chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 17 year old male. 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced product administered to subject of inappropriate age, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Headaches; fever; chills; tiredness; nausea; general feeling of being unwell; muscle pain; This is a spontaneous report from a non-contactable consumer, the patient. A 71-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 26Mar2021 at 10:15 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included elevated cholesterol, bladder and basal cell cancer and COVID-19. The patient did not have any allergies to food, medications, or other products. Concomitant medications included atorvastatin 20 mg (MANUFACTURER UNKNOWN), lactobacillus acidophilus (FLORAJEN) and MULTIVITA, all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the right arm on 05Mar2021 at 10:30 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was 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 26Mar2021 at 18:30, the patient experienced headaches, fever, chills, tiredness, nausea, general feeling of being unwell and muscle pain. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events headaches, fever, chills, tiredness, nausea, general feeling of being unwell and muscle pain. The clinical outcomes of the events headaches, fever, chills, tiredness, nausea, general feeling of being unwell and muscle pain were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
I developed a rash around the injection site, it is red, blotchy and itchy. The rash expanded a large portion of my left arm around the site of injection and it has gone down significantly, however, it is still slightly itchy, red and blotchy. after 8 days.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-NOV-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # M005287, expiration date: 08-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 16.3 degrees Celsius for 8 hours and 38 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Fatigue, headache, nausea, loss of appetite, hives, rash, itching, burning sensation on legs and knees, increased body temperature by 2 degrees
On 12/20/2021, within one hour after receiving my vaccine I was very sleepy. I also had a headache and I was very nauseous again and severe stomach pains. I have Achalasia and I can't throw up due to esophageal surgery, so I think that may be why I had such a horrible pain in my stomach. My left arm was also very sore right below my elbow. I was unable to really do anything for 2 days. I did not seek medical attention from my doctor.
patient bottom lip started swelling morning after receiving covid shot, and painful. today symptoms have decreased but still a little swolleln
Face was swollen; Eyes and then my mouth and lips started swelling; Eyes and then my mouth and lips started swelling; Eyes and then my mouth and lips started swelling; Itching around my neck ears and eyes; Itching around my neck ears and eyes; Itching around my neck ears and eyes; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiry date unknown), via an unspecified route of administration on 28Jan2021 14:00 at a single dose in the left arm for COVID-19 immunisation. Medical history included multiple sclerosis and environmental allerges. Concomitant medications included ascorbic acid (VIT C), colecalciferol (VIT D3), zinc, acetylcysteine (NAC), montelukast, and other unspecified medications. Patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of bnt162b2 (brand: Pfizer, lot number: EL3246) on 07Jan2021 11:00 on the left arm. After the first dose, the patient formed a sty on her right eye and it is still there three weeks later. After second dose, the patient started itching around her neck, ears, and eyes on the day after injection, on 29Jan2021 10:00. By the third day, on 30Jan2021, when she woke up, her face was swollen, especially eyes and then her mouth and lips started swelling and the itching worsened. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient recovered from the events on an unspecified date. Treatment received for the adverse events was Depo-Medrol Injection. The events were reported as non-serious.
Pt reports having received flu vaccine in 10/2014. Reports shortness of breath and nausea within one hour of flu shot. No lip/tongue swelling, rash, or vomiting.
approx 4 1/2 hr p/vax pt began crying & was unconsolable for 45mins; pt stopped crying & became limp; father believed pt stopped breathing for 30-60seconds & lost color from face; pt recovered spontaneously; in ER nl exam
Fever of 101-102. Severe nausea and dizziness. Muscle and joint pain. Head ache. Confusion.
immediate facial tingling right side.  resolved within 5 seconds- did not return during the 30 minutes of observation following the vaccine.
Patient got the MENACTRA vaccine in right deltoid on Sat. 12/6 and on 12/7 (Sun) AM.  Injection site down to elbow was red, hot swollen and itchy. Patient used ice on arm, BENADRYL and Children MOTRIN.
I crave salty things, which I never have.; no appetite; no sense of smell/loss of smell; I had no taste whatsoever/loss of taste; felt under the weather; coffee tasted very vile, water even tasted pretty vile; Fatigue/Extremely tired; Headache; aches by mid afternoon.; Chills/Bothered by chills; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (no sense of smell/loss of smell), AGEUSIA (I had no taste whatsoever/loss of taste), MALAISE (felt under the weather), TASTE DISORDER (coffee tasted very vile, water even tasted pretty vile) and DECREASED APPETITE (no appetite) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011AZ1A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Aspirin allergy), Drug allergy (Cortisone allergy) and Hypothyroidism (Low Thyroid). Concomitant products included LEVOTHYROXINE for Hypothyroidism, MULTIVITAMIN [VITAMINS NOS], GLUCOSAMINE, FISH OIL and ZINC for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN (aches by mid afternoon.), CHILLS (Chills/Bothered by chills) and HEADACHE (Headache). On 06-Mar-2021, the patient experienced MALAISE (felt under the weather), TASTE DISORDER (coffee tasted very vile, water even tasted pretty vile) and FATIGUE (Fatigue/Extremely tired). On 06-Mar-2021 at 8:30 AM, the patient experienced ANOSMIA (no sense of smell/loss of smell) and AGEUSIA (I had no taste whatsoever/loss of taste). On 07-Mar-2021, the patient experienced DECREASED APPETITE (no appetite). On an unknown date, the patient experienced SALT CRAVING (I crave salty things, which I never have.). At the time of the report, ANOSMIA (no sense of smell/loss of smell) and AGEUSIA (I had no taste whatsoever/loss of taste) had not resolved and MALAISE (felt under the weather), TASTE DISORDER (coffee tasted very vile, water even tasted pretty vile), DECREASED APPETITE (no appetite), SALT CRAVING (I crave salty things, which I never have.), PAIN (aches by mid afternoon.), CHILLS (Chills/Bothered by chills), FATIGUE (Fatigue/Extremely tired) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Patient went for COVID rapid test for 4 weeks in a row, all coming out Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported she used LAVENDER, EUCALYPTUS, LEMON AND ROSE ESSENTIAL OILS  and SALINE NASAL SPRAY to try to retrain her sense of smell.     This case was linked to MOD-2021-259014 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Events updated, Treatment information updated
After recieving the flu vaccine, patient felt a little light headed.  She then slumped back in her chair.  Her eyes rolled back and she started to show signs of an adverse reaction to the vaccine and possible seizure.  The patient was layed down flat, 911 was called, and a epi pen was administered.  The patient quickly came to and was kept in a laying position with feet raised until EMT arrived and evaluated patient.  After 20-30 minutes she was deemed ok to leave on her own.
Patient was seen on 11.17.08 and noted: lesion on upper extremity: arm, on the right for 2 days, which has been painful and red. It has been swollen, and has not been draining pus/fluid. Started Sat am after receiving PNEUMOVAX on Friday, low grade fever up to 100 degrees, vomited once, and has a headache. Patient was seen on 11.18.08 and Dr noted: this is a 17 year old female patient who comes in to the clinic in follow up after yesterday's visit. Yesterday we treated her for a cellulitis at the site of injection that had occurred on 11/14/08. The area was red, warm and swollen. I had started her on CLINDAMYCIN orally and that area had actually improved. It is much lighter red, the swelling is better and the warmth is better but overnight she has developed a new area about 2 inches below the site of injection that looks very similar and has been growing bigger. It is very red, warm and swollen as well. They had been putting compresses on the area. She has had three doses of CLINDAMYCIN. Patient was seen on 11.20.08 and Dr noted: 17 year old female here for a follow up reaction to PNEUMOVAX received 11.14.08 However, the injection site for the flu shot has remained uneventful. She was seen at ER for IV antibiotic therapy and is finally responding. She is taking CLEOCIN and DOXYCYCLINE. Patient was seen on 11.21.08 and Dr noted: resolving cellulitis. There is little to no heat or induration of distal aspect of upper arm but small amount of induration remains at injection site.
headache, temp 99.8, fatigue, muscle aches, redness, pain, heat at injection site, restlessness, 8 small red, itchy bumps on upper thighs. Still have symptoms 72 hours later. Took ibuprofen 400mg every 6 hours.
Erythematous, non-fluctuant, indurated area. Warm to touch, no exudate or focus of fluctuance or purulence.
Raised red bump on left arm approx 2 inches from site of vaccine administration. Referred to physician.
2am woke up with severe chills and a severe migraine. At 10am severe migraine progressed to skin on scalp feeling like it was pulled too tight. From there I began to feel an internal tremor in my head, almost like if you ran a jack hammer all day and then stopped, that shaky, off-kilter feeling.  I used the bathroom that morning and had massive diarrhea, experience a vaso/syncope episode and passed out.  All week I felt like this and experienced nausea, dizziness, heart palpitations, severe migraine, internal tremor, severe anxiety and severe thirst.  By Friday, 2/26/21, it got so bad and my blood pressure dropped to 112/50, that I was taken via ambulance to the ER.  They gave me IV fluids, ran labs, EKG, etc.  Blood pressure went up to 137/91.  Released to rehab at home.  2nd ER visit to Hospital on Sunday where they repeated labs, EKG, gave me fluids and treated symptoms. Both trips I was labeled Tachy.
Chest itching per patient after receiving the initial vaccine. Chest itching and rash after receiving MMR 2/2.
Patient feels weak, achy, feverish and vomited within hours of administration. (R) arm is also red and swollen. Iced arm and took ALEVE. Went to MD on 9/29 and was treated with OTC ZYRTEC and MEDROL dose pack for allergic reaction. Reaction progressed down arm as it got better.
Started out with just a sore where injection was given. then it started to swell and turn red and feel warm to the touch . Its now   3 inches long by 2 inches wide.  I have contact agency and they advised me to see my doctor immediately. I hung up from them and contacted my doctor who can not see me until tomorrow at 1:15.  Feb 26,2021
1/15/2022-Presentated to ER, SOB x 3 days and productive cough. T-99.5, Spo2 91% on RA, placed on trach mask PS Fio2 40 Peep 5. Covid + test. Chest x ray-interstitial infiltrates bilaterally, Ct chest with contrast- No evidence of PE, ground glass opacities. Admit acute hypoxic respiratory failure secondary to Covid-19 pneumonia. Start Decadon, remdesivir, baricitinib, Rocephin and azithromycin. Patient is on Xarelto for DVT prophylaxis.  1/18/2022- Spo2 90-100% on trach collar.  1/20/2022-Afebrile, maintaining on current vent settings. Trach changed, pilot balloon and tubing has stiffened.  1/21/22- Completed course of IV remedesivir and baricitinib. Patient is at her baseline oxygenation. Discharge 1/21/2022- to home.   1/22/2022- Presented to ED, readmission from 1/21/2022. Patient RA sat 84%, normally on 5L 02 at home PM. Acute chronic hypoxic hypercanic respiratory failure/ bilateral Covid-19 pneumonia. Oral decadron and doxycycline. Intermittently on trach collar/trach tube with Pressure support and supplemental 02. WBC-15.7. NA 133. Chest x ray- No local infiltrates seen.  1/24/2022- Spo2 sat 90's on 6L via trach collar during AM, Vent in PM- PS Fi02-40, Peep 5. Currently stable. 1/26/2022- Vent weaning trial, not tolerated, desaturated to 86%, currently remaining at 28% Fi02 28% on 5L. 1/27/2022- Acute bilateral Covid-19 pneumonia improving. Sputum culture ordered. Culture + for Klebsiella, (call made after discharge to arrange for treatment) 1/28/2022- WBC-13.8. Patient discharged to home, with home oxygen.
Shot was administered around 4:15 June 29th.  Pt woke up at 6 a.m. the following day crying in pain, headache rated 10 on scale of 1-10.  She had a fever of 101.6, arm hurt and body aches. Took her to Dr. office at 7:20 in the morning, they ran strep test and checked white count which was normal.  No other definitive reason for being ill.
Narrative: 55 year old male admitted on 1/24/22 with SOB and treatment of COVID-19 infection. He had been vaccinated x 2 with Moderna (1st dose: 4/7/21, 2nd dose 5/5/21). He received 5 days of remdesivir and 4 days of IV  dexamethasone for treatment and was discharged on 1/28/22.
Short of breath, flushed, warm and cold shaky, a little hard to breath, little tight in the chest " I have asthma too too hard to tell the difference"   Tearful, skin felt clammy.
Patient found on ground by bystander. Patient responsive, alert and oriented. States does not know what happened. Patient stood and sat in chair. A few seconds later patient had syncopal episode and nursing staff assisted him to the ground. BLS provided, airway maintained. Patient pale, diaphoretic and clammy. BP 110/60, P 51, O2 98%, T 96.3. Monitored until EMS arrived. Paramedics on scene. Vitals BP 89/60, P 67, O2 100%, Blood sugar 81. Patient taken to hospital via ambulance.
minor sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE), administration date: 01Apr2021, when the patient was 60-year-old, for Covid-19 Immunization, reaction(s): "atrial fibrillation", "heart palpitations", "some very slight lesser functioning on the left side of her heart"; Bnt162b2 (DOSE 1, SINGLE, Date: In spring of 2021, believes Mar2021, NDC, lot, expiry: Unknown, vaccination card is at home), administration date: Mar2021, when the patient was 60 years old, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "minor sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter and her husband were both vegan. When possible, they try to avoid products derived from animals. That was one of the reasons they went with the Pfizer BioNTech Covid 19 vaccine. They try to use vegan products within reason and know sometimes things come from cell lines, and it's not like a hamster or cow has to be slaughtered to make each vaccine. Same argument even from fetuses, that it's a cell line not that it's not continuous. She just wanted to let Pfizer know that, when possible, it would be great if products were not manufactured using animal products. Each of them had 6 shots of the Pfizer Covid vaccine, two of the initial and 4 boosters. She only had a reaction after the second shot, not the boosters that are spaced out for 6 months. She had no bad reactions other of the Pfizer Covid vaccines other than minor sore arm with any of the subsequent boosters. She's had no bad reactions with any subsequent boosters other than a sore arm. Reporter stated reporter's husband had sore arm, and maybe was feeling a little beat-up next day, and caller had a similar type thing with all doses. All doses were given 6 months apart, 3rd dose was probably late Sep2021, then 4th dose given 6 months after, so each time like late September and maybe late sometime in April. The patient then was brought back in for unofficial mini echo a couple months later before end of year, either Nov2021 or Dec2021 and function was normal by that time. Reportedly, serious: no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289194 same patient and event, different dose;
pt recv vax & devel swelling @ the inj site;pt devel a2cm by 3cm nodule @ the inj site;
Felt "funny", ached, arm "big & hot"; elbow joint the size of grapefruit with redness, pain, pressure - injection site dark color, slightly raised. Treated with 10 day antibiotic and OTC ibuprofen. 10/26/12 F/u call; most swelling at elbow gone, pain decreased, redness minor - injection site "maroon" in color & size of 1/2 dollar still.
Pfizer booster given on 9/26/22. Admitted for new onset atrial fibrillation 11/26/22
feeling hot; flushing; tachycardia; Rash on her face, chest, eyes, nose, genitals, throat and their mucus membranes; Chills; Very slight fever; Nausea; Classic flu like symptoms; Aches; Redness on the outside and blisters on the inside on her lips and genitals; The rash is red and more a burning sensation than itching; Burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Classic flu like symptoms), PAIN (Aches), ERYTHEMA (Redness on the outside and blisters on the inside on her lips and genitals), RASH PRURITIC (The rash is red and more a burning sensation than itching) and BURNING SENSATION (Burning sensation) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hormone replacement therapy. Concurrent medical conditions included Hashimoto's thyroiditis. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's thyroiditis, ESTRADIOL for Hormone replacement therapy, ESZOPICLONE (LUNESTA) for Sleep disorder.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Classic flu like symptoms), PAIN (Aches), ERYTHEMA (Redness on the outside and blisters on the inside on her lips and genitals), RASH PRURITIC (The rash is red and more a burning sensation than itching), BURNING SENSATION (Burning sensation), RASH (Rash on her face, chest, eyes, nose, genitals, throat and their mucus membranes), CHILLS (Chills), PYREXIA (Very slight fever) and NAUSEA (Nausea). On an unknown date, the patient experienced FEELING HOT (feeling hot), FLUSHING (flushing) and TACHYCARDIA (tachycardia). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and MICONAZOLE NITRATE (MONISTAT) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Classic flu like symptoms), PAIN (Aches), ERYTHEMA (Redness on the outside and blisters on the inside on her lips and genitals), RASH PRURITIC (The rash is red and more a burning sensation than itching), BURNING SENSATION (Burning sensation), FEELING HOT (feeling hot), FLUSHING (flushing), TACHYCARDIA (tachycardia), RASH (Rash on her face, chest, eyes, nose, genitals, throat and their mucus membranes), CHILLS (Chills), PYREXIA (Very slight fever) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-060837 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: significant follow-up received,ADR: safety information
Began to have tinnitus after ~5 hours, fullness of ears and pain in face/right ear. Have no history of tinnitus. Approximately 5 days later, began to experience vertigo. It is now 8 days and there has been no reduction in either symptom after being subscribed prednisone.
Left thigh swollen, red and hot to touch.  7x3 inches area of inflammation.