chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient felt light headed and nauseous after receiving the 2nd dose of pfizer this morning. NP attended to patient, took vitals, and gave patient alcohol swab to smell to relieve nausea.  Patient also told NP she did not eat breakfast this morning BP: 166/96 Temp: 98.4 Oxygen: 100 Sat Heart rate: 77
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of RECOMBIVAX HB (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up information was received from the medical assistant on 06-AUG-2014. The M.A. stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 9 month old patient who on 09-JUL-2014 was vaccinated with improperly stored dose of RECOMBIVAX HB (lot# J007946, expiration date 24-MAR-2016) (dose and route of administration not reported). This is one of several reports received from the same source. Additional information is not expected.
children received a dose of the VARlVAX that was stored out of recommended temperature range; This spontaneous report was received from an other healthcare professional, refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (VARIVAX) injection, 0.5 milliliter (lot # R035226 which has been verified to be valid, expiration date 04-DEC-2020) (route of administration and anatomical location were not reported) for prophylaxis. The vaccine was exposed to temperature of 57.9 degrees Fahrenheit (F) for 49 hours. Digital data logger was involved. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA001660: US-009507513-2009USA001387:
Patient received booster dose of Covid-19 Pfizer vaccine. Patient was observed in exit area for 15 minutes post vaccination with no complaints. As patient was exiting vaccine clinic, patient reported feeling sweaty and sat down on bench outside. Volunteer alerted public health nurse on site and nurse assessed patient. Patient was given bottled water and granola bar. She stated she felt better after water and snack, said she felt well enough to go home. Public health nurse advised patient to follow up with primary care doctor if she has any new symptoms. Patient was able to leave with daughter who brought her to the appointment.
injection site was very sore, large red area that lasted 6 days. Starting 12/31/2022 morning: headache, muscle pain, chills, mild nausea; lasted about 36hours. Fatigue started 12/31/2022 and continues to date. Joint tenderness continues to date. LUQ abdominal soreness, discomfort started about 1 week post vaccination and has increased to date.
headache; dizzy; ringing in her ears for hours -high pitched ring; sore arm where injection was administered; This is a spontaneous report from a contactable nurse (patient).  A 28-year-old female patient (not pregnant) received first dose of bnt162b2 via intramuscular in arm right on 17Dec2020 11:30 at single dose for immunization. The patient medical history was not reported. The patient had no medications, food, or other products allergy history. The patient's concomitant medications were not reported.  The patient reported 8 hours after administration of vaccine, on 17Dec2020 8:00 pm, the patient started to get a headache then dizzy then ringing in her ears for hours -high pitched ring, and sore arm where injection was administered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received in response for reported events. The outcome of the events was recovering. Information on the lot/Batch number has been requested.
Sore throat, hives, and headache. Hives started on wrists/hands but progressed up arms, feet, and top of thighs. No breathing impacts other than sore throat.
Injectin site (L) deltoid swollen radiating to (L) shoulder with pain; warm-to-touch  Trreatment:                                     1) Keflex 500mg cap QID x 10days for cellulitis  2) Motrin 800mg TID PRN
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 29-DEC-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX, Lot number, expiration date, dose, route and anatomical location were not provided. No concomitant medication was reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix on left arm. After receiving the vaccination, the patient experienced pain in her left arm at the injection site. This case has been linked with case US2018GSK169435, for the same patient for 2nd dose.
Papular, erythemtous rash over entire body.  Pruritic in nature.  Follow vaccination by 9 days.  No oral/mucosal lesions or systemic symptoms (no myalgias, arthralgias, etc)
Having burning pain in her arm, veins are burning; Her legs were having burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Having burning pain in her arm, veins are burning) and BURNING SENSATION (Her legs were having burning sensation) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Acid reflux (oesophageal). Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), MULTI VITAMIN & MINERAL for an unknown indication.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN (Having burning pain in her arm, veins are burning) and BURNING SENSATION (Her legs were having burning sensation). At the time of the report, PAIN (Having burning pain in her arm, veins are burning) and BURNING SENSATION (Her legs were having burning sensation) had not resolved.            Concomitant medications included Multi-Vitamin and ultra-mega vitamins.  Treatment information was not provided.
Positive Covid-19 rapid tests; Positive Covid-19 rapid tests; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 at 08:30 as dose 1, single (Lot number: EW0150), in left arm and on 22Apr2021 at 08:30 as dose 2, single (Lot number: E0161) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Dec2021 at 08:30 as dose 3 (booster) single (Lot number: 045J21A) for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing), notes: Vaccine brand other: Moderna, Vaccine dose number: 3. Concomitant medication(s) included: SAFYRAL, start date: 01May2022, stop date: 16May2022; ZINC, start date: 03May2022, stop date: 16May2022; STAR, start date: 03May2022, stop date: 16May2022; VIT C, start date: 03May2022, stop date: 16May2022; VIT D3, start date: 03May2022, stop date: 16May2022; IBUPROFEN; GREY; BAYER; NUTRINOCHE; BARLOW HERBS; EAST STAR; MUNITY BOOST; LDM-100. Past drug history included: Amoxicillin, reaction(s): "Known Allergies: Amoxicillin". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "Positive Covid-19 rapid tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Positive Covid-19 RAPID tests from Company (BinaxNow), FlowFlex, iHealth. Therapeutic measures were taken as a result of covid-19, drug ineffective.
Pt states she jumped when receiving the shot and arm has been in constant pain since receiving. Claims "pinched nerve" but multiple trips to her MD have not revealed the root cause of the problem.
Second dose of vaccine received 5/20 at  5:00 PM. At approximately 4:00 AM 5/21 the patient began experiencing flu like symptoms (fever, chills, body aches, headache) for entire day which had resolved by morning of 5/22. At approximately 6:00 AM 5/23 the patient began experiencing substernal chest pain 5/10 that lasted approximately 3 hours. He sought medical treatment at an urgent care facility and was referred to  Hospital for higher level of care. At the hospital he was found to have an elevated troponin level with a peak of 1.50.  He underwent Coronary Angiography to rule out coronary artery disease. The procedure found no evidence of coronary occlusion and was completed without complication.
Fatigue; Headache; Chills; Fever; Muscle and joint pains.  Headache starting 20 minutes after injection, lasting 48 hours and recurring often for four days. Fever (101.5 for 48 hours, and hot flashes into the fifth day with some nausea.  Motrin taken more the headache but for several days.
Heaviest period to date. Bled through tampons after minutes of having them in. Bled through underwear/pants with tampon in. Heavy bleeding lasted 3 days.
booster; the lymph node under his arm had discomfort and is swollen; the lymph node under his arm had discomfort and is swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "unknown", IMMUNISATION (non-serious), outcome "unknown" and all described as "booster"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "the lymph node under his arm had discomfort and is swollen". The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information  Caller is a consumer that was calling about the Covid-19 Booster that he received on 21Nov2021. Caller said that he noticed maybe 24 hours afterward, he thinks his lymph node under his right arm has some discomfort and noticed today that it feels swollen in that area. He said that he feels fine other than that. Caller said that he does not remember having this issue with the other 2 doses.   No Follow-up attempts are completed. No further information is expected.
Face pain within 10 minutes of injection, pain at back of head with in 20 minutes of injections, acute epigastric pain with in 3 hours, back pain with spasms over several days.
Headache & Fever severe headache, insomnia, fever, chills, pain at injections site, unable to work due to incapacitation on 1/26/2021 1400-1630
19-year-old female passed out after receiving her first Pfizer vaccination she was in 15 min observation area. She was responsive an attended to by medical staff on team. EMS was called individuals vital checked, blood pressure, VGL and oxygen all normal.  Mother was present and patient declined to go to hospital for further evaluation.
severe arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe arm pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (severe arm pain). At the time of the report, PAIN IN EXTREMITY (severe arm pain) outcome was unknown.     Treatment included Tylenol.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Extremely sore arm started next day, fever of 99.7, body aches, chills
Woke up with fever approximately 12 hours after second dose. Fever of 100.1, chills, body aches and arm pain on left side.
03/06/2019 Reaction started around 2000,  Rt side of neck, cheek, and eye lid got swollen. No difficultly breathing at that time. 03/07/2019 continued with swollen neck, cheek and eye lid, around 1313 had difficulty breathing.
9y/o patient was given Kinrix outside of the acceptable age group. No issue after vaccine, follow up done. No side effects noted
Burning and shooting pain on breasts; tingling/pins and needles in shoulder blades and right side of back. Numbness. lol
AFTER INJECTING HALF THE DOSE THE PLUNGER IN THE SYRINGE GOT STUCK SO TRIED TO SLIGHTLY MOVE SYRINGE TO MOVE NEEDLE BACK AND I GOT SPRAYED IN FACE AND LEFT EYE WITH VACCINE.  PT DID NOT RECIEVE FULL DOSE OF VACCINE.  I TOOK CARE OF PT AND HAD HIM WAIT WHILE I RETURNED TO PHARMACY TO FLUSH EYE WITH WATER FOR A FEW MINUTES AND THEN RETURNED TO TALK WITH PT LETTING HIM KNOW HE MAY NEED TO RETURN FOR ANOTHER DOSE OF ZOSTER VACCINE.  I WENT TO OPTICAL DEPT AND DR FLUSHED EYE WITH SALINE, LOOKED AT MY EYE, AND CALLED IN ANTI-VIRAL DROPS FOR ME. I AM TO RETURN TO EYE DR NEXT WEEK FOR FOLLOW-UP.
The night of 09/08/2022, it was more or less the same normal side effects I would have after receiving the vaccines with sore arm and fatigue. I suffered from this from 09/08/2022-09/17/2022. The early morning of 09/18/2022, I tried to get up to go to the restroom and my leg felt numb which caused me to fall to the ground. I disregarded it, thinking it was just a pinched nerve and went back to bed. Hours later, it felt like everything in front of me was spinning and fell again to numbness in my left leg. The next day, the high pitch ringing my ears became louder and more sensitive; my short-term memory was getting worse, my symptoms were progressively getting worse. I tried to downplay the symptoms even as if it got worse. I went to the ER as my loved ones urgently persisted I do; the practitioner there said she's heard symptoms similar to mine after receiving the recent bivalent vaccine. They performed a pinch test to check for a blood clot and CT scan that came back normal. The doctor diagnosed me with post-COVID booster syndrome vertigo, attention dysfunction, and difficulty concentrating. The doctor suggested me to follow up with a neurologist to continue monitoring my symptoms.
had the feeling that my right ear had a bit of pressure in it; This is a spontaneous report from a contactable consumer. A 56-years-old female (not pregnant) patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: EN6205) via unspecified route in the right arm, as a single dose on 19Mar2021 at 09:15 for COVID-19 immunization (at the age of 56-years). The patient's medical history included drug hypersensitivity, penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included estradiol, estriol (BI EST) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient stated that after first dose of the vaccine I felt fine but had the feeling that my right ear had a bit of pressure in it. The clinical outcome for the event was not recovered.  Information on Lot/Batch number is available; Further information has been requested.
Started developing chest pain a week after taking the first dose. Progressively worsened since then till present/had bouts of sharp chest pain/CP; X-Ray showed pleural effusion and slight fullness of main pulmonary artery.; pleural effusion; Fatigue/tiredness/High fatigue and tiredness persisted from right after the vaccine till present; diarrhea; tiredness; high fever; chills; nausea; brain fog; This is a spontaneous report from a contactable consumer. A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Apr2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient started developing chest pain a week after taking the first dose (13Apr2021). Progressively worsened since then till present. At present also have fatigue, diarrhea and tiredness. Yesterday, had bouts of sharp chest pain so got an X-Ray from ED which showed pleural effusion and slight fullness of main pulmonary artery. Doctor stated it was indicative of CP. In the initial few days after the first dose, had high fever, chills, nausea and brain fog. High fatigue and tiredness persisted from right after the vaccine till present. The patient was very healthy and have never had a heart complication before. The timing might be indicative of a causation between the vaccine and the present medical condition. Ae resulted in doctor or other healthcare professional office/clinic visit. There is no other vaccine in four weeks, no other medications in two weeks, no treatment for ae, no covid prior vaccination. The patient tested covid post vaccination (RT-PCR) with Nasal Swab on 03May2021, covid test result was Negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient did not receive within 2 weeks of vaccination. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
In evening started high fever 102 given APAP; vomited; Seen in ER; pt also screamed 5 hrs next day;
Headache, dizziness followed by blackout/fainting resulting in head bruise and swelling. Rest at home, cold compress for swelling, Tylenol.
After the 2nd dose had fever 102 and last for about one day.  I had constipation for a long time , over the summer the symptoms , getting full very quickly and nausea and bothered me most. Not every meal but just more frequent in Jul2021 and saw the doctor mid August2021  biopsy positive for celiac , bloodwork was negative. endoscopy and biopsy came back positive for celiac.
pains; She stated that before the had the vaccine she took 1 Advil. Wanted to know if this will affect the antibody development; achy joints; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pains), DRUG INTERACTION (She stated that before the had the vaccine she took 1 Advil. Wanted to know if this will affect the antibody development) and ARTHRALGIA (achy joints) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pains), DRUG INTERACTION (She stated that before the had the vaccine she took 1 Advil. Wanted to know if this will affect the antibody development) and ARTHRALGIA (achy joints). At the time of the report, PAIN (pains), DRUG INTERACTION (She stated that before the had the vaccine she took 1 Advil. Wanted to know if this will affect the antibody development) and ARTHRALGIA (achy joints) outcome was unknown.            No concomitant medication was not reported. No treatment medication was not reported Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Vaccine Information, second dose added.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001a21a and 001a21a) for COVID-19 vaccination.     No medical history reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown. Not Provided          Other concomitant medications included unspecified thyroid medication. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  Patient was doing fine.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: TCR received. Clinical information updated.
pain to her bones; This is a spontaneous report received from a contactable consumer. This 51-year-old female consumer (patient) reported that:  A 51-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Apr2021 (at the age of 51-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 on unspecified date as single dose for covid-19 immunisation. Patient reported that she had the second dose of the COVID-19 vaccine on 21Apr2021, and she had experienced pain to her bones on an unspecified date in 2021. The outcome of the events was Unknown.   Information about batch/lot number has been requested.
Pt seen in am and describes what appeared like an allergic response after 1st inj. anyway. Pt was given Betamethasone 6 mg IM at approx 1000 this am, Pt returned at 1340 and was given Gardasil. 5 ml IM to (L) deltoid. Within one minute pt c/o tingling to bilat. arms and fingers and dizziness. Pt was laying down and became weak with decreased muscle tone. c/o visual disturbance. Maintained BP + O2 Sat  + Pulse all WNL. (1350) No improvement, Pt was given Benadryl 50 mg IM at 1410. Took 20 minutes for slight improvement. Approx 35 min after Benadryl, pt was improving. Pt. had bee recommended not to receive further doses and will take Benadryl 50mg P.O. daily x 2-3 days per Dr. Pt. d/c'd to home with boyfriend.