chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Dizziness
Clinical narrative: This individual had donated plasma prior to being immunized with the Td vaccine.  Within less than 15 minutes after vaccination, the individual became dizzy.  The individual did not lose conscientious.  The individual recovered with minimal intervention.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The first 2 days after receiving vaccine, she noticed slight redness to the injection site but by the 3rd day, it was swollen and redness increased in size and was warm and sore to touch; she also developed cold symptoms (runny nose, sneezing, headache) like half of her workmates; it is now day 9 since receiving the vaccine and the redness has lessened and it is not as swollen anymore but still sore to touch.  She took some multi-symptom medication for the cold symptoms and applied ice packs to the swollen area in the L upper arm.  Symptoms have improved but not resolved.  She still has slight runny nose and congestion and the redness to the arm is still there.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Nasopharyngitis, Respiratory tract congestion, Rhinorrhoea, Sneezing
Clinical narrative: The first 2 days after receiving vaccine, she noticed slight redness to the injection site but by the 3rd day, it was swollen and redness increased in size and was warm and sore to touch; she also developed cold symptoms (runny nose, sneezing, headache) like half of her workmates; it is now day 9 since receiving the vaccine and the redness has lessened and it is not as swollen anymore but still sore to touch.  She took some multi-symptom medication for the cold symptoms and applied ice packs to the swollen area in the L upper arm.  Symptoms have improved but not resolved.  She still has slight runny nose and congestion and the redness to the arm is still there.
Age: 67.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MNQ, VARZOS
Symptoms: Wrong technique in product usage process
Clinical narrative: Administered IM injection with a 5/8 inch needle by mistake.
Age: 70.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Headache, Hypoaesthesia, Insomnia, Joint swelling
Clinical narrative: Received vaccination on 7/8/19. Symptoms started around 7/23/19 of nausea, severe arthralgias and body aches, severe bilateral wrist pain and swelling, some numbness, tingling to the fingers of the right hand, decreased sleep because of severe pain, and generalized headache. Nausea has resolved. Has been using ice, tylenol, ibuprofen, elevation, compression, rest without relief. No injury, no rheumatological disease history, no excessive lifting. No fever, no rashes. Treating with prednisone and norco.
Age: 70.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Pain, Paraesthesia
Clinical narrative: Received vaccination on 7/8/19. Symptoms started around 7/23/19 of nausea, severe arthralgias and body aches, severe bilateral wrist pain and swelling, some numbness, tingling to the fingers of the right hand, decreased sleep because of severe pain, and generalized headache. Nausea has resolved. Has been using ice, tylenol, ibuprofen, elevation, compression, rest without relief. No injury, no rheumatological disease history, no excessive lifting. No fever, no rashes. Treating with prednisone and norco.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Dizziness, Nausea, Pyrexia, Tremor
Clinical narrative: The patient experienced shaking, nausea, lighheadedness, and a fever of 104-105 degrees. She went to the emergency room approximately 10 hours after receiving the vaccination and was discharged approximately 16 hours later
Age: 46.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: With first MMR, patient got a large red area (approx. 3 in diameter) - within a day of vaccination that lasted a few days - since redness was a side effect, employee health couldn't find that this was a contraindication to a second dose. Within a couple hours of the second dose that was given 2 months later, employee again got a large (approx. 5-6 diameter) very red, indurated area with a 2 blisters approx. 2 cm x 1cm, & 0.5cm x 0.5 cm where injection was administered
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Patient received the first dose of Shingrix vaccine series and left to go shopping in the store. About 15 minutes after, while she was checking out at the front of the store, she started feeling dizzy/faint. She was in a scooter so she did not stand up and just kept repeating that she "didn't feel good". Paramedics were called to check her out, and they cleared her to leave shortly after they got to the store.
Sex: U
Vaccine: RV1
Symptoms: Accidental underdose, Oral administration complication, Regurgitation
Clinical narrative: Regurgitation of medication; underdose; This case was reported by a consumer and described the occurrence of regurgitation of medication in a 8-week-old patient who received Rota (Rotarix) for prophylaxis.   On an unknown date, the patient received Rotarix (oral). On an unknown date, less than a year after receiving Rotarix, the patient experienced regurgitation of medication and accidental underdose. On an unknown date, the outcome of the regurgitation of medication and accidental underdose were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the mother of the patient. The patient spits out some of the rotarix vaccine. Might be half of it, which led to accidental underdose. The reporter asked was it still effective.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via sales rep and described the occurrence of fever in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix. On 17th July 2019, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information received were as follows: The patient had the first injection and developed a fever. The patient asked to the reporter whether they are going to be able to offer some medical advice on the day of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site pain; Injection site swelling; Injection site redness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male 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 injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient had the pain, redness and swelling with the 2nd shot. The reporter was asked to speak with the healthcare provider regarding the events and the healthcare provider will determine the right treatment plan. This case has been linked with US2019AMR131555, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Fu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a female 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms for 6 weeks after 1st shot of vaccine. The reporter gave permission to follow up.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Feeling abnormal, Pain in extremity, Peripheral swelling
Clinical narrative: Felt really awful; My arm felt as if it had been hit by a baseball bat / sore arm; Red arm; Swollen arm; This case was reported by a consumer and described the occurrence of feels awful in a 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 feels awful, pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the feels awful was unknown and the outcome of the pain in arm, erythema of extremities and swelling arm were recovered/resolved.   It was unknown if the reporter considered the feels awful, pain in arm, erythema of extremities and swelling arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in an unknown arm. The patient had the shingles vaccine one of two shots recently and had multiple side effects that seemed way outside of normal. The patient's arm felt like that had been hit by a baseball bat, was extremely sore red swollen for 5 days and patient felt really awful. The patient was almost scared to get the second shot. The patient tried multiple other options of teaching our to your company all fruitless. The reporter gave permission to follow up.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Erythema, Fatigue
Clinical narrative: Felt really awful; My arm felt as if it had been hit by a baseball bat / sore arm; Red arm; Swollen arm; This case was reported by a consumer and described the occurrence of feels awful in a 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 feels awful, pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the feels awful was unknown and the outcome of the pain in arm, erythema of extremities and swelling arm were recovered/resolved.   It was unknown if the reporter considered the feels awful, pain in arm, erythema of extremities and swelling arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in an unknown arm. The patient had the shingles vaccine one of two shots recently and had multiple side effects that seemed way outside of normal. The patient's arm felt like that had been hit by a baseball bat, was extremely sore red swollen for 5 days and patient felt really awful. The patient was almost scared to get the second shot. The patient tried multiple other options of teaching our to your company all fruitless. The reporter gave permission to follow up.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Feeling abnormal, Headache, Influenza like illness, Loss of personal independence in daily activities, Nausea
Clinical narrative: Felt really awful; My arm felt as if it had been hit by a baseball bat / sore arm; Red arm; Swollen arm; This case was reported by a consumer and described the occurrence of feels awful in a 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 feels awful, pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the feels awful was unknown and the outcome of the pain in arm, erythema of extremities and swelling arm were recovered/resolved.   It was unknown if the reporter considered the feels awful, pain in arm, erythema of extremities and swelling arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in an unknown arm. The patient had the shingles vaccine one of two shots recently and had multiple side effects that seemed way outside of normal. The patient's arm felt like that had been hit by a baseball bat, was extremely sore red swollen for 5 days and patient felt really awful. The patient was almost scared to get the second shot. The patient tried multiple other options of teaching our to your company all fruitless. The reporter gave permission to follow up.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia, Skin discolouration
Clinical narrative: Felt really awful; My arm felt as if it had been hit by a baseball bat / sore arm; Red arm; Swollen arm; This case was reported by a consumer and described the occurrence of feels awful in a 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 feels awful, pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the feels awful was unknown and the outcome of the pain in arm, erythema of extremities and swelling arm were recovered/resolved.   It was unknown if the reporter considered the feels awful, pain in arm, erythema of extremities and swelling arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in an unknown arm. The patient had the shingles vaccine one of two shots recently and had multiple side effects that seemed way outside of normal. The patient's arm felt like that had been hit by a baseball bat, was extremely sore red swollen for 5 days and patient felt really awful. The patient was almost scared to get the second shot. The patient tried multiple other options of teaching our to your company all fruitless. The reporter gave permission to follow up.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Sleep disorder
Clinical narrative: Felt really awful; My arm felt as if it had been hit by a baseball bat / sore arm; Red arm; Swollen arm; This case was reported by a consumer and described the occurrence of feels awful in a 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 feels awful, pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the feels awful was unknown and the outcome of the pain in arm, erythema of extremities and swelling arm were recovered/resolved.   It was unknown if the reporter considered the feels awful, pain in arm, erythema of extremities and swelling arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in an unknown arm. The patient had the shingles vaccine one of two shots recently and had multiple side effects that seemed way outside of normal. The patient's arm felt like that had been hit by a baseball bat, was extremely sore red swollen for 5 days and patient felt really awful. The patient was almost scared to get the second shot. The patient tried multiple other options of teaching our to your company all fruitless. The reporter gave permission to follow up.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Influenza like illness, Malaise
Clinical narrative: Felt really awful; My arm felt as if it had been hit by a baseball bat / sore arm; Red arm; Swollen arm; This case was reported by a consumer and described the occurrence of feels awful in a 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 feels awful, pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the feels awful was unknown and the outcome of the pain in arm, erythema of extremities and swelling arm were recovered/resolved.   It was unknown if the reporter considered the feels awful, pain in arm, erythema of extremities and swelling arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in an unknown arm. The patient had the shingles vaccine one of two shots recently and had multiple side effects that seemed way outside of normal. The patient's arm felt like that had been hit by a baseball bat, was extremely sore red swollen for 5 days and patient felt really awful. The patient was almost scared to get the second shot. The patient tried multiple other options of teaching our to your company all fruitless. The reporter gave permission to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Pain
Clinical narrative: Guillain Barre; excruciating pain; This case was reported by a nurse via sales rep and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th March 2019, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and pain. On an unknown date, the outcome of the guillain barre syndrome and pain were unknown.   It was unknown if the reporter considered the guillain barre syndrome and pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and patient experienced excruciating pain post vaccination later diagnosed with Gillian Barre. The reporter was agree to follow up from the Glaxosmithkline.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: sore arm (at injection site); redness (at injection site); swelling (at injection site); hot (at injection site); Fever; Head hurt; Fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 477S3, expiry date 17th October 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse reaction (1st dose received on 27th April 2019 (batch no:99D9F; expiry date 14th April 2020) in right arm and developed bad reaction.).   On an unknown date, the patient received the 2nd dose of Shingrix. On 10th July 2019, less than a year after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth, fever, headache and fatigue. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site warmth, fever, headache and fatigue were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site warmth, fever, headache and fatigue to be related to Shingrix.  Additional case details were reported as follows: Age at vaccination was not reported, but patient could be 54 years old. The reporter confirmed the shingles vaccine as Shingrix. The reporter gave permission to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: sore arm (at injection site); redness (at injection site); swelling (at injection site); hot (at injection site); Fever; Head hurt; Fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 477S3, expiry date 17th October 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse reaction (1st dose received on 27th April 2019 (batch no:99D9F; expiry date 14th April 2020) in right arm and developed bad reaction.).   On an unknown date, the patient received the 2nd dose of Shingrix. On 10th July 2019, less than a year after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth, fever, headache and fatigue. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site warmth, fever, headache and fatigue were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site warmth, fever, headache and fatigue to be related to Shingrix.  Additional case details were reported as follows: Age at vaccination was not reported, but patient could be 54 years old. The reporter confirmed the shingles vaccine as Shingrix. The reporter gave permission to follow up.
Sex: F
Vaccine: HEP, HEP
Symptoms: Circumstance or information capable of leading to medication error, Hepatitis B surface antibody negative, Inappropriate schedule of product administration, Therapy non-responder
Clinical narrative: therapy non-responder; Inappropriate schedule of vaccine; Inappropriate schedule of vaccine; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B at an unknown dose and Engerix B at an unknown dose. On an unknown date, unknown after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced therapy non-responder, circumstance or information capable of leading to medication error and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the therapy non-responder, circumstance or information capable of leading to medication error and inappropriate schedule of vaccine administered were unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The patient had negative titer results for nursing school after Engerix B (unspecified number of doses) and due to which she had orders for an accelerated dosing schedule for Engerix-B, which led to circumstance or information capable of leading to medication error and inappropriate schedule of vaccine administered. No additional information provided. The reporter consented to follow up.      Lab Comments: On an unknown date, the serology test was performed
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Chills; Fever; Pain at Injection Site; Nausea; Severe Headache; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2019, the patient received Shingrix. On 17th July 2019, 1 days after receiving Shingrix, the patient experienced chills, fever, injection site pain, nausea and headache. On an unknown date, the outcome of the chills, injection site pain, nausea and headache were unknown and the outcome of the fever was recovering/resolving.   It was unknown if the reporter considered the chills, fever, injection site pain, nausea and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient who was also a pharmacist. The patient experienced chills, fever, pain at injection site, nausea, severe headache following administration of Shingrix vaccine. Fever was 102 degree F, which came down to 99.5. The patient's normal temperature has been reported as 97.6 degree F. The patient reported that the patient never remember chills like last night post SIngrix. The reporter did not consent to follow-up.      Lab Comments: The patient's body temperature on an unknown date was 99.5
Sex: M
Vaccine: VARZOS, FLUX
Symptoms: Malaise, Pruritus, Pyrexia, Rash, Rash erythematous
Clinical narrative: skin reaction; itching; red tiny; slightly raised bumps on his torso/rash; fever; malaise; This case was reported by a consumer via call center representative and described the occurrence of skin reaction in a male patient who received Herpes zoster (Shingrix) (batch number H3MJ9, expiry date 13th September 2021) for prophylaxis.   The patient's past medical history included hypersensitivity (he did had a hypersensitivity history to medications) and abdominal discomfort (noting mycin containing medications cause some gastroentestinal discomfort). Previously administered products included INFLUENZA SHOT with an associated reaction of malaise (flu shots in the past (manufacturer unknown) that caused fever and malaise but this was more intense than that).   On 16th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th June 2019, 1 days after receiving Shingrix, the patient experienced fever and malaise. On an unknown date, the patient experienced skin reaction, pruritus, red rash and raised rash. The patient was treated with topical steroid nos (Topical Steroid). On an unknown date, the outcome of the skin reaction, pruritus and red rash were not recovered/not resolved and the outcome of the fever and malaise were recovered/resolved and the outcome of the raised rash was unknown.   The reporter considered the skin reaction, pruritus, red rash, fever, malaise and raised rash to be related to Shingrix.  Additional details were provided as follows: The caller stated that he received Shingrix and within 24 hours he experienced a fever of 101.4, and malaise that resolved after 2 days. Ten days ago, he began to have red tiny, slightly raised bumps on his torso, arms and legs that looked like mosquito bites. He noted he was also itching. The patient was told by the Dermatologist that this was a reaction to the Shingrix and has been advised not to get the 2nd.  The reporter did not consent to follow up.  Emergency room visit required. The health care professional declined for follow up and noted he would call back with any updates.
Sex: M
Vaccine: VARZOS, FLUX
Symptoms: Skin reaction
Clinical narrative: skin reaction; itching; red tiny; slightly raised bumps on his torso/rash; fever; malaise; This case was reported by a consumer via call center representative and described the occurrence of skin reaction in a male patient who received Herpes zoster (Shingrix) (batch number H3MJ9, expiry date 13th September 2021) for prophylaxis.   The patient's past medical history included hypersensitivity (he did had a hypersensitivity history to medications) and abdominal discomfort (noting mycin containing medications cause some gastroentestinal discomfort). Previously administered products included INFLUENZA SHOT with an associated reaction of malaise (flu shots in the past (manufacturer unknown) that caused fever and malaise but this was more intense than that).   On 16th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th June 2019, 1 days after receiving Shingrix, the patient experienced fever and malaise. On an unknown date, the patient experienced skin reaction, pruritus, red rash and raised rash. The patient was treated with topical steroid nos (Topical Steroid). On an unknown date, the outcome of the skin reaction, pruritus and red rash were not recovered/not resolved and the outcome of the fever and malaise were recovered/resolved and the outcome of the raised rash was unknown.   The reporter considered the skin reaction, pruritus, red rash, fever, malaise and raised rash to be related to Shingrix.  Additional details were provided as follows: The caller stated that he received Shingrix and within 24 hours he experienced a fever of 101.4, and malaise that resolved after 2 days. Ten days ago, he began to have red tiny, slightly raised bumps on his torso, arms and legs that looked like mosquito bites. He noted he was also itching. The patient was told by the Dermatologist that this was a reaction to the Shingrix and has been advised not to get the 2nd.  The reporter did not consent to follow up.  Emergency room visit required. The health care professional declined for follow up and noted he would call back with any updates.
Sex: M
Vaccine: VARZOS, FLUX
Symptoms: Malaise, Pyrexia
Clinical narrative: skin reaction; itching; red tiny; slightly raised bumps on his torso/rash; fever; malaise; This case was reported by a consumer via call center representative and described the occurrence of skin reaction in a male patient who received Herpes zoster (Shingrix) (batch number H3MJ9, expiry date 13th September 2021) for prophylaxis.   The patient's past medical history included hypersensitivity (he did had a hypersensitivity history to medications) and abdominal discomfort (noting mycin containing medications cause some gastroentestinal discomfort). Previously administered products included INFLUENZA SHOT with an associated reaction of malaise (flu shots in the past (manufacturer unknown) that caused fever and malaise but this was more intense than that).   On 16th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th June 2019, 1 days after receiving Shingrix, the patient experienced fever and malaise. On an unknown date, the patient experienced skin reaction, pruritus, red rash and raised rash. The patient was treated with topical steroid nos (Topical Steroid). On an unknown date, the outcome of the skin reaction, pruritus and red rash were not recovered/not resolved and the outcome of the fever and malaise were recovered/resolved and the outcome of the raised rash was unknown.   The reporter considered the skin reaction, pruritus, red rash, fever, malaise and raised rash to be related to Shingrix.  Additional details were provided as follows: The caller stated that he received Shingrix and within 24 hours he experienced a fever of 101.4, and malaise that resolved after 2 days. Ten days ago, he began to have red tiny, slightly raised bumps on his torso, arms and legs that looked like mosquito bites. He noted he was also itching. The patient was told by the Dermatologist that this was a reaction to the Shingrix and has been advised not to get the 2nd.  The reporter did not consent to follow up.  Emergency room visit required. The health care professional declined for follow up and noted he would call back with any updates.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased, Myalgia, Pyrexia
Clinical narrative: cannot move elbow or has to pick up her hand to move her wrist; fever; muscle aches; joint pain; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 5G7A7, expiry date 18th May 2021) for prophylaxis.   On 3rd April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd April 2019, less than a day after receiving Shingrix, the patient experienced fever, muscle pain and joint pain. On an unknown date, the patient experienced mobility decreased. On an unknown date, the outcome of the fever and muscle pain were resolved with sequelae and the outcome of the joint pain was recovering/resolving and the outcome of the mobility decreased was unknown.   It was unknown if the reporter considered the fever, muscle pain, joint pain and mobility decreased to be related to Shingrix.  Additional details were reported as follows: The reporter stated that, the patient experienced fever, achy muscles and joint pain. The joint pain has continued since the injection, primarily in the patient's hands, elbows and wrists. The pain was steady until June 2019 when patient started having waves of intense pain such that she cannot move her elbow or has to pick up her hand to move her wrist. The reporter stated that between the waves of intense pain patient continued to have achiness all the time.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: swelling arm; redness on arm; painful to the touch; arm a little stiff; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 15th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 16th July 2019, the patient experienced limbs stiffness and pain in arm. On 17th July 2019, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the injection site pain, limbs stiffness, swelling arm, erythema of extremities and pain in arm were recovering/resolving.   It was unknown if the reporter considered the injection site pain, limbs stiffness, swelling arm, erythema of extremities and pain in arm to be related to Shingrix.  Additional details were provided as follows: After receiving the 2nd dose of Shingrix, the patient experienced some soreness in his arm at the injection site. The patient arm was little stiff and also very painful to the touch and noticed redness and swelling in his arm. The patient was concerned by the amount of redness, so went to Urgent Care, where they drew a line around the redness and advised to start antibiotics if the redness spread. The redness has not spread and the patient has not filled the prescription for antibiotics. The symptoms were not improving. The patient consented to follow up. The emergency room visit was required.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: swelling arm; redness on arm; painful to the touch; arm a little stiff; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 15th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 16th July 2019, the patient experienced limbs stiffness and pain in arm. On 17th July 2019, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the injection site pain, limbs stiffness, swelling arm, erythema of extremities and pain in arm were recovering/resolving.   It was unknown if the reporter considered the injection site pain, limbs stiffness, swelling arm, erythema of extremities and pain in arm to be related to Shingrix.  Additional details were provided as follows: After receiving the 2nd dose of Shingrix, the patient experienced some soreness in his arm at the injection site. The patient arm was little stiff and also very painful to the touch and noticed redness and swelling in his arm. The patient was concerned by the amount of redness, so went to Urgent Care, where they drew a line around the redness and advised to start antibiotics if the redness spread. The redness has not spread and the patient has not filled the prescription for antibiotics. The symptoms were not improving. The patient consented to follow up. The emergency room visit was required.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia, Pain
Clinical narrative: Myalgia; aches and pains all over; headache; arthralgia; This case was reported by a physician via call center representative and described the occurrence of myalgia in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced myalgia, general body pain, headache and arthralgia. On an unknown date, the outcome of the myalgia, general body pain, headache and arthralgia were unknown.   It was unknown if the reporter considered the myalgia, general body pain, headache and arthralgia to be related to Shingrix.  Additional information received were as follows: No batch number or expiry date was reported. The patient experienced aches and pains all over. The events were not subsided. The reporter consented to follow up.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis.   Co-suspect products included MMR (Measles mumps rubella vaccine) for prophylaxis.   On 17th May 2019, the patient received the 1st dose of Shingrix and Measles mumps rubella vaccine. On 6th June 2019, 20 days after receiving Shingrix and Measles mumps rubella vaccine, 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 and Measles mumps rubella vaccine.  Additional information received were as follows: The patient broke out with shingles. The batch number of Shingrix was reported as ER52B from the reporter, however, based on a safety lot number review, the batch number was updated to ER5ZB. The reporter consented to follow up.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: huge bruise; This case was reported by a pharmacist via call center representative and described the occurrence of contusion in a 83-year-old female patient who received Herpes zoster (Shingrix) (batch number M77B4, expiry date 8th February 2021) for prophylaxis.   On 13th August 2018, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced contusion. On an unknown date, the outcome of the contusion was unknown.   It was unknown if the reporter considered the contusion to be related to Shingrix.  Additional details were provided as follows: The patient experienced a huge bruise down her arm after receiving Shingrix vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Ecchymosis, Injection site haemorrhage, Lymphadenopathy
Clinical narrative: Swollen Cervical Lymph Node; Ecchymotic marks; This case was reported by a physician via call center representative and described the occurrence of lymphadenopathy cervical in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced lymphadenopathy cervical and ecchymosis. On an unknown date, the outcome of the lymphadenopathy cervical and ecchymosis were unknown.   It was unknown if the reporter considered the lymphadenopathy cervical and ecchymosis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient received Shingrix 5 days ago and at the time of reporting had lymph node swollen in cervical area. The physician stated that 4 to 5 ecchymotic marks a few inches below the injection site. The reporter gave consent to follow up. The physician did not administer the Shingrix and did not have that data.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Vaccination failure; Shingles; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number C523T, expiry date 4th July 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 7X3EJ, expiry date 3rd October 2020) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of herpes zoster.   On 25th April 2018, the patient received the 1st dose of Shingrix (intramuscular). On 31st July 2018, the patient received the 2nd dose of Shingrix (intramuscular). On 10th April 2019, 350 days after receiving Shingrix and 253 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional information was provided as follows: The patient received 1st dose of Shingrix in left deltoid and 2nd dose in right deltoid intramuscularly. The reporter gave consent to follow up. This case has been linked with US2019131757, reported by same reporter.
Age: 55.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Immunodeficiency, Vaccination failure
Clinical narrative: immunocompromised; Shingles; vaccination failure; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26th February 2018, the patient received the 1st dose of Shingrix. On 17th May 2018, the patient received the 2nd dose of Shingrix. On 9th July 2019, 1 year and 133 days after receiving Shingrix and 1 year and 53 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced immunocompromised (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure, immunocompromised and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, immunocompromised and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The register pharmacist (RPH) reported that patient received the Shingrix series dose 1 and dose 2. The patient was immuncompromised and had Shingles 10 days ago. The reporter asked that what was the safety on receiving an additional series. The reporter was consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Neoplasm malignant
Clinical narrative: Cancer; Drug dose administration interval too long; This case was reported by a other health professional via call center representative and described the occurrence of cancer in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix.   On 16th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant) and drug dose administration interval too long. On an unknown date, the outcome of the cancer and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: A Pharmacy Intern reports that a patient received a new diagnosis of cancer (unspecified type or region) 1 week after receiving the second dose of Shingrix. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.  The reporter consented to follow up. The pharmacy intern acknowledged that follow-up will be needed for additional data. TTO was updated to less than a week as per startdate of vaccine and reporting dateand also clarification was raised.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Pt reported severe throbbing pain upon injection. It was treated hours later with hydrocodone/APAP 5-325.  Pt reported pain upon any movement of arm the next day.
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Burning sensation, Injection site pain
Clinical narrative: Severe burning and pain at the exact moment of the injection in my left shoulder on June 6 2019. Sensation of hot molten lava being poured from shoulder down to elbow. This burning and pain have continued, somewhat less but still very present, since that date. Treated symptomatically by the medical practice with only minimal and temporary relief but not trying to identify and treat the injury itself. To sleep I must take NSAID for relief. Limited mobility in that shoulder. Have return visit scheduled for 7/29/2019.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site swelling, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, fever, swollen injection site for at least 48 hours. Weakness that continues 6 days after the event.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Throat tightness
Clinical narrative: Pain, redness and swelling in Lt upper arm below injection site. Throat tightness Hives below injection site
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site erythema, Injection site oedema, Injection site pain, Pain
Clinical narrative: Patient has a history of facial shingles and her PCM recommended the shingrix vaccine. She went AM 19JUL2019, uncomplicated injection. The next morning she woke with body aches and injection site edema/erythema/pain. Those symptoms improved, but over the weekend she also developed a diffuse maculopapular rash sparing the palms/soles that did not appear like hives. Slightly itchy. No other symptoms aside from mild diarrhea/abdominal that had resolved the day of her apt 23JUL2019. Has a sick contact with similar symptoms, but no rash.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Patient has a history of facial shingles and her PCM recommended the shingrix vaccine. She went AM 19JUL2019, uncomplicated injection. The next morning she woke with body aches and injection site edema/erythema/pain. Those symptoms improved, but over the weekend she also developed a diffuse maculopapular rash sparing the palms/soles that did not appear like hives. Slightly itchy. No other symptoms aside from mild diarrhea/abdominal that had resolved the day of her apt 23JUL2019. Has a sick contact with similar symptoms, but no rash.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Sudden chills, severe muscle pain throughout body, very painful headace. Has lasted for 18hrs so far. Still present, have been in bed since 11pm yesterday. I experienced a similar reaction to the first dose, though it took longer to begin.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: - body aches - chills - fever (99.6 deg at 10:00 am, 07/26/2019) - fever (100.9 deg at 4:00 PM, 07/26/2019)
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Musculoskeletal pain, Rash, Rash macular, Skin warm
Clinical narrative: Left shoulder very swollen, sore, red and hot to touch. The swelling went down but Area is still bright red and now has raised patches and hurts. I also have red spots and splotches in my face and scalp that are painful. It actually feels like the vaccine gave me shingles.