chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient is a 35 year old female recently hospitalized with speech difficulties correlated with abnormal MRI findings. She was discharged on April 3, 2010 and is following up as an outpatient today. Earlier today she has seen her ophthalmologist and had an eye exam, which was normal. The patient was in her usual state of health until to weeks prior to her presentation to the hospital on April 2, 2010 when she noticed difficulty with language. She described trouble getting her words out, but knew what she wanted to say. This coincided with the onset of her last menstruation which lasted four days. The symptoms continued, getting worse especially in the afternoon. In addition, she had a slurred speech and some posterior headaches over two days prior to presentation. Her primary physician ordered a brain MRI, which showed multiple ring enhancing lesions. She had a CT of the chest, abdomen, and pelvis which did not show any obvious malignancies and so she was transferred to medical center for further evaluation. On April 2, 2010 the doctor as an inpatient and did a lumbar puncture which showed a slightly elevated WBC of 9 with lymphocytic predominance of 92%, protein 33, glucose 65. Infectious workup are negative so far. Some of the tests are still pending including cytology of the CSF. The differential diagnosis included CNS lymphoma, demyelinating diseases, or an infection. Since her discharge the patient has been stable. She continues to experience difficulty with speech exacerbated by stress and lack of sleep, otherwise she has no neurological findings and no new complaints. She did have a little bit headache after the lumbar puncture. It seems to be worse at night and relieved with p.r.n Tylenol.
This spontaneous report as received from a physician refers to a 56 years old female patient with arthritis. The patient had no other concurrent conditions and no allergies. On 09-JAN-2013, the patient was vaccinated with dose 1 of 0.65 ml live ZOSTAVAX subcutaneously, in the left posterior triceps. Lot number was reported as H019034, the expiration date was not reported. No other co-suspects were reported. There was no concomitant medication. On 13-JAN-2013, the patient experienced rash around the injection site of where live ZOSTAVAX was administered. The type of rash was reported as erythema and it was 22 mm in diameter. Other symptoms included itching. The patient's body temperature was reported to be normal. The patient was enrolled in the Varicella Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with Merck vaccine strain. A sample was obtained on 14-JAN-2013 (viral culture). No results were available at the time of the report. The patient denied recent exposure to chickenpox or shingles. It was reported that the event was treated with ibuprofen. The outcome of rash around the injection site of where live ZOSTAVAX was administered was reported as recovering; when the patient was seen in 14-JAN-2013, she was getting better. The reporter relatedness for rash around the injection site of where live ZOSTAVAX was administered is unknown for live ZOSTAVAX. Additional information is not expected.
At 4:40 side effects began with shooting pains in fingers and legs followed by body aches and chills and skin sensitive to the touch. Fever followed and reached 101.2. Intense headache next with nausea, Around 11pm I began wheezing. Just before this I noticed my heart had begun racing. I drank a lot of water during this time, drank soda to settle my stomach and ate 2 crackers. It seemed as though the crackers gave me heartburn. By 6am the following morning fever had come down to a temp (99.2). My headache was just mild and body aches seemed mild. and Some shooting pains remained. On 4/10 around 3pm I felt as though body aches and my headache were worsening. My pulse sped up and my temp began to rise. My temp had risen to 99.8 and my head was becoming much worse so at 5pm I took 3 extra strength Tylenol. This helped a lot.
Pt recvd vax & p/3rd dose exp nausea, joint achiness, stiffness, muscle pain & vomiting; reporter indicated that pt is having emotional problems;
hand swelling; difficulty walking; difficulty turning over in bed; This is a spontaneous report received from contactable reporter (Consumer or other non HCP).  An 86 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 19Feb2021 (Batch/Lot number: unknown) at the age of 86 years, as dose 2, single for COVID-19 immunisation. Relevant medical history included: "History of remitting seronegative symmetrical synovitis with pitting edema (RS3PE)", start date: Apr2020 (unspecified if ongoing); "Bicuspid aortic valve" (unspecified if ongoing); "aortic root aneurysm" (unspecified if ongoing); "valve and aortic root replacement" (unspecified if ongoing); "prostate cancer" (unspecified if ongoing); "prostatectomy" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Prednisone, start date: Apr2020, for RS3PE. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 21Feb2021, outcome "recovering", described as "hand swelling"; GAIT DISTURBANCE (non-serious) with onset 21Feb2021, outcome "recovering", described as "difficulty walking"; MOVEMENT DISORDER (non-serious) with onset 21Feb2021, outcome "recovering", described as "difficulty turning over in bed". Therapeutic measures were taken as a result of peripheral swelling, gait disturbance, movement disorder. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known food or drug allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was taking unspecified concomitant medications. Two days after the symptoms began, prednisone was restarted at 10 mg. Symptoms were resolving 5 days after restarting prednisone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient had her shots yesterday. Last night, she developed a 103 fever. Her twin sister had the same shots and she developed same symptoms. She has had runny nose for one week, but she did not seem at all sick. After her first set of shots on 8/31/05, she had fever up to 104, which lasted three days and resolved spontaneously. After her second set of shots, she had no problems. The shots that were given both the first and thrid times are the HIB and PREVNAR. Fevers this time lasted 48 hrs.
patient received vaccine and walked to chair and immediately started to c/o headache 2 -advil were given, patient was allowed to lie down on stretcher, close here eyes and ice pack to forehead was given
Pt recvd 1st dose Engerix-B 21DEC90 & exp h/a felt h/a caused by stiff neck; occurred only when activity caused neck pain to radiate thru shoulders; p/2nd dose given 3 wk neck pain; 26MAR91 exp pressure, dull pain fr base of skull to eye, n
Irregular shaped red, warm area on right ant. shoulder w/in musculature but not at shot site.  Slightly painful with external rotation but not with adduction or abduction.
Left arm soreness throughout the day; Tiredness in the evening; Restlessness during the night; Had unusual dreams; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in left arm on 03Mar2021 at 09:30 (at the age of 42-years old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 10Feb2021 at 09:15 (at the age of 42-years old) as a single dose for COVID-19 immunisation. On 03Mar2021 at 18:00, the patient experienced left arm soreness throughout the day, tiredness in the evening and restlessness in the night. The patient also had unusual dreams. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No 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 left arm soreness throughout the day, tiredness in the evening, restlessness during the night and had unusual dreams was recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
Acute Abdominal Cramping, Belching, Nausea began at 10:30pm 7/19/21 4 hours of OTC attempts to relieve pain and pressure. Gas-X and Alka-Seltzer Self-drove to Emergency Room around 2:30am 7/20/21 All Tests Normal, and belching relieved enough pain 4 hours after check-in, so Discharged at 5:15am 7/20/21 w/ Rx for Dicyclomine 20mg Tab and Ondansetron ODT 4mg Disintegrating Tab
Once she did, she had her period for about 8 weeks; did not menstruate for 3 months following vaccine; This is a spontaneous report from a contactable HCP (reporting for self). A 46-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as a single dose (at the age of 46 years old) for COVID-19 immunization. The dose number was not reported. There was no other vaccine administered in the 4 weeks prior. Medical history included penicillin allergy. The patient did not have COVID prior to vaccination. Concomitant medication(s) included omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) taken for an unspecified indication, start and stop date were not reported.  The reporter (patient) stated she did not menstruate for 3 months following vaccine. Once she did, she had her period for about 8 weeks. She was not in menopause and was always very regular. There was no treatment received for the event(s). The patient recovered from "did not menstruate for 3 months" on an unknown date. The outcome of the event "her period for about 8 weeks" was recovering. The patient was not COVID tested post vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Monday morning at 08:00am I experienced a short dizzy spell lasting 3 to 5 seconds while walking in my home. At about 09:30am the same morning I had another dizzy experience for the same duration. The remainder of the day I experienced a light headed feeling all day. The next day  (today) started out normal but by 10:00am I experienced dizziness again for about 8 to 10 seconds and as I write this report I have a light headed feeling again. Note: one week ago I had a sore gland under in my jaw on the left side just below my left ear which lasted for 3 days and went away without treatment. I have not seen a Doctor in reference to this condition yet.
Generalized sz lasted for 1 to 2 min w/high-pitch funny cry; w/in 24hrs of DTP immun;
abscess tooth; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6204), dose 1 via an unspecified route of administration, administered in Arm Right on 10Mar2021 17:45 as 1st dose, single (age at vaccination 77 year old) for covid-19 immunization (Covid protection) at hospital. Medical history included osteopenia and has trouble with her spine from an unknown date. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced abscess tooth on 15Mar2021. Caller mentions that she got the first dose of the Pfizer covid 19 vaccine last Wednesday and yesterday she started feeling like an "abscess tooth" in her cheek. She was wondering if this was something that the vaccine could caused. She saw her dentist a month ago and had X-rays. She did not have an abscess at that time. The adverse event did not require emergency room or physician office. The patient underwent lab tests and procedures which included body height: shrinking and x-ray: did not have an abscess at that time on an unknown date. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
No adverse effects.; an improperly stored VARIVAX was administered.; Information has been received from a medical assistant referring to an unknown gender patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On 13-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N029632, expiration date: 23-OCT-2019, dose, frequency and route were not reported) for prophylaxis. The administered doses experienced a temperature excursion at 13.3F (6°F to 14°F)  for 30 mins; Previous temperature excursions were 15.3F (15°F to 46°F) for 8 hours. The temperature excursions were detected by a data logger (Product storage error). No adverse effects. Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided.
This case was reported by a healthcare professional (nurse) and described the occurrence of hepatitis b antigenemia in a 35-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to azithromycin, allergy to sumatriptan, allergy to tramadol, anxiety, chronic infection and high risk sexual behavior. Concurrent medications included PAROXETINE, Cefixime, Doxycycline, Metronidazole and SKELAXIN. On 30 October 2012 the subject received 1st dose of TWINRIX (20 mcg, intramuscular, left deltoid). On 31 October 2012 to 1 November 2012, approximately 2 days after vaccination with TWINRIX, the subject experienced hepatitis b antigenemia. The reporter stated that the physician had ordered a hepatitis b surface antibody test but the hepatitis b antigen test was run. Relevant test results included hepatitis b surface antigen test on 1 November 2012 which was positive. The reporter stated that it was a "possibility of transient hepatitis B antigenemia or other chronic infection." At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 14 December 2012 via healthcare professional who reported the subject had their blood drawn again on 06 December 2012 and HBsAg was negative. HBsAg [hepatitis B antigenemia] was originally reactive on 01 November 2012 two days post vaccination. The vaccination series with TWINRIX was not delayed or discontinued. The subject did not experience any adverse events following previous vaccinations. The hepatitis B antigenemia resolved on 06 December 2012. The reporting healthcare professional considered the event probably related to vaccination with TWINRIX.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Tongue swollen. Arm itch, red/light purple ring, swollen & painful cannot but even shirt over it. Instructed to take benadryl, ice, see doctor or ER if worsens.
Pt recvd vax 29SEP92 & 30SEP92 exp lt shoulder joint pain which spread to back of neck, upper back & down lt arm;
3 days after receiving MMR-V vaccine in (L) thigh, patient developed a rah in the opposite site of the vaccine.
not feeling great; sore at the site of injection; has been over a year since her first Shingrix administration; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Shingrix (received 1st dose a year ago).   On 10th September 2020, the patient received the 2nd dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season. On 10th September 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site pain and drug dose administration interval too long. On 11th September 2020, the patient experienced malaise. On an unknown date, the outcome of the malaise and injection site pain were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the malaise and injection site pain to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she got  a flu shot and Shingrix shot. The patient experienced sore at the site of injection (left deltoid). The patient was not feeling great although she did work physically hard. The patient reported it had been over a year since her first Shingrix administration, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Swollen Middle Finger, with throbbing pain. I feel as though the vaccine triggered this issue.  My middle finger was not swollen before the 1st vaccine dose.
Pt recvd 1 dose of Engerix-B & 10 minutes p/dose given pt exp unconsciousness, BP was 80/50 & became diaphoretic;
Information has been received from a registered nurse referring to a 15 year old female patient. The patient's medical history and concurrent conditions were not reported. On 26-APR-2016 the patient was vaccinated with a dose of PROQUAD (Merck) (0.5 ml, once, subcutaneous, lot # L050909, expiration date 14-JUN-2017) (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Pain at the time of injection, leading to severe pain and trouble sleeping, reporting that he almost went to the emergency room due to so much pain in the arm.
intern came to help out with the vaccines and processing them, at the store I was floating to. I took out the vaccine from the refrigerator to thaw. I indicated to her as such. But  there were 2 vials( 1 Pfizer+ 1 Moderna) left over from yesterday(12/13) sitting on the other side of the back counter, with a sticker on the bottom indicating the time and date. She thought I already prepared the vaccines and ready to go. So she started giving  vaccines from those vials.  After giving the 2 Pfizer and 3 Moderna vaccines, she realized that it was a bottle from yesterday. She alerted me as such .  None of the patients called back reporting any adverse effects. we reported to out patient care services manager
pre vaccination symptoms of a patient :  panic ; sweating; headache; tingling her hand and leg; very week; shaking and chils.  Symptoms was resolved and patient went home after she took her vaccine.
Temporary blindness; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS TRANSIENT (Temporary blindness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     Concomitant products included QUETIAPINE FUMARATE (SEROQUEL) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced BLINDNESS TRANSIENT (Temporary blindness) (seriousness criterion medically significant). At the time of the report, BLINDNESS TRANSIENT (Temporary blindness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Adverse reaction started with joint stiffness for several days, then started to included joint/body aches on/about Aug 8, continued with fatique, slight headache/stomach ache w/ nausea (stiffness and body aches). Aug 12 left work midday with chills and fatigue. Took a nap and took temperature. Temp = 100.6. All symptoms, except fever, continued with slight improvement into Aug 14-15. Most symptoms minimal by Aug 16. Late, 9:30PM on Aug 16, intense headache with mild nausea started. Could not sleep well and no OTC NSAISD or Tylenol had any impact over the next 24 hrs. Could not work.  Notified PC on Aug 18, still not able to work. Ofc visit with PC on Aug 18. Recommended CT Scan which was take at 3pm. Initial read was clear. RX given (TORADOL 60 mg injection, IMITREX 6mg injection) and observation for 30 min then discharged with greatly reduced pain level. From 7-8 to 3 on 1:10 scale. Rx IMITREX 25mg tab, no more than 2 in 24 hrs. IMITREX moderately effective but next day Aug 19, headache continued at a level of about 3. When RX wore off headache returned to about a 5 level. Reported to PC on the evening of Aug 18. PC scheduled Ofc Visit with neurologist.  Ofc Visit with neurologist, Aug 19. CT scan reviewed again and looked clear. Neurological exam completed with no indications of underlying condition. Conclusion provided was ongoing response to MMR vaccine given lengthy immune system reaction from Aug 6-14. Rx given IMITREX 50 mg tab, no more than 4 in 24 hrs. Better relief provided for 2 days. By Aug 22 or so IMITREX did not seem effective in eliminating head ache.  OTCs continued to not be effective. Headache continued (non stop since Aug 16) but with varying levels ranging from 1-3 on 1:10 scale. Attempted homeopathic approach and started taking Hylands Migraine on Aug 25. Seems most effective in keeping headache level low and is able to reduce a level of 3+ back to a 1-2 if 4 hour dosing is inadvertently extended, typically during the night if I don't get up between 2-4AM. Awoke today at 5AM with level 3-4, highest in a week, and could not get back to sleep for over an hour. I suspect the Hylands taken at 5:15 helped.
within 24 hours, urticarial rash on chest, shortness of breath, and nausea
Swollen, red, warm at injection site dizziness, headache about 10 minutes post injection rash at injection site and across chest 20 hours after injection.