chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm sore; Hurt so bad to move his neck; Behind his left ear to his left shoulder is so painful and feels knots; Behind his left ear to his left shoulder is so painful and feels knots; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm sore), NECK PAIN (Hurt so bad to move his neck), SOFT TISSUE MASS (Behind his left ear to his left shoulder is so painful and feels knots) and ARTHRALGIA (Behind his left ear to his left shoulder is so painful and feels knots) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and U25A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Left arm sore), NECK PAIN (Hurt so bad to move his neck), SOFT TISSUE MASS (Behind his left ear to his left shoulder is so painful and feels knots) and ARTHRALGIA (Behind his left ear to his left shoulder is so painful and feels knots). At the time of the report, VACCINATION SITE PAIN (Left arm sore), NECK PAIN (Hurt so bad to move his neck), SOFT TISSUE MASS (Behind his left ear to his left shoulder is so painful and feels knots) and ARTHRALGIA (Behind his left ear to his left shoulder is so painful and feels knots) had resolved.            Concomitant medication information not provided.  Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up report received on 05 Aug 2021, Updated outcome for the events .
Nausea 14 minutes after first vaccine. Brief loss of consciousness. Given crackers, water. Uses CPAP.
No additional AE; improperly stored temperature excursion vaccine administered; This spontaneous has been received from a medical assistant, concerning a 11 years old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not reported.  On 14-JUL-2021, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T026324 has been verified to be valid, expiration date reported as 22-FEB-2023; strength, dose and route was not provided) for prophylaxis. The temperature of excursion was 19.7 Celsius degree for 7 hours. No previous temperature excursion or digital logger 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: T026324; expirationdate: 22-FEB-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Vaccine admin. and within seconds had what appeared, at the time, to be a seizure, with jerking, garbled speech, eye rolled back. Did recover in seconds but could not stabilize BP - squad called and transported without further incidence. Later dx as syncope.
Site: Pain at Injection Site-Medium, Additional Details: patient says still pain in arm of injection
About 10 minutes after vaccination she experienced chest pain. This lasted for several minutes and then subsided, but she was transported to the ED for evaluation.
GI upset, diarrhea, migraine, body aches, injection site red and swollen for two days.
Severe chills, fever of 101, nausea/vomiting, extreme thirst, headache, body aches (joint pain), Injection site pain/swelling/redness, fatigue. These symptoms started with sever chills about 12 hours after the vaccine dose. It was like being hit by a freight train. With ibuprofen I was able to reduce the fever for a short time, but  the side effects continued for 2 days (until 3/20/2021 7pmish). the injection site pain/swelling/redness continued for another 2 days (until 3/22/2021).
Anaphylaxis following the 15 minute wait period. Patient states that it occurred shortly after arriving home from the store. Self-treated with an Epipen,  States that as of now (10/18/21), she is still experiencing mild shortness of breath and malaise. Told her to go see her physician for further check up on her symptoms.
Painful R arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Painful R arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No medical history was reported by the reporter.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Painful R arm). At the time of the report, PAIN IN EXTREMITY (Painful R arm) had 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 treatment and concomitant medications were reported.
About 24 hours laterI had a red welt about the size is a half dollar mild swelling. That evening, Friday, I felt achy, very tired. This continues through it the whole day on Saturday. The red area grew to about 3 times the size of what it was on Friday. I was still very tired. I was on the couch resting for about 1.5 days. Felt a little better on Sunday, arm looks the same.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug allergies were not reported. The pharmacist reported that physician's are writing a lots of prescriptions for less than 50 years of age clients to be vaccinated with ZOSTAVAX (dosing details were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of the two reports from the same reporter. Additional information has been requested.
Red, swollen and very itchy. The swelling was about 5 inches in diameter.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided. On an unspecified date, the patient received the third dose of GARDASIL 9 two years after the administration of the second dose of GARDASIL 9(strength, dose detail, lot # and expiration date were not reported) intramuscularly for prophylaxis(inappropriate schedule of product administration). No adverse effects was reported. The causality of the event was not provided.
Patient is a previously healthy male who presents with acute onset of chest pain in the setting of 2nd dose of COVID-19 vaccine. Patient received second dose of COVID vaccine on 08/19 and per father he was asymptomatic until the following morning when patient had of fever of 100.4F taken on the forehead. The night prior to presenting to the ED father states patient started with chest pain. Patient describes pain as sharp/achy, 5-6 out of 10 in intensity, and constant. Patient denies any radiation, shortness of breath, or palpitations. Also denies URI symptoms, coughing or trauma to the affected area. Patient does not participate in any sports. He also denies burning sensation or worsening with intake of food. Patient and father state that there is nothing that makes pain worse or better.  This is first time patient has had a pain like this.  No interventions were given at home for symptoms. Reason for ED visit as the acute onset after COVID-19 vaccine and father wanted to make sure that it was not an adverse effect.  Patient has no history suggestive of life threatening conditions and physical exam was normal. Given the non specific nature of the chest pain, well appearing patient, and normal diagnostic studies patient was given motrin for the pain and was discharged home with anticipatory guidance.  Patient was followed by cardiology outpatient.
Shortly after I got the vaccine, I developed severe local pain and local heat.  Over the ensuing 24 hrs, I developed severe pain, swelling and a red rash from my shoulder down to my elbow.  I was prescribed a medrol and doxycycline; my symptoms began to improve a day later.
Fever to 103F, jittery, persistent crying, irritable, poor feeds with 8 oz, weight loss over 2 days.
Irregular menstrual cycle (period more than 2 weeks early and lasted for 10 days). Then had another period 3 weeks later (again early) and lasting 7 days.
Patient received 2nd dose of Pfizer COVID-19 vaccine on 4/1/2021. Vaccine given 0848. Patient complianed of red arm and chest tightness. She was evaluated and given Pepcid 20 mg x1 and Benadryl 25 mg po x1. She was observed for 30 min.
Extreme redness, large area, hard, hot, itchy, pins and needles feeling on site. Still have a distinct mark.
Uncontrollable itch that started on feet, when itching, red/pink welts form and hives. Joint pain the following day in elbows. Extremely pain in feet for 2 days following. Itch has continued, diagnosed by a dermatologist as dermatographia.
Arm felt sore at the injection site (very sore) and it went away within a day. Mostly headache and fatigue, that was the worse of it. Almost like flu symptoms, but mild, like scratchy throat, a little bit of body aches, I noticed it at night, not so much during day time
requested medical records twice; still haven't received them; per death certificate, pt died at Hospital with the causes of death being:  ARF and COVID; pt had a positive COVID test on 9/11/21
Telephone call from mom she stated 4 hours after immunization pt started to get super hives all over body, that got worse through out day, no fever, skin hot to touch, decreased appetite. Treated only with warm bath, ice, continued through night but in am almost all gone.
NO SIGNS AND SYMPTOMS OBSERVED DURING THE 15 MINUTES OBSERVATION  PERIOD.   IN ORDER TO REDUCE  REOCCURRENCE OF THIS TYPE OF INCIDENCE, WE PLAN TO EDUCATE OUR STAFF ON THE STRONG PATIENT IDENTIFIERS ( I.E, NAME, DOB, AND CORRECT AGE OF PATIENT). THEREBY, REINFORCING THE CORRECT VACCINE ADMINISTRATION.
?Moderna COVID?19 Vaccine EUA?  Swollen lymph node of left underarm Earache of left ear Chills Fatigue Joint pain
fever & unable stand/walk x 4days; 8SEP to 12SEP95
Chest pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
After ZOSTAVAX vaccination pt developed a red spot about 1" by 1 1/2" red, hot slight rash. Benadryl 25 1 q4-6h and Hc 1% cream QID.
9:45am dizziness 9:55am voiced that she was feeling better and left site. B/P 122/68, HR 72, O2Sat 98%, BS 86.
This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB lot # L014878 with expiry date on 17-Jan-2018, (strength, dose, route and anatomical location were not reported). No product quality complaint was involved and no adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of tremor in a 71-year-old female patient who received SHINGRIX. Concurrent medical conditions included glaucoma, osteoporosis and heart rate decreased (slow heartbeat). Concomitant products included RESTASIS, carvedilol, KADIAN, LIPITOR, PROLIA, omeprazole, SINGULAIR; LASTACAFT, MOBIC, RANEXA and TRAVATAN Z. On 18th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced feeling bad. On 18th April 2018, the patient experienced tremor, feeling queasy, headache and tiredness. On 19th April 2018, the patient experienced pain in arm, fever and swelling arm. The patient was treated with TYLENOL. In April 2018, the outcome of the tremor, feeling queasy, pain in arm, fever, swelling arm, headache and tiredness were recovered/resolved. On 23rd April 2018, the outcome of the feeling bad was recovered/resolved. The reporter considered the tremor, feeling queasy, pain in arm, fever, swelling arm, headache and tiredness to be related to SHINGRIX. It was unknown if the reporter considered the feeling bad to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient herself. The patient received SHINGRIX on the right arm. An hour after receiving SHINGRIX, the patient experienced shaking, headache, felt queasy and tired. The next day after receiving SHINGRIX, the patient had a fever (body temperature 99.9 degree F), and noted her arm was swollen and sore. She felt bad until 23rd April 2018, Monday and that all events were resolved. The patient considered to call an ambulance, but did not do so. The patient was unable to provide the lot number or expiry date or the name of the pharmacist who administered the SHINGRIX vaccine.
Hospitalized with positive COVID test. Patient had shoulder revision surgery. Tested positive after the surgery. No symptoms of COVID.
2 Varicella given by error. 1 MMR w/ Varicella and 1 Varicella. on the same day. Pt. was checked on the next day by nurse and there were no adverse events at this time. Also, reporter to Dr. and he had no cause for concerns.
flares; flares; This is a spontaneous report from a contactable other hcp and a contactable consumer (patient). A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date (at the age of 41-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had blood draws every few months. The patient previously took unspecified drug (DRUG, UNSPECIFIED) and experienced adverse event of leukopenia. Patient advised to back off dose to once daily or every other day. Patient also reported COVID vaccine caused flares on an unspecified date. Clinical outcome of event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events (Leukopenia, Condition aggravated) and the BNT162B2 cannot be excluded.  "The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate."
Hives appeared last night. Per mom "the rash is in various sized clusters all over her body. In the picture you can kind of see it on her stomach too. The was a cluster under her band aid on her left leg (not sure if it relates to which vaccine she got there). She had clusters on both arms and legs, abdomen, back, neck and face."
This spontaneous report was received from a female patient of unknown age with no drug reactions or allergies. The patient's medical history included pneumonia. In the end of November 2009, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot not reported). No other co-suspects were reported. Concomitant medications included H1N1 and influenza virus vaccine (unspecified). "90" later from the date of vaccination the patient developed searing pain in her back. The patient explained that she never developed a rash or skin lesion, however she was told by her neurologist that the pain was caused as a reaction to ZOSTAVAX. The patient was treated with a dermal patch. At the time of the report, the patient had not recovered from the event; her back pain was spreading. There were no laboratories performed. The relationship between the event and ZOSTAVAX was reported as related by the reporter. Additional information has been requested.
Starting today, my upper arm became hot, red, and itchy.  There also feels like there is a hard bump around the injection site
Patient reports dizzy, "sensation in chest", blurry vision, and "feeling drunk"  and short of breath occasionally about 20 mins after vaccine.  blood glucose level checked -315, patient adjusted own insulin pump.  Felt better at 1:06pm.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The patient's past medical history included Heart disease, unspecified. Concurrent medical conditions included Diabetes. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were provided No Treatment information provided; 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.
raised, red, hot area sl larger than band-aid was noticed by mom, who brought pt in to see MD on 2MAY96;
Information has been received from physician concerning a 17 year old female with no other pertinent medical history reported and no known allergies or adverse drug reactions reported. On 9/26/06 the pt was vaccainted with HPV vaccine (lot 653735/0688F). There were no concomitant medications reported. Subsequently, the pt passed out after receiving the vaccine. The pt sought unspecified medical attention. On 9/26/06, the pt had recovered from the event. Additional information has been requested.
About 2 minutes after vaccination, patient started feeling unwell and was given alcohol to smell. About 5 minutes after vaccination, patient fainted for about 40 seconds. She did not have any other symptoms during or after fainting. 911 was called and they took her to the hospital.
Redness; Itchiness; Rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (Itchiness) and RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) 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 ERYTHEMA (Redness), PRURITUS (Itchiness) and RASH (Rash). At the time of the report, ERYTHEMA (Redness), PRURITUS (Itchiness) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported  No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Reporter details updated, patient details updated
This case involves a patient (Unknown demographics) who had flu (influenza) after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "No thanks every time I get the shot I get the flu Haven't had the shot in 4 years and haven't had the flu." It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, outcome of the event was unknown. The reporter did not report the causality of event with suspect. There will be no information available on the batch number for this case.
Wheezing, hives, itchiness at injection site, shortness of breath 26 minutes post injection.  Treated with Epi 1:1000 0.3 ml SQ,  Prednisone tablet 50 mg,, Diphenhydramine HCl 50 mg.
Exacerbate his symptoms from his back surgery; Back pain; Leg Spasms; Increased back spasms; Achiness; Dizziness; Chills; Nausea; Headache; Fever of 99.2 F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Exacerbate his symptoms from his back surgery), BACK PAIN (Back pain), MUSCLE SPASMS (Leg Spasms), MUSCLE SPASMS (Increased back spasms) and PAIN (Achiness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020 and Spinal stenosis (Multiple surgeries conducted NOS). Concomitant products included GABAPENTIN and MELOXICAM for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION COMPLICATION (Exacerbate his symptoms from his back surgery), BACK PAIN (Back pain), MUSCLE SPASMS (Leg Spasms), MUSCLE SPASMS (Increased back spasms), PAIN (Achiness), DIZZINESS (Dizziness), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever of 99.2 F). At the time of the report, VACCINATION COMPLICATION (Exacerbate his symptoms from his back surgery), BACK PAIN (Back pain), MUSCLE SPASMS (Leg Spasms), MUSCLE SPASMS (Increased back spasms), PAIN (Achiness), DIZZINESS (Dizziness), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever of 99.2 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Body temperature: 99.2 (Inconclusive) 99.2. In November 2020, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.