chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within one month of receiving second dose of the Moderna covid-19 vaccine patient reports she developed postmenopausal bleeding that she defined as heavy (multiple pads daily) and lasting > 7 days.  She has now had two episodes of menstrual bleeding  approximately three weeks apart.  She also reports considerable cramping and lower back pain associated with bleeding.
Losing smell; This is a spontaneous report received from a contactable consumer, the patient. A 29-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep7534,) via an unspecified route of administration in the left arm on 19Mar2021 at 12:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Mar2021 at 21:00, the patient was losing smell. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test on 20Mar2021 which included nasal swab and the test result was negative. The patient did not receive any treatment for the event losing smell. The clinical outcome of the event losing smell was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Patient states that on 05/09/22  he became very dizzy and fainted,  the next day he began to have left chest pain and was taken to  Hospital, where he was admitted and dx with myocarditis ,  was in the hospital for 8 days.
baseball size area, surrounding inj site, raised, red, fine pimple like rash devel w/pruritus;pt c/o pruritis in AM-peak breakout of rash approx 24hr post inj;
Twenty minutes after injection patient noted left sided facial numbness (Same side as injection). Shortly after that she noted some tingling in her throat. She was given diphenhydramine 50mg and monitored for roughly 1 hour total after her injection before having complete resolution of the tingling in her throat and marked improvement in facial numbness.
Information has been received from the Merck Pregnancy Registry from a 22 year old female with no pertinent medical history who on 17-DEC-2007 was vaccinated IM with a first dose of GARDASIL vaccine (lot #659437/1266U). Concomitant therapy included ZOLOFT. It was reported that the patient was vaccinated while she was pregnant. Last menstrual period was 19-NOV-2007 and estimated date of delivery was 25-AUG-2008. It was reported that there was no adverse event involved. There were no laboratory or diagnostic tests performed. Follow-up information received from the patient who reported that she had developed gestational diabetes during the pregnancy. She delivered the baby at term. The baby was healthy and normal "and has had a few colds".
BELLS PALSY; TOO MUCH PAIN; TOO MUCH PAIN TO SLEEP; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included immunocompromised and polyethylene glycol (PEG) allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number unknown and expiry: unknown) dose, start therapy date were not reported with dose number in series was 1, frequency 1 total used for prophylactic vaccination. The batch number was not reported. The company unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced bells palsy, too much pain and too much pain to sleep (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bells palsy, and the outcome of too much pain to sleep and too much pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220112396 -Covid-19 vaccine ad26.cov2.s- Bell's palsy. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
CHILLS; FEVER; EXHAUSTION; This spontaneous report received from a patient . The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry date: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills, fever, and exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and exhaustion was not reported. This report was non-serious.
Arm started hurting, chills, back ache, extremely smelly diarrhea, lots of gas, headache, back ache, joint aches, weakness, and a 100.1 fever that lasted 24 hours only.
Itching; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program, Corporate (Pfizer) Social Media Platforms. A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EL9269), via an unspecified route of administration, administered in the left arm on 09Feb2021 16:00 (at the age of 67-years-old) as dose 1, single for COVID-19 immunization. Medical history included blood pressure high. Concomitant medications included amlodipine, clonazepam, lamotrigine (LAMICTAL), and hydrochlorothiazide/valsartan (VALSARTAN & HCTZ). The patient previously took codeine and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks of the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Feb2021 22:00, the patient experienced itching. The patient has been itching for days. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as result of the event. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
I was giving booster doses of moderna vaccine at a group,  I also offered any staff a booster if they wanted it. Patient is an employee there and she said she needed her booster, she said she had an appointment on 03/15/22 for her booster but had to cancel due to car trouble, I asked her for her immunization card and she didn't have it but she said she was over due for her booster, so I gave her the shot.   When  we went to imput the info on the computer we discovered she wasn't due for another month.   I called patient 03/24/22, she said she felt fine other than a little soreness in her arm and she did discover she was pregnant today.
injection site rash about a week after; muscle soreness lasted about a week then went away; little bit of dizziness; Fever; headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (little bit of dizziness), VACCINATION SITE RASH (injection site rash about a week after), PYREXIA (Fever), HEADACHE (headache) and NAUSEA (Nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided.  Concomitant products included ATORVASTATIN for an unknown indication.   On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced DIZZINESS (little bit of dizziness), PYREXIA (Fever), HEADACHE (headache) and NAUSEA (Nausea). On an unknown date, the patient experienced VACCINATION SITE RASH (injection site rash about a week after) and MYALGIA (muscle soreness lasted about a week then went away). At the time of the report, DIZZINESS (little bit of dizziness), PYREXIA (Fever), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown and VACCINATION SITE RASH (injection site rash about a week after) and MYALGIA (muscle soreness lasted about a week then went away) had resolved.
All symptoms started around 12 midnight; Extreme Chills, fatigue that lasted 24+ hours, Headache, Joint Pain, Fever, and the soreness at the site of injection that I have never felt before.
DEMAND ISCHEMIA ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA CARDIOGENIC SHOCK
This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 25 year old patient of unknown gender. No pertinent history or drug reaction/allergies were provided. On 09-OCT-2013, the patient was vaccinated with MMR II (lot number H016632; expiry date 31-AUG-2014; dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the MMR II administered to the patient was exposed to temperatures above 8 degrees C (approximately between 8/09 and 22.73 degrees C) during approximately 42.78 hours, since 05-OCT-2013. No adverse effect has been reported. This is one of several reports from the same reporter. Additional information has been requested.
6mm x 5mm L arm redness with darker red area 1-15cm.  OMNICEF 250/5 1 tsp BID x10 days.
Couldn't move left arm in so much pain within 6 hrs of shot. 101 temperature for 4 days. Dr gave steroids. I still have pain when using. Supposed to see specialist. At this point it has been 11 days.
Had weakness, numbness, slurred speech, trouble walking/talking, sudden severe headache in the afternoon of 10/7/21.
The adverse side effects were myocarditis. I went to the hospital and they ran many tests to confirm this was the outcome due to the vaccine
Patient reported palpitations, throats feels "funny",  heart fluttering, heavy chest @ 9:19a. EMS called @ 9:22a.  Diphenhydramine 12.5 mg PO administered @ 9:23a. Symptoms resolved in throat per patient @ 9:28a. Patients blood pressure was elevated at 9:20a at 154/111, pulse 85, O2 Sat 97% on outside air, respirations 16. EMS arrived at 9:32a. Patient not transported to hospital. EMS departed. Patients status when leaving was A+O x 4, clear speech, walking, all symptoms resolved.
they gave a Pentacel without the Diluent ,No AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Global Medical Information(Reference number- 00487716) and transmitted to Sanofi on 22-FEB-2021.  This case involves a 2 year old female patient who received DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) without the Diluent, (batch number U6890AA,expiry date 22-mar-2022 ) via Intramuscular route in unknown administration site for prophylactic vaccination on 19-Feb-2021(Product preparation issue).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to active ingredient not added to diluent(latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt came to office next day - Redness on arm, painful Fever 103, vomiting, dehydration - Came in 12/31 - arm worse, area of redness doubled in size.
INJECTION SITE REACTION, SWELLING, REDNESS, HOT TO THE TOUCH, LIMITED TO INJECTION SITE WITH MILD SPREADING NOT BELOW THE ELBOW.
Recieved Flu Vaccine at around 2:00 pm, by 5:00 pm of the same day I had a high fever 101.6, muscle aches, cough, stuffed up nose (so severe everytime I swalled my tongue was sucked up to the back of my throat), red blood shot eyes with yellowish discharge, sore/scrathcy throat, chills/ cold sweat.  When I got up the next morning both eyes were matted shut with a yellowish discharge.  By 12:30 pm the next day I still have a fever, aches, red blood shot eyes, with a yellow discharge and cold chills.
Approx 28 hours after vaccine given, noted right inner eyelid started itching, watering, then started to swell shut after another 2-3 hours. 3 hours later, noted itching and whelps on scalp, back of neck, chest and bil thighs. Took 50mg Benadryl po 1 time at 9pm on 11/12/13. Itching resumed on 11/13/13 at 8:30am. No whelps noted.
Pt developed shingles rash and PMR--polymyalgia rheumatica, lots of joint and muscle pain.
SWEATING ANXIETY, HEADACHE, NAUSEA, SWEATING AT APPROXIMATELY 1410. HR 100-105. OBSERVED 5 MINUTES. DENIED SOB. NO TACHYPNEA, RASH OR ORAL SWELLING. NO AUDIBLE WHEEZING OR STRIDOR. SENT TO ER AT 2:19 FOR OBSERVATION. OBSERVED 1 HOUR.
This spontaneous report was received from a medical assistant regarding unspecified multiple patients with unknown demographics. Information on pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On an unknown date, unspecified multiple patients were administered improperly stored ROTATEQ (lot# M004508 with expiry date: 29-JUN-2017 and lot# M019708 with expiry date: 25-OCT-2017) on multiple unspecified dates. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a medical assistant regarding unknown number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 22-JAN-2015, the patients were vaccinated with ROTATEQ, lot # K001935 (expiration date - 18DEC2015) and lot # K006458 (expiration date 24-FEB-2016) orally which had underwent unsupported temperature excursions (incorrect product storage). No adverse effect was reported. No product quality complaint was involved. No concomitant medication was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
put me flat on my back/not feeling well; chills; pins and needle in face; still ache; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid-19 vaccine (received on an unknown date).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced malaise, chills, pins and needles and pain. The patient was treated with ibuprofen (Advil) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the malaise, chills and pins and needles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the malaise, chills, pins and needles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced such bad reaction worse than the COVID vaccine, put him/her flat on his/her back, chills, pins and needles in his/her face and still ache but not feeling well. The patient stated that Benadryl and Advil took care of that. The patient got tested twice to make sure it was not COVID negative both times. The patient asked did anyone else had a reation to a Shingles vaccine. The patient scared to get it. Still have to get his/her booster dose but there was so much different information on how long to wait after COVID. No further information reported.
pt recvd vax; had red blotchy areas & welts; mom called er; recvd dph; saw MD in am;
Patient called on 1/7/2022 to inform us that on 1/6/2022 she stated that her injected arm (left) started to swell, formed a knot, and itched very much. Patient was instructed to take Benadryl and to seek medical attention if it worsened or spread. She received her 0.25ml Moderna booster on 1/5/2022.
Pt in post vaccination, spouse and pt approached nurses desk. Spouse asked what pt could take for her injection site pain. While standing at desk, pt complained of dizziness, nurse went around desk to assist pt. While spouse and nurse assisted pt to the floor, pt struck head on carpeted floor. Pt remained conscious, hyperventilating,  complaining of left leg cramp. BP 84/68, HR108, O2 100%, Resp 28. EMS called, transported to Hospital per Spouse request.
6:26 PM. Approximately 5 minutes after receiving vaccine, pt's wife informed me that the pt had "passed out " while I was administering her vaccine. I went to waiting area, pt was conscious, very pale, upright , somewhat disoriented in waiting area chair.  Wife stated that pt often faints after blood draws and many other medical procedures.  Very shortly, the patient's color and mental status improved significantly. Pt denied any itching ,throat/tongue issues or difficulty breathing . Pt refused offer to call EMS.   Pt was given something to drink and advised to sit in the waiting area for a minimum of 30 minutes after injection where he was closely monitored. Checked pt's BP at  1845 and it was 105/73 which pt stated was normal for him. Pt left pharmacy at 1853.
Patient called pharmacy where she received shot and explained she was still experiencing nausea. Rph counseled patient to continue symptom treatment with saltine crackers, flat pop if she did preferred not taking medication. If no improvement in a few more days or if symptoms get worse, contact MD.
her arm is sore post vaccination; This is a spontaneous report from a Regulatory Authortity  . A contactable consumer or other non HCP (patient) reported that a 77-year-old female patient received bnt162b2 (BNT162B2, Formulation; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Aug2021 11:10 (Batch/Lot Number: EW0179) as DOSE 1, SINGLE (at the age of 77-year-old) for covid-19 immunisation. Medical history included ongoing asthma (since 3 or 4 years) and sore throat issue from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not have any family medical history relevant with event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient not received other product. The patient experienced her arm is sore post vaccination on 05Aug2021 at 11.10. The patient asked if she could apply ice to help alleviate the soreness. The patient had question as if she gets a headache can she take Tylenol of extra strength. The patient did not visit emergency room or physician office. It was reported that patient could have not hit incorrectly, and she felt sore right away. The patient doesn't have much time as she needs to call her primary care doctor at 16.00 PM. It was reported that patient had a sore throat and needs to have an endoscope done. She went to the throat doctor and had this problem for some time predating the vaccination; she thinks it was allergies and dripping down throat. The patient underwent lab tests and procedures which included swab of throat for Strep: unknown on an unknown date of 2021. The outcome of the event was reported as not recovered.  No follow-up attempts needed. No further information expected.
Patient was under the age of 16 at the time of her appointment and received a booster Pfizer shot.  Pt's father attested verbally at the pod that she was over 16 and later admitted that he knew she wasn?t actually eligible but wanted to "give it a try."
Six days after the second dose of Pfizer I started experiencing shortness of breath so I went to the ER and took a chest x-ray and had fluid in my lungs. Doctors discovered I had Atrial Fibrillation. In January I had an Echo Cardiogram and none of the previous described diagnoses were present then. I was admitted; doctors attempted to shock my heart back into rhythm several times but were unsuccessful. Therefore, I was put on Eliquis (5mg) and a water pill to get rid of the fluid in my lungs (and swollen ankles). I was hospitalized for 9 days where I was evaluated through numerous tests. Eventually it was suggested that I undergo the Watchman's Procedure to get off blood thinners. Everything went well with that surgery on Thursday May 20th; complications arose after the surgery: heart rate and blood pressure spike, lungs started filling up with fluid. Ended up in ICU for four days. I still have a problem with my lungs despite having no history of lung problems and I am now dealing with AFIB. This all started 6 days after my second shot.
11PM 1JUL98 c/o throbbing h/a, rt arm @ inj site red, swollen, warm to touch, back pain from neck to buttocks, T103-took to ER 2JUL98 in AM-no orders from MD except APAP for temp;