chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: Localized pain at injection on left arm site as expected. After a few hours the pain started to radiate from injection site down to my lower arm & fingers. I could not lift my arm due to severe pain, worse at injection site that seemed like into the shoulder socket. Fever resulted that reached 100.9 Used ALEVE for pain and fever, used ice for pain without much effect. Pain so severe that it limited the ability to sleep. During the next day, today, the pain has lessened an localized to the left shoulder joint and am able to use the arm sparingly. Contacted the Dr. office with information and was told "OK let us know if you need anything. I feel that the injection into the shoulder joint contributed to the adverse reaction, I have had plenty of injections but never on so high on my arm.
Age: 65.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: Localized pain at injection on left arm site as expected. After a few hours the pain started to radiate from injection site down to my lower arm & fingers. I could not lift my arm due to severe pain, worse at injection site that seemed like into the shoulder socket. Fever resulted that reached 100.9 Used ALEVE for pain and fever, used ice for pain without much effect. Pain so severe that it limited the ability to sleep. During the next day, today, the pain has lessened an localized to the left shoulder joint and am able to use the arm sparingly. Contacted the Dr. office with information and was told "OK let us know if you need anything. I feel that the injection into the shoulder joint contributed to the adverse reaction, I have had plenty of injections but never on so high on my arm.
Age: 65.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Blood test, Injected limb mobility decreased, Insomnia, Pain in extremity, Pyrexia
Clinical narrative: Localized pain at injection on left arm site as expected. After a few hours the pain started to radiate from injection site down to my lower arm & fingers. I could not lift my arm due to severe pain, worse at injection site that seemed like into the shoulder socket. Fever resulted that reached 100.9 Used ALEVE for pain and fever, used ice for pain without much effect. Pain so severe that it limited the ability to sleep. During the next day, today, the pain has lessened an localized to the left shoulder joint and am able to use the arm sparingly. Contacted the Dr. office with information and was told "OK let us know if you need anything. I feel that the injection into the shoulder joint contributed to the adverse reaction, I have had plenty of injections but never on so high on my arm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Pain in extremity, Tenderness
Clinical narrative: Patient stated she was sore from the shot (Vaccination date 01/17/2019). She followed up with her physicians, manufacturer and still not sure why her arm is still sore. There was redness and tenderness immediately following the vaccine which has subsided but the soreness is still lingering.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Patient reported signs of chills and fever.
Age: 55.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Pyrexia
Clinical narrative: Fever and chills.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient complained of pain in his left arm (especially when straightening). Also there was a noticeable swelling and a large red area around the injection site. This area of the skin was hot to the touch.  Patient also complained the area was "itchy."
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Pain, Pain in extremity, Vomiting
Clinical narrative: Vomiting. Pain. Chills. Lethargy. Arm pain, a lot pf pain. Started on Saturday and has gotten better today Tuesday.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Cellulitis, Pain, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Swollen arm/cellulitis, fever, body aches, vomitting.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood urine present, Pruritus, Rash
Clinical narrative: Blood in urine and rash mid chest following vaccination. Blood in urine lasted for two days. Patient continues to have rash with itchiness on chest up to date.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site erythema
Clinical narrative: Ache, redness, swelling and heat at injection site and throughout upper arm beginning shortly after injection. Still significant at 54 hours. Nausea and decreased appetite, 36 hours. Fatigue, 48 hours. Headache, 48 hours. Chills and shivering, 36 hours.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Ache, redness, swelling and heat at injection site and throughout upper arm beginning shortly after injection. Still significant at 54 hours. Nausea and decreased appetite, 36 hours. Fatigue, 48 hours. Headache, 48 hours. Chills and shivering, 36 hours.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Add vaccine info unknown not given here pt at clinic for tx only. Moderate to severe redness swelling left upper arm tx with Keflex and prednisone and Benadryl.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Anxiety, Chills, Decreased appetite, Fatigue
Clinical narrative: About 12 hours after vaccine, noticed some vague nausea, abdominal discomfort and chills; this was at bedtime. I woke up a couple of times, noticed chills once and next time I woke, I was hot. Felt better initially in AM, but noticed lack of appetite, nausea, muscle aches (lower back), fatigue, but most concerning was feeling of anxiety, irritability, and unease. As the day progressed, these symptoms subsided. The next day I still felt fatigued.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Feeling hot, Irritability, Myalgia, Nausea
Clinical narrative: About 12 hours after vaccine, noticed some vague nausea, abdominal discomfort and chills; this was at bedtime. I woke up a couple of times, noticed chills once and next time I woke, I was hot. Felt better initially in AM, but noticed lack of appetite, nausea, muscle aches (lower back), fatigue, but most concerning was feeling of anxiety, irritability, and unease. As the day progressed, these symptoms subsided. The next day I still felt fatigued.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza like illness, Pain in extremity, Sleep disorder
Clinical narrative: Pain in whole arm Flu like symptoms causing sleep and work issues.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Urticaria
Clinical narrative: Pt reported flu like symptoms and hives on arm, chest. Pt reported no treatment.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Back pain, Chills, Differential white blood cell count normal, Full blood count normal, Metabolic function test normal
Clinical narrative: Note PNEUMOVAX was the 3rd I have had since 2013 - they put PNEUMOVAX (PPSV23) on report given to me. Rx was very painful shoulders, neck and upper back and fever of 100.6 and chills; this first reaction was 3 days beginning on day of vac 1/25/19. I had what appeared to be 2nd reaction on 2/8/19, the same pains only worse and lasted 6 days, fever 6 days. Went to an after hours clinic; they blew me off as "neck strain" - original office ordered blood work which was negative done on 2/14; then Inf Dx blew me off too!
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pyrexia
Clinical narrative: Note PNEUMOVAX was the 3rd I have had since 2013 - they put PNEUMOVAX (PPSV23) on report given to me. Rx was very painful shoulders, neck and upper back and fever of 100.6 and chills; this first reaction was 3 days beginning on day of vac 1/25/19. I had what appeared to be 2nd reaction on 2/8/19, the same pains only worse and lasted 6 days, fever 6 days. Went to an after hours clinic; they blew me off as "neck strain" - original office ordered blood work which was negative done on 2/14; then Inf Dx blew me off too!
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Pruritus, Rash papular
Clinical narrative: About 5 days after I received  the SHINGRIX shot (2-15-19) at Pharmacy my right forearm started to itch. I went to see my dermatologist on 2-28-19. He took a photo of the rash and did a biopsy. The result  was erythematous papules. Today I saw him again and he prescribed a 10% cortizone cream to hasten the rash recovery. My next appointment is in a month to see if the rash heals. The info I have on my receipt says SHINGRIX 50 MCG SUS NDC#58160-823-11.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: PATIENT DEVELOPED REDNESS ON LEFT ARM, ABOUT 3 INCHES BELOW SITE OF ADMINISTRATION, STARTING ABOUT A WEEK AFTER VACCINATION. THERE IS NO RASH, NO ITCHING, NO PAIN OR NO FEVER. PATIENT WENT TO URGENT CARE TO HAVE TREATMENT (NOT SURE WHICH MEDICATION GIVEN). REDNESS HAS GOTTEN WORSE, THEN ALSO APPEARS ON RIGHT ARM (SPOTS), RIGHT SIDE OF BELLY.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Rash started 11 days after vaccination, fever and irritability, rash on face, torso and legs.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Myalgia, Pain, Peripheral swelling
Clinical narrative: 24 hrs after injection: chills, myalgia, arm swelling, erythema, pain.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Rash started 10 days after vaccination, started with fever 100.6, irritable. Rash on face and torso and legs.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Adverse reaction left arm-DTaP given-large swollen arm.
Age: 62.0
Sex: M
Vaccine: HEPAB, MNQ, VARZOS, VARZOS
Symptoms: Injection 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 male patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 21st March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm on the day of reporting and developed swelling at the injection site. The reporter did not consent to follow up.
Sex: M
Vaccine: FLU4, MENB, MNQ, FLUX, MENB, MNQ
Symptoms: Computerised tomogram, Electrocardiogram, Fall, Incoherent, Laboratory test
Clinical narrative: This is a spontaneous report form a contactable health professional via a Pfizer sales representative. A 16-year-old male patient received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunization; influenza vaccine (FLU VACCINE VII), via an unspecified route of administration, on an unspecified date, at unspecified dose, for immunisation and MENACTRA, via an unspecified route of administration, on an unspecified date, at an unspecified dose, for immunisation. The patient received the vaccines the same time, patient was well and not sick that day. The patient's medical history and concomitant medications were not reported. About 3 minutes after administration the patient fainted, lost consciousness and fell off the exam table and split his head open on the floor. The patient was taken to the hospital. He underwent lab tests and procedures which included electrocardiogram: normal, scan: normal. Therapeutic measures were taken as a result of fell off the exam table and split his head open on the floor (head injury) and included sutures. The events were considered life threatening. Outcome of the events was unknown. The information on the lot number has been requested.; Sender's Comments: Based on the information currently available, the known adverse event profile of the suspect product meningococcal group b rlp2086 vaccine and the pathophysiology of the events fainted, lost consciousness and fell off the exam table and split his head open on the floor, the Company cannot completely exclude that the suspect vaccine contributed to the development of the reported events.
Sex: M
Vaccine: FLU4, MENB, MNQ, FLUX, MENB, MNQ
Symptoms: Nervousness, Seizure, Skin laceration, Tremor
Clinical narrative: This is a spontaneous report form a contactable health professional via a Pfizer sales representative. A 16-year-old male patient received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunization; influenza vaccine (FLU VACCINE VII), via an unspecified route of administration, on an unspecified date, at unspecified dose, for immunisation and MENACTRA, via an unspecified route of administration, on an unspecified date, at an unspecified dose, for immunisation. The patient received the vaccines the same time, patient was well and not sick that day. The patient's medical history and concomitant medications were not reported. About 3 minutes after administration the patient fainted, lost consciousness and fell off the exam table and split his head open on the floor. The patient was taken to the hospital. He underwent lab tests and procedures which included electrocardiogram: normal, scan: normal. Therapeutic measures were taken as a result of fell off the exam table and split his head open on the floor (head injury) and included sutures. The events were considered life threatening. Outcome of the events was unknown. The information on the lot number has been requested.; Sender's Comments: Based on the information currently available, the known adverse event profile of the suspect product meningococcal group b rlp2086 vaccine and the pathophysiology of the events fainted, lost consciousness and fell off the exam table and split his head open on the floor, the Company cannot completely exclude that the suspect vaccine contributed to the development of the reported events.
Sex: M
Vaccine: FLU4, MENB, MNQ, FLUX, MENB, MNQ
Symptoms: Electrocardiogram normal, Fall, Head injury, Loss of consciousness, Scan normal
Clinical narrative: This is a spontaneous report form a contactable health professional via a Pfizer sales representative. A 16-year-old male patient received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunization; influenza vaccine (FLU VACCINE VII), via an unspecified route of administration, on an unspecified date, at unspecified dose, for immunisation and MENACTRA, via an unspecified route of administration, on an unspecified date, at an unspecified dose, for immunisation. The patient received the vaccines the same time, patient was well and not sick that day. The patient's medical history and concomitant medications were not reported. About 3 minutes after administration the patient fainted, lost consciousness and fell off the exam table and split his head open on the floor. The patient was taken to the hospital. He underwent lab tests and procedures which included electrocardiogram: normal, scan: normal. Therapeutic measures were taken as a result of fell off the exam table and split his head open on the floor (head injury) and included sutures. The events were considered life threatening. Outcome of the events was unknown. The information on the lot number has been requested.; Sender's Comments: Based on the information currently available, the known adverse event profile of the suspect product meningococcal group b rlp2086 vaccine and the pathophysiology of the events fainted, lost consciousness and fell off the exam table and split his head open on the floor, the Company cannot completely exclude that the suspect vaccine contributed to the development of the reported events.
Sex: M
Vaccine: FLU4, MENB, MNQ, FLUX, MENB, MNQ
Symptoms: Suture insertion, Syncope
Clinical narrative: This is a spontaneous report form a contactable health professional via a Pfizer sales representative. A 16-year-old male patient received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunization; influenza vaccine (FLU VACCINE VII), via an unspecified route of administration, on an unspecified date, at unspecified dose, for immunisation and MENACTRA, via an unspecified route of administration, on an unspecified date, at an unspecified dose, for immunisation. The patient received the vaccines the same time, patient was well and not sick that day. The patient's medical history and concomitant medications were not reported. About 3 minutes after administration the patient fainted, lost consciousness and fell off the exam table and split his head open on the floor. The patient was taken to the hospital. He underwent lab tests and procedures which included electrocardiogram: normal, scan: normal. Therapeutic measures were taken as a result of fell off the exam table and split his head open on the floor (head injury) and included sutures. The events were considered life threatening. Outcome of the events was unknown. The information on the lot number has been requested.; Sender's Comments: Based on the information currently available, the known adverse event profile of the suspect product meningococcal group b rlp2086 vaccine and the pathophysiology of the events fainted, lost consciousness and fell off the exam table and split his head open on the floor, the Company cannot completely exclude that the suspect vaccine contributed to the development of the reported events.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Urticaria
Clinical narrative: The patient developed hives and swelling all over her body that began on 3-24-19. The patient went to Hospital ER on Sunday, 3-24-19. The patient was administered IV SOLU-MEDROL and diphenhydramine during the ER visit. The patient was given a prescription for prednisone 10 mg tablets for a 10 day taper prescribed by the ER physician. The patient picked up the prednisone prescription on 3-25-19.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUA3, MMRV
Symptoms: Pyrexia
Clinical narrative: Fever of 103.4 F that night.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Local reaction, Pruritus, Pyrexia, Tenderness
Clinical narrative: LOCAL REACTION, TENDERNESS, ITCHING, CHILLS AND FEVER 102.7.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue, joint aches, muscle pain, shivering, headache.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Fall, Headache, Nausea, Skin injury, Syncope
Clinical narrative: PATIENT WAS VACCINATED TODAY WITH HPV VACCINATION. AFTER VACCINE, PATIENT HAD SYNCOPAL EPISODE WHILE ATTEMPTING TO STAND FROM TABLE AFTER VACCINATION. HE FELL APPROX 3-4 FEET FROM EXAM TABLE AND HIT POTERIOR SCALP ON FLOOR (CONCRETE WITH OVERLYING VINYL). PATIENT DID NOT LOSE CONCIOUSNESS. BP AT TIME OF EVENT 128/84 HR 70S. PT C/O SEVERE HEADACHE, AND NAUSEA AFTER EVENT. PEERLA. ICE PACK APPLIED AND REFERRED TO ER FOR FURTHER EVAL AND TX. SENT BY PRIVATE VEHICLE. DENIED DIZZINESS, CHEST PAIN, SOB AFTER EVENT.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Concussion, Headache, Nausea, Syncope
Clinical narrative: PATIENT WAS VACCINATED TODAY WITH HPV VACCINATION. AFTER VACCINE, PATIENT HAD SYNCOPAL EPISODE WHILE ATTEMPTING TO STAND FROM TABLE AFTER VACCINATION. HE FELL APPROX 3-4 FEET FROM EXAM TABLE AND HIT POTERIOR SCALP ON FLOOR (CONCRETE WITH OVERLYING VINYL). PATIENT DID NOT LOSE CONCIOUSNESS. BP AT TIME OF EVENT 128/84 HR 70S. PT C/O SEVERE HEADACHE, AND NAUSEA AFTER EVENT. PEERLA. ICE PACK APPLIED AND REFERRED TO ER FOR FURTHER EVAL AND TX. SENT BY PRIVATE VEHICLE. DENIED DIZZINESS, CHEST PAIN, SOB AFTER EVENT.
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event, Product container issue, Product leakage
Clinical narrative: Information has been received from a nurse referring to an unknown gender patient of unknown age. Information about concomitant medications, pertinent medical history and drug reactions/allergies was not reported. On 28-FEB-2019, the patient was vaccinated with ROTATEQ orally (lot # R016271, expiration date: 25-APR-2020, dose and frequency were not reported) for prophylaxis. The ROTATEQ vial split open, causing spillage of an unknown amount of the dose; the vial leaked while the dose was being administered (product leakage and product container issue), and the patient received very little of the dose (incorrect dose administered). No adverse effects were reported in the patient. The outcome of product vial split open and vial leaked was unknown. Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided. The causality assessment was not provided.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown gender patient of unknown age. Information about concomitant medications, pertinent medical history and drug reactions/allergies was not reported. On 27-FEB-2019, the patient was inadvertently vaccinated with PROQUAD (lot # reported as R026350, expiration date: 15-MAR-2020, dose, frequency and route were not reported) and VARIVAX (lot #: R026548, expiration date: 17-SEP-2020, dose, frequency and route were not reported) for prophylaxis. Concomitant therapies included sterile diluent. No adverse effect reported.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report has been received from a nurse referring to a 25 years old female patient. The patient's concurrent condition included alcohol abuse (binge drinking past weekend) ("alcohol abuse" reported as concomitant medication by reporter but processed as concurrent condition to make it more reasonable). Information about pertinent medical history or drug reaction/allergies was not reported. On 28-JAN-2019, the patient was administered the first dose of VARIVAX (lot # R011807 with expiration date of 23-APR-2020, subcutaneously in the left arm) for no immunity to varicella (prophylaxis). On 04-MAR-2019, the patient return to the office and received her second dose of VARIVAX (lot # R011807 with expiration date of 23-APR-2020, subcutaneously in the left arm). On the same day, after administration of the second dose of VARIVAX, she asked for pregnancy test which was positive (maternal exposure during pregnancy; first trimester). The last menstrual period (LMP) was reported as 21-JAN-2019. Gestation Period at Exposure was 1 week. The pregnancy outcome was pending. The present status was reported as not recovered (outcome was captured as unknown in field per internal rule). She did not seek medical attention and no treatment was given for the event. No product quality complaint (PQC) was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent conditions, and drug reactions/allergies was not provided. Concomitant medication included sterile diluent. On 10-MAR-2019, the patient was vaccinated with a dose of VARIVAX (injection, lot # R021098, expiration date: 23-JUL-2020; dose, strength, and frequency were not reported) intramuscularly for prophylaxis (inappropriate route of vaccination). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patients was vaccinated with an improperly stored dose of VARIVAX, lot number involved N021314, expiration date 07-AUG-2020 (dose, route and frequency were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot #, expiration date, dose, route and frequency were not reported). It was also reported that the temperature excursion was 12.9 Fahrenheit degrees (F) during 71 hours and 20 minutes. There were no previous temperature excursions. The call was because of a data logger. No adverse effects were reported.
Age: 17.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse referring to a 17 years old female patient. Information about pertinent medical history, concurrent conditions, and drug reactions/allergies was not provided. Concomitant therapy included sterile diluent. At unspecified time in 2018, the patient was vaccinated with, as first dose, M-M-R II (strength, dose detail, route, lot # and expiration date were not reported) and VARIVAX (strength, dose detail, route, lot # and expiration date were not reported) for prophylaxis. On 19-FEB-2019, the patient was inadvertently administered with PROQUAD (therapy type recombinant Human albumin (rHA); lot # R017630 with expiration date 18-DEC-2019; strength and dose detail were not reported) subcutaneously for prophylaxis. No adverse effects were reported. The causality of the events was not provided.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea
Clinical narrative: This spontaneous report was received from a consumer refers to a currently 45 year old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medication was not reported. On 11-NOV-2018 the patient was vaccinated with GARDASIL 9 dose 1, intramuscular, for prophylaxis (reported as to prevent HPV cancer) (strength, lot # and expiration date were not provided). On 11-NOV-2018, 1 day after onset of therapy, the patient experienced nausea.  On 12-JAN-2019, the consumer had not yet received her second dose of GARDASIL 9. The outcome of nausea was reported as recovered on an unknown date. At the time of the report the causality between GARDASIL 9 and the adverse event was not provided.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 months old patient, of unknown gender. Patient's current conditions, medical history, concomitant medications, drugs allergies or reactions were not reported. On 20-MAR-2019, the patient was vaccinated with improperly stored dose of the following vaccine: VARIVAX lot # R018780 and expiration date 01-JUL-202 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis. Non improperly stored diluent used was reported. The vaccines was exposed to a temperature of 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.9 Fahrenheit degrees) for 66 minutes. There was a previous temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.0 Fahrenheit degrees) for 35 minutes. It was reported that digital data logger was involved. No adverse effects were reported. This case is one of 6 same reporter cases. Sender's Comments: US-009507513-1903USA011480: US-009507513-1903USA011573: US-009507513-1903USA011571: US-009507513-1903USA011574: US-009507513-1903USA011570.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 year old patient, of unknown gender. Patient's current conditions, medical history, concomitant medications, drugs allergies or reactions were not reported. On 18-MAR-2019, the patient was vaccinated with improperly stored dose of the following vaccine:  VARIVAX, lot # R018780  and expiration date 01-JUL-2020(strength, dose, dose number, route and anatomical location were not provided) for prophylaxis. Non improperly stored was reported on the sterile diluent used. The vaccines were exposed to a temperature of 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.9 Fahrenheit degrees) for 66 minutes. There was a previous temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.0 Fahrenheit degrees) for 35 minutes. It was reported that digital data logger was involved. No adverse effects were reported. This case is one of six same reporter cases. Sender's Comments: US-009507513-1903USA011480; US-009507513-1903USA011572; US-009507513-1903USA011571; US-009507513-1903USA011574; US-009507513-1903USA011570.
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report as received from a nurse via Pfizer refers to a 4 month old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot, expiry date, dose, frequency and route were not reported) instead of PREVNAR 13 for prophylaxis (wrong product administered). It was reported that, event did not take place after use of the product (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
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 25-MAR-2019, the patient was vaccinated with an expired dose of M-M-R II (lot # R013129, expiration date 03-FEB-2019; dose was unknown) subcutaneously for prophylaxis. No known adverse effects. The outcome of the events was unknown. No product quality complaint (PQC) presented.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old patient who received SHINGRIX for prophylaxis. On 18th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, headache and joint pain. On an unknown date, the outcome of the influenza-like symptoms, fever, headache and joint pain were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, headache and joint pain to be related to SHINGRIX. Additional details were provided as follows: The patient wanted to know how long would flu like symptoms last.
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of axillary lymph nodes enlarged in a 52-year-old female patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced axillary lymph nodes enlarged and local swelling. On an unknown date, the outcome of the axillary lymph nodes enlarged and local swelling were unknown. It was unknown if the reporter considered the axillary lymph nodes enlarged and local swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 51 years or 52 years. The patient received SHINGRIX on an unknown arm. The physician reported that the patient came to their clinic on 19th March 2019 stating she still had some lymph node swelling in her axillary area on the same side or arm she had her SHINGRIX dose. The patient either had her 1st SHINGRIX dose on 14th March 2019 or 15th March 2019 at reporter's pharmacy. The patient wasn't complaining of any other systemic reactions and there was no redness or swelling at the injection site. The patient just had some swelling in her axilla since receiving the SHINGRIX shot. The physician stated that it did not seem overly worrisome to them and they thought it was just a part of patient's normal immune response to the SHINGRIX vaccine but they wanted to report it in case this was something being commonly reported. The physician did agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Rash papular, Rash pruritic, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a elderly 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 year after receiving SHINGRIX, the patient experienced hives, papular rash and itchy rash. On an unknown date, the outcome of the hives, papular rash and itchy rash were unknown. It was unknown if the reporter considered the hives, papular rash and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient for themselves. The patient stated that they just had the 2nd dose of SHINGRIX and besides the common side effects, they experienced hives, 3 small raised bumps, no colour to them, slight itch. The patient inquired whether they should see the doctor.
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 62-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of urticaria (received on 5th November 2018 and experienced chronic urticarial and itching, refer case US2019049309). On 15th March 2019, the patient received the 2nd dose of SHINGRIX. On 15th March 2019, less than a day after receiving SHINGRIX, the patient experienced hives and pruritus. On 16th March 2019, the patient experienced pain in arm, queasy and pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the hives and pruritus were not recovered/not resolved and the outcome of the pain in arm, queasy and pain were recovered/resolved. It was unknown if the reporter considered the hives, pruritus, pain in arm, queasy and pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for himself. The age at vaccination was not reported but it could be 61 years or 62 years. The patient received SHINGRIX in the left arm and he came home by the time his back was lit up like a Christmas tree with hives. The day after the vaccination, the patient had a sore arm, and felt a little queasy and achy, but those symptoms had resolved. In March 2019, the outcome of the pain in arm, queasy and pain were resolved. The patient had problems with hives and itching at the time of reporting. The patient visited the emergency room. The patient provided the consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 62-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of urticaria (received on 5th November 2018 and experienced chronic urticarial and itching, refer case US2019049309). On 15th March 2019, the patient received the 2nd dose of SHINGRIX. On 15th March 2019, less than a day after receiving SHINGRIX, the patient experienced hives and pruritus. On 16th March 2019, the patient experienced pain in arm, queasy and pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the hives and pruritus were not recovered/not resolved and the outcome of the pain in arm, queasy and pain were recovered/resolved. It was unknown if the reporter considered the hives, pruritus, pain in arm, queasy and pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for himself. The age at vaccination was not reported but it could be 61 years or 62 years. The patient received SHINGRIX in the left arm and he came home by the time his back was lit up like a Christmas tree with hives. The day after the vaccination, the patient had a sore arm, and felt a little queasy and achy, but those symptoms had resolved. In March 2019, the outcome of the pain in arm, queasy and pain were resolved. The patient had problems with hives and itching at the time of reporting. The patient visited the emergency room. The patient provided the consent to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received SHINGRIX for prophylaxis. On 17th March 2019, the patient received the 1st dose of SHINGRIX. On 17th March 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 18th March 2019, the patient experienced fatigue and headache. On an unknown date, the outcome of the pain in arm, fatigue and headache were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, fatigue and headache to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for himself. The patient received SHINGRIX into the left arm and experienced a hurt left arm in the afternoon. In the next morning, the patient experienced fatigue or tiredness and slight headache. On the day of reporting, hurt arm was worsened. The patient did not provide the consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria, Urticaria chronic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 62-year-old male patient who received SHINGRIX for prophylaxis. On 5th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced hives, pruritus and chronic urticaria. On an unknown date, the outcome of the hives, pruritus and chronic urticaria were recovered/resolved.  It was unknown if the reporter considered the hives, pruritus and chronic urticaria to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 61 years or 62 years. The case was reported by the patient for himself. Within a few weeks after the vaccination, the patient started breaking out in hives. The patient started experiencing chronic urticaria that flared up with itching at random times. The patient saw his allergist and it was thought due to food products. The patient visited the emergency room. The patient provided the consent to follow up. For tolerance to the 2nd dose of SHINGRIX, refer case US2019GSK054229.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 18th March 2019, the patient received the 2nd dose of SHINGRIX. On 18th March 2019, less than a day after receiving SHINGRIX, the patient experienced chills. On 19th March 2019, the patient experienced fever. On an unknown date, the outcome of the chills was recovered/resolved and the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the chills and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced chills after receiving SHINGRIX and on the day of reporting the patient had a low grade fever. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 22nd February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced shivering, injection site pain, fatigue and injection site erythema. On an unknown date, the outcome of the shivering, injection site pain, fatigue and injection site erythema were recovered/resolved. It was unknown if the reporter considered the shivering, injection site pain, fatigue and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient received a dose of SHINGRIX on left arm. The patient experienced fatigue and shivering after receiving the vaccine. Patient also developed pain and redness at the injection site. The patient stated that the red spot was approximately the same size as match book (box). The injection site redness disappeared within 1 week. Consent to follow up was requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema 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 injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced a large red area at the injection site after receiving SHINGRIX. No additional details were provided. The reporter declined to provide the patient information as he was trying to receive information pertaining to a medical question.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of blister in a 67-year-old female patient who received SHINGRIX (batch number 2Y9R4, expiry date 28th February 2021) for prophylaxis. The patient's past medical history included blister (On an unknown date, the patient previously experienced Blisters). On 15th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2019, several days after receiving SHINGRIX, the patient experienced blister. The patient was treated with ACYCLOVIR. On an unknown date, the outcome of the blister was unknown. It was unknown if the reporter considered the blister to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in left deltoid. The patient experienced blister like lesion around her mouth. On 20th March 2019, the physician prescribed Acyclovir as a treatment medication to the patient. The reporter did not consent to follow up. The reporter was unable to provide any additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a female patient who received SHINGRIX for prophylaxis. On 2nd October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown. The reporter considered the bell's palsy to be related to SHINGRIX. Additional details were reported as follows: Age at vaccination was not reported. The patient received SHINGRIX dose and experienced Bell's palsy. The patient was very upset due to this. She would not answer any follow up questions. The reporter declined consent for follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient did not have a adverse reaction. The issue at hand is that the patient was given the incorrect vaccine. The patient was not suppose to receive the ZOSTAVAX due to her age and the requirements of the vaccine.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site rash
Clinical narrative: Patient had a large rash appear around the left deltoid and upper arm on the arm where the shot was administered. This was accompanied by servere debilitating flu like symptoms.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: Rash on abd, legs, thighs, back, arms - front and back.
Age: 18.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site injury, Injection site rash
Clinical narrative: 2.5 inch diameter rash around the injection site. Patient was shot with a paintball on the smallpox injection site. Patient informed medical.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: No adverse event, Wrong patient received product
Clinical narrative: Td vaccine was administered to the wrong pt. Pt didnt have a reaction to the vaccine.
Age: 45.0
Sex: M
Vaccine: TYP
Symptoms: Nausea, Vomiting
Clinical narrative: Patient reported nausea and diarrhea after 1st and 2nd dose, then severe nausea and vomiting after 3rd dose, Patient did not take 4th dose.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site reaction, Neuralgia, Pain in extremity
Clinical narrative: The patient experienced a sharp "nerve" pain immediately at the injection site. She reports that the pain has radiated down her arm to her hand. She reports that this pain has been pretty consistent for the past week.
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 17-DEC-2018, the patient was vaccinated with LIQUID 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: 1903USA010362:Original Case : 1903USA004795; 1903USA010363:Original Case : 1903USA004795; 1903USA004795:Original Case : 1903USA004795; 1903USA010361:Original Case : 1903USA004795; 1903USA010360:Original Case : 1903USA004795; 1903USA010365:Original Case : 1903USA004795; 1903USA010358:Original Case : 1903USA004795; 1903USA010359:Original Case : 1903USA004795.