chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received on 14-NOV-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 14-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. Additional information has been requested.
About 3 minutes after leaving the drive-through vaccine center (following the 15 minute wait period during which I felt fine), while driving home, I felt dizzy, ears ringing, and light-headed and it kept increasing.  Luckily, I pulled into a parking lot, called 911, and fainted.  I regained awareness after a couple of minutes with a fire truck arriving, but was foggy and sweating. I recovered after several minutes and did not get transported anywhere. Firemen advised me to drink lots of water.  I felt very tired but otherwise OK by about 35 minutes after the shot.
Immunization was completed at an offsite clinic on 10/15/18. Patient called and spoke to the store manager the morning of 11/5 to inform us that he was still experiencing shoulder pain and that he was going to make a Drs. appoint. During this call the patient mentioned that he felt that the injection was given too high in the arm and that he suspects it hit his bursa. This has not been confirmed by a medical professional.
This spontaneous report was received from a registered nurse refers to 12 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 16-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: L043214, dose, frequency, expiry date were not reported) for prophylaxis. The patient was vaccinated under Vaccines for Children Program (VCF). The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments:  US-009507513-1612USA003706.
mild headache; mild rash; mild stomach upset; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration (left arm) on 15Jan2021 13:30 at single dose for Covid-19 immunization. The patient's medical history included asthma and allergic rhinitis; no known allergies. Concomitant medications included guaifenesin (ROBITUSSIN), levosalbutamol (LEVALBUTEROL), azelastine hcl, and unspecified vitamin (reported as "vit"). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 (15:45), the patient experienced mild adverse events reported as headache, mild rash within approximately 8 hours after vaccination, mild stomach upset in the morning after vaccination. The patient was treated with 10 mls Benadryl and chamomile tea on 16Jan2021 "mor". The patient has been tested for COVID-19 post vaccination (unspecified date) with unknown result. The patient had been tested for Covid with Nasal Swab on 01Jan2021 (Ag) and on 07Jan2021 (PCR) both with negative result. The outcome of events was recovered on an unspecified date in Jan2021.
Approximately 5-10 minutes post-vaccine, patient stated that it felt like her tongue was swelling, and she was beginning to have trouble breathing. Patient's complexion also became somewhat pale, and possibly pink hued. Patient used an inhaler several times during this episode. Patient was given 50mg of oral diphenhydramine shortly after her complaint was made. Emergency responders was called after administering the diphenhydramine. Responders arrived a few minutes later, and patient was conscious and communicative, and did not appear to be in major distress. At one point, patient mentioned that it was possible she was just panicking.
soreness/How can i combat soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness/How can i combat soreness) 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) 1 dosage form. On an unknown date, the patient experienced PAIN (soreness/How can i combat soreness). At the time of the report, PAIN (soreness/How can i combat soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
This spontaneous report was received from a nurse, refers to an unknown amount of patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. Nurse reported that improperly stored VARIVAX, lot # L023587, expiry date 26-JUN-2017, 0.5 ml, vaccines were administered to patients on unspecified dates after temperature excursion (temperature: 19.6 F, time range 1 hour and 30 minutes) on 13-JUL-2016. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
TYPICAL SIDE EFFECTS; FELT TIRED/FATIGUE; NEED OF MORE SLEEP THAN USUAL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAY-2021 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 MAY-2021, the subject experienced need of more sleep than usual. On 26-MAY-2021, the subject experienced typical side effects. On 26-MAY-2021, the subject experienced felt tired/fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from typical side effects on MAY-2021, had not recovered from felt tired/fatigue, and the outcome of need of more sleep than usual was not reported. This report was non-serious.
The site of injection was hot, swollen & red. CNP prescribed cephalexin 500mg 1 PO TID x 7 days.
covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) in an 8-decade-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Fibrosis, Lung cancer stage IV (fibrosis that caused stage 4 lung cancer), Non-smoker and Chemotherapy (undergoing chemo).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19). At the time of the report, COVID-19 (covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Company comment: This is a spontaneous case concerning a 8-decade-old male  patient with Lung cancer stage IV undergoing chemotherapy, who experienced the non-serious unexpected event of COVID-19 (AESI), on an unknown date after the third dose of mRNA-1273 vaccine.  SARS-CoV-2 test was performed with positive result. Patient had fatigue and cough and was not hospitalized.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Concomitant product use was not provided by the reporter.  Patient had cough,  tiredness were considered as symptoms of Covid-19. patient had less fatigue and more cough. It was hard to distinguish what was omicron and what was just his general condition (cough and tiredness). It was also reported that patient had similar symptoms as reporter and 2 or 3 days behind reporter. next round of chemotherapy was put by a week.  Treatment information was not provided.   Reporter did not allow further contact; Sender's Comments: Company comment: This is a spontaneous case concerning a 8-decade-old male  patient with Lung cancer stage IV undergoing chemotherapy, who experienced the non-serious unexpected event of COVID-19 (AESI), on an unknown date after the third dose of mRNA-1273 vaccine.  SARS-CoV-2 test was performed with positive result. Patient had fatigue and cough and was not hospitalized.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Mild arm pain (non-serious AE); This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 02Mar2021 at 10:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, migraine, gastroesophageal reflux disease (GERD), eczema, and environmental/seasonal allergies. 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. The patient had received other unspecified concomitant medications. On 02Mar2021 at 14:00, the patient experienced mild arm pain (non-serious adverse event). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild arm pain (non-serious AE) was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Right anterior thigh, some induration and erythema, warm to touch, measuring a diameter of 4cm with some fine vesiculation apparent along the surface. No other skin rash noted. This reaction appeared first along proximal thigh at the site of DTaP injection. No fever. Playful, acting normally.
Patient experienced blood in his stool beginning on 01/16/2022, continued until 02/05/2022. Patient had stool two times per day during this time period, with most of the stool having blood in it. Blood was bright red, in the stool and also in the water, with blood clots in the water as well.
11 hour sustained heart rate over 100 while sedentary and sleeping. Unexpected spikes to 140. Since event has had intermittent chest pain.
After the second vaccine I began to have trouble breathing, racing pulse when I do  the slightest activity, progressive muscle and joint pain, instability standing and walking, digestive issues, headaches and  extreme fatigue. It continues to get worse instead of improving, and I am getting very concerned. I have made an appointment to see my GP the first week of May in Illinois, when I return from FL. However, if this continues I will go to the ER at the hospital.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (strength, dose, route, lot # were not reported). No Product Quality Complaint (PQC) was involved. This is one of the two reports from the same source. Additional information has been requested.
Menveo without reconstitution; Only liquid portion was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA732A, expiry date 31-OCT-2023) for prophylaxis.   On 18-APR-2023, the patient received Menveo. On 18-APR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo without reconstitution) and inappropriate dose of vaccine administered (Verbatim: Only liquid portion was administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-APR-2023 The pharmacist reported that a patient received a dose of Menveo without reconstitution, only the liquid portion was administered. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received Menveo liquid portion only without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
pt recv vax & father reported that the child does not speak & is in a special school;father stated that he believes child problems may have been caused by DTP;
light headed, flush, wobbly on feet when attempting to stand, BP elevated, diastolic over 100, HR elevated , dilated pupils, became SOB. states she was observed for 30mins post vaccination. was still experiencing weakness when leaving the hospital and got a ride home. states s.sx improved within 10 hrs.
On 10/19 patient seen for petechiae, unexplained bruising and diagnosed w/ ITP.
09/06/22 presents to EC ED for "leg pain". PMHx of "PAF/flutter" "Extensive PAD s/p laser atherectomy RLE 6/2018 and AAA stent 3/2016, DM II, HTN, HLD, COPD, CKD, ADHD and CVA"
Painful infection site, swollen arm, headache.  T/x: Tylenol 1000 mg  2x daily. S/s subside
pt recvd vax; devel welts from inject site up into hair line; instructed to go to hlth deept or er; to er for evaluation;
Fever; Fatigue; This is a spontaneous report from a non-contactable consumer. A non-pregnant female patient (age unspecified) received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration on unknown date in Mar2021 as a single dose for COVID-19 immunisation. Medical history  and concomitant medications were not provided. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient was tested for COVID-19.  On unknown date in Mar2021 the patient experienced fever and fatigue. The patient did not receive any treatment for the events. The clinical outcome of the events fever and fatigue were recovered on unknown date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Allergic Urticaria that started 2 t 3 hours after the injection. She reports fatigue 2 days later with rash resolving with some use of Benadryl. She required additional Steroid injections, pepcid, and Benadryl for outpatient treatment.
Approximately 10 hours after the injection, she experienced one hive on her right cheekbone. She had bilateral ocular swelling the next morning. She used topical benadryl 1-2 times that day and her symptoms resolved completely within 3 days
Migraine; headache; sinus headache; migraine which turns into tension; tension; nauseous; agitated; terrible cough; insomnia; foggy brain; vertigo; lower back have seized up in pain; doing and saying stupid stuff; neck and lower back have seized up in pain.; neck and lower back have seized up in pain.; This is a spontaneous report from a contactable consumer (patient). A 63-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Batch/Lot Number: ew0171) via an unspecified route of administration, administered in Arm Left on 22Apr2021 at 11:45 as DOSE 2, SINGLE for covid-19 immunization (age at vaccination 63-years-old). The patient's medical history included hypothyroidism, menopause, GAD and Allergy: sulfa from an unknown date and unknown if ongoing. Historical vaccination included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Batch/Lot Number: er8737) via an unspecified route of administration, administered in Arm Left on 01Apr2021 at 11:45 as DOSE 1, SINGLE for covid-19 immunization and the patient experienced migraine, achy, temperature, nauseous, fatigue, insomnia, agitated, muscle aches, lasted 4 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Known allergies to trazodone, codeine, steriods, sulfa. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient did not receive any other medications within 2 weeks of vaccination. the adverse event resulted in physician office visit. On an unspecified date of Apr2021 the patient experienced migraine which turns into tension, to vise grip headache to sinus headache, nauseous, agitated, terrible cough, insomnia, foggy brain, vertigo, doing and saying stupid stuff neck and lower back have seized up in pain. Its been 2 weeks. No hospitalization was reported. On 25Apr2021, the patient underwent lab test for COVID-19, post vaccination Nasal Swab and reported as negative. Treatment given with zpak rx told to take Excedrin, Adevele had m. The outcome for the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
depression; feel horrible; repulsion; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (depression), FEELING ABNORMAL (feel horrible) and ANXIETY (repulsion) 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) 1 dosage form. On an unknown date, the patient experienced DEPRESSION (depression), FEELING ABNORMAL (feel horrible) and ANXIETY (repulsion). At the time of the report, DEPRESSION (depression), FEELING ABNORMAL (feel horrible) and ANXIETY (repulsion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were provided. No treatment medications was reported. After introduction of vaccination, the patient was in a little bit of guilt, repulsion and depression with horrible feeling (reported in a crosslinked case). The vaccine should get to everybody and that the formula should be shared.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Non significant follow up received on 22-sep-2021
Pt received Moderna for 1st dose on 7/22/21 and received Pifzer today 8/14/21
a pregnant female recv vax & had an elective abortion 1wk p/vax;pt recovered & since then recv booster vax;
I administered hep b and flu shot for the pt. I went to grab the paperwork for him to bring to his MD.  I had him wait out side of the pharmacy window while I printed them. When I came back out to provide him with the print out, he reported of feeling dizzy. I told him "lets go sit on the bench" and assisted him by his arm to walk him over to the bench. As we were walking, he started swerving and started falling. I believe he lost consciousness for a second or two, then he came back and got up and I assisted him to the bench.
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 65-year-old male patient received BNT162b2 (BNT162B2), on 01Nov2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medications received in two weeks: No. Paxlovid was taken as treatment drug for Covid-19 treatment from 13Aug2022 to Aug2022. Lot number GE4926. Patient have no known allergies. Treatment was not received for AE. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hives appeared all over patient's body and some "tightness" in throat. Symptoms started the afternoon of 8/17/21, after receiving the second dose of the Pfizer COVID-19 vaccine at Tthe Vaccination Center.  Patient given a steroid injection Depo 80mg mixed with Celestone 6mg- IM in our office on 08/18/21. Patient also prescribed Pepcid AC  (famotidine) tablet 20 mg, Take 1 tablet by mouth three times a day and hydroxyzine HCl  (hydroxyzine hcl) tablet 25 mg, Take 1 tablet by mouth three times a day.
Injection was 10/ 18.  The next morning around 8:30 I went to the kitchen to fix my breakfast.  I was standing at the counter.  Next thing I knew I was stretched out on the floor (at 90 deg from where I'd been standing) in severe pain.  There was no warning; one second everything was normal and the next I was aware I was on the floor.  I have never fainted before.  Xrays revealed a severe compression fracture of T8.  It is now over 6 months later.  I still have significant pain when standing, sitting in a straight-back chair, or walking more than 25 minutes on a flat course.
Tested on 6/2 due to upcoming travel.  Bodyaches and low grade also reported on 6/2.
I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 11/9/2021 SHORTNESS OF BREATH I82.409 ACUTE DVT, UNSPECIFIED VEIN 12/1/2021 SHORTNESS OF BREATH
3/20/19 within first few hours of administration patient experienced numbness and tingling in breast which lasted about 10 seconds. On the following day, 3/21/19, patient experienced fatigue. On 3/22/19, patient had severe muscle and joint pain/soreness and pain in hips which caused trouble walking. This lasted the entire day. On 3/23/19 patient had nausea.