chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, Vitamin D
Clinical narrative: Axillary nerve inflammation causing pain  in axillary  and subscapularis nerve and referred pain into neck.  Brachial plexus.  No worse motor involvement only sensory.  It has b een painful since march with no resolution.   Just seen in this facility today and treatment has been directed.    Also rash has persisted.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site paraesthesia, Paraesthesia
Clinical narrative: Arm starting tingling at site of shot and moved down my arm, into my left hand/fingers.  Right hand/fingers also started tingling.    The next night, both hands were tingling, same thing the following night (Sunday).  Monday morning, hands started tingling again again with my feet.  Right now, Monday evening, my left foot is tingling as is my right hand.  Have never had this happen before the shot, and am convinced this is all from the shot.  What do you have in the shot that causes this?
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Breakthrough case of COVID after fully vaccinated.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: fully vaccinated (moderna, 1/14/21, 2/12/21); symptom onset 7/31/21
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Thrombosis
Clinical narrative: I have had three heavy periods after receiving the moderna shot. I have a mirena IUD and had not had a period in about 6 months besides spotting once or twice. My IUD is still effective and not near expiration. I have had very heavy periods with nickel to quarter sized blood clots. Cramping is quite painful. Hoping this information is helpful.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test positive
Clinical narrative: fully vaccinated (moderna, 3/5/21, 4/9/21); onset of symptoms 8/2/2021
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Breakthrough case of COVID after fully vaccinated.  Tested positive at urgent care 7/31/2021.  Received  8/2/2021
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: Severe pain in right ear and just anterior to ear.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage
Clinical narrative: Blood running down arm during vaccination.  The vaccinator wiped my arm down to remove blood at least 3 times.  At the time, I thought she'd spilled some vaccine.  Wasn't until I later removed the bandaid and found it was completely saturated with blood that I realized she'd hit a blood vessel or vein.  The bleeding started immediately as soon as she began injecting me, but she did not remove the needle and start again.  I'm concerned that she injected the vaccine directly into a vessel or vein.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: 100% temporary hearing loss to my Right ear less than 24hrs after first dose of Pfizer vaccine.  Condition lasted approximately 72hrs / 3 day.  After approximately 3 days symptom subsided and regained 100% hearing functionality in my Right ear.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Anosmia, Back pain, Body temperature increased
Clinical narrative: 4/25/2021 Loss of visual acuity in right eye, went to Urgent Care for testing treatment. No improvement MRI scheduled for 8/11 and referral to Rheumatology. 7/16/2021 Woke up early, felt unusually groggy, by 10:00AM I had the chills, 6:38PM temp 100 6:51PM exhausted, chills pulseox (O2) 98 Heart Rate (HR) 86 was asleep by 7:45PM. 7/17/2021 1:38AM woke up with chills temp 99.4 took Benadryl, and a Tylenol. 7:15AM temp 97.5. 10:45AM stomach cramps, achey lower back, rt. side sinuses stuffed up and fatigue 1:15PM woke up from nap, no appetite, took 1/2 hyoscamine drank gatorade. 4:00PM temp 99.4. 5:33PM temp 100 7:08PM 1/4 promethazine for stomach upset, sneezing, congested and headache 7:15PM temp 100.1 8:35PM temp 100.4 9:31PM temp 99.7 took Tylenol. 7/18/2021 7:21AM temp 99.7 O2 98 HR 76 9:00AM 5mL Children's Claritin 8:55AM temp 100.4 11:45AM temp 99.1 6:00PM temp 100.4 O2 97 HR 91, overwhelming fatigue 8:15PM temp 99.9 O2 97 HR 83 took Tylenol. 7/19/2021 6:50AM temp 99.1 O2 97 HR 87 9:00AM went to Urgent Care for symptoms, positive COVID test 11:30AM Tylenol and 5ml children's Claritin O2 98 HR 89 3:00PM temp 99.2 O2 97 HR 85 4:20PM temp 98.6 O2 98 HR 74 6:30PM nasal congestion returned 7:30PM temp 99.1 O2 99 HR 91 Tylenol, drank warm tea and gatorade 8:06PM woke up w/ low back ache and stomach cramping 9:53PM temp 98.0 O2 98 HR 71 10:00PM Sense of Smell disappeared, like a light switch, just vanished. 7/20/2021 1:00AM woke up with stomach cramps temp 98.1 O2 98 HR 71, headache 7:50AM temp 98.5 O2 97 HR 77 8:30AM took Claritin & Tylenol 9:30AM temp 97.7 O2 98 HR 68 headache, super thirsty all morning 11:30AM temp 97.6 O2 98 HR 77 12:45PM O2 98 HR 64 clinic PT/INR 2.9 4:45PM. I happened to have a heart rate monitor from Zio on during this entire time and can obtain that data for your records as well. This session is about to time about in 5 minutes and I don't want to lose what I've typed, have details through today.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Nasal congestion
Clinical narrative: 4/25/2021 Loss of visual acuity in right eye, went to Urgent Care for testing treatment. No improvement MRI scheduled for 8/11 and referral to Rheumatology. 7/16/2021 Woke up early, felt unusually groggy, by 10:00AM I had the chills, 6:38PM temp 100 6:51PM exhausted, chills pulseox (O2) 98 Heart Rate (HR) 86 was asleep by 7:45PM. 7/17/2021 1:38AM woke up with chills temp 99.4 took Benadryl, and a Tylenol. 7:15AM temp 97.5. 10:45AM stomach cramps, achey lower back, rt. side sinuses stuffed up and fatigue 1:15PM woke up from nap, no appetite, took 1/2 hyoscamine drank gatorade. 4:00PM temp 99.4. 5:33PM temp 100 7:08PM 1/4 promethazine for stomach upset, sneezing, congested and headache 7:15PM temp 100.1 8:35PM temp 100.4 9:31PM temp 99.7 took Tylenol. 7/18/2021 7:21AM temp 99.7 O2 98 HR 76 9:00AM 5mL Children's Claritin 8:55AM temp 100.4 11:45AM temp 99.1 6:00PM temp 100.4 O2 97 HR 91, overwhelming fatigue 8:15PM temp 99.9 O2 97 HR 83 took Tylenol. 7/19/2021 6:50AM temp 99.1 O2 97 HR 87 9:00AM went to Urgent Care for symptoms, positive COVID test 11:30AM Tylenol and 5ml children's Claritin O2 98 HR 89 3:00PM temp 99.2 O2 97 HR 85 4:20PM temp 98.6 O2 98 HR 74 6:30PM nasal congestion returned 7:30PM temp 99.1 O2 99 HR 91 Tylenol, drank warm tea and gatorade 8:06PM woke up w/ low back ache and stomach cramping 9:53PM temp 98.0 O2 98 HR 71 10:00PM Sense of Smell disappeared, like a light switch, just vanished. 7/20/2021 1:00AM woke up with stomach cramps temp 98.1 O2 98 HR 71, headache 7:50AM temp 98.5 O2 97 HR 77 8:30AM took Claritin & Tylenol 9:30AM temp 97.7 O2 98 HR 68 headache, super thirsty all morning 11:30AM temp 97.6 O2 98 HR 77 12:45PM O2 98 HR 64 clinic PT/INR 2.9 4:45PM. I happened to have a heart rate monitor from Zio on during this entire time and can obtain that data for your records as well. This session is about to time about in 5 minutes and I don't want to lose what I've typed, have details through today.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sinus congestion, Sneezing, Somnolence, Thirst
Clinical narrative: 4/25/2021 Loss of visual acuity in right eye, went to Urgent Care for testing treatment. No improvement MRI scheduled for 8/11 and referral to Rheumatology. 7/16/2021 Woke up early, felt unusually groggy, by 10:00AM I had the chills, 6:38PM temp 100 6:51PM exhausted, chills pulseox (O2) 98 Heart Rate (HR) 86 was asleep by 7:45PM. 7/17/2021 1:38AM woke up with chills temp 99.4 took Benadryl, and a Tylenol. 7:15AM temp 97.5. 10:45AM stomach cramps, achey lower back, rt. side sinuses stuffed up and fatigue 1:15PM woke up from nap, no appetite, took 1/2 hyoscamine drank gatorade. 4:00PM temp 99.4. 5:33PM temp 100 7:08PM 1/4 promethazine for stomach upset, sneezing, congested and headache 7:15PM temp 100.1 8:35PM temp 100.4 9:31PM temp 99.7 took Tylenol. 7/18/2021 7:21AM temp 99.7 O2 98 HR 76 9:00AM 5mL Children's Claritin 8:55AM temp 100.4 11:45AM temp 99.1 6:00PM temp 100.4 O2 97 HR 91, overwhelming fatigue 8:15PM temp 99.9 O2 97 HR 83 took Tylenol. 7/19/2021 6:50AM temp 99.1 O2 97 HR 87 9:00AM went to Urgent Care for symptoms, positive COVID test 11:30AM Tylenol and 5ml children's Claritin O2 98 HR 89 3:00PM temp 99.2 O2 97 HR 85 4:20PM temp 98.6 O2 98 HR 74 6:30PM nasal congestion returned 7:30PM temp 99.1 O2 99 HR 91 Tylenol, drank warm tea and gatorade 8:06PM woke up w/ low back ache and stomach cramping 9:53PM temp 98.0 O2 98 HR 71 10:00PM Sense of Smell disappeared, like a light switch, just vanished. 7/20/2021 1:00AM woke up with stomach cramps temp 98.1 O2 98 HR 71, headache 7:50AM temp 98.5 O2 97 HR 77 8:30AM took Claritin & Tylenol 9:30AM temp 97.7 O2 98 HR 68 headache, super thirsty all morning 11:30AM temp 97.6 O2 98 HR 77 12:45PM O2 98 HR 64 clinic PT/INR 2.9 4:45PM. I happened to have a heart rate monitor from Zio on during this entire time and can obtain that data for your records as well. This session is about to time about in 5 minutes and I don't want to lose what I've typed, have details through today.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: 4/25/2021 Loss of visual acuity in right eye, went to Urgent Care for testing treatment. No improvement MRI scheduled for 8/11 and referral to Rheumatology. 7/16/2021 Woke up early, felt unusually groggy, by 10:00AM I had the chills, 6:38PM temp 100 6:51PM exhausted, chills pulseox (O2) 98 Heart Rate (HR) 86 was asleep by 7:45PM. 7/17/2021 1:38AM woke up with chills temp 99.4 took Benadryl, and a Tylenol. 7:15AM temp 97.5. 10:45AM stomach cramps, achey lower back, rt. side sinuses stuffed up and fatigue 1:15PM woke up from nap, no appetite, took 1/2 hyoscamine drank gatorade. 4:00PM temp 99.4. 5:33PM temp 100 7:08PM 1/4 promethazine for stomach upset, sneezing, congested and headache 7:15PM temp 100.1 8:35PM temp 100.4 9:31PM temp 99.7 took Tylenol. 7/18/2021 7:21AM temp 99.7 O2 98 HR 76 9:00AM 5mL Children's Claritin 8:55AM temp 100.4 11:45AM temp 99.1 6:00PM temp 100.4 O2 97 HR 91, overwhelming fatigue 8:15PM temp 99.9 O2 97 HR 83 took Tylenol. 7/19/2021 6:50AM temp 99.1 O2 97 HR 87 9:00AM went to Urgent Care for symptoms, positive COVID test 11:30AM Tylenol and 5ml children's Claritin O2 98 HR 89 3:00PM temp 99.2 O2 97 HR 85 4:20PM temp 98.6 O2 98 HR 74 6:30PM nasal congestion returned 7:30PM temp 99.1 O2 99 HR 91 Tylenol, drank warm tea and gatorade 8:06PM woke up w/ low back ache and stomach cramping 9:53PM temp 98.0 O2 98 HR 71 10:00PM Sense of Smell disappeared, like a light switch, just vanished. 7/20/2021 1:00AM woke up with stomach cramps temp 98.1 O2 98 HR 71, headache 7:50AM temp 98.5 O2 97 HR 77 8:30AM took Claritin & Tylenol 9:30AM temp 97.7 O2 98 HR 68 headache, super thirsty all morning 11:30AM temp 97.6 O2 98 HR 77 12:45PM O2 98 HR 64 clinic PT/INR 2.9 4:45PM. I happened to have a heart rate monitor from Zio on during this entire time and can obtain that data for your records as well. This session is about to time about in 5 minutes and I don't want to lose what I've typed, have details through today.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Moderna Vaccine given first dose to 16yrs old pt on July 2nd with no adverse reactions and was instructed by CDC to adminster 2nd dose with same vaccine, Moderna and report to VAERS same as first dose. No adverse events  encountered.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Tardive dyskinesia
Clinical narrative: Four days after the second dose of Moderna vaccine  began involuntary movement of her mouth, tongue, and toes.  Later diagnosed as Tardive Desconecia (TD).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Condition aggravated, Dizziness, Eye pain
Clinical narrative: I felt dizzy, fatigue, muscle pain, weakness, sore injection site, fever and chills, Hives (urticaria) Severe Migraines, pain behind the left eye (Daily). It?s been going on for about more than 4 weeks now.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Migraine, Myalgia, Pyrexia
Clinical narrative: I felt dizzy, fatigue, muscle pain, weakness, sore injection site, fever and chills, Hives (urticaria) Severe Migraines, pain behind the left eye (Daily). It?s been going on for about more than 4 weeks now.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I felt dizzy, fatigue, muscle pain, weakness, sore injection site, fever and chills, Hives (urticaria) Severe Migraines, pain behind the left eye (Daily). It?s been going on for about more than 4 weeks now.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: pt tested positive for covid on 8/1/21. had cough starting  for 1 week
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: temperature excursion vaccine has been administered; No additional AEs reported; This spontaneous report was received from a other reporter referring to some patients of unknown age and gender. The patients' pertinent medical histories, concomitant drugs and drug allergies were not reported.  On 02-JUL-2021, the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status recombinant Human albumin (rHA)) had a temperature excursion. Since then, in July 2021, patients were administered with the vaccine (lot #: T012806, expiration date was reported as 14-APR-2022, dose, strength and route were not reported) for prophylaxis. No further information was available. No additional adverse events reported.  Temperature excursion of this vaccine was 14.3 degrees Celsius for 4 hours and 30 minutes without any previous temperature excursion. The digital data logger was involved in recording excursion details.
Sex: F
Vaccine: VARCEL
Symptoms: Product quality issue, Product storage error
Clinical narrative: no signs or symptoms reported; Was there a product qulaity complaint- yes; was the vaccine/ vaccine-device used accroding to the instruction leaflet?- no; Improperly stored administeted vaccines; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drugs reations or allergies were not provided.  On 07-JUL-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T017686 with expiration date 21-MAY-2022, subcutaneously, in the right arm for prophylaxis. Varicella virus vaccine live (oka/merck)(VARIVAX) was placed in the refrigerator for 648 hours, instead of the freezer. The vaccine was stored in 40.4 Farenheit (F) degrees fo a time frame 1386 hours. There was no revious temperature excursions. No signs or symptoms reported. Data logger was not involved. Product quality complaint was reported. The vaccine was not used according to the instruction leaflet (product storage error, no adverse event, wrong technique in product usage process and product quality issue).
Sex: U
Vaccine: HEPA, UNK
Symptoms: Product storage error
Clinical narrative: no aditional AE reported; vaccine administered after temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medication, drug reactions or allergies.  On 12-JUL-2021, the patient was administered a temperature excursion Hepatitis A Vaccine, Inactivated (VAQTA) (0.5ml, lot number T035720, with an expiration date 15-APR-2022) intramuscularly for prophylaxis (product storage error). The Hepatitis A Vaccine, Inactivated (VAQTA) were improperly stored at a temperature of 9.6 degrees Celsius for 11 minutes. There wasn't a previous temperature excursion, and this was called because of a data logger. No additional adverse events (AE) was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035720; expirationdate: 15-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: PPV, UNK
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; expired dose of PNEUMOVAX23 was administered; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information concerning the patient's concurrent conditions, pertinent medical history and concomitant medications was not provided.   On 16-JUL-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), (Lot # S034299, expiration date 01-JUL-2021), dose, route of administration, and anatomical location were not reported  for prophylaxis. No additional adverse event and no product quality complaint (PQC) were reported. Combination product report: Yes; brand name: PNEUMOVAX23 SYRINGE (DEVICE); common device name: Pneumococcal Vaccine, Polyvalent (23-valent); product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp.; device lot number: S034299; expiration date: 01-JUL-2021; device age and unit: 0 ; malfunction: Unknown; device usage: Initial; reason for non eval: 81 Other; labeled single use device: No; mdcp reportability: No; mdcp rep rationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller reported that VARIVAX that underwent a temperature excursion was administered.; No adverse effect reported; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, route of administration, anatomical site of vaccination and vaccine scheme were not reported; lot number T022312 has been verified to be a valid lot number, expiration date reported and established as 30-JUN-2022) as prophylaxis.   The vaccine was improperly stored at 14 Fahrenheit degrees to 46 Fahrenheit degrees (20.84 Fahrenheit degrees) for 1 hour, 20 minutes (product storage error), which was detected by digital data logger. There was no previous temperature excursion. No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: will need to catch up with a second dose of VARIVAX; will need to catch up with a second dose of VARIVAX; no additional AE was reported; This spontaneous report was received from a nurse prescriber referring to an adult patient of "about 18 or 19 years of age". Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.  The patient's vaccination records showed that only one dose of varicella virus vaccine live (oka/merck)(VARIVAX)  was administered at 12 months of age for prophylaxis (dose, vaccination scheme frequency, route of administration, anatomical site of vaccination, lot # and expiration date were not reported). The reporter indicated that the patient would need to catch up with a second dose of varicella virus vaccine live (oka/merck) (VARIVAX). No additional adverse event reported.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 13 year old male client who received 3 Gardasil 9 doses at 0-6-18 month interval; This spontaneous report has been received from a physician concerning a 13-year-old male patient. The patient's concurrent conditions, medical history, previous drug reactions or allergies, and concomitant medications were not provided.  On unspecified dates, the patient was vaccinated with the three doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration and anatomical site of vaccination were not provided; lot number and expiration date were unknown by the reporter) as prophylaxis. The patient received the doses of the vaccine at an interval of 0, six and eighteen months (inappropriate schedule of product administration). The physician requested information regarding this patient.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3rd dose of GARDASIL 9 not given 6 months after first dose.; This spontaneous report was received from a pharmacist, referring to a 14 year-old male patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided.   On an unknown date, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) at 0.5 milliliter, intramuscularly (frequency, lot # and expiration date were not reported) for prophylaxis.  It was reported that the third dose had been administered 8 months since the first dose instead of 6 months as recommended in the prescribing information. There was no product quality complaint involved.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional adverse effect reported; temperature excursion for GARDASIL 9; This spontaneous report as received from a Medical assistant refers to a 15 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.    On 28-JUL-2021, the patient was vaccinated with an incorrectly storage dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1687291 expiration date 11-SEP-2022 , 0.5 milliliter (route unknown) for prophylaxis, which was stored at a temperature of 80.6 °F for 14 hours and 51 minutes. Previous temperature excursion was reported as 73.2°F for 9 hours and 25 minutes and 73.4°F for 8 hours and 48 minutes. No additional adverse effect reported. The call was registered due to a data logger.    This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA008709: US-009507513-2107USA008566: US-009507513-2107USA008701:
Sex: U
Vaccine: HEPA, UNK
Symptoms: Product storage error
Clinical narrative: No other AE; temperature excursion. VAQTA was administered to one patient; This spontaneous report as received from a Medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On 27-JUL-2021, the patient was vaccinated with an inappropriate storage dose of hepatitis a vaccine, inactivated(VAQTA) lot # T023914 expiration date 31-MAR-2022, 1 time dose (route not provided) for prophylaxis, which was stored at a temperature excursion of 46.8 °F for  1 hour 30 minutes. There was no previous temperature excursion. The call was registered due to a data logger. No signs or symptoms reported and no other events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T023914; expirationdate: 31-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional adverse effect; for temperature excursion for GARDASIL 9. Caller stated the vaccine was given four times today.; This spontaneous report was received from a medical assistant and refers to a 18-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 28-JUL-2021, the patient was vaccinated improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml; lot # 1687291 with expiration date 11-SEP-2022 (exact dose and dose number were not provided) for prophylaxis.  The temperature excursion was 80.6 Fahrenheit (F) for 14 hours and 51 minutes. Previous excursions included: 73.2 F for 9 hours and 25 minutes, 73.4F for 8 hours and 48 minutes. The digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA008566: US-009507513-2107USA008701: US-009507513-2107USA008462:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: patient who received an expired dose of PNEUMOVAX23; no other issues or concerned noted; This spontaneous report has been received from a nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency and route of administration were not reported; lot # S034299, expiration date 01-JUL-2021). The reported wanted to know if the patient should be revaccinated. No other issues or concern were noted. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: S034299; expirationdate: 01-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered
Clinical narrative: No additional AE; Patient was administered Expired VAQTA; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 17-NOV-2020, the patient was vaccinated with expired hepatitis a vaccine, inactivated(VAQTA) lot # S032056 with expiration date 09-NOV-2020, for prophylaxis (strength, dose, rote of administration and anatomical location were not reported). No adverse event was reported. There was not any temperature excursion reported. combination product report: Yes; brand name: VAQTA SYRINGE (DEVICE); common device name: Hepatitis A Vaccine, Inactivated; product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp.; device lot number: S032056; expiration date: 09-NOV-2020; device age and unit: 0 ; serial number: 100424354151; malfunction: Unknown; device usage: Initial; evaluated by mfr: Not returned to manufacturer; reason for non eval: 81 Other; labeled single use device: No; mdcp reportability: No; mdcp rep rationale: Case information does not meet criteria for reportability
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: The patient reported that she is experiencing a flare-up and that her arm is being affected/affects of Rheumatoid Arthritis.; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021113064), license party for etanercept (ENBREL).  This serious solicited report was reported to Amgen on 21/JUL/2021 by a consumer from a commercial program and involves a 48 year old female patient who experienced a flare-up and that her arm is being affected/affects of rheumatoid arthritis [PT: rheumatoid arthritis] while receiving Enbrel. No historical medical condition was reported. No current medical condition was reported. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel on an unknown date. On a unknown date, the patient had a flare-up and that her arm was affected. Advised that when she took the Covid shot she began feeling the affects of rheumatoid arthritis. No treatment information was received. The outcome of the event rheumatoid arthritis was reported as unknown. Action taken with Enbrel was reported as unknown for the event rheumatoid arthritis. The causal relationship between the event rheumatoid arthritis and Enbrel was not provided by the consumer. The reporter did not and would never have access to lot number. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected.  Amgen comments: This individual case report does not change the safety profile of the product.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   Amgen's Causality Assessment:  The event rheumatoid arthritis  was assessed as unrelated to etanercept by Amgen.   The reporter's assessment of rheumatoid arthritis with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: Based on the information provided, the event "The patient reported that she is experiencing a flare-up and that her arm is being affected/affects of Rheumatoid Arthritis" is unrelated to the use of suspect product etanercept and BNT162B2 and is likely to be an intercurrent event in this 48 year old female patient. This case will be reassessed should additional information become available.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Feeling hot, Rash, Scratch, Skin discolouration
Clinical narrative: face is swollen; face turned black, green and blue; spots all over her; feels burning; scratching; over heated; This case was reported by a consumer via patient support programs and described the occurrence of facial swelling in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included brain neoplasm (Brain tumor since 2008).   In May 2018, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced facial swelling, skin discoloration, rash, burning sensation, scratch and hot feeling generalized. On an unknown date, the outcome of the facial swelling, skin discoloration, rash, burning sensation, scratch and hot feeling generalized were not recovered/not resolved.   The reporter considered the facial swelling to be unrelated to Shingrix. It was unknown if the reporter considered the skin discoloration, rash, burning sensation, scratch and hot feeling generalized to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received Shingrix shot and her face turned black, green and blue, had spots all over her, one part of her face was swollen, felt burning, scratching and felt over heated constantly. The patient still had those effects. The patient reported that she only received a letter stating that probably the effects were from something else.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: face is swollen; face turned black, green and blue; spots all over her; feels burning; scratching; over heated; This case was reported by a consumer via patient support programs and described the occurrence of facial swelling in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included brain neoplasm (Brain tumor since 2008).   In May 2018, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced facial swelling, skin discoloration, rash, burning sensation, scratch and hot feeling generalized. On an unknown date, the outcome of the facial swelling, skin discoloration, rash, burning sensation, scratch and hot feeling generalized were not recovered/not resolved.   The reporter considered the facial swelling to be unrelated to Shingrix. It was unknown if the reporter considered the skin discoloration, rash, burning sensation, scratch and hot feeling generalized to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received Shingrix shot and her face turned black, green and blue, had spots all over her, one part of her face was swollen, felt burning, scratching and felt over heated constantly. The patient still had those effects. The patient reported that she only received a letter stating that probably the effects were from something else.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Musculoskeletal chest pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: My arm hurt/ my whole left arm felt like someone took a bat to it; my left rib cage felt like I had broken ribs for a day or two.; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date and experienced pain in arm refer case US2021AMR160228) and COVID-19 VACCINE (received both doses of on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and rib pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the rib pain was recovered/resolved.   It was unknown if the reporter considered the pain in arm and rib pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. Historical medication included first dose of Shingles and both doses of COVID-19  vaccines. The patient received the second dose of Shingles vaccine and his/ her arms started to hurt worse than the two Covid shots and the first shingles shot. The patient's whole left arm felt like someone took a bat to it and the left rib cage felt like he/ her had broken ribs for a day or two. The patient reported that everyone's symptoms may vary or may not be symptomatic at all. He had also heared the second one was a little rough, for some. But he would still take the odds of 97% coverage with the vaccine over getting shingles itself.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR161077:Invalid case US-GLAXOSMITHKLINE-US2021AMR160228:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced 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 details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The patient received the Shingles vaccine and patient experienced shingles again. The reporter stated that it was not fun. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: soreness in/ arm/not the normal soreness; This case was reported by a consumer and described the occurrence of pain in arm in a 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 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The case was reported by patient himself/ herself.  The age at vaccination was not reported. The patient received 2nd dose of Bexsero vaccine in unknown arm almost a week ago and experienced soreness in arm, had not gone away. The patient stated that it's not the normal soreness that he/she had with other vaccines, which he/she had.  The patient asked was this normal. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 8 to 10 months ago and had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose (in 2020) 8 to 10 months ago from reporting date).   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 details were reported as follows: The age at vaccination was not applicable to this report. The pharmacist reported late second doses of Shingrix and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter had no information regarding the age or gender of the patient nor the exact date of the administration and expiration or lot number of the first dose. No further events were reported. The reporter consented to follow up. This is 1 of 4 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR163653:Same reporter US-GLAXOSMITHKLINE-US2021163008:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: diagnosed with shingles/2 months later/shingles; This case was reported by a other health professional via(Shingrix GSK Chatbot) interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose and then was diagnosed with shingles 2 months later. The reporter asked how long till he or she could get their second dose. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Gait disturbance
Clinical narrative: can't walk right anymore!; This case was reported by a consumer via interactive digital media and described the occurrence of walking difficulty in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced walking difficulty. On an unknown date, the outcome of the walking difficulty was unknown.   It was unknown if the reporter considered the walking difficulty to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles shot and the patient could not walk right anymore. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: their arm hurt for days\ arm hurt (at injection site); This case was reported by a consumer via call center representative and described the occurrence of injection site pain in an unknown number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter's son had the Bexsero shot and she reports that, some of his friends got Bexsero and everybody said their arm hurt for days. No further information was known. This case has been linked to the case US2021160393, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021160393:Same reporter
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Fatigue, Feeling abnormal, Musculoskeletal stiffness, Nausea
Clinical narrative: dizziness; nausea / feel nauseous; tiredness; sore throat; fever; stiffness of arm; feeling "out of it."; hypersalivation; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received the 1st dose of Shingrix (intraparietal) .5 ml. In July 2021, less than a week after receiving Shingrix, the patient experienced hypersalivation. On 24th July 2021, the patient experienced dizziness, nausea, tiredness, sore throat, fever, limbs stiffness and feeling abnormal. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the dizziness, nausea, tiredness and hypersalivation were not recovered/not resolved and the outcome of the sore throat, fever, limbs stiffness and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the dizziness, nausea, tiredness, sore throat, fever, limbs stiffness, feeling abnormal and hypersalivation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The patient began to experience dizziness, nausea, tiredness, sore throat, fever, stiffness of arm and feeling out of it.  All symptoms had resolved except the dizziness, nausea and tiredness which she was still experiencing. The patient was referred to health care professional. The patient went to an urgent care on 27th July 2021 and was prescribed Zofran.  The patient was experiencing hypersalivation in less than week after vaccination and continued to feel nauseous. The reporter did not consent to follow-up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oropharyngeal pain, Pyrexia, Salivary hypersecretion
Clinical narrative: dizziness; nausea / feel nauseous; tiredness; sore throat; fever; stiffness of arm; feeling "out of it."; hypersalivation; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received the 1st dose of Shingrix (intraparietal) .5 ml. In July 2021, less than a week after receiving Shingrix, the patient experienced hypersalivation. On 24th July 2021, the patient experienced dizziness, nausea, tiredness, sore throat, fever, limbs stiffness and feeling abnormal. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the dizziness, nausea, tiredness and hypersalivation were not recovered/not resolved and the outcome of the sore throat, fever, limbs stiffness and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the dizziness, nausea, tiredness, sore throat, fever, limbs stiffness, feeling abnormal and hypersalivation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The patient began to experience dizziness, nausea, tiredness, sore throat, fever, stiffness of arm and feeling out of it.  All symptoms had resolved except the dizziness, nausea and tiredness which she was still experiencing. The patient was referred to health care professional. The patient went to an urgent care on 27th July 2021 and was prescribed Zofran.  The patient was experiencing hypersalivation in less than week after vaccination and continued to feel nauseous. The reporter did not consent to follow-up.