chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The MTR of a 2mo pt devel paralysis; poss dx of poliomyelitis; pt was immunized JUL93 w/Tetramune/OPV/HEP B; event reported several mos later; pt medical records requested by attorney;
Received Moderna COVID vaccine yesterday (1/6) at 8:10 am. After about 3 hours, began to experience dizziness, nausea and fatigue that progressively worsened throughout the day. Went home after work, fell asleep and did not eat dinner due to lack of appetite from nausea and dizziness. Woke up in AM following day (1/7), feeling somewhat better, but still slightly dizzy. Appetite has returned and was able to eat regular meals today.
Area of induration & erythema at site of DTaP/IPV on (L) deltoid.
Appointment was scheduled through long-term care facility supervisor, who was unaware that patient had previously been vaccinated at a different facility.  Patient was given Moderna vaccine after previously completing Pfizer vaccine series.  Supervisor was contacted and reported no adverse response.
Extreme nausea and vomiting starting same day as second injection and lasting until today (4/22/21)
On 31OCT91 pt had t102, cough, bilateral ear infect; On 5NOV91 rash started on face & spread to trunk; eyes sensitive to light; ear infect treated 31OCT91 w/Amoxil & on 3NOV91 w/Ceclor;
Callers have cough; Flu; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported that:  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported, expiration date was not reported) via an unspecified route of administration on 16Apr2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient went to 16Apr2021 to take first shot and have appointment for 08May2021 for this Friday, but patient can't go (for the second dose), had flu and cough little bit. Patient don't have right to go there. Patient would like to know if she could go next Monday. The clinical outcome of the event was unknown.   .No follow-up attempts were needed, information about lot/batch number could not be obtained.
Information has been received from a physician concerning a 25 year old female patient with no known pertinent medical history or drug reactions and allergies who on unspecified date was vaccinated with a dose of GARDASIL (Lot # not provide). The Physician stated that the patient experienced generalized aches, joint pain, shortness of breath and weakness after getting GARDASIL. Patient sought unspecified medical attention. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Employee calling to report a reaction after receiving a COVID-19 vaccine.  Vaccine Name -  Pfizer Vaccine Date - ? 09/182021  Is this your first or second dose- 1st Date of symptom onset - ? 09/18/2021 Symptoms - ? Severe fatigue, fever of 100.9, knot at site of injection the size of a walnut, itching, headache, body aches, and congestion Last day of work and shift - 09/19/2021?  Home remedies- Ibuprofen for fever, soreness, and headaches and Benadryl for itching Any improvement- Employee stated the ibuprofen and Benadryl are helping Recommendation- Advised employee to continue take the ibuprofen and Benadryl per pack instructions for symptoms, monitor symptoms and if they worsen or new ones develop to follow up with PCP. Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes
While waiting for the mandated 15 min rest period post influenza mist vaccination, patient developed extreme diaphoresis, felt hot in an air-conditioned room.  Patient vital signs were ok, had chills later but all symptoms resolved after 60 mins post administration.
Initial Report Received: 27-Feb-2019. Non-significant Follow-up Report Received on 06-Mar-2019 included duplicative data that was already received for this report. A nurse reported that patient, a female patient (age and race not provided) was administered with HEPLISAV-B for hepatitis B immunization that was reported to be stored at the wrong temperature. Relevant medical history and concomitant medications were reported as unknown. Allergies were reported as unknown. On an unknown date, the patient received the first injection of HEPLISAV-B (lot #1036463, expiration date 28-Jul-2019, NDC #43528-002-05) by a physician. On 27-Feb-2019, a nurse reported that she received a call from a customer service representative at the distributor, on this day. The nurse was instructed to remove all vaccines that were received because they were stored at the wrong temperature on distributor's end. The nurse was instructed to return it to the distributor and contact Dynavax. The nurse reported that six patients received HEPLISAV-B from the same lot number. The nurse also reported that all six patients were contacted on this day. No adverse events were reported. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI. Sender's Comments: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI.
Pt became unresponsive and appeared to have stopped breathing. Pt was dusky and blue-purplish in color when seen by physician but quickly regained consciousness and awareness.  Cardiac monitor showed atrial fibrillation with a rapid ventricular response.  There was no angioedema or fever to suggest an allergic response.
Migraine-like headache started at around noon, got worse at 2pm, slept from 3-6, still had headache. began feeling nauseous, vomited at 8pm.   Took Tylenol and slept at 11pm, feeling OK with sore arm now.
This spontaneous report as received from a physician refers to a female patient 5 year old with contact allergy to neomycin and no pertinent medical history. The patient was vaccinated with a dose of VARIVAX (merck) (dose, route and lot # not provided) on an unspecified day in July 2012 (reported as 5 months ago) in an unspecified pediatricians office. No other co-suspects were reported. There was no concomitant medication. Patient was sent to him by pediatrician. Physician stated that patient needed to visit emergency room shortly after being vaccinated upon developing giant hives, itching and facial swelling. The patient was BENADRYL in the emergency room and monitored for several hours. Physician reported that he did not have records from initial VARIVAX (merck) vaccination. Patient was seen in physicians office last week to evaluate allergies and the patient was doing fine now. No lab diagnostics studies were performed. The relatedness between therapy with VARIVAX (merck) and the events was unknown. Additional information has been requested.
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 18-Dec-2021, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
A HCP called to report an AE. A patient received her third dose of GARDASIL 9 two months too early. No adverse effects were reported. The caller did not provide the date of administration so the AE onset date is marked as "Unknown". No additional inf; No adverse effects were reported; This spontaneous report as received from a medical assistant concerning a female patient of unknown age. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided.  On an unknown date, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # U039529, expiration date 09-AUG-2024)at a dose of 0.5 milliliter for prophylaxis. The reporter stated that the dose was received two months too early (inappropriate schedule of vaccine administration). No adverse event were reported.
Patient received 1st COVID Pfizer vaccine at a drive through offered by Public Health on 01/23/21 at 2:20 pm. At approx. 2:00 pm on 01/24/21, patient developed hives to hips, groin, and bilateral forearms. Later that evening, patient took benadryl 50 mg PO and then went to bed. Never took any more medication. Hives faded away within 2 days.
severe eczema outbreak occurred all over my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 at 15:45 as dose 1, single (Lot number: EW0150) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ECZEMA (non-serious) with onset 06Apr2021, outcome "not recovered", described as "severe eczema outbreak occurred all over my body". The event "severe eczema outbreak occurred all over my body" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eczema.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Severe eczema outbreak occurred all over body one week after first dose. Managed it with a prescribed ointment. After second dose eczema returned just as bad within days. It leads me to Moderna as my booster in January of 2022 but that also caused an outbreak (was told to expect this). Immune system had not returned to normal yet.  Still have a severe rash. . Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had known allergies.  No follow-up attempts are needed. No further information is expected.
disorientation, lightheadedness, chills, fingers purple, body aches, injection site warm to touch, touching site cause pain, and difficulty sleeping. Pt. reports that Thursday she experienced bumpy raised irritated skin from upper abdomen to mid back area. Pt. reports that today she is experiencing itching.
Patient was found deceased in his own home on Monday, March 15, 2021.  He was found on the floor in a sitting position with three fingers of his right hand on his right carotid.  It appeared that he was getting ready for church, which was a routine event.  Although patient was a diabetic, he never had episodes that were life threatening, and was always able to manage to remediate with insulin or food.  Patient last spoke to a neighbor at 2:30 a.m. on Sunday, March 14th, who said he appeared to be just fine and they scheduled a date with their dogs on Sunday afternoon.  A sheet of instructions found on the kitchen counter at the home informed us that he had a COVID vaccine at the VA Hospital on Wednesday, March 10th.  He was documenting side-effects of very sore  right arm and low blood sugars.  that was unusual because if he was able to manage he wouldn't have noted it.  It was apparent that something sudden happened such that he was unable to get to help and his heart rate must have been of concern.  We believe that patient suffered  onset of some sort of cardiac event, blood clot, high heart rate, or heart attack, that was associated with the vaccine on Wednesday and 4 days later he was suddenly gone, unable to call for help (he has family close by in this community).  We want healthcare providers and individuals to be able to make informed decisions about giving/taking the vaccine when there is another health issue  such as diabetes to consider.  We lost a brother, a father, a friend and a dedicated veteran unnecessarily.
Metallic taste a couple of minutes after vaccination, it disappeared after 30 minutes or so Swallowing lips 4 hours after injection. Numbing sensation on lower lip. This effect lasted 3 to 4 hours Headache, and backache and increase in temperature the next morning 01-03-21 Symptoms improving during the afternoon
My husband was hospitalized on April 27, 2021 for chest pain. All tests came back normal : EKG, blood enzyme levels and normal results from a heart cath.  He was sent home stating that it was an inflammation of the heart lining.  He took a prescribed anti inflammatory for 7 days.  No problems since.
Patient developed intense vesicular rash on head, neck w/ pruritus and, low grade fever, several days after ZOSTAVAX. Clinically consistent w/ Varicella as confirmed by I.D. MD's.
Two weeks after I received the vaccination the site of the injection turned red and spread over an area of 3.5 x 7 inches above and below the injection site. The area warm warm to the touch.
Patient received the bivalent booster before the recommended 2 month waiting period after their last regular booster.  During a vaccine clinic,  Provider and patient did not let us know patient had received booster from another provider 1 month prior.
Persistent elevated heart rate lasting at least 2 months, Erectile Disfunction lasting ~6 weeks
As of 7-17-13, spoke with pt's mom, pt doing fine. No rash, no fever, no swelling at site.
Redness, soreness & swelling rt deltoid area; tx moist warm compress, APAP advised to see MD if sx persist;
Midgut volvulus with bowel ischemia due to intestinal malrotation per autopsy report.
Shallow breathing, 9am-1pm  Fever of 102, 9am-3am (next day) Chills/sweating 9pm day of shot- 3am today Headache whole time since shot Body aches whole tome
Patient received flu shot and approximately 10 minutes later was standing at her car while I administered her husband's flu shot she started to feel like her body was "pulsing". She went to the driver's seat and sat down in obvious discomfort. The pulsing turned into a painful pulse through her entire body and then localized to her lower back. She felt slightly nauseated and within 5-10 minutes began to have a headache. After contacting Sanofi to see if this had been reported per the patient's request, I went back out to the car and patient claimed she felt better as she sucked on a lolipop, but felt like going home to sleep. She felt ok to drive and I said I would call her the next day. After 24 hours, patient returned pharmacist's call to say she was still having a slight headache and was lethargic all day, but was feeling overall better.
Fever up and down as high as 102 - Tylenol - still up and down Muscle pain -Tylenol and Motrin - helps some Joint pain Injection site swelling -wait it out Headache Uncontrollable shivering Fatigue
Patient reports arm became numb right after receiving the COVID-19 vaccine. Two hours later patient reports the numbness being limited to the bottom of the arm and hand. Patient states to being able to use hand but reports there is numbness and tingling.
it is hurting a little more than usual to me; I had the booster shot today; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medically history was not reported. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single and dose 2, single for covid-19 immunisation. Consumer stated that, I take an aspirin every day. But they knew that was my other one, provided they did not talk to me about none of that, but I remember in instructions of what to do and what not to. It said something about not taking an Aspirin after the shot and I take one every morning. Now, I am really concerned about because I have had the other 2 shots and I have taken them, but I forgot and now it is hurting a little more than usual to me and I took another Aspirin, and I was wondering if that was going to hurt me. Because I remember that someone was saying something that can cause inflammation was on my appointment thing. I am not sure, if you can pull it back up, it is nothing that I am on. Consumer stated, I have already done that right? And now, there is nobody I can ask I said I have already taken it and there no place I can find out now you said to wait until Monday. When informed the role of Pfizer  and was suggested to call 911 in case of emergency. Reporter type could not be clarified over the call. Hence, captured as Consumer or other non-health professional. Outcome of the event was unknown.   Follow-up (25Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Approximately 1 wk following injection: large hives 4" to 6" (blister like) on both legs from knee to hip for about 1 week- shooting pains in hands-followed by numbness in fingers- now in finger tips and pain in Achilles tendons (still hurts but not so acute) still injured and shortness of breath.
I was in very bad pain. I have fever, a really bad headache, my body and my joints ached as well. All my lymph nodes  was swollen on the left side of my body. The site where I got my injection was sore for days. I had to be off work for 3 days due to this.
pt recv 2 doses of vax 8JUL(6 & 12JUL96 & 15JUL96 pt exp chickenpox;
Information has been received from a pharmacist, referring to a 82 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-JUL-2015, the patient was vaccinated with the first dose of PNEUMOVAX 23 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. Later, on 19-SEP-2017, the patient received a second dose of PNEUMOVAX 23 (strength, dose, anatomical location and administration route were not reported) also for prophylaxis. No adverse symptoms were reported.
Right arm is swollen and tingling/Right hand is numb and swollen; Right hand is numb and swollen; Right shoulder hurts; Arm is tingling; Fell on right arm; Hurst to move her right arm, hand, and shoulder; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0158), dose 1 via an unspecified route of administration, administered in Arm Right on 14Apr2021 12:15 (at the age of 16-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no medical history and family history. The patient's concomitant medications were not reported. The patient had no other products. The patient had no history of previous immunizations. No additional vaccines administered on same date. The patient had no prior vaccinations within 4 weeks. The patient received first shot yesterday on 14Apr2021. On the same day, at night, she fell on her right arm when she was playing with her dog. On 15Apr2021, symptoms developed about 22 hours later in the morning. Her arm was experiencing pain, numbness and swelling, her right shoulder also hurts, but the dog jumped on her, so she was not sure if it was from the vaccine or not. She asked are these normal side effects. Her right arm was swollen, right hand was numb and swollen, asked if this could be from the shot. Right Arm was tingling. Hurst to move her right arm, hand, and shoulder. Caller was looking on her paperwork and didn't know if this was a side effect. Was it different in children. The patient did not visit any not yet. The patient had no relevant tests. The outcome of the event Fell on right arm was unknown and outcome of all other events was not recovered.   Information on lot/Batch number has been requested.  No follow-up attempts are needed. No further information is expected.
Rheumatoid arthritis. I am currently taking Naproxen 500 mg tablet and see a rheumatologist regularly.
pt recvd vax & the next day reported sore throat, neck stiffness, post nasal drip, low grade fever; reporting MD indicated pt had URI @ time of vax;
Debilitating muscle tightness throughout the body, most significantly in an injured leg that tightened immediately after vaccine and effect now seems permanent
He had eruption of itchy macules on his hands  mostly on palms, also has similar lesions on arm and foot notes that hands occurred after doing yardwork, Notes discomfort with holding things or pressure on the lesions.  It is unclear if this is actually related to the vaccine but is similar to reports of a "covid rash" that has been reported with Moderna  vaccine (generally thought to be harmless)
ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/3/2022 -- RECURRENCE OF SAME SYMPTOMS
SHE COMPLAINED OF DIFFICULTY SWALLOWING AFTER THE VACCINE. ON SITE EMS RESPONDED AND VITALS ARE BELOW. DIPHENHYDRAMINE 25MG GIVEN. VITALS LISTED BELOW. SHE HAS EPI PEN AT HOME DUE TO SHELLFISH ALLERGY. SHE WAS RELEASED TO HOME
Patient reported that after 2 days he broke out in a rash at the injection site. It grew in size over next few days and caused itching. I recommended patient reach out to his doctor for treatment suggestions due to heart condition. I followed up with patient and he said the nurse practitioner told him to take benadryl.
A non-serious spontaneous report of administration of expired dose was received from a health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications were reported. FLUMIST expired on 19-Jan-2011. On 13-Sep-2011, the patient received expired FLUMIST. On 12-Oct-2011, the patient was given a flu shot and the patient did not report any adverse event. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 14-Dec-2011 and incorporated in the narrative: other medications given after the FLUMIST dose and the patient did not report any adverse event. Other additional information received was: reporter information and patient's initials.
w/in 4 hrs pt had chills, coolness of skin, swollen lt arm; @ MD's office pt had fever of 103 R, resp inc, irritability; BY 830PM that evening fever broke; MD dx rxn to DTP shot;