chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mildly feverish evening after vaccine; Soreness and tenderness at left arm injection site; This is a spontaneous report from a contactable physician (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; second dose (lot number: EL1284, expiry date: unknown) via an unspecified route of administration on 07Jan2021 07:00 at single dose (Left arm) for COVID-19 immunization. Patient took bnt162b2 first dose (lot number: EK5730, expiry date: unknown) on 17Dec2020  07:00 am (Left arm) for COVID-19 immunization. Medical history included known allergies: Sulfa, Hypothyroid, Asthma, Hi Cholesterol.  Concomitant medication included cetirizine hydrochloride (ZYRTEC), atorvastatin, levothyroxine. The patient previously took tamiflu and experienced allergies.  Facility type vaccine was hospital. 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. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Mildly feverish evening after vaccine, Soreness and tenderness at left arm injection site on 07Jan2021. The patient took Motrin as treatment. Therapeutic measures were taken as a result of mildly feverish evening after vaccine, soreness and tenderness at left arm injection site. The outcome of the events was recovered on an unspecified date. The events were reported as non-serious.
First when leaving site after 15 min. I felt weird (only way to explain it).  Once I arrived home I started haveing a sever headache as the light on my eyes hurt.  I was very sick to my tummy, felt hot/then cold.    I felt after a couple hours I should try to walk it off - but could only walk to end of block.  sat down for a while and the sounds and light were making me sicker.  I got up from neighbors house as she felt I should go lay down  This is now 4 hours after shot.  I got up and was very dizzy.  walked back to house and laid down.  very dizzy,   I tried hard to relax, but decided I should eat a little something even though tummy was sick.  I had a little bite to eat and laid back down.  I finally took my heat rate, now about 5 hours after shot and AT REST IT WAS 90.  my normal rate is 57-63 at rest.   I drank water and stayed in bed the rest of the day,, although I did not sleep all night.  Next day go up and  felt the same.   but my heart rate was lower at rest to 63.  I was hot/cold all day, felt sick and very very tired.  I rested that day as well and rested for 3 days.  I made myself walk my dog, but no energy.  I made myself eat, but not really hungry, food tasted different. and to this day still does.  I am still feeling very tired and get hot/cold, but after almost two weeks feeling better.   I don't take flu shots because I get sick, I got very sick on this shot.  too bad you don't tell these stories on the news.  I am healthy don't take drugs, hardly take a aspirin.!  I am in good health but now feel my chest is heavy and still tired.
Vaccine vial was first punctured over 24 hours ago (administered); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine vial was first punctured over 24 hours ago (administered)) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 036C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine vial was first punctured over 24 hours ago (administered)). On 04-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine vial was first punctured over 24 hours ago (administered)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that the vaccine was punctured 24 hours prior to administration and kept in the refrigerator. The patient did not report any adverse symptoms following administration.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Initial additional, demographic details updated. On 14-Jun-2021: Initial additional.
redness and swelling at the injection site; redness and swelling at the injection site; This spontaneous report as received from a physician via a company representative refers to a 72-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), one dose subcutaneously for prophylaxis (frequency, lot # and expiration date were not provided). On 12-SEP-2019 (reported as within 24 hours after injection), the patient developed redness and swelling at the injection site. The patient sought medical attention, however there was no treatment given for the events. The outcome of the events was reported as recovered on the same date.  The causality assessment between the events and the suspect vaccine was not reported.
Information has been received from a pharmacist concerning a female patient "around 61 years old" who on 02-NOV-2006 was vaccinated with a first dose of Pneumovax 23 (lot # 651401/0619F).  Subsequently, the patient developed nausea, vomiting, itching and swelling at the injection site.  The patient was treated with BENADRYL and "seem(ed) to be responding."  The pharmacist requested a lot check.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of agency and was released.  Additional information has been requested.
After administering Pediarix in the Right Vastus Lateralis patient immediately had a small isolated cluster of bumps with redness appeared above injection site. Observed for 10 minutes post injection and no sign of progression or improvement. After provider and preceptor evaluation, advised that patient stay in clinic for additional 10 minutes. Another check in on patient and redness had resolved however bumps remained. Provider evaluated again and patient was discharged home with instructions to parents to observe area and to contact our office if worsens
The area (examined by me) is raised, red, painful, itchy, and causing general malaise.  No fever is noted.
No adverse event; lot that had been expired was administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients) and NO ADVERSE EVENT (No adverse event) in a 79-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients).    Patient age was reported as 79 Year 4 Months.  No concomitant medication was provided.  ID number was reported as 80777027399.   Lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022.  Treatment medication was not provided by the reporter.
Extreme fatigue.  Serious pain at injection site. Whole body pain moderate.  Lasting for 20 hours, continues. Lost a day of work.
21MAY91 pt vax; exp temporomandibular joint pain on rt side 2 hrs after vax & temporomandibular joint pain on both sides 16 hrs after vax.
Severe tiredness/Fatigue; Red face; Hot face/Hot; Swollen glands on face; Pinching quick pains in lymph areas of body; Joint stiffness; Muscle soreness for days/Muscle pain; Hot; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Sep2021 13:00 at the age of 60-years-old (Lot Number: FC3182) as single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included Known allergies: Sulfa, Sulfates. There were no concomitant medications. On 12Sep2021 13:15, the patient experienced adverse events: "Red face. Hot face. Swollen glands on face. Pinching quick pains in lymph areas of body. Joint stiffness. Muscle pain. Fatigue. Hot. Severe tiredness. Muscle soreness for days." AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment for AE. The outcome of events was recovered with sequelae.
Near syncope; feeling lightheaded/ dizziness; flue like symptoms; chills; headache; muscle aches/ body aches; fatigue; fever of 101°F; nausea; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (flue like symptoms), PRESYNCOPE (Near syncope), DIZZINESS (feeling lightheaded/ dizziness), MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and CHILLS (chills) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy (cephalosporins) and Drug allergy (sulfa drugs). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Jun-2020 to an unknown date for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 19-Jun-2021. On 02-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (flue like symptoms), DIZZINESS (feeling lightheaded/ dizziness), CHILLS (chills), HEADACHE (headache), MYALGIA (muscle aches/ body aches), FATIGUE (fatigue), PYREXIA (fever of 101°F) and NAUSEA (nausea). On 03-Mar-2021, the patient experienced PRESYNCOPE (Near syncope). On 03-Mar-2021, CHILLS (chills) and PYREXIA (fever of 101°F) had resolved. On 11-Mar-2021, INFLUENZA LIKE ILLNESS (flue like symptoms), DIZZINESS (feeling lightheaded/ dizziness), HEADACHE (headache), MYALGIA (muscle aches/ body aches) and NAUSEA (nausea) had resolved. At the time of the report, PRESYNCOPE (Near syncope) and FATIGUE (fatigue) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CHILLS (chills), HEADACHE (headache), MYALGIA (muscle aches/ body aches), FATIGUE (fatigue), PYREXIA (fever of 101°F) and NAUSEA (nausea) to be probably related. No further causality assessments were provided for INFLUENZA LIKE ILLNESS (flue like symptoms), PRESYNCOPE (Near syncope), DIZZINESS (feeling lightheaded/ dizziness) and MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy).    No treatment information was provided
Mom report on 4JUN91, 1 wk post vax pt had rectal t102 @ 4PM; tx APAP x 2; Pt remained afebrile until 5JUN91 t104 & light colored rash on back & chest was noticed; Pt vomited x 2 also irritable; Seen by MD
31yr old women admitted to Hosp with hives and tightness of her chest for the preceding 36 hours, at least. Approximately 36 hrs after vaccination had hives, prutitus, tightness of the chest, dyspnea, urticaria & wheezing.
At site of injection, patient experienced swelling, soreness, redness, and warmth. Acetaminophen 650 MG Other, cephalexin 500 - Rx, but never too MG QID.
Cannot raise or stretch arm of injection site without considerable pain and tightness.  Must hold arm up with opposing arm to reach full height and stretch.
Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patient's information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
nauseous; dizzy; Threw up 3 times; could not get out of bed for 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Nov2021 15:30 (Lot number: FH8027) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 01Oct2021; ALIGN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2590, Vaccine Administration Time: 03:30 PM), administration date: 19Oct2021, when the patient was 12 years old, for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 13Nov2021 03:00, outcome "recovering", described as "nauseous"; DIZZINESS (non-serious) with onset 13Nov2021 03:00, outcome "recovering", described as "dizzy"; VOMITING (non-serious) with onset 13Nov2021 03:00, outcome "recovering", described as "Threw up 3 times"; BEDRIDDEN (non-serious) with onset 13Nov2021 03:00, outcome "recovered" (14Nov2021), described as "could not get out of bed for 24 hours". Therapeutic measures were not taken as a result of nausea, dizziness, vomiting, bedridden.  Additional Information: Facility type vaccine was other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Other medications in two weeks were OTC Accentrate. Known allergies: Not that we are aware.  No follow-up attempts are possible. No further information is expected.
Narrative:  73yo male Pt with a h/o T2DM, COPD on 2-3L NC at home,  CKD stage 3, NPH s/p VP shunt, OSA on CPAP, PTSD/Anxiety, who presented to  VA ER on 12/23/2021 for shortness of breath x 3 days. Pt was admitted with Acute on Chronic Hypoxic Respiratory Failure 2/2 COPD Exacerbation vs Cor Pulmonale in the setting of Pulmonary Hypertension, poa diagnosis. Pt given antibiotics, treated in the ICU as pt deteriorating. Pt then died on 1/10/2022.  Death was caused by: Severe ARDS secondary to Enterococcus faecium and  Enterococcus faecalis. Pt had received covid vaccines on 1/25/21, 2/22/21, & 11/9/21 from other facility site. This death was not related to covid vaccines.
pt recv vax & began w/rash on chest, itching & whelps; 5MAY95 was gone; then said had forgotten the same kind of sx p/1st inj;
AFTER RECIVING VARICELLA VACCINE, ABOUT FIVE MINUTES LATER DEVELOPED WHEEZING, ITCHING, DIFFUSE SKIN ERYTHEMA.
It started with just a sore arm at injection site but developed to swelling and now redness. Also feel achy and very tired. Unable to work at my job at full capacity. Having to go to bed at 8 pm because of exhaustion. The affects are still prevalent today and I called the pharmacy yesterday to report it but they were not very receptive, telling me that it should to cause reaction because it is not a live virus shot.
At three AM I woke up with the room spinning, I couldn't focus, felt like I was falling. I had horrible pain in my back. I was sweating and vomiting.  My husband carried me to the car and brought me to the ER. At the Er I was given a patch for my back pain, medicine for the dizziness and nausea. The dizziness didn't subside. I couldn't walk. I told them I had gotten the vaccine two weeks before and they said it wasn't related. I was diagnosed with a bladder infection, high blood sugar, and vertigo. I was discharged in the evening but with no improvement.  I was not able to focus or walk for days. I saw my OBGYN, he was the only doctor I could see right away and he referred me to an ENT. The ENT can't see me until the end of June.  I wasn't able to drive for weeks. I am slowly regaining my balance but still feel waves of dizziness and my eyes can't focus well when I am reading. The back pain is gone. My OBGYN also doesn't feel the dizziness is related.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided          Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Multiple hives noted over posterior aspects of bilateral thighs and knees, bilateral  elbows and bilateral axillary areas.  Vaseline and lotion gave temporary relief.  Hives returned back the following day.  This time Rashes completely stopped after taking Zyrtec.
Pt. states that after receiving the 2nd dose of Shingrix 12/07/2021, started experiencing symptoms that evening of fatigue, nausea, and rash at the injection site. Primary visit 12/11/2021 diagnosed with Shingles outbreak. Gabapentin (for pain), Lidocaine, and Valacyclovir for 7 days.
On day 9, the injection site swelled, became raised red and splotchy, itchy, and hot.
Report 20010072721 described antigenemia in a female vaccinee of unspecified age who received hepatitis B vaccine recombinant (engerix-B). Allergies, medical history, and concomitant medications were unspecified. The reporter stated that the vaccinee was presumed to have a negative hepatitis B surface antigen prior to immunization with Engerix-B. On 02/22/2001, the vaccinee received her first "adult" dose of Engerix-B. Labs done on 02/27/2001 showed positive for hepatitis B surface antigent. As of 03/19/2001, the outcome of the event is unknown.
Patient came in for second dose today 6-10-21.  She stated that about 7-10 days after the first shot she had a terrible itching near the injection site.  The left arm had fever, redness, and rash.  It lasted for 3 or 4 days and is fully resolved with no other complications.
40 - 60  minutes I had light-headedness and then several hours later, around 3:30 pm, I started to develop a mild fever - 99.2.  I took a Tylenol to help fever go down. When I woke up the next morning, I felt fine.  I developed a rash about two weeks ago  - April 30th, and that stayed for a good week. The rash was on my pelvic area - worse on my right side than on my left. Two days later it was where I bend my arms on the inside of my elbow. That went away quickly and the other rash on my pelvic area is almost gone. I did have a phone visit with doctor on the 6th - and they prescribed hydrocortisone cream. That helped with the symptoms. Pregnancy history: 1st pregnancy. Due date: 11/19/2021
Patient received her second COVID 19 shot on  April 26, 2021.  She began to feel general fatigue toward middle/end of May. Also at end of May she began to experience chest pain when working out.  On June 14th she felt chest pain just walking and developed a cough.  I took her to ER on June 15th around 1am.  Her chest X-ray showed some abnormality.  Around 3am she had significant difficulty breathing.  She was admitted and a cardiologist and pulmonary physicians determined she was in heart failure with an ejection fraction of 10%.  She was life flighted to another hospital where she spent 3 weeks on Echmo and Impella, received a heart transplant on week 4 and is still in ICU recovering.  We are not sure if the vaccine is related to her illness.  We just know that patient was a healthy 19 year old, former high school athlete, current straight A student having completed her freshman year of college, and no health issues prior to this event.
Local site reaction to PREVNAR vaccine - redness, warmth, induration of whole upper leg x 3 days.
Site: Pain at Injection Site-Medium, Additional Details: pt reported that arm is painful and has been seeking physical therapy for event. Pt did report of soreness with 48 hr window, but there was no contact until a yesterday (8.16.2022). I prompted this report upon conclusion of our conversation.
Case previously recorded as MA2009-3183. Initial case report received from a health care professional, via Novartis Medical Communication, on 20 OCT 2009. A 3 year-old male patient was vaccinated with S-OIV FLUVIRIN (batch no. 100739) i.m. into the left deltoid, on an unknown date. No adverse event was reported. Agency reference no.: NA09-006675.
This spontaneous report was received from a nurse (L.P.N.) refers to unspecified patients who were vaccinated with improperly stored RECOMBIVAX HB. It was reported that the first excursion occurred in May, 2011 where RECOMBIVAX HB were exposed to 31 F to 4 hours and the second excursion occurred on 29-MAY-2012 where RECOMBIVAX HB were exposed to 30F for 12 hours. No adverse effects reported. Additional information has been requested.