chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED BLOOD CLOT; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected blood clot. The reporter stated that his wife was in emergency room with their daughter who received Janssen Covid-19 vaccine a while ago and doctor suspected blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220555974- Covid-19 vaccine ad26.cov2.s - Suspected Blood clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient' concurrent conditions and medical history were not reported. On 05-MAR-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # J006236, expiration date: 25-FEB-2016) dose and route were not reported. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Pt recvd 1 dose of Engerix-B & a couple of days later devel a rash all over body; tx w/DPH;
Patient reported Anthrax was given by Bioject.  Injection site found to be tender to touch, raised and scabbed over.
Diarrhea started at 6:30, Vomiting started at 7:30.  Still vomiting today, May 20 at 11am.  Fever started 5/19.
(L) deltoid pain (shoulder) the day after injection. Never red/swollen, increased soreness w/o known injury. Exam showed pt. improved considerably, consistent w/syn/tendinitis.
Chest pain,loss of breath,dizziness,headache,tingling all over body.
Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe
Shortly after the shot my heart rate increased and I began to have sever itch. It started in the ARM were I received the shot and spread to my whole body. It stop only after taken antihistamines.
I had an anxiety attack, heaviness in my chest, tingling in forehead and lips, rapid heart beat. I had never had an anxiety attack and then gerd symptoms started and they put me on prilosec and I took one prilosec a day. After I was positive for H pylori he put me on 2 antibiotic and protonics. I'm still having anxiety and I have never had anxiety before. I also have a severe vit D deficiency. I'm on a prescription for Vit d for 8 weeks.
break her ankle; nausea; shaking chills; she fell and passed out; severe dizziness; did not feel her self as well for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she fell and passed out) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (she fell and passed out) (seriousness criterion medically significant), DIZZINESS (severe dizziness), MALAISE (did not feel her self as well for a couple of days), NAUSEA (nausea) and CHILLS (shaking chills). On an unknown date, the patient experienced ANKLE FRACTURE (break her ankle). On 04-Feb-2021, LOSS OF CONSCIOUSNESS (she fell and passed out) had resolved, DIZZINESS (severe dizziness) and NAUSEA (nausea) outcome was unknown. At the time of the report, MALAISE (did not feel her self as well for a couple of days), ANKLE FRACTURE (break her ankle) and CHILLS (shaking chills) outcome was unknown. Not Provided          No treatment information was provided. No relevant concomitant medications was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Red and swollen around area of right arm that the Flu and Pneumo shot were given. Swelling has not improved since getting shot about 72 hours ago.
Narrative: COVID infection after completion of COVID vaccine series 03/18 COVID vaccine dose #1 03/23 pt presented to ED with symptoms of chills, body aches, vomiting x 1, self-resolved without treatment 04/08 COVID vaccine dose  # 2 05/14 tested for COVID as part of pre-procedure screening, tested positive for  COVID remains asymptomatic
Vaccine was administered,  Guardian was given the VIS form, educated on side effects from vaccine, Ask patient id she had any reaction to first HPV Gardasil Vaccine, patient stated no reaction. Upon administering advise patient a little sting may occur,  and within  30 seconds of administration patient had a  Vasovagal Syncope  fall into my arms, put exam  chair at 45 degree angle and laid back. Check vitals and were fine. Went Straight to provider. Provider  Checked patient vitals laid a cool compress and patient was asked if she felt Nausea ( slightly) and patient looked to be pale. Encourage to stay in office for another 25 minutes until clear.
Dizzy, vomiting, itchy face, swollen lips: given Benadryl & transported to ER where received IV Normal Saline & Pepcid & Duonebulizer with excellent response.
bad arm pain; severe chills; This is a spontaneous report from a contactable consumer (patient). A 73-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscularly, administered in left arm on 19Mar2021 at 13:50 (at age of 73 years old, Lot Number: ER 8727) as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previous took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscularly, administered in left arm on 26Feb2021 at 13:50 (Lot Number: EN6202) as single dose for covid-19 immunization and experienced severe headache. The patient experienced bad arm pain and severe chills on 19Mar2021 at 18:00. The outcome of events was recovered on 20Mar2021.  No follow-up attempts are needed. No further information is expected.
My arm remained sore where the shot was given that day.  They told me it would for a while; that was normal.  Well now it's been 7 months and it's worse than ever.  There is even a red spot where the needle went in.  The pain radiates down my arm into my wrist and hand.  Hydrocodone does not relieve the pain.  I've told the doctor about it as well as my rheumatologist.  The doctor just made some kind of excuse I didn't understand but basically said I was stuck with the pain and my rheumatologist didn't say anything but neither one suggested I report it as a side effect.  I didn't know others had the same problem until I researched it on the internet.
cold/flu like symptoms; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (cold/flu like symptoms) in a male patient of an unknown age 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 INFLUENZA LIKE ILLNESS (cold/flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (cold/flu like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
This spontaneous report as received from a physician refers to a 12 month old patient of an unknown gender. On 12-JUN-2014, the patient was vaccinated with M-M-R II dose 1 (lot number: 0684AE, exp date 02-APR-2014)(dose and route were not reported) that expired on 02-APR-2014. No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recvd vax on 18AUG92 & the day following exp pain in lt arm;
Fever of 103.2 degrees, severe headaches, fatigue, and dizziness when standing that have lasted 36+ hours.
Redness, swelling, tenderness to touch.  Diagnosed 8 days post-injection by physician as infection at injection site.
pain on the side of the injection increase over the next 2 wks after the shot  to the point of needing assistant to put on a shirt. pain is not getting better, tender at touch, good range of motion just pain and discomfort.
Redness, itchiness, swelling and warmth of the upper arm one week after receiving vaccine
This spontaneous report was received from a consumer refers to herself as a 62 year old female patient. The patient had chickenpox as a child and administered vaccine. When she was seventeen, she contracted herpes (fever blister) on her lower lip. Since, she experienced one to three outbreaks each and every year for forty-one years, faithfully. She reported that never a year passed without at least one outbreak. On 16-SEP-2010 (administered when patient was approximately 58 years) the patient and her husband both personally paid for shingles vaccine. The patient reproted that it's been four years now and she have not had a single outbreak of her fever blister. She reported that not one during that time and she have had stress, sunshine, and perhaps a few low grade fevers. Yet she was happy that she have been symptom free ever since. The patient reported that she understood the herpes virus and the chickenpox virus are in the same family which most probably explains why she was no longer bothered by the blisters. Reported that perhaps that the older one gets the less likely it was that a fever blister will reoccur. Additional information has been requested.
A 71 year old, male patient (with a history of stent (corrected) heart disease, hypertension) was short of breath, had wheezing and coughing within 2 hours after he received Adacel (lot number C2538AA) intramuscularly in the left arm on 13 June 2007. He did not seek medical attention until 6 days later-the cough still persists. He was treated with an Advair inhaler for one week. At the time of the vaccination, he was on heart meds, Zocor and BP meds. At the time of the report, he had not recovered. Follow-up information received on 17 August 2007. The patient had a history of stent. He was diagnosed with an adverse reaction-dyspnoea secondary to Adacel vaccine. The duration of the events was 7-10 days and he is now completely recovered.
From 4/16/21 - 4/22/21 Severe Headache, body aches, severe,  random, sharp pains, chills, slight nausea  4/22/21  body rash -went to urgent care, received intravenous anti inflammatory and steroid  4/24/21  rash on body, ears, face, swelling of fingers  4/25/21 swollen lymph nodes on back of neck and skull Rash subsided Then recurred two more times
Day 1  (day of vaccination) - 6 hrs after injection extreme tenderness of left upper arm Day 2  chills, body aches, sore throat, headache, fatigue, sore injection site - sx lasted all day Day 3  sore injection site - no  other symptoms Day 4  after doing some housecleaning - in afternoon, chills, body aches, sore throat, headache, dizziness and fatigue. lasted 5 hrs (is this from vaccination or post covid episode?)
Fever/Chills, body aches, large red swollen area below the injection site.  Took two Ibuprofen for fever and body aches.
On 08/12/2005 Lt arm 18 1/2 cm (17 1/2 cm = Rt arm), erythema started yest. Warm-red- no pus- no fever, no streaking. Keflex 250.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Dec2022 as dose 3 (booster), single (Lot number: GJ6742) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Gout" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took Paxlovid (lot number: 00069-0345-30) from 13Jun2023 to 18Jun2023 for the treatment of COVID-19.
Experienced chills and arm pain 12 hours after the injection; Experienced chills and arm pain 12 hours after the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Experienced chills and arm pain 12 hours after the injection) and CHILLS (Experienced chills and arm pain 12 hours after the injection) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Experienced chills and arm pain 12 hours after the injection) and CHILLS (Experienced chills and arm pain 12 hours after the injection). In August 2021, PAIN IN EXTREMITY (Experienced chills and arm pain 12 hours after the injection) and CHILLS (Experienced chills and arm pain 12 hours after the injection) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-316020.
Pt recvd vax 23MAR92 no apparent fever until 1APR92 when pt had inc resp difficulties & fever; pt was treated w/APAP & decongestants until 3APR92 when ATB & inhalatin tx ordered pt expired a/recvd tx;
Upper right arm-shoulder to elbow-red and warm to touch. Slight swelling upper right arm also.
inflammation of the tonsils; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR HYPERTROPHY (inflammation of the tonsils) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced TONSILLAR HYPERTROPHY (inflammation of the tonsils). The patient was treated with LORATADINE at a dose of 1 dosage form. At the time of the report, TONSILLAR HYPERTROPHY (inflammation of the tonsils) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information, if any, was not provided by the reporter.
Patient expressed having anxiety to getting vaccines. A few minutes after administering the vaccine the patient reported feeling like he was going to faint. His vision got blurry and he stated that he couldn't see and that he was nauseous. He also said his hands were tingling. He sat in the pharmacy counseling room. He was given water and orange juice. After a few minutes he started to feel better. He called his mother to come and pick him up. He was in the store for about 40 minutes and his symptoms had resolved by the time he left.
Covid-19 J96.90 - Respiratory failure (CMS/HCC) N39.0 - Urinary tract infection A41.9 - Sepsis (CMS/HCC) U07.1, J12.82 - Pneumonia due to COVID-19 virus
Pt states she began to feel very fatigue and have some chest pain with back aches between the shoulders. these symptoms began later that same day.
it has calmed down considerably/the lichen planus has not flared up since/ it started clearing up and has improved ever since; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Mar2021 14:30 (Lot number: ER2613) at the age of 69 years as dose 1, single, intramuscular, administered in arm left, administration date 13Apr2021 13:30 (Lot number: EW0158) as dose 2, single and intramuscular, administered in arm right, administration date 23Nov2021 14:00 (Lot number: FH8028) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lichen Planus" (unspecified if ongoing); "Weakened immune system" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "recovering", described as "it has calmed down considerably/the lichen planus has not flared up since/ it started clearing up and has improved ever since". Relevant laboratory tests and procedures are available in the appropriate section. Additional information  The patient had no adverse reaction but wanted you to know for research that it has slowed  immune system down from turning on itself. The patient hope that in future this can help others with autoimmune disease, feel free to contact  for a better explanation.   No follow-up attempts are possible. No further information is expected.
31MAR 5PM diarrhea; 630PM vomited; has had cont diarreha for 7 days & cranky; spiked fever of 102.6 R on 1APR95; pt has been refusing baby foods since illness; 1APR-sleepy
Pt recvd vax 25SEP92 & exp aching pain in rt deltoid radiating to rt wrist became severe; pt devel atypical brachial neuritis p/initial inject & booster; atypical brachial neuritis;
I had the vaccine and still got shingles/suspected vaccination failure; Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-Jun-2022. Reporter's Comments: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. The patient had the vaccine and still got the shingles. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for herpes zoster were unknown. The follow up would not be possible as contact details were not provided.
Left arm tender when hit car door getting out of car - saw it was red, tender slightly warm to the touch. About 3 in wide - 2 days later Friday May 1st. Doctor thought was localized rx.
11/4/13 Given FLUZONE at 1400. 11/5/13 1400 noticed redness pain swelling to injection site.
At 4:30 I couldn't form words correctly. I took aspirin 81mg and I went to Urgent Care. I saw the doctor within 20-25 minutes but by then I was able to speak slowly and form words correctly. About 10 minutes later I could speak quickly and form words correctly. The doctor sent me to  ER where I had a Cardiogram, CT scan and a chest x-ray. I believe I also had blood work done there. Six hours later I left and went home. I saw my own doctor a couple days later. She had me wear a heart monitor for 24 hours and a doppler monitor. She had more blood work done and an MRI. She then changed my medicine from pravastatin 20 to pravastatin 40. She also had me take an 81mg aspirin every day. My test didn't show any problems. I haven't had any symptoms since.
pt recvd vax; devel blister like bumps on lower extremities; tx oatmeal baths & acetaminophen;
Presented to ED w c/o SOB; is on home O2 and reports having to increase O2; admitted for COVID-19 pna w/ acute resp failure; tx w/remdesivir, abx, steroids, zinc, O2; weaned to home baseline O2 prior to dc home
neuropathy( numbness, tingling, weakness) - that began in the upper extremities bilaterally the first week and now migrated to my lower extremities.  Hand tremor as well
Tachycardia, palpitation, itching, difficulty breathing, wheezing, felt like heart was going to stop.
Pt began having generalized muscle aches and pains the evening of injection. Temperature of 101 and felt lousy for 2 days.
Stopped mensural cycle.. I had Diarrhea the next day following  both vaccine administration, soft and pale stools ever since.
pt recvd vax & started crying on & off; high pitched cry; pt was very pale & was taken to MD;
Cellulitis in left leg (thigh). Seen in ER on 4/03/04 and 4/9/04. Admitted to hospital 4/9/04. Diagnosis MRSA. Cellulitis and septic arthritis of knee (left).