chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received first Pfizer vaccine 4/1/2021 about 0835am at Immun clinic.  She was monitored 15 minutes and left; however she presented to ER about 0922 c/o feeling "weird" with nonspecific tingling all over body and a headache.  She was taken to triage, and when in bathroom she became ataxic with sense of dizziness as if falling  and being off balance and lightheaded.  VSS, normal EKG (NSR).  MD exam was normal with normal neuro and pt stated HA and dizziness better but still present.  CT head w/o contrast normal w/o bleed, tumors, masses.  Pt refused blood work.  She was released at 1352 feeling better and no c/o dizziness, lightheadedness.
soreness/The pain radiates down to her left elbow and also goes up the neck; The pain radiates down to her left elbow and also goes up the neck; The pain radiates down to her left elbow and also goes up the neck; This is a spontaneous report from contactable other HCP (patient' husband). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. No concomitant medications. The patient had a whole lot of soreness on 01Jan2021 and it was not getting any better. His wife had called her health care provider. She had an appointment in several days. The pain radiates down to her left elbow and also goes up the neck in Jan2021. The reporter seriousness for soreness: Medically significant. The outcome of event pain was not recovered. The outcome of rest events was unknown.; Sender's Comments: Based on a compatible temporal relationship, causality between event pain and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.
after second shot of the pfizer , i notice i was breathing heavy and i couldnt breathe correctly and i was trembling .my son rushed  me to the Emergency room and i was told i had a blood clot in my lung and my leg.
Quadracel was given to a 9 month old which is not the recommended age ( 4 years and up)- No signs or symptoms of any reactions
The patient woke up early morning  with itching and swollen hands. She took  some Allergy medication liquid at 0630 AM without improvement. At work sym- ptoms worsened with skin blotches  on the back of her neck and itching  around her waist. No shortness of  breath. Prednisone 40mg daily x 5 days.
third patient they have seen that has received the COVID-19 vaccine and now has cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (third patient they have seen that has received the COVID-19 vaccine and now has cancer) in a  patient of an unknown age and gender 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) at an unspecified dose. On an unknown date, the patient experienced NEOPLASM MALIGNANT (third patient they have seen that has received the COVID-19 vaccine and now has cancer) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (third patient they have seen that has received the COVID-19 vaccine and now has cancer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2021, Positron emission tomogram: abnormal (abnormal) Cancer.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  The patient explained they found a lump just above the left breast. The patient went and had a few test done.  Treatment information was also not reported.  Company comment: Very limited information regarding this event has been provided at this time. Details including patient demographics, medical history, concomitant medications, date of vaccine administration, details of the tests/diagnostics and final diagnosis is required for further assessment.; Sender's Comments: Very limited information regarding this event has been provided at this time. Details including patient demographics, medical history, concomitant medications, date of vaccine administration, details of the tests/diagnostics and final diagnosis is required for further assessment.
Adverse events occurred on two separate dates.  One was the day after the vaccine, I felt weak limbed and extremely tired. Approximately two weeks after the vaccine shot, on 4/4, I lost feeling and went numb on my entire right side, from my head to my feet.  I had no pain other than dizziness, my face did not droop but my tongue was numb.  In the ER they took my blood pressure, and it was 251/112 or so. It was extremely high.  Also, my numbness was intermittent, it would last about 10 minutes and then slowly go away, then a couple of hours later, it might come back.  Saturday 4/3 it occurred about 4 times, on Sunday 4/4, it occurred about twice while in the hospital. I was released to home the evening of 4/4. On Monday it occurred about 1 time.
11-30-21 Severe chest pain at 5:30 PM (debilitating) and heightened markers for blood clots - D-Dimer.  Treated with Toradol.  After a CT scan was diagnosed with inflammation of lungs and rib cage.
Was administered FLUMIST at office 2 pm and mom stated at 7 pm pt c/o stomach hurting. Developed a "seal" like cough, fever 102 and vomited - liquid. Felt fine in the morning.
Within 1/2 hr patient started to have difficulty drawing air in, heart pounding, felt like fainting, about passing out. Her BP elevated to 150/90 mmHg.
received / Pediarix on April 5th 2021/ was reconstituted on April 2nd 2021 with the needle attached to it.; This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in drug usage process in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 1st and 2nd dose on an unknown date).   On 5th April 2021, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 5th April 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong technique in drug usage process. On an unknown date, the outcome of the wrong technique in drug usage process was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received 3rd dose of Pediarix which was reconstituted on 2nd April 2021 with the needle attached to it.  The vaccine was not discarded at the end of the workday and was inadvertently administered to the patient which led to wrong technique in drug usage process. The reporter consented to follow up.
2 inch by 7 inch patch of erythematous urticaria. It is pruritic, warm to the touch, and painful. It was noted to be edematous around 11am and then was further examined at 7pm that night 2/09/21. It is located around the site of vaccine injection. No other symptoms are noted.
Pt recved vax & exp leg cramps; the next 3 days exp flu-like sx which subsided; 4 days later 16JUL93 exp joint sitffness, fatigue, nausea & sweating;
Bleeding like having a period; Spot; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Bleeding like having a period) and VAGINAL HAEMORRHAGE (Spot) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced VAGINAL HAEMORRHAGE (Bleeding like having a period) and VAGINAL HAEMORRHAGE (Spot). At the time of the report, VAGINAL HAEMORRHAGE (Bleeding like having a period) and VAGINAL HAEMORRHAGE (Spot) outcome was unknown. Not Provided
This spontaneous report was received from a physician via company representative regarding multiple female patients of unknown age. The patient's medical history, concurrent condition and concomitant medications were unknown. On an unknown dates, the patients were vaccinated with GARDASIL (strength, dose, frequency, route, lot # and expiry date were not provided) for prophylaxis. According to the cancer statistics review in 1975-2015, the standard incidence of invasive cervical cancer had decreased by 33% between 1989 and 2007 (from 10'7 to 667) before GARDASIL was commercialized but since the vaccination left to decrease (+0.1) in which vaccination coverage was lower than in the previous ones (around 60%), the same discrepancy was observed by age groups, although of lesser magnitude: women over 50 years of age- those not vaccinated. They benefited from a 5% decrease in risk (from 10'37 in 2007 to 9.87 in 2015) while the youngest, which group the vaccinated women saw their risk was increased by 4% (from 5'24 in 2007 to 5'47 in 2015). The physician stated that, the vaccines against HPV virus could produce cancer. The outcome of cervix carcinoma was unknown. The causality assessment for the cervix carcinoma was related with GARDASIL. Upon internal review, the event "cervix carcinoma" was determined to be medically significant.
broke out with a rash around surgical area, ears and head itch/the rash is "raised, red, super itchy"; broke out with a rash around surgical area, ears and head itch/the rash is "raised, red, super itchy"; broke out with a rash around surgical area, ears and head itch/the rash is "raised, red, super itchy"; This is a spontaneous report from a contactable consumer (patient herself). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8727; Expiration Date: 30Jul2021), via an unspecified route of administration in the right shoulder on 18Mar2021 10:00 (age at vaccination: 68 years) as DOSE 1, 0.3ML SINGLE for covid-19 immunisation. The patient's medical history included lateral lumbar interbody fusion from 10Feb2021 to an unknown date. The patient had surgery 5 weeks before. There were no concomitant medications. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer suspect. On 18Ma2021, the patient broke out with a rash around surgical area, ears and head itch/the rash was raised, red, super itchy. The rash was only around her surgical site. The rash was really bumpy and dense. It was mostly around her surgical site on her abdomen. The reporter was thinking that she shouldn't get the second dose because of this. The adverse events did not require a visit to emergency room. The patient has been calling her surgeon. The patient did not have any prior vaccinations in four weeks nor was tested post vaccination. The outcome of the events was not recovered. There was no product quality complaint (PQC) present.  No follow-up attempts are possible. No further information is expected.
12:25 Slight dizziness with an overall hot feeling for @12min, then 2 hours later chills and slight feverish feeling slight nausea,, which lasted ...then just turned into flu like feeling...insomnia with body feeling slightly jittery till 4am ,took nighttime cold tablet. Flu like symptoms till 31st am.
Patient advised staff she felt swelling of the throat, patient requested epi pen informing she left her's at home. Patient self administered epi, first set of vitals were taken with a blood pressure of 179/74, pulse  of 105, oxygen stat of 98%, 16 on breaths, patient was reassessed every 5min, with a pulse of 116 and breaths of 20 only due to monitor going out of service, third assessment with a pulse of 146 and patient informed staff that condition was worse than the start, 911 was contacted, forth assessment withpulse of 152 and 20 on breaths, flight and fire squad on scene, where transfer of care took place with a last set of a  blood pressure of 164/105, pulse of 118, O2 stat of 85% and breaths at 20. -EMT
Immediate swelling at injection site. Only administered 0.15ml of 0.65ml dose. Red/white/swollen: told ice & BENADRYL.
Three to four days post-vaccination the mother noticed her daughter had hives, raised and itchy, from her elbows to her wrists, on the inside of her arms. The mother treated her with BENADRYL with some relief, but the hives reappeared. On 11/6, the child had a temp of 99 F, not eating and still breaking out. The child was brought to the doctor and the mother was told it could be staph infection. The child was treated with amoxicillin for 10 days with no relief. She was again seen by doctor on 11/16/09 and switched to AUGMENTIN for 10 days and received two doses of BENADRYL. The hives disappeared after she was put on AUGMENTIN. The child is up to date on all immunizations.
POSITIVE SIDE EFFECT one weekafter first dose, my lungs started tofeel better, breathing was easier.; This is a spontaneous report from a contactable consumer. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm right on 13Mar2021 at 08:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, endometriosis and environmental allergy. Concomitant medications included salbutamol (ALBUTEROL) taken for an unknown indication started from an unknown date. The patient previously took pseudoephedrine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient was allergic to narcotics. It was unknown whether the patient was diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021, the patient experienced POSITIVE SIDE EFFECT one week after first dose, his lungs started to feel better, breathing was easier. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of this event. The clinical outcome of the event unexpected therapeutic benefit was recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt recvd 2nd dose of vax on 27APR92 & w/in 2 hrs of vax pt exp an allergic reaction including swollen eyes & tightness in chest; treated an ER w/DPH & recovered;
105kg 33 yo F was seen in clinic for asthma flare. While in clinic, pt was given influenza and pneumococcal vaccinations. Each was 0.5ml volume and charted as given IM in the left deltoid at 1250 11/12. Pt presented 11/14 with local cellulitis, swelling and pain in right arm. The symptoms were attributed to the pneumococcal vaccine. Unknown if both the flu and pneumococcal vaccines were both given in right arm or not. Treated with prescriptions for 10 days of clindamycin 300mg PO TID and ibuprofen for pain and swelling. Not thought to be an allergic reaction.
local abscess @ site of inj-responded to broad spectrum ATB w/in 18hr;2 doses were used out of this bottle for different pt & both devel infect;
I have typically had migranes 1 -2 times per year since my mid-20's...never more often than that.  After my first Covid-19 shot on 8/3/2021, I had 3 migranes, 1 per week for each week following the first shot.   I also am in perimenopause and did not have a period since January.  After my shot ( on 9/3/2021, I started bleeding within the following 2 weeks.  Then after my second shot, I had a heavy period lasting for 18 days.    Coincidental or causal??
Intermittent numbness in left hand. Pinky and ring finger down palm to base of hand. Numbers lasts roughly an hour. Comes and goes throughout the day. No loss of function or strength.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 at 13:00 as dose 1, single (Lot number: EW0161), in left arm, on 04May2021 at 15:00 as dose 2, single (Lot number: EW0173), in left arm and on 22Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FH8027) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing), notes: seasonal allergies. Concomitant medication(s) included: ACETAMINOPHEN, start date: 25Apr2022, stop date: 01May2022; LORATADINE, start date: 01Apr2022, stop date: 09May2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 09May2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) positive, notes: Rebound COVID. Started experiencing symptoms and tested positive 7 days after completing treatment. Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are needed. No further information is expected.
Redness, warmth, tenderness, swelling present. Appointment for evaluation scheduled 07/10/2018. 1st pregnancy, 30w4d along (as of 7/9/18).
This spontaneous report as received from a nurse practitioner refers to multiple unspecified patients of an unknown age and gender. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (lot number, expiration date, dose and route of administration were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Pt developed chest tightness, Hives within 10 min of flu vaccine (Fluzone(. Given Epi Pen and transported to ER per paramedics in satisfactory condition.
A non-serious spontaneous report of dizzy, sore throat, headache and extreme fatigue has been received from a consumer concerning a 16-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 25-Sep-2009 for unreported indication. Three weeks after receiving FLUMIST, the patient developed sore throat, headache, extreme fatigue and was dizzy. Laboratory findings were negative for mononucleosis and swine flu. Treatment for the events was not reported. The outcome for the reported adverse events is considered ongoing.
Patient presented to ED via ambulance with fatigue  weakness, poorly controlled Diabetes, hyperglycemia and abdominal pain.  still in hospital on this date
Patient's wife contacted office after husband was taken to hospital due to experiencing chest pain and difficulty breathing. Upon admissions, she stated he was tested for COVID and the test came back as positive. Wife upset due to the belief that the shot has caused her husbands condition and that we should be aware that hospitals are still testing for COVID and considering it positive even though her husband had been vaccinated.  I tried to explain that he had not had the two full weeks since being vaccinated to have full immunity and that he could have been exposed early enough that he was still able to develop into actual illness.
5/5/03 - Erythema with swelling to right thigh - site about 5 x 5cm; also had increased temp - 100.5 24 hours after vaccines - Tylenol/Motrin PRN, Benadryl PRN, warm compress PRN.
Unresponsive; A spontaneous report was received from Pfizer concerning a 58-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) for prophylaxis of COVID-19 infection.  On 04 Jan 2021, the patient died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 04 Jan 2021. The cause of death was unknown/not reported. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
positive for COVID-19; fever; worse cough; body aches; chills; sore throat; minor cough; This spontaneous case was reported by a physician and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), COUGH (minor cough), COUGH (worse cough), COVID-19 (positive for COVID-19) and PAIN (body aches) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and COUGH (minor cough). On 11-Jan-2021, the patient experienced COUGH (worse cough), PAIN (body aches) and CHILLS (chills). On 13-Jan-2021, the patient experienced COVID-19 (positive for COVID-19) and PYREXIA (fever). The patient was treated with VITAMINS NOS at a dose of 1 dosage form; GUAIFENESIN (MUCINEX) at a dose of 1 dosage form; DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at a dose of 1 dosage form; DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at a dose of 1 dosage form; DEXAMETHASONE at a dose of 1 dosage form and AZITHROMYCIN at a dose of 1 dosage form. At the time of the report, OROPHARYNGEAL PAIN (sore throat), COUGH (minor cough), COUGH (worse cough), COVID-19 (positive for COVID-19), PAIN (body aches), CHILLS (chills) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 test: (Inconclusive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator No treatment medications provided by the reporter.
This spontaneous report was received from a Registered Nurse concerning a patient of unknown age and gender. On 08-OCT-2013, the patient was inadvertently vaccinated with a intramuscularly 0.5ml dose of PNEUMOVAX23 (route and dose not reported) (Lot # 671680/1489AA) that had expired on 12-MAY-2013. No adverse effects reported. This is one of five reports concerning the same source. Additional information has been requested.
Atrial fibrillation.  Lasted several hours.  Went to the ER to make sure I wasn't going to die.  They did some tests then sent me home.  Condition was gone by the time I woke up.  This is very likely not related to anything other than my medical history but thought you should have the data.