chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After about 6 hours, I felt weak and began having muscle aches all over. I developed a headache, had no appetite and felt feverish, but did not take my temperature. The nausea began around 10pm and lasted until the morning of 9/15/2022 (32 hours). Dry heaves and dizziness were experienced on 9/14/2022.   I felt bad for a day and a half, unable to sleep or eat.  I was surprised to have severe side effects after having no adverse effects from two Janssen shots in 2021 and the Pfizer booster in May 2022.
Patient presented to pharmacy 2 days after receiving vaccine. Entire back of patient's left arm was red. Around injection site there was a hard knot about 3-4 inches in diameter and the area was warm to the touch. On third day the swelling/redness/warmth was not much better. Patient went to an urgent care and was given a prescription for Keflex antibiotics due to possible infection.
Left arm red and sore area approx 10"x6", no broken area noted or no red streaking from area.
Diluted wrong amount of sodium chloride, (0.9mL intead of 2mL)
Information has been received from a Registered pharmacist concerning a female patient in her 50's, who "several years ago" was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (dose, and lot # unspecified). The pharmacist reported that after administration of a dose of ZOSTAVAX (Merck) (length of time unknown), the patient developed a "swollen arm which went back to normal in time". The patient did not seek for medical attention. Additional information has been requested.
Since 25 December she has complained of recurrent episodes of generalized hives which typically occur at sites where she is scraped, scratched, or exposed to pressure (such as the straps of her backpack or waistband of her pants). Lesions last less than 24 hours, spare palms and soles, and resolve without post-inflammatory changes. Episodes not associated with exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 14 December, 11 days prior to onset of her symptoms. She was seen in the ER on 26 December where she received oral H1 and H1 antihistamines and prednisone. She has used oral antihistamines with benefit. She reports a single episode of lip and mild throat swelling, but otherwise denies laryngeal, pulmonary, GI/GU, neurologic, and cardiovascular symptoms with these episodes. She denies fever/chills, night sweats, unexplained weight loss, and painful/swollen joints.
1-2 days after injection, have experienced constant and irresolvable stomach pain. Seems to lessen with antacids, but does not resolve.
I started Lialda 1.2 g tablets, 4 tabs daily on December 10. Around the 18th I had urgent diarrhea abdominal cramps weakness fatigue. Did not have diarrhea before I started it. I stopped it on the 20th once I realized and after talking to pharmacist and doctor. Symptoms improved after stopping it. I restarted the half dose on the 23rd to the 25th. The morning of the 25th I had a sore throat , neck and upper chest aching and increased pain with inhalation or with lying down. My last dose is the 25th. By the 26th afternoon I was feeling better and the 27th I was back to normal. My GI symptoms started around 2 months after the 2nd Moderna Vaccine. Colonoscopy on 10/21 showed mild inflammation of my colon.
17JUN pt had a fever & a few spots;that noc woke up screaming & w/a rash (red spots) on back & belly (no pussy centers);18JUN had a fever of 103.6, didn't eat good & was not self;was sleepy;rash was still there & now more on arms & legs;
Mom and child told and wrote incorrect date of birth. I had verified more than once patient was 11 years old.  After the vaccine, it was realized the wrong age and birthdate had been given.
Approximately 15 minutes after receiving dose of vaccine, employee states that she began to itch all over.  Eyelids and periorbital area began to swell.  She did not experience any shortness of breath or difficulty swallowing.
Covid vaccine monitoring documentation.  SARS-CoV-2 COVID-19 detected 5/4/21. Patient received dose 1 Pfizer vaccine Lot EN6200 on 2/25/21, dose 2 Pfizer vaccine received 3/18/21 Lot EN6207.
big area with some itchiness; swelling and redness which covers the injection site; swelling and redness which covers the injection site; chills; fever; headache; A spontaneous report was received from a consumer, a female patient, who received Moderna's COVID-19 Vaccine and experienced chills, fever, headache, swelling and redness which covers the injection site, and big area with some itchiness.  The patient's medical history was not provided. Relevant concomitant medications included simvastatin, amlodipine besilate, lisinopril, and hydrochlorothiazide.   On 04 Jan 2021, a day prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 intramuscularly for COVID-19 infection prophylaxis.   On 05 Jan 2021, the patient had chills, fever, and a headache.   On 06 Jan 2021, the patient had a side effect of swelling and redness which covers the injection site. She also stated that around the injection site there was a big area with some itchiness. Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, chills, fever, headache, swelling and redness which covers the injection site, and big area with some itchiness, was considered unknown.; Reporter'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.
When I withdrew the needle from the patient's arm, 2 drops of the vaccine came out of the administration site and rolled down the patient's arm.
On 3rd capsule feels weak & has a cramp like menstrul cramping; some nausea in the morning;
Varicella shot given in Rt. arm.  Dime size wheal produced right away at injection site - time 3:00.  Check by RN & Dr. by 3:05 pm.  by 3:15 wheal size quarter.  Given 6.25 mL Benadryl & Tylenol 3.25.  Check again at 3:25 wheal the same 3:30 released.  Wheal decrease in size.  Pt active & alert whole time.
12/14/22 presents to ED for "SOB". PMHx of "prostate cancer, status postradiation colonic tubular adenomas, and diverticulosis"
patient got flu; Initial information was received on 25-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer (Patient).  This case involves patient of unknown demographics who got flu (influenza),while patient received vaccine INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got non serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Day 10 post vaccine #2, about 6 hours of severe shaking chills.  No fever
Swollen lymph nodes in neck and left armpit. Itchiness at vaccination site.
Wheal on injection site (4cmx3cm), low grade fever, chills, nausea
Initial information was received 24 October 2014 from a healthcare professional. A 70 year old female patient was vaccinated intramuscularly on 17 October 2014 with a first dose of INFLUENZA HIGH DOSE, batch U5044BA, site not reported. The patient was not ill at the time of vaccination. It is unknown if the patient had any other vaccinations within 4 weeks of vaccination or was taking any concomitant medications. Pre-existing allergies were reported as "PCN Unknown". The patient called the reporter on 24 October 2014 to say that she had her flu shot on 17 October 2014 and on 18 October 2014 she developed a high temperature of 104, had shakiness and general malaise. She stayed in the hospital for three days and was diagnosed with viral illness vs shot reaction". Laboratory tests were unknown and treatments were not reported. No further details were available at the time of this report. The patient outcome is recovered on an unreported date. Documents held by sender: None.
Patient received dose from a vial kept more than 12hrs at room temperature post first puncture; Patient received dose from a vial kept more than 12hrs at room temperature post first puncture; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture) and EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 07-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture). At the time of the report, PRODUCT STORAGE ERROR (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture) and EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, the vial was initially stored in the refrigerator on 14-Apr-2022 On 06-May-2022 at around 09.30 am, the vial was first punctured. Pots punctured; the vial was stored at room temperature for 29 hours in temperature range (8 to 25 Degree Celsius = 46 to 77 Degree Fahrenheit). Later on, 07-May-2022, 4 doses were administered to the patient at 11:20 AM, 11:49 AM, 12:05 PM and 12:30 PM.  The vial did not undergo the temperature excursion.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2022: Live Follow-up information received includes patient demographics, and vaccine details were updated.
Ran fever 12-2-16 then on 12-3-16 shoulder pain and sick stomach thru 12-5-16. Now stomach is ok but shoulder is still hurting.  I have been using heat and taking nor out for pain.
This 46 year old woman was admitted with abdominal pain. CT abdomen showed inflammatory changes in sigmoid area.  Pelvic u/s showed mild fluid in pelvis but did not show significant pathology. Last colonoscopy did not show diverticula. She was seen by surgery and GI and has improved with iv antibiotics. She is eating well and will go home to complete antibiotics. She will follow up with pcp and GI. She was diagnosed with COVID 19 on admission but required no treatment and remained asymptomatic throughout admission.
pt recv vax 4DEC95 & pt exp polyneuritis & inj site soreness;f/u pt MD stated that pt did not have polyneuritis but only intense persistent pain @ inj site;22MAR96 pt exp worsening of pain @ inj site & limping;
A few weeks after getting the booster I noticed that I had pain in my left arm, there was a lump in that arm but I had ignored it. I had gone in to my OBGYN to get an immunization and I talked to them about it because I had noticed the lump prior to coming in and was concerned. The OBGYN told me to give it a few weeks and then to check back as I had a number of shots in the same arm in a short time frame. It was still bothering me and the lump was still there by January. I ended up seeing a dermatologist and got a sonogram and learned that I had a cyst in that arm. I ended up being treated with cortisone shots and and that did take care of the cyst.
Eye styes bilateral that are now reoccurring and I?ve never had a stye in my life prior to this event
This child received her immunizations at 11 AM on 02/14/01. By 1:30 PM, she had a fever of 101. It peaked at 103. The next morning she had a seizure. The mother took her to their family physician. She was admitted to the hospital and diagnosed with pneumonia. She was treated with IV antibiotics and discharged on 02/18/01. She had been seen on 02/12/01 at the ER for a dry cough. Discharged. Chest x-ray had been negative. The child is doing well at the present.
Lost consciousness approximately 36 hours after vaccine, uncontrollable vomiting, for 4 hours, Anaphylaxis reaction, swollen throat, face, lips.   When to emergency room.  Released after 3 hours. IV for nausea. Prescription for prednisone .
Mom called the office at 10:38 am on 11/4/09 - stating childs rt arm, subq area was red & w/streak going up arm. Warm to touch - measured 6x2 cm - cool packs - observe.
fatigue; injection site pain; muscle aches; head aches; Vertigo; dizziness; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the arm left on 30Mar2021 at 15:00(at the age of 34-year-old), as a single dose for COVID-19 immunisation. Medical history included sleep apnea. The patient received birth control, vitamins, cbd within two weeks of vaccination. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), as a single dose for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021 at 14:00, the patient experienced fatigue, injection site pain, muscle aches, headaches, vertigo and dizziness. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue, injection site pain, muscle aches, headaches, vertigo and dizziness was not resolved.   No follow-up attempts are needed. No further information is expected.
24 hours after administration of vaccine, she developed symptoms: chills, nausea, extreme dizziness; weakness rapid heart rate extremities flushed with burning sensation - like sunburn, nose red and swollen while face pale, client allergic to numerous antibiotics - PCN, vancomycin and many in that class. Did not recognize gentamicin or neomycin as other list of allergies.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of VARIVAX (Merck) (lot #, dose and route not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that on an unknown date, the patient developed a rash. No treatment information was reported. It was unknown if the patient sought medical attention. The outcome of rash was unknown. The relatedness for rash was not provided for VARIVAX (Merck). Additional information is not expected.
Pt reports pain & swelling under Rt arm near breast temp 102. 4/27 feels better now. Declines ov or further treatment will call if needed for follow up.
I had the COVID booster and had a negative reaction. I vomited for 2 days, was very nauseous, had a terrible migraine and my blood pressure was extremely elevated.
Myopercarditis. Chest pain began 12/15 night into morning of 12/16. Presented to ED on 12/18 and found to have elevated troponins.  Treated with colchicine and ibuprofen. Cardiology consulted.
tired; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received second dose of BNT162B2 (BNT162B2; Solution for injection; Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: unknown) on an unspecified date as first dose for covid-19 immunization. On an unspecified date, after vaccination the patient felt tired. It was reported that a female patient was unable to exercise the day following her second covid-19 vaccine dose because she was extremely tired. She indicted she felt better the next day. Reporter was not comfortable in a setting with 20 other people to ask for details (nor was it appropriate), so unsure that which brand she received. Many other attendees chimed in to give details of their friends /family members experience with covid-19 vaccine. They indicated that the second dose caused more AEs and that they felt it was worse if the person had been previously infected with the covid virus. None indicated the brand received. Reporter had no further details to provide. Outcome of the event was unknown.  Information on Lot/Batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
sick as a dog; flu like symptoms; aches; fever; chills; actual flu; Based on information previously received, the case assessed as non-case was reassessed as valid.  Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves patient (unknown demographics) who was sick as a dog (malaise), flu like symptoms (influenza like illness), aches (pain), fever (pyrexia), chills and actual flu (influenza), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick as a dog (malaise), flu like symptoms (influenza like illness), aches (pain), fever (pyrexia), chills and had the actual flu twice (influenza) (unknown latency, non-serious events) following the administration of INFLUENZA VACCINE.  The patient did not receive vaccine since 1989. It was gone after 24 hours. The patient had no medications and was not hospitalized  No laboratory data was provided  At the time of report (after 24 hours), the events recovered.  There will be no information available on lot number.
Within 1 hr of receiving H1N1 vaccination, developed few urticaria on mid-chest and c/o chest tightness. School nurse administered BENADRYL 50 mg PO, notified mother who took her to her pediatrician. Given Rx for oral BENADRYL, took one dose after initial dose given by school nurse. Mother states completely recovered by 11 PM same day. Mother stated pt has multiple antibiotic allergies, none listed on consent form and mother stated MD would have to be contacted to find out what they were. 12/31/09:  Primary care records received for date of service 12/16/09.    Presented with chest tightness and itchy rash, benadryl administered, sx. improving.  C/o feeling very tired.
This spontaneous report was received from a physician via a company representative and refers to a 18-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-SEP-2017, the patient was vaccinated with a first dose of GARDASIL 9 (route, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unknown date in 2017 (reported as after receiving the vaccination), the patient experienced a lump on an unspecified arm. The lump looked like "a mosquito bite" and the patient also was having "aching flu like symptoms". No treatment was given for the events and no laboratory diagnostics were performed. The patient did not seek medical attention. The outcome of the events was not recovered. The causality between the events and GARDASIL 9 was not reported.
received the adjuvanted diluent without it being reconstituted; received the adjuvanted diluent without it being reconstituted; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number MM59F, expiry date 14th October 2022) for prophylaxis.   On 1st April 2021, the patient received Shingrix. On 1st April 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows:  Medical assistant reported that the patient received only adjuvant part of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Pain in hand where vaccine was administered, unable to hold a pen.  Also experiencing dizzy spells.
The injection site was itchy, hot and red. Over the course of 30hrs, the symptoms subsided.
body aches, chills, elevated temp, sweating, headache, upset stomach, lethargy
Hallucinating; He was not feeling good; His vitals, is 97 over 133 and it keeps going up; His temp was 102.4; Felt weak; Headache; This is a spontaneous report from a contactable consumer (patient is the grandson).   A 14-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EW0153), via an unspecified route of administration, administered in left arm on 02Aug2021 in the afternoon (at the age of 14-years-old) as dose 2, single for COVID-19 immunisation. The patient preciously took first dose of bnt162b2 on 09Jul2021. The patient did not received any other vaccine within 4 weeks. Medical history included allergies. There were no concomitant medications.  On 03Aug2021 at about 01:00 the patient experienced hallucinating, he was not feeling good, his vitals were 97 over 133 and it kept going up, his temp was 102.4, he felt weak and he had headache. It was reported that patient got his Pfizer shot on 02Aug2021 afternoon and the morning of 03Aug2021 he told to reporter that he was not feeling good. So, they gave him the Tylenol 500 mg (treatment). The reporter went to check his vitals, was 97 over 133 and it kept going up and his temp was 102.4 and he was hallucinating and he got terrible headache and he felt weak. The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected
The day after her second dose the patient had a fever of 102.6, heart rate consistently over 115 beats per minute for several hours, headache, muscle and joint pain.  She called her primary care physician.  She was advised to watch fever.  She had a apple watch that showed her heart rate but was also able to let her know if she actually when into afib. The patient was symptom free on 1/31/2021
Gave a Moderna booster to a 16 year old.  No sign or symptoms.  Patient is doing  well
fainted a couple of  mins, regained consciousness but feeling light headed, nauseated reported a cold sweat. had diarrhea. was not still feeling well so 911 called and was taken to a hospital