chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash and bruised appearance around injection site, one week after vaccine was administered.  Experiencing tight muscles and soreness.
52 days post first shot and has not received the second shot yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (52 days post first shot and has not received the second shot yet) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (52 days post first shot and has not received the second shot yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (52 days post first shot and has not received the second shot yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant meds reported.  No treatment information provided.
chills, lack of appetite, tired    Took Tylenol   Lasted 3 days
past medical history of anxiety, brain mass, chronic mixed headache syndrome, and a VP shunt placed in 2005 presenting with moderate headache that began 4 days ago, with a gradual onset, that is currently persistent.  Patient also informed me that she received the Pfizer vaccine on 8/19/21 and she is since subsequently had drooping of the left eyelid, stuttering of her speech, but no slurred speech.  Patient also endorses left-sided weakness worse in the lower extremity when compared to upper extremity. Patient has also been having persistent chronic headache, in which she takes baclofen, Fioricet, lorazepam, Norco and tramadol for pain.  Patient has a history of a VP shunt and she denies any visual changes at this time.  The patient has had similar headaches in the past, however this 1 is unable to be controlled with her prescription medication.  Diagnosis/Assessment/Plan      1. Left-sided Bell's palsy     2. Headache  3. Nausea  4. Slurred speech  5. Left-sided weakness  6. Vaccine reaction
Covid arm; Hives all over chest and back; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE URTICARIA (Hives all over chest and back) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE URTICARIA (Hives all over chest and back). At the time of the report, VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE URTICARIA (Hives all over chest and back) outcome was unknown. Not Provided          No concomitant medication were reported. No Treatment information was provided .
Menstrual Cycle - Heavier periods; started and continue to spot a week before period.
Breakthrough case admission after 3 vaccines Moderan 5/21/21 Lot# 005C21A;  Moderna 6/18/21 Lot# 053C21A;  Moderna 12/15/21 Lot# 012H21B
tested positive for COVID 19 after she received both shots.; tested positive for COVID 19 after she received both shots.; This is a spontaneous report from a contactable consumer (patient's husband). A 45-years-old female patient received second dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810), via an unspecified route of administration, left shoulder on 08Feb2021 at 12:20 (at the age of 45 years) as single dose for covid-19 immunisation. The patient had no medical history and family history. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient historical vaccine included first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), via an unspecified route of administration, left shoulder on 18Jan2021 at 10:20 as single dose for covid-19 immunisation. On 20Apr2021, the patient was tested positive for Covid-19 after receiving both shots. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Elbow pain; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Elbow pain) and ARTHRALGIA (Joint Pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced ARTHRALGIA (Elbow pain) and ARTHRALGIA (Joint Pain). At the time of the report, ARTHRALGIA (Elbow pain) and ARTHRALGIA (Joint Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Pt recvd first Hepatitis B shot at 1 wk old. Within 1 month, his head circumference was noticeably larger. On 10/25/00, pt recvd polio, DPT, HIB and #2 Hepatitis B. Pt developed sessions of high pitched screaming. A full body rash developed. On 12/27/00, he received more polio, DPT and HIB vax. 1/3/01 CT scan showed blood on brain. 1/5/01 he had head surgery to relieve pressure and blood matter. Seizures followed. Doctors deny vaccine adverse event once again. Diagnosed with subdural hemetoma
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I was in the military for 8 years. In 2000, I was selected to deploy. This was my third deployment in my career. I was told that I would be given the Anthrax vaccine before and during my deployment. I began my injections and immediately we saw severe localized reactions around the injection site. My arm was inflamed, swollen and red as an apple. I received two injections state side and my third immediately after stepping off the plane. After my third injection, I began having problems. There were huge gaps in my memory. I couldn't remember anything from specific days that were only a couple days past. The skin on my fingers and hands began to separate like from a blister only there was no fluid involved. I could peel my fingers like a banana. This wasn't dry skin mind you; it was thick and moist and pliable. I developed lesions on my arms. I had heard stories of other solders when they went to the doctors office with concerns about the effects of the vaccine, so when I went I made no mention of the vaccine. I was given different diagnoses every time I went in. I was prescribed all sorts of creams, ointments, and antibiotics, none of which worked. My mom had started me on a strong regiment of herbs and vitamins to build and strengthen my immune system before I started the shots. I continued on these and it still took me over two years to recover. I still take these today over four years later. My wife says that I still have occasional memory losses.
Patient developed Shingles 3 days after my 2nd vaccine dose.  .; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old adult patient of unknown gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: En6205) via an unspecified route of administration in the right arm on 07Mar2021 (at the age of 52-years-old) at 11:45, as a single dose for COVID-19 immunisation. Medical history included hypertension and sleep apnea from an unknown date. Concomitant medications included patient received unknown medications within 2 weeks of vaccine. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not tested for COVID-19. Since the vaccination, patient had not tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: El9266) via an unspecified route of administration, on 14Feb2021(at the age of 52-years-old) at 11:45, as a single dose for COVID-19 immunisation. On 10Mar2021 at 07:00, the patient had shingles, patient never had chickenpox and wondering whether it was possible that the vaccine had contributed to the shingles. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of adverse events included OTC pain medications and hydrocortisone cream. The clinical outcome of the event shingles was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2015, the patient received a dose of M-M-R II (lot#, expiration date, dose and route of administration were not reported) that was inadvertently reconstituted with improperly stored sterile diluent (dose one, lot# reported as L016272, expiration date 24-FEB-2018, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received vaccination in my L shoulder.  One week later at injection sight a medium sized knot formed.  It was warm to touch, hard and painful to touch.    Called doctor to get in to see her and three days later after the knot formed it traveled to my forearm.   Received an ultrasound of forearm and confirmed it was a superficial bloodclot
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2 NOS), on 30Sep2022 at 15:00 as dose number unknown , single (Lot number: GTS5342) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: 01Dec2022, stop date: 28Mar2023. The following information was reported: COVID-19 (medically significant) with onset 28Mar2023, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 28Mar2023, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Felt good and tested negative; (28Mar2023) Positive, notes: COVID 19 symptoms and tested positive on  28Mar. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Had COVID 19 symptoms and tested positive on 28Mar2023; started taking Paxlovid on the same day. Finished Paxlovid in 5 days. Felt good and tested negative. But, four days later, symptoms came back, and tested positive again. The patient had no known allergy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148450 same patient, different drug/event;
Very sore arm within 12 hours of 2nd shot on Wednesday March 24th. Woke up the next day feeling "off" and irritated. By 9pm Thursday my entire body ached severely as if I had a very bad flu. By 11pm I had very severe cold & hot shakes and felt extremely nauseous until the next morning. I checked my temp every couple hours and never was I above 98.5 but, I felt extremely sick until about 48 hours after the 2nd shot. On Friday, and for the next 2-3 days, I felt fatigued as if I was recovering from the flu. Only a flu that was without fever or any respiratory issues.  By Monday I felt normal again.
cardiac arrest on 4/30 followed by medically-induced coma followed by bringing back to normal body temperature followed by recovery.  in ICU almost a week and heart hospital a week.  Nearly full recovery at this time.  Going to cardiac rehab and working to build strength/stamina.
Tiredness, lethargy, loss of appetite, sleepiness, jerking, staring, fever (102.1 oral around noon, 103.6 by 1:30 pm) with lowered consciousness and vomiting. First gave Tylenol then phoned on-call nurse who said it was just a coincidence and nothing to do with vaccine. Gave tepid sponge bath and Children's Motrin followed by popsicle.
I was diagnosed with AFIB in 2019.  Very rarely had episodes.  18 days  after 2nd shot, I had another AFIB episode.    March 2021 I had four episodes, April I had 4, May I had 1, June I had 0, July I had 2 episodes, Aug  I had 3 episodes, and extreme dizziness.  Went to the ER on Aug 10 with erratic heart rate and extreme dizziness; stayed for 3 days, they changed my meds, now doing much better.  Ill see an electrophysiologist in Oct 2021
hot, red, itchy, swollen area around the injection site.  Area at this time is larger than the diameter of a softball.  Pain in lymph nodes on right side armpit, collarbone, and neck.  Intermittent body/neck aches, headaches, fatigue, tightness in lungs, mild coughing.  Intermittent skin itching all over body.
Having respiratory issues; Fever for 2 days; Booster; received 3cc's of Booster Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administration date 20Sep2021 (Lot number: FC3184) at the age of 40 years as dose 3 (booster), 3 ml single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, administration date 2021. Vaccination history included: Bnt162b2 (Dose:1, Lot Number: EL1284, NDC and Expiry Date unknown), administration date: 23Dec2020, when the patient was 40 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, Lot Number:EL3246), administration date: 12Jan2021, when the patient was 40 years old, for COVID-19 Immunization, reaction(s): "Fever for 12 hours". The following information was reported: IMMUNISATION (non-serious) with onset 20Sep2021, outcome "unknown", described as "Booster"; OVERDOSE (non-serious) with onset 20Sep2021, outcome "unknown", described as "received 3cc's of Booster Vaccine"; PYREXIA (non-serious) with onset 21Sep2021, outcome "recovered" (23Sep2021), described as "Fever for 2 days"; RESPIRATORY DISORDER (non-serious) with onset Dec2021, outcome "not recovered", described as "Having respiratory issues". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) negative, notes: has tested negative for Covid 19 twice; (2021) negative, notes: has tested negative for Covid 19 twice. Additional information: No additional Vaccines Administered on Same Date of the Pfizer Suspect. Caller states that he had a Flu Vaccine a couple of weeks after the booster dose of the Covid 19 Vaccine  Follow-up attempts are completed. No further information is expected.
pain in arm; muscle pain at the site of injection; My arm still hurts/It hurts when I raise the arm to 90 degrees and if I extend it; Shoulder is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), JOINT SWELLING (Shoulder is swollen), VACCINATION SITE PAIN (muscle pain at the site of injection) and MYALGIA (My arm still hurts/It hurts when I raise the arm to 90 degrees and if I extend it) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced JOINT SWELLING (Shoulder is swollen) and MYALGIA (My arm still hurts/It hurts when I raise the arm to 90 degrees and if I extend it). On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (muscle pain at the site of injection). On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in arm), JOINT SWELLING (Shoulder is swollen) and MYALGIA (My arm still hurts/It hurts when I raise the arm to 90 degrees and if I extend it) outcome was unknown and VACCINATION SITE PAIN (muscle pain at the site of injection) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included Ibuprofen and naproxen . Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: treatment medication was updated
Sore arm; Dizziness, ran into a wall; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 4993L) for prophylaxis.   In NOV-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Sore arm) and dizziness (Verbatim: Dizziness, ran into a wall). The outcome of the pain in arm was unknown and the outcome of the dizziness was resolved (duration 3 hrs).   It was unknown if the reporter considered the pain in arm and dizziness to be related to Shingrix.     It was unknown if the company considered the pain in arm and dizziness to be related to Shingrix.   Additional Information: GSK receipt date: 12-APR-2023 The pharmacist reported that a coworker (patient) took the first dose of Shingrix and developed dizziness about 15 to 16 hours after receiving it.  She was able to get up but ran into a wall.  She was also able to take a shower and went to work that lasted about 3 hours.  The dizziness was not debilitating. The vaccine administration facility was the same as primary reporter. The expiry date of the vaccine was not available.  The reporter consented to follow up by postal. The present case US2023053375 was found to be duplicate of the case US2023053376. All the future information corresponding to the US2023053376 (case of deletion) to be submitted in the case of the record (US2023053375).
Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Rheumatoid arthritis.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 21-Feb-2021, PAIN IN EXTREMITY (Pain in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Tachycardia, fever, malaise, progressed to dyspnea, hypoxia, AMS, myocarditis with confirmed EKG changes, elevated troponins, CRP and BNP also developed superimposed PNA.
pt recvd vax;lt leg started redness & swelling w/in 1/2 hr; cried off & on 10:30am-9PM then unconsolable cry from 9pm-12am;slept after all noc;t 101 ax w/ apap; no problems next day;
Developed a migraine within 5 minutes after the injection, the migraine has not subsided since the injection.
Face is red with rash, puffy,  burning, and itchy. Itchy at site of injection and arm pain.
I have been suffering from dizziness and vertigo since two hours after my first dose on 1/31/21. It continues now for 13 weeks.
Malaise, chills, localized injection site pain 12-30 hours post injection thought to be normal side effect of Covid Booster.  Appearance of NEW Lipshutz type vulvular lesion 3 days post Pfizer Covid Booster.  We did not link Covid Booster with initial appearance of Lipshutz ulcer until recently re-visiting history as subsequent Lipshutz pharyngeal and vulvular ulcers appeared again on April 29.
syncope; This spontaneous report as received from a nurse prescriber via a company representative, concerning a 14 year old female patient. There was no information about the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  In approximately 2016 (reported as "about 6 years ago"), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided). In approximately 2016 (reported as "about 6 years ago"), the patient experienced an episode of syncope after quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) vaccination. The patient was seated in chair after syncopal episode and recovered on the same day. Parents of patient opted out of subsequent doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). The outcome of syncope was reported as resolved. The reporter did not provide any causality assessment.     Upon internal review, the event syncope was determined to be a medically significant event.
Received Pfizer vaccines on  8/6, 8/27/21 COVID-19 positive by PCR on  1/3/22 admitted to hospital 1/10-1/11/22 for evaluation of Right adnexal lesion and not due to COVID. Did receive remdesivir.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 03Sep2023 to 07Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2, bnt162b2 omi ba.4-5 in this patient cannot be completely excluded
Presented with chills and headache and general feeling of Blah a few hours after receiving shot.   Went to bed with these symptoms.  Awoke following morning feeling ok.
Subsequent to vax, this pt developed a fever of 101.8. Additionally, she experienced chills, myaliga, neck pain and hot induration at the injection site. Swelling occurred form the site to the elbow.
1/1/21 sore throat lung pain in back . F/U with Dr antibiotic Amoxicillin Strep diagnosis, swollen pressure in lungs, antibiotic  has provided some relief to lungs but pain continues, feels lungs are fatigue and worked. 20 days swollen throat has continued, and small  rashes with no itch come and go on eyelid, chin, shoulder.