chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse prescriber, referring to an adult patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not disclosed. In September 2017 the patient was vaccinated with the first dose of GARDASIL 9, for prophylaxis, lot # N004799, expiration date 15-NOV-2019 (dose, route of administration, and anatomical location were not reported). The nurse prescriber informed that the patient would return on 02-NOV-2018 to receive the second dose of the vaccine (inappropriate schedule of drug administration). At the time of this report, the second dose had not been administered yet and no adverse event was noted.
Case number PHEH2015US019853, is an initial spontaneous report received from a pharmacist on 02 Oct 2015. This report refers to a 56 year old female patient. Historical conditions and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514801) intramuscularly at a dose of 0.5 ml on 02 Oct 2015. The pharmacist reported that the vaccine FLUVIRIN that had reached 52 degree for 30 minutes was administered to the patient. No adverse event was reported following the medication error.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On unknown dates, the patients were vaccinated with GARDASIL 9 (dose, route and site not reported), Lot# L014415 with expiration date on 25-JUL-2017 or Lot# L045711 with expiration date on 08-MAY-2017, that on an unspecified date were improperly stored at -1.7 C during 24 hours. It was reported that the vaccine did not experienced previous temperature excursion. It was unknown if the patients sought medical attention. No product quality complain was involved. This is one of several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
Severe headache and nasal stuffiness starting at around 2 am. Excedrin (acetaminophen 500 mg/ASA 500 mg/caffeine 130 mg) and pseudoephedrine 60 mg taken around 9 am. Relief from symptoms beginning around 11 am.
Rapid heartbeat, hand tremors, hot flashes, headaches, insomnia started about 3ish months after 1st Covid vaccine
ARM PAIN, SWELLING, TIREDNESS, HEADACHE, MUSCLE PAIN, FEVER, CHILLS, THROWS UP
The area where i received the injection gradually became sore and overnight slight stiffness down to elbow area - I am sure it will go away with time if it gets worse will call Dr
Patient c/o throat swelling, became pale, light headed. Reports throat problem lasted 5 minutes.  Faintness for half an hour.  Vitals within normal limits, laid down for half an hour. Offered Benadryl and prednisone which patient declined.  She was to take oral Benadryl and Zantac as soon as she got home.  Mother in attendance and verbalized understanding.
Tinnitus; This is a spontaneous report from a contactable nurse, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248) via an unspecified route of administration in the left arm on 08Jan2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Concomitant medication included vitamin d nos (MANUFACTURER UNKNOWN); taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH9899) via an unspecified route of administration in the left arm on 18Dec2020 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, approximately 4 weeks after second dose, the patient experienced tinnitus. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 09Apr2021, the patient underwent PCR (nasal swab) test for COVID-19 and the result was negative. No therapeutic measures were taken as a result of the event. The clinical outcome of the event tinnitus was not recovered at the time of this report.
knot on the arm; Headache; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 08Sep2021 (Batch/Lot number: unknown) 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: NODULE (non-serious) with onset 08Sep2021, outcome "not recovered", described as "knot on the arm"; HEADACHE (non-serious) with onset 08Sep2021, outcome "unknown", described as "Headache". The events "knot on the arm" and "headache" were evaluated at the physician office visit. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had just finished a 10 hour shift, my left upper arm where vaccine was given was tender, I continued working all night in the ER to do call for Radiology dept. around 11:30 pm I started feeling a slight dizzy feeling and tired due to being very busy with ER call backs. at around 12:30 am I just finished a pt. and then shared with ER crew that I do not feel myself and wasn't sure if I was tired from work or maybe from vaccine.. I took my temperature and headed to bed to rest, feel asleep and work up for another call and felt like my fever had broken with a sweat feeling. I felt much better and finished my night on call and home on holiday at 1 pm.
pt recv vax 27NOV95 & 28NOV95 pt exp non-varicella like rash @ inj site;pt was treated w/topical steroid solutions w/no relief;10JUL96 pt presented to MD office w/persistent rash;itches;
Patient developed Rash on left thigh. Patient was prescribed cephalexin at urgent care before coming to office.
No additional AE; A 4-month-old child missed his 2nd dose of ROTATEQ.; A 4-month-old child missed his 2nd dose of ROTATEQ.; This spontaneous report was received from a consumer (patient's mother) and refers to a 4 months old infant patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On an unknown date in 2023, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (strength, dose, lot #, and expiration date were not provided) for prophylaxis. On an unknown date in 2023, the patient missed the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (Incomplete course of vaccination). No adverse events were reported (No adverse event).
This case was reported by a other health professional via call center representative and described the occurrence of fever in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional called to asked about reimbursement. On an unknown date, the patient's body temperature was recorded as 102 degree F. The healthcare professional refused to answer any further questions and asked for codes, when notified a transfer would need to occur to answer that question and asked if there were any other questions before that transfer asked for side effect information, VIS lack. Attempt was made to collect adverse events but The healthcare professional stated not having time and hung up. This case was 1 of the 2 cases, reported by the same reporter.
After I got the 1st dose, I had a headache and then 2 days after I had a migraine and was puking. I was dizzy and went to ER 5 days after dose. I was sick for 7 days. I puked for 5 and stayed in bed, I could not get out of bed.  I could not hold any food or fluids for 5 days, I never felt like this before.  I missed 3 days of work.
Information was received on 17-NOV-2016 from a nurse. The nurse reported that on an unspecified date, a patient (age and gender not reported) received a dose of PEDVAXHIB (lot # M021594, expiration date 22-MAR-2019) and a dose of ROTATEQ (lot # M007301, expiration 19-NOV-2017) that were improperly stored. The temperature was 49.5 degrees Fahrenheit for 9 hours and 2 minutes. No previous temperature excursion were reported. No adverse effects were reported. Additional information has been requested.
Plaintiffs allege that as a result of immun on 9JAN90, following which the pt exp an unspecified adverse reaction for which medical care was sought on 11JAN90, pt died on 11JAN90;
metallic taste; burning on the tongue; Feeling stuffed up; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (metallic taste), TONGUE DISCOMFORT (burning on the tongue) and NASAL CONGESTION (Feeling stuffed up) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced DYSGEUSIA (metallic taste), TONGUE DISCOMFORT (burning on the tongue) and NASAL CONGESTION (Feeling stuffed up). At the time of the report, DYSGEUSIA (metallic taste) and TONGUE DISCOMFORT (burning on the tongue) had not resolved and NASAL CONGESTION (Feeling stuffed up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Started with a slight headache, soreness at the injection site and fatigue the day after the vaccination.  Then as the night progressed I had chills and then a 101.2 degree fever.  Within 48 hours all symptoms had subsided.    Took Motrin during the time to reduce fever and headache.
Lost all muscle control; Could not walk; Could not stand up; Brain fog; Bulging disc; Fever of 101 degrees Fahrenheit; A spontaneous report was received from a consumer concerning a 78-years-old, male patient, who received Moderna's covid-19 vaccine (mRNA -1273) and experienced events, lost all muscle control(muscle weakness), could not walk(gait inability) or could not stand up(dysstasia), fever(pyrexia), brain fog(feeling abnomal) and a bulging disc(intervertebral disc protrusion).  The patient's medical history was not provided. Concomitant medications included a shingles vaccine.   On 06 FEB 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06 FEB 2021, the patient received the mRNA-1273 vaccine and on 28 FEB 2021, the patient received Shingles vaccine. On 04 MAR 2021, the patient was hospitalized with the events lost all muscle control, could not walk or stand up, fever and brain fog. On an unspecified date in MAR 2021, the lab tests performed included, stress test and MRI and found a bulging disc and he had a fever of 101 degrees Fahrenheit. Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, brain fog, was considered to be not resolved.  The outcome of the events, bulging disc, lost all muscle control, could not walk or stand up and fever,  was unknown.  Patient's consent to follow-up with safety was obtained.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, confounding factor is the Shingles vaccine, which was received 4 days before the symptoms vs Moderna vaccine which was received 26 days prior to the symptoms starting.
This spontaneous report as received from a health care professional refers to a multiple unspecified patients of unknown demographics. Approximately in November 2015 (also reported as on or after 13-NOV-2015) the patients were vaccinated with improperly stored VARIVAX injection (L025206, 07-JUL-2017) (dose and route unspecified). No adverse effects reported. Additional information has been requested.
Client and father came in requesting moderna and they both received moderna, however, child should have received pfizer b/c he is only 14 yo. Dr. (medical director) made aware and father made aware. Per Dr., will give child Pfizer for second dose of COVID vaccine.
PATIENT COMPLAINED OF PAIN AND BRUISING IN THE INJECTED SHOULDER. THE BRUISING WAS SEVERAL INCHES ABOVE INJECTION SITE.  PATIENT WAS COUNSELED TO USE ICE AND BENADRYL AND TO SEEK MEDICAL ATTENTION IF CONDITION WORSENS.
Irregular heartbeat - triggered AFib - required hospitalization  Started at 6:30am - ER visit required many meds - finally broke by almost passing out at 8:00am the following day.  Result: Rhythm restored, heart monitor required for 14 days to track heart rate after hospital release.
Relatively high fever above 102. General extreme body-aches, malaise., extreme tiredness. This lasted for several days. Also, my previous gastrointestinal distress was severely exacerbated. And has never returned to its pre-vaccine condition.
pt recv vax 11NOV98 child very upset even a/shots were given;extremely upset;13NOV98 rt thigh very swollen, very warm & extremely cranky;
A report has been received from a Pharmacist concerning a 49 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on 16-Dec-2014. The patient was administered by expired FLUMIST quadrivalent which started on 16-Dec-2014. FLUMIST quadrivalent was discontinued on 16-Dec-2014. The outcome of the event of expired FLUMIST quadrivalent administered is unknown. The report was considered to be non-serious.
redness, induration.  150 x 120 mm erythema, 270 mm induration.
received a 3rd dose because of a mistake instead of a booster dose; This spontaneous case was reported by a consumer and describes the occurrence of TRANSCRIPTION MEDICATION ERROR (received a 3rd dose because of a mistake instead of a booster dose) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021c21a, 013a21a and 042l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced TRANSCRIPTION MEDICATION ERROR (received a 3rd dose because of a mistake instead of a booster dose). On 10-Nov-2021, TRANSCRIPTION MEDICATION ERROR (received a 3rd dose because of a mistake instead of a booster dose) had resolved.            No concomitant medication reported. No treatment medication reported.
Local irritation, with pain and redness to the site.  No itching to the site.  Warmth to the site along with streaking going up the limb.
Each -> 2 weeks: FAMVIR, VALTREX, tetracycline. Pox-like blisters/lesions: neck, chest, scalp, breast, arms, thighs, face, eyelid, abdomen - some occurring now, 6 months after vaccination.
Abnormal uterine bleeding (prolonged and heavy), June 2021 requiring ultrasound to detect possibility of cervical stenosis. Discussed possibilty of vaccine causing the adverse events. I asked about the possibility of needing an ablation or hysterectomy bc of AUB. Prolonged periods in the months of March 2021-on, with the exception of amenorrhea in September 2021. I was prescribed transexamic acid to help control w/little to no relief. Passing large clots, 27 days of bleeding in the month of October 2022, prescribed norethindrone 5 mg/daily to stop bleeding and prevent anemia,  Stopped norenthindrone January 13, 2022, amenorrhea since  Third vaccine 2/4/22 and still no menstruation
Patient received injection at 8pm, at a public health clinic held in the community. At around 9 pm she began to feel swelling of her lips and tongue. Was transported to ED at 9:35 pm, where VS were stable. Was treated with Pepsid  & Solumedrol IV, Vistaril PO.  Patients symptoms resolved and she was discharged with medications including one EPI PEN.
Pt received Moderna 12+ dose which was incorrect - MA did not scan the correct product and manually entered the 12+ dose.  Pt should have received Moderna 6-11yr.  VAERS report filed.
Fever chills, headache, nausea , vomiting , a large amount of pain from vaccination. The first one no pain . The second one really hurt maybe due to the person giving it . I had a fever low grade till noon 1/31/21. The scariest was pain and swelling in my lower armpit on my left arm where vaccinated. I found a study that it can happen but I freaked out . 48 after I experienced the lymphnodes swelling the pain went away but still swollen . I think this should be listed as people with a cancer history will freak out if they think their cancer is back . Lymphoma or breast . I aldd also read that vaccinated women need to alert their radiologists before a mammogram as the swollen lymphnodes could mimic Breast cancer and lymphnodes involvement, which would scare women to death .  Physicians should be made aware and the public should be iNformed of the above to reduce panic and unnecessary testing .
Redness and swelling starting from within arm pit area, lymph nodes. Up across deltoid to posterior of arm.   Approximately 10cm in length, 4cm high, swelling ~1/2 cm.   As of today (Monday 8/14, 3 days post-injection), area is itching.
Pt began having mild COVID symptoms (lost of taste/smell, mild cough, mild dyspnea on excertion) and presented herself to the ER for evaluation.  She tested positive for COVID but was not ill enough to be admitted.  Pt was fully vaccinated with Pfizer vaccine.
Lethargic; tremendously achy/ body pain; This is spontaneous report from a contactable consumer (patient). A patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation and methotrexate sodium for Rheumatoid arthritis. Medical history included Rheumatoid arthritis. Concomitant medications were unknown. The patient experienced lethargy, tremendously achy/ body pains on unknown date. The outcome of the events was unknown. Follow up are needed. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021577670 same reporter/drug/event, diff patients
Initial unsolicited report received from healthcare professional on 03 Nov 2014. A 67-year-old male patient, whose concomitant medications were not reported, had received a dose of FLUZONE HD (batch number: U5024CA, expiry date: 12 May 2015), dose number, route of vaccination not reported) in left deltoid on 27 Oct 2014. The patient had a medical history of COPD, congestive heart failure, hyperextension, sleep apnea. The patient had reported allergies to percocet, prednisone, penicillin, Novocain. It was reported that on 28 Oct 2014, that is one day after vaccination, patient woke up with congestion, headache, fever (with temperature of 99.8 degree Fahrenheit) and had sweating. On 29 Oct 2014, the patient developed itchy rash on back and continued to have congestion with some shortness of breath and wheezing. Lab details and corrective treatments were not reported. The outcome of the event was reported as not recovered. Documents held by sender: none. Follow-up information received from a healthcare professional on 02 June 2015. It was reported that after receiving a dose of FLUZONE HD, patient was in bed for a whole week and became dehydrated on an unspecified date. The symptoms lasted for 7 days. Patient had previous Flu vaccinations before and never had a problem. At the time of this report the patient had completely recovered. Documents held by sender: none.
pt recv vax JUL96 & 1-2 days p/vax pt exp soreness to touch @ inj site which resolved w/o tx;
After injection, site was sore on 1/5 . Next day removed bandage and insertion site was raised and red  on 1/6. On 1-8 and 1-9 the redness has spread but less swollen.
On 5/4/22, he woke up at 0200 with ringing in his ears; resolved in 6 hours after taking sudafed
Pain and redness in arm (widespread), fever (recorded at 100.6F with 800 mg of ibuprofen in system), chills, sweats, body aches, severe headaches, neck pain and stiffness, sore throat, cough, nausea, blurry vision, dizziness, confusion, general weakness, numbness in toes. The symptoms lasted for 3 days before beginning to improve. I did call the doctor's office but I did not go in for a visit.
BRAIN FOG; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.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 batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced brain fog, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from brain fog, and fatigue, and was recovering from headache. This report was non-serious.
This spontaneous report as received from a physician, via company representative, refers to a pediatric 6 weeks old patient of unknown gender. On 22-OCT-2013 the patient received a dose of RECOMBIVAX HB (lot number, route and dose were not reported), and a dose of PEDIARIX (lot number, route and dose were not reported, during the same office visit. Concomitant medication were not reported. No adverse effects reported. Additional information has been requested.
Spouse of an existing client signed up for a COVID-19 vaccination and received his first injection of Moderna on 03/07/21 by ARNP.  He denied any symptoms of illness, including COVID-19, on the vaccination date. He was educated re: possible side effects and adverse effects and was asked to report any such effects; no interim contact received. This provider's office called the existing client on 03/15/21 with a routine matter and was advised that this individual had passed away the preceding day. This provider spoke to the existing client, who reported that the cause of death is unknown.  The existing client did not believe that her spouse's death and the vaccination were related. She was asked to notify this provider if any further information is discovered and agreed to do so.
Right arm became sore after about 1 week from the flu shot. I still have residual pain from upper shoulder down to my mid elbow.
Face got beet red for approximately 3 hrs. Next day woke up with heavy wheezing and it felt like bronchitis. By next morning I was fine.
Pt. received vaccine that was used greater than 12 hours after drawn up. MD notified. No adverse event. Pt. chose to get revaccinated.