter