chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Bronchitis, Laboratory test
Clinical narrative: This spontaneous report was received from a currently 69 year old male patient reporting on himself. The patient's medical history included a prostate condition. It was also reported, the patient takes other unspecified concomitant medications. No information was provided regarding the patient's drug reactions/allergies. On 29-JUN-2014, the patient had a drilled splinter in his hand, therefore he was taken to the emergency room of an unspecified hospital. As a result he was vaccinated with PNEUMOVAX 23, lot # K004930, expiration date 06-MAR-2015 for prophylaxis (dose and route of administration were not reported). In November 2018, the patient developed bronchitis, and subsequently was treated and recovered. On an unknown date, laboratory test and blood work were performed. On an unspecified date in March 2019, also reported as (now), the patient experienced bronchitis symptoms again and was inquiring on re-vaccination as he felt the PNEUMOVAX 23 was preventive in not allowing him to get Pneumonia, "flu", or more serious illness. At the time of the report, the patient had not recovered from bronchitis. The causal relationship between the event and therapy with PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 26-SEP-2018, the patient was vaccinated with PEDVAXHIB (lot # N003698 with expiry date 31-OCT-2019, dose, strength, route, vaccination site unspecified) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 47 degrees Fahrenheit (53.37 F) for 3 hours and 46 minutes, as recorded by a data logger. No previous temperature excursion. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010362: Original Case: 1903USA004795; US-009507513-1903USA010363: Original Case: 1903USA004795; US-009507513-1903USA010364: Original Case: 1903USA004795; US-009507513-1903USA010361: Original Case: 1903USA004795; US-009507513-1903USA010360: Original Case: 1903USA004795; US-009507513-1903USA010365: Original Case: 1903USA004795; US-009507513-1903USA004795: Original Case: 1903USA004795; US-009507513-1903USA010359: Original Case: 1903USA004795.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: his spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 01-OCT-2018, the patient was vaccinated with PEDVAXHIB (lot # N003698 with expiry date 31-OCT-2019, dose, strength, route, vaccination site unspecified) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 47 degrees Fahrenheit (53.37 F) for 3 hours and 46 minutes, as recorded by a data logger. No previous temperature excursion. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010362: Original Case: 1903USA004795; US-009507513-1903USA010363: Original Case: 1903USA004795; US-009507513-1903USA010364: Original Case: 1903USA004795; US-009507513-1903USA010361: Original Case: 1903USA004795; US-009507513-1903USA010360: Original Case: 1903USA004795; US-009507513-1903USA010365: Original Case: 1903USA004795; US-009507513-1903USA010358: Original Case: 1903USA004795; US-009507513-1903USA004795: Original Case: 1903USA004795.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 22-OCT-2018, the patient was vaccinated with PEDVAXHIB (lot # N003698 with expiry date 31-OCT-2019, dose, strength, route, vaccination site unspecified) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 47 degrees Fahrenheit (53.37 F) for 3 hours and 46 minutes, as recorded by a data logger. No previous temperature excursion. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010362: Original Case: 1903USA004795; US-009507513-1903USA010363: Original Case: 1903USA004795; US-009507513-1903USA010364: Original Case: 1903USA004795; US-009507513-1903USA010361: Original Case: 1903USA004795; US-009507513-1903USA010365: Original Case: 1903USA004795; US-009507513-1903USA010358: Original Case: 1903USA004795; US-009507513-1903USA010359: Original Case: 1903USA004795.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 24-OCT-2018, the patient was vaccinated with PEDVAXHIB (lot # N003698 with expiry date 31-OCT-2019, dose, strength, route, vaccination site unspecified) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 47 degrees Fahrenheit (53.37 F) for 3 hours and 46 minutes, as recorded by a data logger. No previous temperature excursion. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010362: Original Case: 1903USA004795; US-009507513-1903USA010363: Original Case: 1903USA004795; US-009507513-1903USA010364: Original Case: 1903USA004795; US-009507513-1903USA004795: Original Case: 1903USA004795; US-009507513-1903USA010360: Original Case: 1903USA004795; US-009507513-1903USA010365: Original Case: 1903USA004795; US-009507513-1903USA010358: Original Case: 1903USA004795; US-009507513-1903USA010359: Original Case: 1903USA004795.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 12-DEC-2018, the patient was vaccinated with PEDVAXHIB (lot # N003698 with expiry date 31-OCT-2019, dose, strength, route, vaccination site unspecified) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 47 degrees Fahrenheit (53.37 F) for 3 hours and 46 minutes, as recorded by a data logger. No previous temperature excursion. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA004795: Original Case: 1903USA004795; US-009507513-1903USA010363: Original Case: 1903USA004795; US-009507513-1903USA010364: Original Case: 1903USA004795; US-009507513-1903USA010361: Original Case: 1903USA004795; US-009507513-1903USA010360: Original Case: 1903USA004795; US-009507513-1903USA010365: Original Case: 1903USA004795; US-009507513-1903USA010358: Original Case: 1903USA004795; US-009507513-1903USA010359: Original Case: 1903USA004795.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored VAQTA (lot # R018935, expiration date 05-SEP-2019; dose was unknown) intramuscularly for prophylaxis. The storage temperature of the vaccine was reported as 0.4 degrees Celsius for a time frame of 40 minutes. There was no previous temperature excursion. No adverse effect was reported. No product quality complaint (PQC) was involved. The call was due to a data logger.
Sex: M
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging, Pain, X-ray
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received both doses of SHINGRIX and at the time of reporting the patient experienced pain that lasted for several months to the point that they received both a MRI and X-RAY. It was unknown if the patient experienced pain after receiving the 1st dose or 2nd dose of SHINGRIX. No other resolution or details were provided.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Dizziness, Injection site pain, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tremor in a 82-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on unknown date). On 11th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced tremor, general body pain, diarrhea, movement disorder, weakness, difficulty sleeping, injection site pain and dizziness. On an unknown date, the outcome of the tremor, general body pain, diarrhea, movement disorder, weakness, difficulty sleeping, injection site pain and dizziness were recovered/resolved. It was unknown if the reporter considered the tremor, general body pain, diarrhea, movement disorder, weakness, difficulty sleeping, injection site pain and dizziness to be related to SHINGRIX. Additional case details were provided as follows: The patient received the dose of SHINGRIX in his left arm. The patient had experienced shakiness all over the body, body ache, diarrhea, trouble moving, weakness, trouble sleeping, pain at injection site and dizziness. All of this symptoms lasted for about 4 days and he has now recovered. The reporter has been given consent for follow up. This case has been linked to US2019047144 reported by same reporter (Husband).
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Movement disorder, Pain, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tremor in a 82-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on unknown date). On 11th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced tremor, general body pain, diarrhea, movement disorder, weakness, difficulty sleeping, injection site pain and dizziness. On an unknown date, the outcome of the tremor, general body pain, diarrhea, movement disorder, weakness, difficulty sleeping, injection site pain and dizziness were recovered/resolved. It was unknown if the reporter considered the tremor, general body pain, diarrhea, movement disorder, weakness, difficulty sleeping, injection site pain and dizziness to be related to SHINGRIX. Additional case details were provided as follows: The patient received the dose of SHINGRIX in his left arm. The patient had experienced shakiness all over the body, body ache, diarrhea, trouble moving, weakness, trouble sleeping, pain at injection site and dizziness. All of this symptoms lasted for about 4 days and he has now recovered. The reporter has been given consent for follow up. This case has been linked to US2019047144 reported by same reporter (Husband).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 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 group was not reported but was selected as an adult as per vaccine indication. The patient developed shingles after a SHINGRIX injection (further information on number of doses administered is unknown). The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Inflammation, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever, myalgia and inflammatory reaction. On an unknown date, the outcome of the fever, myalgia and inflammatory reaction were unknown. It was unknown if the reporter considered the fever, myalgia and inflammatory 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 it was selected as adult as per the vaccine indication. The physician reported that the patients have experienced fever and myalgia when using SHINGRIX. The reporter asked was it recommended that the patients be revaccinated with SHINGRIX 5 to 10 years after the initial series. The reporter asked did the patients that develop a more robust inflammatory response with SHINGRIX (fever, myalgia) tend to develop the most effective immune protection.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 61-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. On 8th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site swelling and injection site discoloration. On an unknown date, the outcome of the injection site swelling and injection site discoloration were recovered/resolved. It was unknown if the reporter considered the injection site swelling and injection site discoloration to be related to SHINGRIX. Additional details were provided as follows: The pharmacist had a consumer that experienced significant swelling at the injection site that lasted for two weeks after receiving the first dose of the SHINGRIX vaccine into the right deltoid. After that, the injection site was somewhat discolored for about one month. The pharmacist did not provide the consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a adult female patient who received SHINGRIX for prophylaxis. On 12th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2019, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site allergic reaction. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site allergic reaction were not recovered/not resolved. The reporter considered the injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported the case on behalf of the patient. The age at vaccination was not reported. The patient never had chickenpox but the health care professional recommended her to receive the SHINGRIX. The patient received SHINGRIX on an unknown arm. The patient had redness, swelling and a lot of itching at the injection site. On 15th March 2019, the patient reported that the itching was severe and she probably should have contacted the pharmacist sooner regarding these symptoms. The pharmacist advised her to contact her health care professional for evaluation of the itching. There was no associated PQC (product quality complaint). The local and general adverse reactions were reviewed with the pharmacist, who also had a copy of the PI (package insert) for SHINGRIX. The pharmacist would reach out to the patient again to have her contact with physician for possible allergic reaction to the vaccine.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by an other health professional via call center representative and described the occurrence of fever in a 75-year-old male patient who received SHINGRIX (batch number L7SY9, expiry date 4th July 2021) for prophylaxis. On 13th March 2019, the patient received the 1st dose of SHINGRIX. On 13th March 2019, less than a day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: On 13th March 2019, the patient experienced fever of 100 F after the SHINGRIX 1st dose.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of general body pain in a adult patient who received 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 general body pain and leg pain. On an unknown date, the outcome of the general body pain was recovered/resolved and the outcome of the leg pain was unknown. It was unknown if the reporter considered the general body pain and leg pain 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 it was selected as an adult as per the vaccine indication. The physician reported that the patient had body aches for one week after receiving SHINGRIX immunization. The patient also experienced leg pain.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case is linked to cases 2019SA077925 and 2019SA077907, same reporter. This case involves a 4 years old female patient who received vaccine IPOL. The patient's past medical history, concomitant medication and family history were not provided. On 01-Mar-2019, the patient received injection of suspect IPV (VERO) lot number, expiry date not reported via unknown route in unknown administration site. It was an actual medication error due to product storage error. It was reported that there was a power outage and the opened MDV IPOL vaccine was administered to patient that reached a temperature of 34-33 degrees F. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
Age: 3.0
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case is linked to cases 2019SA077920 and 2019SA077907, same reporter. This case involves a 4 years old female patient who received vaccine IPOL. The patient's past medical history, concomitant medication and family history were not provided. On 15-Feb-2019, the patient received injection of suspect IPV (VERO) lot number-N1J451M, expiry 05-Oct-2019 via unknown route in unknown administration site. It was an actual medication error due to product storage error. It was reported that there was a power outage and the opened MDV IPOL vaccine was administered to patient that reached a temperature of 34-33 degrees F. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose normal, Dizziness, Immediate post-injection reaction
Clinical narrative: Pt was fine immediately after vaccine so waiting to leave in waiting room. Pt's mother reports that she then became dizzy and felt as if she'd faint. Pt was then brought back to exam room via wheelchair,  layed down on exam table, feet propped up, checked her sugar, given a cold wash cloth to put on the forehead. Pt did have a sugar of 86 and given crackers and gatorade at this time. Pt started to feel better around 20 minutes after the episode.
Sex: U
Vaccine: HEP, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous, non-valid report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot# R007212, expiration date: 04-NOV-2020) (route of administration not provided), M-M-R II (N011005, expiration date: 05-APR-2019, therapy type: rHA) (route of administration not provided) and ROTATEQ (lot# R016791, expiration date: 16-APRP-2020, orally) (exact doses were not reported for any vaccine). M-M-R II, was reconstituted with properly stored sterile diluent. There was no adverse effects reported. Administered doses of vaccines experienced the lowest temperature excursion below 36 degrees Fahrenheit (F) (also reported as 35.2 F) for 41 minutes and the highest temperature above 47 F (also reported 47.4) for 17 minutes. Digital Data Logger was involved. There was no previous temperature excursion reported. This is a non-valid report due to lack of the patients' identifiers.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. The patient was treated with antibiotics. On an unknown date, the outcome of the injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional information was provided as follows: The reporting nurse was the patient. The age at vaccination was not reported. The patient received dose of SHINGRIX a few weeks before the reporting date and had a bad reaction. The patient said that the area where the injection was given got very red and swollen so much that she needed to be given an antibiotic. The reporter did not consent to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Asthenia, Condition aggravated, Fatigue, Heart rate increased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rheumatoid arthritis aggravated in a 53-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. The patient's past medical history included cancer. Concurrent medical conditions included rheumatoid arthritis. On 13th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 14th March 2019, 1 days after receiving SHINGRIX, the patient experienced rheumatoid arthritis aggravated (serious criteria GSK medically significant), fatigue, heart rate increased, arthritis, sleepiness, weakness and blistering of mouth. On an unknown date, the outcome of the rheumatoid arthritis aggravated, fatigue, heart rate increased, arthritis, sleepiness, weakness and blistering of mouth were unknown. It was unknown if the reporter considered the rheumatoid arthritis aggravated, fatigue, heart rate increased, arthritis, sleepiness, weakness and blistering of mouth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The patient called and reported that, she was experiencing fatigue, weakness, increased heart rate, rheumatoid arthritis symptoms, painful arthritis, blisters in her mouth and sleepiness. The patient also stated that, she had cancer and rheumatoid arthritis in the past and has never felt like this before. No further details were provided.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal blistering, Rheumatoid arthritis, Somnolence
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rheumatoid arthritis aggravated in a 53-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. The patient's past medical history included cancer. Concurrent medical conditions included rheumatoid arthritis. On 13th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 14th March 2019, 1 days after receiving SHINGRIX, the patient experienced rheumatoid arthritis aggravated (serious criteria GSK medically significant), fatigue, heart rate increased, arthritis, sleepiness, weakness and blistering of mouth. On an unknown date, the outcome of the rheumatoid arthritis aggravated, fatigue, heart rate increased, arthritis, sleepiness, weakness and blistering of mouth were unknown. It was unknown if the reporter considered the rheumatoid arthritis aggravated, fatigue, heart rate increased, arthritis, sleepiness, weakness and blistering of mouth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The patient called and reported that, she was experiencing fatigue, weakness, increased heart rate, rheumatoid arthritis symptoms, painful arthritis, blisters in her mouth and sleepiness. The patient also stated that, she had cancer and rheumatoid arthritis in the past and has never felt like this before. No further details were provided.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Immediate pain at injection site which progressively became more sore as the day went on. Pain started spreading to entire arm. By 6:00pm started experiencing headache, chills, low grade fever, tiredness which lasted until the next morning at about 8:00am. Pain in the arm persisted and the injection started started to swell and redden. Redness at injection site continues to expand but pain and swelling has decreased 72 hours later.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Immediate pain at injection site which progressively became more sore as the day went on. Pain started spreading to entire arm. By 6:00pm started experiencing headache, chills, low grade fever, tiredness which lasted until the next morning at about 8:00am. Pain in the arm persisted and the injection started started to swell and redden. Redness at injection site continues to expand but pain and swelling has decreased 72 hours later.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Muscle spasms, Pain
Clinical narrative: Arm severely sore by 5:00 pm on Friday 3/22/2019. Body aches and muscle cramps by night. Temp 100.4 w/chills. Fatigue and soreness all weekend. Took Ibuprofen on Friday and Saturday for pain. Rested all day Sunday.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm severely sore by 5:00 pm on Friday 3/22/2019. Body aches and muscle cramps by night. Temp 100.4 w/chills. Fatigue and soreness all weekend. Took Ibuprofen on Friday and Saturday for pain. Rested all day Sunday.
Age: 33.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Chills, Diarrhoea
Clinical narrative: Chills, weakness, diarrhea.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Induration, Nodule, Skin warm
Clinical narrative: 3/22/19 admin time 1515 - noticed @ 0200 on 3/23/19 small hard knot, progressed to 70 mm x 130 mm round, raised, swollen, warm to touch area. Also noticed fatigue and headache for at least 24 hours after vaccine admin.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: 3/22/19 admin time 1515 - noticed @ 0200 on 3/23/19 small hard knot, progressed to 70 mm x 130 mm round, raised, swollen, warm to touch area. Also noticed fatigue and headache for at least 24 hours after vaccine admin.
Sex: U
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 07-MAR-2019, the patient was vaccinated with improperly stored GARDASIL 9 (via intramuscular, lot #: R020948, expiration date: 04-MAY-2021; strength and anatomical location were not reported) for prophylaxis. No adverse effect was reported. The GARDASIL 9 was exposed to 31.6 degree Fahrenheit for 40 minutes and 47.8 degree Fahrenheit for 20 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA006961: US-009507513-1903USA006952: US-009507513-1903USA006953: US-009507513-1903USA006954: US-009507513-1903USA006955: US-009507513-1903USA006956: US-009507513-1903USA006957: US-009507513-1903USA006958: US-009507513-1903USA006959: US-009507513-1903USA006960: US-009507513-1903USA006285.
Sex: M
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a male patient of unspecified age reporting on himself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, injection (dose number, exact dose, route of administration, administration site, lot # and expiration date were not provided) for prophylaxis. It was reported that the patient had an unspecified extreme reaction to PNEUMOVAX 23 and almost died. The outcome of the event was not provided. The reporter considered the event to be related to the suspect therapy.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 12-DEC-2018, the patient was vaccinated with PEDVAXHIB (lot # N003698 with expiry date 31-OCT-2019, dose, strength, route, vaccination site unspecified) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 47 degrees Fahrenheit (53.37 F) for 3 hours and 46 minutes, as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010362: Original Case: 1903USA004795; US-009507513-1903USA004795: Original Case: 1903USA004795; US-009507513-1903USA010364: Original Case: 1903USA004795; US-009507513-1903USA010361: Original Case: 1903USA004795; US-009507513-1903USA010360: Original Case: 1903USA004795; US-009507513-1903USA010365: Original Case: 1903USA004795; US-009507513-1903USA010358: Original Case: 1903USA004795; US-009507513-1903USA010359: Original Case: 1903USA004795.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Feeling abnormal, Injected limb mobility decreased, Injection site streaking, Vaccination complication
Clinical narrative: Patient's mother called into the office on 3/20/19, states that after immunization in the evening on 3/19/19 patient reported that affected arm felt "weird." Patient presented to school nurse on 3/20/19 with complaints that he cannot move Left arm well, cannot lift it up per report. School nurse evaluated area and called mother to report that there was a red streak from the presumed injection site on Left arm going towards Left armpit. Patient did not have a fever/chills. Patient's mother was encouraged to bring patient for evaluation due to nature of possible reaction. Patient's mother reports that patient went to a local urgent care facility on 3/20/19 and an infection was ruled out, was told that it was a reaction to vaccine. This office called mother on 3/21/19 for follow up, and mother declined need for further evaluation. Some improvement but not full resolution of symptoms at that time.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Injection site erythema, Injection site pain, Pain
Clinical narrative: Patient said she woke up in the night of 3/22/19 and ached from her neck to her toes, even her elbows. She felt chilled and felt like she needed more clothes on. She said Friday, 3/22/19 was a bad day, she didn't do much of anything. Saturday, 3/23/19 she felt better but still not right. She had redness at injection site and it is still sore today, 3/25/19 when I spoke to her on the phone.
Age: 94.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Feeling cold, Loss of personal independence in daily activities, Pain
Clinical narrative: On the evening of 3/21/19 patient was very cold and had chills. In the early morning of 3/22/19 she woke up and was very sore, all over and did not feel good all through the day. She didn't leave the house or do her normal activities. Saturday, 3/23/19 felt better but still not right.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Angioedema, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: Patient reported diarrhea, headache, fever, chills, muscle pain throughout body, nausea, tightening of throat, and angioedema of bottom lip.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pyrexia, Throat tightness
Clinical narrative: Patient reported diarrhea, headache, fever, chills, muscle pain throughout body, nausea, tightening of throat, and angioedema of bottom lip.
Sex: U
Vaccine: HPV9, MMR, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, PNEUMOVAX 23 and M-M-R II (doses, lot numbers, expiration dates, routes of administration were not provided for any vaccine). The vaccines were reconstituted with properly stored (reported as properly) sterile diluent. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 1.1 degrees Celsius for 37 minutes. Digital Data Logger was involved. There was no previous excursion.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX (batch number L7SY9, expiry date 4th July 2019) for prophylaxis. On 13th March 2019, the patient received SHINGRIX .5 ml. On 14th March 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain and shivering. On 15th March 2019, the patient experienced injection site erythema, injection site warmth and injection site induration. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth and injection site induration were recovering/resolving and the outcome of the shivering was recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, shivering, injection site warmth and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The patient received Shingrix in the left arm. Two days after receiving vaccination, the day of reporting the injection site area was red, warm and felt a little hard. The lot number was from the vial. The reporter had discarded the box. The reporter gave consent to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Pain in extremity
Clinical narrative: Patient said her arm was sore and redness which had grown from a penny size to a quarter size. Wasn't feeling well either - tired. MD is informed and will call us back with any updates.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, X-ray limb
Clinical narrative: Shoulder pain at injection site. Patient noticed worsening two weeks after injection. Has been chronic, not resolving.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Injection site erythema, Rash
Clinical narrative: 1 cm red around injection site in all 4 areas vaccines given. Rash on face and forehead also noted - BENADRYL administered pt observed for 25 minutes.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Gait disturbance, Headache
Clinical narrative: Bruising and swelling at injection site for 1 week headache, nausea, high fever/chills severe joint pain, difficulty walking weakness; symptoms lasted for 4 days. Still some soreness in muscles.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site swelling, Myalgia, Nausea, Pyrexia
Clinical narrative: Bruising and swelling at injection site for 1 week headache, nausea, high fever/chills severe joint pain, difficulty walking weakness; symptoms lasted for 4 days. Still some soreness in muscles.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Headache, Injection site bruising, Injection site pain
Clinical narrative: Bruising at injection site, pain at injection site, swelling at injection site, headache, muscle pain, fever, severe dizziness, and fainting. Also had severe joint pain.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Pyrexia, Syncope
Clinical narrative: Bruising at injection site, pain at injection site, swelling at injection site, headache, muscle pain, fever, severe dizziness, and fainting. Also had severe joint pain.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Injection site urticaria
Clinical narrative: She reported that hives occurred at the injection site the day after the vaccine was administered. No respiratory response.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Feeling abnormal, Injection site pain, Rash, Scab
Clinical narrative: On the same evening of my first Zoster shot, it made a small sore in the center of my chest, above the breast area. The next day the sore dried up and became a scab, which went away. From the first injection/shot on 06/27/2018, until this day, my left upper arm is still sore and hurts a lot.  Sometimes I feel like I'm about to have a heart attack, and experienced short of breath.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: At 3:00pm on March 20, 2019 began to feel extremely tired, slight headache and nausea then chills. Took 2 TYLENOL and laid down for several hours headache and nausea went away. Continued to feel chilled and tired. Went to bed earlier then normal. Upon awakening in the morning I felt fine.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Urticarial like rash.
Age: 52.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Chills, Malaise, Pyrexia, Rash papular
Clinical narrative: Fever 102, chills, malaise, papular rash on ankles (Also given PREVNAR at the same time).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Areflexia, Blood test normal, Burning sensation, Chills, Guillain-Barre syndrome
Clinical narrative: The night after her second shingle injection she had generalized aching and chills. Within 24 hours she developed tight burning tingling paresthesias in her lower extremities, over the next 2 weeks spreading to the upper extremities as well. No weakness, but she became areflexic. Had difficulty working because of pain. Widespread painful numb tingling burning paresthesias. Didn't respond much to our best symptomatic medications, and only modest response to prednisone. Gamma globulin infusions were started in November 2018 and an almost immediate robust resolution of her paresthesias, and return of deep tendon reflexes. Gamma globulin infusions were continued until March. At this point asymptomatic, and the treatment discontinued. My impression that of an acute post immunization inflammatory neuropathy, a variant of Guillain-Barré syndrome affecting primarily sensory nerves, especially sensory nerve terminals. Triggered by the second dose of SHINGRIX. My office notes provide more detail.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Impaired work ability, Nerve conduction studies abnormal, Pain
Clinical narrative: The night after her second shingle injection she had generalized aching and chills. Within 24 hours she developed tight burning tingling paresthesias in her lower extremities, over the next 2 weeks spreading to the upper extremities as well. No weakness, but she became areflexic. Had difficulty working because of pain. Widespread painful numb tingling burning paresthesias. Didn't respond much to our best symptomatic medications, and only modest response to prednisone. Gamma globulin infusions were started in November 2018 and an almost immediate robust resolution of her paresthesias, and return of deep tendon reflexes. Gamma globulin infusions were continued until March. At this point asymptomatic, and the treatment discontinued. My impression that of an acute post immunization inflammatory neuropathy, a variant of Guillain-Barré syndrome affecting primarily sensory nerves, especially sensory nerve terminals. Triggered by the second dose of SHINGRIX. My office notes provide more detail.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: The night after her second shingle injection she had generalized aching and chills. Within 24 hours she developed tight burning tingling paresthesias in her lower extremities, over the next 2 weeks spreading to the upper extremities as well. No weakness, but she became areflexic. Had difficulty working because of pain. Widespread painful numb tingling burning paresthesias. Didn't respond much to our best symptomatic medications, and only modest response to prednisone. Gamma globulin infusions were started in November 2018 and an almost immediate robust resolution of her paresthesias, and return of deep tendon reflexes. Gamma globulin infusions were continued until March. At this point asymptomatic, and the treatment discontinued. My impression that of an acute post immunization inflammatory neuropathy, a variant of Guillain-Barré syndrome affecting primarily sensory nerves, especially sensory nerve terminals. Triggered by the second dose of SHINGRIX. My office notes provide more detail.
Age: 17.0
Sex: F
Vaccine: FLUC4, MENB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red raised 2 inch radius around injection site to Right Deltoid from Influenza vaccine. Skin warm to touch, and reddened, no bruising, swelling, or excudate from site.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, X-ray limb
Clinical narrative: Arm has hurt since shot. The pain is progressively worse.  It hurts almost all of the time.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: Muscles cramping. Constant movement of muscle in arm, mid drift and legs - on going. Diagnosed by Dr.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: Patient stated that in the evening after her vaccine that her arm started to bother her. When she woke up the next morning her arm was red, painful and swollen. She reported this to the pharmacy and it was recommended that she see a physician. She was seen by the physician listed above in number 14.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Gait disturbance
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 9-year-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unspecified date in February 2019 (reported as last week), the patient was vaccinated with GARDASIL 9 injection (dose, route of administration, vaccination site, lot # and expiration date were not provided) for prophylaxis. On an unspecified date in February 2019 (also rpeorted as the following day after vaccination), the patient had difficulty walking. The patient sought medical attention and was seen by the physician. She advised the farther to take the child to the emergency room. The physician reported that there was no follow-up from the father. The outcome of the event was unknown at the time of the report. The causality assessment between the event and the suspect vaccine was not provided.