chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day p/vax woke up w/generalized macular papular rashes on rt forehead, upper back, abd, legs, & groin; Both knees asymmetrically, tender, warm, red, swollen, & dec mobility;
SORE ARM ON INJECTION SITE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 1 in total, dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced sore arm on injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm on injection site. This report was non-serious.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient passed out about 3 minutes afte receiving both vaccines. Informed us he didn't eat in the morning. Once passed out when giving blood.
near syncopal episode.  pt went to ED and recovered quickly and returned to work at the hospital that day
She thinks, twice contracted Covid. Also experienced Covid like symptoms with each vaccine/booster received.; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (She thinks, twice contracted Covid. Also experienced Covid like symptoms with each vaccine/booster received.) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Allergies to vaccines, medications, food, and other products-describe reaction in parentheses (e.g. Sulfa (hives)) was unknown.     On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (She thinks, twice contracted Covid. Also experienced Covid like symptoms with each vaccine/booster received.). At the time of the report, COVID-19 (She thinks, twice contracted Covid. Also experienced Covid like symptoms with each vaccine/booster received.) had resolved.            Concomitant medications were not reported.  It was reported that patient was contracted with Covid twice. Also experienced the Covid like symptoms with vaccine  The symptoms from virus and shots lasted a couple of days before subsiding.  Treatment information was not reported.   This case was linked to MOD-2023-718542 (Patient Link).
Initial information received from a health care professional on 03 April 2014. A 33-year-old female patient whose medical history and concomitant medication were reported as unknown, had received an intradermal dose of ADACEL (lot number UT4722BA, dose number was unknown and anatomical site of administration were reported as "left:) on 18 October 2013. On 18 October 2013, same day after vaccination, the patient experienced injection site small lump under. The patient also experienced another small lump medial to the intradermal injection site appeared a few days ago under the skin. Laboratory investigation and corrective treatments were not reported. Documents held by sender: none
Patient received 2 doses of Hib on 7/13/12. Pt received PENTACEL plus an extra Hib.
I experienced chest pains, pains traveling around my body, high blood pressure of 160/110, swelling and pain in my left arm, headaches, dry mouth and my heart rate was higher than usual.
left arm occasionally painful; Rash; Injection site raised; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm occasionally painful), RASH (Rash) and VACCINATION SITE SWELLING (Injection site raised) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm occasionally painful), RASH (Rash) and VACCINATION SITE SWELLING (Injection site raised). At the time of the report, PAIN IN EXTREMITY (left arm occasionally painful), RASH (Rash) and VACCINATION SITE SWELLING (Injection site raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include Allergy Medicine. No treatment details were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-059847 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-059847:cross_link report
Lower body gave out, resulting in collapse.  Lower body basically paralyzed for approximately 20 minutes. Could not sit up or turn over to get up.
2nd day - rash below the administration site. Saw MD on the 4th day - was given triamcinolone and ciprofloxacin (made the condition worse), now given cetirizine and prednisone.
Fever (102), vertigo/dizziness, pallor, nausea, fatigue
Pt received Anthrax #1 and Typhoid in separate deltoids. After 2nd injection, patient states started feeling numb and felt himself about to pass out. He then became pale and slouched in chair. Was in this state for about 5-7 seconds until shaken. Woke up feeling ok. Laid patient down, placed cool cloth on forehead, elevated his legs. Pt felt back to normal after about 5 minutes.
tired; sore from the tension; migraine; extreme discomfort; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot: EN6201, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 19Feb2021 at 08:30 (at the age of 71 years old) as dose 2, single for covid-19 immunisation. Also, patient has previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was reported as EL9262, Expiry date was not reported) via an unspecified route of administration, administered in Right arm on29Jan2021 at 08:45 AM as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history includes, Metastatic melanoma, post-menopausal migraine, known allergies were reported as Sulfa and Penicillin from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID), desvenlafaxine succinate (PRISTIQ), latanoprost (LATANOPROST), vitamins. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient has received other medications in two weeks which includes, synthroid, pristiq, latanoprost, vitamins. The reporter reported that, after he was administered with second Covid vaccine in the morning he was fine. At 3 am (on 20Feb2021) he woke with a migraine, one of the worst that he has had in eight years. Was in extreme discomfort and in bed the rest of the day. Next day, besides being somewhat tired and sore from the tension of the prior day, he was fine. he has been under the care of a neurologist for many years for postmenopausal migraine, complex. Just wanted others to know that this might occur and be prepared for it. It was not just a headache. Patient received no treatment for the event. The outcome for the event migraine, extreme discomfort and tired was recovered and for the event sore from the tension was recovering.   Follow-up attempts completed. No further information expected.
Within one week of anthrax vaccine began passing out. After testing (cardio echo, stress test, tilt table) medical staff concluded diagnosis was syncope. Initial symptoms were dizziness, nausea, tachycardia feeling, cold sweats, shaking, tunnel vision, blood pressure drop, pass out.
Systemic: Other- 1/28 early morning visual disturbance, lost balance and fell,lasted until mid day wednesday 1/28
PASSED OUT; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient passed out immediately upon receiving the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of passed out was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210428755.; Sender's Comments: V0: 20210429067-covid-19 vaccine ad26.cov2.s-passed out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Immunized at age 12; Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from a physician concerning an 12-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, immunized at age 12 and administered vials that were exposed to room temperature for more than 12 hours.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient received a vaccine dose of mRNA-1273 that had been left at room temperature more than 12 hours. It was originally thought that the freezer which stored the mRNA-1273 vaccine died on 04 Jan 2021 at 2am, so vaccine administration occurred up until 2pm. After checking freezer temperature logs, it was discovered the freezer had died at 1:11am. Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The events, immunized at age 12 and administered vials that were exposed to room temperature for more than 12 hours, were considered resolved on 04 Jan 2021.; Reporter's Comments: Company comment: This report refers to a case of 12- year-old patient who was administered vaccine outside the lower age limit for Moderna's mRNA-1273 vaccine,  and received a vaccine dose that had been left at room temperature more than 12 hours (lot # unknown, Exp. unknown). There were no reported AEs associated with this case of vaccine and is outside the lower age limit for Moderna's mRNA-1273 vaccine and  vaccine dose of mRNA-1273 that had been left at room temperature more than 12 hours.
Two significant side effects: 1. A break-through menstrual period starting 3-4 days after the second dose 2. Muscle soreness and weakness beginning the day after the second dose near the site of injection and lasting for 5 months  In addition, I had severe general weakness, soreness, fever, and nausea for 30 hours, but this was not the reason for reporting.
arm was sore after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore after the 1st dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore after the 1st dose). At the time of the report, PAIN IN EXTREMITY (arm was sore after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication provided. No concomitant medication provided.   This case was linked to MOD-2021-214787 (Patient Link).
approx Two minutes after 3 vaccines (Proquad, DTaP, IPV) administered, pt developed cough. He then vomited x once. This cough continued. Benadryl (12.5/g) 1 1/2 tsp po given. flushed face, puffy eyes and few hives on palms/wrist developed. Epinephrine 0.15mg IM given. Pt sx improved. Pt transported to hospital via EMS.  05/29/2007 MR received for o/n hospitalization for an allergic reaction to vaccinations. W/in 2 minutes of receiving vax child began to cough and vomited x 1. He developed hives, puffy eyes, facial flushing and began to itch. Continued coughing.  Admitted for observation. DX:  Allergic reaction after immunization.
Confused; Diarrhea; Nausea; This spontaneous case was received on 14-Sep-2020 from other non-health care professional (consumer) to agency (reference number: SEQW20-01634) and concerned a 64-year-old, female patient.  The patient's concurrent conditions included hypothyroidism and high cholesterol. The patient's concomitant medications included levothyroxine and pravastatin both for an unreported indication.  On 13-Sep-2020 at 12 am, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml) for influenza prophylaxis. The batch number reported was P100251765 and expiry date was 30-Jun-2021.  On the same day at 7:00 pm, 5 hours after receiving Afluria Quadrivalent, the patient started to experience nausea and diarrhea.   On 14-Sep-2020, the pharmacist was called and confirmed the narrative above. The pharmacist reported that the patient seemed confused. At 2:00 am, the patient took one Tylenol (paracetamol) as treatment.  On the same day, the patient recovered from the event of nausea.  At the time of initial reporting on 14-Sep-2020, the patient had not recovered from the event of diarrhea.  The outcome of the event confused was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: The patient developed confusional state, nausea and diarrhoea on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. No alternative aetiology was provided. Considering above mentioned, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed confusional state, nausea and diarrhoea on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. No alternative aetiology was provided. Considering above mentioned, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Temperature of 101.9 the entire day; Nausea; Vomiting and couldn't keep liquids down; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting and couldn't keep liquids down), HEADACHE (Headache) and PYREXIA (Temperature of 101.9 the entire day) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting and couldn't keep liquids down) and HEADACHE (Headache). On 06-Feb-2021, the patient experienced PYREXIA (Temperature of 101.9 the entire day). On 07-Feb-2021, NAUSEA (Nausea), VOMITING (Vomiting and couldn't keep liquids down), HEADACHE (Headache) and PYREXIA (Temperature of 101.9 the entire day) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Body temperature: 101.9 101.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitent medication provided Treatment inciuded  ibuprofen and Tylenol   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up received on 22-apr-2021,NNI
Five days after 3rd shot (booster):   1) vomiting,  diarrhea, dizziness, High blood pressure (161/95) , extreme fatigue (in bed for full 3 weeks) , extreme night sweats, pounding heart and intermittent low grade fever (varies 97.1 to 100.2) , brain fog, coughing up green flem.   Weight loss.  Most prominent symptoms  today are pounding heart when waking up/ after eating/ after excercise, extreme fatigue
Body aches, fatigue, headache, runny nose which lasted about 8 days.  The fatigue has improved moderately but not completely.
My ear and head hurt so bad it was like they were going to explode. Felt dizzy and whole body hurt. Was not able to stand up straight and walking was difficult. I took Tylenol for the fever that ranged into 102.6 for a couple days. My body hurt so bad I used my Vicodin to try and ease the pain but it didn't work to well. I will never get another flu shot if it is a 3in1 again. I wanted to die to get rid of that pain. This is my 4th day and I still ache bad and my head doesn't feel normal, foggy headache.
3/4 very sore arm. 3/6 arm soreness gone. 3/7 at 2:30am awoke with rapid heart rate. Continued to mid morning and developed chills, fatigue, slight fever, no appetite. By days end felt much better. However the very next day 3/8  woke up feeling fine but by days end lower abdomen painful. Pain continued into 3/9. I called my family Dr and went over systems on phone. Diagnoses, bout of Diverticulitis. Which I have had before. The times before required antibiotic etal, not this time. I writing this today 3/12 to say feeling much better. I?m on a light diet and this seems to have helped this time.
Pt seen 10/16/02 12x8cm erythema/induration at site of injection, developed over lost 24 hours since injection. Resolving as of 10/18/02.
pt recvd vax; itching, swelling, pain at site x 1 week;
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 60-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 11-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Petechiae B/L cheeks & under eyes. No other bruising. No other petechiae.
8/29: Lesions developed. Fatigue, confusion, photosensitivity.
29SEP94 flu like sx, t102.4; to MD secondary rash on legs & @ skin fold-swollen glands: rx erythromycin & cephtin also for URI @ the same time;
Developed low grade fever after receiving the vaccine, became extremely lethargic. Fever continued into the next day. That next morning, patient had a seizure lasting about 8 minutes before falling completely limp, unresponsive, and required rescue breaths. Luckily, we were in public and emergency services came soon after. Patient regained consciousness and was breathing fine after his IV. Several hours later, we were discharged, but came in periodically to see the doctor.
Information has been received from a medical assistant concerning an 83 year old female with allergies to codeine and morphine and no medical history, who on 10-MAR-2010 was vaccinated intramuscularly with a 0.5 mL dose of PNEUMOVAX 23 (lot # 664864/1365Y). Concomitant therapy included alendronate sodium (MSD), nitroglycerin, calcium (unspecified) (+) vitamin D (unspecified), ANTIVERT, atenolol, simvastatin (manufacturer unknown) aspirin, digoxin, COUMADIN, omeprazole, and KAYEXALATE. On 10-MAR-2010 the patient developed a cellulitis like reaction at the injection site. The patient complained of the site being itchy, red, hot and swollen. The patient was put on KEFLEX and CLARITIN for the treatment. No laboratories studies performed. The patient sought medical attention through her physician. At the time of this report the patient was recovering. Follow up information has been received from the medical assistant who indicated that the patient was a retired female who on 10-MAR-2010, was vaccinated with the first dose of PNEUMOVAX 23 (lot # 664864/1365Y) into her left deltoid at 11:00 AM. No illnesses were reported prior to the time of vaccination. On 10-MAR-2010, at 09:30 PM the patient's upper left arm got red, tender and hot with cellulitis. A clinical evaluation was done in the office and treatment was done with antibiotics and ice. The patient recovered on approximately 20-MAR-2010. The reporter considered the patient's upper left arm red, tender and hot with cellulitis to be other important medical events. Additional information is not expected.
Within an hour, localized pain.  Within two hours, general achiness, coughing, running nose, earaches, sore throat, intense itching of forearms.
16.5 hrs after injection stomach cramping and diarrhea every 2 hrs x 3. 24 hrs after injection chills, fever (99.1), joint pain, fatigue.
4/3/2021- c/o nausea and chills, dry cough and decrease in O2 sat (86% RA), increase pulse (107), T-101.4. Rocephin 1 gram x1 given. Urine culture obtained- > 100,000 pseudomas aeruginosa. Midline placed IV Zosyn started. On 4/11/2121 he had acute onset L upper extremity weakness with facial droop and slurring of speech. Sent to facility and TPN administered. Returned to facility on 4/14/2021 with L upper ext weakness.
Within 5 minutes I started feeling weak, sweaty, like I was going to pass out. Then my throat felt like it was closing up and I had a hard time breathing. It is not over 24 hours later and I am weak, feverish with a headache.
they are now testing positive for COVID 19; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 25Aug2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient was received her first dose of the Pfizer COVID 19 vaccine on 25Aug2021. The patient states that they have not been exposed to anyone with COVID 19 and that they are now testing positive for COVID 19. The patient states that it has been 8-9 days and the patient tested positive on Saturday (04Sep2021). The patient would like to know if this is because of the vaccine and that they really don't have the virus. The patient makes an example of when people get the flu shot and then get sick with the flu. The patient states that it's the same because the vaccine is COVID that they put in their body. The patient was like to know if she can still get her second dose of the vaccine now since she has tested positive after the first dose. The patient states that this vaccine was the virus so that was why patient was testing positive right, patient states that the vaccine puts the virus in your body. Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
pain everywhere, woke up very uncomfortable, vomiting, weak, muscle ache, fever, hot and cold chills, headaches, diarrhea