chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/12/21: Pt presented to ED with L sided facial droop, L sided weakness to arm and leg, numbness to L face L arm and left leg.  Presentation consistent with acute ischemic stroke. Risks and benefits discussed with the patient, who agreed to proceed with tPA. MRI brain 1/12: "Acute infarct right MCA territory predominantly involving the right parietal/insular lobes. No acute hemorrhage or midline shift." Started on aspirin 325 mg daily and rosuvastatin dose increased to 40 mg daily 24 hours post tPA. Patient reported a history of a-flutter many years ago for which she was on a beta-blocker, but the diagnosis remains unconfirmed. Tele reviewed during stay, no arrhythmias. ECHO, normal EF, NO PFO. Discharged to rehab on 1/15.
Restriction in normal breezing when sleeping, feels like a lump in my lower throat; Restriction in normal breezing when sleeping, feels like a lump in my lower throat; This is a spontaneous report from a contactable other healthcare professional (patient herself).  A 77-year-old female patient (not pregnant) received her second dose of bnt162b2 (BNT162B2 also reported as Covid19 Brand: Pfizer, lot EK4176), intramuscular in left arm on 15Jan2021 15:45 at SINGLE DOSE for Covid-19 vaccination. Medical history included Irritable Bowel Syndrome, Sinal Stenosis, Atrial Fibrillation, Lactose intolerant and Gluten intolerant. She received her first dose of bnt162b2 on 23Dec2020 (lot number: EL128), given via IM in left arm. Concomitant medications included paracetamol (TYLENOL), atropine sulfate, diphenoxylate hydrochloride (DIPHENOXYLATE/ATROPINE) and metoprolol tartrate. The patient experienced restriction in normal breezing when sleeping and felt like a lump in her lower throat on 15Jan2021 22:00. No treatment given. The outcome of events was not recovered.
Tdap 0.5 mL IM 4/24/08.  On 4/26/08: "Nausea, fever, inj. site knot & discomfort."  Also noted ~6 cm below inj site an area of minor pruritis, erythema ~9x4 mm now resolving.
finger turned purple, then white w/in minutes of inject; No other sx; vax in the past w/o problem;
Initial report received on 02 November 2006 from a health care provider.  An unspecified number of patients had received an intramuscular injection of Fluzone SV 2006-2007, lot number U2164AA, on unspecified dates.  "Black dots" were noted as soon as the needle was removed following administration of the vaccine.  The reporter was unsure of the number of patients that had experienced this event.  The syringe used was a BD safety glide, and the needle was a 25 gauge, one inch needle.  Recovery status was unknown.
Redness near injection site, advised to go to ER where I received IV antibiotic. Went to ER again next day and saw my private physician three times. Was on antibiotics for 10 days.
Information has been received from a physician assistant concerning a 65 year old female who on 08-JUL-2008 was vaccinated with ZOSTAVAX (Oka/Merck) and Tdap in the same arm (left or right unspecified). In 2008, the patient developed an open infection of the arm at the injection site. As of 6-AUG-2008, the patient was being treated with BACTRIM and the injection site infection persisted. The patient sought medical attention with an office visit. Additional information has been requested. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a physician assistant concerning a 65 year old female with allergies to codeine, ibuprofen, CYMBALTA and a history of edema while in NEURONTIN, who on 08-JUL-2008 at 11:00 AM was vaccinated with ZOSTAVAX (Oka/Merck) (lot no. 659408/0300X) subcutaneous into the upper left arm and DTP (manufacturer unknown) in the same arm. The patient had no illnesses at the time of the vaccination. On 9-JUL-2008 at 10:00 AM, the patient had a red, swollen, hot injection site necrosed that was treated as cellulitis. The wound was debrided. Packing was applied. As of 6-AUG-2008, the patient was being treated with BACTRIM. On 07-AUG-2008, the patient recovered from the open infection of the arm at the injection site and injection site necrosed. The patient sought medical attention with an office visit. No further information is available.
having the fever; chills; headache; weekends; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th April 2020, the patient received the 1st dose of Shingrix. In April 2020, less than a week after receiving Shingrix, the patient experienced fever, chills, headache and weakness. On an unknown date, the outcome of the fever, chills, headache and weakness were unknown.   It was unknown if the reporter considered the fever, chills, headache and weakness to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient's wife. The reporter stated that the patient  experienced fever, chills, headache and weakness after vaccination. The reporter asked how long the event last.
Felt really cold like all the blood was moving away from my extremities, labored to breathe
Swelling, Redness, Hives, Welts, Trouble Breathing, Cough Pt tried BENADRYL Decongestant at home. did not work. Pt went to Hosp ER next day.
Client received HBV #2 5/11/07. Started within a few hours developed runny nose the next day had hives on face and legs and swollen face. Called her physician was gave a "steroid shot and steroid dose pack. Before completion of dose pack hives returned requiring another steroid dose pack hives then resolved. No rxn to HBV #1 given at health department states had reaction to dose #2 and did not think it would be a problem to receive HBV despite "slight yeast allergy"
Pt called pharmacy and stated developed football sized rash, redness, swollen arm, hot and little bumps, legs swollen from knee down and pt feels hard to walk, will be seeing the MD (Monday).
A report was received from a healthcare professional who was also the consumer on 10/20/2003 concerning a 48 year old female vaccinee who experienced local erythema and pruritis minutes after receiving Fluvirin on 10/16/2003. On 10/16/2003 the vaccinee experienced local erythema and pruritis extending from the injection site to her left underarm to under her left breast.  The vaccinee self treated with oetrizine hydrochloride, diphenhydramine hydrochloride and prednisone.  The local reaction resolved within half an hour.  The outcome of the pruritis was not reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/25/2003 Follow up information received from a healthcare professional indicated that the vaccinee experienced severe erythema and urticaria, localized to the left shoulder, left upper arm, left arm and left breast.  The event resolved on an unspecified date. The reporter has assessed the relationship of Fluvirin to the event as probably related.
Pt received first Moderna shot here in office. Pt sent to waiting room for 30 min observation. Pt stated in phone call on 4/8/21 that as soon as he sat in waiting room he started to feel weird - heart pounding, vision weird, sweaty palms and that he did not alert any office staff like he was told to at injection appt. He stated that he tried deep breathing and that helped to relieve symptoms and it settled. The symptoms then started again per pt. Did deep breathing again and they resided. So pt went out to car and never made any staff aware. Symptoms started again in car. Pt drove away but came back when symptoms were still happening. By this time the office was closed, pt banged on door. He stated when someone answered he asked them what was going on and they told him to go to ER. So pt drove to ER where he was evaluated, given IV fluids, had bloodwork done and released when feeling better. Spoke to pt today 4/8/21 on phone and he stated he was feeling much better.
Redness and warmth 3" diameter. Possible infection. Treated with Keflex 500 mg by mouth, 1 a day for 7 days.
Numbness (L) arm 6:30. Eye twitching 10:30PM. 11PM went to ER.
* Note for ITEM 17 - 2nd dose received on Apr 25, 2021 at 130pm ET (could not delete the line so filled in, plus, additional adverse events occurred after 2nd dose explained below  - 1st Vaccine on Apr 2 - Apr 16 adverse event occurred: *heart and chest tightened *entire left side of body numb *racing heart with sweating *dizzy *nausea *fainted *all occurred while driving, pulled over and called 911 on roadside  - 2nd Vaccine on Apr 25 - Multiple events since 2nd vaccine *ongoing fatigue *headaches *daily pains around heart (sporadic throughout the day) *consulted with doctor Oct 14 - swollen and tender nymph nodes around neck and collarbone plus right side arm pit Dec 6 - bad cold with headache, sore throat, fatigue, cough Dec 13 - leg cramping and pain in dime size spots along both legs while walking Dec 18 - leg cramping in left leg with swelling at the knee plus swollen varicose veins; hot around knee
Next day had painful heart palpitations/chest pain, nausea, severe diarrhea. SVT shown on the heart monitor and low potassium levels.
hospitalized for a medical emergency she had two surgeries from sinus fluid leaking into her brain; This is a spontaneous report from a contactable consumer. A female patient of unspecified  age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation:Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on 04Apr2021 at unknown Dose 2, Single for Covid-19 immunization. Medical history include historical vaccine as first dose , asthma and diabetes. No concomitant medications reported. On 30Jun2021, the patient was hospitalized for a medical emergency she had two surgeries from sinus fluid leaking into her brain. The patient underwent SARS-CoV-2 test and found negative. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Large red welt where the vaccine was administered.  It's getting larger each day.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Large red welt where the vaccine was administered.  It's getting larger each day.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Large red welt where the vaccine was administered.  It's getting larger each day.). At the time of the report, VACCINATION SITE URTICARIA (Large red welt where the vaccine was administered.  It's getting larger each day.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment medication was reported.   Reporter did not allow further contact
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 20-JUN-2017 the patient was vaccinated with ROTATEQ lot # M031802, oral for prophylaxis. Concomitant therapies included PREVNAR 13, (DIPHTHERIA TOXOID (+) HIB CONJ VACCINE (UNSPECIFIED CARRIER) (+) PERTU) and hib conj vaccine (unspecified carrier)(HIB CONJ VACCINE (UNSPECIFIED CARRIER)). On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006507.
The pt experienced a large local reaction at the site. Treated with aspirin and Motrin.
Dizzy; Weak; body not responding correctly; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Weak) and VACCINATION COMPLICATION (body not responding correctly) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy), ASTHENIA (Weak) and VACCINATION COMPLICATION (body not responding correctly). At the time of the report, DIZZINESS (Dizzy), ASTHENIA (Weak) and VACCINATION COMPLICATION (body not responding correctly) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was reported.
Flu growed intensely; Intense diarrhea for over 3 weeks; Swelling  in the injection site growed intensely; Pain in the injection site growed intensely; Body ache growed intensely; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu growed intensely), DIARRHOEA (Intense diarrhea for over 3 weeks), VACCINATION SITE SWELLING (Swelling  in the injection site growed intensely), VACCINATION SITE PAIN (Pain in the injection site growed intensely) and MYALGIA (Body ache growed intensely) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and COPD. Concomitant products included AMLODIPINE and AMLODIPINE BESILATE, VALSARTAN (AMLOSARTAN [AMLODIPINE BESILATE;VALSARTAN]) for Blood pressure.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced INFLUENZA (Flu growed intensely), DIARRHOEA (Intense diarrhea for over 3 weeks), VACCINATION SITE SWELLING (Swelling  in the injection site growed intensely), VACCINATION SITE PAIN (Pain in the injection site growed intensely) and MYALGIA (Body ache growed intensely). At the time of the report, INFLUENZA (Flu growed intensely), DIARRHOEA (Intense diarrhea for over 3 weeks), VACCINATION SITE SWELLING (Swelling  in the injection site growed intensely), VACCINATION SITE PAIN (Pain in the injection site growed intensely) and MYALGIA (Body ache growed intensely) had not resolved.            Patient taken steroids for COPD Ammonium for two weeks to treat the diarrhea.   This case was linked to MOD-2021-404104 (Patient Link).
Arm red, blister at injection site. T 99.4 9/18/03 1220. No treatment, symptoms subsided 9/19/03.
Swelling of arm throwing off strong heat.  Fever for 48 hours,  sore throat, dizzy.
04/20/2022, I started having a dry cough all day. 4/21, it turned into a productive cough. I had sinus congestion, headache, body aches and fever. Everything got worse. 4/22, I had a tele health visit. He sent me for COVID test which was positive. He sent me to have a Monoclonal Antibodies Infusion. Within 24 hours, I felt perfect for a couple of days. The next week I began having the same symptoms. 5/9/2022, I tested positive with a home COVID test. I then had a tele health with my APN on 5/11/22 and asked if I could have a monoclonal antibodies infusion again. I was not able to. So he prescribed Paxlovid and I was unable to fill the prescription before it was too late to work. I still have a cough and sinus congestion.
Case number PHEH2015US019582, is an initial spontaneous report received from a healthcare professional on 30 Sep 2015. This reports refers to a 26 year old female patient. Historical condition and concomitant medication were unknown. The patient was vaccinated with FLUCELVAX, (batch number: 173539) intramuscular at a dose of 0.5 ml on 23 Sep 2015. It was reported that the FLUCELVAX vaccine was stored at room temperature for 24 hours and then it was administered to the patient. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided.
Wasn't able to get second dose/ NOBODY had it; This case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 2 years ago from  the date of reporting on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, did not receive 2nd dose of Shingrix as nobody had it, which led to product supply issue. The reporter stated that, it had been almost 2 years and doctor said that could just get 2nd dose but did not need to start over.
Pt had localized pain and swelling to inj site, high fever, nausea and vomiting, became very tachycardic as did the baby (pt was 31 weeks preg).
The day after the shot, I had intense pain in my left glenohumeral joint, present with all motions, that persisted for ~4 months.  About 3-4 weeks afterwards I began having swelling and arthralgia in my left proximal interphalangeal on digit 4 and right metacarpophalangeal joint on digit 3, which persists to this day.  About 1 week after the injection I began developing constant gut discomfort, which required me to decrease the amount of foods I consumed, as well as avoid ingesting any food or drinks past 8 pm. The discomfort presented in symptoms of bloating, nausea, and constant feeling of fullness in stomach. This continued for 4 months. About 2-3 weeks after the injection, I began presenting severe pounding in my head that correlated to heart rate during exercising on a stationary bike at ~10-15 minutes, and would have to suspend activity due to this. This continued for 3 months. In November I attempted to donate blood but was rejected because the blood flow was being stopped by clotting, which has never happened in the 20+ years that I have been donating blood (which normally is 2-4 times/year). The symptoms stated above were ones that had not present before receiving the injection.
Large swollen lump at injection site; red area around injection site; injection site itchy and painful to the touch. Symptoms so far have  lasted 5 days and don't appear to yet be improving. For the Yellow Fever vaccine. Never have had a reaction to a vaccine previously.
Severe diarrhea and nausea and fatigue starting the day after vaccination.  The side effects lasted approximately 6 hours.
Patient was given x1 dose of Janssen & Janssen COVID 19 vaccine at Health Center on 6/14/21 while at the hospital, sent by our facility. This patient returned with discharge documentation that did not reflect the vaccine being administered. The patient did not report to health staff that he had received the vaccine prior. He placed a request to receive the vaccine while incarcerated and it was administered on 6/28/21. The patient did provide a consent form where another COVID vaccine was denied. The duplicate vaccine was only discovered upon entering the vaccine received at County. Medical Center notified and Medical director of the local Health Dept. was notified.
Cellulitis / due to injury on lower leg; Cellulitis / due to injury on lower leg; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 12:00 (Lot number: ER8730) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Lot number=EN6205, Administration time= 12:00 PM, Vaccine location=Left arm), administration date: 02Mar2021, when the patient was 65 years old, for Covid-19 immunization. Prior to vaccination, the patient did not have COVID-19 and since vaccination, has not been tested for COVID-19. The following information was reported: CELLULITIS (medically significant), INJURY (non-serious) all with onset Jul2021, outcome "unknown" and all described as "Cellulitis / due to injury on lower leg".
Moderna COVID-19 Vaccine EUA  - I received my second dose IM in my left arm at 9:16 a.m. on Friday, February 12, 2021.  Within a couple of hours, I experienced soreness at the vaccination site (as I was expecting based on information provided by Department of  Health and Human Services).  By about 7:00 p.m. I began experiencing some of the expected side-effects (achy shoulder, arm, neck, ribs, and eyeballs).  I took an Aleve (NSAID) for the pain at about 9:00 p.m.  I felt a little better in the morning on Saturday, February 13, 2021.  I took my second (and last) Aleve at about 7:00 a.m. that same morning and then slept for a few hours longer.  By the afternoon on Saturday, February 13, 2021 most of the previously described symptoms had subsided.  When I woke up at around 3:00 a.m. on Sunday, February 14 , 2021 I woke up with a painful (pain level 7/10) sore throat (mostly on the R side of my throat ), noticed that I had a small blister on the left side of my lower lip, and had what looks like oral thrush or ?COVID-19 tongue?, (bumpy white patches on the tongue).  I slept poorly until about 3:00 p.m.  and was still experiencing these 3 oral syptoms at 5:30 p.m. on Sunday, February 14, 2021 (about 56 hours after receiving Moderna dose #2).
- Sore arm lasting about five days - Fatigue day after vaccination, lasting one day - Body aches day after vaccination, lasting one day - Shivering day after vaccination, lasting only 10 minutes - Slightly swollen/tender lymph node in left armpit, lasting about five days
Within hours after injection arm became red, swollen, hard knot. Saw MD 7/24/03. Instructed to use ice observe. On 7/28/03 reported arm remained swollen and with rash per mother. Also noted this child has very sensitive skin.
Slight induration 1x1cm (R) thigh anteriorly. No pain with palpation mild erythema no fluctuance.
10 minutes after getting the Johnson and Johnson vaccine, while patient was waiting in the waiting area for 30 minutes due to history of bee allergy and anaphylaxis, she reported shortness of breath and dizziness to nurse. Assisted her to the floor with her legs up- obtaining pulse ox and BP/HR, which were stables. Patient reported shortness of breath and dizziness, worsening symptoms, she was tearful, and stated symptoms are the same as her previous anaphylaxis reaction. I informed her I was giving her a dose of epi, and injected 0.3 ml of epi, adult dose to left thigh. Patient reported immediate relief,  EMT arrived, At 15 minutes, patient was crying and laughing, reporting worsening SOB again.  EMTs arrived and took over the scene. Patient was transported to hospital.
Next day following flu shot, pt. developed severe headache, which became worse.  On 12/23 she called Dr. who ordered Butalbital.  Pt. is improving.