chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Blister, Drug eruption, Pruritus, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 84-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included dry skin (during winter). Concomitant products included atorvastatin calcium (Lipitor) and metoprolol succinate (Toprol Xl). On 28th March 2018, the patient received the 1st dose of SHINGRIX. On 4th June 2018, 68 days after receiving SHINGRIX, the patient experienced drug eruption vesicular and blister. On an unknown date, the patient experienced pruritus, pimples and welts. The patient was treated with corticosteroid nos (Oral Corticosteroids (Nos)). On an unknown date, the outcome of the pruritus, drug eruption vesicular and welts were not recovered/not resolved and the outcome of the pimples and blister were unknown. It was unknown if the reporter considered the pruritus, drug eruption vesicular, pimples, welts and blister to be related to SHINGRIX. Additional information was reported as follows: The batch number or expiry date for SHINGRIX was not reported. On 4th June 2018, the patient visited his dermatologist after noticing the welts. At the beginning the physician just diagnosed the patient with blistering disease. The patient received one shot of corticosteroids, he was prescribed with a 10 day treatment of oral corticosteroids. The patient was later diagnosed with bullous drug eruptions after vaccination with the first dose of SHINGRIX series, but however he didn't specific the dates for receiving the diagnosis. The patient also experienced welts and itchiness. The patient couldn't exactly remember, how soon after receiving the SHINGRIX vaccine, he started experiencing itching. However the patient stated that he had itching for a while and then he started developing the welts. The patient stated that he was still developing new welts, out of which some other were not welts but they looked like hard pimples. The patient was on Lipitor and Toprol X before he visited his dermatologist on 4th June 2018. The patient's dermatologist took him off from Lipitor and kept him on Toprol XL. The patient was not on Lipitor schedule since 4th June 2018.  The patient used cream on the affected areas. Till the time of reporting, the events were not resolved yet.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 84-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included dry skin (during winter). Concomitant products included atorvastatin calcium (Lipitor) and metoprolol succinate (Toprol Xl). On 28th March 2018, the patient received the 1st dose of SHINGRIX. On 4th June 2018, 68 days after receiving SHINGRIX, the patient experienced drug eruption vesicular and blister. On an unknown date, the patient experienced pruritus, pimples and welts. The patient was treated with corticosteroid nos (Oral Corticosteroids (Nos)). On an unknown date, the outcome of the pruritus, drug eruption vesicular and welts were not recovered/not resolved and the outcome of the pimples and blister were unknown. It was unknown if the reporter considered the pruritus, drug eruption vesicular, pimples, welts and blister to be related to SHINGRIX. Additional information was reported as follows: The batch number or expiry date for SHINGRIX was not reported. On 4th June 2018, the patient visited his dermatologist after noticing the welts. At the beginning the physician just diagnosed the patient with blistering disease. The patient received one shot of corticosteroids, he was prescribed with a 10 day treatment of oral corticosteroids. The patient was later diagnosed with bullous drug eruptions after vaccination with the first dose of SHINGRIX series, but however he didn't specific the dates for receiving the diagnosis. The patient also experienced welts and itchiness. The patient couldn't exactly remember, how soon after receiving the SHINGRIX vaccine, he started experiencing itching. However the patient stated that he had itching for a while and then he started developing the welts. The patient stated that he was still developing new welts, out of which some other were not welts but they looked like hard pimples. The patient was on Lipitor and Toprol X before he visited his dermatologist on 4th June 2018. The patient's dermatologist took him off from Lipitor and kept him on Toprol XL. The patient was not on Lipitor schedule since 4th June 2018.  The patient used cream on the affected areas. Till the time of reporting, the events were not resolved yet.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Neuralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (In 2016). Concurrent medical conditions included drug allergy (to sulfa and codeine with upset stomach, and weakness) and pollen allergy. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site stinging, nerve pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site stinging and injection site warmth were recovered/resolved and the outcome of the nerve pain was unknown. It was unknown if the reporter considered the injection site erythema, injection site stinging, nerve pain and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: The caller reported she received SHINGRIX the first week in April. The same day she states she experienced stinging with administration and redness and hotness at the site. She noted it was the size of an orange on her arm, this patch of angry redness and warmth. She states the second week it wasn't hot and still red. She noted it took 3 weeks to disappear then she states she felt pings of nerve pain like she did when she had shingles about a year and a half ago. She noted it was pain in the nerve endings. She was determining if she would get the 2nd dose or not.
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Headache
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a adult female patient who received ENGERIX B (batch number 94522 ?, expiry date 4th September 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, the patient experienced diarrhea and headache. On an unknown date, the outcome of the diarrhea was recovered/resolved and the outcome of the headache was unknown. It was unknown if the reporter considered the diarrhea and headache to be related to ENGERIX B. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced severe liquid diarrhea and headache for a full day after receiving their first dose of ENGERIX B. No further details were provided by the pharmacist.
Age: 51.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Headache, Paraesthesia, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 51-year-old female patient who received SHINGRIX (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis. Co-suspect products included INFLUENZA VACCINE (SANOFI PASTEUR) for prophylaxis. On 17th August 2018, the patient received SHINGRIX and SANOFI PASTEUR SEASONAL INFLUENZA VACCINE. On an unknown date, several days after receiving SHINGRIX, the patient experienced fever, chills, headache and tingling sensation. The patient was treated with ibuprofen and TYLENOL. On an unknown date, the outcome of the fever, chills, headache and tingling sensation were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, headache and tingling sensation to be related to Shingrix.  Additional details were provided as follows: The health care professional reported that the patient received Shingrix on arm. On the same day of Shingrix administration, the patient received flu shot by Sanofi in the alternate arm. Possibly within a few days after receiving Shingrix, the patient experienced internal fever and chills, headache and tingling sensation across back. The symptoms had not resolved and appear to intensify during the evenings. The patient was self treating the symptoms with ibuprofen, Tylenol, warm showers for chills and cool packs during feverish moments. It was unknown if the reporter considered the fever, chills, headache and tingling sensation to be related to Flu vaccine. No further information reported regarding the event.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of muscle pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 4th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 4th September 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain, headache, injection site pain, influenza-like symptoms, injection site erythema, injection site swelling, fever and chills. On an unknown date, the outcome of the muscle pain, headache, injection site pain, influenza-like symptoms, injection site erythema, injection site swelling, fever and chills were not recovered/not resolved. It was unknown if the reporter considered the muscle pain, headache, injection site pain, influenza-like symptoms, injection site erythema, injection site swelling, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient's body temperature went as high as 102 degrees fahrenheit.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of muscle pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 4th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 4th September 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain, headache, injection site pain, influenza-like symptoms, injection site erythema, injection site swelling, fever and chills. On an unknown date, the outcome of the muscle pain, headache, injection site pain, influenza-like symptoms, injection site erythema, injection site swelling, fever and chills were not recovered/not resolved. It was unknown if the reporter considered the muscle pain, headache, injection site pain, influenza-like symptoms, injection site erythema, injection site swelling, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient's body temperature went as high as 102 degrees fahrenheit.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Gingival discolouration, Gingival erythema, Gingival swelling, Noninfective gingivitis, Oral pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of redness gum in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced redness gum, oral pain, gingival discoloration, gum swelling and gingival inflammation. On an unknown date, the outcome of the redness gum, oral pain, gingival discoloration, gum swelling and gingival inflammation were recovering/resolving. It was unknown if the reporter considered the redness gum, oral pain, gingival discoloration, gum swelling and gingival inflammation to be related to SHINGRIX. Additional details were provided as follows: Within a week of having the vaccine, she started to have redness around her gums along with white spots. The patient stated that her gums were inflamed, swollen and her mouth was very painful. The patient thought might be she had brushed her teeth too hard but decided to go to dentist for assessment. The dentist did not think that the patient had any type of gum disease but could not give her a definitive diagnosis. The patient did suggest that she do a few things to help with her symptoms which included rinsing her mouth with salt water. The patient's symptoms were improving but her dentist suggested that she have a biopsy if her symptoms were not resolved. The patient would back to the dentist the day after reporting. The reporter was inquiring if these types of symptoms had been reported and informed that did not see similar symptoms reported but that we would certainly document her experience.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 70-year-old female patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. On 29th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st August 2018, 2 days after receiving SHINGRIX, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was unknown. It was unknown if the reporter considered the erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The health care professional reported that a patient developed a red rash on their left arm between the injection site and the patient's elbow 2 days after receiving SHINGRIX. The healthcare professional stated that unsure of red rash had resolved at this time of not but as of now 9 by 2 rash was still there. The healthcare professional told the patient to call her if the rash got worse, stated that she had not heard from the patient. The healthcare professional reported a second patient with a different rash at the same time. This case has been linked with US2018161575, reported by the same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 70-year-old female patient who received SHINGRIX (batch number P45M9, expiry date 27th February 2021) for prophylaxis. On 3rd September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, less than a day after receiving SHINGRIX, the patient experienced pain, fever, upset stomach, swelling and erythema. The patient was treated with TYLENOL and medication unknown, Ice Pack (NOS). On an unknown date, the outcome of the pain, fever, upset stomach, swelling and erythema were recovering/resolving. It was unknown if the reporter considered the pain, fever, upset stomach, swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid and that night, she experienced pain, swelling, fever and an upset stomach. The pharmacist stated that, the patient also reported redness and it was unknown about when and where the redness had occurred. In the morning (unspecified), the patient still had pain so the patient was recommended to take TYLENOL and use Ice. The patient reported to the pharmacist that, as of 5th September 2018 evening, her condition was 50 per cent better. No additional details were available.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 77-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGLES VACCINE (received on an unspecified date) and Flu vaccine (received on an unspecified date). On 18th August 2018, the patient received the 1st dose of SHINGRIX(intramuscular) .5 ml. On 18th August 2018, 6 hrs after receiving SHINGRIX, the patient experienced shivering. On an unknown date, the outcome of the shivering was recovered/resolved. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient's concomitant product included blood pressure medication. The patient reported that she received the SHINGRIX vaccine and experienced shivering that woke her up at night. The patient received the vaccine between 4:00 and 5:00 pm and approximately six hours later she had the shivers which resolved. The patient had denied permission to contact their physician.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old male patient who received SHINGRIX for prophylaxis. On 18th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 18th August 2018, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient received the vaccine between 4:00 to 5:00 PM. The wife of the patient reported that the patient (her husband) received the SHINGRIX vaccine and he experienced soreness at the injection site. The soreness resolved and was only temporary on the day of his vaccination. The patient had denied permission to contact their physician.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 80-year-old female patient who received SHINGRIX (batch number B9739, expiry date 20th November 2020) for prophylaxis. On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st May 2018, 1 days after receiving SHINGRIX, the patient experienced generalized rash. In June 2018, the outcome of the generalized rash was recovered/resolved. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced full body rash and it was resolved after 4 days. The pharmacist stated that the patient did not report full body rash at the time, only reported the rash once the pharmacist called them for a reminder for dose two of their SHINGRIX vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 60-year-old female patient who received SHINGRIX (batch number 97H2?, the reported lot number does not match with any GSK lot number, expiry date 8th February 2021) for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX. On 31st August 2018, 1 days after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported via chat. The patient experienced a full body rash.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: This case was reported via chat. The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The reporter had consulted a pharmacist at one of his stores reported that SHINGRIX has had more reactions than any vaccine he had given and also reported that, it was kind of a systemic reaction. The reporter stated, they give a lot more of these shots. The reporter abandoned the chat before further information could be obtained. Another adverse event was collected from this healthcare professional previously during the chat (reported by another agent), which had more specific details but was otherwise unrelated to this particular report.
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased, Chills, Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On 5th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, less than a day after receiving SHINGRIX, the patient experienced fever, blood sugar increased, nausea, shivering and general body pain. On an unknown date, the outcome of the fever, blood sugar increased, nausea, shivering and general body pain were unchanged. It was unknown if the reporter considered the fever, blood sugar increased, nausea, shivering and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine in the left arm in the evening of a day before reporting. On 6th September 2018, the patient woke up at 5:00 AM with 102 degree fever, shivering, body ache, nausea and increase in blood sugar. The patient would follow up with his physician and gave permission to contact his healthcare provider. No further details were provided.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Initial insomnia, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 81-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received 6 month from the date of reporting). On 2nd September 2018, the patient received the 2nd dose of SHINGRIX. On 2nd September 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue. On 5th September 2018, the patient experienced injection site rash, injection site itching, injection site erythema and trouble falling asleep. The patient was treated with BENADRYL and Hydrocortisone Cream. On an unknown date, the outcome of the injection site rash, injection site itching and injection site erythema were not recovered/not resolved and the outcome of the fatigue was recovered/resolved and the outcome of the trouble falling asleep was unknown. It was unknown if the reporter considered the injection site rash, injection site itching, fatigue, injection site erythema and trouble falling asleep to be related to SHINGRIX. Additional details were reported as follows: The doses were administered in her upper left arm. The day of vaccination, in the evening she started feeling fatigue, and she felt very fatigued on 3rd September 2018. On 4th September 2018, she felt better. On 5th September 2018, 3 days after vaccination, she woke up and noticed a red, itchy rash around the injection site. She saw her pharmacist, who suggested taking some BENADRYL. Overnight the itching bothered her enough that it was hard to sleep. She had also applied hydrocortisone cream to the rash.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 51-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 10 days after receiving SHINGRIX, the patient experienced shingles and drug dose administration interval too short. On an unknown date, the outcome of the shingles and drug dose administration interval too short were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 6th July 2018, the patient received 1st dose of SHINGRIX. The patient received 2nd dose of SHINGRIX about 10 days before the 2 months mark, which led to shortening of vaccination schedule. The healthcare professional did not know the exact date of 2nd dose or lot number since this patient went to a different pharmacy. The patient broke out with shingles and the patient stated it was the worst case of shingles she has ever had. The healthcare professional had not seen this patient.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injected limb mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. In July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced fever, headache, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the fever and headache were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the fever, headache, pain in arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she had 1st dose of SHINGRIX in May 2018 with no side effects and received 2nd dose in late July 2018 in right arm, with dose 2 the patient experienced fever and headache, which began the same day, but resolved the next day. The patient reported that she had a sore arm, which began on the day of the injection, but at time of reporting had not resolved. She could not raise her arm. The call was completed with an interpreter, the dates of vaccination were not known. The patient had denied permission to contact their physician.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 84-year-old female patient who received SHINGRIX (batch number P45M9, expiry date 2nd February 2021) for prophylaxis. On 4th September 2018, the patient received the 1st dose of SHINGRIX .5 ml. In September 2018, less than a week after receiving SHINGRIX, the patient experienced erythema, swelling and skin warm. On an unknown date, the outcome of the erythema, swelling and skin warm were unknown. It was unknown if the reporter considered the erythema, swelling and skin warm to be related to SHINGRIX. Additional details were provided as follows: The caller was a pharmacist reported that the patient received a dose of SHINGRIX on and experienced a red, swollen and warm circle on the arm 3 to 4 inches below the injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Peripheral swelling, Rash, Rash papular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received previously on an unknown date with no issues). On an unknown date, the patient received the 1st dose of SHINGRIX. In July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, swelling arm, skin warm, pain in arm, papular skin eruption and pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, skin warm and papular skin eruption were not recovered/not resolved and the outcome of the swelling arm, pain in arm and pain in arm were recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure, shingles, swelling arm, skin warm, papular skin eruption and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. In 2018, the patient received 1st dose of SHINGRIX in the left arm and experienced arm soreness that lasted a couple of days. About 3 months later receiving 1st dose, the patient received 2nd dose of SHINGRIX in the right arm. The patient's arm was swollen and she broke out with bumps on her back. The patient was diagnosed with shingles on her back. The patient provided name of her dermatologist. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation of Varicella-Zoster virus (VZV) infection and time to onset for event were not provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received previously on an unknown date with no issues). On an unknown date, the patient received the 1st dose of SHINGRIX. In July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, swelling arm, skin warm, pain in arm, papular skin eruption and pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, skin warm and papular skin eruption were not recovered/not resolved and the outcome of the swelling arm, pain in arm and pain in arm were recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure, shingles, swelling arm, skin warm, papular skin eruption and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. In 2018, the patient received 1st dose of SHINGRIX in the left arm and experienced arm soreness that lasted a couple of days. About 3 months later receiving 1st dose, the patient received 2nd dose of SHINGRIX in the right arm. The patient's arm was swollen and she broke out with bumps on her back. The patient was diagnosed with shingles on her back. The patient provided name of her dermatologist. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation of Varicella-Zoster virus (VZV) infection and time to onset for event were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Lethargy, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, diarrhea and lethargy. On an unknown date, the outcome of the fever, chills, diarrhea and lethargy were unknown. It was unknown if the reporter considered the fever, chills, diarrhea and lethargy to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The caller said her friend had a reaction to the vaccine. Above information was all that was able to be obtained.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Local reaction, Pain in extremity, Skin lesion
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of influenza like illness (1st dose received on an unknown date, for tolerance refer case US2018GSK167275). In August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, local reaction, pain in arm and skin lesion. On an unknown date, the outcome of the influenza-like symptoms, local reaction and pain in arm were unknown and the outcome of the skin lesion was not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, local reaction, pain in arm and skin lesion to be related to SHINGRIX. Additional details were provided as follows: The patient received the 2nd dose of SHINGRIX about 3 weeks before the date of reporting. The patient had flu-like symptoms and a local reaction. The patient also experienced arm soreness which was persistent and a lesion that looked very much like the remnants of her smallpox vaccine. Since it had been three weeks, the patient wanted to know if this was normal and would it resolve or she needed to see her physician.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 70-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, less than a year after receiving SHINGRIX, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were recovered/resolved. The reporter considered the pain in arm and influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced pain in arm for 2 days (no restriction using arm) and flu-like symptoms for 2 days. The reporter did not agree to follow up from GlaxoSmithKline.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling arm in a 16-year-old female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a day after receiving BEXSERO, the patient experienced swelling arm, erythema of extremities and pain in arm. On an unknown date, the outcome of the swelling arm, erythema of extremities and pain in arm were unknown. It was unknown if the reporter considered the swelling arm, erythema of extremities and pain in arm to be related to BEXSERO. Additional details were provided as follows: Within 24 hours of administration of BEXSERO, the patient's arm got swollen, red, and sore. The patient returned to the office the day after the vaccine to see the doctor.
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling, Rash erythematous
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of swelling arm in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than a year after receiving BEXSERO, the patient experienced swelling arm and erythematous rash. On an unknown date, the outcome of the swelling arm and erythematous rash were unknown. It was unknown if the reporter considered the swelling arm and erythematous rash to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. They had a patient with a swollen arm and red raised bump for 5 days.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Local reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and local reaction. On an unknown date, the outcome of the influenza-like symptoms and local reaction were unknown. It was unknown if the reporter considered the influenza-like symptoms and local reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu like symptoms and also had a local reaction. For tolerance after 2nd dose of SHINGRIX, refer case US2018GSK162977.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Inflammation, Mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: Patient states that Pharmacist administered the injection much too high on the shoulder and it caused excruciating pain. Arm became inflamed and was immobile. Has been slowly but steadily improving over the last few days but patient still experiencing great deal of discomfort leading to her call to the pharmacy.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient said she has pain and redness on the arm that she received the shot.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased eye contact, Demyelination, Nuclear magnetic resonance imaging abnormal, Speech disorder
Clinical narrative: Mother reports: in the month after vaccination child went from saying about 30 words to saying only 2-3. He also quit having eye contact with family members.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Urticaria, Wheezing
Clinical narrative: Full body hives, wheezing. Had to get a steroid shot from medical doctors office.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Systemic urticarial rash.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Hemiparesis, Laboratory test normal
Clinical narrative: Patient had generalized weakness in left side of body, including arm and leg.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Lymphadenitis, Neck pain
Clinical narrative: Patient has had lymphadenitis, neck pain, and headache.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Feeling abnormal, Pain, Palpitations, Rash pruritic
Clinical narrative: Patient received shot on 9/10/18 in the afternoon and sometime in the evening patient felt "like having a heart attack". He had shortness of breath and his heart was racing. He also developed a rash on his arm which was itchy and he felt achy all over.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Patient experienced lightheadedness and dizziness 5 minutes after administration. Side effects lasted a total of 5 minutes and were alleviated after patient laid on the floor with feet elevated.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Limb discomfort, Peripheral swelling
Clinical narrative: Red swollen area about 6in lt arm with a 2in darker red area in middle with discomfort down to hand with some swelling, pt was given BENADRYL and PEPCID to take every 8hr x 2 days and instructed to use TYLENOL/ADVIL and apply warm moist heat to arm. And to contact family medical MD if needed or call 911.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site bruising, Peripheral swelling
Clinical narrative: Patient received the shot Monday afternoon around 134pm then called the pharmacy on Wednesday September 12th in the later afternoon. I was unavailable and didn't want to speak with the other pharmacist. I spoke to the pt. early Thursday morning when she presented to the pharmacy with a red, swollen arm. The arm didn't look "angry" or feel hot. There was a bruise in the middle of her left deltoid indicating the shot wasn't given too high or too low. I explained that if she had previously had the PREVNAR or PNEUMOVAX this type of reaction may occur. I told her to keep an eye on it to make sure it doesn't get worse, keep it elevated, use an occasional ice bag to reduce swelling and unless told otherwise by provider; use acetaminophen. I also instructed her to call me if her symptoms don't improve.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Chest pain, Hypoaesthesia, Pain in extremity
Clinical narrative: Pt complained of numbness and pain to right arm and across right chest area for approximately one hour then symptoms subsided. No further issues reported after f/u call the next day 9/13/2018.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia
Clinical narrative: Tenderness in muscles (upper extremities and lower), as if though I was going to get a cramp.
Age: 48.0
Sex: M
Vaccine: HEPA
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Initially noticed tingling in hands which turned into numbness in hands up to mid forearms.  Also c/o numbness around lips.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Fatigue, Injection site pain, Musculoskeletal pain
Clinical narrative: Dizziness, weakness, neck pain, shoulder pain in both shoulders, fatigue.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Spinal X-ray
Clinical narrative: Dizziness, weakness, neck pain, shoulder pain in both shoulders, fatigue.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Metrorrhagia, Night sweats, Pain in extremity
Clinical narrative: A few hours after vaccine was given pt had menstrual spotting (she is on continuous oral contraceptives) which she felt was due to the shot. I discussed with pt and suggested this was not likely due to the shot but she is convinced it was due to HPV shot. Later pt had significant arm pain and has had night sweats each night for past 3 nights after immunization. No fever.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Myalgia
Clinical narrative: Awakened next day (9/13) with extreme fatigue. I was very weak. Slept most of the day. Little or no appetite. Muscle aches in my back, thighs and shoulders. However I did not have a fever and did not feel otherwise ill - similar to influenza symptoms. Today (9/14) I feel much better - still tired but much less so.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: I had severe nausea, fever (103), chills, and swelling/redness/pain at injection site.  It started just after the injection, and has persisted for 2 days.  The injection site is red, raised, and very painful.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: I had severe nausea, fever (103), chills, and swelling/redness/pain at injection site.  It started just after the injection, and has persisted for 2 days.  The injection site is red, raised, and very painful.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Injection site erythema, Injection site mass
Clinical narrative: I had severe nausea, fever (103), chills, and swelling/redness/pain at injection site.  It started just after the injection, and has persisted for 2 days.  The injection site is red, raised, and very painful.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: I had severe nausea, fever (103), chills, and swelling/redness/pain at injection site.  It started just after the injection, and has persisted for 2 days.  The injection site is red, raised, and very painful.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: PNEUMOVAX 23 was mistakenly administered intravenously rather than intramuscular route. No adverse effects were noted.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed Shingles on opposite arm within 24 hours of SHINGRIX injection. No reaction in injected arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient was given Shingrix vaccine by subcutaneous route.  No side effects reported.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: The night of the shot, redness and itching developed around injection site. By the next morning, patient had fever, burning eyes, itchy throat and injection site was red, and painfully swollen. Went to ER and received 7 day steroid therapy.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Throat irritation
Clinical narrative: The night of the shot, redness and itching developed around injection site. By the next morning, patient had fever, burning eyes, itchy throat and injection site was red, and painfully swollen. Went to ER and received 7 day steroid therapy.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 04-JAN-2016, the patient was inoculated with ZOSTAVAX at a clinic as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-AUG-2016, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed VALTREX for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.