chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Eczema, Exfoliative rash, Rash erythematous, Rash generalised
Clinical narrative: spongiotic dermatitis; red eruption on her legs; rash spreading to her arm and torso/eruption on legs; itchy eruption on her legs; scaly eruption on her legs; This case was reported by a physician via call center representative and described the occurrence of subacute spongiotic dermatitis in a adult 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, less than a week after receiving Shingrix, the patient experienced subacute spongiotic dermatitis, erythematous eruption, generalized rash, itchy rash and rash scaly. On an unknown date, the outcome of the subacute spongiotic dermatitis, erythematous eruption, generalized rash, itchy rash and rash scaly were unknown.   It was unknown if the reporter considered the subacute spongiotic dermatitis, erythematous eruption, generalized rash, itchy rash and rash scaly to be related to Shingrix.  Additional details were reported as follows: This case was received from live chat. The physician reporting a patient experienced a red itchy scaly eruption on her legs within 1 week of receiving Shingrix vaccination.  The physician stated the rash had been present since October and was now spreading to her arms and torso.  A skin biopsy showed spongiotic dermatitis.  The physician also noted this might not be related to the shot.      Lab Comments: lab test were performed on an unknown date
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: spongiotic dermatitis; red eruption on her legs; rash spreading to her arm and torso/eruption on legs; itchy eruption on her legs; scaly eruption on her legs; This case was reported by a physician via call center representative and described the occurrence of subacute spongiotic dermatitis in a adult 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, less than a week after receiving Shingrix, the patient experienced subacute spongiotic dermatitis, erythematous eruption, generalized rash, itchy rash and rash scaly. On an unknown date, the outcome of the subacute spongiotic dermatitis, erythematous eruption, generalized rash, itchy rash and rash scaly were unknown.   It was unknown if the reporter considered the subacute spongiotic dermatitis, erythematous eruption, generalized rash, itchy rash and rash scaly to be related to Shingrix.  Additional details were reported as follows: This case was received from live chat. The physician reporting a patient experienced a red itchy scaly eruption on her legs within 1 week of receiving Shingrix vaccination.  The physician stated the rash had been present since October and was now spreading to her arms and torso.  A skin biopsy showed spongiotic dermatitis.  The physician also noted this might not be related to the shot.      Lab Comments: lab test were performed on an unknown date
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: shoulder achy; This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingrix.  Additional details were provided as follows: The age and age group of the patient was not reported, but taken as an adult as per vaccine indication. Pharmacist reported a group of patients experienced an achy feeling in their shoulders for 24 to 48 hours after receiving one or both doses of Shingrix. The patient experienced an achy feeling in their shoulders for 24 to 48 hours after receiving Shingrix vaccine. This was the same reporter but different patients reported on the same day to different agents.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: About 2 days before the date of reporting, the patient received Shingrix in the left arm. The patient did not consent to follow up. No further details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Chills, Condition aggravated, Confusional state, Dizziness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of visual impairment in a adult male patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) and (batch number 4F7K7, expiry date 5th December 2020) for prophylaxis.  Co-suspect products included SHINGRIX (batch number G933B, expiry date 22nd September 2020) and (batch number 4F7K7, expiry date 5th December 2020) for prophylaxis. On 21st September 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, the dose was an unknown dose. On 3rd December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 21st September 2018, less than a day after receiving SHINGRIX and less than a month after receiving SHINGRIX, the patient experienced chills (serious criteria hospitalization) and fever (serious criteria hospitalization). On 23rd September 2018, the patient experienced visual impairment (serious criteria hospitalization), shingles (serious criteria hospitalization), balance difficulty (serious criteria hospitalization), dizziness (serious criteria hospitalization), confusion (serious criteria hospitalization) and leg pain (serious criteria hospitalization). On an unknown date, the patient experienced activities of daily living impaired and condition aggravated. On an unknown date, the outcome of the visual impairment, balance difficulty, dizziness, confusion and leg pain were recovering/resolving and the outcome of the shingles, chills and fever were recovered/resolved and the outcome of the activities of daily living impaired and condition aggravated were unknown. It was unknown if the reporter considered the visual impairment, shingles, balance difficulty, dizziness, chills, fever, confusion, leg pain and activities of daily living impaired to be related to SHINGRIX and SHINGRIX. It was unknown if the reporter considered the condition aggravated to be related to SHINGRIX. Additional details were reported as follows: On the same day of vaccination, the patient experienced chills and fever that was lasted for 24 hours. The patient vision was impaired like the patient was looking through a kaleidoscope and the patient's balance was off. The patient had dizziness and pain in his left leg. The patient had shingles on head, down the face and in the right eye. On 24th September 2018, the patient was hospitalized for 4 days. The patient had testing for a stroke but the tests came back negative for a stroke. All of the symptoms improved but did not resolve. After received of a 2nd dose of SHINGRIX, the patient experienced the symptoms worsened again. In early January 2019, the patient went to the emergency room but was not admitted into the hospital. The patient was referred back to his neurologist. The reporter stated that, the vaccine was ruined the patient's life. The patient lost his job and was a shell of the man he was prior to getting SHINGRIX. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test normal, Loss of personal independence in daily activities, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of visual impairment in a adult male patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) and (batch number 4F7K7, expiry date 5th December 2020) for prophylaxis.  Co-suspect products included SHINGRIX (batch number G933B, expiry date 22nd September 2020) and (batch number 4F7K7, expiry date 5th December 2020) for prophylaxis. On 21st September 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, the dose was an unknown dose. On 3rd December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 21st September 2018, less than a day after receiving SHINGRIX and less than a month after receiving SHINGRIX, the patient experienced chills (serious criteria hospitalization) and fever (serious criteria hospitalization). On 23rd September 2018, the patient experienced visual impairment (serious criteria hospitalization), shingles (serious criteria hospitalization), balance difficulty (serious criteria hospitalization), dizziness (serious criteria hospitalization), confusion (serious criteria hospitalization) and leg pain (serious criteria hospitalization). On an unknown date, the patient experienced activities of daily living impaired and condition aggravated. On an unknown date, the outcome of the visual impairment, balance difficulty, dizziness, confusion and leg pain were recovering/resolving and the outcome of the shingles, chills and fever were recovered/resolved and the outcome of the activities of daily living impaired and condition aggravated were unknown. It was unknown if the reporter considered the visual impairment, shingles, balance difficulty, dizziness, chills, fever, confusion, leg pain and activities of daily living impaired to be related to SHINGRIX and SHINGRIX. It was unknown if the reporter considered the condition aggravated to be related to SHINGRIX. Additional details were reported as follows: On the same day of vaccination, the patient experienced chills and fever that was lasted for 24 hours. The patient vision was impaired like the patient was looking through a kaleidoscope and the patient's balance was off. The patient had dizziness and pain in his left leg. The patient had shingles on head, down the face and in the right eye. On 24th September 2018, the patient was hospitalized for 4 days. The patient had testing for a stroke but the tests came back negative for a stroke. All of the symptoms improved but did not resolve. After received of a 2nd dose of SHINGRIX, the patient experienced the symptoms worsened again. In early January 2019, the patient went to the emergency room but was not admitted into the hospital. The patient was referred back to his neurologist. The reporter stated that, the vaccine was ruined the patient's life. The patient lost his job and was a shell of the man he was prior to getting SHINGRIX. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of visual impairment in a adult male patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) and (batch number 4F7K7, expiry date 5th December 2020) for prophylaxis.  Co-suspect products included SHINGRIX (batch number G933B, expiry date 22nd September 2020) and (batch number 4F7K7, expiry date 5th December 2020) for prophylaxis. On 21st September 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, the dose was an unknown dose. On 3rd December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 21st September 2018, less than a day after receiving SHINGRIX and less than a month after receiving SHINGRIX, the patient experienced chills (serious criteria hospitalization) and fever (serious criteria hospitalization). On 23rd September 2018, the patient experienced visual impairment (serious criteria hospitalization), shingles (serious criteria hospitalization), balance difficulty (serious criteria hospitalization), dizziness (serious criteria hospitalization), confusion (serious criteria hospitalization) and leg pain (serious criteria hospitalization). On an unknown date, the patient experienced activities of daily living impaired and condition aggravated. On an unknown date, the outcome of the visual impairment, balance difficulty, dizziness, confusion and leg pain were recovering/resolving and the outcome of the shingles, chills and fever were recovered/resolved and the outcome of the activities of daily living impaired and condition aggravated were unknown. It was unknown if the reporter considered the visual impairment, shingles, balance difficulty, dizziness, chills, fever, confusion, leg pain and activities of daily living impaired to be related to SHINGRIX and SHINGRIX. It was unknown if the reporter considered the condition aggravated to be related to SHINGRIX. Additional details were reported as follows: On the same day of vaccination, the patient experienced chills and fever that was lasted for 24 hours. The patient vision was impaired like the patient was looking through a kaleidoscope and the patient's balance was off. The patient had dizziness and pain in his left leg. The patient had shingles on head, down the face and in the right eye. On 24th September 2018, the patient was hospitalized for 4 days. The patient had testing for a stroke but the tests came back negative for a stroke. All of the symptoms improved but did not resolve. After received of a 2nd dose of SHINGRIX, the patient experienced the symptoms worsened again. In early January 2019, the patient went to the emergency room but was not admitted into the hospital. The patient was referred back to his neurologist. The reporter stated that, the vaccine was ruined the patient's life. The patient lost his job and was a shell of the man he was prior to getting SHINGRIX. The reporter consented to follow up.
Age: 14.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Deafness unilateral, Depressed level of consciousness, Headache, Malaise, Oxygen therapy
Clinical narrative: Patient complained of left arm hurting after receiving  Hep A vaccine but stated he was okay to receive the Hep B vaccine. Moved client to exam table before administering other vaccine, after receiving Hep B vaccine he complained he was not feeling well, severe throbbing HA, unable to hear out of right ear, syncope like episode with decreased LOC. BP 112/80 @ 1319, BP 122/80 @ 1319, 118/74 @ 1327, @1351 BP 118/76, R. 16 P 82. Treatment: Pt laid back on exam table with head lowered and feet elevated, wet paper towels to back of neck, fan blowing to keep him cool. EMS called stayed with patient until EMS arrived @ 1354, @1356 VS y EMS BP 130/82 pulose Ox 83% blood sugar 91. EMS applied O2 and transported to ER at 1405. At 1555 client and his father returned to home to get shot record and VIS that he left behind, and to schedule appointment for other vaccines.
Age: 14.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Pain in extremity, Presyncope
Clinical narrative: Patient complained of left arm hurting after receiving  Hep A vaccine but stated he was okay to receive the Hep B vaccine. Moved client to exam table before administering other vaccine, after receiving Hep B vaccine he complained he was not feeling well, severe throbbing HA, unable to hear out of right ear, syncope like episode with decreased LOC. BP 112/80 @ 1319, BP 122/80 @ 1319, 118/74 @ 1327, @1351 BP 118/76, R. 16 P 82. Treatment: Pt laid back on exam table with head lowered and feet elevated, wet paper towels to back of neck, fan blowing to keep him cool. EMS called stayed with patient until EMS arrived @ 1354, @1356 VS y EMS BP 130/82 pulose Ox 83% blood sugar 91. EMS applied O2 and transported to ER at 1405. At 1555 client and his father returned to home to get shot record and VIS that he left behind, and to schedule appointment for other vaccines.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Rash generalised, Rash macular
Clinical narrative: Generalized macular rash on body from head to toe.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Acute kidney injury, Alopecia, Anaemia, Biopsy skin abnormal, Blood creatinine increased
Clinical narrative: Acute renal failure  necrosis of skin with permanent injury  lost her job now disabled despite meds Basically fired because she was unable to return to work due to open sores
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Depression, Disability, Haemoglobin decreased, Impaired work ability, Skin necrosis
Clinical narrative: Acute renal failure  necrosis of skin with permanent injury  lost her job now disabled despite meds Basically fired because she was unable to return to work due to open sores
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Skin ulcer, Vasculitis necrotising
Clinical narrative: Acute renal failure  necrosis of skin with permanent injury  lost her job now disabled despite meds Basically fired because she was unable to return to work due to open sores
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Malaise, Peripheral swelling, Skin tightness, Skin warm
Clinical narrative: Within hours, swelling of arm above elbow -- red, tight, warm; on second day, swelling extended below elbow. No fever, but general sense of malaise for 3 days.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B core antibody negative
Clinical narrative: received 3 doses of Recombivax/ had titers for anti-HB concentrations, drawn for nursing school entry, that were negative; This spontaneous report was received from a nurse and refers to a 20-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On unknown dates, the patient was vaccinated with three doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot number, expiration date, anatomical location, route of administration and dose were not provided) for prophylaxis.         On an unknown date, the patient had titers for anti-HB concentrations drawn for nursing school entry, that was negative. The patient sought medical attention.    The outcome of negative titers for hepatitis B was unknown.  The causality assessment between the event and the suspect therapy was not provided.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: injection site soreness; terrible aches in her neck; pain shoulder; aches in her back; aches in her sternum; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th April 2019, 1 days after receiving Shingrix and an unknown time after starting excedrin unknown and Motrin, the patient experienced injection site pain, neck pain, shoulder pain, back pain and sternal pain. The patient was treated with excedrin unknown and ibuprofen (Motrin). On an unknown date, the outcome of the injection site pain, neck pain, shoulder pain, back pain and sternal pain were unknown.   It was unknown if the reporter considered the injection site pain, neck pain, shoulder pain, back pain and sternal pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in the evening, and the next morning she woke up with terrible aches in her neck, shoulders, back, sternum.  She also was very sore around the injection site. She was going to call the pharmacist who gave her the injection at the time reporting. She took some Excedrin and some Motrin which helped for a little while, but then all the pain came back. She wants to call pharmacist at the time of reporting.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthritis, Pain in extremity, Spinal X-ray abnormal, Walking aid user, X-ray of pelvis and hip abnormal
Clinical narrative: A couple days after vaccination, began having pain in the left thigh at the site a previous shingles outbreak approximately 5 years ago.  Pain progressed rapidly to the point of requiring a cane.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Neuralgia, Walking aid user
Clinical narrative: A couple days after vaccination, began having pain in the left thigh at the site a previous shingles outbreak approximately 5 years ago.  Pain progressed rapidly to the point of requiring a cane.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: feverish, somnolent for two days, body aches, fatigue, shoulder pain at injection site
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Patient reported experiencing neck stiffness, injection site redness that appeared to be slightly spreading and the injection site was hot to touch. He was advised to report any worsening symptoms and should make his doctor aware.
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Hyperresponsive to stimuli, Lacrimation increased, Lethargy, Malaise
Clinical narrative: Mother states the child has been sick, personality changes, napping frequently and has watery eyes and a runny nose. She was vaccinated on 4/11, developed a low grade fever and lethargy on 4/16. By 4/20 mother reports she had a fever of 103 degrees taken orally with a bad cough and a large amount of mucus from chest and nose. On 4/22 and 4/23 she was kept out of school for continued fever of 103 degrees. On 4/28 she got a rash on her cheeks, by 4/29 rash has spread to chest, back, arms and thighs. Parent describes rash as pink and raised, but not filled with fluid. She reports child has been very sensitive to things in her environment and has a high pitched scream when she is upset, which is abnormal for her.
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Personality change, Pyrexia, Rash, Rhinorrhoea, Screaming
Clinical narrative: Mother states the child has been sick, personality changes, napping frequently and has watery eyes and a runny nose. She was vaccinated on 4/11, developed a low grade fever and lethargy on 4/16. By 4/20 mother reports she had a fever of 103 degrees taken orally with a bad cough and a large amount of mucus from chest and nose. On 4/22 and 4/23 she was kept out of school for continued fever of 103 degrees. On 4/28 she got a rash on her cheeks, by 4/29 rash has spread to chest, back, arms and thighs. Parent describes rash as pink and raised, but not filled with fluid. She reports child has been very sensitive to things in her environment and has a high pitched scream when she is upset, which is abnormal for her.
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Somnolence
Clinical narrative: Mother states the child has been sick, personality changes, napping frequently and has watery eyes and a runny nose. She was vaccinated on 4/11, developed a low grade fever and lethargy on 4/16. By 4/20 mother reports she had a fever of 103 degrees taken orally with a bad cough and a large amount of mucus from chest and nose. On 4/22 and 4/23 she was kept out of school for continued fever of 103 degrees. On 4/28 she got a rash on her cheeks, by 4/29 rash has spread to chest, back, arms and thighs. Parent describes rash as pink and raised, but not filled with fluid. She reports child has been very sensitive to things in her environment and has a high pitched scream when she is upset, which is abnormal for her.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test, Computerised tomogram, Syncope, X-ray
Clinical narrative: Weak, Fainting,  Dr kept me in hospital over night  To see my GP today
Sex: F
Vaccine: VARZOS
Symptoms: Delirium
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of delirium in a 62-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 6 hrs after receiving SHINGRIX, the patient experienced delirium (serious criteria GSK medically significant). On an unknown date, the outcome of the delirium was recovered/resolved. It was unknown if the reporter considered the delirium to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced delirium set in around 6 hours and was gone by 15 hours. The reporter gave consent for follow up. This case is linked to case US2019GSK076490, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Delirium
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of delirium in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced delirium (serious criteria GSK medically significant). On an unknown date, the outcome of the delirium was unknown. It was unknown if the reporter considered the delirium to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter gave consent for follow up. This case is linked to case US2019AMR069893, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a elderly male patient who received SHINGRIX (batch number 27KF5, expiry date 10th June 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown 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 and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced shingles after receiving SHINGRIX vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for infection, time to onset for event and laboratory confirmation for varicella zoster virus infection were not provided.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site erythema, Injection site pain, Injection site warmth, Visual impairment
Clinical narrative: floaters worsened; Condition aggravated; bloking vision; redness; arm was sore; heated up in the area of the injection; This case was reported by a consumer via call center representative and described the occurrence of eye floaters in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Influenza Shot (received on an unknown date). Concurrent medical conditions included eye floaters.   In April 2019, the patient received the 1st dose of Shingrix. In April 2019, 1 day after receiving Shingrix, the patient experienced eye floaters, condition aggravated, injection site erythema, injection site pain, injection site warmth and vision decreased. In April 2019, the outcome of the injection site erythema, injection site pain and injection site warmth were recovered/resolved. On an unknown date, the outcome of the eye floaters was not recovered/not resolved and the outcome of the condition aggravated and vision decreased were unknown.   It was unknown if the reporter considered the eye floaters, condition aggravated and vision decreased to be related to Shingrix. The reporter considered the injection site erythema, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows:  The patient stated after getting the 1st dose of the vaccine in last week from the date of reporting. The patient noticed the floaters worsened in his left eye the day after. The patient had a history of floaters, but this worsened and he compared it to looking through a spider web describing it as blocking his vision. The patient said it comes and goes. He visited an eye doctor over the weekend who could find nothing wrong. However, he had an appointment with his regular eye doctor later this week. A couple of days after getting the vaccine, his arm became red at the site of the injection and his arm was sore. It heated up in the area of the injection.  This lasted about three to four days.  The reporter gave consent to follow up. Emergency room visit required.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Vitreous floaters
Clinical narrative: floaters worsened; Condition aggravated; bloking vision; redness; arm was sore; heated up in the area of the injection; This case was reported by a consumer via call center representative and described the occurrence of eye floaters in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Influenza Shot (received on an unknown date). Concurrent medical conditions included eye floaters.   In April 2019, the patient received the 1st dose of Shingrix. In April 2019, 1 day after receiving Shingrix, the patient experienced eye floaters, condition aggravated, injection site erythema, injection site pain, injection site warmth and vision decreased. In April 2019, the outcome of the injection site erythema, injection site pain and injection site warmth were recovered/resolved. On an unknown date, the outcome of the eye floaters was not recovered/not resolved and the outcome of the condition aggravated and vision decreased were unknown.   It was unknown if the reporter considered the eye floaters, condition aggravated and vision decreased to be related to Shingrix. The reporter considered the injection site erythema, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows:  The patient stated after getting the 1st dose of the vaccine in last week from the date of reporting. The patient noticed the floaters worsened in his left eye the day after. The patient had a history of floaters, but this worsened and he compared it to looking through a spider web describing it as blocking his vision. The patient said it comes and goes. He visited an eye doctor over the weekend who could find nothing wrong. However, he had an appointment with his regular eye doctor later this week. A couple of days after getting the vaccine, his arm became red at the site of the injection and his arm was sore. It heated up in the area of the injection.  This lasted about three to four days.  The reporter gave consent to follow up. Emergency room visit required.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Pruritus generalised, Rash generalised
Clinical narrative: shingles; head to toe rash; severe pain/agony; itch; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 32ZG4, expiry date 9th July 2021) and (batch number GG9SB, expiry date unknown) for prophylaxis.   On 9th February 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles, generalized rash, pain and generalized pruritus. The patient was treated with prednisone, triamcinolone (Triamcinolone Cream), sulfamethoxazole + trimethoprim (Bactrim), valaciclovir hydrochloride (Valtrex), gabapentin and atarax (nos) (Atarax). On an unknown date, the outcome of the shingles, generalized rash, pain and generalized pruritus were recovered/resolved.   It was unknown if the reporter considered the shingles, generalized rash, pain and generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The caller was the pharmacist who reported that the patient received Shingrix and then developed a head to toe rash, itch, severe pain she was in agony. She went to the emergency room and had 2 rounds of prednisone, triamcinolone cream, Bactrim, Valtrex and gabapentin. She also had to use Atarax. She would not be getting the 2nd shot per her doctor who said she got the Shingles. The patient was finally ok at the time of reporting.  She was in a study. Did not consent to follow up.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site induration
Clinical narrative: Parent reports 1.5 x 2 inch hard area at inj site left leg area of hardness is at outer thigh and towards posterior.  Area is non tender and does not bother patient. Parents will monitor area and follow up if anything changes. Mom states that they are not overly concerned.
Age: 65.0
Sex: M
Vaccine: HEPA
Symptoms: Tinnitus
Clinical narrative: Patient reported severe tinnitus the night following vaccinations - has persisted thus far as of 4/29/19.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Bronchial hyperreactivity, Cough, Hypersensitivity, Paraesthesia, Skin test negative
Clinical narrative: Within 45 minutes of IIV receipt, patient developed face/arm paresthesia, vision changes, shortness of breath, and later, cough and hives on back and arms. She sought evaluation in a civilian emergency room (name unknown, no records available) where she was treated with Epi-pen, Benadryl, Steroids, and an albuterol treatment. Symptoms resolved shortly after treatment, patient was observed several hours before release.  She was prescribed an Epi-pen and later referred to a civilian Allergist/Immunologist. Patient completed allergy skin testing  and no specific allergens identified.  Allergist concerned about overall hyperresponsiveness to many exposures and general reactive airway disease (RAD) symptoms and  prescribed medications for symptom control (Zyrtec, Singulair, Flovent, ProAir HFA).
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Herpes zoster
Clinical narrative: Shingles was reactivated within 2 hours of shot in the same place it has appeared several times. Lasted a few days. Used a creme doc gave me. Did not seek treatment.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Dizziness, Pyrexia
Clinical narrative: Fever started around 8:00 pm on the same day (4/24/19) Tdap was given, also had intermittent left sided chest pain, dizziness, and chest pain.  Pt presented to Health services around 2:20 the following  day (4/25/19).
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain
Clinical narrative: Patient experienced chest pain the day after getting vaccine. He took a nitroglycerin tablet and chest pain was resolved. Patient has a history of heart attack.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Monoplegia, Neck pain, Pain
Clinical narrative: Patient called the next day after recieving her vaccine at around 9am with complaints of left arm pain. The patient stated that she had arm pain going up to her neck and then down her arm as well. When asked if patient had pain radiating to her back, she said yes. Patient stated no relief with ibuprofen and tylenol and icing the arm. I recommended that she see her physician. Of note, I called the patient back a couple hours later at around 11:30am,  to see how she was doing and patient told me that she already has issues in her left arm and neck issues including that she has a fused neck and she is 10% disabled in her left arm. When giving the patient the vaccine, the patient preferred the left arm for the vaccine to be given. The patient went to her physician that same day and recieved a tramadol prescription for the pain. The patient also did mention to the pharmacist that she has had similar pain when recieving other vaccinations in the past. The patient did not need the pneumonia shot unfortunately. The reason I thought she was due for it was because when pulling up her profile, the PPSV23 vaccine with the date of 10/15/2009 stated not valid next to it, Therefore thinking she actually did not recieve the vaccine and that it was an invalid entry.  Patient came into the pharmacy over the weekend and was ok with no complaints of pain.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: redness/swelling to right deltoid, fever (unsure how high body just feels warm) since vaccination but worsening.   on exam erythematous, edematous and warm to touch approximately 3 inches in diameter surround IM injection site.  Diagnoses as cellulitis.  Treatment with keflex orally and resolved without complications.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Developed shingles rash the next day. Now taking valtrex antiviral
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram abnormal, Injection site joint effusion, Injection site pain, Joint dislocation, Muscle atrophy
Clinical narrative: Severe left shoulder pain CT scan with Evaluation limited, superior subluxation of the humeral head         abutting the acromion, likely related to complete full-thickness         tear of the supraspinatus tendon with severe muscular atrophy.          Possible partial thickness tear of the infraspinatus tendon mild         atrophy of the muscle.                   Long head of biceps tendon not well seen in the bicipital groove         likely subluxed or torn.                   Severe degenerative changes noted affecting the a.c. and         glenohumeral joint joint effusion noted.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Tendon rupture
Clinical narrative: Severe left shoulder pain CT scan with Evaluation limited, superior subluxation of the humeral head         abutting the acromion, likely related to complete full-thickness         tear of the supraspinatus tendon with severe muscular atrophy.          Possible partial thickness tear of the infraspinatus tendon mild         atrophy of the muscle.                   Long head of biceps tendon not well seen in the bicipital groove         likely subluxed or torn.                   Severe degenerative changes noted affecting the a.c. and         glenohumeral joint joint effusion noted.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blood test abnormal, Chills, Pain, Palpitations
Clinical narrative: Chills, aches, rash, stomach upset, heart palpitations (lasting several hours each time  and over 3 days)
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: White blood cell count decreased
Clinical narrative: Chills, aches, rash, stomach upset, heart palpitations (lasting several hours each time  and over 3 days)
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Lethargy, Myalgia, Pyrexia
Clinical narrative: Began with hives, moved to joint and muscular soreness with a 36 hour time of lethargy, low grade fever and chills
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Began with hives, moved to joint and muscular soreness with a 36 hour time of lethargy, low grade fever and chills
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Five days after receiving the shot the patient experienced neck and shoulder pain and is still experiencing that today as of 04/29/2019.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Patient had headache, fever of 102 degrees and localized redness and warmth 4x5 cm in the right upper arm at the injection site
Age: 19.0
Sex: M
Vaccine: HEPA, MENB, HEPA, MENB
Symptoms: Presyncope
Clinical narrative: Vaso-vagal response within a minute of vaccination.
Age: 19.0
Sex: M
Vaccine: HEPA, MENB, HEPA, MENB
Symptoms: Chest pain, Decreased appetite, Dysphonia, Dyspnoea, Heart rate decreased
Clinical narrative: Vaso-vagal response within a minute of vaccination.
Age: 19.0
Sex: M
Vaccine: HEPA, MENB, HEPA, MENB
Symptoms: Heart rate increased, Injection site pain, Lethargy, Lip swelling, Lymphadenopathy
Clinical narrative: Vaso-vagal response within a minute of vaccination.
Age: 19.0
Sex: M
Vaccine: HEPA, MENB, HEPA, MENB
Symptoms: Musculoskeletal pain, Pain in extremity, Presyncope, Productive cough, Syncope
Clinical narrative: Vaso-vagal response within a minute of vaccination.
Age: 19.0
Sex: M
Vaccine: HEPA, MENB, HEPA, MENB
Symptoms: Wheezing
Clinical narrative: Vaso-vagal response within a minute of vaccination.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pain, Pruritus
Clinical narrative: painful next day. Thirty hours after injection started to get red and itch. Their were 2 small areas about 1 inch in diameter. On April 12th the area was bigger about 4 inches in diameter and red. On April 13th it started itching in the morning and by afternoon was bright red and 6 inches in diameter including going down the inside of my arm. At this point the area went from just below injection site to the crease in my elbow and about 3 inches down the inside to the crease in my arm
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling on right thigh. Diagnosed with cellulitis. Prescribed Keflex tid x 5 days.
Age: 7.0
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PEDIARIX was administered to t 8 Y.O Child.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; inadvertently received an expired dose of MMRII; This spontaneous report as received from a medical assistant (also reported as administrator) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided.   On 22-APR-2019, the patient inadvertently received an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (exact dose, anatomical location and route of administration were not provided, lot # N025889 with expiration date of 18-APR-2019) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot # N023306, expiration date: 20-JAN-2020). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Immunodeficiency, Product supply issue, Renal disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of immunocompromised in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and 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 immunocompromised (serious criteria GSK medically significant), renal disorder, shingles and product supply issue. On an unknown date, the outcome of the immunocompromised, renal disorder, shingles and product supply issue were unknown. It was unknown if the reporter considered the immunocompromised, renal disorder and shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received 1st dose of SHINGRIX 8 months prior to the report. The patient was immunocompromised due to kidney transplant and was facing constant issue of shingles. The patient was unable to receive 2nd dose of SHINGRIX due to product supply issue.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Arrhythmia, Chills, Condition aggravated, Fatigue, Heart rate increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of arrhythmia in a 75-year-old male patient who received SHINGRIX (batch number D9474, expiry date 10th September 2021) for prophylaxis. The patient's past medical history included arrhythmia (the patient had not had any episodes in 4 months). On 13th April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th April 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, fatigue and chills. On 15th April 2019, the patient experienced arrhythmia (serious criteria GSK medically significant), heart rate increased and low blood pressure. On an unknown date, the outcome of the arrhythmia, heart rate increased and low blood pressure were not recovered/not resolved and the outcome of the pain in arm was recovering/resolving and the outcome of the fatigue and chills were recovered/resolved. The reporter considered the arrhythmia, pain in arm, fatigue, chills, heart rate increased and low blood pressure to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in right arm and his arm was sore following the injection and got worse 3-4 hours later. That evening he developed fatigue and chills. The fatigue and chills have resolved and his arm is less sore, but around 3:30 AM on the day of reporting the patient developed a very fast heart rate, arrhythmia and low blood pressure. This was still happening during the reporting. The patient had a history of arrhythmia, but had not had any episodes in 4 months. The reporter was consented to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypotension, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of arrhythmia in a 75-year-old male patient who received SHINGRIX (batch number D9474, expiry date 10th September 2021) for prophylaxis. The patient's past medical history included arrhythmia (the patient had not had any episodes in 4 months). On 13th April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th April 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, fatigue and chills. On 15th April 2019, the patient experienced arrhythmia (serious criteria GSK medically significant), heart rate increased and low blood pressure. On an unknown date, the outcome of the arrhythmia, heart rate increased and low blood pressure were not recovered/not resolved and the outcome of the pain in arm was recovering/resolving and the outcome of the fatigue and chills were recovered/resolved. The reporter considered the arrhythmia, pain in arm, fatigue, chills, heart rate increased and low blood pressure to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in right arm and his arm was sore following the injection and got worse 3-4 hours later. That evening he developed fatigue and chills. The fatigue and chills have resolved and his arm is less sore, but around 3:30 AM on the day of reporting the patient developed a very fast heart rate, arrhythmia and low blood pressure. This was still happening during the reporting. The patient had a history of arrhythmia, but had not had any episodes in 4 months. The reporter was consented to follow up.