chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Asthenia, Back pain, Blood test abnormal, C-reactive protein normal
Clinical narrative: In the afternoon the day after I received the booster, I began feeling chest pain. The center of my chest ached and I felt shooting pains into my back, up my neck, and down my left arm. I also felt short of breath and it was very painful to lay down flat. The pain was worsened if I moved around or tried to walk. Since the pain was severe and I had never experienced chest pain before, I went to the ER on the morning of Sunday January 30th 2022. There, the EKG and Chest X Ray were clean. The doctor heard a hurt murmur and also said that my bloodwork indicated the expected immune response to the vaccine. He suspected it was a bad reaction to the vaccine and I would feel better in a few days. After a few days, I did not feel better and saw a cardiologist at facility. She suspected pericarditis and started me on colchicine. I noticed minor improvement, but not significant improvement. After two months on colchicine, since all tests were clear (MRI, EKG, ECG, Xray) and she felt that the structure of my heart was okay, she recommended I discontinue colchicine.   At the recommendation of a second cardiologist and a rheumatologist, I began amitryptalline 3 weeks ago, but have yet to notice significant improvement.  Currently, I am undergoing rheumatological and lung work ups with a rheumatologist. I continue to experience significant, debilitating symptoms. The day before I got the booster, I ran 8 miles. I was in excellent shape and was training for a marathon. Now, I have to sit down after walking up a flight of stairs because the chest pain and shortness of breath is so severe. I cannot walk more than 6 minutes without needing to rest. I struggle with fatigue. Laying down flat and laying on my right side (even if elevated) makes the pain worse. I feel best resting (no movement) and sitting either slightly slumped forward or reclining slightly. I sleep with an incline wedge pillow. I have a handicap parking pass because walking even very short distances is extremely difficult.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac murmur, Chest X-ray normal, Chest pain, Dyspnoea, Dyspnoea exertional
Clinical narrative: In the afternoon the day after I received the booster, I began feeling chest pain. The center of my chest ached and I felt shooting pains into my back, up my neck, and down my left arm. I also felt short of breath and it was very painful to lay down flat. The pain was worsened if I moved around or tried to walk. Since the pain was severe and I had never experienced chest pain before, I went to the ER on the morning of Sunday January 30th 2022. There, the EKG and Chest X Ray were clean. The doctor heard a hurt murmur and also said that my bloodwork indicated the expected immune response to the vaccine. He suspected it was a bad reaction to the vaccine and I would feel better in a few days. After a few days, I did not feel better and saw a cardiologist at facility. She suspected pericarditis and started me on colchicine. I noticed minor improvement, but not significant improvement. After two months on colchicine, since all tests were clear (MRI, EKG, ECG, Xray) and she felt that the structure of my heart was okay, she recommended I discontinue colchicine.   At the recommendation of a second cardiologist and a rheumatologist, I began amitryptalline 3 weeks ago, but have yet to notice significant improvement.  Currently, I am undergoing rheumatological and lung work ups with a rheumatologist. I continue to experience significant, debilitating symptoms. The day before I got the booster, I ran 8 miles. I was in excellent shape and was training for a marathon. Now, I have to sit down after walking up a flight of stairs because the chest pain and shortness of breath is so severe. I cannot walk more than 6 minutes without needing to rest. I struggle with fatigue. Laying down flat and laying on my right side (even if elevated) makes the pain worse. I feel best resting (no movement) and sitting either slightly slumped forward or reclining slightly. I sleep with an incline wedge pillow. I have a handicap parking pass because walking even very short distances is extremely difficult.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram normal, Exercise tolerance decreased, Fatigue
Clinical narrative: In the afternoon the day after I received the booster, I began feeling chest pain. The center of my chest ached and I felt shooting pains into my back, up my neck, and down my left arm. I also felt short of breath and it was very painful to lay down flat. The pain was worsened if I moved around or tried to walk. Since the pain was severe and I had never experienced chest pain before, I went to the ER on the morning of Sunday January 30th 2022. There, the EKG and Chest X Ray were clean. The doctor heard a hurt murmur and also said that my bloodwork indicated the expected immune response to the vaccine. He suspected it was a bad reaction to the vaccine and I would feel better in a few days. After a few days, I did not feel better and saw a cardiologist at facility. She suspected pericarditis and started me on colchicine. I noticed minor improvement, but not significant improvement. After two months on colchicine, since all tests were clear (MRI, EKG, ECG, Xray) and she felt that the structure of my heart was okay, she recommended I discontinue colchicine.   At the recommendation of a second cardiologist and a rheumatologist, I began amitryptalline 3 weeks ago, but have yet to notice significant improvement.  Currently, I am undergoing rheumatological and lung work ups with a rheumatologist. I continue to experience significant, debilitating symptoms. The day before I got the booster, I ran 8 miles. I was in excellent shape and was training for a marathon. Now, I have to sit down after walking up a flight of stairs because the chest pain and shortness of breath is so severe. I cannot walk more than 6 minutes without needing to rest. I struggle with fatigue. Laying down flat and laying on my right side (even if elevated) makes the pain worse. I feel best resting (no movement) and sitting either slightly slumped forward or reclining slightly. I sleep with an incline wedge pillow. I have a handicap parking pass because walking even very short distances is extremely difficult.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Immune-mediated adverse reaction, Immunisation reaction, Magnetic resonance imaging heart, Magnetic resonance imaging normal
Clinical narrative: In the afternoon the day after I received the booster, I began feeling chest pain. The center of my chest ached and I felt shooting pains into my back, up my neck, and down my left arm. I also felt short of breath and it was very painful to lay down flat. The pain was worsened if I moved around or tried to walk. Since the pain was severe and I had never experienced chest pain before, I went to the ER on the morning of Sunday January 30th 2022. There, the EKG and Chest X Ray were clean. The doctor heard a hurt murmur and also said that my bloodwork indicated the expected immune response to the vaccine. He suspected it was a bad reaction to the vaccine and I would feel better in a few days. After a few days, I did not feel better and saw a cardiologist at facility. She suspected pericarditis and started me on colchicine. I noticed minor improvement, but not significant improvement. After two months on colchicine, since all tests were clear (MRI, EKG, ECG, Xray) and she felt that the structure of my heart was okay, she recommended I discontinue colchicine.   At the recommendation of a second cardiologist and a rheumatologist, I began amitryptalline 3 weeks ago, but have yet to notice significant improvement.  Currently, I am undergoing rheumatological and lung work ups with a rheumatologist. I continue to experience significant, debilitating symptoms. The day before I got the booster, I ran 8 miles. I was in excellent shape and was training for a marathon. Now, I have to sit down after walking up a flight of stairs because the chest pain and shortness of breath is so severe. I cannot walk more than 6 minutes without needing to rest. I struggle with fatigue. Laying down flat and laying on my right side (even if elevated) makes the pain worse. I feel best resting (no movement) and sitting either slightly slumped forward or reclining slightly. I sleep with an incline wedge pillow. I have a handicap parking pass because walking even very short distances is extremely difficult.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Pericarditis, Red blood cell sedimentation rate normal
Clinical narrative: In the afternoon the day after I received the booster, I began feeling chest pain. The center of my chest ached and I felt shooting pains into my back, up my neck, and down my left arm. I also felt short of breath and it was very painful to lay down flat. The pain was worsened if I moved around or tried to walk. Since the pain was severe and I had never experienced chest pain before, I went to the ER on the morning of Sunday January 30th 2022. There, the EKG and Chest X Ray were clean. The doctor heard a hurt murmur and also said that my bloodwork indicated the expected immune response to the vaccine. He suspected it was a bad reaction to the vaccine and I would feel better in a few days. After a few days, I did not feel better and saw a cardiologist at facility. She suspected pericarditis and started me on colchicine. I noticed minor improvement, but not significant improvement. After two months on colchicine, since all tests were clear (MRI, EKG, ECG, Xray) and she felt that the structure of my heart was okay, she recommended I discontinue colchicine.   At the recommendation of a second cardiologist and a rheumatologist, I began amitryptalline 3 weeks ago, but have yet to notice significant improvement.  Currently, I am undergoing rheumatological and lung work ups with a rheumatologist. I continue to experience significant, debilitating symptoms. The day before I got the booster, I ran 8 miles. I was in excellent shape and was training for a marathon. Now, I have to sit down after walking up a flight of stairs because the chest pain and shortness of breath is so severe. I cannot walk more than 6 minutes without needing to rest. I struggle with fatigue. Laying down flat and laying on my right side (even if elevated) makes the pain worse. I feel best resting (no movement) and sitting either slightly slumped forward or reclining slightly. I sleep with an incline wedge pillow. I have a handicap parking pass because walking even very short distances is extremely difficult.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Scan with contrast normal, Sinus bradycardia
Clinical narrative: In the afternoon the day after I received the booster, I began feeling chest pain. The center of my chest ached and I felt shooting pains into my back, up my neck, and down my left arm. I also felt short of breath and it was very painful to lay down flat. The pain was worsened if I moved around or tried to walk. Since the pain was severe and I had never experienced chest pain before, I went to the ER on the morning of Sunday January 30th 2022. There, the EKG and Chest X Ray were clean. The doctor heard a hurt murmur and also said that my bloodwork indicated the expected immune response to the vaccine. He suspected it was a bad reaction to the vaccine and I would feel better in a few days. After a few days, I did not feel better and saw a cardiologist at facility. She suspected pericarditis and started me on colchicine. I noticed minor improvement, but not significant improvement. After two months on colchicine, since all tests were clear (MRI, EKG, ECG, Xray) and she felt that the structure of my heart was okay, she recommended I discontinue colchicine.   At the recommendation of a second cardiologist and a rheumatologist, I began amitryptalline 3 weeks ago, but have yet to notice significant improvement.  Currently, I am undergoing rheumatological and lung work ups with a rheumatologist. I continue to experience significant, debilitating symptoms. The day before I got the booster, I ran 8 miles. I was in excellent shape and was training for a marathon. Now, I have to sit down after walking up a flight of stairs because the chest pain and shortness of breath is so severe. I cannot walk more than 6 minutes without needing to rest. I struggle with fatigue. Laying down flat and laying on my right side (even if elevated) makes the pain worse. I feel best resting (no movement) and sitting either slightly slumped forward or reclining slightly. I sleep with an incline wedge pillow. I have a handicap parking pass because walking even very short distances is extremely difficult.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Had fever  for 3 days within 12 hours of getting vaccine, vomiting and diarrhea as well.  Still having a little bit of diarrhea for over a week.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Differential white blood cell count, Full blood count, Skin depigmentation, Skin hypopigmentation
Clinical narrative: 27 Oct 2021 Medication: TACROLIMUS 0.1 % TOP OINT [30GM] Medication: CLOBETASOL PROP 0.05 % TOP CREA [30 GM]  24yo M with patchy areas of depigmentation, concerning for vitiligo. Discussed these findings with the  patient. Considered fungal, however symptomology and distribution made it unlikely. Discussed with Dermatologist who also agreed. Plan to treat depigmentation with steroid cream with exception of tacrolimus  for genital region depigmentation. 26 Apr 2022 Pt is a 24 y/o M who presents for follow up for Vitiligo. Pt was diagnosed with vitiligo on October 2021. On exam, pt has hypopigmentation of right and left forearms, hands, shins and groin area. Pt denies pruritus or burning. No known family hx of vitiligo or autoimmune disease. Pt was prescribed steroid cream and tacrolimus in October but hasn't been applying everyday. -Discussed with pt his diagnosis of vitiligo. Educated pt the importance of covering and applying sunscreen to exposed areas for sun protection. -Pt Education on vitiligo provided to pt. - Prescribed Fluocinonide 0.05% on arms and legs and Tacrolimus to apply to genital areas only. Medication(s): - Medication: FLUOCINONIDE 0.05 % TOP OINT [15 GM]; SIG: APPLY A THIN LAYER TO AFFECTED AREA 1 TIMES A DAY AS DIRECTED #1 RF3 - Medication: TACROLIMUS 0.1 % TOP OINT [60GM]; SIG: APPLY A THIN LAYER TO GROIN EVERY DAY AS DIRECTED #1 RF3 Laboratory(ies):
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: 27 Oct 2021 Medication: TACROLIMUS 0.1 % TOP OINT [30GM] Medication: CLOBETASOL PROP 0.05 % TOP CREA [30 GM]  24yo M with patchy areas of depigmentation, concerning for vitiligo. Discussed these findings with the  patient. Considered fungal, however symptomology and distribution made it unlikely. Discussed with Dermatologist who also agreed. Plan to treat depigmentation with steroid cream with exception of tacrolimus  for genital region depigmentation. 26 Apr 2022 Pt is a 24 y/o M who presents for follow up for Vitiligo. Pt was diagnosed with vitiligo on October 2021. On exam, pt has hypopigmentation of right and left forearms, hands, shins and groin area. Pt denies pruritus or burning. No known family hx of vitiligo or autoimmune disease. Pt was prescribed steroid cream and tacrolimus in October but hasn't been applying everyday. -Discussed with pt his diagnosis of vitiligo. Educated pt the importance of covering and applying sunscreen to exposed areas for sun protection. -Pt Education on vitiligo provided to pt. - Prescribed Fluocinonide 0.05% on arms and legs and Tacrolimus to apply to genital areas only. Medication(s): - Medication: FLUOCINONIDE 0.05 % TOP OINT [15 GM]; SIG: APPLY A THIN LAYER TO AFFECTED AREA 1 TIMES A DAY AS DIRECTED #1 RF3 - Medication: TACROLIMUS 0.1 % TOP OINT [60GM]; SIG: APPLY A THIN LAYER TO GROIN EVERY DAY AS DIRECTED #1 RF3 Laboratory(ies):
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Cardiac stress test normal, Chest pain, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Patient has severe chest pain at random interval and with physical exertion. pain started on the 15th of September 2021 and is ongoing as of 02 August 2022. Patient is seeing by cardiologists, no diagnoses. Patient was seen by the emergency room 3 times, nothing was discovered.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray normal
Clinical narrative: Patient has severe chest pain at random interval and with physical exertion. pain started on the 15th of September 2021 and is ongoing as of 02 August 2022. Patient is seeing by cardiologists, no diagnoses. Patient was seen by the emergency room 3 times, nothing was discovered.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Heart rate increased, Malaise, Nasal congestion
Clinical narrative: Fri 7/29/2022: Loose stool (2-3 times); nasal congestion at night. Sun 7/30/2022: Wet cough (nasal congestion at night continued). Mon 8/1/2022: Began feeling unwell at school, but temperature okay. Coughing/congestion throughout day. 100.4 fever at 6:00 pm, gave 7.5mL ibuprofen. Gave 2.5mL Benadryl at 8:30 pm. Fast heartbeat/breathing. Fever came back around 3:00, gave 7mL ibuprofen. Fast heartbeat/breathing continued.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Pyrexia
Clinical narrative: Fri 7/29/2022: Loose stool (2-3 times); nasal congestion at night. Sun 7/30/2022: Wet cough (nasal congestion at night continued). Mon 8/1/2022: Began feeling unwell at school, but temperature okay. Coughing/congestion throughout day. 100.4 fever at 6:00 pm, gave 7.5mL ibuprofen. Gave 2.5mL Benadryl at 8:30 pm. Fast heartbeat/breathing. Fever came back around 3:00, gave 7mL ibuprofen. Fast heartbeat/breathing continued.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Since I got the vaccine I'm allergic every day; I have hives all over my body, huge, red, itchy bruises; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "not recovered", described as "Since I got the vaccine I'm allergic every day"; URTICARIA (non-serious), outcome "not recovered", described as "I have hives all over my body, huge, red, itchy bruises". Therapeutic measures were taken as a result of hypersensitivity, urticaria.  Additional Information: Everyday patient needed to take anti-allergic.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; A HCP called and reported that an expired dose of MMR II was administered to a patient on 5 JUL 2022.; This spontaneous report was received from a registered nurse and refers to a 48-year-old patient. The patient's medical history, and concurrent conditions were not provided. Concomitant therapies included sterile diluent  On 05-JUL-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) lot # T013003, expiration date 15-APR-2022, 0.5 milliliter/once (rout of administration was not provided) for prophylaxis (expired product administered). No adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; dose of improperly stored ROTATEQ was administered on 22 Jun 2022; This spontaneous report was received from health care professional referring to unspecified age and gender patient whose medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.   On 22-JUN-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (lot number: 1837116 which was verified to be valid with expiration date: 24-MAR-2023, strength, dose, and vaccination scheme frequency were not provided) (product storage error).  The dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored in a temperature above 47 degrees Fahrenheit (F) (48.7F) for 0 hours, 11 minutes, 0 seconds. No previous temperature excursion was reported. No adverse events were reported.  This is one of two reports received from the same reporter.
Age: 44.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: no adverse event; missed second dose; This spontaneous report has been received from a pharmacist referring to a 44-years-old male patient. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies was provided.  On 13-JAN-2022, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration were not reported, lot number 1775809 and expiration date 18-AUG-2023). It was reported that the patient missed his second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product dose omission issue). The patient had not received his second dose at the time of reporting. No other adverse events were reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP calling to report that an expired dose of PROQUAD was administered to a patient on 14JUL2022.; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender.   The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.    On 14-JUL-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection,(strength, dose, units, vaccination scheme, frequency, route of administration and anatomical site of injection were not provided), lot number T030944 has been verified to be a valid lot number with expiration date on 09-MAR-2022, and was reconstituted with sterile diluent (MRK) (strength, dose, units, vaccination scheme, frequency, route of administration and anatomical site of injection were not provided), lot number T020661has been verified to be a valid lot number with expiration date on 24-DEC-2022, both administered as prophylaxis. No additional adverse event was provided.   Concomitant therapie included sterile diluent (MERCK STERILE DILUENT) Lot #T020661 (had been verified to be a valid number; expiration date 24-DEC-2022, and upon internal validation established as the same date) for prophylaxis.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple temperature excursions for GARDASIL 9; This spontaneous report was received from a nurse prescriber referring to a patient of unspecified age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies was provided.  On 06-JUN-2022, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (dose at 0.5 milliliter, lot # T036444, expiration date: 09-APR-2023, strength, vaccination scheme frequency, and anatomical location were not reported) for prophylaxis after the excursion occurred (product storage error). Temperature and period of time of the temperature excursion were not provided. It was unknown if it had previous temperature excursion. No additional adverse event was reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA007365: US-009507513-2207USA007332: US-009507513-2207USA007632: US-009507513-2207USA007383: US-009507513-2207USA007612: US-009507513-2207USA007323: US-009507513-2207USA007382:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple temperature excursions for GARDASIL 9; This spontaneous report was received from a nurse prescriber referring to a patient of unspecified age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies was provided.  On 25-MAY-2022, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (dose at 0.5 milliliter, lot # T036444, expiration date: 09-APR-2023, strength, vaccination scheme frequency, and anatomical location were not reported) for prophylaxis after the excursion occurred (product storage error). Temperature and period of time of the temperature excursion were not provided. It was unknown if it had previous temperature excursion. No additional adverse event was reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA007630:
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Hypoacusis, Neuropathy peripheral
Clinical narrative: neuropathy; vision loss; issues with hearing; This spontaneous report was received from a lawyer regarding a case in litigation and refers to an approximately 61 year old patient (pt) of unknown  gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 09-JUL-2008, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, and lot # not provided) for long-term prevention of shingles and zoster-related conditions. Subsequently, as a direct result of zoster vaccine live (ZOSTAVAX) use, the patient was treated for neuropathy, vision loss, and issues with hearing. At the time of the report, the pt's outcome was unknown.  Upon internal review neuropathy and vision loss were considered to be medically significant.
Age: 42.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details were provided.; PNEUMOVAX 23 syringes expired 30MAY2022 and were administered to a patient on 31MAY2022; This spontaneous report was received from a pharmacist referring to a 42-year-old patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 31-MAY-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, dose of 0.5 mL administered intramuscularly, lot number: T032761, expiration date: 30-MAY-2022 (dose number and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse event (AE) details were provided (no adverse event). The reporter stated that pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe has never experienced a temperature excursion.
Sex: U
Vaccine: HEP
Symptoms: Exposure to communicable disease, Hepatitis B antibody
Clinical narrative: Nonresponder; Titer < 10; Initial Report Received on 24-Jun-2022, 18-Jul-2022 (non-significant from QA confirmed no action at this time).   A registered nurse reported that a patient  (age, race, and ethnicity unknown), who received Heplisav-B had a titer <10 following vaccination with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history at the time of vaccination was reported.   No concomitant medications at the time of vaccination were reported.  On unspecified dates, the patient received a full series of HEPLISAV-B injections (no details provided). It was reported that she was not given titers thereafter because HEPLISAV-B has >90% seroconversion.   On an unspecified date, months after having received HEPLISAV-B, the patient (employee) had an exposure (unspecified) and titers were checked. Titers were reported as <10.   The reporter was unable to be reached for follow-up; therefore no additional information was available.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Titers Show No Response; Initial Report Received on 27-Jun-2022 and 28-Jul-2022 (QA confirmed no potential impact to lot identified.)  A pharmacist reported that a 44-year-old female patient (race and ethnicity unknown), received 2 doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and her titer showed no response.  Medical history at the time of vaccination was unknown. The patient did not have any allergies.  Concomitant medications at the time of vaccination was not provided.  On 12-Apr-2022, the patient received the first dose of HEPLISAV-B (Lot # 934975 expiration date 13-Aug-2022, NDC # 43528-003-05; route and injection site unknown).   On 13-May-2022, 32 days after having received the first dose, the patient received the second dose of HEPLISAV-B (Lot # 934975 expiration date 13-Aug-2022, NDC # 43528-003-05; route and injection site unknown).   On an unspecified date, her titers showed no response to the HEPLISAV-B vaccinations.  No other information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: VARZOS
Symptoms: Rash papular, Rash pruritic
Clinical narrative: bumpy rash; broke out in a bumpy rash that itches; This case was reported by a consumer via interactive digital media and described the occurrence of papular rash in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced papular rash and itchy rash. On an unknown date, the outcome of the papular rash and itchy rash were recovered/resolved.   It was unknown if the reporter considered the papular rash and itchy rash to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 22-Jul-2022. Reporter's Comments: This case was reported by the patient's wife via interactive digital media. The reporter's husband got the 1st vaccine and the next day broke out in a bumpy rash that itches. It came and gone, and he never had anything like it before. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: Pain at the injection site; tired; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   In July 2022, the patient received the 2nd dose of Shingles vaccine. In July 2022, 1 day after receiving Shingles vaccine, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the injection site pain and tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-Jul-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient stated that he/she had just got the 2nd dose and was tired the next day and had some pain at the injection site.  A few coworkers have had shingles and said it was the worst pain they ever had. The patient  was fine after that and stated to get the vaccine. Follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle soreness; This case was reported by a consumer via interactive digital media and described the occurrence of muscle soreness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was not recovered/not resolved.   It was unknown if the reporter considered the muscle soreness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-JUL-2022 Reporter's Comments: This case was reported by consumer (patient) via interactive digital media. The patient asked could he/she take an aspirin or ibuprofen for muscle soreness on 2nd day of first shot.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: flu symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of flu symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   In July 2022, the patient received the 2nd dose of Shingles vaccine. In July 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced flu symptoms. On an unknown date, the outcome of the flu symptoms was recovered/resolved.   It was unknown if the reporter considered the flu symptoms to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR112016   Additional Information: GSK Receipt Date: 25-Jul-2022. Reporter's Comments: This case was reported by the patient via interactive digital media. The patient just got the 2nd vaccine shot last week. It was reported as give yourself a few days to recover from it.  The patient had flu symptoms for a couple days. It was well worth it though if it kept him/her from getting shingles. Additional Supportive Information: The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR112016:1st dose case same patient (deletion case)
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Condition aggravated, Pain in extremity, Rash
Clinical narrative: sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain in hip, arthritis (gave a cortisone shot), nerve damage, swelling of legs, swelling of feet, restless legs syndrome and difficulty sleeping. Previously administered products included Cortison.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR112120   Additional Information: GSK Receipt Date: 25-JUL-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter stated that in January 2018 he/she woke up with the most excruciating pain in his/her hip that he/she had ever experienced. The reporter stated that their rheumatologist thought it was their arthritis and gave a cortisone shot. The reporter stated that he/she did not break out until two weeks later down his/her leg. His/her life was changed. He/she had nerve damage, swelling in both feet and legs, restless leg syndrome and trouble sleeping. The reporter stated that he/she wish he/she had known about the vaccine before. The reporter stated that a small sacrifice of a sore arm. He/she have had his/her vaccine shots. The reporter stated his/her neighbor told that she had the shingles twice, so the reporter did not want to chance it. The reporter stated that he/she encourages anyone that has had the chicken pox, to go get the vaccine. Additional supportive information: No follow-up was possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR112120:same report, other dose
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: sore for several days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 27-JUL-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, it was sore for several days, but that's all.  Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: I'm still overly fatigued; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The patient was curious and he/she got the first dose a week ago.  The patient still overly fatigued The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at the injection sight; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 27-Jul-2022. Reporter's Comments: This case was reported by the other health professional via interactive digital media. The patient got the vaccine after a gentle scolding from a family member wondering why he/she had not since it was available to him/her. The patient was spurred on. 1. the fact that she had shingles and could not get vaccinated because too young.  2. ran into 2 of his/her patients with active shingles in the same week of the scolding. The patient figured someone was tried to tell something.  The patient tolerated the vaccine, slight pain at the injection site for a day or two, no big deal. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: Muscle weakness; This case was reported by a consumer via interactive digital media and described the occurrence of muscle weakness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced muscle weakness. On an unknown date, the outcome of the muscle weakness was unknown.   It was unknown if the reporter considered the muscle weakness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Jul-2022. Reporter's Comments: This case was reported by the patient via interactive digital media. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: arm was in pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, 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 Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 26-JUL-2022 Reporter's Comments: The patient was a reporter's daughter. The reporter stated that, the patient received Bexsero injection before going to college and her arm was in pain for about 3 weeks afterwards. The reporter mentioned, he/she knew the second dose could be given 1 month after the first dose but how far past one month could it be given. The reporter just wanted to know if they could wait longer than a month to get the second dose. The consent to follow-up was requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown 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.     Linked case(s) involving the same patient: US2022112326   Additional Information: GSK Receipt Date: 28-JUL-2022 Reporter's Comments: The case was self reported by the patient. The patient received first dose of Shingrix vaccine and experienced a sore arm. Patient gave consent to follow up with HCP (pharmacy). Additional supportive information: For tolerance of 2nd dose, refer case US2022112326.; Sender's Comments:  US-GSK-US2022112326:Same reporter, same case
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: injection site pain, other symptoms; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Jul-2022 Reporter's comment: The patient received Bexsero and experienced injection site pain and other symptoms that led her to visit the emergency room. No other details were given. The reporter consented to follow up. Additional Supportive Information: This case had been linked with US2022AMR112712, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR112712:same report, other patient
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: Injection site pain; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Jul-2022 Reporter's comment: The nurse reported that the patients received Bexsero and had experienced injection site pain and other symptoms that led her to visit the emergency room. No other details were given. The reporter consented to follow up. Additional Supportive Information: This case had been linked with US2022AMR112709, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR112709:same report, other patient
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: moderate headache; Fever; This case was reported by a other health professional and described the occurrence of headache in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2022 14:30, the patient received Shingrix. In July 2022, 13 hrs 30 min after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown.   The reporter considered the headache and fever to be related to Shingrix.  Additional Information: GSK Receipt Date: 28-Jul-2022. Reporter's Comments: The case was self-reported by the patient who was other health professional. After receiving the Shingrix and after going to sleep at 11:30 PM on the same day. The patient woke up on 28th July 2022 at 4:00 AM with moderate headache and fever. The reporter believed these were the side effects of the vaccine. The reporter consented to follow up. Additional Supportive Information: To reflect precise time to onset for the events, partial event onset dates were captured.