chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 12 minutes after receiving covid vaccine, pt felt like she had a lump in her throat.  No difficulty breathing or swallowing.  No facial swellling. Pt was evaluated by PA from urgent care.  Pt was transferred to urgent care for antihistamine administration.  Vitals remained stable.  12/23/20 @ 1212: Note copied from UC Visit: Diagnosis Allergic reaction (ICD10-CM T78.40XA, Working, Medical). Summary:  0916 "Lump is still there but much smaller" Still no sign of intraoral swelling 0925 Patient reports symptoms have almost resolved completely, comfortable going home. Instructed to take Zyrtec tonight before work and for the next couple of days and to go to hospital for SOB, worsening sensation of lump in throat. Patient verbalized understanding and is in agreement with treatment plan. Opportunity for questions was given, all questions answered.. Pharmacy: diphenhydrAMINE (Benadryl) AMB (Order): 25 mg, IM, InOffice.
Very sleepy; This is a spontaneous report from a contactable consumer, the patient. An 82-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Mar2021 at 11:15 (at the age of 82-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient included heart condition irregular heartbeat. It was unknown if the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included amiodarone (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 12Mar2021 at 15:00, the patient experienced very sleepy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not tested for COVID-19. The clinical outcome of the event very sleepy was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
30 min- after given, sudden onset head ache stomach pressure and nausea, last 2 hours with sudden relief. Also during this time family noted Pt had some episodes of mild confusion and forgetfulness. During night calf, ankle and foot cramping (bilateral). All resolved in AM.
Stroke like symptoms: 1 day after vaccine developed left hip pain with frequent falls. Days later developed slurred speech, memory impairment and facial droop.
Fever, chills, body aches for 2 days, pain discomfort at the injection site for 3-4 days
Has been coughing since 12/07/09.  No fever.  Lots of phlegm, water on ears, diagnosis from doctor, just allergies.
Hallucinations of people in the shadows with knives trying to kill her. She was screaming and scared. It lasted an hour until she fell asleep after for 11 hrs. Neurology was called (was seen the next day) and she was seen the next day. Dr. felt this might be vaccine related and has seen several other cases like this in the past few weeks from the H1N1 vaccine.
A 58-year-old female patient with past medical history of hypothyroidism, depression and allergy to certain medications including Thorazine, had received a dose of Decavac, lot number U1221CA, in the left deltoid on 20/May/2006. The route of administration of the vaccine was not reported. Approximately five days post-immunization on 25/May/2006, the patient developed dull aching pain in the lower extremities. Her pain was still persisting two weeks later. Treatment received was not reported. The recovery status of the patient was reported as not recovered. Follow-up information received on 07/Aug/2006. Per the reporter, it is unknown if the patient had received any previous vaccinations of Tetanus or Diphtheria. The reason the patient received the Decavac was that she had a lacerated finger. No relevant diagnostic tests/laboratory date were performed. After receiving the Decavac injection on 20/May/2006, the patient went out of state and later called this reporter to report the dull aching pain in the lower extremities. The patient was not seen in this facility after this. Reportedly, the patient's recovery status is unknown. No further information is expected. A corrective version was created on 02 April 2007 with the LRD of the previous version (07 August 2006) in order to document "yes" to medically confirmed in the record.
Got pregnant the night of first shot. Ended up being an ectopic pregnancy that ruptured right after my second shot.  Had to have emergency surgery for ruptured ectopic pregnancy and ovary removed.
Information has been received from a health professional concerning a 7 year old male who on 17-JAN-2007 was vaccinated, subcutaneously, with a dose of Varivax (Lot# 635452/0768K). On 23-JAN-2007 the patient experienced multiple skin lesions of the face, trunk, extremities and buttocks. Some of the lesions were red, papular, some vesicular. Patient was afebrile. Outcome of the event was unknown at the time of the report. No further information is available.
arm pain with the first shot at the injection site; diarrhea; arm pain with the first shot at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 14:00 (Lot number: EN6204) at the age of 69 years as dose 1,single for covid-19 immunisation. Relevant medical history included: "Infectious mononucleosis" (unspecified if ongoing), notes: Verbatim: Mononucleosis; "COVID" (unspecified if ongoing), notes: She had the actual COVID back in November. The patient's concomitant medications were not reported. Past drug history included: Flu shot, notes: flu shot -She would have gotten it in October. The following information was reported: PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 2021, outcome "recovering" and all described as "arm pain with the first shot at the injection site"; DIARRHOEA (non-serious) with onset 2021, outcome "recovering", described as "diarrhea".  Additional information: Patient had arm pain with the first shot at the injection site. It wasn't excruciating. It felt like a flu shot. The pain was there for a couple of days. She had diarrhea after the first injection of COVID19 Vaccine. It wasn't bad but it was there. That lasted for maybe three days. By Tuesday, she was back to normal or where it was in the past. She would say she was starting to feel better than she had been. She has talked to her one friend that had COVID virus. No one caller knew got it except her. She had mononucleosis when she was a teenager and caller did too. Caller is A positive. She is thinking a lot of people are O and those are the people that have not gotten COVID and not gotten sick with the vaccine. Why did she get sick? No further details provided. AE(s) following prior vaccinations: with a flu shot kind of sort of. It wasn't really bad. She wouldn't get deathly ill. She doesn't have NDC, lot, and expiry for flu shot. She would have gotten it in October, and she always gets them at pharmacy.  No follow-up attempts are possible. No further information is expected.
tiredness; Pain in arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and FATIGUE (tiredness) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 013M20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Plaque psoriasis.    Concurrent medical conditions included Drug allergy. Concomitant products included CLOBETASOL for Psoriasis.   In 2016, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 08-Feb-2021, the patient experienced FATIGUE (tiredness). On 11-Jan-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. On 08-Feb-2021, FATIGUE (tiredness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (Pain in arm) and FATIGUE (tiredness) to be possibly related.    Treatment information was not provided.    This case was linked to MOD-2021-087452 (Patient Link).
Initial report received from a pharmacist on 04 Mar 2010: This patient was vaccinated with FLUVIRIN 0.5 ml intramuscular injection, on an unspecified date in Nov 2009. The patient had experienced injection site pain on an unspecified date in Nov 2009. According to the reporter, the patient continued to experience pain in his arm near the site of injection. The outcome of the event was not reported. The seriousness criteria of the event was not reported and no further information was provided at the time of report.
left hand tingling like pins and needles; Numbness in hands (left); numbness on left side of the face; This spontaneous case was reported by a consumer and describes the occurrence of   in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Dental treatment NOS.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.
The physician reports that doses were given following possible excursions in August, September, and October of 2022.; Product temperature excursion issue; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The physician reports that doses were given following possible excursions in August, September, and October of 2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The physician reports that doses were given following possible excursions in August, September, and October of 2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The physician reports that doses were given following possible excursions in August, September, and October of 2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The physician reports that doses were given following possible excursions in August, September, and October of 2022.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue).    No concomitant medications were reported. It was reported that he physician reported that doses were given following possible excursions in August, September, and October of 2022.  No treatment medications were reported.
After the second shot, have people complained about having a metal taste in their mouth; This spontaneous case was reported by a nurse and describes the occurrence of DYSGEUSIA (After the second shot, have people complained about having a metal taste in their mouth) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (After the second shot, have people complained about having a metal taste in their mouth). At the time of the report, DYSGEUSIA (After the second shot, have people complained about having a metal taste in their mouth) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment details were provided.   Reporter did not allow further contact
passed out; Fell on floor; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 19:00 (Batch/Lot number: unknown) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LISINOPRIL. There were no other vaccine in 4 weeks. Vaccination history included: Bnt162b2 (previous dose product=COVID 19, previous dose administration date=20Mar2021 , previous dose dose number=2), administration date: 20Mar2021, when the patient was 38 years old, for Covid-19 immunization; Bnt162b2 (previous dose product=COVID 19, previous dose administration date=27Feb2021, Previous dose number = 1), administration date: 27Feb2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (non-serious) with onset 03Dec2021 04:00, outcome "unknown", described as "passed out"; IMMUNISATION (non-serious) with onset 02Dec2021 19:00, outcome "unknown", described as "Booster"; FALL (non-serious) with onset 03Dec2021 04:00, outcome "unknown", described as "Fell on floor". The events "passed out" and "fell on floor" were evaluated at the physician office visit and emergency room visit. The night patient received the vaccine at 4 am got up to go to the bathroom and than passed out in the bathroom for about a minute. Patient fell on floor. Therapeutic measures were not taken as a result of loss of consciousness, fall. Patient was not diagnosed with covid prior to vaccination and had not been tested post-vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. The patients concurrent or historical conditions was not reported. The medical assistant reported that over the last several years, an unknown number of patients have been administered doses of VARIVAX (Merck) (frequencies, routes, lot numbers and expiration dates not reported) that have reached higher than recommended temperatures during the defrost cycling. No adverse effects reported. This is one of two reports from the same reporter. Additional information has been requested.
Copied from. Topic: Medical Question >> May 19, 2021 10:51 AM wrote: Pt was to have a colonoscopy tomorrow and was informed that her Covid test returned with a positive result. Pt had her 2nd Covid vaccine on 4/11/21.  Pt has been wearing a mask everywhere and social distanced and has not been exposed to anyone who is Covid +.
Intended to give HPV (Gardasil 9) and instead gave PCV13 (prevnar) along with her seasonal quadrivalent flu shot (in same arm). Pediatrician called mom and explained that patient will still need second HPV and that we (I) mistakenly gave the PCV13 instead of patient's final dose of HPV.
This spontaneous report as received from a medical assistant refers to one unspecified patient of unknown age. Medical history, concurrent conditions and concomitant medications were not reported. On 07-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose, frequency and route of administration were not provided). No adverse events were reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Muscle spasms for entire right arm and side, nonstop since both vaccine doses  Vaccines were 2 weeks apart  1 week after 2nd dose, visited primary care doc and received muscle relaxers. Did not stop spasms.  Uses heating pad, Icy Hot, ibuprofen  3 weeks after 2nd dose, muscle spasms stopped and pain in right arm and shoulder began. Continued regime above.    June 1 I went to ER for extreme shoulder pain. They ran  blood and ultrasound to check for blood clots, gave morphine and muscle relaxer, and discharged. Visited primary care doc again same day and received cortisone injection in right shoulder to finally relieve pain
Received flu shot and experienced instant headache, followed by severe fatigue, elevated heart rate and respiratory rate, diaphoresis and mild nausea. Symptoms lasted until approx. 9pm. Vaccine received at approx.1pm.
Irregular menstrual bleeding/spotting . Since on Mirena IUD menstruating is extremely rare. After 1st vax I had some light spotting and cramps. This time 3 weeks after 2nd dose I am having a light period (which I have not had in several years so this is unusual)
About 20 minutes after vaccine about a dime to nickel sized bump/swelling at injection site, turned red and was itchy around the outside perimeter. When pt was in the pharmacy cold cloth was applied and pt stayed to be monitored for 30 minutes, no increase with swelling. Pt felt better, then notice the night of 10/31 that it was swelling again and was itchy. Pt took Benadryl that night. Morning of 11/1 pt said swelling was ~4-5 inches long, and 2-3 inches wide. Ice has reduced swelling and redness a little and has taken more Benadryl.
Error in administration: Pt already received and completed primary series in 2018. 3rd Shingrix vaccine was given in error due to not verifying shot record in system. Flu like symptoms reported by patient after administration.
Pt showed no response 3 mo p/ last inject in series of 3 hep B vax.
Throat tightening and ear pressure started about 5-10 minutes after injection and lasted for about 20 minutes.  Concern for Type I hypersensitivity reaction.   Ultimately in next 36 hours- rigors, n/v/d and headache. I did fine with the first 2 doses.
Five days after receiving his MMR, (the child) had a seizure. He did not have a fever. He had a CT + bloodwork- Normal. He had an EEG which showed "spikes". He had more seizures. He had a 48 hour EEG with video monitoring on 11/10/02 -11/11/02. At this time, he was diagnosed with epilepsy. He is currently on Phenobarbitol, which has controlled his seizures. He does, however, continue to have "episodes" where his eyes rolled back for a few seconds and he collapses. (The child) has also been diagnosed with a developmental delay. He was not walking at 15 months and was refereed to a physical therapist. He is still not walking at 20.5 months although he is talking some steps. He had no developmental delays prior to receiving the MMR shot  As per follow up letter; the pt has not recovered fron vaccination. Pt has seizures daily. He was hospitalized in August and he was specifically diagnosed with complex partial seizures. Although pt began pulling up to standing at 12 months, he just started walking at 22 1/2 months. The annual follow up received on 8/5/03 states pt was averaging 40 seizures per day until 7/14/03. He is now on the ketogenic diet and seizure-free for 2 weeks. He will have to remain on this diet for at least 2 years. Pt still has developmental delays. He receives speech, OT and PT. He will have to start pre-school in October for physically challenged children. He had no delays prior to the MMR and varicella vaccines.
Other than feeling warmer than usual within minutes after the injection at  0715 AM I had no other symptoms until 430 PM when I began to develop a headache, muscle aches and joint pain.  It came on slowly but by 930 that evening I was shaking uncontrollably for about 3 hours with chills and severe joint pain. My headache grew worse and lingered for several days after as well.  I still have a mild headache today (4/13/21) and feel lethargic and almost foggy.
Rash on lower extremities which has progressed since last week. Generalized patterns of vesicular rah in varying stages. No crusting.
Information has been received from a physician concerning a 2-month-old female who was vaccinated PO with the first 2.0 mL dose of ROTATEQ. It was noted that the patient was being fed formula (nor further specified). The physician reported that the patient subsequently held her breath and turned blue. Unspecified medical attention was sought. The patient subsequently recovered. Additional information has been requested.
Intense itching/redness at injection site - started approx. 10 min after injection. No progression of sx. Did take BENADRYL dose x 1 after multiple hours (72) which helped to resolve sx.
Feels anthrax immunization caused chronic diarrhea. Causality Assessment: Indeterminate.
This report is not related to an adverse event that was noted. The child received a additional dose of PCV13 vaccine that was not needed per vaccination records. No reports of any issues r/t additional dose.
Pt recvd 3 doses of Engerix-B vax & was determined to be a non-responder; pt recvd a booster dose of Engerix-B 8AUG91 & 17OCT91 HBSAB was pos & hence resolved;
VACCINE ADMINISTERED APPROXIMATELY 24 HOURS AFTER INITIAL VIAL PUNCTURE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a physician concerned a 40 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: 11-DEC-2021) dose was not reported, administered on 24-NOV-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced incorrect product storage. On 24-NOV-2021, the patient experienced vaccine administered approximately 24 hours after initial vial puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered approximately 24 hours after initial vial puncture and incorrect product storage was not reported. This report was non-serious.
c/o pain warm to touch ichchy, redness, raised at he varicella site that started n two days