chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Malaise, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: On Friday, November 25, 2022, after the holiday after work I had a sore throat.  The next morning, I could barely swallow my throat hurt so bad.  I was coughing and I had body aches.  On Sunday I tested positive for COVID-19 at home.  I called the doctor on Monday and had a video call and was prescribed Paxlovid.  I had the side effect of a metal taste.  I had diarrhea and now I feel like I have a fever and still fatigued.  I don't really feel like eating much because it makes me feel sick.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: On Friday, November 25, 2022, after the holiday after work I had a sore throat.  The next morning, I could barely swallow my throat hurt so bad.  I was coughing and I had body aches.  On Sunday I tested positive for COVID-19 at home.  I called the doctor on Monday and had a video call and was prescribed Paxlovid.  I had the side effect of a metal taste.  I had diarrhea and now I feel like I have a fever and still fatigued.  I don't really feel like eating much because it makes me feel sick.
Age: 0.83
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given an extra dose of HEP B. Patients mother stated the baby is fine no adverse reactions noted.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea, SARS-CoV-2 test, Sleep disorder
Clinical narrative: Starting yesterday 12/12/2022 really bad cough and runny nose; awaked out of sleep with coughing spells.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received the Pfizer monovalent vaccine noted above instead of receiving the Pfizer bivalent vaccine booster.  NO adverse reactions. Pt notified of vaccine error, denies any side effects/adverse effects.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: NO adverse reactions.  Patient received the Pfizer monovalent vaccine noted above instead of receiving the Pfizer bivalent vaccine booster.  Pt notified of vaccine error, denies any side effects/adverse effects.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Had a swollen hard red mark about 2 inches in length and 1 inch across. His brother & I had same vaccine without any hard knots under the skin or redness. The area does not blanch when pushed or squeezed.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Developed bilateral tinnitus approximately 48 hours after receiving COVID bivalent booster.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Throat tightness, Tongue discomfort
Clinical narrative: tightening of throat and tongue within approximately 45 minutes  pt took benadryl and had epipen on hand if needed
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Nodule, Pain
Clinical narrative: Pt reported on 12/13/22 that he had pain and a small nodule after getting moderna back on 3/01/22.  The pain and nodule lasted a couple of months but has resolved completely.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema
Clinical narrative: burning redness on lower back that persists.
Age: 45.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Patient was given expired hep B.  vaccine.  Vaccine given on 10/12/22.  The expiration for the vaccine was 10/08/22 (expired by 4 days).  The Provider and Patient was notified right away.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Injection site pain, Lymphadenopathy, Nausea, Pain
Clinical narrative: Fever of 100.3 on and off for 48 hours, violent chills, body aches, nausea, pain at injection site, swelling of lymph nodes in left armpit for several days after injection
Age: 16.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Dizziness, Injection site pain, Loss of consciousness, Pallor, Syncope
Clinical narrative: Patient felt dizzy after getting Flucelvax shot since it "hurt". Waited a minute and then gave COVID booster when patient was ready. Patient began to feel more lightheaded and turned pale. Patient fainted and had difficulty coming to. Pharmacy Intern got the pharmacist for help and called 911. Patient was moved to the floor. Paramedics arrived and took over the situation. Patient was transported out on a stretcher but was alert and oriented.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient stated presently having left arm pain/discomfort with limited range of motion which has continued since vaccine administration.  Pt has taken both Tylenol 500mg & Ibuprofen 800mg at different times w/c would give her temporary relief. Hot/cold compresses have not been effective.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis, Embolism venous, Pain in extremity, Tenderness, Tendonitis
Clinical narrative: Developed venous thromboembolism x 2 (popliteal and posterior tibial) in left lower extremity..  Received vaccination on Thursday, 10/20 around 6pm, Woke up Saturday, 10/22 around 6am with LLE pain and tenderness.  Was seen by provider at my MD office on 10/24 and treated for tendinitis.  Pain worsened on 10/29 and had venous doppler on 11/2 showing clots.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: Developed venous thromboembolism x 2 (popliteal and posterior tibial) in left lower extremity..  Received vaccination on Thursday, 10/20 around 6pm, Woke up Saturday, 10/22 around 6am with LLE pain and tenderness.  Was seen by provider at my MD office on 10/24 and treated for tendinitis.  Pain worsened on 10/29 and had venous doppler on 11/2 showing clots.
Age: 5.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Incorrect vaccine and dosage were administered. The patient received 0.25 mL of Moderna vaccine approved for ages 6+ (Gray border).  There were no adverse signs or symptoms reported.
Age: 5.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Fatigue, Incorrect dose administered, Malaise, Nausea, Vomiting
Clinical narrative: Incorrect vaccine and dosage were administered. The patient received 0.25 mL of Moderna vaccine approved for ages 6+ (Gray border).  There were no adverse signs or symptoms reported.
Age: 10.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok intended for 18 yo or older administered to pt. no treatment, no side effects, no concerns
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Psychotic disorder, Schizophrenia
Clinical narrative: Mental psychosis psychotic schizophrenic
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Showed patient due for 5th COVID shot. The patient actually was not due.
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok vaccine intended for 18 yo and older administered to pt, no side effects, treatment required
Age: 23.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: A rash on my upper left arm surrounding the injection shot site where a small raised area in a circle surrounded the injection location. This occurred 3.5 days after receiving the injection
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Low Fever, Chills and Body Aches
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Blood sodium increased, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Sternum rebound tenderness.  Severe Chest pain in the center of chest wall. Shortness of breath Dizziness Pounding Heart rate and Tachycardia
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Full blood count normal, Musculoskeletal chest pain, Palpitations, Tachycardia
Clinical narrative: Sternum rebound tenderness.  Severe Chest pain in the center of chest wall. Shortness of breath Dizziness Pounding Heart rate and Tachycardia
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: PFIZER 12+ DOSE WAS GIVEN INSTEAD OF PFIZER 5-11YRS DOSAGE. NO ADVERSE REACTION DURING THE 15 MINUTES OBSERVATION PERIOD
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Fatigue for 24 hours
Age: 52.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient came back after 1 hour of receiving his vaccines. He said that the left side of his face were "tingling" or feeling a little numb. Patient asked if he should go to the hospital. I advised the patient it would be a good idea to be checked out. Patient was well enough to drive and leave.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FluBlok vaccine intended for 18 yo and over was administered. No side effects or concerns
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Pain in extremity, Peripheral swelling
Clinical narrative: Prior of receiving my 1st dose of the full COVID-19 Moderna the COVIDF vaccine. I ask my primary care Dr. if there is any side effect from this COVID vaccine, Dr. informed me that there is NO side effect from this COVID-19 vaccine.  Well I signed up and got my 1st full dose of Moderna the COVID vaccine on 3/25/2021, couple days later my left leg calf swelled up so bad that I had a very hard time walking, and that I thought I develop a blood clot from the vaccine. I went out to Hospital. This is when the emergency room was experiences lots of people coming in with the same issues that I was having. An Ultra sound was done to see if there was a blood clot in my left leg.  This is when the doctor came into the room and informed me that they are seeing lots of patients that received the 1st full dose vaccine as a side effect causing their leg to swelled up. The next day I email my primary care CDr., about this. It took a while for the swelling to go down in the left leg. Then 2nd full dose of vaccine of Moderna on 04/22/2101, the same thing happened a couple days later left leg calf swelled up again. I email Dr. about this.  When they came out with the booster shots, I informed Dr. that I am NOT going through this and NO more of these COVID vaccine/boosters.  Dr. said the booster is half the dose over the full dose vaccine and will not have the side effect.  He advised me in getting the 1sst booster, received 1st booster on 11/03/2021 at pharmacy, and BINGO once again the left calf swelled up.  I informed Dr. this is it for me I'm NOT getting any more COVID vaccine/booster.  Well Dr. and Dr. (podiatric), told me to get the 2nd Booster since I was going in as outpatient for surgery on my right foot since COVID counts was so HIGH once again.  So, I went and got the 2nd Moderna booster on 06/20/2022, at Pharmacy. BINGO once again left leg calf swelled up. After this 4th COVID shot my left leg calf is still swallow and it has not gone down at all now the leg hurts.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects occurred after vaccination. Patient received the adult dose for the COVID vaccine under Pfizer manufacturer during the age of 11 years old.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: I always get a sore arm where I get the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hip replacement" (unspecified if ongoing). Concomitant medication(s) included: AMOXICILLIN taken for hip arthroplasty. Vaccination history included: Bnt162b2 (Dose: 01, Lot number: unknown), for COVID-19 immunization, reaction(s): "I always get a sore arm where I get the shot"; Bnt162b2 (Dose: 02, Lot number: unknown), for COVID-19 immunization, reaction(s): "I always get a sore arm where I get the shot". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I always get a sore arm where I get the shot".  Additional information: The patient received the newest booster dose. She consulted her dentist and recommended her to take amoxicillin due to the history of a hip replacement. At the vaccination time, she always got a sore arm where she got the shot. The patient stated that she did share information about her friends that came down with Covid-19 a few weeks (approximately 2 weeks) after receiving their Pfizer newest booster dose. She reported that she's being bombarded with multiple (8 packs) of mailed packages. She doesn't want to get any more questionnaires regarding the provided information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Asthenia, Full blood count normal, Gait inability, Metabolic function test normal, Myalgia
Clinical narrative: swollen bright red injection site, couldn't walk,  severe arm/neck pain, very fatigued, spent 6 hours in the ER.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Pyrexia
Clinical narrative: swollen bright red injection site, couldn't walk,  severe arm/neck pain, very fatigued, spent 6 hours in the ER.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Fatigue, Gait disturbance, Injection site erythema, Injection site swelling, Neck pain
Clinical narrative: swollen bright red injection site, couldn't walk,  severe arm/neck pain, very fatigued, spent 6 hours in the ER.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Pain in extremity
Clinical narrative: swollen bright red injection site, couldn't walk,  severe arm/neck pain, very fatigued, spent 6 hours in the ER.
Age: 55.0
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Caller reported patient has received 2 PNEUMOVAX 23 vaccines.  One was administered when patient was 53 years old and the other when patient was 55 years old.  No other information provided.  No additional AEs or PQC reported.  AE filed after call co; No additional AEs or PQC reported; This spontaneous report was received from a pharmacist and refers to a 55-yers-old patient of unspecified gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On an unknown date, also reported as when patient was 53-years-old, the patient was vaccinated with 1st dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (strength, dose, vaccination schedule, lot #, expiry date, site and route of administration were not provided) for prophylaxis. On an unknown age, also reported as when patient was 55-years-old, the patient was vaccinated with 2nd dose pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (Inappropriate schedule of product administration). No additional adverse events were reported.
Sex: F
Vaccine: PNC13, PNC15, PPV
Symptoms: Extra dose administered
Clinical narrative: MVCC transferred customer who had questions on appropriateness of receiving PNEUMOVAX 23 vaccine after she's already had 3 previous unspecified pneumonia vaccines. She states she is 78 years old and her healthcare provider chose to give her 3 previo; This spontaneous report was received from a 78-year-old female patient, who was referring to herself. Her concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (strength, vaccination schedule, lot #, expiry date, site and route of administration were not provided) for prophylaxis. The patient had questions on appropriateness of receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) after she already had 3 previous unspecified pneumonia vaccines, suspected to be pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (strengths, vaccination schedules, lot #, expiry dates, sites and routes of administration were not provided), or pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (formulation, strength, vaccination schedule, lot #, expiry date, site and route of administration were not provided), administered for prophylaxis (Extra dose administered). The patient reported she received 3 previous doses due to her health history as per healthcare provider's decision. No additional information was provided.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE was reported; The caller states her daughter is two and a half years old and received her second dose of the VARIVAX vaccine yesterday, November 22, 2022.; This spontaneous report was received from a consumer (patient's mother) and refers to a 2,5-year-old female patient. Her concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On an unknown date in 2021, also reported as during 12-month check up, the patient was vaccinated with 1st dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, exact dose, lot #, expiry date, site and route of administration were not provided) for prophylaxis. On 22-NOV-2022, the patient was vaccinated with 2nd dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, exact dose, lot #, expiry date, site and route of administration were not provided) (Product administered to patient of inappropriate age). The consumer was inquiring about the information on the dosing schedule of the vaccine. No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details were provided and no additional AE's were reported.; a patient was administered a dose of MMR-II on after it expired; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. Information of the patient's medical history, concomitant medication and concurrent condition was not reported.  On 18-OCT-2022, the patient was administrated a dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) subcutaneous injection 0.5ml (lot # 2034391 was evaluated and changed to the valid Lot #T034391, expiry date was reported as 08-OCT-2022, strength, route of administration and anatomical location were not provided) for prophylaxis after it expired (expired product administered). No additional AE details were provided and no additional AE's were reported (no adverse event).
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event, Product administered to patient of inappropriate age, Product quality issue
Clinical narrative: Caller (NURSE PRESCRIBER) called to know about need to give a 3rd dose of GARDASIL 9 to a female patient (23 years old); No other AE/PQC reported.; second dose of HPV 4 or GARDISIL 9 on 7/3/2017. The second dose was not in the recommended interval, it was late.; second dose of HPV 4 or GARDISIL 9; This spontaneous report was received from a nurse prescriber referring to a currently 23-years-old female patient. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 15-AUG-2014 (also reported as when she was 14-years-old, per her immunization record), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (reported as human papillomavirus vaccine [HPV 4]) (exact dose, route of administration, anatomical location, lot number and expiration dose were not reported) for prophylaxis.  On 03-JUL-2017 (per her immunization record ), the patient was vaccinated with a second dose of either of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (reported as HPV 4) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDISIL 9) (exact dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis; the second dose was not in the recommended interval, it was late (inappropriate schedule of product administration, interchange of vaccine products). Caller was not able to clarify about the HPV 4 or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDISIL 9) and what patient received, as on the immunization record it stated "HPV 4". Caller stated there was no record of the patient getting the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDISIL 9) and the patient was not sure if she received the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDISIL 9) or not. Caller wanted to know if they can give/the need to give her the third dose of the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDISIL 9) (inappropriate schedule of product administration). No other adverse event (AE)/ product quality complaint (PQC) was reported (no adverse event).
Age: 1.5
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no additional Ae; Caller states the medical assistant who administered the GARDASIL9 stated she thought she administered "Hepatitis A vaccine".; This spontaneous report has been received form a nurse, referring to a 18-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications were not provided.  On 28-NOV-2022, the patient was inadvertently vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0,5 milliliter (lot number 1775827 has been verified to be a valid lot number, expiry date 27-JUN-2024) (strength, frequency, and administration route were not reported) instead of hepatitis a vaccine, inactivated (VAQTA) oral (strength, dose, frequency, lot number, and expiry date were not reported) (wrong product administered)indicated as prophylaxis.   No additional adverse events reported.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: patient had syncope 10 minutes; This spontaneous report was received from a physician via a company representative, referring to a 12-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were unknown.   On an unknown date, 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) injection (lot #U031056, expiration date was not reported, but upon internal validation established as 16-JUN-2024) for prophylaxis (dose, strength and route of administration were not provided).  On an unknown date, the patient had syncope 10 minutes after vaccination. At the time of reporting, the outcome of the event syncope was unknown.  It was unknown whether lab diagnostics/ studies were performed, whether the patient sought medical attention or whether the patient was given treatment for the event syncope.   The causal relationship between syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.   Upon internal review, the event syncope was determined to be medically significant. ; Sender's Comments:  US-009507513-2212USA002944:
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Customer reported expired GARDASIL 9 was a administered to a patient today (12/08/2022). She said the vaccine had expired in Sep2022 (exact date was unknown to the caller). She was calling to check if the vaccine was still viable? She said she would; This spontaneous report was received from a nurse and refers to a female patient of unknown. The patient's pertinent medical history, drug allergies or reactions, and concomitant medications were unknown by the reporter.  On 08-DEC-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL (route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number 1687291, with an expiration date of 11-SEP-2022) administered for prophylaxis (expired vaccine used). No additional adverse event (AE) or product quality complaint (PQC) were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored vaccine involved in a temperature excursion was administered to a patient; No additional AE reported; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (lot # W006595 has been verified to be a valid lot number haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date reported and establish 10-OCT-2024) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 57.49° Fahrenheit (F) for 1 hour and 45 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported; the patient received the third dose in the series before the minimum 16 week interval from the first dose; This spontaneous report was received from a medical assistant referring a 49-year-old female patient. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 09-SEP-2022, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 1 milliliter (mL) (route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis. On 07-OCT-2022, the patient was vaccinated with the second dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 1 milliliter (mL) (route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis. On 09-DEC-2022, the patient was vaccinated with the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 1 milliliter (mL) (route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis (only 13 weeks from first dose). No additional information provided.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine involved in a temperature excursion; no additional AE reported; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. Information regarding medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On an unspecified date, the patient was administered an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (dose, route of administration, and anatomical site of vaccination were not reported; lot number W006595 has been verified to be valid, expiration date reported and established as 10-OCT-2024).   It was reported that the vaccine was involved in a temperature excursion of 57.49 degrees Fahrenheit for 1 hour and 45 minutes (product storage error). No additional adverse event reported (no adverse event).
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine involved in a temperature excursion was administered to a patient; No additional AE reported; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On an unspecified date, the patient was administered an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, route of administration, and anatomical site of vaccination were not reported; lot number W006595 has been verified to be valid, expiration date reported and established as 10-OCT-2024) for prophylaxis.   It was reported that the vaccine was exposed to a temperature excursion of 57.49 degrees Fahrenheit for 1 hour and 45 minutes (product storage error). No additional adverse events were reported (no adverse event).
Age: 0.17
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received Bexsero at 2 months; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male 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 inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   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: 03 DEC 2022 Reporter's comment: This case was reported by the patient's parent via interactive digital media. The reporter stated that patient received 1st dose of Bexsero vaccine at the age of 2 months. Additional supportive information: The patient received Bexsero at the age of 2 months which led to inappropriate age at vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose year ago, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received more than a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 05-Dec-2022 The Patient said she received her first shingrix shot more than a year ago and had not received the second shingrix shot. No further information was reported.  The reporter did not consent to follow up.  Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Illness, Pain
Clinical narrative: GOT LITTLE BIT SICK; BIG BRUISE HURTS LIKE HELL; ACHES AND PAINS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: chemotherapy (when she was 21 years old), and concurrent conditions included: bronchitis (from childhood), immunocompromised, traumatic brain injury (brain damage) (The patient is wheel chair bound, had a second delay, sounds like she is interrupting all the time. The processor in her brain doesn't process exactly the way it supposed to every single second, so occasionally could not come out with the right words), and paralysis on right side (sound like she was speaking weird), and other pre-existing medical conditions included: The patient did not have covid-19 and cold after vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 23-SEP-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced got little bit sick, big bruise hurts like hell, and aches and pains. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got little bit sick, big bruise hurts like hell and aches and pains was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date the next month after vaccination, the patient experienced stroke, and was in a wheel chair, probably will be rest of life. As per the patient, "I got the J & J vaccine and had stroke the next month. Still in a wheel chair and probably will be rest of my life. Cannot believe that do not have to compensate us for this". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221217904- Stroke.  The event has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Agency Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: CSF test, Central nervous system inflammation, Magnetic resonance imaging
Clinical narrative: PERSISTENT CENTRAL NERVOUS SYSTEM INFLAMMATION; This spontaneous report was received via literature: This report concerned a 43 year old female of an unspecified race and ethnicity. The objective of this study was to report a case series of 3 patients who developed neuro-inflammation following administration of the J and J vaccine. Spinal cord was involved in all 3 patients, brain in 2, and peripheral nervous system involvement (facial nerve enhancement, radiculitis) in 2 patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, approximately 4 weeks after vaccination, the patient experienced persistent central nervous system inflammation. It was reported that approximately 4 weeks after vaccination, the patient developed progressive gait difficulty and ascending paresthesias in bilateral lower extremities. Laboratory data (dates unspecified) included: CSF (Cerebrospinal fluid) test unremarkable, except for matching bands in CSF and serum, and Magnetic resonance imaging revealed multiple enhancing cervical and thoracic cord lesions and one small enhancing subcortical brain lesion. On an unspecified date (three months later), patient developed symptom recurrence with persistent enhancement and enlargement of one cord lesion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent central nervous system inflammation. The authors concluded that central and peripheral nervous system inflammatory involvement without clear alternative explanation can rarely be seen in close temporal relationship to administration of the J and J covid-19 vaccine. Unusual feature of this cases was clinical/radiographic worsening and persistent enhancement several months after initial presentation. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20221219487 and 20221219559.; Sender's Comments: V0: 20221218576-persistent central nervous system inflammation.. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: SEVERE VACCINE INJURIES; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced severe vaccine injuries. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe vaccine injuries was not reported. This report was non-serious. This case, from the same reporter is linked to 20221222509. Sender's Comments: This report is for multiple patient. Number of patients- numerous (not known exact number of patients).
Sex: M
Vaccine: COVID19
Symptoms: Death, Sepsis
Clinical narrative: PASSED AWAY; SEPSIS; This spontaneous report received from a consumer via a company representative via social media and concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sepsis and passed away. On an unspecified date, the patient died from unknown cause of death. It was unknown if autopsy was performed. Reporter stated that "Took the j &j now have stents in my legs, had a blood clot, hubby had Sepsis and passed away. I trusted because they had been around forever and should know what they are doing". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of passed away on an unspecified date, and the outcome of sepsis was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20221222579.; Sender's Comments: V0-20221222577-passed away. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20221222577-Sepsis. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID/ SOME TWICE; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced covid/ some twice. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The outcome of covid/ some twice was not reported. This report was non-serious. This case is a duplicate of 20221222696. This case, from the same reporter is linked to 20221222695, 20221222719 and 20221222717. This report was associated with a product quality complaint: 90000262535 and 90000262538.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT ISSUES; This spontaneous report received from a consumer via a company representative through media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot issues. It was reported as "One friend had blood clot issues and is still in bad shape from it". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot issues. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221222696, 20221222717 and 20221222719.; Sender's Comments: V0: 20221222695- blood clot issues. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious. This case, involving the same patient is linked to 20221222848.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a consumer via a company representative through social media concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose and start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The patient experienced side effects (adverse event NOS) when treated with covid-19 vaccine ad26. cov2 (Dose number in series 1). The outcome of side effects was not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number and expiry were not reported) dose and start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced side effects (Adverse event NOS) (Dose number in series 2) and it was reported as "Ok, make that my wife. We've lived through these side effects mysteriously since 2 days after each of her injections. All the gaslit will swear by anything the government. So the actual truth is pointless to the uninformed sheep." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious. This case, involving the same patient is linked to 20221222808.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: SEIZURE; This spontaneous report received from a consumer via a company representative via social media (J and J Corporate account) concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced seizure. It was reported as "Their vaccine caused a seizure and more for my husband. Dollar 13K in medical bills. No one cares, least of all J and J. I reported it to VAERS anyway". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221222880-seizure. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Illness
Clinical narrative: GOT SICK/ALMOST DIED THE FIRST GO ROUND; WAS IN BED SO ILL FOR 3 WEEKS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced got sick/almost died the first go round and was in bed so ill for 3 weeks. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient recovered from got sick/almost died the first go round and was in bed so ill for 3 weeks. This report was non-serious.