chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Patient was getting a booster dose. Had no problems with the primary series. Mother called 1 1/2 hours after patient had the vaccine to say that patient had itching all over and tingling. Instructed to give benadryl and watch if needed to take into the emergency room. Spoke with mother again today and said the symptoms had all gone away after the benadryl and patient was fine now.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Pain
Clinical narrative: Swollen left ankle and right knee. Minor pain
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested Positive for COVID on 6/20/2022
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, COVID-19, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: In late May I got a very sore throat and lost my voice and then 2 weeks later tested positive for Covid
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Blindness, Chest pain, Hypoaesthesia oral, Migraine
Clinical narrative: Heart/chest pain, Loss/Blurred vision, Tingling in left arm/fingers/toes, heart racing, Migraines, tongue numbness
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Vision blurred
Clinical narrative: Heart/chest pain, Loss/Blurred vision, Tingling in left arm/fingers/toes, heart racing, Migraines, tongue numbness
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Mechanical urticaria, Myocarditis, Peripheral coldness, Skin discolouration
Clinical narrative: Myocarditis, chronic urticaria/dermatographia, difficulty breathing, blueish/purple/yellow/cold hands and feet
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria chronic
Clinical narrative: Myocarditis, chronic urticaria/dermatographia, difficulty breathing, blueish/purple/yellow/cold hands and feet
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities
Clinical narrative: On June 20 of this present year,  I went to a Vaccination room to get 4 doses vaccination here in locally, the fourth dose with the Moderna vaccine, after that I felt normal symptoms after vaccination, but after 2 days the normal pain in shoulder disappeared. But after 5 days I began to feel pain in the arm Joint (elbow), which does not allow me to do my daily activities normally, I have tried to take pain medications, such as paracetamol, dolocordralan, ibuprofen, Diclofenac, Naproxen and Vitamins such as B Complex, etc.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Sciatica
Clinical narrative: sciatica severe pain
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Loss of consciousness, Nausea
Clinical narrative: 2nd Pfizer booster (initial vaccine was JJ&J single dose). Normal side-effects during first day after injection, including sore arm, headache, fatigue, mild nausea, and slightly elevated heart rate.  One day after injection (~27 hours) vasovagal syncope; unconscious 1-2 minutes with full recovery with 10-15 minutes; evaluated by EMTs immediately after syncope event. Otherwise athletically fit and healthy.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Syncope
Clinical narrative: 2nd Pfizer booster (initial vaccine was JJ&J single dose). Normal side-effects during first day after injection, including sore arm, headache, fatigue, mild nausea, and slightly elevated heart rate.  One day after injection (~27 hours) vasovagal syncope; unconscious 1-2 minutes with full recovery with 10-15 minutes; evaluated by EMTs immediately after syncope event. Otherwise athletically fit and healthy.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Thrombosis
Clinical narrative: Patient was menstruating regularly before vaccination. Not heavy flow.  No period for May and June 2021. July - period for about 3 weeks. Aug - period with huge  table tennis ball size clots. Clots at least 3 times a day. Flow become heavy. Pads would drip blood. Had to move from ultra thin to heavy pads. Don't remember menstruating this heavy even in my younger days.   Periods every 2 weeks. 2022 ? still having more blood loss compared to before vaccine but less than after vaccine.  Clot size now small. Maybe size of 3 cherries.   Still having to use medium size pads instead of ultra thin pads.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: covid
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Aspiration, COVID-19, SARS-CoV-2 test positive
Clinical narrative: 01/20/22 presents to EC ED for "was eating and aspirated". PMHX of "Liver failure, Anxiety, Asthma, BCC, DM, Bipolar, GERD, and Pulm HTN"
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Breakthrough Case of COVID -19; At night I could not sleep and felt pretty crappy at first, and I was just two weak, I felt sweaty and lightheaded and the next morning I woke up with a cough and a sore throat, and later that day I took the Test at home and it was positive. Took the 5 day treatment of PAxlovid. After 5 days I tested negative, and then 3 days later I started feeling bad again and tested positive for COVID-19 again. I was not feeling good for another 6 days and then tested negative again. Still not as strong as I used to be and not as perky as I used to be, I am having some shortness of breath as well.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, COVID-19, Cough, Dizziness
Clinical narrative: Breakthrough Case of COVID -19; At night I could not sleep and felt pretty crappy at first, and I was just two weak, I felt sweaty and lightheaded and the next morning I woke up with a cough and a sore throat, and later that day I took the Test at home and it was positive. Took the 5 day treatment of PAxlovid. After 5 days I tested negative, and then 3 days later I started feeling bad again and tested positive for COVID-19 again. I was not feeling good for another 6 days and then tested negative again. Still not as strong as I used to be and not as perky as I used to be, I am having some shortness of breath as well.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Feeling abnormal, Hyperhidrosis, Insomnia, Oropharyngeal pain
Clinical narrative: Breakthrough Case of COVID -19; At night I could not sleep and felt pretty crappy at first, and I was just two weak, I felt sweaty and lightheaded and the next morning I woke up with a cough and a sore throat, and later that day I took the Test at home and it was positive. Took the 5 day treatment of PAxlovid. After 5 days I tested negative, and then 3 days later I started feeling bad again and tested positive for COVID-19 again. I was not feeling good for another 6 days and then tested negative again. Still not as strong as I used to be and not as perky as I used to be, I am having some shortness of breath as well.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection, X-ray
Clinical narrative: Breakthrough Case of COVID -19; At night I could not sleep and felt pretty crappy at first, and I was just two weak, I felt sweaty and lightheaded and the next morning I woke up with a cough and a sore throat, and later that day I took the Test at home and it was positive. Took the 5 day treatment of PAxlovid. After 5 days I tested negative, and then 3 days later I started feeling bad again and tested positive for COVID-19 again. I was not feeling good for another 6 days and then tested negative again. Still not as strong as I used to be and not as perky as I used to be, I am having some shortness of breath as well.
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Generalised tonic-clonic seizure, Petit mal epilepsy, Vaccination site cellulitis, Viral rash
Clinical narrative: She has had three tonic/clonic seizures and an absent seizure. The last tonic/clonic was on 7/13/2022 and lasted for 7 minutes and did not stop for diastat. She also did not have control of her left arm after this event. This is a major increase in seizure activity because she had been without a seizure since April. She has now started on Zonisamide on addition to the keppra to try and control the increased activity.
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Generalised tonic-clonic seizure, Motor dysfunction, Neurological symptom, Petit mal epilepsy
Clinical narrative: She has had three tonic/clonic seizures and an absent seizure. The last tonic/clonic was on 7/13/2022 and lasted for 7 minutes and did not stop for diastat. She also did not have control of her left arm after this event. This is a major increase in seizure activity because she had been without a seizure since April. She has now started on Zonisamide on addition to the keppra to try and control the increased activity.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I did not have an adverse reaction to the vaccine. I started feeling bad on 06/14 through 06/16. I had sinus drainage and sore throat. On 06/17 I tested positive for COVID-19 at a satellite office of my primary care doctor. They prescribed PAXLOVID. I took the first evening dose and work up early and could not breathe. I went to the ER and it felt like my throat was closing. They kept me overnight for observation. I continue to have drainage.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, Feeling abnormal, Oropharyngeal pain, Paranasal sinus hypersecretion
Clinical narrative: I did not have an adverse reaction to the vaccine. I started feeling bad on 06/14 through 06/16. I had sinus drainage and sore throat. On 06/17 I tested positive for COVID-19 at a satellite office of my primary care doctor. They prescribed PAXLOVID. I took the first evening dose and work up early and could not breathe. I went to the ER and it felt like my throat was closing. They kept me overnight for observation. I continue to have drainage.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Sleep disorder, Throat tightness
Clinical narrative: I did not have an adverse reaction to the vaccine. I started feeling bad on 06/14 through 06/16. I had sinus drainage and sore throat. On 06/17 I tested positive for COVID-19 at a satellite office of my primary care doctor. They prescribed PAXLOVID. I took the first evening dose and work up early and could not breathe. I went to the ER and it felt like my throat was closing. They kept me overnight for observation. I continue to have drainage.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: He was fine until exactly 7 days post-injection when he grabbed his upper left arm and said "ow it hurts".  He had a large, round  red swelling greater than 3 mm in diameter,  It felt hot to the touch.  After it did not resolve within two days, I took him to be seen by his primary doctor's practice.  They said they thought it was an injection reaction and to treat it with ice packs and ibuprofen, which we did for a couple of days.  It improved significantly that weekend.  Now, three weeks later, there is only mild discoloration remaining at the injection site.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Pain in the shoulder, restrictions of movement
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Cough, Headache, Malaise, Pyrexia
Clinical narrative: Fever, headache, malaise, cough, runny nose, GI upset
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: Fever, headache, malaise, cough, runny nose, GI upset
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Nausea, vomiting and sweating.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; PNEUMOVAX 23 was administered to the patient after the excursion occured; This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 17-MAR-2022, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #U022819, expiration date: 14-JAN-2023) for prophylaxis (strength, dose and route of administration were not provided) (product storage error).  It was reported that the suspect vaccine was exposure to a temperature of 0.8 degree Celsius for a time frame of 24 hours. There was previous temperature excursion. No additional adverse event was reported.   This is one of the several reports reported by the same reporter. ; Sender's Comments:  US-009507513-2206USA006770: US-009507513-2206USA006587: US-009507513-2206USA007094: US-009507513-2206USA006674: US-009507513-2206USA007098: US-009507513-2206USA007068:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported; VARIVAX was delivered on 07JUN2022 after the receive by date of 06JUN2022; This spontaneous report was received from a medical technologist lab manager and refers to a specific patient (age and gender not provided). The pertinent medical history, concomitant therapies and drug allergy or reactions were not provided.  The manager reported that the varicella virus vaccine live (oka/merck) (VARIVAX) was delivered on 07-JUN-2022 after the receive by date of 06-JUN-2022 (temperature and time frame were unknown). On 15-JUN-2022, the patient was vaccinated with the varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W002599 has been verified to be a valid lot number, expiration date: 24-JAN-2024) for prophylaxis (formulation, strength, dose, and route of administration were not provided) (Product storage error). No additional adverse event (AE) or product quality complaints (PQC) reported (no adverse event). There was no Previous temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; a dose of PROQUAD that experienced a temperautre excursion was administered to the patient after the excursion occured; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 15-JUN-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine (live recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection (0.5 milliliter, lot #U039262, expiration date: 09-JUN-2023) administered for prophylaxis (strength, and route of administration were not provided) (product storage error).  It was reported that the suspect vaccine was exposed to a temperature of 7.7 Fahrenheit (F) for a time frame of 30 minutes. There was previous temperature excursion.  No additional adverse event was reported.   This is one of the several report received from the same reporter.; Sender's Comments:  US-009507513-2206USA007839: US-009507513-2206USA007845:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; a dose of VARIVAX that experienced a temperautre excursion was administered to the patient after the excursion occured.; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 14-JUN-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (0.5 milliliter, lot #U029496, expiration date: 21-SEP-2023) administered for prophylaxis (strength, and route of administration were not provided) (product storage error).  It was reported that the suspect vaccine was exposed to a temperature of 7.7 Fahrenheit (F) for a time frame of 30 minutes. There was previous temperature excursion.  No additional adverse event was reported.   This is one of the several report received from the same reporter.; Sender's Comments:  US-009507513-2206USA007839: US-009507513-2206USA007845:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired VAQTA was administered to a patient; This spontaneous report was received from a medical assistant and referred to a patient of unknow age and gender. The medical history, current conditions and concomitant medications were not provided.  On 30-JUN-2022, the patient was administered with expired hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot #T031201, expiration date: 14-JUN-2022; strength, dose, frequency and route were unknown) for prophylaxis (expired product administered).  The hepatitis a vaccine, inactivated (VAQTA) had been stored according to the labeling through the date of administration. No additional AE details. No additional adverse event was reported.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Caller states an expired dose of PNEUMOVAX 23 (pfs) [ lot: T035379; exp: 5/31/2022] was administered to a patient; This spontaneous report was received from an office manager (also reported as a health care business professional) and referred to a 73 years old female patient. The medical history, current conditions and concomitant medications were not provided.  On 29-JUN-2022, the patient was administered with expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose: 1 (unit not provided), lot # T035379, expiration date: 31-MAY-2022; strength and route were unknown) for prophylaxis (expired product administered).  The vaccine was stored at the recommended storage range until administration. The reporter was provided with supported disclaimer per article guidance and post expiry memo. No additional AE reported.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse reaction or symptoms; a dose of PNEUMOVAX 23 was ordered to be given in December 2022. However, the dose was given today, 06/30/2022; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 30-DEC-2021, the patient was vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (strength, dose, route of administration, anatomical location, indication, lot# and expiration date were not reported). On 30-JUN-2022, the patient was vaccinated with an early dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # U022984, expiration date was not reported, but upon internal validation established as 29-JAN-2023; strength, dose, route of administration and anatomical location were not reported) for prophylaxis, which was ordered to be given in December 2022 (inappropriate schedule of product administration). The patient had no adverse reaction or symptoms from receiving either vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available.; 10 total doses of VARIVAX (6 doses) and PROQUAD (4 doses) that have been stored outside of recommended range have been administered to patients; This spontaneous report was received from an office manager in charge of vaccine storage and refer to a patient of unknown age and gender. Concomitant medications included sterile diluent (manufacturer unknown). Pertinent medical history and drug reactions/allergies were not reported.  On 28-JUN-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot #U039722, expiration date: 15-DEC-2023), administered for prophylaxis (strength, dose, and route of administration were not provided) (product storage error).  It was reported that the suspect vaccine was exposed to a temperature of 6 degree Fahrenheit (F) up to 14 F for 0 hour 50 minutes 0 second; 14 F up to 46 F (15 F) for 0 hour 30 minutes 0 second. There were no previous temperature excursions. No additional adverse event (AE) details were available.  This is one of the several report received from the same reporter.; Sender's Comments:  US-009507513-2207USA000680: US-009507513-2207USA000470: US-009507513-2207USA000563: US-009507513-2207USA000544:
Sex: U
Vaccine: MMRV
Symptoms: Product use issue, Wrong product administered
Clinical narrative: HCP reporting a patient older than 13 years of age was administered PROQUAD instead of MMR II and VARIVAX; HCP reporting a patient older than 13 years of age was administered PROQUAD instead of MMR II and VARIVAX; This spontaneous report was received from a nurse and referred to an older than 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (product use issue; wrong product administered).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE details available; stored outside of recommended range; This spontaneous report was received from an office manager in charge of vaccine storage, referring to a patient of unknown age and gender. The medical history and current conditions were not provided. The concomitant medication included sterile diluent (manufacturer unknown).   On 28-JUN-2022, the patient was administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) subcutaneous injection (lot #W006585, expiration date: 23-AUG-2023; strength, dose, frequency, lot# and expiration date were unknown) for prophylaxis, which was a frozen and refrigerated product and had been stored outside of recommended range (Incorrect product storage). The temperature excursion (TE) frame was 6 degree Fahrenheit up to 14 degree Fahrenheit for 0 hour 50 minutes 0 second, 14 degree Fahrenheit up to 46 degree Fahrenheit (15 Fahrenheit) for 0 hour 30 minutes 0 second. There was no previous temperature excursion. No additional AE details available.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA000680:MSD US-009507513-2207USA000771:MSD US-009507513-2207USA000470:MSD US-009507513-2207USA000561:MSD US-009507513-2207USA000544:MSD US-009507513-2207USA000552:MSD US-009507513-2207USA000563:MSD US-009507513-2207USA000765:MSD US-009507513-2207USA000553:MSD
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; administration of expired ROTATEQ vaccine.; This spontaneous report was received from an office manager referring to a 2-month-old female patient. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 05-JUL-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (2 ml/once, lot # 1707469, expiration date: 31-MAR-2022; strength was not reported) orally for prophylaxis (expired product administered). No adverse effects were reported at that time.
Age: 70.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product confusion, Wrong product administered
Clinical narrative: patient was asymptomatic. No additional AE reported.; accidentally administered PNEUMOVAX 23 instead of PREVNAR 20; product confusion; This spontaneous report was received from a clinical assistant referring to a 70-year-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 10-JUN-2022, the patient was accidentally administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (once, lot # U026796, expiration date: 28-JAN-2023; strength, dose, route of administration and anatomical location were not reported) for prophylaxis, instead of pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) (strength, dose, route of administration, anatomical location, indication, lot# and expiration date were not reported) (wrong product administered and product confusion). Agent was filing an event due to product confusion. The patient was asymptomatic. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles shot, got a severe case of shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-Jul-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The reporter was patient wife. The reporter and her husband paid for shingles shot and the husband got severe case of shingles. The reporter mentioned many people who have taken the expensive shot and later still got shingles. The shot was expensive and did not work. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case has been linked with the case US2022AMR105921 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105921:same report, other patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: shingles, having them, shots help with pain/ suspected vaccination failure; shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 68-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-JUL-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The reporter stated he/she urge you to get vaccinated even though you have shingles now. The patient stated that in his 68 years of having them they did not ever go away completely but the shots help with the pain. Additional supportive information This case was considered as suspected vaccination failure the details regarding completion of primary vaccination schedule time to onset and laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: severe headache; nausea; fever; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a 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, 18 hrs after receiving Shingles vaccine, the patient experienced headache, nausea and fever. On an unknown date, the outcome of the headache, nausea and fever were unknown.   It was unknown if the reporter considered the headache, nausea and fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-JUL-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient received first dose Shingles vaccine and about 18 hours later experienced severe headache, nausea and a fever of 100.5 (unit unknown). The patient read somewhere that if GlaxoSmithKline had side affects GlaxoSmithKline should report them. Additional supportive information: The follow-up would not possible as no contact details were available.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the adjuvant component; received only the adjuvant component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 3BD53, expiry date 7th July 2023) for prophylaxis.   On 8th July 2022, the patient received the 1st dose of Shingrix. On 8th July 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 08 July 2022 Reporter's Comments:  The reporter stated patient received only the adjuvant component of the vaccine. The patient was monitored for 2 hours and there were no reactions. The reporter consented to follow up. Additional supportive information As patient received only adjuvant component of the vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 0.25
Sex: F
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Hiberix mixed with sterile water; Hiberix mixed with sterile water administered; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 3-month-old female patient who received Hib (Hiberix) (batch number FY4E9, expiry date 20th June 2023) for prophylaxis.   On 8th July 2022, the patient received Hiberix. On 8th July 2022, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 08-JUL-2022 Reporter's Comments:  The clinical manager reported that administered Hiberix mixed with sterile water to a pediatric patient on 8th July 2022.  After uncovering the vaccine was reconstituted with sterile water rather than the appropriate saline diluent. This reporter wanted to know if they need to contact the patients parents to get revaccinated due to saline diluent not used to reconstitute. This adverse event was reported even when another GSK representative was first to hear about it. This exact scenario and patient could already be reported by another instance. The reporter consented to follow up. Additional Supportive Information: The patient received Hiberix vaccine, which was reconstituted with sterile water rather than the appropriate saline diluent, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. This case was identified as duplicate of case US2022104931. All future correspondence would be added in case US2022104421, which stands as case of record for this patient and the case US2022104931 would be deleted.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022104931:duplicate case
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Night sweats, Pain, Pyrexia
Clinical narrative: Night sweats; Achiness; Slight fever; Headache; This spontaneous case was reported by a patient and describes the occurrence of NIGHT SWEATS (Night sweats), PAIN (Achiness), PYREXIA (Slight fever) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 032L20A and 025L20A) for COVID-19 prophylaxis.     The patient's past medical history included Flu vaccination. Concurrent medical conditions included Drug allergy (Codeine and derivates), High cholesterol (Start Date : 35 or 40 years ago), Esophageal reflux (Start Date : 25 or 30 years ago) and Asthma (Start Date : 25 or 30 years ago). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, SIMVASTATIN for High cholesterol, FLUOXETINE HYDROCHLORIDE (PROZAC), PRIMIDONE, CALCIUM and VITAMINS NOS for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced NIGHT SWEATS (Night sweats), PAIN (Achiness), PYREXIA (Slight fever) and HEADACHE (Headache). On 30-Oct-2021, NIGHT SWEATS (Night sweats), PAIN (Achiness), PYREXIA (Slight fever) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had received flu shot before 1st booster.  Other concomitant medications includes Nexium .  After the first dose, On 30-Dec-2020, the patient experienced Night sweats, Achiness, Slight fever and Headache. On 31-Dec-2020 events had resolved. After the second dose, On 25-Jan-2021, the patient experienced Night sweats, Achiness, Slight fever and Headache. On 26-Jan-2021 events had resolved.  No treatment information was provided.   This case was linked to MOD-2022-607741 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Influenza like illness, Pain
Clinical narrative: Flu like symptoms; Pains; Low energy/ Moderna Covid 19 vaccine and these doses took her down for 2 days.; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pains) and ASTHENIA (Low energy/ Moderna Covid 19 vaccine and these doses took her down for 2 days.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A, 036B21A and 03421F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Food allergy, Allergy to grains, Vegetable allergy and Drug allergy. Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pains) and ASTHENIA (Low energy/ Moderna Covid 19 vaccine and these doses took her down for 2 days.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pains) and ASTHENIA (Low energy/ Moderna Covid 19 vaccine and these doses took her down for 2 days.) had not resolved.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error
Clinical narrative: Vaccine was stored on 2Jun2022 and administered on 6Jul2022; Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.; second dose 10-Feb-22 and booster dose 6-Jul-22; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 10-Feb-22 and booster dose 6-Jul-22) and PRODUCT STORAGE ERROR (Vaccine was stored on 2Jun2022 and administered on 6Jul2022) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 068H21A and 066H21A) for COVID-19 prophylaxis.     Patient had no known allergies.    On 13-Jan-2022 at 8:34 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 10-Feb-2022 at 8:37 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 10-Feb-22 and booster dose 6-Jul-22). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored on 2Jun2022 and administered on 6Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 10-Feb-22 and booster dose 6-Jul-22) and PRODUCT STORAGE ERROR (Vaccine was stored on 2Jun2022 and administered on 6Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  The patient had never been diagnosed with/ tested positive for COVID 19.  Acute illness at the time of vaccination and up to one month before was reported as none. Patient received a booster dose of vaccine from a vial that had exceeded its 30 day working expiration. No adverse events noted at the time of reporting. Number of doses and vials were reported as 15 doses and 3 red cap vials.  Vial was initially stored in the refrigerator on 02-JUN-2022  The vial did not undergo any temperature excursions.  Treatment details were not reported by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022.; Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022.) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 034F21A, 048B21A and 018B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension (No recent change.) since 01-Nov-2018, Glaucoma (No recent change.) since 19-Jun-2020, Osteoarthritis (No recent change.) since 05-Dec-2018, GERD (No recent change.) since 13-Jan-2021 and Chronic pain (No recent change.) since 13-Jan-2021. Concomitant products included OMEPRAZOLE from 19-Jun-2020 to an unknown date for GERD, BRIMONIDINE TARTRATE (BRIMONIDINE [BRIMONIDINE TARTRATE]) from 08-Apr-2022 to an unknown date and LATANOPROST from 14-Mar-2019 to an unknown date for Glaucoma, AMLODIPINE from 19-Jun-2020 to an unknown date for Hypertension, CELECOXIB from 13-Jan-2021 to an unknown date for Osteoarthritis and Chronic pain.   On 21-Mar-2021 at 10:08 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 20-Nov-2021 at 9:19 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 05-Jul-2022 at 1:34 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 05-Jul-2022 at 1:34 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 02-Jun-2022  The vial did not undergo any temperature excursions.  No adverse events had occurred.  Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine stored in refrigerator on 02Jun2022 and administered on 07Jul2022; Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 02Jun2022 and administered on 07Jul2022) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 026A21A and 031M21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergic reaction to antibiotics, Bipolar disorder, Post-traumatic stress disorder, Restless legs syndrome, Hypothyroidism, Osteoporosis, Sleep disorder and Depression. Concomitant products included ESCITALOPRAM from 17-Jun-2021 to an unknown date for Bipolar depression and Depression, LEVOTHYROXINE from 20-Aug-2020 to an unknown date for Hypothyroidism, TRAZODONE from 13-Sep-2021 to an unknown date for Post-traumatic stress disorder and Sleep disorder, ROPINIROLE from 13-Dec-2021 to an unknown date and GABAPENTIN from 16-Jun-2021 to an unknown date for Restless legs syndrome, ACICLOVIR (ZOSTER) for an unknown indication.   On 12-Feb-2021 at 9:28 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Mar-2021 at 1:29 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 07-Jul-2022 at 9:59 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 02Jun2022 and administered on 07Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 02Jun2022 and administered on 07Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial was initially stored on refrigerator on 02-Jun-2022. The vial did not undergo any temperature excursion.  No adverse events noted at the time of reporting.  No treatment was reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Overdose, Product storage error
Clinical narrative: Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration; Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration; Patient received a booster dose of Moderna COVID vaccine (0.5 ml Dose reported); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration), EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and OVERDOSE (Patient received a booster dose of Moderna COVID vaccine (0.5 ml Dose reported)) in a 46-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2022 at 1:31 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 06-Jul-2022 at 1:31 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and OVERDOSE (Patient received a booster dose of Moderna COVID vaccine (0.5 ml Dose reported)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration). At the time of the report, PRODUCT STORAGE ERROR (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration), EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and OVERDOSE (Patient received a booster dose of Moderna COVID vaccine (0.5 ml Dose reported)) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The vial was initially stored in the refrigerator on 02-Jun-2022.  No adverse events noted at this time.  The vial did not undergo any temperature excursions.  No treatment information were provided.