chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Eye pruritus, Flushing, Headache
Clinical narrative: rash that went up the front of her neck to her chin; soreness at the injection; her left eye became very red; both the left and right eye were itchy; developed itching on her neck, both arms, and face (primarily centered around the chin, nose area, and cheeks).; facial flushing; Tingling; Headache; Dizziness; Chills; feel like she had the flu; Body aches; This case was reported by a consumer via call center representative and described the occurrence of facial flushing in a 33-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E4T, expiry date 1st October 2021) for prophylaxis.   On 30th October 2019, the patient received Boostrix (intramuscular). On 30th October 2019, less than an hour after receiving Boostrix, the patient experienced facial flushing, tingling, headache, dizziness, chills, influenza-like symptoms and general body pain. On 31st October 2019, the patient experienced eye red, eye pruritus and pruritus. On an unknown date, the patient experienced rash and injection site pain. On an unknown date, the outcome of the facial flushing, tingling, headache, dizziness, chills, influenza-like symptoms, general body pain and eye pruritus were unknown and the outcome of the eye red, rash and pruritus were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the facial flushing, tingling, headache, dizziness, chills, influenza-like symptoms, general body pain, eye red, rash, eye pruritus, pruritus and injection site pain to be related to Boostrix.  Additional details were provided as follows: At 10:00 am, the patient received Boostrix on left deltoid. It was reported that,within 45 minutes after receiving Boostrix, the patient experienced facial flushing, tingling, headache, dizziness, and chills. By the afternoon after receiving Boostrix, she experienced body aches which made her feel like she had the flu.  The next day, after receiving Boostrix, her left eye became very red and both the left and right eye were itchy. The left eye stayed red and itchy for a week while the right was intermittently itchy throughout the week. It was reported that, as the eye symptoms began to resolve, she started to develop a rash that went up the front of her neck to her chin and developed itching on her neck, both arms, and face (primarily centered around the chin, nose area, and cheeks). The patient also experienced soreness at the injection that lasted for a couple of days after receiving the Boostrix. The reporter did not consent to follow-up.  The reporter was unable to obtain additional information.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Injection site pain, Ocular hyperaemia, Pain, Paraesthesia
Clinical narrative: rash that went up the front of her neck to her chin; soreness at the injection; her left eye became very red; both the left and right eye were itchy; developed itching on her neck, both arms, and face (primarily centered around the chin, nose area, and cheeks).; facial flushing; Tingling; Headache; Dizziness; Chills; feel like she had the flu; Body aches; This case was reported by a consumer via call center representative and described the occurrence of facial flushing in a 33-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E4T, expiry date 1st October 2021) for prophylaxis.   On 30th October 2019, the patient received Boostrix (intramuscular). On 30th October 2019, less than an hour after receiving Boostrix, the patient experienced facial flushing, tingling, headache, dizziness, chills, influenza-like symptoms and general body pain. On 31st October 2019, the patient experienced eye red, eye pruritus and pruritus. On an unknown date, the patient experienced rash and injection site pain. On an unknown date, the outcome of the facial flushing, tingling, headache, dizziness, chills, influenza-like symptoms, general body pain and eye pruritus were unknown and the outcome of the eye red, rash and pruritus were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the facial flushing, tingling, headache, dizziness, chills, influenza-like symptoms, general body pain, eye red, rash, eye pruritus, pruritus and injection site pain to be related to Boostrix.  Additional details were provided as follows: At 10:00 am, the patient received Boostrix on left deltoid. It was reported that,within 45 minutes after receiving Boostrix, the patient experienced facial flushing, tingling, headache, dizziness, and chills. By the afternoon after receiving Boostrix, she experienced body aches which made her feel like she had the flu.  The next day, after receiving Boostrix, her left eye became very red and both the left and right eye were itchy. The left eye stayed red and itchy for a week while the right was intermittently itchy throughout the week. It was reported that, as the eye symptoms began to resolve, she started to develop a rash that went up the front of her neck to her chin and developed itching on her neck, both arms, and face (primarily centered around the chin, nose area, and cheeks). The patient also experienced soreness at the injection that lasted for a couple of days after receiving the Boostrix. The reporter did not consent to follow-up.  The reporter was unable to obtain additional information.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash
Clinical narrative: rash that went up the front of her neck to her chin; soreness at the injection; her left eye became very red; both the left and right eye were itchy; developed itching on her neck, both arms, and face (primarily centered around the chin, nose area, and cheeks).; facial flushing; Tingling; Headache; Dizziness; Chills; feel like she had the flu; Body aches; This case was reported by a consumer via call center representative and described the occurrence of facial flushing in a 33-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E4T, expiry date 1st October 2021) for prophylaxis.   On 30th October 2019, the patient received Boostrix (intramuscular). On 30th October 2019, less than an hour after receiving Boostrix, the patient experienced facial flushing, tingling, headache, dizziness, chills, influenza-like symptoms and general body pain. On 31st October 2019, the patient experienced eye red, eye pruritus and pruritus. On an unknown date, the patient experienced rash and injection site pain. On an unknown date, the outcome of the facial flushing, tingling, headache, dizziness, chills, influenza-like symptoms, general body pain and eye pruritus were unknown and the outcome of the eye red, rash and pruritus were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the facial flushing, tingling, headache, dizziness, chills, influenza-like symptoms, general body pain, eye red, rash, eye pruritus, pruritus and injection site pain to be related to Boostrix.  Additional details were provided as follows: At 10:00 am, the patient received Boostrix on left deltoid. It was reported that,within 45 minutes after receiving Boostrix, the patient experienced facial flushing, tingling, headache, dizziness, and chills. By the afternoon after receiving Boostrix, she experienced body aches which made her feel like she had the flu.  The next day, after receiving Boostrix, her left eye became very red and both the left and right eye were itchy. The left eye stayed red and itchy for a week while the right was intermittently itchy throughout the week. It was reported that, as the eye symptoms began to resolve, she started to develop a rash that went up the front of her neck to her chin and developed itching on her neck, both arms, and face (primarily centered around the chin, nose area, and cheeks). The patient also experienced soreness at the injection that lasted for a couple of days after receiving the Boostrix. The reporter did not consent to follow-up.  The reporter was unable to obtain additional information.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient's arm was sore for  24 to 36 hours, after receiving the first dose of the Shingrix vaccine. Unable to obtain additional details. The permission to follow up was denied. The outcome of soreness was reported as recovered/resolved in the system however in source document, it was mentioned as recovered/resolved with sequelae.
Sex: M
Vaccine: VARZOS
Symptoms: Cough
Clinical narrative: cough; This case was reported by a consumer via call center representative and described the occurrence of cough in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced cough. On an unknown date, the outcome of the cough was unknown.   It was unknown if the reporter considered the cough to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that he received dose 1 of Shingrix about 4 weeks before the time of reporting and has been experiencing cough. The reporter did not consent to follow-up. The reporter did not wish to proceed with safety report questions.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site warmth, Pain in extremity, Pruritus
Clinical narrative: injection site warm to touch; headache; severe itching; pain in arm radiating to elbow; pain in arm radiating to elbow; "5 pink spots that merged into one giant spot with red on the inside"; "5 pink spots that merged into one giant spot with red on the inside"; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th November 2019, 2 days after receiving Shingrix, the patient experienced injection site warmth, headache, pruritus, pain in arm, pain in elbow, red rash and skin discoloration. On an unknown date, the outcome of the injection site warmth, headache, pruritus, pain in arm, pain in elbow, red rash and skin discoloration were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, headache, pruritus, pain in arm, pain in elbow, red rash and skin discoloration to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in unknown arm. The patient was advised to follow up with her physician and told her to go to the emergency room. The patient wanted to know how the virus is extracted to create the vaccine. The patient did not want to provide any demographic information. No other information was obtained. The reporter did not consented to follow up. The outcome of the events were reported as not recovered/resolved in the database however in source document, it was mentioned as recovering/resolving.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin discolouration
Clinical narrative: injection site warm to touch; headache; severe itching; pain in arm radiating to elbow; pain in arm radiating to elbow; "5 pink spots that merged into one giant spot with red on the inside"; "5 pink spots that merged into one giant spot with red on the inside"; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th November 2019, 2 days after receiving Shingrix, the patient experienced injection site warmth, headache, pruritus, pain in arm, pain in elbow, red rash and skin discoloration. On an unknown date, the outcome of the injection site warmth, headache, pruritus, pain in arm, pain in elbow, red rash and skin discoloration were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, headache, pruritus, pain in arm, pain in elbow, red rash and skin discoloration to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in unknown arm. The patient was advised to follow up with her physician and told her to go to the emergency room. The patient wanted to know how the virus is extracted to create the vaccine. The patient did not want to provide any demographic information. No other information was obtained. The reporter did not consented to follow up. The outcome of the events were reported as not recovered/resolved in the database however in source document, it was mentioned as recovering/resolving.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chemotherapy, Lung neoplasm malignant
Clinical narrative: lung cancer diagnosis; This case was reported by a pharmacist via call center representative and described the occurrence of lung cancer in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis.   On 25th June 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced lung cancer (serious criteria GSK medically significant). The patient was treated with chemotherapy,nos (Chemotherapy). On an unknown date, the outcome of the lung cancer was unknown.   It was unknown if the reporter considered the lung cancer to be related to Shingrix.  Additional case details were reported as follows: The patient did not receive the 2nd dose of Shingrix within 2 to 6 month window due to diagnosis of lung cancer and undergoing chemotherapy. The reported batch number has been updated from 9YB45 to 9YD45, as per sales data sheet.
Age: 80.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Insomnia, Pain in extremity
Clinical narrative: arm pain; unable to sleep; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included Flu vaccine (On an unknown date, the patient received flu vaccine and he never had such symptoms before.).   On 5th November 2019, the patient received Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. In November 2019, less than 2 weeks after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced pain in arm and sleeplessness. In November 2019, the outcome of the pain in arm and sleeplessness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and sleeplessness to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Shingrix as well as the flu vaccine [unknown brand] about 10 days before. The patient assumed that the adverse events are on Shingrix because he received the flu vaccine before and he never had these symptoms before. The patient also said that he received one vaccine on each arm and so he can clearly see that the pain in his arm was on the side where he received the shingrix vaccine. The reporter couldn't confirm that the patient didn't make a mistake about which vaccine he had on which arm, but that was what the patient said.   The patient had severe pain in his arm where he believe he got the shingrix vaccine. The pain was so significant that he didn't sleep in his bed for 10 full days. He was sleeping in a lazy boy this week but last night he was able to sleep in his own bed for the first time since he received the vaccines. Filing adverse event on flu vaccine and Shingrix because it's known that patient had both vaccines, even though the patient was not attributing adverse event to flu vaccine and only to shingrix.
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Rash/ rash developed on her back, mostly on her left side; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number K3593, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, 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 Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter stated that she received the Fluarix Quadrivalent vaccine on either 31st October 2019 or 1st November 2019 on the left arm. Within 24 hours, a rash developed on her back, mostly on her left side. The patient still had the rash. The reporter was unwilling to provide additional information.
Sex: M
Vaccine: VARZOS
Symptoms: Local reaction, Muscular weakness
Clinical narrative: Large local reaction; Weaknessin lower extremities; This case was reported by a nurse via call center representative and described the occurrence of local reaction in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included walking aid user (uses a walker and a cane).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced local reaction and lower extremities weakness of. On an unknown date, the outcome of the local reaction and lower extremities weakness of were unknown.   It was unknown if the reporter considered the local reaction and lower extremities weakness of to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  Post vaccination with Shingrix the patient experienced a large local reaction and felt weakness in their lower extremities. The reporter consented to follow up. No further details regarding events or vaccine was given.  It was unknown who administered the vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: Skin reaction; This case was reported by a physician via call center representative and described the occurrence of skin reaction in a adult male 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 skin reaction. On an unknown date, the outcome of the skin reaction was unknown.   It was unknown if the reporter considered the skin reaction to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The batch number and expiration date were not available since the vaccine was administered in a different facility.  The reporter consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: itchy rash on neck; Varicella like rash; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number M9P52, expiry date 18th December 2021) for prophylaxis.   On 8th November 2019, the patient received the 1st dose of Shingrix. On 10th November 2019, 2 days after receiving Shingrix, the patient experienced itchy rash and varicella-like rash. On an unknown date, the outcome of the itchy rash and varicella-like rash were unknown.   It was unknown if the reporter considered the itchy rash and varicella-like rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient received 1st dose of Shingrix vaccine and developed itchy rash behind her neck. The rash was approximately 2 inch circle, appeared like shingles with no blisters. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced 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:  The age at vaccination was not reported. The age group was not reported but was selected as adult as per the vaccine indication. The reporter stated that one of the patient was on a similar medication to Creon. The patient had a bad reaction to the Shingrix vaccine. The reporter did not describe what bad reaction meant. No further details were provided. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The consumer reported to pharmacist that she saw her physician for her events and was told by the physician that his wife experienced the same issue of shingles after receiving shingles despite that shingles was not live and did not cause shingles. The pharmacist did not have specifics on the physicians wife. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles and time to onset for the event was unknown at the time of reporting. This case is 2 of 2 case, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral, Swelling face
Clinical narrative: tongue tingles; jaw swollen; This case was reported by a consumer via call center representative and described the occurrence of tingling tongue in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included food allergy.   On 14th November 2019, the patient received the 1st dose of Shingrix. On 15th November 2019, 1 days after receiving Shingrix, the patient experienced tingling tongue and facial swelling. On an unknown date, the outcome of the tingling tongue and facial swelling were unknown.   It was unknown if the reporter considered the tingling tongue and facial swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix and the morning after, the patient experienced tingling in her tongue and a swollen jaw. The patient reported that she contracted a tick borne condition that makes her allergic to ingesting mammalian derived items. The patient did not wish to participate in a safety report without consulting with doctor.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Laboratory test, Pain
Clinical narrative: Shingles; small vesicles; itching; Pain; Erythema; This case was reported by a physician via call center representative and described the occurrence of shingles in a 84-year-old male patient who received Herpes zoster (Shingrix) for an unknown indication.   Concurrent medical conditions included gluten intolerance, allergy to chemicals (Autoimmune disorder as secondary to agent orange), atopic dermatitis and penicillin allergy.   On 29th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 30th October 2019, 1 days after receiving Shingrix and an unknown time after starting cortisone acetate and Valtrex, the patient experienced pain and erythema. On an unknown date, the patient experienced shingles, vesicles and pruritus. The patient was treated with cortisone acetate, OPIOIDS {NOS} (OPIOIDS) and valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles, erythema, vesicles and pruritus were not recovered/not resolved and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the shingles, pain, erythema, vesicles and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine on the left deltoid and on the next day he the patient developed pain (9 on a scale from 1-10) and a large erythematous area approximately 9 inches in size on his left chest and belt line. In the erythematous area, the patient had small vesicles and intense itching. The doctor suspects that the patient had Shingles. The doctor started the patient on a short course of cortisone, opioids and Valtrex. The patient had experienced partial pain relief. The reporter consented to follow up.      Lab Comments: On an unknown date, lab test was performed for pain which was 9 on a scale from 1 to 10
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Shingles; small vesicles; itching; Pain; Erythema; This case was reported by a physician via call center representative and described the occurrence of shingles in a 84-year-old male patient who received Herpes zoster (Shingrix) for an unknown indication.   Concurrent medical conditions included gluten intolerance, allergy to chemicals (Autoimmune disorder as secondary to agent orange), atopic dermatitis and penicillin allergy.   On 29th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 30th October 2019, 1 days after receiving Shingrix and an unknown time after starting cortisone acetate and Valtrex, the patient experienced pain and erythema. On an unknown date, the patient experienced shingles, vesicles and pruritus. The patient was treated with cortisone acetate, OPIOIDS {NOS} (OPIOIDS) and valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles, erythema, vesicles and pruritus were not recovered/not resolved and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the shingles, pain, erythema, vesicles and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine on the left deltoid and on the next day he the patient developed pain (9 on a scale from 1-10) and a large erythematous area approximately 9 inches in size on his left chest and belt line. In the erythematous area, the patient had small vesicles and intense itching. The doctor suspects that the patient had Shingles. The doctor started the patient on a short course of cortisone, opioids and Valtrex. The patient had experienced partial pain relief. The reporter consented to follow up.      Lab Comments: On an unknown date, lab test was performed for pain which was 9 on a scale from 1 to 10
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Diarrhoea, Pain in extremity, Skin irritation, Weight decreased
Clinical narrative: 10 inch line of blisters around her ankle; irritated; Lost weight; Diarrhea; arm hurt; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th July 2019, the patient received the 1st dose of Shingrix. On 26th July 2019, 1 days after receiving Shingrix, the patient experienced diarrhea. On 27th July 2019, the patient experienced weight loss. On 30th July 2019, the patient experienced blister and irritation skin. On an unknown date, the patient experienced pain in arm. The patient was treated with cannabidiol (Cannabidiol Cream). On an unknown date, the outcome of the diarrhea, weight loss and pain in arm were recovered/resolved and the outcome of the blister and irritation skin were unknown.   It was unknown if the reporter considered the diarrhea, blister, weight loss, pain in arm and irritation skin to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and the next day after receiving the vaccine she had diarrhea 4-5 times. The next day she noted that she had lost six pounds.   The patients arm hurt for three days after receiving the vaccine.   Five days after receiving the Shingrix vaccine, she noted a 10 inch line of blisters around her ankle that was irritated.   She has put CBD cream on it and now it healed but looks like a scar. The reporter was extremely difficult to understand due to a strong accent and was unable to obtain additional details.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Fatigue; Headache; Myalgia; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 753RM, expiry date 3rd December 2021) and (batch number 7RK7K, expiry date 26th November 2021) for prophylaxis.   On 12th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. In November 2019, less than a week after receiving Shingrix, the patient experienced fatigue, headache and myalgia. On an unknown date, the outcome of the fatigue, headache and myalgia were unknown.   It was unknown if the reporter considered the fatigue, headache and myalgia to be related to Shingrix.  Additional details were provided as follows: The healthcare professional (HCP) stated any information on 2nd dose reactions, would they be worst than the 1st dose a patient experienced of typical side effects of headache, fatigue and myalgia from 1st dose. The pharmacist asked any information on 2nd dose reactions of Shingrix. The adverse event (AE) collected. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Meniere's disease
Clinical narrative: Meniere's flared up after 1st dose of Shingrix; This case was reported by a physician via call center representative and described the occurrence of meniere's disease aggravated in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included meniere's disease.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced meniere's disease aggravated (serious criteria GSK medically significant). On an unknown date, the outcome of the meniere's disease aggravated was unknown.   It was unknown if the reporter considered the meniere's disease aggravated to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The physician writing about a patient that received Shingrix. The patient suffers from Menieres and feels that his Menieres flared after the shingrix shot 1. The patient had asked healthcare professional (HCP) to let you all know and if you have heard of other cases. The adverse event (AE) collected. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous, Rash pruritic
Clinical narrative: shingles; rash to her right hip/outbreak on her left hip/big red, horrible bits that were itchy; rash to her right hip/outbreak on her left hip/big red, horrible bits that were itchy; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced shingles, itchy rash and red rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles, itchy rash and red rash were unknown.   It was unknown if the reporter considered the shingles, itchy rash and red rash to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported, however the patient could be 86 or 87 years old. The patient received a dose of Shingrix in right arm. The patient developed a rash to her right hip.  She described it as big red, horrible bits that were itchy.  The patient stated that her dermatologist told she had shingles and prescribed Valacyclovir.  On 13th November 2019, the patient then stated that she developed another outbreak on her left hip and saw her general practitioner who told her she had shingles again and prescribed Valcyclovir.  The patient was concerned about receiving 2nd dose as she was worried she would get shingles again and have to take valcyclovir again.  It was discussed that as Shingrix was not a live vaccine, it was not able to cause disease.  The patient gave medical information for her doctor to follow up for more information.  The reporter did not consent to follow-up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Computerised tomogram head normal, Discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: Discomfort; tingling; Numbness facial; burning; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 22nd October 2019, 1 days after receiving Shingrix, the patient experienced tingling, numbness facial and burning sensation in face. On an unknown date, the patient experienced discomfort. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the tingling, numbness facial, burning sensation in face and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the tingling, numbness facial, burning sensation in face and discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and next day, experienced tingling, numbness and burning on the right side of his face going from his temple down to his jawbone. The patient went to emergency room (ER) and had a computerised tomogram (CT) scan that did not show any blockages in his head. The patient saw his primary care provider and she could not tell him anything other than that it might be nerve related. The patient was still experiencing the symptoms and they have not changed. It was not painful. The reporter consented to follow up.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Patient got shingles are completing the Shingrix series; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 81-year-old male patient who received Herpes zoster (Shingrix) (batch number 7457P, expiry date 2nd October 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 453B2, expiry date 11th February 2022) for prophylaxis.   On 21st June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 27th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In October 2019, between 3 and 5 months after receiving Shingrix and between 1 and 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The pharmacist on the line reporting. On 21st June 2019, the patient received 1st dose and on 27th August 2019 received 2nd dose of Shingrix. The reported batch number for 2nd dose may or may not be adjuvant. In early October 2019, the patient experienced shingles and was still having trouble with it. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient got sick after receiving Shingrix. The reporter did not provide any additional details regarding the event or the patient.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Pain in extremity, Pneumonia, Pyrexia
Clinical narrative: pneumonia; arm pain; tired; low grade fever; felt bad; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2019, the patient received the 1st dose of Shingrix. On 13th August 2019, 1 days after receiving Shingrix, the patient experienced pneumonia (serious criteria GSK medically significant), pain in arm and tiredness. In August 2019, the patient experienced low grade fever and feeling bad. The patient was treated with azithromycin (Z Pak). On an unknown date, the outcome of the pneumonia, pain in arm, tiredness and low grade fever were recovered/resolved and the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the pneumonia, pain in arm, tiredness, low grade fever and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient experienced symptoms of arm pain, tiredness the day after receiving Shingrix. A few days later she noticed a low grade fever but could have had it prior to the time she actually took her temperature. The doctor prescribed a Zpac which she took but still felt bad a week later after receiving Shingrix and went back to the doctor who diagnosed pneumonia. The reporter consented to follow up.
Sex: U
Vaccine: PNC13
Symptoms: Injection site irritation, Injection site swelling
Clinical narrative: swelling and irritation at the injection site; swelling and irritation at the injection site; This is a Spontaneous report from a contactable physician based on the information received by Pfizer from Merck & Co., Inc. (Case Number: 013999141). A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date at single for immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced swelling and irritation at the injection site  on an unspecified date with outcome of unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy
Clinical narrative: Velamentous cord insertion; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 20-Nov-2019, concerning a 23-year-old, pregnant, female subject of body weight: 125 lbs, height: 66 inches and body mass index (BMI): 20.2, enrolled in, a prospective observational safety study.  The subject's obstetrical history included one previous full-term live birth. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The concomitant medications of the subject included Prenatal Vitamin (minerals nos, vitamins nos) for neonatal care.   The subject's last menstrual period (LMP) date was 19-Feb-2019, the estimated date of delivery (EDD) was reported as 26-Nov-2019 and corrected estimated date of delivery (CEDD) was reported as 22-Nov-2019. The type of pregnancy was singleton.   On 22-Apr-2019, the subject underwent ultrasound scan and no MCM was noted.   On 23-May-2019, the subject underwent First trimester screen and no MCM was noted.  On 17-Jul-2019, the subject underwent ultrasound scan and no MCM was noted.   On 10-Oct-2019, approximately at 33 weeks of gestation, the subject was administered Flu Vaccine Cell Subunit QIV NVD (Flucelvax QIV) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261207, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] for an influenza immunization (explicitly coded as 'Vaccine exposure during pregnancy').  On 20-Nov-2019, when pregnancy status was collected it was noted that pregnancy was complicated with velamentous cord insertion.   At the time of initial reporting, the outcome was not reported.   The case was assessed as serious (medically significant). The reporter did not provide causality assessment to Flucelvax (QIV).  Company Comment: The subject experienced velamentous cord insertion after vaccination with the suspect Flucelvax QIV at third pregnancy trimester (at 33 weeks of gestation). Chronology is implausible because placenta with cord insertion site is fully formed by the end of first trimester. Considering all the above mentioned, causal relationship between the suspect product and the event velamentous cord insertion is assessed not related. Exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: The subject experienced velamentous cord insertion after vaccination with the suspect Flucelvax QIV at third pregnancy trimester (at 33 weeks of gestation). Chronology is implausible because placenta with cord insertion site is fully formed by the end of first trimester. Considering all the above mentioned, causal relationship between the suspect product and the event velamentous cord insertion is assessed not related. Exposure during pregnancy is assessed as not related per company's conventions.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Injection site pain, Pain
Clinical narrative: pain at the injection site and the muscle; pain at the injection site and the muscle; Any time I try to move it in any way, I very much feel it, the pain; Information was received from a registered nurse referring to a 39 years old female patient. The patient was not pregnant. The patient had none concomitant medication, pertinent medical history or drug reactions/allergies.  Approximately 10-15 years ago, the patient received the full quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) series (frequency, anatomical location and route of administration, lot number and expiration date were unknown) for prophylaxis. On 17-OCT-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (first dose, lot number S008154 and expiration date 20-NOV-2021; frequency and anatomical location were unknown) intramuscularly for prevention.  On the same date, the patient had been having continuous pain at the injection site since then and the muscle. Any time she tried to move it in any way, she very much felt the pain. The patient had been taking ibuprofen daily, which helped with the pain.  No product quality complaint (PQC) was involved. No labs diagnostics/studies were performed. The patient did not seek medical attention. The outcome of the events was reported as not recovered. The causality assessment was not provided.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; one patient was administered improperly stored PROQUAD; This spontaneous report was received from an administrator referring to a 5 years old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 12-OCT-2019, the patient was administered improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)(lot number S022568 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date was reported as 04-FEB-2020)(exact dose and route of administration were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent(STERILE DILUENT)(lot# and expiration date was unknown). The vaccine was exposed from 6 degree Fahrenheit (F) to 14F for 420 hours and from 15F to 46F for 106 hours. The previous temperature excursions was from 6F to 14F for 200 hours and from 15F to 46F for 18 hours . A "data logger" was involved. No adverse effects reported.; Sender's Comments:  US-009507513-1911USA000877:
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: developed a "large red raised area" on his arm that was painful; developed a "large red raised area" on his arm that was painful; This spontaneous report has been received from a pharmacist via a company representative referring to an 82 years old male patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.       On 24-OCT-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date, strength, frequency and dose details were unknown) intramuscularly for prophylaxis.         On 25-OCT-2019, the patient experienced a "large red raised area" on his arm that was painful (not detailed further).  The outcome of the events and the causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.