chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cold sores on mouth; Itchy, painful shingles like rash; Shingles like rash; Flu like symptoms; Achy; Back felt on fire; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 12May2021 at 14:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBSD), celiac disease, depression, anxiety and penicillin allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included citalopram hydrobromide (CELEXA), lactulose (MANUFACTURER UNKNOWN), amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL), diazepam (VALIUM) and folic acid (MANUFACTURER UNKNOWN) taken for unknown indication from an unknown start date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 at 08:15, the patient woke up with cold sores on her mouth. On an unknown date in May2021, several days later vaccination, the patient experienced itchy, painful shingles like rash which appeared on her back. The patient was also achy with flu like symptoms, but no fever and back felt on fire. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events included treatment with anti-viral medications (unspecified) and prednisone. The clinical outcome of events cold sores on mouth, itchy, painful shingles like rash on back, achy with flu like symptoms and back felt on fire were not resolved, at the time of this report.  No follow-up attempts are needed. No further information is expected.
The patient has been having fevers up to 103 degrees, has trouble walking , neck pain. The symptoms were bad  enough to require hospitalization. Now his kidney function has decreased so he has not been released from the hospital.
pt received first dose of Moderna Vaccine on Nov 9, 2021. Pt had hx of prior COVID infection Dec 25, 2020. Pt still had positive spike protein antibodies October 2021. Vaccine was given due to government mandate for healthcare workers. Pt started to have sciatica pain in January that escalated to where the pt was having difficulty sitting and walking. Pt then notice rash on Jan 18th and went to PCP office on Jan 20th. She had confirmed diagnosis of shingles and was given Valtrex and Flexeril for muscle spasms
Redness at injection site. No pain. No other symptoms. Red circle the size of a silver dollar.
injection site pain that traveled down arm and to back and neck; sore throat; fever; Awful headache; muscle pain; joint pain; chills; injection site pain that traveled down arm and to back and neck; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (injection site pain that traveled down arm and to back and neck), OROPHARYNGEAL PAIN (sore throat), PYREXIA (fever), HEADACHE (Awful headache) and MYALGIA (muscle pain) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 20-Aug-2021.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PAIN (injection site pain that traveled down arm and to back and neck), OROPHARYNGEAL PAIN (sore throat), PYREXIA (fever), HEADACHE (Awful headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and VACCINATION SITE PAIN (injection site pain that traveled down arm and to back and neck). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (injection site pain that traveled down arm and to back and neck), OROPHARYNGEAL PAIN (sore throat), PYREXIA (fever), HEADACHE (Awful headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and VACCINATION SITE PAIN (injection site pain that traveled down arm and to back and neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, Body temperature: 100.6 f (High) 100.6 F. On 08-Sep-2021, Body temperature: 101.7 f (High) 101.7 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were not reported.
Patient hospitalized twice within 6 weeks of receiving COVID vaccination. First hospitalization was 4/20/2021 - 4/23/2021, second hospitalization was 4/23/2021 - 4/27/2021.
ABOUT 10 MINUTES AFTER GETTING THE SECOND DOSE PATIENT FAINTED , BUT GAINED CONSCIOUSNESS IMMEDIATELY AND BLOOD PRESSURE WAS IN NORMAL RANGE.
no AE; temperature excursion 47 F to 77 F (54.9F); This spontaneous report as received from a licensed vocational nurse (LVN) and refers to a 4-year-old female patient. No information regarding her pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 11-NOV-2020, the patient was vaccinated wit an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot # T015599, expiration date: 02-NOV-2021, 0.5 milliliter one time (injection site and route of administration were not provided) for prophylaxis.  The administered dose experienced the temperature excursion of 47 degrees Fahrenheit (F) to 77 degrees F (54.9 F) for 1 hour and 25 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No other adverse events (AE) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2011USA008842: US-009507513-2011USA008619:
Shortly after receiving his second dose of  Covid 19 vaccine, he reported feeling throat and chest tightness, SOB and palpitations.
Presented for an office visit with PCP on 3/12/2021 complaining of dark colored urine, fatigue, diffuse itching without rash, and upper abdominal pain (RUQ>LUQ) which began 2-3 days after receiving the vaccine.  Exam notable for jaundice. Labs significant for elevated AST, ALT, total and direct bilirubin.  Started cholestyramine for pruritis. Had abdominal ultrasound which showed mild intrahepatic biliary ductal dilitation and surgically absent gallbladder. Had consult with gastroenterology the following week, diagnosed with likely immune-mediated hepatitis, liver function tests were trending down at that time, no further treatment required.
She was really really sick on Sunday night after she got the vaccine and typically has a fever; fevers; Fatigue; aches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (aches), ILLNESS (She was really really sick on Sunday night after she got the vaccine and typically has a fever), PYREXIA (fevers) and FATIGUE (Fatigue) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    It was reported that patient had no allergies. Past medical history was nothing serious.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose) on 19-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd dose) on 09-Mar-2021 and PFIZER BIONTECH COVID-19 VACCINE (Booster) on 09-Oct-2021; for COVID-19 prophylaxis: Moderna (W8G252) on 06-May-2022, Moderna (055F22B) on 06-Oct-2022 and Moderna (A57642B) on 04-Jun-2023. Past adverse reactions to the above products included No adverse event with Moderna, Moderna, Moderna, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Osteoporosis.   On 01-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2023, the patient received dose of INFLUENZA VACCINE (INFLUENZA) (unknown route) 1 dosage form. On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 01-Oct-2023, the patient experienced PAIN (aches), PYREXIA (fevers) and FATIGUE (Fatigue). On 08-Oct-2023, the patient experienced ILLNESS (She was really really sick on Sunday night after she got the vaccine and typically has a fever). At the time of the report, PAIN (aches), ILLNESS (She was really really sick on Sunday night after she got the vaccine and typically has a fever), PYREXIA (fevers) and FATIGUE (Fatigue) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that it packed more of a punch this time. This one hit her pretty hard. She was feeling well last night and then started feeling achy and had a fever but not high. She was really sick on sunday night after she got the vaccine and typically had a fever. Patient was concerned that since it was 36 hours after the vaccine that she was still experiencing these reactions. No treatment information was provided.
Overnight I had chills and was aching, injection site didn't feel sore until the next day. The day after around 11pm I had to go home because I had a fever of 102.6. Continued with a fever for two days, with chills and body aches. Especially a headache was noted even after my fever broke on the third day. Also a large, itchy rash is still around my injection site and I am on day three post shot. Went home from work early with a bad headache.
Flu like symptoms, swollen armpit and shoulder pain. Treatment take Tylenol and ice the area. Currently still having symptoms.
This case was reported by a healthcare professional (subject and receptionist of physician office) and described the occurrence of numbness at the injection site in an adult female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). In July 2013 the subject received a dose of BOOSTRIX (unknown details, left deltoid). In July 2013, less than one day after vaccination with BOOSTRIX (described as "throughout the day of receiving the vaccine"), the subject experienced numbness at the injection site (described as "localized numbness"), injection site throbbing (described as local reaction of "arm was throbbing"). In July 2013, at an unknown duration of time after vaccination with BOOSTRIX, the subject experienced red welt at injection site, bruise injection site and injection site discoloration. The reaction was described as looking "like a bruise in the deltoid muscle that was wide in circumference along with a red welt at the site of injection." The subject's arm was still green in color at the time of reporting. At the time of reporting the events of numbness at the injection site and injection site throbbing had resolved. At the time of reporting, the events of red welt at injection site, bruise at injection site and injection site discoloration had been reported as improved by the subject.
diagnosed with a neurological condition called cervical dystonia; Severe head tremor; dysphagia; This is a spontaneous report received from a contactable reporter (other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) via an unspecified route of administration on 03Feb2021 (batch/lot number: EN9581) at the age of 44 years old, as DOSE 2, SINGLE for COVID-19 immunization. Relevant medical history included: "Hypothyroid" (unspecified if ongoing). Patient was not diagnosed with COVID prior vaccination. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose, via an unspecified route of administration (batch/lot number: EL3248), as DOSE 1, SINGLE), administration date: 13Jan2021, when the patient was 44 years old, for COVID-19 immunization. Patient did not receive other vaccine in four weeks. The following information was reported: TORTICOLLIS (disability) with onset 01Mar2021, outcome "not recovered" described as "diagnosed with a neurological condition called cervical dystonia"; HEAD TITUBATION (disability) with onset 01Mar2021, outcome "not recovered" described as "Severe head tremor"; DYSPHAGIA (disability) with onset 01Mar2021, outcome "not recovered" described as "dysphagia." The events "diagnosed with a neurological condition called cervical dystonia", "severe head tremor" and "dysphagia" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: esophagogastroduodenoscopy: unknown results, notes: Multiple EGD's. Therapeutic measures were taken as a result of torticollis, head titubation, and dysphagia which included botox injection of back of neck and multiple EGD's (as reported). The patient received the third dose via an unspecified route of administration on 01Sep2021 (batch/lot number: 30130BA) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient has not tested for COVID post vaccination.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events
Upon trying to return unused vaccine to another store we realized that the vaccine was only good 30 days from deep freeze.  We thought is was good until 10-30-2022 according to the mfg website when kept in the fridge. We received this medication on 06-02-2022 and vaccinated on 08-02-2022.  We reported this problem to the mfg and they are going to do batch testing to see if we need to revaccinate
next day, pt c/o raised dime-size bump @ inj site lt deltoid w/a central blister-like area;also c/o red spots/blotching @ knees, nose & face;pt spoke to MD who told pt was an allerg rxn & pt should not have further hep B vax;DPH taken
A total of 140 pts were vaxed, 1 pt was borderline responder following a series of 3 Engerix-B vax & 23 pts did not respond (see also EBU910616);
PATIENT PRESENTED TO THE PHARMACY THE MORNING AFTER SHE WAS GIVEN HER FLU SHOT WITH HIVES OVER HER ARMS AND TORSO. SHE HAD BEEN RECOMMENDED BY HER PHYSICIAN TO PICK UP CLARITIN TO HELP RESOLVE HER REACTION.
Patient reports bilateral leg swelling, temp 102, 1-2 days after COVID vax. He looked up DVTs, found that they are usually unilateral. No medical care sought.  Swelling now resolved. Fever resolved.
1145PM flu vax recvd; 16mm knot arose @ inject site-non tender; pt x 15mins; in no distress, BP 150/98-lt office; returned @ 440PM, knot still a site; non tender-no pain according to MD;
fever to 104 on 19PAR95 accompanied by 30min gen sz; went on to devel other neurological sx such as ataxia; As of 4MAY95 dx acute disseminated encephalomyelitis;
4/30-A few hours after injection: left arm soreness and discomfort 5/1-Approximately 12 hours after injection (6:30am): arm soreness plus chills, headache and fast heartbeat/palpitations; did not take any medication as there was no fever (94 degree temp) but side effects improved with rest and sleep and were minor by evening (7pm). 5/2-AM: Arm soreness and occasional sharp pain mid chest (on sternum); side effects improved during the day but worsened in the evening @11pm with arm soreness, headache, fast heartbeat and sharp chest pain through the night. Took Tums and drank magnesium carbonate with L-thiamine but symptoms remained. Slept upright as this seemed to lessen pain. 5/3 - Intermittent chest pain and fast heartbeat throughout day.
The patient received an expired vaccine (12/31/2021).  The patient is not reporting any adverse events.
Patient received HPV around 4:40 pm 5/24/10.  States she developed itching interior aspect of both thighs around 9:00 p.m. on 5/24 with raised reddened areas on interior thighs, posterior aspect right axilla and small area right forearm; larger area left forearm.  Used Benadryl itch cream.  Still demonstrating symptoms around 3:30 on 5/25 when came to health department.
Information has been received from a health professional concerning a patient who about two weeks ago was vaccinated IM with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (658450/1380U). On the same day of vaccination, the patient experienced injection site redness, swelling and pain. Unknown medical attention was sought. The patient's was recovered. No product quality complaint was involved. This is one of multiple reports from the same source. Other (WAES# 0802USA02058 and 0802USA05540). Additional information has been requested.
made me horribly sick; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious social media case received from non-health care professional.  This case involves a patient of unknown demographics who made horribly sick (Illness), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, family history and concurrent condition were not provided. Concomitant medication was not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route on unknown site of administration for prophylactic vaccination.   On an unknown date, the patient reported that made horribly sick (Illness, non-serious) (Unknown latency) following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for sickness, at the time of reporting.  There will be no information available on the batch number for this case. No further information was reported.
Patient received Tdap vaccine without problem. After patient left the facility she became lightheaded and vomited. Patient returned to office. We brought her back to a room and she laid down for 20 min. and was given apple jc. When she felt better she was leaving and began to vomit again. Pt. seen by a provider.
HCP reports no signs or symptoms noted. HCP has no further AE information.; HCP called to report a dose of VARIVAX that expired on 6/28/2023 was administered on 6/30/2023. Sterile Diluent used was also expired as of 1/26/2023.; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On 30-JUN-2023 the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U020240, which is valid lot number and expiration date was established as 28-JUN-2023, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided). Other suspect therapies included expiered sterile diluent (STERILE DILUENT) lot # T022569 and expiration date 26-JAN-2023 for prophylaxis (expired product administered and no adverse event
Almost immediately after the injection the site started to itch, not severe but an itch that compelled me to scratch it. Today is day 2 and tho not constant, the desire to touch/scratch the site is quite strong. There?s a hardness and some swelling in the area , a bit warm to the touch.
sore arm, chills, low-grade fever, muscle aches, foot pain (arthritis?), loss of appetite, fatigue (enough to go to bed), stayed in bed all afternoon, got up for dinner (couldn't eat normal amount) and went back to bed and slept all night. Woke up ok on January 21 but still have light fatigue.
Arm pain for 5 days. Fever, cough, sore throat and nausea
Tdap given 4/21/15-area is red, swollen and warm to touch.
Patient has been having chest pain, shortness of breathe after 2 weeks of getting vaccine and  was diagnosed with pericarditis on 06/22/2021.
This spontaneous report as received from a 93 years old male patient refers to himself. The patient's pertinent medical history was not provided. He had no drug reactions/allergies and was taking unspecified concomitant medications. In approximately 2014 (reported as "last year"), the patient was vaccinated with a dose of ZOSTAVAX (vial) (dose, route of administration, expiration date and lot # not reported). On approximately 24-APR-2015 (reproted as "2 to 3 weeks ago"), the patient began to experience itching on his breast, back and neck area. His left arm down to his elbow was red, and then there were the blue patch areas. The redness and blue patches had dissipated. He went to see his physician, and the physician stated it was allergy. Skin test was done and the patient was prescribed with CLARITIN. The itching continued and the patient went to see an unspecified allergist, who prescribed prednisone (manufacturer unknown) tablets. The physician didn't diagnose the patient with "shingles", but the patient felt he had "shingles" since an unspecified date in 2015. Neither treatment with CLAIRITIN nor prednisone (manufacturer unknown) had been effective for the itching (captured in MARRS# 1505USA010597 and MARRS # 1505USA010598). The patient sought medical attention via office visit. The outcome of adverse events was reported as not recovered at the time of the report. The relatedness between adverse events and ZOSTAVAX was unkonwn. This is one of several reports received from the same reporter. Additional information has been requested.
pt passed out within a minute of receiving injection.  He became pale in color, eyes slowly rolled back. We called 911.  The chair had armrails.  He slowly slouched back in chair and then we placed him  comfortably as possible on the floor by his wife and pharmacy assistant. Once unresponsive to touch we called 911.  Within 10 seconds he began to respond slowly.  He drank some Gatorade that we offered.  He became alert and responsive while still on floor.  Paramedics arrived by approximately 335pm to take over.  Patient wanted to leave on his own accord.  Paramedics took him inside ambulance to evaluate.  The time now was about 442 pm.  (times are estimates)
When I got the shot I felt okay for the rest of the day, but the injection site on my right arm hurt a bit for the rest of the day. The next morning my right arm still hurt, but it was not worst. However my left hand and left elbow felt very stiff. When I tried to bend my left elbow it hurt a bit. When I tried to bend my fingers on my left hand it hurt very much. I couldn't even make a fist it hurt so much. I kept slowly bending my elbow and bending my fingers until the pain and stiffness would go away. Most of the pain and stiffness went away, but a little still remained. It feels like I have some kind of Arthritis in my left hand and left elbow, but I have never had it before. Since I got the COVID-19 vaccine, every time I wake up I have been experience the same thing.
Patient wife called stating that after receiving vaccine patient was very lethargic/feverish and had swollen glands. Patient is not a patient here at medical center and was advised to call PCP office.
I tested positive for COVID on 6/1/2022.  I experienced cough, congestion, aches, sore throat, fever, aches and nausea.  Symptoms kept me in bed for 3 days, then improved over the next 4 days.  I contacted my PCP at onset of symptoms and was prescribed Paxlovid which I took for 5 days.
Had an unconsolable cry for about 3 hrs. Had fever-unmeasured. Also describes cry as high pitch shrill cry.