chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable consumer or other non-HCP (the patient). A 77-year-old male patient received the 3rd booster dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 76, in left arm, on Sep 9, 2021, at 15:00, single dose, for COVID-19 immunization. Vaccination history included the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in left arm, on Feb 9, 2021, at 17:00, and received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in left arm, on Jan 19, 2021, at 17:00; both single dose, for COVID-19 immunization. Medical history included chronic heart disease (unspecified if ongoing). Concomitant medication included metoprolol; isosorbide mononitrate; irbesartan; atorvastatin; levothyroxine; vitamin D 2000. The patient experienced ineffective drug (medically significant), with outcome of unknown and COVID-19/initial COVID-19 bout (medically significant), with outcome of recovered. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; negative antigen test, notes: After recovery from initial bout with COVID-19 and a negative antigen test, there was a complete rebound of symptoms and positive antigen testing. Therapeutic measures were taken as a result of COVID-19. Clinical course: Other medication in 2 weeks: One-A-Day multivitamin and turmeric tab. The patient has no known allergies. The information on the batch/lot number for  BNT162B2 requested and will be submitted if and when received.
Pt. recieved the COVID 19 vaccine at 5:05 in her left Deltoid. Pt. was had answered no to all questions on the COVID questionnaire. Pt. was to be observed for 15 minutes.  At 5:24 the pt. came back from the bath room complaining of her lips not feeling right. Pt. bought into my office VS taken BP 151/83, HR 82, Resp 18, O2 sat 98%. Pt. then started to voice complaints of her tongue not feeling right as well. Pt. advised that she needed to be taken to the ER via ambulance to be checked out due to the concern of anaphylactic reaction. Pt. declined to go by ambulance and states that she has someone in the car with her who can take her.Friend out to get the pt. friend. Continue to monit pt. O2 sats. Sats dropped to 88% but when mask removed from pt. O2 sat went back up to 90%. Advised the pt. and the gentlemen that the pt. needed to go to the ER via ambulance. Pt. again declined and states I want him to take me.The gentlemen states that he will take the pt. to ER. Phone call to ER and spoke with RN and report given that the pt. was on her way.
Patient became extremely fatigued after vaccinations and took a few hour nap from which he woke crying and screaming from what seemed to be pain. I assumed the pain was due to the injection site being sore but also wondered if it was due to brain swelling. I treated him with Tylenol and the issue seemed to resolve within a day.
This spontaneous report as received from a healthcare worker refers to approximately 15 year old patient of unknown gender. On 09-SEP-2013, the patient was vaccinated with GARDASIL (lot# J003727 and expiration date 07-NOV-2015 (also reported as 08-NOV-2015). It was reported that the vaccine was improperly stored and was exposed to below 31.6 Fahrenheit from 09-SEP-2013 to 23-SEP-2013. No further information was available at the time of the report. The case is linked to 1312USA001445, 1312USA008847, 1312USA008941, 1312USA008942, 1312USA008943, 1312USA008944, 1312USA008945 (Same reporter link). Additional information has been requested.
Mastocytoma on abdomen changed from reddish in color and mostly flat to yellowish in color and raised, rough and harder. Warm rash developed on parts of head, shoulder and abdomen and lasted about an hour. Knot formed at injection site.
Eyelids blinking/ Not Responding  BP 164/106,  EMS called In a few minutes she was responsive, anxious had a tremor, but according to caregiver at facility the tremor was normal. EMS took her to hospital as a precaution, thought she had a seizure due to anxiety. She is treated for anxiety and seizures.
I got my first Pfizer  shot Thursday  08/05/2021. Friday 08/06 both feet were numb.  Saturday/Sunday feet were numb and tingling.   Monday 8/9 my legs and feet felt numb and tingling. Tuesday I started having numbness and tingling in my hands, arms, feet, legs and face. Today date is 08/11 and I?m still having symptoms.
Leg swelling, fever 100 - 101, fussy x 2 days.
Loud ringing in the right ear lasted all night starting at 7 pm June 30, 2021 until the next morning around 9am. Had a hearing test and results showed sudden hearing loss in that right ear. Another episode occured on Friday July 2, 2021 . It started 7pm lasted all night until 9am next morning.  The following week I experienced 4 episodes of vertigo on July6. JUly 7, July 10, and July 12, 2021. Each episode lasted any where from 1 and half hours to 5 hours. The Vertigo episode on July 10th required a trip to the ER at the Hospital because I almost passed out.
Patient Received vaccine and proceeded to walk to table before waiting area. Patient reported feeling anxious and shaky and staff was able to assist patient to the floor for on site EMS to assess. Patient was wheezing in all lung fields and was transported to hospital for a full assessment. Labs and cat scan were performed with no adverse findings however patient was kept overnight to monitor for hypertension related to anxiety.
No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female child exposed to mRNA-1273 (Spikevax) (batch no. AS1412B) , while the mother received the product for COVID-19 prophylaxis.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    MEDICAL HISTORY (Patient): No allergy, concomitant diseases and risk factor was reported.     On 10-Jan-2023, the mother received second dose of mRNA-1273 (Spikevax) (Transmammary) .25 milliliter. Last menstrual period and estimated date of delivery were not provided. On 10-Jan-2023, the child was diagnosed with EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the child was diagnosed with NO ADVERSE EVENT (No adverse event). The Child was exposed to mRNA-1273 (Spikevax) during pregnancy. The delivery occurred  on 20-Feb-2018, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date).    No concomitant and treatment medications were reported.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.
Injection 1 - Slight headache. Appeared a couple hours after shot, went away about 4 hours after that. Injection 2 - Sore at injection sight. About 12 hours after injection, woke up with moderate chills and joint & muscle ache, diarrhea. Developed headache a few hours after this.  All of these symptoms went away after 5 - 6 hours except for joint/muscle ache.  Those took about a day to dissapear.  On the 5th day after 2nd injection I developed a cough in the chest trying to expel phlem.  Still have a little bit of chest cough (10th day) but very minor.
Severe back pain starting at 5pm on April 2, 2021. Frequent urination throughout the night, cold chills. April 3, 2021, 4:50am got up to use the bathroom and had extreme nausea and lightheadedness. Passed out and seized up. EMS arrived, BP 80's/50's and low grade fever. Put in chair to transport me downstairs and passed out and seized up again. Threw up. Transported to ER and still weak and severe back pain. Was given something for nausea. Two bags of fluid. EKG, blood work, and urine test. Left ER around 10 am
Information has been received from a physician concerning a 12 year old white female student who on 31-AUG-2007 at 10:20 was vaccinated intramuscularly in the left arm with a first dose of GARDASIL (lot #657006/0188U), 0.5 ml. Concomitant suspect vaccinations included a dose of VARIVAX (lot # "05950"), administered in the left arm. Concomitant vaccinations included Dtap ( lot # OC2775AA) and meningococcal (lot # U2326AA), both administered in the right arm. There were no illnesses at the time of vaccination. On 01-SEP-2007 the patient "broke out with herpes" (unspecified). It was reported that the patient had no history of sexual activity. The patient was seen at the office. A serum Herpes simplex virus immunoglobulin M antibody test was performed and was positive. The rash resolved with treatment. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.
36 weeks pregnant, edd 12/19/22, weight 188 lbs. within 24 hours of booster vaccine: full headache, sore arm, nausea, vomiting, fatigue. Lasted 1 day for all symptoms.
Vaccinated while laying on table and waited a few minutes after vaccination to move into chair next to mom. Client then became light headed, pale, and dizzy with 15-20 second loss of consciousness with head on mom's shoulder while mom held her.  Client grunted with a breath and arms contracted for a couple seconds. Client came to and was sweaty and vomited once. Elevated feet and water given.
Onset of chills and fever 12 hours after vaccination. Fever worsened throughout that night and reached ~101-102 F. The next morning, approximately 24 hours after vaccination, fever started to improve. That same morning (3/3/21), started having headaches, nausea, fatigue, and chest pain. No medication or treatment was used and symptoms resolved within 24 hours.  However, chest pain persisted for about 2-3 days.
Headache, pain at injection site, and excessive swelling of lymph nodes under left arm pit only.
Shaking chills, fever, aches, Tachycardia lasted 24 hours.
Fever 101, headache, chills, muscle pains, skin sensitivity, unable to concentrate, no treatment, resolved within 24 hours after vaccine
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated IM with the first dose of GARDASIL in approximately 2011 ("about 1 year ago") and would be vaccinated with the second dose of GARDASIL on 08-AUG-2012. No known adverse effects. Additional information has been requested.
Roughly 10 minutes after receiving a Pfizer vaccine, patient lost consciousness for less than 5 seconds (caught by friend/partner - no injury).  Patient vomited upon waking.  Patient felt better then had another similar episode of lightheadedness and vomiting, but with no loss of consciousness.  Patient then continued to feel better and better.  Patient remained in the area for roughly one hour before leaving.  When patient went home, she felt better, took a nap, and is feeling great now at roughly 6pm as I am checking in with her.
Patient developed sudden onset of high grade fever(103F),chills,weakness and malaise.  11/2/09:  Hospital Records and Discharge Summary received for dates of service 10/29/09 to 10/30/09.  Dx:  Severe Dehydration. Assessment:  Pt. with hx. of malabsorption syndrome and immunoglobulin deficiency presented to hospital with sudden onset of high grade fever (103-104), chills, cough, pain, weakness, malaise, increased diarrhea and tachycardia.  Clinically improved after IV hydration and discharged to home.
Day 8 evening, I noticed my arm felt stiff. When I checked, I saw a large (3 in x 2 in) irregularly shaped erythema on my left arm, about 2 inches below the injection site. It was warm to touch and slightly raised. But no pain.  Rash persisted on Day 9.
tingling in his left leg; constipated/been using the bathroom like a rabbit; really bad gas/nothing is coming out just horrible smell; Pain at site; felt like he had a fever; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in his left leg), CONSTIPATION (constipated/been using the bathroom like a rabbit), FLATULENCE (really bad gas/nothing is coming out just horrible smell), VACCINATION SITE PAIN (Pain at site) and PYREXIA (felt like he had a fever) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling in his left leg), CONSTIPATION (constipated/been using the bathroom like a rabbit), FLATULENCE (really bad gas/nothing is coming out just horrible smell), VACCINATION SITE PAIN (Pain at site) and PYREXIA (felt like he had a fever). At the time of the report, PARAESTHESIA (tingling in his left leg), CONSTIPATION (constipated/been using the bathroom like a rabbit), FLATULENCE (really bad gas/nothing is coming out just horrible smell), VACCINATION SITE PAIN (Pain at site) and PYREXIA (felt like he had a fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow-up received with no new information.
I work in public security. On June 22, they gave me the Johnson vaccine, at 11:15 a.m., that day I get off at night and to this day I continue to menstruate a lot and many clots I went to the gynecologist and he gave me contraceptives to cut the period but I am still menstruating a lot and I feel weak and would like information or what can I do? I do not omit that days before the Johnson vaccine I had my menstruation which was June 17, 18, 19 and on the 20th it stopped, (which was my normal period without any anomaly), on Tuesday June 22 when I got the vaccine for the Tomorrow night I started to menstruate, it is already 14 days menstruating a lot, which is not normal, I feel my body weak and tired. I hope news soon I would appreciate it very much!
Heart Palpitations, Dysphagia, Dysmotility, Malaise, Fatigue, Cramps, Esophagitis, Weakness, Weight loss, Loss of appetite, Hypersalivation, Inconsistent blood pressure.
Received second dose of COVID vaccine on 8/5/21, on 8/8/21 started having chest pain no SOB. I ordered labs and the results were: ?. esr 14, crp 35.3, troponin 249. Sent to ED where he was admitted for three days. He had CXR and ECHO but I do not have these results. Saw the patient today 8/12/21, chest pain resolved with vitals normal.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 27-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 648 hours, the lowest recorded temperature was 20 degrees F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
8-18-09 Erythema, swelling at site. Temp 100.1, left thigh 4.5" x 3.75" raised erythematous macule, warm to touch. 8-19-09 increased in size, no itch.
ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/30/2022 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN  ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/30/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
hot, red, swollen, raised, itchy 2"x5" bump on upper arm around administration site, still persisting at least until 10/20/21, treating with triamcinolone prescribed from doctor as of 10/20/21, outcomes TBD
Total hair loss more than 70% including body hair .diagnosed as  AA after head biopsy
c/o aches & pain 9 days post vax; 18NOV93 pt stated was taking  radiation therapy for prostate cancer daily;
no adverse events; improperly stored vaccine was administered; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 03-MAR-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (therapy type: Digital Data Logger) (ROTATEQ) one dose orally for prophylaxis (lot # 1660942, expiration date reported as 06-FEB-2021, strength was not reported) (product storage error). No adverse effects were reported. The nurse reported that the vaccines underwent multiple temperature excursions below 2 degree Celsius (1.28Celcius) for a time frame of 2 hours and 30 hours as recorded by a data logger. The vaccines had no previous temperature excursion. No product quality complaint was reported. The outcome of product storage error and no adverse event was unknown.
received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR201274:Same reporter. US-GLAXOSMITHKLINE-US2021AMR211145:Original Case : US2021AMR211145,same reporter
A Medical Assistant administered the over 3 prefilled syringe dose, instead of the 6-36 month prefilled dose syringe.
Information has been received from a physician concerning a male who was vaccinated with a dose of MMR (lot # 645621/0271N). Concomitant therapy that day included a dose of varicella virus vaccine live. Ten days later, on 3/16/06, the patient presented to the office with falling to one side. The physician had the patient walk the halls, and the child seemed OK. As the day progressed, the patient's symptoms worsened. He was sent to the hospital with loss of motor skills. Over the night, the patient was sent to a specialized hospital, and diagnosed with acute disseminated encephalomyelitis. He was in the hospital for one week (7 days). The mother reported to the nurse that the first four days were very scary because the child had lost the ability to walk. One week after admission, the child was diagnosed to home. The patient presented to the physician's office on approximately 3/28/06 and was walking fine but was cranky. At this time, the child as recovered. The plan for this child is serial MRI's. It was noted that if this does recur, it is possible that he may have multiple sclerosis. There was no product quality complaint. The physicians at the hospital indicated that the symptoms were probably related to vaccination with the MMR. Additional information has been requested.
Information has been received from a physician concerning a 21 year old female patient who in 2007 (three years ago) received three doses of GARDASIL (lot not reported). It was reported that on an unspecified date, the patient was ascus (+) and HPV positive. At the time of reporting the outcome of the patient was unknown. Additional information has been requested.
Achy feeling like I have a fever started in the middle of the night the night I got the shot, and continued into the next morning. A bit of joint achy-ness.
One week after injection, server pain on the whole left arm, arm pit, and back shoulder blade. The pain has not gone away.
serious neurological symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 Immunization; Bnt162b2 (Dose 2, After the second shot, I had some significant side effects, insignificant ones for two boosters, then the worst symptoms from the Omicron booster.), for COVID-19 Immunization, reaction(s): "serious neurological symptoms"; Bnt162b2 (1st Booster, dose 3, After the second shot, I had some significant side effects, insignificant ones for two boosters, then the worst symptoms from the Omicron booster.), for COVID-19 Immunization, reaction(s): "serious neurological symptoms". The following information was reported: NEUROLOGICAL SYMPTOM (medically significant), outcome "unknown", described as "serious neurological symptoms". Clinical course: After being extremely thankful for the amazingly quick development of the Pfizer COVID-19 vaccine, patient had ever single one, including the omicron booster. After the second shot, patient had some significant side effects, insignificant ones for two boosters, then the worst symptoms from the Omicron booster. Patient told the doctor shortly after and to patient's surprise, doctor said they were serious neurological symptoms and getting another would be dangerous. Patient was very concerned about COVID.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300005067 same reporter/pt/event, different dose;
Patient called 1 week after getting vaccine--explaining that her arm still hurt to the point where it was difficult to get dressed--also said she had lost some range of motion--asked what to do and wanted to make us aware of the situation--told patient if not feeling better may want to contact primary doctor go to a Urgent Care or Emergency room. I would document situation and contact her again.