chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site rash in a adult male patient who received SHINGRIX. On 16th April 2018, the patient received the 1st dose of SHINGIRX. On an unknown date, the outcome of the injection site rash was unknown. The reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a clinical study coordinator. The age at vaccination was not reported. The reporter felt that the patient experienced herpes type rash at injection site. The reporter was wondering if the 2nd dose should be administered. The reporter felt that the product created reaction.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Right upper extremity redness and swelling. Treatment: ice, BENADRYL, KEFLEX capsule TID x 7 days.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site warmth, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received SHINGRIX. On 10th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain, tiredness, difficulty sleeping, injection site erythema, injection site itching and injection warmth. On an unknown date, the outcome of the muscle pain, tiredness, difficulty sleeping, injection site erythema, injection site itching and injection site warmth were unknown. It was unknown if the reporter considered the muscle pain, tiredness, difficulty sleeping, injection site erythema, injection site itching and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient never had allergies and problems with vaccines. The patient experienced extremely severe muscle pain that night and also felt tired and could not sleep. In April 2018, less than a week after receiving SHINGRIX, the patient had large red circle with heat and itch at the site of vaccination. The reporter asked do these reactions sound normal and will second shot have these side effects.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received SHINGRIX. On 10th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain, tiredness, difficulty sleeping, injection site erythema, injection site itching and injection warmth. On an unknown date, the outcome of the muscle pain, tiredness, difficulty sleeping, injection site erythema, injection site itching and injection site warmth were unknown. It was unknown if the reporter considered the muscle pain, tiredness, difficulty sleeping, injection site erythema, injection site itching and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient never had allergies and problems with vaccines. The patient experienced extremely severe muscle pain that night and also felt tired and could not sleep. In April 2018, less than a week after receiving SHINGRIX, the patient had large red circle with heat and itch at the site of vaccination. The reporter asked do these reactions sound normal and will second shot have these side effects.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a male patient who received SHINGRIX. On 12th April 2018, the patient received SHINGRIX. On 13th April 2018, 1 days after receiving SHINGRIX, the patient experienced fever and muscle pain. On an unknown date, the outcome of the fever and muscle pain were unknown. It was unknown if the reporter considered the fever and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on the past Thursday before the date of reporting. A day before reporting, in the afternoon, the patient started to experience bad muscle aches and fever. The patient wondered how long the side effects would last.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Aphasia, Electroencephalogram, Inability to crawl, Insomnia, Screaming
Clinical narrative: 3 hours after vaccine, he screamed in agony for hours, stopped sleeping, stopped crawling, stopped talking. He just turned 3 still doesn't talk. We had a EEG done following issues. They gave me no info whatsoever I was simply told he won't have seizures. When I asked for copies of the scan they told me $25 per copy. Recommended by Doctor. I had also brought up that I didn't want to further vaccinate and that I have a autoimmune disorder (psoriasis). I was hushed right there.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site scab
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site scab in a 70-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date unknown). Concurrent medical conditions included diabetes. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 7 days after receiving SHINGRIX, the patient experienced injection site scab. On an unknown date, the outcome of the injection site scab was not recovered/not resolved. The reporter considered the injection site scab to be unlikely related to SHINGRIX. Additional details were provided as follows: The nurse reported to a field representative that a patient had a scab, about 1 to 1.5 inches long and the width of a pencil, horizontal across her arm where she received SHINGRIX in right deltoid. The nurse noted that it looked like the patient had scratched the area, but the patient denied doing so. There was no redness, welling or pain that the patient reported. The reporter had followed-up with the patient immediately after the injection and the patient reported no adverse events. The patient was in the office of an unrelated reason in the week of reporting date and that was when the nurse noted the scab.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Swelling, Vomiting
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of generalized muscle aches in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized muscle aches, swelling and vomiting. On an unknown date, the outcome of the generalized muscle aches, swelling and vomiting were unknown. It was unknown if the reporter considered the generalized muscle aches, swelling and vomiting to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient felt a possibility of having a vomiting episode.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced feeling unwell. The patient was treated with ibuprofen. On an unknown date, the outcome of the feeling unwell was recovered/resolved. The reporter considered the feeling unwell to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that, a nurse, in passing, mentioned that, she felt rough and later, felt fine. When asked, the caller stated that, she had limited information and cannot further expand on details other than the nurse stated she felt rough after receiving the vaccine. The date, time and site of vaccination as well as lot number and expiry dates are all unknown. The caller believed that, this occurred the day after the vaccination and lasted for about a day and resolved. She thought that, the nurse took a couple ibuprofen and assumed that, the nurse was fully recovered. No additional information was provided.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). Concomitant products included oxybutynin. On 13th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th April 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site muscle pain and injection site swelling. On an unknown  date, the outcome of the injection site erythema, injection site muscle pain and injection site welling were not recovered/not resolved. The reporter considered the injection site erythema, injection site muscle pain and injection site swelling to be probably related to SHINGRIX. Additional details were provided as follows: On 13th April 2018 at 15:10 hours, the patient received SHINGRIX on left arm. The patient experienced redness, swelling and muscle pain around the injection site. The reporter thought that, on 15th April 2018, the symptoms were started. On 16th April 2018, the patient was seen at pharmacy and at the time she visited, the symptoms were getting worse. There was no itching.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a adult male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 6 days 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 reported as follows: The patient was the reporter's neighbor. The age at vaccination was not reported. The patient had no health issues and received SHINGRIX due to his age. The patient broke out in the worst case of Shingles his physician had ever seen. The reporter knew it was not a live vaccine but that was just a little too coincidental. The patient refused to get the second dose. The reporter asked if GlaxoSmithKline of any other weird scenarios like this.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 77-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). Concurrent medical conditions included allergy to vaccine (allergy to ZOSTAVAX, unsure of which component). On 13th April 2018, the patient received the 1st dose of SHINGRIX. On 14th April 2018, 1 days after receiving SHINGRIX, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was recovering/resolving. It was unknown if the reporter considered the erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced rash described as a flat, red, patchy rash all over her body except her face. The patient might had been seen by her physician but the health care professional was unsure.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Eye swelling, Fatigue, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 64-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). The patient's past medical history included blood pressure high and eye disorder. On 13th April 2018, the patient received SHINGRIX. On 14th April 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fatigue, injection site erythema, injection site pain and fever. In April 2018, the patient experienced rash, diarrhea and eye swelling. On an unknown date, the outcome of the chills, fatigue, injection site erythema, rash, diarrhea, fever and eye swelling were not recovered/not resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the chills, fatigue, injection site erythema, injection site pain, rash, diarrhea, fever and eye swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Friday afternoon, the patient received an injection of SHINGRIX. On the next day at 4 AM, the patient began to experience chills, fever, and fatigue. The patient also reports she experienced injection site redness and pain at the injection site. Less than a week after receiving SHINGRIX, the patient experienced puffy eyes, diarrhea and mild rash. The patient did not specify when the events began other than the fever, chills, and fatigue. At time of report, the patient was still experiencing these events.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 64-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). The patient's past medical history included blood pressure high and eye disorder. On 13th April 2018, the patient received SHINGRIX. On 14th April 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fatigue, injection site erythema, injection site pain and fever. In April 2018, the patient experienced rash, diarrhea and eye swelling. On an unknown date, the outcome of the chills, fatigue, injection site erythema, rash, diarrhea, fever and eye swelling were not recovered/not resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the chills, fatigue, injection site erythema, injection site pain, rash, diarrhea, fever and eye swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Friday afternoon, the patient received an injection of SHINGRIX. On the next day at 4 AM, the patient began to experience chills, fever, and fatigue. The patient also reports she experienced injection site redness and pain at the injection site. Less than a week after receiving SHINGRIX, the patient experienced puffy eyes, diarrhea and mild rash. The patient did not specify when the events began other than the fever, chills, and fatigue. At time of report, the patient was still experiencing these events.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Tongue eruption
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 69-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). On 13th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 15th April 2018, 2 days after receiving SHINGRIX, the patient experienced erythema of extremities and itching both hands. In April 2018, the patient experienced rash tongue and patchy rash. On an unknown date, the outcome of the erythema of extremities, itching both hands, rash tongue and patchy rash were unknown. The reporter considered the erythema of extremities, itching both hands, rash tongue and patchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness on her left hand and itchiness two days after receiving the SHINGRIX vaccine. Less than a week, after vaccination, the patient also had a patchy rash all over her tongue and also on her upper neck. The patchy rash was more pronounced on the left side. The patient experienced redness at the injection site and it spread from there. No additional details were provided as she had not seen the patient since the symptoms occurred. The caller states that one of her colleagues had seen the redness and patchy rash on the patient.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). On 4th April 2018 14:20, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 4th April 2018, several hours after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. In April 2018, the patient experienced fever and fatigue. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever and fatigue were recovered/resolved. The reporter considered the injection site erythema, injection site swelling, fever and fatigue to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to a doctor. The patient received SHINGRIX in the left deltoid. The night after vaccination, the patient experienced redness and swelling at the injection site. Less than month after receiving SHINGRIX, the patient also experienced fever and fatigue that lasted the next couple of days.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Nausea, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 68-year-old male patient who received SHINGRIX (batch number B327C, expiry date 4th January 2020). On 12th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced rash. On 16th April 2018, the patient experienced fatigue, chills, fever, nausea and influenza-like symptoms. In April 2018, the outcome of the fatigue, chills, fever, nausea and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the fatigue, chills, fever, nausea, influenza-like symptoms and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. Four days after vaccination, the patient experienced fatigue, chills, fever, nausea and influenza-like symptoms. An actual temperature was not provided. The patient said he felt feverish. The patient stated that his flu like symptoms had resolved, however he had not developed a rash on his neck along the same side that he had the SHINGRIX injection.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 68-year-old male patient who received SHINGRIX (batch number B327C, expiry date 4th January 2020). On 12th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced rash. On 16th April 2018, the patient experienced fatigue, chills, fever, nausea and influenza-like symptoms. In April 2018, the outcome of the fatigue, chills, fever, nausea and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the fatigue, chills, fever, nausea, influenza-like symptoms and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. Four days after vaccination, the patient experienced fatigue, chills, fever, nausea and influenza-like symptoms. An actual temperature was not provided. The patient said he felt feverish. The patient stated that his flu like symptoms had resolved, however he had not developed a rash on his neck along the same side that he had the SHINGRIX injection.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced fever and swelling arm. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the swelling arm was unknown. It was unknown if the reporter considered the fever and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. However, it could be in between 55 to 65 years. The patient's body temperature was recorded as 104 degree F. It was reported that half the patient's arm was swollen. The temperature went down but the arm was still swollen at the time of reporting. The patient was on vacation. The health care professionals were concerned that the patient might not get 2nd dose.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced fever and swelling arm. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the swelling arm was unknown. It was unknown if the reporter considered the fever and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. However, it could be in between 55 to 65 years. The patient's body temperature was recorded as 104 degree F. It was reported that half the patient's arm was swollen. The temperature went down but the arm was still swollen at the time of reporting. The patient was on vacation. The health care professionals were concerned that the patient might not get 2nd dose.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shivering in a elderly female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering. On an unknown date, the outcome of the shivering was recovered/resolved. It was unknown if the reporter considered the shivering to be related to SHINGIRX. Additional details were provided as follows: The age at vaccination was not reported. The patient in her 70s or 80s, received SHINGRIX in the physician's office and physician felt like it was administered. After vaccination with SHINGRIX, the patient experienced shivering for 1 day. The patient brought the SHINGRIX medication from the pharmacist and the healthcare professional administered it. This case has been linked with case US2018GSK066621, reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shivering in a elderly female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering. On an unknown date, the outcome of the shivering was recovered/resolved. It was unknown if the reporter considered the shivering to be related to SHINGIRX. Additional details were provided as follows: The age at vaccination was not reported. The patient in her 70s or 80s, received SHINGRIX in the physician's office and physician felt like it was administered. After vaccination with SHINGRIX, the patient experienced shivering for 1 day. The patient brought the SHINGRIX medication from the pharmacist and the healthcare professional administered it. This case has been linked with case US2018GSK066621, reported by same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of hives in a adult female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to Influenza vaccine Quadrivalent. Additional details were provide as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced an allergic reaction described as hives after receiving an unknown brand flu vaccine. No additional information was available.
Age: 0.75
Sex: M
Vaccine: HEP, PNC13
Symptoms: Injection site erythema, Injection site swelling, Rash, Rhinorrhoea
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 9-month-old male patient who received ENGERIX B (batch number 9554M, expiry date 30th May 2020). Concomitant products included nystatin and PREVNAR 13. On 17th April 2018, the patient received the 4th dose of ENGERIX B (intramuscular) .5 ml. On 18th April 2018, 1 days after receiving ENGERIX B, the patient experienced injection site swelling, injection site erythema, rash and runny nose. On an unknown date, the outcome of the injection site swelling, injection site erythema, rash and runny nose were unknown. The reporter considered the injection site swelling, injection site erythema, rash and runny nose to be possibly related to ENGERIX B. Additional details were provided as follows: This case was reported by the site manager. On 17th April 2018, the patient concomitantly received 3rd dose (0.5 mg)of PREVENAR 13 on the right side. At 14:08, the patient received ENGERIX B on the right side. The patient's parent called after hours and reported that the patient experienced a red swollen area where the shot was given, has a runny nose and a rash patch the size of a 50 cent piece, but had no fever.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of pain in arm in an unspecified number of  adult patient's who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The sales representative of other manufacturer called about the new product SHINGRIX and reported that she was just speaking with one of her pharmacists and sharing some data on adverse reactions that could occur post-vaccination. The pharmacist reported that she had been seeing a lot of arm soreness with the SHINGRIX vaccinations. The pharmacist did not name any specific patients and stated that she had been vaccinating quite a few patients and many of them complained about arm soreness. The sales representative did not know the dates of the adverse event. The reported arm soreness she believed occurred recently. She did not have the lot number, NDC, or expiration dates for the vaccines or any product information on hand. She did not know the dose. She believed they would be administered the medication if their doctor recommended it. She did not know the treatment dates. It was verified that she did not know any concomitant medications, other medical conditions, or investigations to report. The sales representative did not have the reporter's email address. The reporter's business details were provided. She did not have any patient identifying data to include initials, date of birth, age, sex, height, weight, or ethnicity. She did not know any of the prescribing physician's information. There was no product complaint to report. There was no medical information request. This case was 1 of the 6 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of pain in arm in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The sales representative of other manufacturer called about the new product SHINGRIX and reported that she was just speaking with one of her pharmacists and sharing some data on adverse reactions that could occur post-vaccination. The pharmacist reported that she had been seeing a lot of arm soreness with the SHINGRIX vaccinations. The pharmacist did not name any specific patients and stated that she had been vaccinating quite a few patients and many of them complained about arm soreness. The sales representative did not know the dates of the adverse event. The reported arm soreness she believed occurred recently. The pharmacist stated that she administered 5 of the vaccines specifically and people were complaining about the arm soreness so she felt this occurred relatively recently. She did not have the lot number, NDC, or expiration dates for the vaccines or any product information on hand. She did not know the dose. She believed they would be administered the medication if their doctor recommended it. She did not know the treatment dates. It was verified that she did not know any concomitant medications, other medical conditions, or investigations to report. The sales representative did not have the reporter's email address. The reporter's business details were provided. She did not have any patient identifying data to include initials, date of birth, age, sex, height, weight, or ethnicity. She did not know any of the prescribing physician's information. There was no product complaint to report. There was no medical information request. This case was 1 of the 6 cases reported by the same reporter.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site induration in a 16-year-old female patient who received the BEXSERO. Concomitant products included MENACTRA. On 16th April 2018, the patient received BEXSERO (intramuscular) .5 ml. In April 2018, 12 hrs after receiving BEXSERO, the patient experienced injection site induration and injection site swelling. On an unknown date, the outcome of the injection site induration and injection site swelling were not recovered/not resolved. The reporter considered the injection site induration and injection site swelling to be almost certainly related to BEXSERO. Additional information was reported as follows: The patient received a dose of BEXSERO on the left deltoid. On 16th April 2018, the patient received MENACTRA on right deltoid. The patient had a 6 by 10 sized raised induration at the injection site. The patient concomitant medication also included unspecified birth control pills. The manufacturer for MENACTRA was reported as non-GlaxoSmithKline.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Influenza vaccine Quadrivalent. The patient's past medical history included surgery (had an operation on her left hand a few weeks before the date of reporting). Concomitant products included Pneumonia Vaccine. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The patient experienced sore arm also after receiving unspecified Pneumonia vaccine. The age at vaccination was not reported. This case has been linked with case US2018065890, reported by the same reporter for the same patient.
Age: 14.0
Sex: M
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Syncope, Unresponsive to stimuli
Clinical narrative: This case was reported by a non-health professional via call center representative and described the occurrence of syncope in a 14-year-old male patient who received BEXSERO (batch number 16D301, expiry date 28th February 2019). On 10th April 2018 16:30, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. On 10th April 2018, immediately after receiving BEXSERO, the patient experienced syncope. In April 2018, the outcome of the syncope was recovered/resolved. The reporter considered the syncope to be almost certainly related to BEXSERO. Additional details were reported as follows: The patient received BEXSERO on left deltoid. Shortly after receiving the vaccine, the patient was unresponsive for a few seconds.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Influenza vaccine Quadrivalent. Concomitant products included Aspirin, Vitamin C, vitamin D and NOS Multivitamin. In August 2017, the patient received Influenza vaccine Quadrivalent (intramuscular). In August 2017, less than a day after receiving Influenza vaccine Quadrivalent, the patient experienced injection site erythema and pain in arm. On an unknown date, the outcome of the injection site erythema and pain in arm were recovered/resolved. The reporter considered the injection site erythema and pain in arm to be related to Influenza vaccine Quadrivalent. Additional information was reported as follows: The patient stated that, she received the flu vaccine; she was not sure which flu vaccine she received. The manufacturer of the vaccine was unknown. The patient reported that, after vaccination, later on the same day, she experienced redness to the size of a dime at the injections site and soreness in her right arm as well. She also reported that the redness and soreness only lasted 2 or 3 days then went away.
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis A antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a adult male patient who received TWINRIX. On an unknown date, the patient received TWINRIX at an unknown dose. On an unknown date, unknown after receiving TWINRIX, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decrease was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to TWINRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received TWINRIX series and reported low titers of Hepatitis (low seroconversion to hepatitis B vaccine).
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Dizziness, Headache
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of headache in a 16-year-old female patient who received BEXSERO. Co-suspect products included HAVRIX and MENVEO. On 16th April 2018, the patient received BEXSERO, HAVRIX and MENVEO. In April 2018, less than a week after receiving BEXSERO, HAVRIX and MENVEO, the patient experienced headache and dizziness. On an unknown date, the outcome of the headache and dizziness were unknown. The reporter considered the headache and dizziness to be unrelated to BEXSERO, HAVRIX and MENVEO. Additional details were provided as follows: The age at vaccination was reported but could be 15 years or 16 years. Exact spelling of nurse's name was not provided.
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; An expired dose of PROQUAD that had no previous temperature excursions, was inadvertently administered to an unspecified patient; This spontaneous report as received from a registered nurse referring to a 5 year old male patient. The patient's concurrent condition included seasonal allergies. The patient was previously vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus v (M-M-R) and varicella virus vaccine live (Oka/Merck) (VARIVAX). On 28-APR-2017 09:00, the patient was inadvertently vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) Human serum albumin (HSA)(lot # L024497, expiry date : 01-JAN-2017), for prophylaxis (expired product administered). On 09-MAY-2017 09:15, the patient was vaccinated with dose 5 of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid(DAPTACEL) from lot C5117AA intramuscular in the right arm and dose 4 of poliovirus vaccine inactivated (vero)(IPOL) from lot L024497 subcutaneous in the right arm; for prophylaxis. Concomitant therapies included sterile diluent(Manufacturer Unknown) (Lot# and expiration date was unknown by the reporter). There was no previous temperature excursions. No adverse effects reported. There was no product quality complaint involved.  This is one of the several reports linked via same reporter link.
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; An expired dose of PROQUAD that had no previous temperature excursions, was inadvertently administered to an unspecified patient; This spontaneous report as received from a registered nurse referring to a 5 year old male patient. The patient's concurrent condition included seasonal allergies. The patient was previously vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus v (M-M-R) and varicella virus vaccine live (Oka/Merck) (VARIVAX). On 09-MAY-2017 09:15 the patient was inadvertently vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) Human serum albumin (HSA)(lot # L024497, expiry date : 01-JAN-2017), for prophylaxis (expired product administered). On 09-MAY-2017 09:15, the patient was vaccinated with dose 5 of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid(DAPTACEL) from lot C5117AA intramuscular in the right arm and dose 4 of poliovirus vaccine inactivated (vero)(IPOL) from lot L024497 subcutaneous in the right arm; for prophylaxis. Concomitant therapies included sterile diluent(Manufacturer Unknown) (Lot# and expiration date was unknown by the reporter). There was no previous temperature excursions. No adverse effects reported. There was no product quality complaint involved.  This is one of the several reports linked via same reporter link.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Two hours after administration I encountered headache, shivering, fever, muscle pain, and nausea.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Type III immune complex mediated reaction
Clinical narrative: Patient came to the pharmacy with significant swelling throughout arm under where shot was administered the day prior. She also had redness which was severely itchy. Pharmacist advised her to go to MD office and MD prescribed Prednisone course for patient and said she should not have any further Pneumonia vaccination as she had an arthus reaction.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Warm, red area just below site of injection that started Friday morning the day after vaccine administration. Site of redness has increased a little in size since Friday and is still warm to the touch.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Impaired work ability, Insomnia, Pain in extremity
Clinical narrative: Patient reports pain in both thumbs, both wrists, both rotator cuffs, back, both thighs near groin and both hip bone areas. Patient has a history of bilateral torn rotator cuffs. Patients reports no decrease in pain since vaccine administration. Patient has been suffering from pain since the vaccine administration, difficulty sleeping and working due to pain.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Tendon pain
Clinical narrative: Patient reports pain in both thumbs, both wrists, both rotator cuffs, back, both thighs near groin and both hip bone areas. Patient has a history of bilateral torn rotator cuffs. Patients reports no decrease in pain since vaccine administration. Patient has been suffering from pain since the vaccine administration, difficulty sleeping and working due to pain.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Myalgia, Pyrexia
Clinical narrative: Patient reports diarrhea, fever, chills, systemic muscle aches. Beginning the morning after vaccination. Referred to primary care doctor if symptoms persisted or became more severe.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever 100 degrees, sore arm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Discomfort, Fatigue, Injection site pain
Clinical narrative: Soreness at site of infection for about 5 days. The first night I had muscle aches, discomfort and couldn't sleep. The second night I had those same symptoms plus chills. Continued to feel extremely fatigued, no appetite, slightly queasy and aching for 7 days. ON THE FIRST NIGHT I EXPERIENCED THE SENSATION OF A MAJOR FEVER BLISTER OUTBREAK AND TOOK VALACYCLOVIR. DID NOT GET THE FEVER BLISTERS BUT AM CONCERNED THAT THIS MEDICATION ENHANCED MY REACTION AND REDUCED EFFECT OF VACCINE.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia, Nausea, Pain, Sensory disturbance
Clinical narrative: Soreness at site of infection for about 5 days. The first night I had muscle aches, discomfort and couldn't sleep. The second night I had those same symptoms plus chills. Continued to feel extremely fatigued, no appetite, slightly queasy and aching for 7 days. ON THE FIRST NIGHT I EXPERIENCED THE SENSATION OF A MAJOR FEVER BLISTER OUTBREAK AND TOOK VALACYCLOVIR. DID NOT GET THE FEVER BLISTERS BUT AM CONCERNED THAT THIS MEDICATION ENHANCED MY REACTION AND REDUCED EFFECT OF VACCINE.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Crying, Full blood count normal, Irritability, Urine analysis normal
Clinical narrative: Extreme fussiness and extended crying periods, temperature of 100 rectally. Began afternoon on day of vaccines and lasted 4 days.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: High temperature. Day 1, 100.6; day 2, 99.5, day 3, 99.7 day 4, 98.5. A general feeling of aches and pains. The first day, I actually went to bed. A heating pad was placed on arm, neck and shoulder for the subsequent four days.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: High temperature. Day 1, 100.6; day 2, 99.5, day 3, 99.7 day 4, 98.5. A general feeling of aches and pains. The first day, I actually went to bed. A heating pad was placed on arm, neck and shoulder for the subsequent four days.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The injection site got swollen and red 2 days post administration of vaccine. Patient was instructed to put ice and take TYLENOL for mild to moderate pain.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia, Nuclear magnetic resonance imaging brain, Pain, Pyrexia
Clinical narrative: SEVERE DOUBLE VISION, TEMPERATURE, FEVER & BODY ACHE.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Laboratory test normal, Ultrasound antenatal screen
Clinical narrative: LMP per patient first week of March 2018. No pregnancy testing done prior to immunization. Ultrasound done on 4/2/2018 shows a 5 5/7 weeks pregnancy - making her 3 weeks and 5 days at the time of immunization. Her EDC is Nov 27, 2018.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Eye pain, Limb discomfort, Pain, Pain in extremity
Clinical narrative: Vaccine was given on Sunday, April 22, 2018. Sunday evening, patient began to develop a fever and body hurt...her eye(s) also began hurting. She reported feeling achy with no energy and her left arm was very sore and felt very heavy, like she couldn't lift it. On Monday night, she noticed a rash all over her body of fine, little dots. These spots were/are very itchy! On Tuesday, patient contacted the prescriber and was instructed to take BENADRYL to help with itchy rash. It has been close to a week now and the rash has not resolved on its own.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: Vaccine was given on Sunday, April 22, 2018. Sunday evening, patient began to develop a fever and body hurt...her eye(s) also began hurting. She reported feeling achy with no energy and her left arm was very sore and felt very heavy, like she couldn't lift it. On Monday night, she noticed a rash all over her body of fine, little dots. These spots were/are very itchy! On Tuesday, patient contacted the prescriber and was instructed to take BENADRYL to help with itchy rash. It has been close to a week now and the rash has not resolved on its own.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: Patient came to the pharmacy with a discharge letter stating that she was diagnosed with Left sided Bell's Palsy. The doctor had not indicated whether or not this diagnosis was a direct outcome of the vaccination. She went to the emergency room with her face numb and drooping. No further information was provided to me aside from the discharge diagnosis. No labs were provided either.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient reports it was too painful to raise arm above shoulder height. Pain started the night of vaccine administration and started to subside two days later. Patient stated it has resolved.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Loss of consciousness, Nausea, Seizure, Syncope
Clinical narrative: Patient experienced nausea, lightheadedness, fainting, seizure, loss of consciousness.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Caesarean section, Cyanosis, Foetal exposure during pregnancy
Clinical narrative: The baby was born via emergency C-section; however, she was healthy. My mother repeatedly during our 5 day stay and even I as a nurse questioned the nurses about a bluish tinge around my newborns mouth. The nurses all responded with "That's normal for her age".