chrisvoncsefalvay/vaers-outcomes huggingface dataset:
spent one day in bed with still all the symptoms; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunisation and experienced spent two days in bed with everything - a headache and all the symptoms. On an unspecified date, the patient experienced spent one day in bed with still all the symptoms. It was reported that the patient had the vaccine in April and she will  be travelling to Europe so the airlines wanted proof of her vaccination which has to be official and they have to be able to scan it, and they cannot use the card. The patient stated that she received the vaccine at the parking lot and that nurses gave the vaccine. She also stated that she had two vaccines and needed proof. The patient reported that on the first vaccine she had spent two days in bed with everything - a headache and all the symptoms. On the second vaccine, patient stated only one day in bed but still all the symptoms. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician assistant refers to a adult patient of unknown age and gender. The patient concurrent condition, medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # N003997 for prophylaxis. The temperature was reported as 9 degree Celsius to 25 degree Celsius (10 Celsius). The time frame was reported as 72 hours. No previous temperature excursion was noted. No adverse effects reported. Additional information has been requested.
Donor stated that her Left leg started to cramp up. Her injection site was red/itchy with a lump/nodule that was <2x2 in size along with a purple bruise. Donor left before any recovery question can be asked.
Information has been received from a 68-year-old female consumer with thyroid disorder, a history of shingles and no known allergies or drug reaction who "last Monday, 23-JUL-2007" was vaccinated in the left arm with a dose of Zostavax (Merck). Concomitant therapy included hormones (unspecified), CELEBREX and PROTONIX. On approximately 23-JUL-2007, "2 days ago," the patient noticed a red spot on her left arm about 1 centimeter in diameter and there was pain associated with it, "the pain had increased gradually until today" (approximately 25-Jul-2007). Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. The outcome was reported as not recovered. No product quality complaint was involved. Additional information is not expected.
This spontaneous case was reported by a consumer and describes the occurrence of CIRCUMORAL SWELLING (face swelling located around eyes and mouth), CHILLS (chills), MYALGIA (muscle pain), MYALGIA (body aches) and ADVERSE REACTION ("strong reaction") in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE for an unknown indication. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced ADVERSE REACTION ("strong reaction"). On 17-May-2021, the patient experienced CHILLS (chills), MYALGIA (muscle pain) and MYALGIA (body aches). On 18-May-2021, the patient experienced CIRCUMORAL SWELLING (face swelling located around eyes and mouth). On 18-Apr-2021, ADVERSE REACTION ("strong reaction") had resolved. On 18-May-2021, CIRCUMORAL SWELLING (face swelling located around eyes and mouth), CHILLS (chills), MYALGIA (muscle pain) and MYALGIA (body aches) had resolved. Treatment information not provided. Action taken with mRNA-1273 in response to the event/s was not applicable.
Swelling of lymph node in left arm pit and now a knot on my forearm near where someone would typically draw blood.
A mother reported that her 12 month old daughter received her fourth dose of Prevnar and subsequently developed a fever of 101.7 deg. F. The fever resolved after two days. The reporter declined to provide any additional information and declined to grant permission for follow-up investigation.
Pt had a pneumococcal shot on 1-6-11 and on 1-7-11 her arm is all red, swollen from site of injection to elbow.
Vaginal herpes; This case was reported by a physician via call center representative and described the occurrence of genital herpes in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced genital herpes. On an unknown date, the outcome of the genital herpes was unknown.   It was unknown if the reporter considered the genital herpes to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that a patient who was approximately 55 years old at the time of reporting, experienced an outbreak of vaginal herpes 3 to 4 days after the administration of the first dose of Shingrix.  The physician reported the patient had not had any vaginal herpes outbreaks in the last 30 years. The reporter consented to follow up.
Local swelling at injection site, per mother's report had bluish hue 3 days after injection then red, hive like  now red flat confluent area with satelite redness
Information has been received from a Nurse Practitioner concerning a 24 year old female who on 25-JUL-2007 was vaccinated IM with a first dose of GARDASIL vaccine (yeast), lot #657868/0523U. On an unspecified date the patient received a second dose of GARDASIL vaccine (yeast), lot #658558/1061U. Concomitant therapy included alprazolam (XANAX) and duloxetine hydrochloride (CYMBALTA). On 01-AUG-2007 the patient experienced heavy menstrual bleeding. The patient experienced the excessive menstrual bleeding after her first dose of GARDASIL vaccine (yeast). In September 2007, the patient experienced another episode of heavy menstrual bleeding. The patient saw the Nurse Practitioner, and a pelvic sonogram was performed (results not reported). The patient's outcome was not reported. Additional information has been requested.
Prevnar ordered, Pneumovax administered instead, with the flu shot - (R) deltoid 11/27/07.  12/7/07 Reviewed hospital medical records which reveal patient experienced significant swelling, pain, induration & redness of right arm w/fever x 2 days.  Initially had nausea & only injection site was involved but then spread to involve entire right arm.  Seen at urgent care & dx w/allergic reaction to vax.  Condition worsened & seen by PCP, started on antibiotics & instructed to go to hospital if worsened.  Continued to worsen & admitted 11/29-12/4/2007.  Surgery consult done.  To OR on 12/1/07 for abscess I/D & biopsy of deltoid fascia.  No d/c summary available, obtained admit/dc dates from ROI. FINAL DX: right arm cellulitis & abscess s/p immunization; I/D of abscess.
Patient experienced swelling that went down her arm, pain, sensitivity, headache, and tingling in her hands. Patient took TYLENOL for pain and used ice. Provider recommended a low dose of Benadryl for further treatment.
This spontaneous report was received from a medical assistant, refers to an unspecified patients. No pertinent medical history was reported. Since 12-SEP-2014, an unspecified number of patients have been administered RECOMBIVAX HB (dose, frequency, route were not reported), all of which underwent supported temperature excursions. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
Pain began in both arms within hours of injection. Sleep disruption due to pain began 1/26/18 in both arms. Right arm still painful but full range of motion by 2-1-2018. Left arm continued to be painful with around a 90 degree range of motion max w/ impingement. Visit to convenient care facility 2-1-2018 for pain management and evaluation of left arm. 2-4-2018 diagnosis of adhesive capsulitis w impingement of left arm. Tx: anti-inflammatories, warm compress, exercise, cold compress. PT to begin next.
10 minutes after the shot my neck was stiff and my upper body felt hot. I went home to rest. 3 hours later the body aches started which I was expecting. I took 2 Tylenol which usually works for me after a flu shot. An hour later chills started along with headache, dizziness, and nausea. I took 600mg Advil and Zofran which helped slightly. An hour later I vomited 3 times and went to bed with a heating pad to help with chills. My throat and lips started itching 5 hours after the shot. I alternated Advil and Tylenol through the night. Currently, 19 hours after the shot I feel fatigue and slight nausea. I am still taking Tylenol every 6 hours.
Immediately after the PNEUMOVAX 23 was administered IM - her arm swelled up. Ice applied. Pt. had excruciating arm pain at 3am and could not move arm - progressively got better and fine at 1:00 pm on Sunday.
I experienced dizziness on 07/30/2021 and it became work during the 1st week in August. I had to take off again because of the coughing, headaches, and dizziness. I also experienced nausea and pressure in my head along with chest pains. I went to the ER because of the chest pains. An EKG, CT Scan, and blood work. The doctors assumed that it was a Sinus infection and was placed on antibiotics brain scope was done and I am functioning at 80%. I went to see my PCP on 10/15/2020 and referred to a Neurologist (awaiting appt) and a Pulmonary Specialist on 11/10/2021 at 09:00AM. I have an appointment for an Ultrasound on my Gall Bladder, 10/18/2021 for the diarrhea that I continually experience. The symptoms continued to happen so my workplace had me take off because they wanted to make sure that I didn't have COVID-19.
feverish; chills; throbbing headache; nausea; restlessness; insomnia; tired feeling; Loss of appetite.; felt high immediately afterreceiving the dose; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via unspecified route of administration in the right arm on 22Mar2021 at 08:15 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included redundant colon. The patient was allergic to penicillin and erythromycin. The patient did not have any concomitant medications. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via unspecified route of administration in the right arm on 01Mar2021 at 08:45 as a single dose for COVID-19 immunization and the patient felt high immediately after receiving the first dose. Prior to vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 22Mar2021 at 08:15, the patient felt high immediately after receiving the vaccine. On 22Mar2021 at 20:15, the patient experienced feverish, chills, throbbing headache, nausea, restlessness, insomnia, overall tired feeling and loss of appetite. No therapeutic measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
stomach infection; blood sugar increased; nausea; vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (stomach infection) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 37B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Chronic kidney disease and Thyroid disorder. Concomitant products included SODIUM BICARBONATE for Chronic kidney disease, LEVOTHYROXINE for Thyroid disorder, INSULIN ASPART (NOVOLOG) and INSULIN GLARGINE (BASAGLAR) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach infection) (seriousness criterion hospitalization) BLOOD SUGAR INCREASED (blood sugar increased), NAUSEA (nausea), and VOMITING (vomiting). The patient was hospitalized for 4 days due to ABDOMINAL DISCOMFORT. At the time of the report, ABDOMINAL DISCOMFORT (stomach infection), BLOOD SUGAR INCREASED (blood sugar increased), NAUSEA (nausea), and VOMITING (vomiting)outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high (High) sugar was too high..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Treatment medications were reported.   This case was linked to MOD-2021-221039 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Additional information included non-significant information. Patient Initials were updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Pneumonia vaccine given in rt arm.  Pt started getting cellulits on his rt arm the next evening of 12/6/12.  Pt reported, pain, swelling and generalized ill feeling.
Patient was diagnosed with new-onset type I Diabetes presenting in DKA on 11/5/11.
10/2: Received shots (Shingles #1, Td booster, and B-12 injection) in the morning @9am.  Went to work and started to not feel well after 2:30pm.  Decided to go home @3:30.  Took temperature it was 99.4.  I also had headache, a little nausea, and muscle aches.  Over the next several hours my temperature kept going up and muscle aches expanded to entire body and were severe.  Fever peaked (I think) at 102 degrees F @1AM (10/3).  Muscles aches so bad that I took 2 motrin at that time and tried to get some sleep.    10/3:  Woke up and temp was done but not completely gone.  99.9F  I stayed home from work.  Still had headache and muscle aches.   Within 2 hours of waking, temp was up to 101 where it stayed until I went to bed that evening.  Still severe muscle aches throughout the day.  10/4: Woke up and fever was completely gone.  Muscle aches were gone.  Went to work.  Still a little tired/weak but able to work full day.  Continued back to feeling 100%.  No other symptoms.
Received booster on 11/28/2021: Felt fatigue, chills, hot flashes, body ache on day two and three after the vaccine was administered. On Wednesday 12/1/2021 around 0800 I started to vomit continuously for two straight hours, had excruciating stomach pain on the lift side. Family transported my to urgent care where the ED doctor did the following tests: CBC with Differential Comprehensive metabolic panel Lipase Pregnancy screen, urine Urinalysis, Microscopic Urinalysis, culture if indicated Treatment: IV of sodium chloride, ondansetron (PF) (ZOFRAN), ketorolac (TORADOL)
I also got the second Pfiszer-BioNTech shot on January 9th. On April 2nd, I was laying on the couch watching a movie and I had petechaie on my back from the couch. I also had it in a few spots on my chest. I did not have any bleeding. During my work shifts, I was fatigued during most of them that month. I saw my primary care doctor on April 29th and got labs drawn. The next day he called saying that my platelets were 5,000 and I did not have petechaie or bleeding at that time. Treatment has been 4 consecutive days of 40 mg of dexamethasone. My platelets dropped back to a similar level, so I was placed on prednisone 60 mg with a taper once I started 4 weekly Rituxamab treatments. I just finished those and my hematologist is recommending a spleenectomy at this time.
Patient developed swelling, redness, blisters and itching of the left arm. The symptoms were lower than the injection site.
It is hot again; She started with itching at injection site; It is red again; It is swollen again; She had body shakes next day after receiving 1st dose; It was really hot; About 24 hours later, her left arm at injection site got swollen.; It was really red; It was really painful; She also had fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (She had body shakes next day after receiving 1st dose), VACCINATION SITE WARMTH (It was really hot), VACCINATION SITE WARMTH (It is hot again), VACCINATION SITE PRURITUS (She started with itching at injection site) and VACCINATION SITE SWELLING (About 24 hours later, her left arm at injection site got swollen.) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.     On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced TREMOR (She had body shakes next day after receiving 1st dose), VACCINATION SITE WARMTH (It was really hot), VACCINATION SITE SWELLING (About 24 hours later, her left arm at injection site got swollen.), VACCINATION SITE ERYTHEMA (It was really red), VACCINATION SITE PAIN (It was really painful) and PYREXIA (She also had fever). On 05-Aug-2021, the patient experienced VACCINATION SITE WARMTH (It is hot again), VACCINATION SITE PRURITUS (She started with itching at injection site), VACCINATION SITE ERYTHEMA (It is red again) and VACCINATION SITE SWELLING (It is swollen again). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 01-Aug-2021, VACCINATION SITE WARMTH (It was really hot), VACCINATION SITE SWELLING (About 24 hours later, her left arm at injection site got swollen.), VACCINATION SITE ERYTHEMA (It was really red) and VACCINATION SITE PAIN (It was really painful) had resolved. At the time of the report, TREMOR (She had body shakes next day after receiving 1st dose) and PYREXIA (She also had fever) had resolved and VACCINATION SITE WARMTH (It is hot again), VACCINATION SITE PRURITUS (She started with itching at injection site), VACCINATION SITE ERYTHEMA (It is red again) and VACCINATION SITE SWELLING (It is swollen again) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included: Birth control
Large, red, lesion / rash  in area of injection site.  Tender and hot to the touch.
constipation; Bloating; This is a spontaneous report from a contactable Nurse (patient). A 58-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN-6205 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 13:30 as SINGLE DOSE for covid-19 immunisation(Age at Vaccination was 58years). Medical history included hypothyroid, depression, migraine and known allergies: Sulfa. Concomitant medications included levothyroxine, liothyronine (NP THYROID), escitalopram oxalate (LEXAPRO), montelukast sodium (SINGULAIR) and ergocalciferol (VIT D). The patient received historical vaccine of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM-9809 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 01:00 PM as SINGLE DOSE for covid-19 immunisation. The patient experienced constipation and bloating on 05Mar2021 07:00AM (Six days later (one BM, day 4 with help of stool softer / laxative) and still trying to get through it). No treatment received for the events. Outcome of the events was not recovered..  No follow-up attempts are possible. No further information is expected.
Incorrect dosing for Moderna mRNA booster. 0.5 ml was given instead of 0.25 ml. She has no adverse effect to report as of the day after.
Administration of vaccines, patient started immediately:  12:05 Mom, noted that she is having some hiccups while crying: 1207 Pt was drinking milk just before the completion of Pediarix (1st Vaccine). I  performed back slaps on the pt, then alerted our allergist . Pt was transferred to ER by 1213
Pfizer-BioNTech COVID-19 Vaccine EUA Patient received Pfizer-BioNTech COVID Vaccines on 2/4/2021 and 2/25/2021. Patient diagnosed with COVID-19 on 8/6/21 presented to ED complaining of worsening repsiratory status over a couple of days.  1 day prior to ED visit pt was given Decadron and discharged from unknown location per provider note. Associated symptoms include headache, cough, fever (T-max 104°), chills, decreased appetite/thirst, abdominal cramping with cough, and fatigue. X-ray shows moderate bilateral airspace opacities left greater than right, most consistent with multilevel low-grade pneumonia in this clinical setting. Pt treated with ceftriaxone, azithromycin x 3days 8/10, solumedrol #4 cont.
patient got the moderna covid bivalent booster dose on 9/22/22, he came to the pharmacy  on 2/1/23 and said his left arm is still sore. Pharmacy contacts the office of PRIVATE to inform doctor regading this issue on 2/2/23.
This retrospective pregnancy case was reported by a consumer and described the occurrence of polydactyly of fingers in a neonate male subject who was exposed to FLULAVAL (GlaxoSmithKline) transplacentally when his mother was vaccinated during pregnancy. A physician or other health care professional has not verified this report. On 21 September 2011 the 29-year-old mother of the subject received a dose of FLULAVAL (intramuscular, left arm). The mother's last menstrual period was 18 July 2011 and estimated date of birth was unknown. The neonate was exposed to FLULAVAL at 8 weeks gestation during the first trimester. Ultrasound performed in December 2011 was normal; there was no evidence of a defect from prenatal testing. on 21 April 2012, after 39.5 weeks gestation the neonate was born by unknown delivery method and weighed 3.43 kilograms. Apgar score was not provided. Birth defects were noted. The neonate was born with congenital anomaly of variant polydactyl. "Variant polydactyl neonate was born with two nails on his right thumb. His right thumb looked like two digits glued tighter. Everything else seems ok with with the baby so far". At the time of reporting the outcome of the polydactyl was unspecified. For details regarding the mother case please see A0975588A.