chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Less than five minutes after administering vaccine patient reported feeling lightheaded and nauseated. She also was sweating profusely. She never fainted but sat on the floor x10-15minutes until she felt stable enough walk. She drank several glasses of water. She used the restroom and then upon return to pharmacy waiting area, she vomited. After vomiting, she said her nausea improved. She was experiencing cramps related to menstrual period. After vomiting, main discomfort came from cramps. Patient did not report feeling faint, or lightheaded.
On 4/7/22 patient received 2nd Covid booster 3 months after 1st booster rather than the recommended 4 month interval.  Patient reported a headache beginning 4/9/22.  She was unsure if it was related to the booster.
Overall achiness, tiredness, sore throat, back pain. Symptoms have persisted since early in the morning the day after receiving the vaccination.
Redness and raised approximately 3 inch in diameter around injection site slightly itchy, painful if lays on it. Does not feel feverish. Patient called for follow up w/MD.
Dizziness; Chest pains; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and CHEST PAIN (Chest pains) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and CHEST PAIN (Chest pains). At the time of the report, DIZZINESS (Dizziness) and CHEST PAIN (Chest pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications details were provided.  No Treatment Medications details were provided.   Reporter did not allow further contact
This initial spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The reporter stated that on multiple unspecified dates ranging from 30-SEP-2015 through 13-OCT-2015, the patients received improperly stored doses of GARDASIL injection (lot # K010215 with expiration date 15-MAY-2017, lot# K016966 with expiration date 10-MAY-2017 and lot# K023432 with expiration date 18-JUN-2016; dose, frequency and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a consumer regarding her daughter with no reported concomitant medications or medical conditions who in early February 2012 received her first dose of GARDASIL and the patient was "perfectly fine". On 24-SEP-2012 the patient received her second dose of GARDASIL. After the vaccine had been administered, the patient stood up and while waiting in line to pay for the vaccine, the patient passed on on the receptionist's laminate floor. The patient hit her jaw and she had a knot on her forehead. On 25-SEP-2012 the patient was lying in bed and she felt dizzy and very nauseous. It was very hard for the patient to chew her food. The patient received unspecified treatment. At the time of reporting, there was no additional information provided and the patient was recovering. Additional information is not expected.
Patient received vaccine at 1:30 pm (L) thigh red, swollen, hard to touch. Inconsolable crying x 4 hrs. Seen by Dr. at 7:10pm.
Patient fainted immediately following administration. Unconscious approximately 10 seconds from onset. Immediate recovery. Patient stated he has history of syncope following injection with similar outcomes. No further issues following recovery.
I had a cough and fatigue. I completed an at home COVID-19 test and it was negative. I tested positive on the 2nd day, and I had started to feel faint and was told to go to the ER. They retested me for COVID-19 again and, I was positive. Through blood test they determined my sodium levels were really low around 127. They indicated this was why I was feeling. I started Paxlovid and Sodium Tablets. I was discharged after 2 days.  I have been doing blood test every day. The sodium levels leveled off and the specialist had me stop taking the medication. My doctor told me I had mercer in my nose, and they gave me some ointment.
Bell's palsy; anxiety; This is a spontaneous report from a contactable consumer (patient's friend). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at a single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient received the Covid-19 vaccine and ended up in the hospital with Bell's Palsy. The reporter was not sure if this was related to the vaccine. The reporter wanted to know if there were any similar reports of this. The reporter also stated that the patient also experienced anxiety after the vaccine administration. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Moderna on 3/1 and 4/1. Positive on 8/27 admitted 9/8 to current
stroke; This is a spontaneous report form a non-contactable consumer (co-worker). A female patient of an unspecified age received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, dose number unknown, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, two weeks after the shot, the patient had a stroke, assessed as medically significant. At the time of the report the event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
body pain; tired; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body pain), FATIGUE (tired), HEADACHE (headache) and PYREXIA (fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body pain), FATIGUE (tired), HEADACHE (headache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (body pain), FATIGUE (tired), HEADACHE (headache) and PYREXIA (fever) had resolved.            Concomitant product use was not provided.   This case was linked to MOD-2021-416990 (Patient Link).
pt was noted on morning p/vax given to have large area of redness around inj site;area felt hot & caked;on observation 2nd day p/immun bruised area noted @ inj site w/large area of erythema in surrounding tissue;area swollen & warm to touch
I experienced swollen lymph node in my collar bone about 6 days after my first vaccine. I had gone to see a fertility doctor on 02-22-2021 because something with my uterus, had some tissue removed, my ovarian reserve was extremely low and this was 2 weeks after my first dose. We did fertility treatment, because I though I had diminished ovarian reserve. My ANH was .5. I am 31 years old and it should be 2-3 over 1 is normal. My ovarian reserve is completely back to normal and my doctor thinks it was to my immune response. I also had a sore arm after my first vaccine. My doctor is a good doctor and he tried to ask if they have seen it it another patients. I had 4 follicles in my ovaries the normal is 10-12 and now I can say I have 20 follicles in my ovaries. It took me about 5 months for my follicles in my ovaries to get back to normal.
Information has been received from a certified medical assistant for the Pregnancy Registry for GARDASIL concerning a female who on 26-MAR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# not reported). There was no concomitant medication. On 28-MAY-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot# not reported) and was pregnant. The patient's LMP was approximately 15-APR-2008. Subsequently the patient experienced no known symptoms. The patient has a positive pregnancy test on 10-JUN-2008. The patient's outcome was not reported. Follow-up information has been received from a physician for the Pregnancy Registry for GARDASIL concerning the 25 year old female with asthma and anxiety, a history of 1 pregnancy and 1 normal delivery and a history of vaginal disorder and some complication on 26-MAR-2008 was vaccinated IM with the first dose GARDASIL, on 28-MAY-2008 was vaccinated with the second dose and on 11-MAR-2009 was vaccinated with the third dose (lot #: 660553/0070X). The patient became pregnant in April 2008, the date of last menstrual period was 18-APR-2008, estimated delivery date was 25-JAN-2009. On 22-JAN-2009 the patient delivered a normal, female infant with no congenital anomalies. The baby's weight was 7 LB 14.5 ounce, length was 21.75 inch, head circumference was 14.25 inch. Apgar test score was 8/9. On an unspecified date, group B strep test of the infant was positive. Initial complete blood count secondary to group B strep positive was 9 band. C-reactive protein test was negative and blood culture was negative. At the time of this report, bandemia resolved. No further information is available.
Information has been received from a physician's assistant concerning a 55 year old female with a pcn allergy and a history of osteopenia and varicella as a child who on 10/29/2001 was vacicnated with a first dose of varicella vaccine in the right arm. The pt's VZV antibody titer was negative despite having varicella as a child. Concomitant therapy included aledronate sodium and atorvastatin calcium. There was no illness at the time of vaccination. On 11/05/2001 the pt developed posterior left thigh pain which the pt quantified as an 8. On 11/07/2001, the pain worsened and the pt developed a vesicular rash with an erythematous base i the dermatome. The vesicles crusted. On 11/07/2001, the pt was seen by her doctor followed by a dermatologist. A viral cultures of a vesicular lesion was VZV positive, and PCR analysis identified wild type varicella virus. The pt was diagnosed with herpes zoster. The pt was treated with Fanvir and an unspecified nonsteroidal anti-inflammatory medication. Subsequently, the pt recovered. No additional info is expected.
Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2010, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Information has been received from a registered nurse concerning her son who on an unknown date was vaccinated with a dose of VARIVAX (Merck) (Lot number not provided). The nurse reported that her son received VARIVAX (Merck) "when he was little" and he developed 3-4 chicken pox lesions several days after he received VARIVAX (Merck). At the time of the report, the patient's outcome was unknown. This is one of two reports from the same source. Additional information has been.
slight headache; low grade fever and chills for approx 10 hours post injection; low grade fever and chills for approx 10 hours post injection; This is a spontaneous report from a contactable other healthcare professional (HCP). A 65-year-old female patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), intramuscular on 08Jan2021 18:00 (reported as 06:00 PM) at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. There were no other medical history. No known allergies. The patient's concomitant medications were not reported. No other vaccine in four weeks. Facility type vaccine was hospital. No COVID prior vaccination. The patient experienced slight headache, low grade fever and chills for approximately 10 hours post injection on 09Jan2021 02:00 PM. No treatment for the events. Outcome of the events was recovered in Jan2021. Patient was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
PT OBSERVED IN CLINIC. 20 MINUTES POST VACCINE PT REQUESTED TO LAY DOWN.PT HAD SYNCOPAL EPISODE.   TO STRETCHER.CAT CALLED. PT DIAPHORETIC. VITALS #1 BP 81/51 HR 39 SPO2 99% 9:19 PT C/O NAUSEA   #2 BP 90/60  HR 67 SPO2 99% 9:20#3 100/65   HR 61 SPO2 99% 9:25   #4 103/64  HR 65  SPO2 100% 9:32#5  106/60  HR 69 SPO2 99% 9:35   PT STATES NAUSEA, VOMITTING AND DIZZINESS HAS RESOLVED.PT NEEDED TO USE RESTROOM, ACCOMPANIED TO RESTROOM. PT   NO LONGER COMPLAINED OF ANY SYMPTOMS. LAST VITALS SIGNSAFTER AMBULATING TO THE RESTROOM 109/72 HR 56 SPO2-99%
Itchy hives developed on both hands ~24 hours after injection. Most bumps are on his hands and wrist with a few on his elbows.
I was extremely fatigued an hour or two after the shot.  The next day (today), I woke up with full on body aches, so much pain I could barely stand and walk around for more than a few minutes.  I also had chills and now I have a fever.
The evening of 9/04/2018 Pt started with a moderate red rash on abdomen, groin, left and right arms.
Moderna vaccine was administered to patient past the 12 hour beyond use time.  No adverse reactions occurred or have been reported by the vaccinated individual.  Moderna manufacturer was contacted and we are awaiting a return call from a vaccination expert.  No Adverse reactions were observed by pharmacist within 15 minutes after vaccination. Patient did not contact us as of 6 hours after vaccination to report adverse reactions.
chills; fatigue; sore arm; fever of 99.1; body aches; stomachache; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 09Jan2022 11:00 (Lot number: FJ5683) at the age of 13 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "FPIES" (unspecified if ongoing), notes: FPIES. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for COVID-19 Immunization.  The following information was reported: CHILLS (non-serious) with onset Jan2022, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset Jan2022, outcome "unknown", described as "fatigue"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "sore arm"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "fever of 99.1"; PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "body aches"; ABDOMINAL PAIN UPPER (non-serious) with onset Jan2022, outcome "unknown", described as "stomach ache"; OROPHARYNGEAL PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Male 13 year old patient, experienced chills, fatigue, sore arm, fever of 99.1, and body aches, stomach ache and sore throat after receiving booster Covid 19 vaccine on 09Jan2022.  Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Even stronger positive than my original; (14Sep2023) Negative, notes: I tested negative last Thursday; (21Sep2023) Positive, notes: Today is Thursday again / I just tested positive on two different brands of at home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever 101.7 all day and night April 22 and fatigue Tylenol  and slept all day and night
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Vomiting-Mild
headache; chills; A spontaneous report was received from a consumer concerning a 66 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On 25 Feb 2021, approximately 1 day prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 015M20A) via unknown route for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the event(s) headache, chills.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of event(s), headache, chills was unknown.
A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse concerning a patient of unknown age in a pediatrician's office. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error at the time of the report, nor when contact was made with the site approximately two weeks later; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medications errors that occurred shortly after the product expired. Follow-up received 07-Oct-2008. No adverse events had been reported. Follow-up received 20 Mar-2009: added product complaint investigation results.
Information has been received from a register nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and drug reactions was not provided. On 19-JAN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD, (lot # M039447, expiry date 20-MAR-2018) (route of administration and anatomical location were not reported) for prophylaxis. The PROQUAD was reconstituted with properly stored sterile diluent (manufacturer unknown), (lot # M017324, expiry date 25-SEP-2018). No adverse effects were reported. The temperature excursion for the PROQUAD was 12°F during 42 minutes. The previous temperature excursions for the vaccine were 6°F to 14°F for 1 hour 46 minutes and then 15°F to 46°F (24°F) for 10 hours and 14 minutes. The call was made because of a data logger.
Information has been received from a female consumer who on 30-JAN-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included hormone replacement therapy and "standard medications." Ten days later vaccination, on 09-FEB-2007 the patient was experiencing vertigo, hearing loss and tendonitis. The patient stated that she had to go to the emergency room and get an MRI and CT scan and that she has seen her doctor many times. There was no product quality complaint involved. Additional information was received from the physician. A 60 year old white female with allergies to penicillin, sulfa, cefixime (SUPRAX), levofloxacin (LEVAQUIN), metronidazole (FLAGYL), cefdinir (OMNICEF), ramelton (ROZEREM), duloxetine hydrochloride (CYMBALTA) and doxycycline, was vaccinated with a dose of Zostavax on 30-JAN-2007. On 06-FEB-2007 the patient's ears were plugged "ETD". on 08-FEB-2007 the patient developed cystitis and was treated with azithromycin (Z-PAK), phenazopyridine hydrochloride (PYRIDIUM) and fluconazole (DIFLUCAN). On 20-FEB-2007 the patient was diagnosed with sinusitis and was treated with clarithromycin (BIAXIN), fluticasone propionate (FLONASE), guaifenesin (MUCINEX), acetaminophen (+) propoxyphene napsylate (DARVOCET-N) and "ETD.". On 27-FEB-2007 the patient's prescription was changed to gemifloxacin mesylate (FACTIVE). On 01-MAR-2007 the patient saw an ENT and it was noted that her left arm was blocked, the patient was treated with prednisone. On 04-MAR-2007 the patient fainted at the gym 1 1/2 hours after steam and the patient was dizzy. The patient presented to the ER where a CT scan was "negative." It was reported that since 04-MAR-2007 the patient has been bedridden with dizziness. The patient was again seen on 20-MAR-2007 and ENT had done an MRI which showed that the acoustic nerve was "OK." It was reported that the patient is now with hearing loss, tinnitus and dizziness being treated with hydrochlorothiazide (+)  triamterene (DYAZIDE). Subsequently the patient developed facial pains and was diagnosed with a dental abscess and treated with clindamycin, then ciprofloxacin hydrochloride (CIPRO) and now a mouth piece for teeth grinding. The hydrochlorothiazide (+) trimaterene (DYAZIDE) was stopped and the patient developed severe incapacitating vertigo x 3 days. At the time of the report the patient had some improvement with dizziness, it was possible that her hearing loss was less and she still had tinnitus. The patient had a hearing test with her ENT which showed left hearing loss. At the time of the report the patient had not recovered. No further information was provided. The patient's events were considered disabiling/incapacitating. No further information is available.