chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effect reported; an 18-year-old female patient received the adult formulation of properly stored VAQTA in her left deltoid; This spontaneous report was received from a pharmacist concerning an 18 years old female patient of unknown race. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 24-JUN-2019, an 18 years old patient was vaccinated with the adult formulation of properly stored Hepatitis A Vaccine, Inactivated (VAQTA) (product use in unapproved population) 50 (units not reported), intramuscular in her left deltoid, lot number R014952 with expiration date on 09-AUG-2019 (dose and frequency were not reported) for prophylaxis. No adverse effects were reported. The outcome of product use in unapproved population was unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; improperly stored doses of ROTATEQ were administered; Route of Administration: intramuscular; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 24-JUN-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R033255, expiration date 26-JUN-2020, intramuscular (dose, frequency and anatomical location were not reported). The vaccine was stored in temperature above 47 Fahrenheit degrees for 2 hours. The temperature was measured by "data logger". There was no previous temperature excursion. No adverse effect was reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA009902: US-009507513-1906USA009882: US-009507513-1906USA009880: US-009507513-1906USA009914: US-009507513-1906USA010076:
Sex: M
Vaccine: ANTH
Symptoms: Headache, Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Raised, reddened and highly-itchy rash; Raised, reddened and highly-itchy rash; Raised, reddened and highly-itchy rash; Headache; Itching; Spontaneous report received on 28MAY2019 from a face to face interview with an employee who experienced rash and headache following the administration of BioThrax.  On 21MAY2019, a male employee received a dose of BioThrax intramuscularly in the right arm. This was approximately his 14th dose; he had been receiving immunizations since 2008.  He denied prior adverse events following previous doses of BioThrax.  On 24MAY2019, about 72 hours after receiving the dose, the employee noticed that his bilateral forearms and upper legs began to itch. Within 24 hours after beginning to itch, a raised, reddened and highly-itchy rash developed on his extremities. The employee began treating the rash with an available prescription-strength steroid cream, used in the past to treat eczema. Concurrent with the rash, the employee developed a moderate headache, for which he took 600mg of ibuprofen every 6 hours. Throughout the next several days both the rash and headache persisted with despite continued treatment.   On 28MAY2019, the male presented to the Emergent pharmacovigilance department to report the adverse experience. He denied use of any new possible irritants, medications, or foods. The red, raised rash was observed on his bilateral forearms. He reported that his headache had improved at the time of this report with only mild symptoms and treatment with ibuprofen was no longer required. The rash and its associated itching however, continued to persist at the time of the report.  Additional information has been requested.  Company Comment: This is a spontaneous report of an adult male experiencing pruritis; an itchy, raised, erythematous rash; and a headache occurring almost 3 days after receiving Biothrax vaccination.  He denies use of additional medications or contact with irritants prior to vaccination.  Each of these symptoms have been known to occur with AVA injection. Given this patient's history of eczema and prior exposures to Biothrax vaccination, a hypersensitivity reaction can also be considered. In light of the strong temporal association and the nature of the stated events, the causality association is determined to be related.; Sender's Comments: This is a spontaneous report of an adult male experiencing pruritis; an itchy, raised, erythematous rash; and a headache occurring almost 3 days after receiving Biothrax vaccination.  He denies use of additional medications or contact with irritants prior to vaccination.  Each of these symptoms have been known to occur with AVA injection. Given this patient's history of eczema and prior exposures to Biothrax vaccination, a hypersensitivity reaction can also be considered. In light of the strong temporal association and the nature of the stated events, the causality association is determined to be related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced shingles that was really bad and was in the hospital. The patient asked if the patient could receive the 2nd dose of Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: felt like room was spinning; Felt off balance; Pricking Skin sensation; hotness at injection site; redness at injection site; injection site soreness; injection site swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Shingrix. On 20th June 2019, 1 days after receiving Shingrix, the patient experienced injection site warmth, injection site erythema, injection site pain, injection site swelling and tingling skin. On 21st June 2019, the patient experienced room going round and balance disorder. On an unknown date, the outcome of the injection site warmth, injection site erythema, injection site pain, injection site swelling, room going round, balance disorder and tingling skin were recovered/resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site pain, injection site swelling, room going round, balance disorder and tingling skin to be related to Shingrix.  Additional information was provided as follows: The patient received 1st dose of Shingrix at 2 PM. The pharmacist said that it would hurt and might got red swelling at the injection site. By Thursday, it was little bigger than a silver dollar. It was very red, hot and very sore to touch and felt like needles were pricking at the injection site. Friday morning, the patient woke up with same symptoms but felt off balance when she tried to get out of bed. She did not felt like the room was spinning while laying down but only when standing up. On Saturday and Sunday the soreness and redness subsided. The patient was afraid to receive 2nd dose of Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Paraesthesia, Vertigo
Clinical narrative: felt like room was spinning; Felt off balance; Pricking Skin sensation; hotness at injection site; redness at injection site; injection site soreness; injection site swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Shingrix. On 20th June 2019, 1 days after receiving Shingrix, the patient experienced injection site warmth, injection site erythema, injection site pain, injection site swelling and tingling skin. On 21st June 2019, the patient experienced room going round and balance disorder. On an unknown date, the outcome of the injection site warmth, injection site erythema, injection site pain, injection site swelling, room going round, balance disorder and tingling skin were recovered/resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site pain, injection site swelling, room going round, balance disorder and tingling skin to be related to Shingrix.  Additional information was provided as follows: The patient received 1st dose of Shingrix at 2 PM. The pharmacist said that it would hurt and might got red swelling at the injection site. By Thursday, it was little bigger than a silver dollar. It was very red, hot and very sore to touch and felt like needles were pricking at the injection site. Friday morning, the patient woke up with same symptoms but felt off balance when she tried to get out of bed. She did not felt like the room was spinning while laying down but only when standing up. On Saturday and Sunday the soreness and redness subsided. The patient was afraid to receive 2nd dose of Shingrix.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pruritus, Skin warm
Clinical narrative: redness; heat; itchy; hurt at injection site; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular). In June 2019, less than a week after receiving Shingrix, the patient experienced erythema, skin warm, pruritus and injection site pain. In June 2019, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the erythema, skin warm and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the erythema, skin warm, pruritus and injection site pain to be related to Shingrix.  Additional details were provided as follows: One week before the time of reporting, the patient received a dose of Shingrix. The reporter told that, the injection was given into the muscle and it hurt the minute the needle was inserted. The patient had redness over 5 inch long and 5 inch wide. The call center called back to the reporter and asked additional questions regarding adverse event. The reporter did not have lot number and expiration date. The patient's physician was allergist.
Sex: U
Vaccine: VARZOS
Symptoms: Insomnia, Pain in extremity
Clinical narrative: arm pain; Could not sleep; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and insomnia. On an unknown date, the outcome of the pain in arm and insomnia were unknown.   It was unknown if the reporter considered the pain in arm and insomnia to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. After vaccination, the patient could not sleep because his arm hurt so much.
Sex: M
Vaccine: MENB
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Bexsero.  Additional details were provided as follows: The reporter was the patient's parent. The age at vaccination was not reported. The reporter reported that, the patient had allergic reactions to dose of Bexsero. The reporter was scared.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: tingling/tingling from the corner of ear to the center of chin; Shingles; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 64-year-old 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 month after receiving Shingrix, the patient experienced tingling and shingles. On an unknown date, the outcome of the tingling and shingles were unknown.   It was unknown if the reporter considered the tingling and shingles to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. A month ago, the patient received 1st dose of Shingrix. About the same time, the patient developed an infrequent tingling from the corner of my left ear to the center of my chin. The patient had developed a mild case of shingles.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: Low titers; This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B at an unknown dose. On an unknown date, unknown after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B.  Additional information received were as follows: The age at vaccination was not applicable for this report. The physician on the line reported that he has had patients that did not respond to Engerix-B, which led the patient to be therapy non-responder. No further information was provided. This case has been linked with US2019116825, reported by the same reporter.      Lab Comments: On an unknown date, the patient's had test for Hepatitis B antibody was found to be zero titer.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Injection site pain, Loss of consciousness, Malaise, Nausea
Clinical narrative: passing out; he was shaking when he passed out; left arm hurting; head hurting; Feeling queasy; getting sick; This case was reported by a nurse via sales rep and described the occurrence of passed out in a 10-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 25th June 2019 11:45, the patient received Bexsero and Menveo. On 25th June 2019, less than a day after receiving Bexsero and not applicable after receiving Menveo, the patient experienced injection site pain, headache, feeling queasy and sickness. On 25th June 2019 16:10, the patient experienced passed out (serious criteria GSK medically significant) and tremor. On an unknown date, the outcome of the passed out, tremor, headache and feeling queasy were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the sickness was unknown.   It was unknown if the reporter considered the passed out, tremor, injection site pain, headache, feeling queasy and sickness to be related to Bexsero. It was unknown if the reporter considered the passed out, tremor, headache, feeling queasy and sickness to be related to Menveo.  Additional details were provided as follows: On 25th June 2019 at 11:45 AM, the patient received Bexsero in left arm and Menveo in right arm .  The patient stayed 15 mins after vaccination with Bexsero. Then, he went home and took a nap.  Later in the day, when the patient was on the way to his father's house, started complaining of left arm hurting. He also complained of head hurting and feeling queasy. His brother pulled over and the patient got sick.  At around 4:10, the patient reached to his father's house. When he arrived he passed out and was shaking when passed out.  The patient's brother called EMT's (emergency medical technicians). The patient was fine but got sick again while EMT's were there.  The patient complained about headache for the rest of the day.  The next day he was fine. He denied headache, nausea or vomiting but his left arm was still sore. The reporter was not sure if this was a reaction to the vaccine or if patient just got sick.  The VAERS had been done.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pain in extremity, Tremor
Clinical narrative: passing out; he was shaking when he passed out; left arm hurting; head hurting; Feeling queasy; getting sick; This case was reported by a nurse via sales rep and described the occurrence of passed out in a 10-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 25th June 2019 11:45, the patient received Bexsero and Menveo. On 25th June 2019, less than a day after receiving Bexsero and not applicable after receiving Menveo, the patient experienced injection site pain, headache, feeling queasy and sickness. On 25th June 2019 16:10, the patient experienced passed out (serious criteria GSK medically significant) and tremor. On an unknown date, the outcome of the passed out, tremor, headache and feeling queasy were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the sickness was unknown.   It was unknown if the reporter considered the passed out, tremor, injection site pain, headache, feeling queasy and sickness to be related to Bexsero. It was unknown if the reporter considered the passed out, tremor, headache, feeling queasy and sickness to be related to Menveo.  Additional details were provided as follows: On 25th June 2019 at 11:45 AM, the patient received Bexsero in left arm and Menveo in right arm .  The patient stayed 15 mins after vaccination with Bexsero. Then, he went home and took a nap.  Later in the day, when the patient was on the way to his father's house, started complaining of left arm hurting. He also complained of head hurting and feeling queasy. His brother pulled over and the patient got sick.  At around 4:10, the patient reached to his father's house. When he arrived he passed out and was shaking when passed out.  The patient's brother called EMT's (emergency medical technicians). The patient was fine but got sick again while EMT's were there.  The patient complained about headache for the rest of the day.  The next day he was fine. He denied headache, nausea or vomiting but his left arm was still sore. The reporter was not sure if this was a reaction to the vaccine or if patient just got sick.  The VAERS had been done.
Age: 19.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain, Off label use, Pain, Product administered to patient of inappropriate age
Clinical narrative: Shingles; Pain and pinching sensation in the buttocks area; Pain and pinching sensation in the buttocks area; Inappropriate age at vaccine administration; off label use; Suspected vaccination of failure; This case was reported by a physician via other manufacturer and described the occurrence of suspected vaccination failure in a 19-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz) for an unknown indication.   Previously administered products included Humira (the patient experienced lack of response to Humira).   On an unknown date, the patient received Shingrix at an unknown dose and Xeljanz 10 mg twice daily (20 mg daily). On an unknown date, 84 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles (serious criteria hospitalization), buttock pain (serious criteria hospitalization), pain (serious criteria hospitalization), inappropriate age at vaccine administration and off label use. The patient was treated with acyclovir and steroids nos (Steroid Therapy Nos). Xeljanz was continued with no change. On an unknown date, the outcome of the vaccination failure, inappropriate age at vaccine administration and off label use were unknown and the outcome of the shingles, buttock pain and pain were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, buttock pain and pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by Pfizer. It was reported that the patient was switched from Humira to Xeljanz 10 mg Bid because of lack of response to Humira. The patient received Shingrix nearly 4 weeks prior to start of xeljanz. The patient was able to get a prescription for Shingrix because she was hospitalized at that point, which led to inappropriate age at vaccine administration and off label use. Nearly 8 weeks into receiving Xeljanz, the patient contacted the physician with some pain and pinching sensation in the buttocks area. The patient was diagnosed with Shingles due to Herpes zoster. She was treated with Acyclovir. She was kept on Xeljanz and still is on xeljanz. The patient was better and the physician was planning to keep the patient on Xeljanz 10 mg bid. The patient was also on steroid therapy as well. The physician was gradually tapering her off of her steroid while on Xeljanz. The shingles symptoms happened when the patient steroid dose was down to 15 mg/wk. The physician expressed his surprise that patient shingles developed shingles while on lower dose of steroids rather than higher doses. This case was considered as suspected vaccination failure, since the details regarding the dose number were not provided. Reporter did not wish to be contacted for follow-up.
Age: 19.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Shingles; Pain and pinching sensation in the buttocks area; Pain and pinching sensation in the buttocks area; Inappropriate age at vaccine administration; off label use; Suspected vaccination of failure; This case was reported by a physician via other manufacturer and described the occurrence of suspected vaccination failure in a 19-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz) for an unknown indication.   Previously administered products included Humira (the patient experienced lack of response to Humira).   On an unknown date, the patient received Shingrix at an unknown dose and Xeljanz 10 mg twice daily (20 mg daily). On an unknown date, 84 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles (serious criteria hospitalization), buttock pain (serious criteria hospitalization), pain (serious criteria hospitalization), inappropriate age at vaccine administration and off label use. The patient was treated with acyclovir and steroids nos (Steroid Therapy Nos). Xeljanz was continued with no change. On an unknown date, the outcome of the vaccination failure, inappropriate age at vaccine administration and off label use were unknown and the outcome of the shingles, buttock pain and pain were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, buttock pain and pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by Pfizer. It was reported that the patient was switched from Humira to Xeljanz 10 mg Bid because of lack of response to Humira. The patient received Shingrix nearly 4 weeks prior to start of xeljanz. The patient was able to get a prescription for Shingrix because she was hospitalized at that point, which led to inappropriate age at vaccine administration and off label use. Nearly 8 weeks into receiving Xeljanz, the patient contacted the physician with some pain and pinching sensation in the buttocks area. The patient was diagnosed with Shingles due to Herpes zoster. She was treated with Acyclovir. She was kept on Xeljanz and still is on xeljanz. The patient was better and the physician was planning to keep the patient on Xeljanz 10 mg bid. The patient was also on steroid therapy as well. The physician was gradually tapering her off of her steroid while on Xeljanz. The shingles symptoms happened when the patient steroid dose was down to 15 mg/wk. The physician expressed his surprise that patient shingles developed shingles while on lower dose of steroids rather than higher doses. This case was considered as suspected vaccination failure, since the details regarding the dose number were not provided. Reporter did not wish to be contacted for follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone disorder, Feeling abnormal
Clinical narrative: disintegrating feeling in her bones; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (she had previous shingles). Previously administered products included Shingrix with an associated reaction of neck pain (received 1st dose on 28th December 2018, refer case US2019114051).   In 2019, the patient received the 2nd dose of Shingrix. On an unknown date, several weeks after receiving Shingrix, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was not recovered/not resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received her second dose in 2019 and after a couple of weeks she was experiencing a disintegrating feeling in her bones which was similar to a feeling she had with her previous case of shingles. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Bone pain, Joint noise, Muscle tightness, Neck pain
Clinical narrative: felt extreme weakness; neck soreness; bones with achiness; muscle tightness; Popping in her bones; This case was reported by a consumer via call center representative and described the occurrence of feelings of weakness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 28th December 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced feelings of weakness, neck pain, bone pain, muscle tightness and joint clicking. The patient was treated with non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the feelings of weakness, neck pain, bone pain, muscle tightness and joint clicking were recovering/resolving.   It was unknown if the reporter considered the feelings of weakness, neck pain, bone pain, muscle tightness and joint clicking to be related to Shingrix.   Additional details were provided as follows: The patient reported that she received Shingrix in the left arm and she felt extreme weakness during the winter. The patient was not certain when the weakness started. The patient had neck soreness with popping of her bones with achiness which she had been experiencing in the past 5 months.  The patient had been seeing a physical therapist and her therapist said that she was having a tight muscle which was causing her symptoms. The bone popping was occurring on the upper part of her body in her muscles but mostly in her trunk.  The patient's symptoms were getting worse but were better at the time of reporting.  At the time of this reporting the extreme weakness was resolved. The patient claims that she was in good physical shape otherwise for her age and she works half days (1/2) during the week.  The reporter consented to follow up. This case has been linked to the US2019AMR118249, reported for the dose 2 of the same patient.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pain in extremity, Pyrexia
Clinical narrative: arm soreness; fever; chills; unwell; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm, fever, chills and unwell. On an unknown date, the outcome of the pain in arm, fever, chills and unwell were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fever, chills and unwell to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The reporter reported that her husband got his first dose of Shingrix at the end of May 2019, in the left arm.  For about two days the patient experienced fever and chills, and just unwell for three days. He also experienced a very sore arm for about a week.  The patient still plan to get the second dose. The patient had not reported these events to his physician.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip blister, Oral herpes, Oral mucosal blistering
Clinical narrative: Fever blisters in mouth and lips; Fever blisters in mouth and lips; Fever blisters in mouth and lips; This case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced fever blister, blistering of mouth and lip blister. On an unknown date, the outcome of the fever blister, blistering of mouth and lip blister were unknown.   It was unknown if the reporter considered the fever blister, blistering of mouth and lip blister to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient broke out in fever blisters after receiving a dose of Shingrix. The pharmacist described breaking out in fever blisters as fever blisters on the roof of the patients mouth and on the lips.  Shingrix was administered at another location, so the health care professional did not have lot number and expiration date.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Influenza like illness, Injection site erythema, Injection site pruritus
Clinical narrative: fatigue and tiredness; arm soreness; flu like symptoms; feeling sick; redness on arm; rash on upper arm; itching on upper arm; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 22nd April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fatigue, pain in arm, influenza-like symptoms, feeling unwell, erythema of extremities, rash and itchy upper limbs. On an unknown date, the outcome of the fatigue, pain in arm, influenza-like symptoms, feeling unwell, erythema of extremities, rash and itchy upper limbs were recovered/resolved.   It was unknown if the reporter considered the fatigue, pain in arm, influenza-like symptoms, feeling unwell, erythema of extremities, rash and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 67 or 68 years. The patient experienced fatigue, tiredness, arm soreness, flu like symptoms, feeling sick. She also experienced redness, itching and rash in the whole upper part of the arm where she got the vaccine. She said that her arm soreness and itching lasted about 3 days. Other symptoms cleared up in about a week. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Malaise, Pain in extremity
Clinical narrative: fatigue and tiredness; arm soreness; flu like symptoms; feeling sick; redness on arm; rash on upper arm; itching on upper arm; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 22nd April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fatigue, pain in arm, influenza-like symptoms, feeling unwell, erythema of extremities, rash and itchy upper limbs. On an unknown date, the outcome of the fatigue, pain in arm, influenza-like symptoms, feeling unwell, erythema of extremities, rash and itchy upper limbs were recovered/resolved.   It was unknown if the reporter considered the fatigue, pain in arm, influenza-like symptoms, feeling unwell, erythema of extremities, rash and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 67 or 68 years. The patient experienced fatigue, tiredness, arm soreness, flu like symptoms, feeling sick. She also experienced redness, itching and rash in the whole upper part of the arm where she got the vaccine. She said that her arm soreness and itching lasted about 3 days. Other symptoms cleared up in about a week. The reporter did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: hurting area; warm area; chills; nausea; pink area; puffy area; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   On 18th June 2019, the patient received the 2nd dose of Shingrix .5 ml. On 19th June 2019, 1 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On 20th June 2019, the patient experienced injection site pain, injection site warmth, chills and nausea. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site warmth were unknown and the outcome of the injection site pain, chills and nausea were recovered/resolved and the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix the right deltoid region of the arm.  The patient notice a 2 by 3 inch area which was pink and puffy.  On 20th June 2019, 2 days after receiving Shingrix, the patient had stated the area got worser which was pinker, warm and hurting with chills and nausea.  On 20th June 2019, the patient did contact her physician and the physician had advised her to take Tyelnol (dose unspecified) and the patient stated the pain, chills and nausea did resolve.  On 22nd June 2019, the reporter tried to follow up but was unable to reach the patient. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea
Clinical narrative: hurting area; warm area; chills; nausea; pink area; puffy area; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   On 18th June 2019, the patient received the 2nd dose of Shingrix .5 ml. On 19th June 2019, 1 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On 20th June 2019, the patient experienced injection site pain, injection site warmth, chills and nausea. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site warmth were unknown and the outcome of the injection site pain, chills and nausea were recovered/resolved and the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix the right deltoid region of the arm.  The patient notice a 2 by 3 inch area which was pink and puffy.  On 20th June 2019, 2 days after receiving Shingrix, the patient had stated the area got worser which was pinker, warm and hurting with chills and nausea.  On 20th June 2019, the patient did contact her physician and the physician had advised her to take Tyelnol (dose unspecified) and the patient stated the pain, chills and nausea did resolve.  On 22nd June 2019, the reporter tried to follow up but was unable to reach the patient. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy breast normal, Headache, Influenza like illness, Lymphadenitis, Lymphadenopathy
Clinical narrative: swollen lymph nodes; lymph nodes were very inflammed; headache; flu-like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of enlargement of lymph nodes in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 92M54, expiry date 2nd June 2021) for prophylaxis.   On 30th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th May 2019, several hours after receiving Shingrix, the patient experienced enlargement of lymph nodes and lymphadenitis. On 31st May 2019, the patient experienced headache and influenza-like symptoms. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the enlargement of lymph nodes was not recovered/not resolved and the outcome of the lymphadenitis was unknown and the outcome of the headache and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the enlargement of lymph nodes, headache and influenza-like symptoms to be related to Shingrix. The reporter considered the lymphadenitis to be possibly related to Shingrix.  Additional details were provided as follows: This case was identified as duplicate of case US2019114238. All future correspondence would be added in case US2019114241, which stands as case of record for this patient and the case US2019114238 would be deleted. The pharmacist reported this case for his wife. The patient received Shingrix in her left arm, and a few hours later she had a mammogram.  The mammogram showed lymph node swelling in her right arm. One lymph node was still swollen a few weeks later.  The biopsy was negative for cancer, but the reporter said that, the provider had not seen this before. The patient experienced a headache and flu-like symptoms the next day after receiving Shingrix.  The patient took Aleve, and she felt better 12 to 14 hours later. The reporter consented to follow up. This case has been linked to the case US2019114246, reported by the same reporter. The reported batch number 92M53 was corrected to 92M54 as per sales data review.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Mammogram abnormal, Ultrasound breast normal
Clinical narrative: swollen lymph nodes; lymph nodes were very inflammed; headache; flu-like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of enlargement of lymph nodes in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 92M54, expiry date 2nd June 2021) for prophylaxis.   On 30th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th May 2019, several hours after receiving Shingrix, the patient experienced enlargement of lymph nodes and lymphadenitis. On 31st May 2019, the patient experienced headache and influenza-like symptoms. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the enlargement of lymph nodes was not recovered/not resolved and the outcome of the lymphadenitis was unknown and the outcome of the headache and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the enlargement of lymph nodes, headache and influenza-like symptoms to be related to Shingrix. The reporter considered the lymphadenitis to be possibly related to Shingrix.  Additional details were provided as follows: This case was identified as duplicate of case US2019114238. All future correspondence would be added in case US2019114241, which stands as case of record for this patient and the case US2019114238 would be deleted. The pharmacist reported this case for his wife. The patient received Shingrix in her left arm, and a few hours later she had a mammogram.  The mammogram showed lymph node swelling in her right arm. One lymph node was still swollen a few weeks later.  The biopsy was negative for cancer, but the reporter said that, the provider had not seen this before. The patient experienced a headache and flu-like symptoms the next day after receiving Shingrix.  The patient took Aleve, and she felt better 12 to 14 hours later. The reporter consented to follow up. This case has been linked to the case US2019114246, reported by the same reporter. The reported batch number 92M53 was corrected to 92M54 as per sales data review.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number H549S, expiry date 1st October 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were unknown.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient complained of having chills and evening fevers after receiving Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness; Swelling; This case was reported by a nurse via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Shingrix. On 22nd June 2019, 3 days after receiving Shingrix, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were recovering/resolving.   It was unknown if the reporter considered the erythema and swelling to be related to Shingrix.  Additional details were provided 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 experienced redness and swelling after 1st dose of Shingrix vaccine. Redness and swelling characterized by MD as grade 3 (about 100 mm). Antibiotics and prednisone taper were prescribed at emergency room.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash, a rash on her arms and back; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included methotrexate.   On 21st June 2019, the patient received the 1st dose of Shingrix. On 25th June 2019, 4 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient for herself. The patient stated that late in the evening of 25th June 2019, she noted a rash on her arms and back. The patient would plan to discuss with her physician.  The patient did not consent to follow up and declined providing health care professional information.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: chills; fever; flu like symptoms; Body pain; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 19th September 2021) for prophylaxis.   On 25th June 2019 04:00, the patient received the 1st dose of Shingrix .5 ml. On 25th June 2019, several hours after receiving Shingrix, the patient experienced chills, fever, influenza like illness and general body pain. On an unknown date, the outcome of the chills, fever and influenza like illness were not recovered/not resolved and the outcome of the general body pain was unknown.   It was unknown if the reporter considered the chills, fever, influenza like illness and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine in the left arm yesterday afternoon between 4:00 to 4:30 pm from the date of reporting. The same night she began to experience chills, fever and flu like symptoms. The patient stated that the only part of her body that did not hurt was her right arm. The reporter consented to follow-up.