chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Donor 5-10 minutes after injection , c/o nausea & queasiness in stomach.  Approx. 1/2 hrs later c/o continued nausea with small am't of vomiting.  Another 1/2 hr donor stated he felt better & no further complaints was able to eat & drink.  This is his 2nd injection.
Getting dizzy and lightheaded; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female non-pregnant patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 19Jan2021 13:00 at right arm, at single dose for covid-19 immunization.  Medical history included Asthma, allergies, diabetic, high BP, hypothyroidism and Known allergies: Penicillin and Sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had Other medications in two weeks. Within 5 minutes of receiving her first dose of the vaccine the patient started getting dizzy and lightheaded at 19Jan2021 13:15 (as reported). Lasted 10 minutes then it gradually went away. No treatment was received. The outcome of the event was recovered on 19Jan2021 13:25. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Severe diarrhea, totally liquid, beginning the next morning after the COVID-19 shot and lasting 5 days until over-the-counter medication for diarrhea taken on the morning of the 5th day of occurrence. Next morning, no bowel movement. Next morning, seven days after the vaccination,  bowel movement almost "normal".
Redness, swelling and warmth at injection site extending from right axilla to right elbow.
Blood pressure jumped to 220/140; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208),  via an unspecified route of administration on 18Mar2021 (at the age of 65 years) at a single dose in the left arm for COVID-19 immunization. Medical history included atrial fibrillation, high blood pressure, and stage 3 kidney disease. No allergies to medications, food, or other products. Concomitant medications included atenolol; losartan; allopurinol and multivitamins. The patient previously took the first dose of BNT162B2 (lot number: CN6198) on 25Feb2021 at 12:00 pm (age: 65 years) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 30Mar2021 at 11:00, the patient blood pressure jumped to 220/140. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized for 4 days. Therapeutic measures were taken as a result of the event which included lab tests and medications. The outcome of the event was recovered with sequel in Apr2021.
General side effects were felt overnight;  Chills, nausea and low grade fever;  Pain  / Soreness at injection site became worse 24 hours after dosage
On 11/2 found injection site reddened in a 4cm x 5 cm area, warm to the touch, and he c/o itching.
Raised her arm and saw and felt there was a lump under the armpit; pain in the armpit; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Raised her arm and saw and felt there was a lump under the armpit), AXILLARY PAIN (pain in the armpit) and LYMPHADENOPATHY (Swollen lymph nodes) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced MASS (Raised her arm and saw and felt there was a lump under the armpit), AXILLARY PAIN (pain in the armpit) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form. At the time of the report, MASS (Raised her arm and saw and felt there was a lump under the armpit), AXILLARY PAIN (pain in the armpit) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took Tylenol for the pain and said she was getting ready to put on warm compresses. Concomitant product use was not provided by the reporter.
Approximately 5 mins after vaccine administration, patient became lightheaded and fainted. Patient regained consciousness and recovered quickly.
W/in 24 hrs of vax developed pruritic papular rash on arms & trunk; Lab eval showed CBC & ESR normal; Rec'd 2nd dose w/no adverse reaction;
Contracted COVID; Contracted COVID; almost died; antibodies were 1100; This is a spontaneous report from a Pfizer via a Non-contactable female consumer (patient, self-reported).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history included arthritus (she was unable to take Methotrexate for her arthritus). Concomitant medications were not reported. The patient reported that received both vaccines. On an unspecified date, she contracted COVID after first dose and was hospitalized on an unspecified date for 2 months where she was unable to take Methotrexate for her arthritis and stated almost died and antibodies were 1100, refused to get booster shot. The patient underwent lab test and procedure included antibody test on an unspecified date with a result of 1100 and SARS-CoV-2 test on an unspecified date with a result of Contracted COVID. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This infant had 0.8 cm x 5 cm irregular, slightly raised erythematous area on his left thigh. A- local reaction, B- observe.
Bad reaction within a few hours after getting the vaccine, nerves went haywire. Sharp shooting pains firing randomly in legs, feet, arms. Also had skin crawling sensation, tingling, paresthesias, twitching, and burning and tingling sensations. Also developed some numbness in distal extremities, which gradually subsided. Pain and twitching/spasms were bothersome enough to make it difficult to fall asleep, sometimes taking up to a half hour to fall asleep. This was frequent and intense for at least several weeks, but continued for several months, and still persists today almost 2 years later. After a few months, since the symptoms were persisting, started on Low Dose Naltrexone, which helped the nerve pain symptoms. My entire right arm was very sore and achy for about a week following the Tdap injection. I had never had that painful muscles after prior vaccinations of Tetanus, expected a little soreness for a few days, but this was more pain than usual and lasted longer.
Fully vaccinated patient admitted through ED for increasing shortness of breath found to be COVID positive.  Provider discharge note below:    Patient was hospitalized with increasing SOB found to have covid pneumonia. She was placed on a covid protocol, including ,regeneron infusion,  on admission of a 5 day steroid + remdesivir daily infusion. She has comorbidity of COPD on chronic oxygen she was quite stable requiring 2-3 liters NC oxygen which is her home level. She was found to have desaturations prn with activity normalizing with rest. She has chronic bronchiectasis and was maintained on mucinex in the hospital. On the day of discharge she was clinically stable, AO, up to the bathroom, eating well with baseline pulmonary exam of chronic mild wheezing and rhonchi. She is discharged home to a family situation of non vaccinated individuals they are planning on risk modification. ( masks, wipes, isolating) She is placed on a tapering prednisone protocol in view of her recent prolonged steroid use. "
Patients were administered from vaccines that experienced a T excursion; Patients were administered from vaccines that experienced a T excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients were administered from vaccines that experienced a T excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients were administered from vaccines that experienced a T excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients were administered from vaccines that experienced a T excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  HCP stated they had a temperature excursion and patients have been administered from these affected vaccines but did not have more information about the patients. The vaccines reached a Maximum temperature of 1.6 °C for 1 hour and 12 min.  Storage condition at the time of the excursion was refrigerated. Maximum or minimum temperatures reached, as applicable was Minimum 1.6 °C on 24-Mar-2022. Excursion duration was Hour and 12 min. Date vial(s) moved from freezer to refrigerator was 13-Mar-2022. The vials were stored in refrigerator now. Number of vials/doses impacted was 4 vials. Pertinent details, whether the vial(s) were punctured, any previous excursions with the impacted vial(s) was unpunctured and no excursions before.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2022: Non-significant follow up information received.
No adverse effect was reported.; Nurse reports that one dose of an improperly stored vaccine, VARIVAX (Lot #  R010466 / Expiration Date:  4/10/2020), was administered to one patient with the initials "AB" on 3/18/2019.; This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. Information of concomitant medication, pertinent medical history and drug reactions/allergies was not provided. Concomitant therapy included sterile diluent.   On 18-MAR-2019, the patient was administered with one improperly stored dose only of varicella virus vaccine live (oka/merck)(VARIVAX) (route: subcutaneous(reported as SQ); lot # R010466 with expiration date 10-APR-2020; strength and dose detail were not provided) to the arm for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck)(VARIVAX) was exposed to temperature excursion of 10.6 fahrenheit degree for 9 hours and previous temperature excursion of 9.5 fahrenheit degree for 5 hours and 15 minutes and 10.8 fahrenheit degree for 7 hours. No adverse effect was reported. Data logger was involved.
severe chills and shivering for about 2 hours. buried myself in blankets but could barely talk I with shivering so bad. woke up at 2:00 a.m. Sunday morning and was no longer shivering but I had muscle aches all over for another day
Menstrual period delayed by 8 days. Heavy PMS symptoms including breast tenderness, irritability, headache, cramping and bloating lasting for 10 days accompanied by a heavier than usual menstrual period but lasting a shorter amount of time than typically experienced previously (typical period is about 5-6 days long, this period was only 4 days in duration).  Worth noting the reason I was hyper aware that my period was late is 1) it has never been late in my entire life and I am 41 years old. 2) I use an app to track my cycle and it kept alerting me that it was late. I am on birth control and knew that I was not pregnant, however, it caused distress because I didn't know what was wrong with me and no one wants to have severe PMS for 10 days with no relief in sight.
Acute high fever increased 105 (Ax). Inconsolable crying 3-4 hrs. Infant's father had the same reaction as a baby with dose #2 and 3. Paternal grandfather is an MD and baby's PCP. Requested DT pediatric dose #4.
This is an instance of breakthrough COVID-19 after which death occurred. The indiviudal was vaccinated with the Pfizer product on 01/12/2021 and 02/02/2021. They tested positive for COVID-19 on 10/09/2021 at the nursing home at which they were a resident. I see no indication that the individual was hospitalized, but the nursing home healthcare provider may have more information. It was thought the only symptom the individual had was diarrhea. The individual died on 10/10/2021.
Event: Syncope  Duration: 1 minute  Treatment: Juice, snack, ice pack and rest  Outcome: patient recovered with treatment above within 10 minutes
Information has been received from a physician concerning a 17 year old female who on 31-AUG-2007 was vaccinated with the first dose of 0.5 ml Gardasil injection.  On 31-AUG-2007, the patient experienced nausea and hyperventilation.  The patient was taken to the emergency room.  Urinalysis, serum glucose, and metabolic profile were within normal limits.  Subsequently, the patient recovered from nausea and hyperventilation on 31-AUG-2007.  No further information is available.
Father said child complained his leg was sore on 6-4-07. Better on 6-5-07. Wrong vaccine given to patient should have been ProQuad - not Zostavax
24hr p/vax lt upper arm remains sore;48hr p/vax fatigue, gen muscles aches;72 hr p/inj inc intensity of muscles aches;48hr p/vax noticed 3" oval area of soreness, warmth & tenderness lt upper arm;pain w/touch/movement;no fever;no fati
1 hour - silver dollar-sized bruise. 2 days - first rash, itching, pain. 7 days - diagnosed chicken pox per pt prescribed ZOVIRAX and ALLEGRA.
Tired; Sleepiness and Groggy; The injection arm is sore like a 4-5 out on of 10 as far as pain; Sleepiness and Groggy; This is a spontaneous report received from a contactable consumer, the patient.  A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunisation.  The patient medical history was not reported.  The patient reported no concomitant drugs ("Extremely healthy, I take no medicine"). The patient reported that on 03Mar2021, the injection arm was sore like a 4-5 out on of 10 as far as pain and she felt a bit tired. She slept 10 hours yesterday (03Mar2021)  and feel a little groggy today (on 04Mar2021). The outcome of the events was unknown.   Follow up attempt possible. Information on the lot/batch number has been requested.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Additional Details: Received 2 shots on left arm same day. Pt received shots lower than usual and is bruised. Experiences sharp pain on arm on and off.
Patient received 2nd dose 2 weeks after the first dose (2weeks earlier) and we can not reach the pt
Pt received 3 vax on 7/31/2000 and 2 days later had redness & broke out with multiple blisters on palms and soles. Very itchy palms and soles have persisted though the blisters healed over one week. No other rash or sx, still mildly symptomatic.
pt c/o pain @ site of inj lt deltoid erythema 59 x 70mm;skin warm, hard to touch;abscess formation;t102;med given;
Pt. received Shingles vaccine 2/26/08. On March 14 she noticed areas on her extremeties and around her waistline (abdomen) that appeared to look like a rash, brownish in color and did itch
ON 2/22/07 PATIENT STARTED WITH TINGLY,ITCHY AREA ON BACK THAT BECAME A RAISED ,RED RASH ON BACK. IT IS MOSTLY ON ONE SIDE MORE THAN THE OTHER AND IS VERY PAINFUL AND CAUSES HER LEFT SIDE TO BE TINGLY. SHE WENT TO THE WALK-IN BECAUSE IT WAS THE WEEKEND AND THEY DIAGNOSED HER WITH SHINGLES. SHE WAS STARTED ON A COURSE OF VALTREX TO TAKE TID FOR ONE WEEK. SHE IS FOLLOWING UP WITH HER PRIMARY CAE M.D. WHO IS POSSIBLY TO DO LAB WORK.
Inflammation; my lymph nodes were swollen but I also have like this lymph node near my collar bone/Swollen lymph node next to collar base; Armpit soreness; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot Number: EW0183, Expiration date: not reported) via intramuscular, administered at hospital in left arm on 17May2021 at 11:00 (at the age of 42-years-old) as dose 2, single for covid-19 immunization. Medical history included, GERD/Acid Reflux start from Oct2020 to ongoing, Melanoma start and stop on Oct2008, Stage 1- surgery cancerous removed mole. Family medical history includes Autoimmune disease (e.g. diabetes), colon cancer, heart disease. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number: EW0171), via Intramuscular in the right arm on 24Apr2021 at 13.00 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Concomitant medication(s) included omeprazole (OMEPRAZOLE) taken Every other day by oral/mouth for gastrooesophageal reflux disease from Nov2020 to May2021; colecalciferol (VIT D [COLECALCIFEROL) taken for an unspecified indication, start and stop date were not reported. On 17May2021, patient experienced armpit soreness, on 19May2021 at 09.00, my lymph nodes were swollen but i also have like this lymph node near my collar bone/swollen lymph node next to collar base visited to physician office, On an unspecified date, inflammation. Patient did not received any treatment. Two days after receiving the second Pfizer dose, I noticed a lump on my collarbone not too far from the site where I received the injection. The lump was large and felt hard. Later in the day, I noticed it would move up and down and disappear. For two weeks now, it still pops out but moves and disappear behind the collarbone. It has decreased in size and is very mobile. The nurse told me it can take 2-4 weeks to dissolve. On an unspecified date, patient underwent lab tests and procedures which included on an unspecified date, blood test: came back fine, physical examination: came back great. The outcome of event inflammation was unknown rest all events was recovering.  Follow-up attempts are completed. No further information is expected.
Brief Description Patient presents to clinic to receive second dose Pfizer Covid 19 vaccine, parent present.. Parent provided Covid 19 Vaccination Record Card that showed 1st dose Pfizer was given. Parent requesting second dose of Pfizer Covid 19 vaccine. Upon documentation, it was discovered that patient had received second dose of Pfizer Covid 19 vaccine. Parent advised that patient had received second dose in the past. Parent continued to deny vaccine was given. Parent requesting for Covid 19 Pfizer second dose to be given today..
More than a week after injection, noticed itching. When looked saw redness and a lot of swelling in area of shot.
Pt states after receiving MMR and an TD on 2/17/00, skin broke out with a rash, hives, headache, seen at an ER on 2/17/00. Pt was diagnoses with allergic rash. Prescribed Benadryl and Aveeno bath.
This spontaneous prospective pregnancy report was received from a registered pharmacist concerning a female patient of unknown age. On unknown dates the patient was vaccinated with two doses (first and second doses) of GARDASIL (lot number, expiry date, dose and route unspecified). Two doses of GARDASIL were administered on schedule. No concomitant therapy was reported. On an unknown date, the patient became pregnant after the second dose of GARDASIL was administered. The outcome of pregnancy was pending. Fetal outcome was unknown. Additional information has been requested.
Patient presented to pharmacy on 8/11/17 with generalized redness on bicep. Patient was prescribed medrol dosepak by her family physician, Dr and was told to purchase and use over the counter hydrocortisone cream.
A physician reported that a 9 month old female received her second dose of Prevnar on 11/21/00. On 4/15/01, at 14 months of age, she was hospitalized due to pneumonia. An unspecified culture was performed for strain determination and was positive for "Group 19". Follow-up information received on 5/18/01, indicated that the pt was febrile for 1 week. She was hospitalized for 1 week and a blood culture was performed and it was positive for streptococcus pneumonia. The pt was administered a 10 day course of unspecified antibiotics. The pt recovered. Additional blood work included pneumococcal antibody titers performed prior to 5/16/01 (on this date her 3rd dose of Prevnar was administered) and were reported as "normal". A titer on serotype 19F was also included in this group. Follow-up information received on 5/23/01, indicated that the pt's white blood cell count was "high" for 10 days. The titer result indicated that the pneumococcus was serotype 19. Further follow-up info received on 06/05/2001 indicated tha tthe specimen was serogrouped; however, the reporter was unable to obtain the serotype of the blood culture isolate.
Ache on the arm; Slight fever, it was 99.8; This is a spontaneous report from a contactable consumer (Patient).  A Patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6201), via unspecified route of administration, on unspecified date as a dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on unspecified date as a dose 1, single for COVID-19 immunization. Patient was informed about Pfizer Medical Information Department. Patient reported that they had COVID and their second COVID vaccination was yesterday, this morning other than a small ache on the arm, patient had a slight fever, it was 99.8 and patient was wondering if patient was contagious. Patient queried for going to the church this morning. Patient were probed if patient had any discomfort from first dose, it was reported that patient had not felt anything. The outcome for the Ache on the arm and Slight fever, it was 99.8 was unknown. Follow-up attempts are completed. No further information is expected.
I developed extremely itchy, burning skin all over my body, and upon itching the skin rose into large red welts. This episode repeated a couple times over the following days. Sometimes large red patches developed for no apparent reason that weren't itchy.
pt recvd vax; devel pain, swelling & redness at inject site; dx w/ cellulitis; fever & entire arm was swollen;
Vesicle in erythematous base at site of injection. Most likely varicella 2 hours to injection.
Numbness and tingiling on fingers ( both hands and feet). Unable to extend without feeling severe  pain on ring and pinky fingers on right hand.
24hrs after vaccination severe myalgia, chills, headache, nausea, diarrhea, swollen lymph nodes, loss of appetite, and fatigue continued into 02/02/2021
Symptoms- fever greater than 100.4F, myalgia, headache; Treatment- Ibuprofen q4hrs prn, 64+ fl.oz. of water daily, monitor for worsening sx's; Outcome- unknown, treatment advised this AM.