chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PCR positive COVID; PCR positive COVID; then intractable nausea; sick; dose 3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Nov2021 (Lot number: FF2589) at the age of 53 years as dose 3 (booster), single, administration date 27Feb2021 (Lot number: EL3247) as dose 2, single and administration date 27Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 12Nov2021, outcome "unknown", described as "dose 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "PCR positive COVID"; ILLNESS (non-serious) with onset 04Jan2022, outcome "unknown", described as "sick"; NAUSEA (non-serious) with onset 06Jan2022, outcome "unknown", described as "then intractable nausea". The event "pcr positive covid" and "pcr positive covid" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) negative, notes: Unknown; (06Jan2022) positive, notes: Unknown.  Clinical course: It was reported that daughter was sick on 04Jan and covid and then intractable nausea on 06Jan and hospital visit for treatment and PCR positive COVID. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19. And since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Immunisations, Vaccination failure, COVID-19 cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
RED ITCHY RASH ON KNEES, ELBOWS, BELLY, LEGS AND ARMS; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 200 pounds, and height was not reported. The patient's pre-existing medical conditions included patient had no known history of allergies. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced red itchy rash on knees, elbows, belly, legs and arms. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine was not applicable. The patient was recovering from red itchy rash on knees, elbows, belly, legs and arms. This report was non-serious.
Patient given second dose of Moderna COVID vaccine- age 17 I have called but have been unable to reach patient or parent so unable to comment on adverse events.  Patient received first dose on 03/09/21 and presented for second vaccine 04/09/2021 without complaints or concerns.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Reporter states that because their facility has not been able to download the digital data logger, they have been put on hold at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the agency is made. There have been no power outages that would have impacted the Moderna vaccine. However, she reiterates that because her facility is unable to download the digital data logger, they will need to treat this issue as a temperature excursion. The data logger that caller is unable to download are for the months of DEC2021, JAN2022, and FEB2022. She says that they are filling out a temperature excursion assessment with the agency at this time. Patients have been administered doses while the temperature excursion assessment has been ongoing.  No adverse reactions were reported by any patients.  No treatment information provided.
6-8-09 Presented to our ER with an injection injury.  Received a Tdap.  According to pt arm swelled up size of basketball, red, blotchy, fever.  Seen in another hospital- received BACTRIM.  Dx cellulitis.
MOP made appointment to see our pediatrician after pt complained of extreme neck pain and would not stop crying for about an hour.
Fainted, hit head - call to 911 - out for approx. 10 sec. Was limp - came to good color. Alert x 3, pulse 80. Sat on floor - applied ice pack to forehead - small bump. No bleeding. Paramedics came checked her out - refused to go to hospital - Mom took home.
I got the Booster vaccine (Pfizer COVID 19 Vaccine); I got the Booster vaccine (Pfizer COVID 19 Vaccine); I have been sick; I ran out Fever; I ran out Fever and have sweat; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on Aug2021 as dose 3, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose and second dose of bnt162b2 both for COVID-19 immunization. On Aug2021, the patient experienced been sick, ran out fever, had sweat. Outcome of the events was unknown.  F/U #1 (PRD/SRD 08Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Approximately 5 mins after vaccine administered, pt. c/o "pounding" headache, followed by lightheadedness, dizziness, and "ringing in ears". Advissed pt to remain sitting until she felt she could ambulate. After 15 minutes with pt, observing her. I assisted her to private vehicle. Advised mother to take pt to ER ASAP or PMD.
UNABLE TO DETERMINE Narrative: EMPLOYEE STATES, "I CAN'T DESCRIBE HOW IM FEELING. WHEN IM LAYING IN BED IM OK" ENDORSED THESE FEELINGS OCCURED 4 HOURS POST VACCINATION.
Pt states after she got the booster by later that evening her BP went up and her heart was racing.  BP was 134/100 and pulse was 124.  She contacted her Cardiologist and was told to take and extra half of her medication amlodipine which did not seem to help.  These symptoms continued about 24 hours.
11/01/06 Complain of swelling, redness advised to apply ice and TYLENOL for discomfort.  Call in 2 days to report per doctor.  11/07/06 Area clear no swelling, redness after applying ice.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI 12/16/2021 -- RECURRENCE OF SAME SYMPTOMS
This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 64-year-old male patient who received SHINGRIX. On 2nd February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, 1 hr after receiving SHINGRIX, the patient experienced pain in arm, fever and shivering. In February 2018, the outcome of the pain in arm and shivering were recovered/resolved. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the pain in arm, fever and shivering to be related to SHINGRIX. Additional details were reported as follows: The patient came into the pharmacy and got his first dose of SHINGRIX in left deltoid. The patient had symptoms which began an hour after the injection with heavy pain in his left arm radiated down his entire arm. The pain lasted approximately for 72 hours and then began to dissipate. The patient experienced fever (body temperature 101 degree C). The patient experienced shivering 4 hours after the vaccination and discontinued about 48 hours after the vaccination.
Patient got pfizer vaccine at age 11 due to parent writing  then wrote a 9 over the 8. Then proceeded to write age 12 for age. No reactions reported.
Fever, chills with intense shaking, aches - began several hours after injection - fever/chills subsided after seven hours - aches subsided after 16 hours
Congestion, cough, fever, aches, difficulty concentrating, fatigue Positive antigen test Paxlovid Sudafed  Tussin  Hydration Rest Isolation
This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 13-JUN-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010 and expiry date: 23-OCT-2015) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, , 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA01304 (same reporter link).
Sharp and dull re-occuring head aches behind eyes, sharp pain in the lower back/spine, sharp pains/cramp like in lower abdominal area/ uterus.  Heart Flutters re-occuring  on and off several times a week but by December 2021 flutters are daily occurance. The pain was speratic in nature and in times of occurances.  They lasted for approximately 2 1/2 months and then went to dull headaches behind the eyes.  MRI, Ultra sound, Eyes exams, Cardio work up with heart monitor were preformed. Also burning and itching began  late Novemeber and progressively worsening into January 2022. - of the head hands and feat.  The burning has now progressed to the neck and torso - leaving red sploches and then they go away.  This happens several times a day - no particular times.
Long lasting pain and numbness in left aft (injection arm). The pain and numbness has lasted since injection. I also have muscle knots in that arm.
This spontaneous report as received from two physicians of the same office refers to an unspecified number of patients of unknown demographics. The concurrent condition and medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, frequency and lot details unavailable). The concomitant medication was not reported. On an unknown dates the patients developed shingles. The outcome of shingles was reported as resolved on an unknown date. The causality was unspecified. Additional information has been requested.
"Pt w/ hx of Asthma and Anxiety.  No current information regarding pt medications available.  NKDA at the time of vaccination. Pt presented for 2nd dose on 7/1.  Pt noted that after first dose Pfizer, pt had neck tightness and angioedema.  Time course unclear.  Pt was administered Janssen IM Left Deltoid 206A21A as an alternative to 2nd dose Pfizer.  No reaction noted after vaccination on 7/1."
Pfizer vaccination administered into left deltoid at 0849. Reporter, RN arrived to patient at 0855 after being notified patient had fallen off his chair. Patient found to be laying facedown and unconscious near the chair he was sitting in. No initial response by patient to verbal and physical cues. Patient was pale in color and diaphoretic. Patient was placed into right side laying position. After about a minute of being in side laying position and continued verbal/physical cueing, patient awakened. Assisted patient to supine position, cool packs placed to armpit area, Excess sweat on face wiped. Two small  abrasions noted to left side of face; nose and near top of mouth.  Upper and lower extremities also had small abrasions.  Patient reported he started to feel dizzy and tired shortly after receiving the Pfizer vaccination. Patient does not recall falling. Mother confirmed patient had eaten breakfast, no history of low blood glucose levels. Denied experiencing shortness of breath prior to fall and while nursing staff was present, No neurological deficits noted during assessment. No rash noted. Patient continued to be diaphoretic. Reported stomach was upset. Vitals taken at 0902; blood pressure 116/74, pulse 74, respirations 18, oxygen saturation 98% on room air. Permission by parent given to treat patient with epinephrine. Patient received 0.5 mg of epinephrine at 0900 and again at 0905. EMS arrived at 0912. Patient more alert at this time and diaphoresis subsided at this point. After EMS obtained further information, patient was assisted into a sitting position on the floor. Patient complained of stomach upset again and vomited two times. Ambulance arrived at 0935 and patient placed onto gurney. Ambulance departed at 0935 to transfer patient to Medical Center for further observation.
approx 45min p/vax pt reported numbness on lt side of body;BP 130/70, P 102, R20;911 called transported to hosp where seen;pt reports tx w/APAP & released;
I passed out; This is a spontaneous report from a contactable consumer (patient). This 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, lot Number: EL3248), via an unspecified route of administration, administered in arm left on 05Mar2021 11:00 am as a single dose for COVID-19 immunization. Medical history included hypertension (blood pressure). The patient is not a pregnant. Concomitant medications in two weeks included ashwagandha taken for an unspecified indication, start and stop date were not reported, and blood pressure meds (unspecified). There is no other vaccine received in four weeks. The patient passed out Sunday night, 07Mar2021 23:00, she's not sure if it was related to the vaccine. The AE resulted in: Doctor or other healthcare professional office/clinic visit. No Covid prior vaccination. No Covid tested post vaccination. Therapeutic measures were taken for the AE. The outcome of event was recovered on an unspecified date in Mar2021.
Client received HIB vaccine (Rt Deltoid) on 8/12/02. On 8/14/02, reported to Health Dept with reddened area on upper right arm approx. 1/4" below injection site. Area was warm to touch, approx. 2 1/2" X 3" in diameter. There appeared to be another puncture wound in the center of reddened area. Referred to ER. Parent stated on 8/14/02, that child had local swelling at injection site.
Information has been received from a physician for GARDASIL, a Pregnancy Registry Product, concerning a 22 year old female patient with no pertinent medical history and no known drug reactions/allergies, who on 23-FEB-2011 was vaccinated IM with the first dose of GARDASIL (Lot # 667194/1271Z and expire date 12-DEC-2011). On 28-FEB-2011 the patient found out she was pregnant. On an unspecified date a pregnancy test, an ultrasound and a blood work test were performed (results for ultrasound and blood work not provided). The physician reported that the patient was not resuming the GARDASIL series until she would give birth. Patient's last menstrual period was approximately on 24-JAN-2011. Expected date of delivery was on 31-OCT-2011. Follow-up information was received from an initial pregnancy questionnaire from a health professional concerning a patient that worked with no previous pregnancies, no illness at the time of vaccination and no pre-existing allergies, birth defects or medical conditions who on 23-FEB-2011 was vaccinated with the first dose of GARDASIL intramuscularly in the right arm. On 21-MAR-2011, an ultrasound was performed and a cyst was seen (365 x 283). The ultrasound showed an intrauterine pregnancy of approximately 7.6 weeks. The patient did not seek medical attention. Additional information has been requested.
04/21/2021,  a few hours after the 2nd vaccine shot, I developed a fever and saw black spots. It went away after 24 hours. Then on 05/01/2021, in the evening, the spots returned this time with wiggly lines and floaters. it is mostly in the right eye... and it remains presently.
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023. The patient reported this case via interactive digital media. The reporter stated that he/she know 2 people that got Shingles right after they got the Shingles shot.; Sender's Comments:  US-GSK-US2023AMR067378:Same reporter
Information has been received from a health care professional concerning a 10 year old male who on 9/1/99 was vaccinated with the first dose of Hep B. On 9/2/99, the pt experienced fever of 102 and chills and achiness. On 9/3/99, the pt's mother phoned the physician's office and noted that the child's temperature was 99. The pt sought unspecified medical treatment. Additional information has been requested.
Dose was given and was beyond use date, was not expired. Left masseage on 12/29/22
Shingles/I had it/ worst thing you ever had in your life/no one wants them  horrible they are horrendous; This case was reported by a consumer via media and described the occurrence of shingles 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 shingles. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had the shingles shot and was just recovering from the shingles right then. The patient had the shingles and stated that they were the worst thing one could ever have in their life, no one would want them as they are horrible and horrendous. The patient stated that they dont know what others are talking about that shot, but they had one from it.
Shortly after receiving her first INFLUENZA vaccine, patient started feeling lightheaded. B/P 99/62 (supine) P-66 at 11am. 11:05 am: C/O thickness in throat. No itching or difficulty breathing. 11:07 am: B/P 102/63 P-59. 11:12 am: 129/82 P-79. BENADRYL 50 mg p.o. x 1 lungs clear. POX 99%. 11:25 AM: 99/65 P-73 lightheaded. Thick throat: to Emergency Room.
Pt. has no temp, area not reddened, non irritated, area not warm to the touch. There is a small area where the needle was inserted, that has a grey to silver particle - that can be felt - just intradermal. Mom has not noticed it before. Area of inj was Lt Vastus lateralis.
Pt was vaccinated 11/15/06, 11/17/06 at 2am started with headache, chills, aching joints and temp 102-103, 11/16/06 swelling at site of injection.
pt inadvertently recv vax & devel an inj site rxn characterized by swelling & redness which extended to the elbow;
This spontaneous report as received from a nurse refers to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route, and lot # not provided), and was vaccinated with the second dose of GARDASIL subsequently on an unspecified date. On an unspecified date, the patient was administered a dose of CERVARIX (dose, route, lot # not reported), instead of GARDASIL, to complete a GARDASIL series. No adverse effects were reported. Additional information has been requested.
serum like sickness with polyarthralgias, malaise and fatigue Treatment with NSAIDS, rest