chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1454- Pt received Pfizer vaccine.  1455- Pt slumped over in chair. Pt did not loose pulse or stop breathing. Pt lips cyanotic but peripheral pulses <3 sec cap refill.  Pt regained consciousness while in sitting position. Pupils equal and reactive 5 PERRLA. 1457- VSS as follows : HR: 80 BP: 109/66 SpO2: 99%, Temp: 36.8C. S1 and S2 noted with regular rhythm.    1459- MD at bedside to assess pt. Pt laying at this moment.  Per MD, monitor pt in sitting and standing position before pt goes home. Pt verbalizes feeling ok.    1525- HR 96, BP: 116/81 (93), SpO2 97%. No complaints of dizziness or feeling light headed. Per pt, feels ok to go. Pt and pt's father leaving vaccination clinic at this time.
This spontaneous report as received from a physician refers to an unspecified number of unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since an unspecified date in May 2015 (exact date unspecified, approximately in 2015), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K016279, expiration date 24-APR-2016, oral, dose not reported). Information regarding concomitant medications was not reported. No adverse effected reported. This is one of several reports received from the same source. Additional information has been requested.
I experienced severe depression, cold to the touch but not running a fever and I would be bright red like I had a fever.
My reaction is hives located first on both my knees, and sides of shins. Also, hives are located on upper left arm.
burning sensation to the left side of her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 64-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 13:30 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "arthritis inflammation" (unspecified if ongoing); "pain" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; ASPIRIN 81. The following information was reported: BURNING SENSATION (non-serious) with onset 12Mar2021, outcome "unknown", described as "burning sensation to the left side of her arm".  Additional information: Patient just got her 1st dose of the vaccine today, on 12Mar2021, was feeling a burning sensation on her arm and wants to know if she can take painkillers if she will feel pain later on. Patient asking if she can take a Vicodin, Tylenol, or Motrin if she has pain after getting the vaccine. She received her first vaccine dose in her right arm about 30 minutes ago and while she reports not having pain, she did report having a burring feeling to her left arm even though she received the vaccine in her right arm. She denied any other questions at this time about the vaccine or side effects. Patient asking if she can take her 800mg Ibuprofen if she had pain. Patient says she took her first dose of the Pfizer COVID-19 vaccine today around 01:30PM, and she asked people at the site questions which they answered for her, but she has questions about taking her medications for arthritis pain if pain comes from getting the shot. She says she would like to know if she can take Ibuprofen 800mg, or Aspirin 81 mg which she takes once a day to keep her from having a heart attack, or Norco, for any pain. She says she would like to know if regarding the shot it would be ok. She says she was not having pain now; she was concerned how everything will go for her, and she already takes pain medications for arthritis inflammation or pain. She says that the only problem she has really had was a burning sensation to the left side of her arm, but she took the shot on the right side, so she wants to know also if this is common. She says she just wants to find out her one question if she can take pain medication or if it will affect her shot. She says she started not to take the shot, since it was hard to get information from it, which she gets from the TV. She says her sister was 71 and she got both doses of it, and the second one was yesterday and she was ok after the first one and says that she was ok today after the second dose she got yesterday. She says that her sister just had a little pain where the shot was given.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3MAR91 dyspepsia p/2nd dose HBV;11MAR91 upper resp;22MAR91 anaphylaxis rash, bronchospasm, irritability, insomnia;24APR91 lymphadenopathy;3JUN91 rhinos;
Chills; Fever; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included NAPROXEN SODIUM (ALEVE) for an unknown indication.    On 28-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 CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
A few days after the vaccine I woke up with shape pin pricking pain in the center of my chest.  I laid back down for a while and the symptoms dimished.  Throughout the day they came and went but by the end of the day they left completely.  That Wed the same feeling came back and was off and on until that Friday causing me to reach out to my physician. At 5pm that Friday I had an EKG performed which was good.  And by that Sat all symptoms had subsided.  I was also extremely tired during this time but that dimished as well when the symptoms subsided.
Fever, Chills, Joint pain, Headache, Fatigue, increased nerve pain, arm pain at injection site
Narrative:  Patient received Moderna covid vaccine #1 on 2/10/21. He had never been seen at our facility prior to that visit but did not have a pre-screening visit note on 1/27/21 that indicated he had a mass on his liver. On 3/17/21, a note was entered that he was in the hospital for cirrhosis of the liver and would be starting chemotherapy. No other notes in database system or scanned records available. A date of death of 2/16/21 was recorded. Time from vaccine to date of death was 6 days. No autopsy reports available.
UNABLE TO WALK; STOMACH CRAMPS; TINGLING; SHOOTING PAIN; THUMPING SHARP PAIN BEHIND EARS; BACK PAIN; FEELING HOT; ARM SORENESS; NAUSEA; HEADACHE; HOT FLASHES; THROWN UP IN HER MOUTH AND SWALLOWED; FELT SUFFOCATING; CHILLS; NUMBNESS IN LEG / NUMBNESS IN ARM FROM WRIST TO SHOULDER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A ) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced numbness in leg / numbness in arm from wrist to shoulder. On 09-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced felt suffocating. On 10-APR-2021, the subject experienced thrown up in her mouth and swallowed. On 12-APR-2021, the subject experienced hot flashes. On an unspecified date, the subject experienced unable to walk, stomach cramps, tingling, shooting pain, thumping sharp pain behind ears, back pain, feeling hot, arm soreness, nausea, and headache. Treatment medications (dates unspecified) included: naproxen sodium, and paracetamol.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thrown up in her mouth and swallowed, recovered with sequelae from nausea, had not recovered from numbness in leg / numbness in arm from wrist to shoulder, unable to walk, headache, stomach cramps, tingling, shooting pain, chills, hot flashes, arm soreness, and back pain, and the outcome of feeling hot, thumping sharp pain behind ears and felt suffocating was not reported. This report was non-serious.
Temp of 106.1 right arm at injection swollen, red, hard and hot to the touch applied warm compress to area, Tylenol 1000mg taken temp down to 101.2 the next day 3/7/2014 as of 3/8/2014 no temp area remain red, swollen and tender to the touch and swollen area approximately 4cmx8cm not as painful today.
redness @ inject site of DTp; not using arm normally; running temp 102-103; not going down w/APAP;
Parent reported to physician at 16 mo well, states child had fever 102-103.4 (started 8 days post MMR given) with small papillar rash on cheeks, stomach, back and thigh, no swollen glands, no dyspnea, no other sx noted. Call MD on call, lasted 3 days.
Product was administered to patient after temperature excursions; This spontaneous report was received from a certified medical assistant and refers to a 4-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 21-JAN-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), dose/frequency reported as once, lot # T0235408 (invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), and does not match any Company product as confirmed by Lot Verification team), expiration date 14-APR-2022 (exact dose, dose number, route of administration and vaccination site were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of 7.4 degrees Fahrenheit for 25 minutes, 6.4 degrees Fahrenheit for 20 minutes and 5.9 degrees Fahrenheit for 15 minutes. There were previous temperature excursions, 31.3 degrees Fahrenheit for 10 hours 28 minutes, between range of 6 to 14 degrees Fahrenheit (no exact temperature was provided) for 1 hour 15 minutes and 11 degrees Fahrenheit for 4 hours 6 minutes.
It felt like a torn intercostal muscle tear at first; sore on under my left arm across my chest area for almost 8 weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (manufacturer unknown), for COVID-19 Immunization. The following information was reported: MUSCLE RUPTURE (medically significant), outcome "recovered", described as "It felt like a torn intercostal muscle tear at first"; AXILLARY PAIN (non-serious), outcome "recovered", described as "sore on under my left arm across my chest area for almost 8 weeks". The patient underwent the following laboratory tests and procedures: mammogram: (15Nov2021) unknown results. The patient was sore on under left arm across chest area for almost 8 weeks. It felt like a torn intercostal muscle tear at first. The patient did let doctor know and they said to see if it gets better after 2 weeks. The discomfort did lessen, but it took about 8 weeks. The patient did also have a mammogram that same morning (15Nov2021) but she has never been sore after a mammogram.  The lot number for bnt162b2 was not provided and will be requested during follow-up.
1/19/2022- Presented to ER from office appt. at primary office via ambulance, complaint of SOB and congestion. Patient did miss dialysis on 1/17 but received it today. Covid + test. WBC 16.3. D-dimer 578. CRP-18.7. Chest x-ray Left lower patchy alveolar disease. Start decadron and azithromycin and vitamins. Not given remdesivir or baricitinib due to kidney function. Currently on 95% on 4L via NC. 1/20/2022- Positive for C-diff after many bouts of loose stools. Oral vancomycin ordered. HD three times weekly. 1/23/2022- Afebrile, O2 sats on RA 97-99%. 1/24/2022- Cough, Ct chest -complex cavitary parenchymal abnormality in left lower lobe. Seen on prior imaging, will follow outpatient. 1/27/2022- WBC-15.3. Firmer stools. Tolerating RA maintaining o2 sat High 90's. Discharge to home.
SEVERE SWELLING AND REDDNESS OF INJECTION SITE, FOLLOWED BY RASH OF EFFECTED LEG, THEN RASH SPREAD TO REST OF BODY.
Red; Hot; Muscle Soreness; Rash; pinkish bumps; Rash on the back of neck; Chills; Swelling; arm  a little itchy; Inflammation; This case was reported by a consumer via call center representative and described the occurrence of chills in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ambiguous medication nos (Cortisone (Nos)) for muscle soreness.   On 1st December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started Cortisone (Nos) at an unknown dose and frequency. On 3rd December 2019, 2 days after receiving Shingrix, the patient experienced chills and swelling. On 6th December 2019, the patient experienced erythema of extremities, extremities hot feeling of, muscle soreness, red rash, papular rash and rash. In December 2019, the patient experienced inflammation and itchy upper limbs. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On 8th December 2019, the outcome of the erythema of extremities and extremities hot feeling of were recovered/resolved. On an unknown date, the outcome of the chills, swelling and inflammation were recovered/resolved and the outcome of the muscle soreness and itchy upper limbs were unknown and the outcome of the red rash, papular rash and rash were recovering/resolving.   It was unknown if the reporter considered the chills, swelling, erythema of extremities, extremities hot feeling of, muscle soreness, red rash, papular rash and rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter stated that, less than 3 weeks after vaccination, the patient experienced muscle soreness and itchy rash. On Friday after the day of vaccination, the patient arm was red and hot below the injection site. Three weeks after vaccination, the patient had an ongoing rash that consist of itchy, reddish/ pinkish bumps on left arm and the back of her neck below her hairline. The patient stated that rash on the back of neck not as bad as the rash on arm. The pharmacist told the patient to use cortisone and an ice pack. The patient stated that, the cortisone made the patient's arm little itchy, but the inflammation went away with ice pack. The patient reported that, the bumps were not oozing or blistering. The reporter stated that, visiting to physician who did not feel rash was shingles or chicken pox and might be visit a skin doctor. The reporter consented to follow up.
during the call he also mentioned that sometimes he can not understand words because he has hearing problems; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) as dose 2, single and as dose 1, single, both via an unspecified route of administration on an unspecified date for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease (COPD), ongoing emphysema, both were underlying conditions. The patient's concomitant medications were not reported. The patient wants to know if he should receive a third booster dose of the Pfizers COVID-19 vaccine, he saw on the news that adults who are 65 years of age can receive the vaccine, he also stated that he saw that patients with aids and undergoing certain procedures could be eligible as well. He was a patient with certain underlying conditions: he has Chronic obstructive pulmonary disease and emphysema. During the call he also mentioned that sometimes he can not understand words because he has hearing problems on an unknown date. He already received two doses of the Pfizer COVID-19 vaccine and wants to know if he requires a prescription from his doctor to receive the booster dose. Response received like a single dose of the booster dose may be administered to individuals who are 65 years of age and older. The outcome for the event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
We had a patient that received their primary doses in another country. First dose was Sinovac and the second dose AstraZeneca. NP made the call to restart primary series for patient as both Sinovac and AztraZeca are not FDA approved.
Eczema like rashes in different parts of the body - around the lips, face and back
Have 2 vaccine and 2 boosters (Pfizer) prior to first time COVID diagnosis; Have 2 vaccine and 2 boosters (Pfizer) prior to first time COVID diagnosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Have 2 vaccine and 2 boosters (Pfizer) prior to first time COVID diagnosis".  Clinical information : Are you reporting any issues (side effects, complaints, etc.) with the product? Yes.Did the reported issue occur after use of the product? YesEvent information: Had to stop Paxlovid after 4 full days due to extreme diarrhea, Admission to hospital due to the event? NoAny treatment received? No, Still experiencing? Fine now.Are there any other product(s) that were taken together with those indicated above? No.Any additional information: Needed Imodium (word not legible) to stop diarrhea. Have 2 vaccines and 2 boosters (Pfizer) prior to first time COVID diagnosis.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
8 days after my first dose I developed a rash or hives on my thighs first, and then to my entire legs, feet, upper arms, hands and buttox within 2 additional days.  Bumps are mostly small, singular and very red, raised and itchy- not painful.   They are not on my belly, back, face, chest or breasts.
INCREASED PHLEGN IN THROAT Narrative: PATIENT REPORTS WAKING UP FEELING FATIGUE SHAKY AND WEAK WITH INCREASED PHLEGM IN THROAG WITH ODOR. FEELING BETTER SEVERAL DAYS AFTER BUT NOT 100%. TOOK APAP -TOOK SEVERAL DOSES BEFORE HELPED.
Woke up day after shot 10:00 a.m with dry heaves for 10 minutes, sweaty also.  Woke same day after nap, 4:00 p.m. with dry heaves and sweats.  Mild temperature of 100.6 to 101 for 3 days.  Upper stomach pain (mild to moderate) for 3 - 4 weeks began 5 days after booster.   Now mostly resolved.  Extreme outbreak of sacral herpes within 5 days of booster shot.  Now resolved -- taking daily medication, 500 mg. Valacyclovir HCI.
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt passed out 1 minute after giving 0.3ml of pfizer IM to left arm......pt was seated so gently fell forward onto my legs and then laid on the floor. pt regained consiousness within 10 seconds. Mom saw a twich and insisted I call 911 to ensure he was not having a seizure, which he was not. Paramedics came and assessed vitals, which were all good and pt walked out with them and parents. I called the pt the next day to follow up and patient was fine. No other issues.
was only given one moderna on 9/9/2021  Patient had her first vaccine 8/12/21, Second 9/9/21 (moderna, same location lot 002F21A) without any acute complications or severe side effects.  She was a 28 year old healthy G3P2 without any significant prior  or current obstetric concerns who presented to L&D in active labor and was found to have a fetal demise at 35 6/7 weeks.  EDC was 11/22/2021, She presented on 10/24 and delivered on 10/25/2021 a 2440 female without any significant obvious fetal malformations.  fluid was adequate, but bloody.   She did have some spotting on 9/1; however, her follow up sonogram was normal and this never recurred.  She delivered vaginally without complications; however, she represented with active bleeding 10/29 requiring an emergent D&C and transfusion of 3 units with a hg of 5.  fetal anatomy scan at 28/31 weeks were both normal.
Fever, hot flashes, jaw pain, plantar faciitis, rash, had to get on steroids.
Events started approximately 5-6 hours after vaccination. Arm became swollen, red, firm, and very sore. Majority of the symptoms weren't at the site of injection, rather in tricep/elbow area of (L) arm.
440PM constriction chest sensation;mild cough;BP 110/80, T97.6 lungs-clear;15MAY mild wheezing w/abatement of chest sx;
pt recv vax; day p/ vax, fatigue & lethargy; given fluids & low dose dph; recovered;
I experienced ringing in my ears and a feeling like my ears are stopped up. This came about 72 to 96 hours after the vaccine. I used a combination of 91% alcohol and 3% Hydrogen Peroxide on a 1 to 1 ratio. I pour it in my ear and drain and do the other one. It does not seem helpful; it just makes my ears feel clean. The doctor asked me to come in on November 8 but I am going tomorrow as I am tired of waiting. It has gotten worse since the original onset.
PAIN WHEN RAINING; FEELING TIRED; ARM HURT; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, series 1, administered on 20-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. Concomitant medications included leflunomide. On JUL-2021, the patient experienced arm hurt. On an unspecified date, the patient experienced pain when raining, and feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from arm hurt, and was recovering from feeling tired, and pain when raining. This report was non-serious.