chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 31-MAR-2023; no adverse event; 5 patients received expired doses/Dose administered after 30-day Use By Date (patient #4); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients received expired doses/Dose administered after 30-day Use By Date (patient #4)), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 31-MAR-2023) and NO ADVERSE EVENT (no adverse event) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Mar-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients received expired doses/Dose administered after 30-day Use By Date (patient #4)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 31-MAR-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients received expired doses/Dose administered after 30-day Use By Date (patient #4)), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 31-MAR-2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (5 patients received expired doses/Dose administered after 30-day Use By Date (patient #4)) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 31-MAR-2023).    No concomitant medications was reported. The size of vial was 2.5 ml. The vial was initially stored in the refrigerator on 10-feb-2023. The vial did not undergo any temperature excursions. No treatment drug details was reported.
11 hours after injection (10pm) starts full body, intense aches and pains (injection site hurts very much), violent chills tensing all my muscles (teeth literally chattering). I took 800mg (4 200mg tablets) ibuprofen, which helped immensely. 2 hours later at midnight I went to bed and was very hot and sweating all night. Symptoms continued, alternating between chills and sweats about every 2-4 hours during the day on Feb 4.  Went to bed about 11pm, was comfortable all night and slept almost 12 hours. Currently minor aches in my back are my only symptom.
Muscle pain to left leg, calf and knee areas.  Has taken Tylenol and ibuprofen for pain, for 3 days.  Sought massage therapist for the lower leg, two events of seeking massage therapy.  Mid March, and late march.  Can't recall dates of massage.  Using lidocaine pain patch and knee support brace.
Bell's palsy; My face is paralyzed/I was quite upset when my side of my face was down and I couldn't feel it; the disabilities that I had, the intensity that I had, the emotion that I had is terrible; Its very emotional, traumatizing for me/ I was very traumatic; my right eye did not shut/ I had to sleep at night with my eyes open; my body, my eyes froze; When I had my first shot then I haven't I just held off by falling; I was very upset / Its been a horrible experience; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Apr2021 (Lot number: ER8734) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: BELL'S PALSY (medically significant) with onset 2021, outcome "unknown", described as "Bell''s palsy"; FACIAL PARALYSIS (medically significant) with onset 2021, outcome "unknown", described as "My face is paralyzed/I was quite upset when my side of my face was down and I couldn't feel it"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "the disabilities that I had, the intensity that I had, the emotion that I had is terrible"; EMOTIONAL DISTRESS (non-serious) with onset 2021, outcome "unknown", described as "Its very emotional, traumatizing for me/ I was very traumatic"; EYE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "my right eye did not shut/ I had to sleep at night with my eyes open"; FREEZING PHENOMENON (non-serious) with onset 2021, outcome "unknown", described as "my body, my eyes froze"; FALL (non-serious) with onset 2021, outcome "unknown", described as "When I had my first shot then I haven't I just held off by falling"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "I was very upset / Its been a horrible experience". The events "bell''s palsy", "my face is paralyzed/i was quite upset when my side of my face was down and i couldn't feel it", "the disabilities that i had, the intensity that i had, the emotion that i had is terrible", "its very emotional, traumatizing for me/ i was very traumatic", "my right eye did not shut/ i had to sleep at night with my eyes open", "my body, my eyes froze", "when i had my first shot then i haven't i just held off by falling" and "i was very upset / its been a horrible experience" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: ophthalmological examination: (2021) unknown result, notes: I had to go through quite a few procedures in the eye ophthalmologist office. Therapeutic measures were taken as a result of bell's palsy, facial paralysis, malaise, emotional distress, eye disorder, freezing phenomenon, fall, feeling abnormal. Treatment: Consumer stated, "Yes I was under neurological and medical doctors care and an eye doctor as well".  Follow-up attempts are completed. No further information is expected.
brown and red spots on lower legs that became raised; Flegel disease; brown Rash/spots on face; brown and red spots; brown and red spots on lower legs that became raised sores; This case was reported by a consumer via call center representative and described the occurrence of flegel disease in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2020, the patient received the 1st dose of Shingrix. In January 2020, between 3 and 4 weeks after receiving Shingrix, the patient experienced flegel disease, rash, red spotty rash and generalized raised red spots limbs. On an unknown date, the patient experienced skin ulcer. The patient was treated with dermatologicals nos (Unspecified Cream). On an unknown date, the outcome of the flegel disease, rash, red spotty rash and generalized raised red spots limbs were not recovered/not resolved and the outcome of the skin ulcer was unknown.   It was unknown if the reporter considered the flegel disease, rash, red spotty rash, generalized raised red spots limbs and skin ulcer to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix in left arm. Approximately 3 to 4 weeks later developed rash described as initially brown and red spots on lower legs that became raised sores. Later on, she found out it was rare skin disease called Flegel.  The patient still having rash and being treated by an unspecified cream. The initial cream was described as being strong and current cream not as strong. The patient reported now having spots on arm that developed approximately 3 months post 1st dose Shingrix and then spots on face approximately months post 1st dose Shingrix. The reporter consent to follow up.
A report has been received from a Pharmacist concerning, male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 14-Nov-2012. The patient experienced POSITIVE INFLUENZA TEST which started on 19-Nov-2012. The outcome of the event of POSITIVE INFLUENZA TEST is unknown. The report was considered to be non-serious. Laboratory values are available.
Numbness in hands and feet progressing to weakness in legs, arms - suspected Guillain Barre.
Roughly 5 days after receiving "his" 2nd dose of the vaccine, "he" began experiencing great difficulty standing/walking; Roughly 5 days after receiving his 2nd dose of the vaccine, he began experiencing great difficulty standing/walking; "He" had gone from being able to move around free of any assistance (albeit slowly), to requiring assistance standing, walking, bathing/showering, dressing, going to the bathroom, and getting in and out of bed.; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 23Feb2021 at 09:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included parkinson's disease (w/Lewy body) , heart disorder(unspecified) and diabetes. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), quetiapine (MANUFACTURER UNKNOWN), memantine (MANUFACTURER UNKNOWN), metoprolol tartrate (MANUFACTURER UNKNOWN), carbidopa, levodopa (MANUFACTURER UNKNOWN), furosemide (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), insulin glargine (LANTUS), insulin aspart (NOVOLOG), cyanocobalamin (MANUFACTURER UNKNOWN), tamsulosin (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), lactobacillus acidophilus (ACIDOPHILUS PROBIOTIC), docusate sodium, senna alexandrina (SENOKOT-S), docusate sodium (STOOL SOFTENER), ubidecarenone (COQ 10) and acetylsalicylic acid (ASPIRIN), Men's One-a-day vitamin (MANUFACTURER UNKNOWN) taken for an unknown indication on an unknown date and unknown if ongoing. On 28Feb2021 at 08:00, roughly 5 days after receiving second dose of the vaccination, the patient experienced great difficulty standing/walking. The patient had gone from being able to move around free of any assistance (albeit slowly), to requiring assistance standing, walking, bathing/showering, dressing, going to the bathroom, and getting in and out of bed. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown, if therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events great difficulty standing/walking, assistance (albeit slowly), to requiring assistance standing, walking, bathing/showering, dressing, going to the bathroom, and getting in and out of bed were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
had been running a temperature of 99.5 to 101; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female non-pregnant patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL 3249 and expiry date unknown) via unspecified route of administration at the left arm on 11Jan2021 at single dose for Covid-19 immunization. The patient medical history was not reported. The patient has no covid prior vaccination. Concomitant medication included losartan and vitamin; both from unspecified date for unspecified indication. The patient previously took vancomycin and Keftab; both experienced allergies. The patient had no other vaccine in four weeks. The patient had been running a temperature of 99.5 to 101 since Monday 11Jan2021 during the night (also reported as 11Jan2021 12:00 AM). The patient was not covid tested post vaccination. The patient did not receive treatment due to the event. The outcome of the event had been running a temperature of 99.5 to 101 was not recovered.
Initial unsolicited report received from a consumer on 08-Jan-2018. This case involves a male patient (age not reported), who was vaccinated with INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, route and site of administration not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient seemed worse with his learning and he was diagnosed with mercury poisoning and heavy metal poisoning and he had autism diagnosis at the age of 11 (unit unspecified). Lab test and corrective treatment was not reported. Outcome of the events were unknown. Upon internal review the case was considered as serious because of important medical events. Documents held by sender: none. Sender's Comments: Time to onset was not known. No medical history or condition the time of vaccination was reported. Latency was also not reported. It is possible that the patient could have acquired heavy metal poisoning from alternate sources which should be investigated. Additional information regarding lab tests to confirm the diagnosis, medical history and name or lot number of the vaccine should also be requested to ascertain the causality with respect to the product. Based upon reported information the role of the vaccine cannot be assessed.
2/5/2012 - Burning, redness and swelling at injection site. 2/6/2012 - development of itchy rash near injection site (posterior right arm). 2/7/2012 - rash, itching, inflammation spreading from injection site. Appearance of burns to physician. Physician treated rash for burn with Silvadene ointment. 2/8/2012 - itching on chest and neck. Began self treatment with Benadryl and Hydrocortisone cream (OTC). 2/9/2012 - small, itching papules emerged on chest, spreading to neck. 2/10/2012 - intense itching, rash spread from chest and neck to both arms, face, stomach, back and legs. 2/11/2012 - Dr. visit. Physical examination. Encouraged to continue Benadryl and hydrocortisone treatment. 2/16/2012 - two physician visits. CBC performed with physician visit #2.  Referred to dermatologist.  Doctor order two skin biopsies. Began treatment with Zantac, Zyrtec and Claritin and Clobetasol cream. Itching and rash resolved within a week.
Soreness and swelling,  then about 12 hours after vaccination: hot flash, nausea, spike in blood pressure, spike in  heart rate
This spontaneous case was reported by a patient and describes the occurrence of SNEEZING (sneezing), BONE PAIN (bone pain), DIARRHEA (diarrhea), HEAVY MENSTRUAL BLEEDING (I had my menstrual period for 10 days and usually last four to five days) and DRUG INEFFECTIVE (lack of drug effect) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included PARACETAMOL (TYLENOL) for Paracetamol, IBUPROFEN for an unknown indication. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced MYALGIA (very little arm pain), PYREXIA (fever) and HEADACHE (headache). On 17-May-2021, the patient experienced DRUG INEFFECTIVE (lack of drug effect). On an unknown date, the patient experienced SNEEZING (sneezing), BONE PAIN (bone pain), DIARRHOEA (diarrhea) and HEAVY MENSTRUAL BLEEDING (I had my menstrual period for 10 days and usually last four to five days). On 17-May-2021, DRUG INEFFECTIVE (lack of drug effect) outcome was unknown. At the time of the report, SNEEZING (sneezing), BONE PAIN (bone pain), DIARRHOEA (diarrhea), HEAVY MENSTRUAL BLEEDING (I had my menstrual period for 10 days and usually last four to five days), MYALGIA (very little arm pain), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, SARS-CoV-2 test: positive (Positive) Abnormal. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-154759. Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Upon internal review on 16 Jul 2021, an event (lack of efficacy) was added at Moderna's request.  Event of SARS-COV-2 TEST POSITIVE deleted as this is captured in relevant labs.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received dose #1 of Moderna, then inadvertently received dose #2 with Pfizer. No known sequelae, but reporting per CDC recommendations (Appendix A- vaccine administration errors and deviations in Interim Clinical Considerations).
DVT blood clot in left calf verified via utrasound on 2/17/2021. Symptoms:  pain in left calf and foot proceeded by chills/fever and right fingers/hand inflammation.  Symptoms began 2/08/2021.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 11-JAN-2018, the patient was vaccinated with a dose of improperly stored Oka/Merck VARIVAX lot number N001527, expiration date 13-JAN-2019 for prophylaxis (frequency and route of administration were not reported). The sterile diluent (MERCK STERILE DILUENT) used for reconstitution was properly stored. On unknown dates, the doses of Oka/Merck VARIVAX underwent temperature excursions of 6 degrees F to 14 degrees F for 69 hours 2 minutes, 15 degrees F to 46 degrees F for 36 hours 14 minutes. A previous temperature excursion of 15 degrees F to 46 degrees F for 60 hours was reported. Temperature excursions were detected by the data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1801USA010690: US-009507513-1802USA004842: US-009507513-1802USA004843.
rash on sacral area; Suspected vaccination failure; rash was shingles.; Itching rash; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 24-AUG-2023, the patient received the 2nd dose of Shingrix (left deltoid). On 20-JUN-2023, the patient received the 1st dose of Shingrix. On 20-JUL-2023, not applicable after receiving Shingrix and 30 days after receiving Shingrix, the patient experienced itchy rash (Verbatim: Itching rash). In SEP-2023, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: rash was shingles.). On 25-SEP-2023, the patient experienced rash (Verbatim: rash on sacral area).  The patient was treated with antipruritics nos (Anti-Itch Cream (Medication Unknown)). The outcome of the vaccination failure was not reported and the outcome of the shingles and itchy rash were unknown and the outcome of the rash was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix. It was unknown if the reporter considered the itchy rash to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix. It was unknown if the company considered the itchy rash to be related to Shingrix.   Additional Information: GSK receipt date: 27-SEP-2023 The reporter was a customer who stated that he was out of the country recently.   When he returned from his trip he received his first Shingrix vaccine and 1 month after his first dose of Shingrix he developed a rash on sacral area, described as bottom of spine tail bone area.   The patient was not evaluated by his physician and did not report rash to his physician.   He treated rash with an OTC anti-itch cream and states the rash was shingles.   The patient then stated that he received his second dose of Shingrix and reported approximately 1 month after second dose of Shingrix he again had the itching rash on his sacral area and he believed the recurring rash was shingles.   The reporter did not see his physician after return of rash and again treated himself with an OTC anti-itch cream. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. Consent to follow up was obtained. The reporter did not had his physicians information and stated that he will call back with the information.  The reporter would like to be contacted via email with any correspondence from Safety Team.
Information has been received from two physicians concerning a female who was vaccinated with a dose of Gardasil. Subsequently the patient experienced injection site and arm pain for 2-3 weeks after the vaccination. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Pt experienced increased swelling, and redness to left deltoid area with fever and itching. Pt was seen in the ER and diagnosed with Cellulitis and allergic reaction to immunization. Pt was treated with Benadryl and antibiotic by ER physician.
Rash to cheeks, arms and legs after immunizations given 08/22/16 at night and running a temperature 101.9 ax per mother. Mother gave child TYLENOL q 8 hrs on 08/22/16 and then MOTRIN on 08/23/16 at 10:00 am and then 5:00 pm.
headache and fatigue for 24 hours; headache and fatigue for 24 hours; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 14 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), FATIGUE (non-serious), outcome "recovered" and all described as "headache and fatigue for 24 hours". Additional information: It was reported that brothers 14 and 15 yo males experienced headache and fatigue for 24 hours following second dose of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.