chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female 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 adverse reaction. SHINGRIX was discontinued. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient's husband. The age at vaccination was not reported. The patient experienced adverse effects and was hesistant to receive the 2nd dose of SHINGRIX. The case was linked with cases US2019023148 and US2019GSK027918 (husband's cases).
Sex: U
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergy in a patient who received FLUARIX QUADRIALENT (2018-2019 season) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIALENT 2018-2019 season, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown. It was unknown if the reporter considered the allergy to be related to FLUARIX QUADRIALENT t 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that the patient reported allergy after receiving FLUARIX. The reporter did not have patient demographics, lot number and expiration date or the specific symptoms that were experienced by the patient. The reporter stated that the patient was consulting an allergist.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Limb discomfort, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 8th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 8th March 2019, less than a day after receiving SHINGRIX, the patient experienced fever, headache, shooting pain, chills, weakness, fatigue and pain in extremity. On an unknown date, the outcome of the fever, headache, shooting pain and chills were recovered/resolved and the outcome of the weakness, fatigue and pain in extremity were not recovered/not resolved. The reporter considered the fever, headache, shooting pain, chills, weakness, fatigue and pain in extremity to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient received a dose of SHINGRIX in the left deltoid. The patient stated that starting the evening of vaccination, she had fever, headache, shooting pain and aching in her legs, chills, weakness, fatigue and a sore arm for that night and all next day. In March 2019, all the events had resolved except the weakness, fatigue. At the time of this report, the patient's arm was still sore. The patient provided the consent for follow up and stated that she had an appointment to see her doctor.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 8th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 8th March 2019, less than a day after receiving SHINGRIX, the patient experienced fever, headache, shooting pain, chills, weakness, fatigue and pain in extremity. On an unknown date, the outcome of the fever, headache, shooting pain and chills were recovered/resolved and the outcome of the weakness, fatigue and pain in extremity were not recovered/not resolved. The reporter considered the fever, headache, shooting pain, chills, weakness, fatigue and pain in extremity to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient received a dose of SHINGRIX in the left deltoid. The patient stated that starting the evening of vaccination, she had fever, headache, shooting pain and aching in her legs, chills, weakness, fatigue and a sore arm for that night and all next day. In March 2019, all the events had resolved except the weakness, fatigue. At the time of this report, the patient's arm was still sore. The patient provided the consent for follow up and stated that she had an appointment to see her doctor.
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of swelling in a 74-year-old female patient who received BOOSTRIX for prophylaxis. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were unknown. It was unknown if the reporter considered the swelling and erythema to be related to BOOSTRIX. Additional case details were provided as follows: The age at vaccination was not reported. The patient received a BOOSTRIX (Tdap vaccine) and had significant swelling and redness. On call with health care professional, the patient stated that about prior reaction due to electronic medical record (EMR) warning when SHINGRIX was order (has not been administered). The brand name and batch number of the GSK Tdap were unavailable but health care professional stated it was a GSK Tdap, agent filing conservatively as BOOSTRIX.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received SHINGRIX (batch number 353S5, expiry date 29th May 2021) for prophylaxis. On 8th February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional case details were provided as follows: The patient received the dose of SHINGRIX in left deltoid and experienced left arm soreness. According to sale data sheet, the batch number was updated to 353S5 from 3535S.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysuria, Urinary tract infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of painful urination in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 10th March 2019, the patient received the 2nd dose of SHINGRIX. On 10th March 2019, less than a day after receiving SHINGRIX, the patient experienced painful urination and urinary tract infection. On an unknown date, the outcome of the painful urination and urinary tract infection were resolved with sequelae. It was unknown if the reporter considered the painful urination and urinary tract infection to be related to SHINGRIX. Additional details were provided as follows: The patient got her 2nd dose of SHINGRIX on Sunday. During the night she started having pain during urination. She saw a physician on Monday and was diagnosed with a urinary tract infection and started on an antibiotic. She was feeling better now.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Testicular pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of abdominal pain in a 50-year-old male patient who received SHINGRIX (batch number LL552, expiry date 20th May 2021) for prophylaxis. On 12th March 2019, the patient received SHINGRIX (intramuscular). On 12th March 2019, less than a day after receiving SHINGRIX, the patient experienced abdominal pain and testicular pain. On an unknown date, the outcome of the abdominal pain and testicular pain were unknown. It was unknown if the reporter considered the abdominal pain and testicular pain to be related to SHINGRIX. Additional information were provided as follows: The patient began to experience severe abdominal pain as well as testicular pain. The batch number was changed from ii552 to LL552, as per sales data sheet.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 75-year-old female patient who received SHINGRIX (batch number 353S5, expiry date 29th May 2021) for prophylaxis. On 10th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th February 2019, 10 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX into the left deltoid.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling of elbows in a 83-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling of elbows, swelling arm, burning sensation, pruritus and hives. The patient was treated with triamcinolone acetonide, benzalconium chloride, salicylic acid. On an unknown date, the outcome of the swelling of elbows, swelling arm, burning sensation, pruritus and hives were not recovered/not resolved. It was unknown if the reporter considered the swelling of elbows, swelling arm, burning sensation, pruritus and hives to be related to SHINGRIX. Additional details were provided as follows: The reporter reported on behalf of his wife. After receiving SHINGRIX, the patient experienced swelling of elbows, swelling arm, burning sensation, pruritus and hives. The patient went to a dermatologist and was prescribed Triamcinolone but it was not relieving her symptoms. The reporter was going to have her try an Antihistamine next.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ringing in ears in a 55-year-old male patient who received SHINGRIX for prophylaxis. On 27th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 8th March 2019, the dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was not recovered/not resolved. It was unknown if the reporter considered the ringing in ears to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient could not recall when the event began but believed it was at least 6 weeks ago. Did not consent to follow up. The patient did not want to provide his physician contact information.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, myalgia and shivering. On an unknown date, the outcome of the fever, myalgia and shivering were unknown. It was unknown if the reporter considered the fever, myalgia and shivering to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported but could be 65 or 66 years.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 10-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse via office staff. This case involves two-month old female patient who received an expired dose of PENTACEL (batch number C5384AA), expiry date 30 June 2018 in left thigh. It was actual medication error due to expired vaccine used as 2 month old was administered PENTACEL that expired on 06/30/2018. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none. Follow up information received on 15-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse via office staff. No new information updated. Documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Initial information received on 15-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves unknown age of male patient who experienced fever and diarrhea, while he received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 14-Mar-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date (unknown latency) after receiving meningococcal A-C-Y-W135 (D conj) vaccine, the patient developed a non-serious fever and diarrhea. Relevant laboratory test results included: Body temperature - On an unknown date: 101 F. Final diagnosis was diarrhea and fever. An unknown corrective treatment was received: rest and let it run its course. The outcome of event of was unknown. List of documents held by sender: none.
Age: 0.75
Sex: F
Vaccine: MMRV
Symptoms: Dermatitis diaper, Diarrhoea, Immediate post-injection reaction, Pyrexia, Rash
Clinical narrative: Fever for two days immediately following vaccine. 5 days later, she broke out in a rash on her face, chest, stomach, back, arms, and legs. It has been over 2 weeks since her vaccine and she still has the rash, and has run a fever for 2 days and also has diarrhea. The diarrhea has caused a terrible diaper rash on top of all other issues.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperaesthesia teeth, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: ARM BECAME VERY SORE AT INJECTION SITE STARTING A FEW HOURS AFTER INJECTION. THE FOLLOWING MORNING, PATIENT AWOKE WITH CHILLS, BODY ACHES, AND OTHER FLU-LIKE SYMPTOMS AS WELL AS TINNITIUS. AS THE DAY PROGRESSED, PATIENT FELT TINGLING ACROSS BACK, TOOTH SENSITIVITY, AND A LARGE RED AREA SURROUNDING THE INJECTION SITE. ALL ADVERSE EVENTS DISSIPATED AFTER 24 HOURS EXCEPT THE RED PATCH WHICH HAS PERSISTED TO TIME OF REPORTING 3 DAYS POST-INJECTION.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Tinnitus
Clinical narrative: ARM BECAME VERY SORE AT INJECTION SITE STARTING A FEW HOURS AFTER INJECTION. THE FOLLOWING MORNING, PATIENT AWOKE WITH CHILLS, BODY ACHES, AND OTHER FLU-LIKE SYMPTOMS AS WELL AS TINNITIUS. AS THE DAY PROGRESSED, PATIENT FELT TINGLING ACROSS BACK, TOOTH SENSITIVITY, AND A LARGE RED AREA SURROUNDING THE INJECTION SITE. ALL ADVERSE EVENTS DISSIPATED AFTER 24 HOURS EXCEPT THE RED PATCH WHICH HAS PERSISTED TO TIME OF REPORTING 3 DAYS POST-INJECTION.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Employee developed rash on injection site. No fever.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Swelling
Clinical narrative: Pain swelling red rash.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site irritation, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Pt was given Dose 1 of SHINGRIX. An unclear number of days after the vaccine, pt experienced injection site reactions, itching, irritation, warmness. Pt was advised to have a physician look at area to determine if any intervention in needed. Pending a status update.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Headache, Oedema, Pyrexia, Restless legs syndrome
Clinical narrative: PT HAD A FEVER WITH RESTLESS LEGS THE NIGHT VACCINE WAS GIVEN. HEADACHE THE NEXT DAY. HAD LEFT AXILLARY EDEMA WITH PAIN TIMES 1 MONTH.
Age: 31.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Nausea, Pain, Paraesthesia, Pyrexia
Clinical narrative: Paresthesias to bilat hands, respiratory distress, fever, nausea/vomiting/diarrhea, body pain.
Age: 31.0
Sex: M
Vaccine: TYP
Symptoms: Respiratory distress, Vomiting
Clinical narrative: Paresthesias to bilat hands, respiratory distress, fever, nausea/vomiting/diarrhea, body pain.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-MAR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 30-JUL-2013, the patient was administered the ZOSTAVAX vaccine (lot # and route not specified) by a healthcare provider. On an unspecified date, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 12th March 2019, the patient received SHINGRIX. On 12th March 2019, less than a day after receiving SHINGRIX, the patient experienced headache and general body pain. On an unknown date, the outcome of the headache and general body pain were not recovered/not resolved. It was unknown if the reporter considered the headache and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient got the shingles vaccine and the same night she got the worst headache and body aches. She was just wondering how long side effects last. She could find nothing but saying what they were-no idea how long they would last. Hopefully it was very short lived.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pain, Swelling, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema urticarial in a 74-year-old male patient who received SHINGRIX for prophylaxis. On 19th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 7 days after receiving SHINGRIX, the patient experienced erythema urticarial, pain, burning sensation, swelling and erythema. The patient was treated with prednisone. On an unknown date, the outcome of the erythema urticarial, pain, burning sensation, swelling and erythema were not recovered/not resolved. It was unknown if the reporter considered the erythema urticarial, pain, burning sensation, swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The caller reports that about 1 week after getting the dose he started getting red welts about the size of a nickle that were painful and felt like they were burning. After about a day or two the swelling would go down and the redness would start going away. The patient saw his doctor and took prednisone for a period of time, but he was eventually taken off prednisone and the welts are still occurring. The patient has never had more than 2 welts at a time. The welts occur on his torso from his naval to his shoulders. Emergency room visit was required.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in heel in a female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. In January 2019, 14 days after receiving SHINGRIX, the patient experienced pain in heel. On an unknown date, the outcome of the pain in heel was not recovered/not resolved. It was unknown if the reporter considered the pain in heel to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. On around 21st December 2018, the patient received the dose of SHINGRIX. Two to three weeks later, she experienced sudden onset of bilateral heel pain. The symptoms were similar to those noted in plantar fasciitis. The pain had not gone away, it waxes and wanes but did not entirely disappear. The patient asked, whether there had been reports of delayed reactions that fit her situation, since she never had a history of such heel pain. The agent attempted to call the health care professional with phone number provided in request to clarify details, obtain date of birth, and inquire about batch/expiry date, however the phone number was not valid. Agent was unable to clarify details or obtain any additional details for adverse event.  Agent filled limited adverse event conservatively.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular, Skin lesion
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vesicular rash in a 58-year-old male patient who received SHINGRIX (batch number 3Z53C, expiry date 13th March 2021) for prophylaxis. On 9th January 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vesicular rash and skin lesion. On an unknown date, the outcome of the vesicular rash and skin lesion were not recovered/not resolved. It was unknown if the reporter considered the vesicular rash and skin lesion to be related to SHINGRIX. Additional details were provided as follows: The patient experienced multiple shingles like lesions on extremities after second dose of SHINGRIX vaccine. The SHINGRIX batch number was reported as 3Z53, however based on a batch number review, the batch number was corrected to 3Z53C. No further information provided.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 35-year-old female patient who received BOOSTRIX for prophylaxis. On 10th March 2019, the patient received BOOSTRIX (subcutaneous). On 10th March 2019, unknown after receiving BOOSTRIX, the patient experienced intramuscular formulation administered by other route. In March 2019, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth, injection site pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth and injection site pain to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 34 or 35 years. A nurse reported that the patient received BOOSTRIX subcutaneously and had been experiencing increased redness, swelling, warmth and pain at the injection site. The area was described as being bigger than a golf ball. The vaccine was given at a separate location and an urgent care. The batch number and expiration date was not reported.
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a adult female patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. On a recent unspecified date, the patient was given a FLUARIX QUADRIVALENT injection as a requirement for her employment. After an unspecified period of time after the injection, the patient broken out in a rash. The patient did not consent to follow-up. The caller did not wish to participate in answering questions for an adverse drug event report.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 73-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever, myalgia and shivering. On an unknown date, the outcome of the fever, myalgia and shivering were unknown. It was unknown if the reporter considered the fever, myalgia and shivering to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever, myalgia, and shivering after the second dose of SHINGRIX. He did not receive the vaccine at the reported pharmacy.
Sex: U
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of product supply issue 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 product supply issue. On an unknown date, the outcome of the product supply issue was unknown. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The pharmacist mentioned vaccine shortage in a call about the appearance of the powder vial. No patient or additional details were provided in the call. It was reported after reviewing call notes.
Sex: U
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer Sales Representative.  An adult patient of an unspecified gender received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient received PREVNAR 13, but was hospitalized at some point afterwards for communicate acquired pneumonia on an unspecified date with outcome of unknown. The information on the lot number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
Age: 56.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient came into office on 03/22/2019 with redness and swelling up upper left arm. Patient states she had been running low grade fever but was not at time in office. Provider ordered BACTRIM DS 800-160mg tablet twice daily for 7 days as well as ice and compression. Patient was instructed to come back to clinic on 03/25/2019 if no symptom improvement or to seek emergency medical care if worsening reaction arises.
Age: 58.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Fever, chills, myalgia, joint pain, headache/migraine, erythema injection site, swelling/induration.
Age: 58.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Migraine, Myalgia, Pyrexia
Clinical narrative: Fever, chills, myalgia, joint pain, headache/migraine, erythema injection site, swelling/induration.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Local urticaria and pruritus near injection site, 2 days after the injection, improving but still present after several hours.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Six hours after receiving shot, had fever continued through the night. OK in the morning.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Insomnia, Myalgia, Nausea
Clinical narrative: Chills, fever, shivering, nausea, prevented sleep, muscle aches, headache -- lasted most of the night. Around 8 am the next morning most symptoms had subsided.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, fever, shivering, nausea, prevented sleep, muscle aches, headache -- lasted most of the night. Around 8 am the next morning most symptoms had subsided.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Vaccination site erythema, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Patient reports local reaction after receiving the vaccine. On Friday 3/22 she came back into the pharmacy and showed the area of vaccination which was still red about 2 inches around injection site. She reports on Thursday 3/21 not being able to really even lift her arm. She states the area was extremely swollen and red.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 35.0
Sex: F
Vaccine: FLUC4, HEPA, PPV, TDAP
Symptoms: Hypersensitivity, Injection site nodule, Injection site reaction, Injection site warmth, Paraesthesia oral
Clinical narrative: Inmate notified nurse at 1400 that "allergic reaction" to vaccine. Right upper arm noted to be red, blotchy, knot at injection site, warm to touch. Red blotches start mid bicep and spread up to clavicle region. Initially Benadryl 25mg give at 1400 and at 1700. Approximately 1915 patient  complained of "tongue feels funny"  report to emergency department at 1950. Recommended antihistamines for 24 hours.
Age: 35.0
Sex: F
Vaccine: FLUC4, HEPA, PPV, TDAP
Symptoms: Rash macular
Clinical narrative: Inmate notified nurse at 1400 that "allergic reaction" to vaccine. Right upper arm noted to be red, blotchy, knot at injection site, warm to touch. Red blotches start mid bicep and spread up to clavicle region. Initially Benadryl 25mg give at 1400 and at 1700. Approximately 1915 patient  complained of "tongue feels funny"  report to emergency department at 1950. Recommended antihistamines for 24 hours.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to two non-pregnant female patients between 40 and 50 years old. The patients were exposure to measles outbreak and were allergic to codeine. The patients' medical history and concomitant medications were not reported. On 15-MAR-2019, the patients were vaccinated with 1 injection for third dose of M-M-R II lot # R002049 with expiration date on 22-JAN-2020, intramuscular (strength, dose, and anatomical location were not reported) to protect against measles outbreak. On 15-MAR-2019, the patients received the vaccine intramuscularly instead of subcutaneously. The patients were not experiencing any side effects from receiving the vaccine intramuscularly and had not received any treatment for this for what the pharmacist wondered if they need to be vaccinated again. The patients did not seek medical attention.
Sex: U
Vaccine: PPV, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 13-FEB-2019, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # R018735, expiry date: 06-APR-2020) for prophylaxis. Temperature and time frame of temperature excursion was noted as from 29-JAN-2019 (12 Degree Celsius for 1 hour 21 minutes) to 26-FEB-2019 (10 Degree Celsius for 22 minutes). It was reported that there was no previous temperature excursions. Digital data logger was noted as Yes. No adverse events were reported. The outcome of product storage error and no adverse event was unknown. This was one of nine reports mentioned in the report. Sender's Comments: US-009507513-1903USA009846: US-009507513-1903USA009847: US-009507513-1903USA009849: US-009507513-1903USA009850: US-009507513-1903USA009845: US-009507513-1903USA009844: US-009507513-1903USA009843: US-009507513-1903USA009848.
Sex: U
Vaccine: PPV, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 07-MAR-2019, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # R018735, expiry date: 06-APR-2020) for prophylaxis (Product storage error). Temperature and time frame of temperature excursion was noted as from 29-JAN-2019 (12 Degree Celsius for 1 hour 21 minutes) to 26-FEB-2019 (10 Degree Celsius for 22 minutes). It was reported that there were no previous temperature excursions. Digital data logger was noted as Yes. No adverse events were reported (no adverse event). The outcome of product storage error and no adverse event was unknown. This was three of nine reports mentioned in the report. Sender's Comments: US-009507513-1903USA009054:Master case.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX for routine health maintenance and for the prevention of shingles (lot number, dosage and route of administration not provided). On an unknown date "shortly after" receiving the ZOSTAVAX, the patient developed a painful rash on her back. In response to these symptoms, the patient presented to a medical provider and was diagnosed with herpes zoster. As a result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of her use of ZOSTAVAX. The outcome of the herpes zoster was considered to be not recovered. Herpes zoster was considered to be disabling. Additional information has been  requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 25-FEB-2019, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # R018735, expiry date: 06-APR-2020) for prophylaxis. Temperature and time frame of temperature excursion was noted as from 29-JAN-2019 (12 Degree Celsius for 1 hour 21 minutes) to 26-FEB-2019 (10 Degree Celsius for 22 minutes). It was reported that there were no previous temperature excursions. Digital data logger was noted as Yes. No adverse events were reported. The outcome of product storage error and no adverse event was unknown. This was two of nine reports mentioned in the report. Sender's Comments: US-009507513-1903USA009054.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 10th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, 12 hrs after receiving SHINGRIX, the patient experienced fever, chills and myalgia. The patient was treated with TYLENOL. On 12th March 2019, the outcome of the fever, chills and myalgia were recovered/resolved. The reporter considered the fever, chills and myalgia to be probably related to SHINGRIX. Additional details were provided as follows: Medicine of doctor received SHINGRIX at retail pharmacy on Sunday and on 11th March 2019, Monday morning he developed a fever of 102 degree F, shivering and myalgia over the course of the day. The suspect drug course for vaccines was not discontinued. The events did not cause the patient to be admitted to the hospital overnight or prolong an existing hospitalization. The reporting health care professional did not consider the events to be life threatening. The reporting health care professional did not consider the events to result in persistent or significant disability or incapacity. The patient did not die. The events did not require surgical or medical intervention to prevent one of the outcomes described in preceding questions. The events did not result in a congenital anomaly or birth defect.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 63-year-old patient who received SHINGRIX (batch number P57AA, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 9th March 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, erythema of extremities and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were unknown and the outcome of the erythema of extremities was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, erythema of extremities and injection site pain to be related to SHINGRIX. Additional details were provided as follows: After receiving the 2nd shot of SHINGRIX on Saturday before reporting date on left arm, the patient experienced normal side effects of redness, localized swelling in area around the injection site and pain, but at the time of reporting, the patient experienced that, the stripe of redness had begun at the edge of primary swelling was heading towards chest by leaving the generalized area. The stripe of color begun at the edge of the swelling was approximately 1 to 2 inch wide and about an inch and a half to 2 inch long. The patient just wanted to make sure that there was not some type of infection developing that was traveling in bloodstream. The patient's oncologist suggested to receive these vaccines before beginning rituxan infusions.
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes, Prostatic specific antigen increased, Rash generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever blister in a 70-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced fever blister and generalized rash. On an unknown date, the outcome of the fever blister and generalized rash were recovered/resolved. It was unknown if the reporter considered the fever blister and generalized rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient could be around 69 years old at the time of vaccination. The patient received 1st dose of SHINGRIX in March or April 2018, the patient developed fever blisters that began about 2 weeks after the dose. The patient also reported unidentified spots around his body. After one week, the events resolved. For tolerance of 2nd dose, refer case US2019045198.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Blood immunoglobulin G increased, Electrophoresis protein abnormal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of immunoglobulin G increased in a 55-year-old male patient who received BOOSTRIX for prophylaxis. On 31st January 2019, the patient received BOOSTRIX. In February 2019, 8 days after receiving BOOSTRIX, the patient experienced immunoglobulin G increased and total protein high. On an unknown date, the outcome of the immunoglobulin G increased and total protein high were unknown. It was unknown if the reporter considered the immunoglobulin G increased and total protein high to be related to BOOSTRIX. Additional details were provided as follows: One week and one day later, the patient had drawn laboratory test for routine physical. The laboratory tests were normal except, high immunoglobulin and high total protein. The serum protein electrophoresis test was performed and confirmed with high immunoglobulin G. The physician was not in office and did not have patient chart in front of her at the time of this call.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes, Prostatic specific antigen increased, Rash generalised, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever blister in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of oral herpes (1st dose received in March or April 2018, for tolerance, refer case US2019GSK052324). In October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced PSA increased. On an unknown date, the patient experienced fever blister and generalized rash. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever blister and generalized rash were not recovered/not resolved and the outcome of the PSA increased was unknown. It was unknown if the reporter considered the fever blister, generalized rash and PSA increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient could be around 69 years old at the time of vaccination. After receiving the 2nd dose of SHINGRIX, the fever blisters on his lips returned 2 weeks after the dose. They were worse in appearance and size than after dose number 1. The patient reported spots on his body, but most prevalent around the neck. In October 2018, the PSA (prostatic specific antigen) of the patient were increased from 1.7 to 2.9. Follow up contact was consented. Permission to send letter for MD information was granted on an unspecified date (date not known by the reporter).
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect dose administered, Induration, Pain, Product preparation issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in a 55-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 11th March 2019, the patient received SHINGRIX (intramuscular). On 11th March 2019, immediately after receiving SHINGRIX, the patient experienced pain, skin warm, inappropriate preparation of medication and inappropriate dose of vaccine administered. On 12th March 2019, the patient experienced erythema of extremities and induration. On an unknown date, the outcome of the pain, skin warm, erythema of extremities and induration were not recovered/not resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the pain, skin warm, erythema of extremities and induration to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left deltoid. The patient had a red indurated spot on arm. The patient stated that the warmth and soreness started almost immediately, the induration and erythema were noted morning of the reporting day. The patient received only the adjuvant part without the powder part of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not have diluent to provide lot number/expiry date.  Lot number/expiry date provided from SHINGRIX box.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in a 55-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 11th March 2019, the patient received SHINGRIX (intramuscular). On 11th March 2019, immediately after receiving SHINGRIX, the patient experienced pain, skin warm, inappropriate preparation of medication and inappropriate dose of vaccine administered. On 12th March 2019, the patient experienced erythema of extremities and induration. On an unknown date, the outcome of the pain, skin warm, erythema of extremities and induration were not recovered/not resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the pain, skin warm, erythema of extremities and induration to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left deltoid. The patient had a red indurated spot on arm. The patient stated that the warmth and soreness started almost immediately, the induration and erythema were noted morning of the reporting day. The patient received only the adjuvant part without the powder part of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not have diluent to provide lot number/expiry date.  Lot number/expiry date provided from SHINGRIX box.