chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd 3 doses of Engerix-B & 2 days p/3rd dose devel photosensitivity & eye swelling which are persisting; 2 wks p/3rd dose devel whole body itching/tingling which is improving; also had h/a;
High Fever over 103 since 6/8/2017 still has high fever currently as of 6/11/2017, treating with Ibuprofen,Tylenol and cool bath. 2 seizures occurred Thursday both afternoon around 3:00pm and around 9:00pm.
No additional AE reported. No PQC; V ARlV AX was administered after a temperature excursion; This spontaneous report was received from a medical assistant referring to a 16-months-old patient of an unknown gender. Concomitant medications included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and diluent (STERILE DILUENT). Patient's concurrent conditions, medical history and drug allergies were not provided.  On 22-FEB-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot# U016065, expiration date 20-MAY-2023, at a dose 0,5 milliliter (route of administration and dose number were not provided) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored diluent (STERILE DILUENT) on the same day. The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at temperature 9.9F for 1 hour 22 minutes. No previous temperature excursion involved. No additional AE was reported. No PQC reported.
1 vial (2 doses were administered past 24 hours); vial stayed in refrigerator for about 24 hours after 1st puncture to administration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vial stayed in refrigerator for about 24 hours after 1st puncture to administration) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1 vial (2 doses were administered past 24 hours)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (vial stayed in refrigerator for about 24 hours after 1st puncture to administration). On 18-Sep-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1 vial (2 doses were administered past 24 hours)). On 17-Sep-2021, PRODUCT STORAGE ERROR (vial stayed in refrigerator for about 24 hours after 1st puncture to administration) outcome was unknown. On 18-Sep-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1 vial (2 doses were administered past 24 hours)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.  Date the vial was initially stored in the refrigerator: 13Sep2021
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's current condition and pertinent medical history were not mentioned. On unspecified dates the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 of batch# L035687, expiry date: 16-FEB-2017 (route and indication not reported). The vaccine was stored at 70 degrees Fahrenheit for a time frame of 24 hours. There was no previous temperature excursion. No adverse effects reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested.
Late local reaction with swelling, erythema, and pain around L wrist; also some swelling by deltoid; these symptoms began 3 days after vaccination and continued for 1 week
administered expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number FS734, expiry date 21st January 2022) for prophylaxis.   On 26th January 2022, the patient received the 2nd dose of Boostrix. On 26th January 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The reporter reported a patient was administered an expired dose of the Boostrix vaccine inadvertently in left deltoid, which led to expired vaccine used. The reporter consented to follow up. The case has been linked to US2022014885,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022014885:Same reporter
Right thigh swollen, hard and hot to touch, tender, fever 100-103 x 24 hrs
Continued pain at injection site for 23 days at this time - no swelling, redness seen or reported; some limitation of movement reported due to pain; states it is resolving very slowly and is worse upon awakening in the morning.
Information has been received from a physician concerning a 16 year old female who was vaccinated with GARDASIL.  Subsequently the patient fainted about 1 week after receiving the vaccination.  Per the reporter this patient also fainted two more times in the week following her initial episode of fainting.  The patient sought unspecified medical attention in the physician's office and was referred to a cardiologist.  No other information is available at this time.  Additional information has been requested.
pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). On 08-Jan-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The start date of pregnancy was reported as 02-JUL-2020. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.
Patient presented to medical facility and reported to 2 separate staff that he had never received a covid 19 vaccine. Upon attempting to document vaccination, patient was listed as having received the Janssen vaccine on 3/7/2021. Clinic called patient to verify this information was correct. Patient stated to staff "I know it was deceitful on our part, but we wanted to receive a booster because of the delta variant. We lied to your staff to get an extra dose, because that is what the media and our family and friends recommended." Patient reported a health care facility in that is giving out booster doses. Patient was advised by clinic staff that this was considered an adverse event, as it was not the current recommendations for vaccination and that the clinic would not see them for a second dose of the pfizer series and to seek medical care if patient becomes ill. Patient verbalized understanding of the situation.
I went to bed for 12 hours before I could even get up and function, its kind of stroke'; nauseous; lack of balance; I went to bed for 12 hours before I could even get up and function; I am speeding up a clear substance looks like white blood cell or something ''flams'' it comes up all the times; I got terrible adverse effect; I got definitely ill on both of the shot, terribly ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: 330258D) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Enlarged prostate" (unspecified if ongoing), notes: Verbatim: Enlarged prostate. Concomitant medication(s) included: TAMSULOSIN HYDROCHLORIDE taken for prostatomegaly. Vaccination history included: Bnt162b2 (1st dose of covid vaccine), administration date: 06Mar2021, when the patient was 79 years old, for COVID-19 Immunization, reaction(s): "I had no adverse event from this first shot.".  The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome "unknown", described as "I went to bed for 12 hours before I could even get up and function, its kind of stroke'"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nauseous"; BALANCE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "lack of balance"; SLEEP DISORDER (non-serious) with onset 2021, outcome "unknown", described as "I went to bed for 12 hours before I could even get up and function"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "I am speeding up a clear substance looks like white blood cell or something ''flams'' it comes up all the times"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I got terrible adverse effect; I got definitely ill on both of the shot, terribly ill". Therapeutic measures were not taken as a result of cerebrovascular accident, nausea, balance disorder, feeling abnormal, illness. Therapeutic measures were taken as a result of sleep disorder. NDC and UPC number of COVID-19 Vaccine were unknown. Treatment for Adverse Event: Consumer stated, "No I didn't take any treatment for that except sleep."  No follow-up attempts are possible. No further information is expected.
Moderna COVID-19 Vaccine EUA - rash at injection site one week post-injection in left upper arm
On 4/6/2021 pt started having a severe stomach pains, fatigue, fever, chills, loss of appetite, and vomiting.  She has a stabbing pain in the back, body aches and pains.  She has a rash on her face and around eyes.   She says she no longer has fever but now has diarhea.
No additional AE reported.; Patient was administered Improperly Stored PEDVAXHIB on 03/16/2023; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-MAR-2023, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W015927, expiration date: 15-FEB-2025, administered for prophylaxis (dose, strength, and route of administration were not provided) (product storage error). It was reported that the vaccine underwent temperature excursions on 06-MAR-2023 (temperature: 44.6 Fahrenheit (F), time frame: 15 minutes), and on 03-MAR-2023 (temperature below 36 F (31.8F) for 45 minutes). No additional adverse event was reported (no adverse event).
sciatica; Severe low back pain; stiffness; sitting was very difficult and painful; Inflammation; pain; Booster; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received third dose of bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: FC2589), via intramuscular route, administered in arm left on 04Oct2021 at 13:00 (at the age of 69-year-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization at pharmacy or drug store. The patient medical history included glaucoma. Other Medical history was reported as None. Concomitant medications included influenza vaccine (FLU VACCINE VII) on 30Sep2021, dose 1 on 01Oct2021 in left arm, LATANOPROST for glaucoma. Historical vaccine included first dose of bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EN6206), via an unspecified route of administration, administered in arm left on 10Mar2021 at 13:00 (at the age of 68-year-old) as DOSE 1, SINGLE and second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: ER8733), via an unspecified route of administration, administered in arm right on 01Apr2021 at 13:00 (at the age of 68-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. The patient had no known allergies. On 10Oct2021, the patient experienced sciatica, severe low back pain at 09:00, stiffness, sitting was very difficult and painful and inflammation and had pain. On 04Oct2021, patient reported immunization.  Relevant test done was reported as none. The patient reported that she woke up on 10Oct2021 with lower back pain and stiffness. she  tried streatching to relieve it. Sitting was very difficult and painful. she used turmeric/ginger capsules and occasionally tried Delta 9 cannabis (low the /high cbd) to relieve the pain and inflammation, which relieved it temporarily to some degree. she also tried taking ibuprofen (2 tablets every 4-6 hours) for 1 days. But it upset her stomach and was not very effective, so she  went back to just turmeric/ginger capsules and cannabis 2x day. Nothing resolved the issue. Adverse events (sciatica and severe back pain) required a visit to physician office. Therapeutic measures were taken as a result of the events which included chiropractic treatment. The outcome of the event (sciatica) was not recovered, and other events were recovered with sequel on 10Nov2021.  Follow-up attempts are completed. No further information is expected.
PATIENT STATES HAVING TREMORS IN LEFT ARM, GENERAL WEAKNESS THROUGHOUT BODY.
Patient began itching in both arms approximately 13 minutes after receiving the injection. The itching worsened and urticaria developed on her right wrist, left upper arm. She was given 50mg benadryl and monitored. Itching resolved and she was taken home by a co-worker. She was advised to follow up with her
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old patient received BNT162b2 (BNT162B2), on 01May2022 as dose 1, single (Batch/Lot number: unknown), in left arm and on 29May2022 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Brain injury" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative, notes: About 4 days after treatment and testing negative two times 48 hours apart; (Nov2022) Negative, notes: About 4 days after treatment and testing negative two times 48 hours apart; (Nov2022) Positive, notes: I started feeling sick again and tested positive for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: About 4 days after treatment and testing negative two times 48 hours apart, patient started feeling sick again and tested positive for COVID. Vaccine lot unknown reason: Not available/provided to reporter at the time of report completion. Vaccine administration date was 19Dec2021, vaccine dose number: 3.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jun2022 as dose 3 (booster), single (Lot number: FM7553) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Oct2021 as dose 2, single (Lot number: 014F2119), in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 16Mar2021 as dose 1, single (Lot number: 1805018), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hEDS" (unspecified if ongoing), notes: Other medical history: hEDS; "POTS" (unspecified if ongoing), notes: Other medical history: POTS; "Exocrine pancreatic insufficiency" (unspecified if ongoing), notes: Other medical history: Exocrine pancreatic insufficiency; "hypothyroidism" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "vasomotor symptoms" (unspecified if ongoing), notes: Other medical history: vasomotor symptoms; "interstitial cystitis" (unspecified if ongoing), notes: Other medical history: interstitial cystitis. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; CLONIDINE; DESMOPRESSIN; MIDODRINE; PYRIDOSTIGMINE; TIZANIDINE; AMITRIPTYLINE; CREON; GABAPENTIN; ESTRADIOL TRANSDERMAL; PROGESTERONE; TRAZODONE; CBD OIL; CALCIUM + MAGNESIUM; FISH OIL; DHEA; MELATONIN; THERMOTABS. Past drug history included: Percocet, reaction(s): "Known allergies: Percocet", notes: Known allergies: Percocet; Dilaudid, reaction(s): "Known allergies: Dilaudid", notes: Known allergies: Dilaudid; Cymbalta, reaction(s): "Known allergies: Cymbalta (sensitivity)", notes: Known allergies: Cymbalta (sensitivity). Other medication in 2 weeks product also included multi-vitamin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient took the paxlovid for 5 days (from 31Jul2022 to 04Aug2022); felt a bit better. Then all the symptoms came roaring back for the most part. The patient was still sick after Day 10. The patient was in another country when she got sick and took the paxlovid. The patient flew back to her home country when she thought she was better. The patient also reported adverse event country as her home country. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment.   Follow-up attempts are completed. No further information is expected.
Significant facial swelling on left side. Arm pain on left side. Numbness in neck/jaw area on left side. No other signs of allergic reaction  Received shot on left side.  Transported by companion in personal vehicle.
Sudden onset short term memory loss. Testing has included MRI, CT, EEG, extensive blood tests, including Lab (rare neurological disorders). All are normal. SARS test was negative with disclaimer that it didn't eliminate the possibility of her having Covid. Currently receiving high dosage of Prednisone for "encephalopathy" diagnosis. She is not responding. This has been going on for 3 months.
genital ulcer; fever; headache; vomiting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. n/a), administration date: 04Sep2021, when the patient was 16 years old, for COVID-19 immunization. The following information was reported: GENITAL ULCER SYNDROME (non-serious) with onset 21Nov2021, outcome "unknown", described as "genital ulcer"; PYREXIA (non-serious) with onset 21Nov2021, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset 21Nov2021, outcome "unknown", described as "headache"; VOMITING (non-serious) with onset 21Nov2021, outcome "unknown", described as "vomiting". The events "genital ulcer", "fever", "headache" and "vomiting" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of genital ulcer syndrome, headache, vomiting.  Additional Information: No other vaccine in fourweeks and also no other medication in two weeks. No covid prior vaccination and no covid tested post vaccination. Known allergies and Other medical history were not reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
symptoms occurred at home with following symptoms dizziness, fast heart beat (120-125) all day, generalized body aches, pressures and tightness/numbness on the back of head.  Took Tylenol 48hrs. HR still occasionally goes up.    Both arms and hands occasionally goes numb with a shock feeling and drops things. PCP follow up appt 2/2. 2nd dose was in 2nd arm.
Patient complain about severe pain in arm where she received flu shot, with feeling of hot, tenderness and redness around it. Patient saw Dr and got Ibuprofen, PEPCID & Hydrocortisone and feeling better after couple days of therapy.
ran fever over 101 24hr p/vax;pt may have devel pharyngitis-pt ran fever for 3 days;
after administration patient felt flush, heart racing, and shaky.  The patient was given juice and crackers, then felt improved. patient was released on their own accord.
The day after getting the vaccine i experienced terrible nausea, headaches, chills and lack of appetite. I also had a slight rise in temperature
Whole body aches, fever, headache, extreme chills, fatigue, dizziness,  sore throat, not hungry
Infection on their finger; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Infection on their finger) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced INFECTION (Infection on their finger). At the time of the report, INFECTION (Infection on their finger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe Chills Nausea & vomiting/throwing up; Severe Chills Nausea & vomiting; Severe Chills Nausea & vomiting; This is a spontaneous report from a contactable consumer. A 60-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot Number: ER2613), via an unspecified route of administration, administered in Deltoid Right on 22Mar2021 10:00 (at the age of 60 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included none. Concomitant medication included cefixime (FLEXERIL [CEFIXIME]); ibuprofen; diphenhydramine hydrochloride (BENADRYL), were taken for an unspecified indication, start and stop date were not reported. The patient had Pfizer Covid on 22Mar2021, at 10:00 and tonight he has had severe chills (23Mar2021 at 22:30) for about an hour and then in the middle of the night he started vomiting (24Mar2021) purposely. Today or tonight or this morning he has had extreme nausea (24Mar2021) and vomiting.  He just won't stop vomiting. The patient was treated with Dramamine/N for nausea and vomiting and also took Ibuprofen. The patient vomiting was slowing down, but it was not done, so slightly improved and the reason being was because he has been throwing up all night, not taking anything in. So, that was the only reason he was improving. He still has chills. The outcome of the event chills was not recovered, the event nausea was unknown, and the event vomiting was recovering. . No follow-up attempts are needed. No further information expected.