chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports vomiting and fever on 02/12/2020 at school. Arrived at ER at 4:30pm on 02/12/2020 with c/o vomiting, fever, carpopedal spasms, feet and facial tingling. Patient was able to move all 4 extremities and neuro was intact. Patient was given Lorazepam injection, and diphenhydramine injection while in ER along with ibuprofen. Patient condition improved and patient was discharged from ER at 7:30pm on 02/12/2020 with medication of Naproxen 500 MG twice daily for 10 days for pain. Patient seen in PCP office for follow up on 02/14/2020, patient reports minor pain in left carpal but otherwise no pain or tingling in extremeties or face. Patient is advised to continue Naproxen for 5-7 days. Patient understands and agrees to plan and will follow up with PCP in 2 weeks.
pt fell asleep p/vax upon awakening had a sick sounding cry & did not have control of facial muscles, face was drooping & could not smile, & was not as alert as usual;this lasted for about 20min probably a sz;
Intense shoulder and bicep pain near injection sight. First happened for first 3 days after shot. Than again for 3 more days around day 10. Then again around day 16. Tried ice and Tylenol, doesn't help
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 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Nov2022 as dose number unknown (booster), single (Lot number: GH9697) at the age of 42 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Nov2021 as dose number unknown, single (Lot number: FF2590), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing), notes: other medical history: Hypercholesterolemia; "chronic acid reflux" (unspecified if ongoing), notes: other medical history: chronic acid reflux. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2010; PANTOPRAZOLE, start date: 01Jan2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No known allergies.
On March 27, 2021 I woke up in the morning with a red and itchy circle at the injection site.  I took an antihistamine which helped with the itch.  By April 1, 2021 the area was back to normal. The red circle was about 2 inches in diameter.
headache nausea   all muscles in body ache  dizzy  symptoms still present on 4th day after shot  equally severe
Patient contacted the pharmacy stating that he received the vaccine from us and he informed us of a cough but with no fever or other symptoms.  The same day the patient had headache, diarrhea, and fever, and eye pain.  The cough also worsen and did not go away.  He was then treated in the hospital with IV fluids and medication.  He spent many days without food and was very weak.
States she has GARDASIL (1) dose  & 2 days later she had HPV.  Her period came early & heavy & lasted 7 days she then stopped & 2 wks later had a regular cycle.  She feels it was due to both shots so close.
23OCT96 1st ER visit w/ c/o lt arm pain, lt arm tingling, pain on flexion pulling/lifting dec grip strength;f/u visits x 3 w/hand specialist (NOV,DEC,JAN) requiring rest & advil;
heart muscle felt excruciatingly hot followed by pain and inflammation and nausea the first day. nausea persisted for 3 days. heart still hurts and some shortness of breath periodically since then
Syringe failure occured when the dose was injected. Needle was injected into the patient's arm and when the plunger was pushed, the vaccine leaked from the barrel of the syringe and the patient did not receive the dose. Patient was re-vaccinated with another dose in a different syringe with no incident.
About 14 hours after injection I awoke suddenly with severe joint pain in both knees, (8 on pain scale of 1-10) muscle aches in quadriceps and calves, as well as chills. Had a fever of 101 degrees.  As the hours passed, the joint pain spread to both hips  and ankles. Alternated Motrin and Tylenol with fever reduced to 100 degrees. All muscle aches, joint pain and chills continued for the next 2 days. Finally by day 3 the fever was down to 99.  Experienced fatigue, followed by severe vertigo by day 3.  Although muscle aches and joint pain slowly decreased over time, the vertigo has persisted and at times is accompanied by nausea and vomiting.
hot freakish burning feeling" headache, " spine felt like lava headache,  fever taking Migraine medication
Passed out at home 3 times. Heart racing. Severe leg weakness. Leg gives out after walking for a fe minutes.
TIA- mini stroke; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 12:00 PM (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included lisinopril. On 27Feb2021 14:00, the patient experienced TIA- mini stroke. The AE resulted in Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on 27Feb2021.  Therapeutic measures were taken as a result of tia- mini stroke. The outcome of the event was recovered.
Severely sore should/arm.  Extreme fatigue and hot sweats at second day.  No side effects at day two of vaccination.
Pt stated that she got a low grade fever the night that she received the vaccine, but the swelling and redness didn't start until the morning after. She has been taking TYLENOL and put ice on the redness and swelling area. Now fever is gone, but she still has a lot of redness and a little swelling. Advise pt to check with MD.
On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ERYTHEMA (Red hot), FEELING HOT (Red hot) and SWELLING (Swollen like a bee sting). At the time of the report, ERYTHEMA (Red hot), FEELING HOT (Red hot) and SWELLING (Swollen like a bee sting) outcome was unknown. Not Provided      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 assessment.  Treatment information was not provided.
Six hours s/p injections developed fever, rash up right arm, right side of neck and face. Also developed sore throat in 24 hours. Temp = 102. Rash responded to Benadryl except for local injection sites. Is having RLQ pain but that started before injections. Generally feels fatigued as well. No rash on left arm.
Chronic headache. Tension, pressure in back of head and scalp. 24/7 head tension for 23 days and on going. Occasional lightheaded symptoms and dizziness. OTC medication has minimal effect.
Nausea, body aches, hot + chills.  Fever of 101.3, which continued for a couple days and then went to low grade fever for several more days.  Tingling and shaking in hands and feet.  Body aches, headache.  Swollen lymph nodes, especially in quadrant where I had the shot. Most of these effects passed after one week, but some lingered for two weeks.
75 y/o gentleman who is also a diabetic who received a PCV injection at the site of interest, right deltoid 3 days ago. He reports within 12 hrs. feeling pain, swelling.
Employee had Tdap on 6/25/11 at 9 AM, by Sunday night her arm at injection site was red, swollen & hard. Monday 6/28/11 she work in ER one of the PA look at her & diagnosis cellulitis & place her on KEFLEX. Her arm at that time was red, not swollen on hand & redness was below injection site by 2 inch. Today talk with her much improved, almost gone.
itchy sensation near injection site; Injection site rash; swelling (hardness) near injection site; Painful arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), VACCINATION SITE PRURITUS (itchy sensation near injection site), VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE SWELLING (swelling (hardness) near injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Painful arm). On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy sensation near injection site), VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE SWELLING (swelling (hardness) near injection site). The patient was treated with CORTISONE at a dose of 1 dosage form. On 31-Jan-2021, PAIN IN EXTREMITY (Painful arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchy sensation near injection site), VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE SWELLING (swelling (hardness) near injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
received 2 doses of Gardasil 9 and never returned for third dose of Gardasil 9/unable to determine dosing schedule of Gardasil 9 doses which were received; No adverse effects; This spontaneous report was received from a healthcare worker via field employee and refers to a male patient of unknown age (reported as in teenage years). There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or past medical history provided.  On unspecified dates, the patient received two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, routes of administration, anatomical location, lot# and expiration dates were not provided) for prophylaxis and never returned for third dose. It was unable to determine dosing schedule of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) doses which were received. No adverse effects were reported.
Fever ranging from 101-104 F began on 6/28/22 and is still occurring as of today (6/30/22) Also accompanied with headache, nausea and pain when swallowing
No additional adverse events; Inappropriate schedule of vaccine administered; This spontaneous report has been received from a pharmacist, referring to a 17-years-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies was not reported.  On an unknown date in 2015 (also reported as "at 11 years old"),  the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, formulation, lot number and expiration date were not reported) for prophylaxis.     On 11-SEP-2021, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, formulation, lot number and expiration date were not reported), this dose was out of the permitted vaccination's scheme timeframe (inappropriate schedule of product administration). No additional adverse event was reported.
Shot given 10/14/10 on 10/22/10 chest and head congested shot area sore & still sore. Nausea, fever, chills, sweats, aching all over. Went to urgent care ctr on Sunday 10/24/10.
Developed a red spot below injection site about 24 hours after the first dose. Did not itch, was slightly painful to touch (almost felt like a bruise). Faded over the next 7 days and on Day 8 post-injection had large hives in same area (about 2-3 inches below injection site). Was itchy and lasted about a week. As of 2.5 weeks after injection it is now resolved (just slight skin discoloration).
Acute gout on right foot, 4th toe.; The gout was accompaniedby tophi.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 10:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 10:00 (at the age of 64-years-old) 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, two days after the second vaccine, the patient developed acute gout on right foot, 4th toe. It lasted for 2 weeks. The doctor took off indomethacin, which had not helped and put the patient on prednisone, which seemed to be helping. The gout was accompanied by tophi. At the time of report, the patient felt like the gout was moving to big toe on the same foot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of adverse events and included treatment with indomethacin, prednisone and cephalexin. The clinical outcome of the events acute gout on right foot and gout accompanied by tophi were not resolved at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
She became ill after the second injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "She became ill after the second injection". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a patient and describes the occurrence of FALL (Elbow abrasion with bleeding suffered after fell while standing on boat), SKIN ABRASION (Elbow abrasion with bleeding suffered after fell while standing on boat), SKIN HAEMORRHAGE (Elbow abrasion with bleeding suffered after fell while standing on boat), MALAISE (fever with malaise) and PYREXIA (Fever with malaise) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphoid leukemia. Concurrent medical conditions included Chronic lymphoid leukemia. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. In May 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. In 2022, the patient experienced MALAISE (fever with malaise) and PYREXIA (Fever with malaise). On an unknown date, the patient experienced FALL (Elbow abrasion with bleeding suffered after fell while standing on boat), SKIN ABRASION (Elbow abrasion with bleeding suffered after fell while standing on boat) and SKIN HAEMORRHAGE (Elbow abrasion with bleeding suffered after fell while standing on boat). In 2022, MALAISE (fever with malaise) and PYREXIA (Fever with malaise) had resolved. At the time of the report, FALL (Elbow abrasion with bleeding suffered after fell while standing on boat) outcome was unknown, SKIN ABRASION (Elbow abrasion with bleeding suffered after fell while standing on boat) was resolving and SKIN HAEMORRHAGE (Elbow abrasion with bleeding suffered after fell while standing on boat) had resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medication was not provided by the reporter.
Cervical dysplasia and malignancy after HPV vaccination; This literature marketed report has been received from the authors of a published literature article and refers to female patient of unknown age.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) (route and site of administration, lot # and expiration date were not reported) as prophylaxis. She received at least 2 doses of the vaccine.  On an unknown date, between 2007- 2017, after immunization, the patient was treated for cervical dysplasia or invasive carcinoma (vaccination failure). At the time of the last follow-up, she had recurrence carcinoma treated with pelvic exenteration. The outcome of vaccination failure was not reported.  The authors considered vaccination failure to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown).      This is one of two reports derived from the same literature article (cross referenced with US-009507513-1910USA009632); Sender's Comments:  US-009507513-1910USA009632:
pt states she started feeling very bad and everything hurt the day after getting the vax.  She has a lot of hair loss.  She had to stay in the bed for the next couple of days because she had fatigue and body aches.   5 weeks after taking the vax she has swollen lymph nodes in both arm pits and he developed sore knots under the skin on the outside of her thighs.  Her BP has become uncontrollable.  She was on 10mg of bp medicine and then it was upped to 20 mg.  About 7 days ago a diuretic and her BP is still very high.  on 3/20/2021 it was 180/89.   she checked it again a couple of hours later and it was 165/92.  She has had symptoms of GERD since 3/22/2021.  Blood work she had on 3/18/21 shows way too much carbon monoxide in her CO2.  Her anxiety has increased since she was vaccinated.   She has an appt w/ her PCP on 4/9/21.  She is very concerned that she is going to die from taking this vax.
This spontaneous report as received from a Licensed Practical Nurse refers to a 15 year old female patient. Not current conditions and medical history were provided. On 10-MAY-2011 the patient was vaccinated with one dose of CERVARIX, (dose, lot number, expiration date and route of administration were not provided); on 11-JUN-2012 the patient was vaccinated with another dose of CERVARIX (dose, lot number, expiration date and route of administration were not provided) and then on 03-JUN-2015 the patient was vaccinated with a dose of GARDASIL, (dose, lot number, expiration date and route of administration were not provided); which was considered an interchanged of vaccine products. The patient had not reported or demonstrated an adverse effect. Additional information has been requested.
One week after second dose of the Pfizer Covid vaccine, my son had terrible stomach pain which ended up being an inflamed appendix/appendicitis which resulted in an appendectomy.
SMALL HEMATOMA (BLISTER) APPROXIMATELY 2CM IN DIAMETER ON LEFT THIGH.
I went unconscious and went to hospital. I was then taken to the hospital where they found out I had a pontine stroke with vertebral dissection and they tried emergency brain surgery but it was too risky to do anything about it. I want in their ICU from 3/10-3/13. I then went to another hospital (not ICU) from 3/13-3/18. Then to a rehabilitation facility from 3/18-4/9 were I had: Speech, Rec therapy, OT and PT.
Within one hour of receiving my second Pfizer covid 19 shot, I started experiencing ringing in my ears. It has not gone away 5 days later.; This is a spontaneous report from a contactable consumer (Patient). A 36-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 06Aug2021 12:00 (at vaccination age of 36-year-old) as single dose, dose 1 via an unspecified route of administration, administered in Arm Left on 16Jul2021 13:15 (lot number: EW0186) (at vaccination age of 36-year-old) as single dose for COVID-19 immunisation. The patient medical history was reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no any other medications the patient received within 2 weeks of vaccination. Relevant past drug history was reported as no. The patient experienced 'Within one hour of receiving my second Pfizer Covid 19 shot, I started experiencing ringing in my ears. It has not gone away 5 days later' on 06Aug2021 13:00. Hospitalization prolonged was reported as no. Treatment received was reported as no. Facility where the most recent COVID-19 vaccine was administered was in doctor's office/urgent care. As reported, within one hour of receiving his second Pfizer Covid 19 shot, he started experiencing ringing in his ears. It has not gone away 5 days later. Since the vaccination, the patient had not been tested for COVID-19. The seriousness was reported as disability. Device date was 11Aug2021. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
anaphylaxis with immediate whole body swelling. Epinephrine 0.3mg IM administered
Pt devel cellulitis consisting of tenderness, redness & swelling 2 1/2 - 3 in in diameter) @ inject sie p/receiving Td; Pt was seen in ER on 13JAN91 & was treated w/ Eryc;
Pain between shoulders, raised into collarbone area; cold; runny nose; Left arm pain, arm of injection; Left leg pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm pain, arm of injection), PAIN IN EXTREMITY (Left leg pain), NASOPHARYNGITIS (cold), RHINORRHOEA (runny nose) and ARTHRALGIA (Pain between shoulders, raised into collarbone area) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03021A) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy, Osteoarthritis and Headache.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left arm pain, arm of injection) and PAIN IN EXTREMITY (Left leg pain). On 12-Mar-2021, the patient experienced NASOPHARYNGITIS (cold) and RHINORRHOEA (runny nose). On 15-Mar-2021, the patient experienced ARTHRALGIA (Pain between shoulders, raised into collarbone area). The patient was treated with DIPHENHYDRAMINE ongoing since an unknown date at an unspecified dose and frequency. On 13-Mar-2021, PAIN IN EXTREMITY (Left arm pain, arm of injection), PAIN IN EXTREMITY (Left leg pain), NASOPHARYNGITIS (cold) and RHINORRHOEA (runny nose) had resolved. At the time of the report, ARTHRALGIA (Pain between shoulders, raised into collarbone area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included neuropathy, osteoarthritis, headache and opiate medications. Treatment information included Opiate pain medications.