chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe hives all over the body, beginning about 48 hours after vaccine; This is a spontaneous report received from a non-contactable consumer (reporting on herself). A 71-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm Right on 06Feb2021 09:15 as single dose for COVID-19 immunization. Medical history included contrast media allergy from an unknown date and unknown if ongoing. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19 Since the vaccination, the patient has not been tested for COVID-19. On 08Feb2021 01:00, patient experienced severe hives all over the body, beginning about 48 hours after vaccine. Patient did not received any treatment for adverse event. The outcome of the event was recovering.   No follow-up attempts are possible. Information on the lot/batch number can not be obtained . No further information is expected.
patient developed a reaction with the formation of necrotic tissue at the injection site; This serious case was reported by a other health professional via sales rep and described the occurrence of injection site necrosis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site necrosis (Verbatim: patient developed a reaction with the formation of necrotic tissue at the injection site) (serious criteria GSK medically significant).  The outcome of the injection site necrosis was unknown.   It was unknown if the reporter considered the injection site necrosis to be related to Shingrix.     It was unknown if the company considered the injection site necrosis to be related to Shingrix.   Additional Information: GSK Receipt date: 28-AUG-2023 A reporter reported that a patient developed a reaction with the formation of necrotic tissue at the injection site after receiving a dose of Shingrix.  They provided limited information and gave the e-mail of the aforementioned healthcare professional. The reporter consented to follow up.
(L) deltoid has small scattered hives and redness. 2 tsp po Benadryl (12.5 mg/5 ml) given. Pt observed for additional 30 min - hives gone. No s/s of reaction. Pt in stable condition.
Bacterial bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS BACTERIAL (Bacterial bronchitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not reported.).   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced BRONCHITIS BACTERIAL (Bacterial bronchitis) (seriousness criterion medically significant). At the time of the report, BRONCHITIS BACTERIAL (Bacterial bronchitis) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant medications and relevant medical history were not reported. The patient received her first dose of the vaccine on 23-Mar-2021.  She "got bacterial bronchitis after the second dose starting 02-Apr-2021."     This case was linked; Sender's Comments:  brother case
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID: A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches". Additional information: The reporter said he talked to 200 people who have a headache from that booster shot. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300034302 Same reporter/ drug/ event for different patients;
Approximately 3 hours following the vaccination, I started having hives/rashes across my body, starting below my neck, chest, and moving to my arms and stomach and back area.   Approximately 7 hours later, hives still remain.
Headache and dizziness started at 9:00PM and 400mg of ibuprofen was taken (13 hours after vaccination).  Chills and body aches began shortly after at 9:30PM.  By 10:00PM all symptoms drastically worsened with a pounding headache, extreme dizziness and nausea, severe chills and aching with uncontrollable shaking, fever of 103°F, and delirium that continued until 1:00AM.  At 1:00AM chills, aching, and delirium were gone but 101.5°F fever remained with headache and dizziness.  The day after the vaccination, low grade fever of 100°F, headache, dizziness, and exhaustion persisted all day long from 7:00AM until sleep at 11:00PM.  There was also minor pain at the vaccination site in right arm.  By the third day, headache and dizziness were gone but still feeling tired and pain at vaccination site.  On the fourth day almost entirely back to normal.
Vaccine administered at 1:20 pm and patient reported feeling hot, dizzy, and was worried he was going to faint at 1:30pm.  The patient laid on the ground and was pale and visibly sweating. Patient was given gatorade and began feeling better within 2 minutes.  Blood Pressure and Heart Rate were taken at 1:32pm and 1:50pm and both within normal limits.
Tinnitus developed in left  ear approximately 2 weeks after first covid vaccine dose. It has persisted with no sign of waning.  High pitched frequency is heard constantly.  No treatment sought yet.
I received the first dose of the corona vaccine on 02/06/21.  On the following day, 02/07/21, I noticed a pimple or red mark on the my left side near my ribs.  The next day, 02/08/21, the red mark or pimple was more noticeable.  The area itches me.  On 2/09/21, I noticed the pimple or red mark getting bigger.  On 2/10/21 I noticed that I have three more pimples or red marks on my stomach.  The biggest one is on my left side by my ribs.  The biggest one seems to have liquid inside, it itches, and burns a little.  I went to the pharmacy on 2/10/21 and asked them what I should put on it.  I explained that I think it is a reaction to the vaccine.  The doctor at the pharmacy told me to put cortizone cream on it and it should get better in a few days.  She said if it does not then I should see a doctor.
heart arrhythmia; This is a spontaneous report from a contactable consumer (patient).   A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on Mar2021 (Lot Number: ER8732) (at the age of 43-year-old) as single dose for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL) taken for an unspecified indication, start and stop date were not reported.  The patient experienced heart arrhythmia on Mar2021. The patient outcome of the event was unknown.
INSULIN NEEDLE TO ADMINISTER JANSSEN COVID-19 VACCINE WITH INJECTED IT AT 90 DEGREE ANGLE; This spontaneous report received from a physician via a company representative concerned a 6 decade old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAY-2021, the subject experienced insulin needle to administer janssen covid-19 vaccine with injected it at 90 degree angle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of insulin needle to administer janssen covid-19 vaccine with injected it at 90 degree angle was not reported. This report was non-serious.
swelling, redness, tendernes around inject site, fever elevated; uss afebriel, 3cms x 3cms inflammed tender, red area around puncture site; cellulitis pt given Cloxacillin;
Red rash on her arm; it is itchy; soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on her arm), VACCINATION SITE PRURITUS (it is itchy) and VACCINATION SITE PAIN (soreness in her arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness in her arm). On 20-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on her arm) and VACCINATION SITE PRURITUS (it is itchy). At the time of the report, RASH ERYTHEMATOUS (Red rash on her arm), VACCINATION SITE PRURITUS (it is itchy) and VACCINATION SITE PAIN (soreness in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
sore shoulder at shot location, fatigue, body aches, headache, nausea; took naproxen on 7/11 in the morning at time of onset and in evening before bed, rested entire day; symptoms resolved by following morning 7/12
FATIGUE; TIREDNESS; VOMITING; CHILLS; RASH ON MY NECK, ARMS AND UPPER CHEST; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid 19, and covid 19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced chills.  On APR-2021, the subject experienced rash. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced fatigue.  On 13-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, nausea, vomiting, headache, fever, fatigue, tiredness and rash was not reported. This report was non-serious.
pt recv vax 23JUL98 & on 25JUL98 vesicles stayed herpetic periorbital;cellulitis w/conjunctivitis dx 27JUL98;tx med;seen by ophthalmologist;
Later in the evening after receiving the vaccine, I had severe pain behind/underneath my right ear. It was a throbbing pain and when I pushed down in that area with my finger, I cried in pain. My pulse was elevated and I took an aspirin in case it was a clotting issue. Woke up the next morning feeling fine.
EXPIRED VACCINE ADMINISTERED; PUNCTURED VIAL WAS STORED IN THE REFRIGERATOR FOR  6 HOURS AND 36 MINUTES; This spontaneous report received from a pharmacist concerned a 56 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced punctured vial was stored in the refrigerator for 6 hours and 36 minutes. On 02-JUN-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered and punctured vial was stored in the refrigerator for 6 hours and 36 minutes was not reported. This report was non-serious.
After receiving 3 vaccinations (KINRIX, MMR, Varicella) pt fainted. Pt revived on her own. Provided cool cloth and water. Parent told to f/u with PCP.
High fever at 100.6 degrees Fahrenheit Body aches and pains Stuffy nose
Swelling of left arm around area of injection with warmth to touch and soreness for a few days. At site of injection there is still persisting pea sized red rash. For first week of rash at area of injection there were also white bumps. While rash area persists there is no current pain or itchiness.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: pt fainted for a few second then he regain his consciousness and response to his family questions. pt look a little pale.
Non responded following 2nd complete series of Hep B vaccine. Follow up information - Vaccine manufacturer , vaccine lot number, and vaccine administration date provided.
Minor case of shingles on right side approximately 8 days after 1st dose of vaccine
Vomiting 24 hours later. The next few days intense heartburn followed by a full body rash (small red hive looking bumps) and extremely swollen feet  (May 11). Swelling on lip and leg May 15 too.
Small hive like localized about 1 inch x 2 inch in size on right middle back/waist. Patient states she has pain from that area radiating toward right armpit/breast.
Tested Positive for Covid. Fully vaccinated; Tested Positive for Covid. Fully vaccinated; This is a spontaneous report from a contactable consumer (Pfizer employee) via COVID-19 Vaccine Adverse Event Self-Reporting portal. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 1, single, and via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 2, single, for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had no Covid prior vaccination. On 04Aug2021, the patient tested positive for Covid (post vaccination). The patient was fully vaccinated. Treatment for the adverse event (AE) was unknown. The patient was recovering from the event.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Redness at injection site, tender to the touch, warn at redness but not like an infection. Much like I get from the TB tine test. This is 8 days after covid injection.
Urticaria generalized, thorax, abdominal wall, arms, legs, hands and genitalia and tongue swelling  4/2/201. Rash persistent to date but has diminished with Allegra 180mg once a day and Prednisone 20mg once a day for 7 days then 10mg once a day for 7 days which started just yesterday (had no ride to get meds up until yesterday)
Patient had mild pain in the arm where injection was placed (more bothersome than painful). Also reported mild eye pain, rated as a 2-3 out of 10 on the pain scaled, noticeable if presses on eyelids, remains regardless if outdoor or indoor. Mentioned that his boss was gone the week previous to symptoms and he worked extra hours at a construction site and thinks eye pain may be due to that.
About 24 hours after I received the first dose of the Moderna vaccine, I broke out in itchy hives all over my body.  I too two Benadryl and the hives went away.
After receiving Covid Vaccine EE c/o tingling in lips no swelling noted no other c/o.  B/p 128/74HR 70 )2 Sat 98% monitored employee for total of 30 minutes RRT and eval in the ED refused upon leaving EE reports the tingling  to be minimal.
C/O a red and raised welt about 2 inches in diameter, with some discomfort. 05/16/2008 Information has been received from a medical assistant concerning an 8 year old female, with no pertinent medical history, drug reactions or allergies, who on 31-OCT-2003 was vaccinated with her first dose of VARIVAX (Oka/Merck). On 06-MAR-2007 the child was vaccinated subcutaneously in the right arm with her second dose of VARIVAX (Oka/Merck), (Lot #654756/1335F). She also was vaccinated with VAQTA (MSD) that same day. The child developed a red raised welt; about two inches in diameter after her second dose with VARIVAX (Oka/Merck). It was reportedly uncomfortable. Treatment was cold compresses. No lab diagnostic studies were performed. The patient's status at the time of the report was recovering. Unspecified medical attention was sought. There was no product quality complaint. The office requested a lot check on Lot # 654756/1335F. This report is one report of five reported by the same source. A review of the release testing data revealed that the lot in question conformed to all required testing at the time of product release. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is expected.
I came down with flu-like symptoms within four hours on the vaccine: severe fatigue, aches in most muscles, tiredness, chills and sweats. These symptoms faded on the evening of the second day after my vaccine, but then in the evening of 9/22/22, I began feeling strong heart flutters, with pressure in my chest during the skipped beats. This continued for the next few days and I scheduled an appointment with my primary. On 9/26/22, my primary put a Holter monitor on me for 48 hours. It showed PVCs with a burden of 8%. My primary then put me on Metropolol, which I took for several days, but it did not help and the side effects were too unpleasant.  Over the next few days/weeks, the PVCs became more frequent, making it difficult to sleep. I then scheduled an appointment with an electrophysiologist. On 10/26/22, Dr. ordered an MRI and stress tests. The tests showed I had a borderline enlarged aortic root, PVC's, and several other issues such as a partial  bundle branch blockage, reduced perfusion during exercise. These results were reviewed by Dr. who then referred me to a cardiologist, at the same facility. I saw Dr. on 1/6/23, and he still heard the PVCs. He referred me for further study (heart CT), which is pending. Although the PVCs has lessened in frequency, the still occur at various times throughout the day, especially when laying down. I had never had PVCs before the vaccine and have had numerous EKGs before surgical procedures.
By 4pm in the afternoon, my arm (from elbow up to my neck) became extremely painful. I couldn't lift the arm without using my right arm as a helper. I had to cancel a social engagement that evening because I wasn't capable of driving. Also, Thursday and Friday I was nauseous, light headed, and fatigued. Friday my arm felt a little better, but I still wasn't able to put a shirt on over my head. Saturday (today) the arm was sorer again, but in a more concentrated location, at the top of the shoulder. Also, by Saturday morning I'd developed a mild "butterfly" rash across my chest.
Have sore arm; headche; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On 14-SEP-2023, the patient received RSV vaccine and INFLUENZA VACCINE. On 14-SEP-2023, less than a day after receiving RSV vaccine and an unknown time after receiving INFLUENZA VACCINE, the patient experienced pain in arm (Verbatim: Have sore arm) and headache (Verbatim: headche).  The patient was treated with paracetamol (Tylenol). The outcome of the pain in arm and headache were not resolved.   It was unknown if the reporter considered the pain in arm and headache to be related to RSV vaccine.     It was unknown if the company considered the pain in arm and headache to be related to RSV vaccine.   Additional Information: GSK receipt date: 14-Sept-2023 The case was received from the patient via  interactive digital media. The patient got the flu and RSV vaccines on the day of reporting and less than a day after vaccination, had sore arm and a headache right now but nothing he or she can not live with.  The patient took Tylenol and should be good by tomorrow. It was unknown if the reporter considered the pain in arm and headache to be related to flu vaccine.
His arm hurt; A little tired; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had zero issues, his arm hurt. The patient was fine, nothing happened to him, he had nothing, he was a little tired and his arm hurt. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a male smoker patient with chronic obstructive pulmonary disease who in 2008 was vaccinated with 0.05 ml dose of PNEUMOVAX as if it were for a PPD test under the skin. It's unknown if product confusion. The patient developed an unspecified reaction that affected his total arm affecting his ability to work. The patient has sought medical attention at office. This happened in 2008 and PNEUMOVAX given as a PPD test by mistake which resulted in "arm disability" that is the subject of a lawsuit. No further information available. Legal Issue Involved - AE sent to Legal. Affected ability to work was considered to be disabling by the physician. Additional information has been requested.
Patient fainted for 5 seconds after received vaccines. Her skin was pale, moist, warm to touch. Patient recovered without receiving any treatment.
DOSE ADMINISTERED WAS USED FROM A VIAL IN THE FRIDGE THAT WAS 6 DAYS PAST EXPIRATION
Facial swelling: In the morning following vaccination, patient woke up with puffy and swollen eyes and cheeks. Eyes were really puffy but looked better by doctor's appointment later in the morning.  No difficulty breathing, no difficulty swallowing, no rash.  Vomiting: Vomited 2-3 times at night when the vaccinations were administered in the afternoon.  No vomiting the following day.
This spontaneous report as received from a pharmacist refers to a "roughly" 65 years old female patient with allergy to RITUXAN and no pertinent medical history. On an unknown date, the patient was vaccinated with a dose of PCV (manufacturer unknown, PNEUMOVAX could not be ruled out) (dose, route and lot# number not provided). Other suspect therapies included influenza virus vaccine (unspecified) (dose, route and lot# number not provided) administered on an unknown date. On an unknown date, the patient developed severe swelling in her arm. The outcome of severe swelling in her arm was reported as recovered on an unspecified date. Causality between the event and suspect therapies was not provided. Additional information has been requested.