chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 12-19-06, patient rec'd the MMR, HIB, Hep B & Varicella vaccinations. He should not have had the shots since he was recovering from a cold but the Dr. never told us that. My husband & I refused the MMR shot several times while in the Dr's office but we were intimidated by the Dr & his staff to give it. Patient immediately developed flu-like symptoms & a full body rash. The flu symptoms lasted about 2 wks & the rash about 2 days. Patient lost speech & communication including up to 15 words he had learned. Patient became catatonic & non-responsive to physical & verbal cues. Patient began Tx with a Holistic Physician immediately who placed him on a wheat-free, gluten-free, dairy-free diet including holistic vitamins & probiotics. Patient currently is developing physically, verbally & cognitively at a normal level for his age. He has met all of his major milestones. Patient is a fraternal twin & IVF baby using PGD.
Extreme pain in right arm and shoulder; unable to move right arm or shoulder. ER  2/22/2021 - Las Vegas two days later -(First, I did Teladoc first and they had me put a cold compress on it for a day or two (I tried cold and eat). ) Time kept going on and I kept not getting better. I waited two weeks to see my regular doctor and then I ended up in ER again because of pain. They gave me a shot of morphine. Sent me for an MRI and told me to see my doctor. My doctor sent me to another surgeon who had worked  on my arm on my left shoulder  . Months went by before I found out there was not anything physically wrong with the arm/shoulder. Trying to do Physical therapy twice a week - I'm unable to fully work - I'm a licensed aircraft technician. I'm doing a desk job and  type with one hand.
5 days post vax PT developed high fever 102.9 and lasted 5 days. 8 days post vax developed rash, which covered his entire body except for his hands & feet. Rash lasted 4 days. During fever and rash contacted MD office. No other information was made available for the vaccines.
sweat; Chills; Headache; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (sweat), CHILLS (Chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chills (No reported medical history), Headache, Joint pain and Nausea.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced HYPERHIDROSIS (sweat), CHILLS (Chills) and HEADACHE (Headache). On 17-Jan-2021, HYPERHIDROSIS (sweat), CHILLS (Chills) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment details was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Right after shot was given, patient experienced nausea (w/ salty and bloody taste), cold sweat, dizziness and his face got pale. He drank water and orange juice and with a little rest he got better. 911 was called but mom cancelled shortly after since he was getting better.
"Trouble breathing & getting air" R ear & neck tenderness.  Received IV BENADRYL in ambulance with relief.  Observed - E.R. X 2 1/2 hours.  Taking Benadryl PO Q6 hours X 5 days.
Chills, rigors, muscle aches  Took Ibuprofen 800mg approximately 15 minutes after onset. Symptoms subsided approximately 30 minutes after taking medication.
Pt was given the below named vaccines she immediately developed papular erythematous lesion on the face and extremities which was covered by 0.1 ml of epinephrine and 1.5cc of Prelone.
Elevated T, pulling on ears,inc lethargy, watery stools starting 15Feb91.Otoscopic:Red T.M's bilat.Lungs clear.Pt was teething /w molars.
Onset of tinnitis about an hour after vaccine administration.  No treatment.  Still persists now, 16 weeks later.
No additional AEs; we had a delivery of GARDASIL 9 that did not arrive for more than 5 days, when the product was received it was supposed to be returned to the wholesaler, instead they were placed in the refrigerator; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On an unknown date in April 2021, there was a delivery of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) that did not arrive for more than 5 days, when the product was received it was supposed to be returned instead of placing in the refrigerator (temperature was unknown by reporter).   On 13-MAY-2021, the patient was vaccinated with the improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (1 time dose, lot# T026168, expiration date 04-DEC-2022; route was not reported) for prophylaxis (product storage error). It was reported that 5 bad doses were given and six potential patients were involved, one of the six patients involved was administered a valid dose. It could not be confirmed which patient received the valid dose. There was no previous temperature excursion. No data logger was involved. No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
mom states t99-100 w/ear thermometer @ 4-5PM 27MAR95; convuls @ 12MN took to ER; t100.4 @ ER treated w/APAP supp; rt leg swollen & red w/marks below; rt leg inj site had hard nodule but no redness or tenderness; slow to respond; shaking;
? Reaction to MENACTRA - started with symptoms per mom '10 minutes after leaving office. Symptoms included "weird feeling", arm felt heavy, tongue swelling. mouth itching, chest pains. Instructed  mom to given BENADRYL and call 911 for transport to nearest ER. I was already home when she called off back. ER gave prednisone, famotidine,  and cetirizine. Epipen prescribed.
PT. DEVELOPED BODY RASH, FACIAL SWELLING, AND REDNESS AT THE INJECTION SITE OF THE PROQUAD. HE RECEIVED OTHER VACCINES BUT THE SITE THAT WAS REDDNED WAS WHERE THE PROQUAD WAS GIVEN.
Swelling on the administration site - Rt arm also noted reddish discoloration swelling size 55 x 60.
secondary immune thrombocytopenia; Based on the current case data, this case has been classified as invalid. This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (secondary immune thrombocytopenia) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (secondary immune thrombocytopenia) (seriousness criterion hospitalization). At the time of the report, IMMUNE THROMBOCYTOPENIA (secondary immune thrombocytopenia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: unknown unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The case pertains to 11 patients from a literature article review.  Concomitant medication use was not reported Treatment information was not reported.  Very limited information regarding the event has been provided at this time.   Very limited information regarding the event has been provided at this time.   This case was linked to MOD-2021-096709 (E2B Linked Report).; Sender's Comments: Very limited information regarding the event has been provided at this time. MOD-2021-096709:Same literature article (37-yo male)
Febrile episode with seizure 12 hrs after DTaP, Prevnar and IPV
fast heart rate, very fatigued but felt that if I laid down I would go to sleep and not wake up.  I knew I could not drive  and so I left my house and walked around to try to shake the feeling, told a neighbor in case I passed out.  After about 15-20  minutes, symptoms subsided.  Next 2 days, I had dark diarrhea, but no blood evident.  I went online and discovered I had a .01% of the side effects.  I told my doctor at my last visit to him, but not sure it was reported.
"Moderna Arm" - slightly raised red rash-like reaction around injection site, sloping downward along bicep muscle.  Warm to the touch, not painful but slightly itchy.  Noticed roughly 8-9 days after 1st dose.
Leg cramps; Sharp pain localized to one spot; 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 MUSCLE SPASMS (Leg cramps) and MYALGIA (Sharp pain localized to one spot) 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 MUSCLE SPASMS (Leg cramps) and MYALGIA (Sharp pain localized to one spot). At the time of the report, MUSCLE SPASMS (Leg cramps) and MYALGIA (Sharp pain localized to one spot) outcome was unknown.            Reporter did not allow further contact
pt recv vax 27APR98 & 6MAY98 pt was pinched on nose by another child resulting in excessive bruising of area;pt hosp platelet count reported depressed @ 29,000, hemoglobin 13.9, WBC 7.2, tx w/IV immune globulin;platelet count 198,000
Subsequent to receiving the third dose of Engerix B the pt experienced swelling and redness at the injection site. the most recent information received reports the condition of the pt is unknown.
Pt states that her RIGHT elbow started hurting the day after the vaccine and within the last few days her RIGHT shoulder is hurting her. Her vaccine was given in the left arm.
I had a laryngectomee in Sep 2012.  Since then I cough up mucous through my stoma. After the vaccine I started coughing up frothy white mucous which I never had done before.  I looked it up and found it was a symptom of COPD which I never had or was diagnosed for.  A year later I still frequently cough up frothy white mucous.  Before the shot it was always clear.
Patient had localized soreness, redness, feeling hot to the touch, and swelling approximately 12 hours after injection. Applied an ice pack. Recommended further treament with ibuprofen for the pain and BENADRYL and diphenhydramine if any itchiness.
Pain in arm/ Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm/ Sore arm) and HEADACHE (Headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 022B21A) for COVID-19 vaccination.     The patient's past medical history included Liver transplantation in February 2021. Concurrent medical conditions included Spleen disorder NOS (A blood clot that burst in spleen.) since 05-Aug-2021 and Pancreatic insufficiency (Exocrine pancreatic insufficiency(EPI)). Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) and TACROLIMUS for an unknown indication.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm/ Sore arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain in arm/ Sore arm) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On unknown date patient had CT Scan and the result was not provided. The concomitant medications include other antirejection medications No treatment information provided.   This case was linked to MOD-2021-320594 (Patient Link).
This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 18-AUG-2013, the patient was vaccinated with GARDASIL dose 1 and dose 2 on 17-JUN-2016, dose 3 on 18-AUG-2014, intramuscular. On 30-AUG-2016, fourth dose was administered of GARDASIL 9. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
started with swelling and pain at the site, then progressed to swelling of entire upper arm down to the elbow. Redness and fever (hot to the touch) of the entire upper arm down to the elbow with increased pain of the entire upper arm down to the elbow. Doctor "on call" (it was Sunday) prescribed benadryl and lortab for pain, plus putting ice on upper arm for fifteen minutes four times a day.
Joint aches and pain, nausea, chills, fever, headache, dizzy/ unstable occurring 24 hours after 2nd  shot.
Blood clot in the left eye after the 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (Blood clot in the left eye after the 3rd dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Cancer and Immunocompromised.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced CONJUNCTIVAL HAEMORRHAGE (Blood clot in the left eye after the 3rd dose) (seriousness criterion medically significant). At the time of the report, CONJUNCTIVAL HAEMORRHAGE (Blood clot in the left eye after the 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.  Visited Doctor on 30-Sep-2021.  Company Comment This case concerns a 72 year old female with relevant medical history of Cancer in iummnocompromised state, who experienced, serious , unexpected event of Conjunctival hemorrhage which occurred 1 month and  3 days after vaccination with the 3rd dose of mRNA-1273 Vaccine (Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since no additional doses will be administered and the outcome of the event is unknown. The benefit - risk relationship of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) is not affected by this report.; Sender's Comments: This case concerns a 72 year old female with relevant medical history of Cancer in iummnocompromised state, who experienced, serious , unexpected event of Conjunctival hemorrhage which occurred 1 month and  3 days after vaccination with the 3rd dose of mRNA-1273 Vaccine (Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since no additional doses will be administered and the outcome of the event is unknown. The benefit - risk relationship of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) is not affected by this report.
Right upper lip fever blister / cold sore.  Herpes simplex Virus (HSV-1).
15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; They reported significant body aches.; nausea; vomiting; diarrhea; 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; This is a spontaneous report from a contactable physician. This physician reported similar events for 15 patients. This is 15th of 15 reports. This physician reported for a patient that A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) dose number unknown via an unspecified route of administration on an unspecified date as 1.3 mL, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 ml instead of 1.8 ml, they reported significant body aches, nausea, vomiting, diarrhoea, on an unspecified date. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient
On 11/07/2001 pt developed fever for 3 days. On 11/09/2001-11/11/2001 developed rash, observe. Phone follow up 11/13/2001 doing okay.
Fever; body aches; chills; This is a spontaneous report from a non-contactable Consumer or other non-HCP. A 26-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EM9809; Expiration date: Unknown), via an unspecified route of administration in the left arm on 22Feb2021 (at the age of 26-years-old) as single dose for COVID-19 immunization. Patient's medical history was not reported. Patient had no known allergies. Patient's concomitant medications included birth control pills. The patient previously administrated with first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL9262; Expiration date: Unknown), via an unspecified route of administration in the left arm on 01Feb2021 at 10:45 AM as single dose for COVID-19 immunization. On 22Feb2021, after 22hrs:30min from vaccination, she experienced fever, pain, chills. She did not receive any treatment. She did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, she was not diagnosed with COVID-19. Since the vaccination, she had not been tested for COVID-19. The outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Patient was scheduled for a 6 month well child exam 2 days prior to turning 6 months. MA did not realize that the patient was not 6 months of age and administered the flu vaccine.
2 weeks or so, after injection. Left leg numbness for 2 hours. Then, left leg tremors when standing and walking. Has continued ever since the onset, when standing and walking. MRIs; CT Scans; EMG; Blood Tests. Nothing shown as the cause. Tried PT. Doesn't do anything to help the tremors. Just began taking Clonazepam .5 mg tablets/day to start. Don't know if it will alleviate the tremors or not.
1ST dose experienced SWOLLEN PAINFUL arm for about 4 DAYS; 2ND DOSE HAD CHILLS AND SHAKING AND VERY EXHAUSTED. Patient stated after 48 hours he felt fine.
At the injection site it is still pink.; It has been almost 3 months since she received her last dose and her arm is getting sore and more sore each day; She states her whole shoulder hurts in that area.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (At the injection site it is still pink.), PAIN IN EXTREMITY (It has been almost 3 months since she received her last dose and her arm is getting sore and more sore each day) and ARTHRALGIA (She states her whole shoulder hurts in that area.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL from 07-Jan-2010 to an unknown date, HYDRALAZINE from 07-Jan-2020 to an unknown date, HYDROCHLOROTHIAZIDE (HYDROCHLOROTH) from 07-Jan-2010 to an unknown date and VALSARTAN from 07-Jan-2010 to an unknown date for Blood pressure management, ATORVASTATIN from 07-Jan-2018 to an unknown date for Hypercholesteremia.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (At the injection site it is still pink.), PAIN IN EXTREMITY (It has been almost 3 months since she received her last dose and her arm is getting sore and more sore each day) and ARTHRALGIA (She states her whole shoulder hurts in that area.). The patient was treated with MENTHOL (BENGAY PAIN RELIEVING) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOLOURATION (At the injection site it is still pink.) was resolving and PAIN IN EXTREMITY (It has been almost 3 months since she received her last dose and her arm is getting sore and more sore each day) and ARTHRALGIA (She states her whole shoulder hurts in that area.) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Patient demographics, race and ethnicity were updated. Concomitant medication were added. Events outcome was updated.
Patient was diagnosed with COVID 19 on 16 Feb. 11 Days after first vaccine.
Patient was administered 2nd dose of Moderna vaccine. Patient is under 18 years of age.
pt states she was short a breath and pain from chest to back, she stated she felt like she is having an panic or anxiety attack, asked if she had medication and she took it and symptoms became worse, she was having an  headache and pain going down left arm, worse SoB, chest pain was getting worse, pt went to hospital to check out . doctor states that it was an vaccine adverse reaction gave her fluids and medication which lowered reaction and felt good to go home