chrisvoncsefalvay/vaers-outcomes huggingface dataset:
23 month old adopted from China on 10/00 with reliable government immunization records. On 12/4/01, at around 08:00, the pt had a 2 minute generalized seizure. This was a 1st time seizure. She was postictal for several hours in the ER. No other signs or symptoms. Afebrile.
mom reported that pt cried for 8-10 hrs, screamed if skin touched or moved, very irritable, site of DTP inject was hard & red w/o abscess, did not contact CHN or MD; reported adverse affect when presented for 2nd immun;
This spontaneous report was received from a medical assistant referring to 20 unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in March 2015, the patients were vaccinated with improperly stored doses of VARIVAX lot # L001335 with expiration date 31-JAN-2017 (dose and route were not reported). It was stated that the temperature excursion was 74 F for 37 minutes. No previous temperature excursions were reported. It was stated that the call was made because a data logger. No adverse effects reported. There was not a product quality complaint (PQC) involved. This is one of several reports from the same source. Additional information has been requested.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 14:30 (Lot number: FF2587, Expiration Date: 30Dec2021) at the age of 61 years as dose 3 (booster), 0.3 ml single for Covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose-1, Manufacturer: Pfizer, Lot: Either EN6208 or FN6208, providing from patient record card, EXP: Unknown, Received in left arm), administration date: 16Mar2021, when the patient was 61 years old, for Covid-19 immunization, reaction(s): "Eyes started burning a lot", "Sore arm"; Bnt162b2 (dose-2, LOT: EP7533, Dose: Unknown , Received in left arm), administration date: 06Apr2021, when the patient was 61 years old, for Covid-19 immunization, reaction(s): "Arm was more sore than the first dose", "Had mild eye burning"; Shingles (Vaccine Name: Shingles, Lot Number: Unknown, Date: 03Sep2021, Second dose schedule for: 03Nov2021), administration date: 03Sep2021; Flu. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 06Oct2021, outcome "unknown", described as "States that he would bet his house on it that it did not go into muscle"; PAIN (non-serious) with onset 06Oct2021, outcome "unknown", described as "he says that he didn't have soreness really, just a little when he laid on his left side/ Didn't feel a big amount of pain after administration, was just a tap on the arm". The patient underwent the following laboratory tests and procedures: allergy test: normal, notes: Had testing and allergist said it was ok. No follow-up attempts are possible. No further information is expected.
Pt recv vax on 10/9/97; 6 min post vax pt exp hypotension, coldness, clammy sweat, almost passing out
It was reported that a pt was administered  with Menomune A/C/Y/W-135 (lot#UB206AA, expiration date 8/20/03) on 8/9/02. The pt experienced arm weakness and some flu-like symptoms. The initial redness and soreness at the site had dissipated. The onset date for the events was not reported.
Information has been received from a nurse practitioner concerning a 38 year old female patient with migraines and no allergies who on unspecified date "as young child" was vaccinated with a w/diluent s-dose of MMR II (Lot# not reported). There was no concomitant medication. The nurse reported that on 14-JAN-2011 a titer was performed, that was negative at 0.46 measles. At the time of the report the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 22Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunization. The patient's relevant medical history included: "Unspecified/intermittent joint inflammation" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bacitracin, reaction(s): "Allergies"; Amoxicillin, reaction(s): "Allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 06Oct2023 and stopped on 11Oct2023.  Clinical course: It was reported that, patient experienced Paxlovid rebound. Two days after completed paxlovid, she started feeling sick again which developed into severe cold and flu like symptoms. Not received any treatment for these symptoms and was not recovered from symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I AM WORRIED ABOUT MY 2ND DOSE - I'D LIKE TO BE MONITORED IN A PROPER CLINICAL ENVIRONMENT. MY SYMPTOMS WERE MUCH MORE PRONOUNCED & DIFFERENT FROM WHAT THE MAJORITY OF PEOPLE REPORTED! DAY 1 - 4/10/2021 11:50 am Got the first shot of Moderna Stayed for 15 min before being released. No symptoms at that time.  12:35 pm The following symptoms started (in that order) 1. Shivering + symptoms of a cold 2. Mucus in the throat 3. Mild headache 4. Pain in the jaw, jaw muscle weakness (cotton mouth?)  it felt like my jaw was shaking as if I had drunk a lot of coffee 5. Tongue felt numb, I couldn't talk properly 6. Salivated a lot 7. Elevated heart rate 8. Whole face, jaw, head, hands and body were shaking 9. Teeth grinding
ache-y and had low energy after her 2nd dose of the Pfizer COVID vaccine.; ache-y and had low energy after her 2nd dose of the Pfizer COVID vaccine.; This is a spontaneous report from a Non-contactable reporter (consumer).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for Covid-19 Immunisation. The following information was reported: PAIN (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "ache-y and had low energy after her 2nd dose of the Pfizer COVID vaccine.".  Additional information: My female friend (49) told me that she felt ache-y and had low energy after her 2nd dose of the Pfizer COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT REPORTS SLIGHT FEVER, BODY ACHES FOR LESS THAN ONE DAY FROM 3RD DOSE
I got the vaccine but still got shingles\ suspected Vaccination failure; got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got the Shingles vaccine and still got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Pt admitted to the Hospital from 10/18 - 10/23/21 for COVID with AHRF; treated with O2 supplementation, dexamethasone, steroids; dc'd to home with hospice care; pt died in her home with COVID 19 being one of the causes of death per her death certificate
Patient received Pfizer Booster only 2 months after series completion. Patient didn't express any adverse reactions while waiting her 15 minutes after her vaccination. Discussed with provider, no additional recommendations. Left message on voicemail to inform patient.
patient stated later in the day of vaccination she had swelling in her face and her face was flushedq
ON JANUARY 18TH PATIENT WAS BROUGHT IN BY MOTHER ALONG WITH A FEW OF HER SIBLINGS AND COUSINS. PT WAS GIVEN THE PFIZER 5-11 YR OLD VACCINE MISTAKENLY DUE TO MOTHER SHUFFLING KIDS AND NOT LETTING ME GO IN ORDER OF THE FORMS I HAD. MOTHER WAS NOTIFIED THAT PATIENT WASN'T SUPPOSED TO GET THE VACCINE. MOTHER BRUSHED IT OFF AND SAID IT WAS FINE, STATED THAT THE PATIENT WOULD INDEED BE ALRIGHT.
Information has been received from a licensed practical nurse concerning a 17 week (4 months) old white female birth weight 3.72 kg with a history of being hospitalized for respiratory syncytial virus infection (RSV) and no history of drug reactions/allergies who on an unspecified date was vaccinated with first dose of COMVAX. The patient did not have a reaction with the first injection. On 20-SEP-2006, the patient was vaccinated with second dose of COMVAX (lot # 653773/0197F) 0.5 ml intramuscularly right thigh at 1030 hours. Concomitant therapy also given on 20-SEP-2006 included PREVNAR. The nurse reported that the injection site was found to be red shortly afterwards. Medical attention was sought. The nurse was not sure how many days after the injection, the redness occurred, however, the site was still red presently and it was 1 month after the injection. The site was red (approximately 1.5 cm) but there was no pain. At the time of reporting, the patient had not recovered. At the time of reporting, no further information was available. Additional information was received from the physician. At the time of vaccination, the patient had no illness and no pre-existing medical conditions, allergies, or birth defects. On 20-SEP-2006, the patient developed a lump at the vaccination site on her right thigh. This slowly progressed and came to the surface and an abscess developed. It was subsequently incised and drained. A culture of the abscess did not reveal any bacterial growth. On 10-NOV-2006, the patient recovered. The event was reported as non-serious. Additional information was received by the LPN. The patient reported that the patient developed a sterile abscess at the immunization site that required an incision and drainage. Culture was negative for organisms. Additional information was received from the patient's mother who reported that she believes her child was given the first dose at 4 months of age and dose 2 was given at 6 months of age but she was not positive. Her daughter also developed a hard knot at the injection site with dose 1. PREVNAR was also given on the same day as dose 2 but was not sure if it was a different site. She did not know if PREVNAR was administered with dose 1 as well. Her daughter developed a "sterile abscess" at the injection site on her leg where the second dose of COMVAX was administered. It initially developed as a hard knot a couple days after administration but after a month it came to a "head". The physician lanced the area and had the sample analyzed. Results came back that it was sterile. At the time of reporting, the patient was recovering (reported as recovered by the physician). No additional information is expected.
Based on age patient was to receive a regular dose flu. Patient was give a high dose flu for ages 65 and over in error. Provider and patient were informed of the event. Patient monitored in the clinic. No adverse reactions noted.
Myalgia FATIGUE Narrative:  MISSING WORK TODAY DUE TO SIDE EFFECTS  Other Relevant History:
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies reported. On 23-OCT-2015, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot# L023589, expiration date 26-JUN-2017, dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a 71 year old Caucasian female consumer with hypertension, sulfa allergy (rash, nausea) and degenerative joint disease who on 11/14/2001 at 14:30 was vaccinated IM in the right deltoid with the first dose (lot number 1497K reported, invalid for the product) of pneumococcal vaccine 23 polyvalent. Concomitant therapy on 11/14/2001 included a dose in her thigh of influenza virus vaccine (manufacturer not reported). Additional concomitant therapy included ramipril (ALTACE) and estrogens, conjugated (PREMARIN). On 11/14/2001 at 17:00 the patient developed pain at the injection site and her arm became swollen and painful from her shoulder to her elbow, and then down into her forearm. She reported that her arm was red, inflamed and sore. She noted that as of 11/20/2001, her arm seemed to be better. Unspecified medical attention was sought. Follow up information received from a woman in the physician's office indicated that the patient developed a localized reaction characterized by redness and swelling. She also indicated that there was soreness at the injection site in the patient's right deltoid. No further information is available.
I didn't feel well all night, achy and uncomfortable. In the morning, while getting ready to shower for work, I got extremely hot and laid on the bathroom floor. Shortly thereafter, my left hand began to tingle and became numb and the numbness extended to my entire arm.  My fingers locked into a claw and I couldn't move them. Then, my right hand and arm did the same although not as severe. My feet began to tingle too. It lasted probably a couple minutes and then all went away and I actually felt better than before. I showered, went to work but felt stiff, achy, headache and very tired. I left work at 12:30pm and went home and slept. The following day was much better, just slight headache and I now have a cough that I didn't have before.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CARBAMAZEPINE (TEGRETOL), RISPERIDONE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
large local react @ site-pain, swelling, redness, heat; arm sore for about 1 wk; almost 1 yr later noticed cust-like lesion beneath skin below site; present for many months;
Injection given 2/2/21 at 318 PM. Pt started with chills, body aches, HA, heart racing, heart pounding at 2 AM - Woke up with symptoms. (2/3/21)
This case was reported by a physician's assistant and described a 32 year old female subject who was vaccinated with Twinrix during the first trimester of pregnancy. Concurrent medications included Ambien, Prevacid, Zyrtec, Colace, and "Urisodil"(unspecified medication). On 10 August 2005, the subject received 1st dose of Twinrix (lot AhABB030AA). The physician assistant reported that, "the patient was 5 weeks pregnant when the Twinrix was administered" (first trimester). At an unspecified time later, the subject experienced uterine and abdominal cramping. Further immunization with Twinrix was delayed until after delivery "or as directed by obstetrician." At the time of reporting, the outcome of the events were unknown; however, the pregnancy was ongoing. Follow-up received on 31 July 2006 from the physician's assistant indicated that the mother had  a history of hypertension, extreme obesity, gastroesphaeal reflux, seasonal allergies and "years" status gastric banding. The abdominal cramping resolved following treatment with Colace and Dulcolax suppositories. The abdominal cramping was attributed to constipation. On 11 April 2006, the mother delivered a healthy, term male via spontaneous vaginal delivery. His APGARS were 9 (one minute) and 10 (five minutes). The infant was reportedly "doing fine" and developing normally.
"Pt w/ hx of Gluten allergy. Pt c/o sweating/flushing and dizziness ~5mins post vaccination and was brought to triage area. Pt verbalized hx of vasovagal sxs and anxiety after blood draws and vaccinations.    V/S @432PM: BP - 113/74, HR - 69, RR: 18   Assessed by PA. Offered and provided fluids/water. Continued to monitor pt for add'l 15 min. Pt verbalized improvement to sx, denied any other abnormal sx. Given OK by PA to be released from clinic.  Note: first dose given 4/24.
Starting 04/23/2021 I woke up with severe nausea, vertigo and vomiting that was so severe that that night I was unable to get out of bed. I was taken to the ER, and they treated me for dehydration and the nausea. I remained in the hospital for 3 days until this episode calmed down. Doctors are unsure if this was related to the vaccine or another virus. Followed up with my PCP about 4 weeks afterwards and all my bloodwork was normal.
Took Influenza & Pneumoccal shot at same time. Take Influenz every year with no reaction ever. I became aware things were not right aboput five hours after the shot.  Went to bed but did not sleep. Started to cough at intervals for 4-5 hours. Breathing was most difficult.  Could hardly get enough air. Stayed home next day & slept most of the day. Got up at 5:30pm and all was OK. Left w/minor cough at this stage.
Severe nerve pain on right side banding from abdomen to back- this lasted until November 15th and then a rash broke out where the nerve pain was, and doctor diagnosed me with Shingles. I also had a pvc/pac episode 4 days after being administered the shot. My glands in neck were also swollen one week after shot, and my eyelids swelled up 2 days after shot. I also felt tightness in my chest about 6 hours after the shot. I will NEVER get a flu shot again. I was in generally great health prior to this flu shot administered. I've never had the shingles before in my life.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 05-JUL-2016, the patient was vaccinated with a third dose of VARIVAX (dose and route of administration were not reported, lot# reported as 1048467, expiry date on 02-DEC-2017). No adverse reactions were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sharp pain in left arm where the shot was given. Dull pain for approximately 30 days after shot was given.
Redness around site of injection.Felt like fever, headache, stomach ache.Lasted 72 hrs. 9Jul91 feels fine-no sxs.Everything normal
This spontaneous report as received from a registered nurse refers to five patients of unknown demographics. Pertinent medical history and concomitant therapies were not reported. The nurse reported that patients received improperly stored PROQUAD (Merck) (lot # L008353, expiry date 11-SEP-2016, 0.5ml, subcutaneously). Four doses were administered on 17-AUG-2015 and one dose was administered on 20-AUG-2015. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Pain in arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced MYALGIA (Pain in arm). On 02-Apr-2021, MYALGIA (Pain in arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications  were not reported  Treatment was not specified   This case was linked to MOD21-071233 (E2B Linked Report). This case was linked to MOD-2021-069581 (Patient Link).; Sender's Comments:  MOD21-071233:wife's case
GOT RID OF ALLERGIES; SLEEPY; TIRED; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's past medical history included sinusitis, and allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The company was unable to perform follow up to request batch number. No concomitant medications were reported. On 03-MAR-2021, the subject experienced sleepy. On 03-MAR-2021, the subject experienced tired. On APR-2021, the subject experienced got rid of allergies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, sleepy and got rid of allergies was not reported. This report was non-serious.
11/04/2021 - 5:00 pm chills and body aches 11/05/2021 - early morning hours (4:00 am) chills, body aches, headache, nausea, fatigue 11/05/2021 - 11:00 am vomiting (dry heaves), body aches, headache, fatigue      *1:00 pm contacted my doctor's office to request anti-nausea medication (Ondansetron ODT 4 mg)          5:00 pm began medication which resulted in vomitting ceasing 11/06/2021 - 2:00 am took another Ondansetron and was able to eat crackers, 1:00 pm took another Ondansetron and ate more food 11/072021 through 11/09/2021 - mild headache and mild nausea continued (no more vomiting) 11/10/2021 feeling okay
Increased blood pressure; This case was reported by a consumer via call center representative and described the occurrence of increased blood pressure in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension. Concomitant products included lisinopril.   On 4th July 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th July 2020, 2 days after receiving Shingrix, the patient experienced increased blood pressure. On an unknown date, the outcome of the increased blood pressure was recovering/resolving.   It was unknown if the reporter considered the increased blood pressure to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reporting blood pressure elevation of 20 points following vaccination with Shingrix.  The patient also added, his blood pressure appeared to be declining towards normal.  Limited information was available.  Lot and expiration date unavailable. The reporter did not consent to follow up.