chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: Unknown), in right arm 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) and as dose 3 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. The patient relevant medical history included: "CLL stage 1" (unspecified if ongoing), notes: No treatment. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. The patient received Paxlovid from 13Jul2022 to 18Jul2022 for treatment of COVID-19. The patient had no Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Injection was administered SQ not IM.  I initially had arm pain, redness, and swelling in the arm at the injection site for three days and then those improved.  On day three I began to have fatigue.  Over the next 10 days the fatigue became progressively worse.  I felt extremely tired and didn't want to get out of bed.  I also had waves of nausea.  There was no vomiting or diarrhea.  I had no fevers.  I also experienced a loss of appetite during that time.  After 10 days I improved and am now back to normal.
T104-105 on 22AUG91; sz; PT is on phenobarbitol for sz that occurred p/DPT when 4 mo old; PT has sz disorder--tuberous sclerosis;
Pt received HPV (GARDASIL) on 9/24/10. Came back into office today because of pain & swelling at injection site persisting. Pain localized to (L) deltoid area. No radiation of pain. No meds needed or given.
Reported sensitivity right chest and flank on 10/23/2013.  Subsequently diagnosed with shingles and treated with anti-viral medication.
felt "overall icky"; feverish feeling; felt tired; Body aches; fever; chills; headaches; nausea; swollen lymph node under the left arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt "overall icky"), PAIN (Body aches), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Hypothyroidism, Penicillin allergy and Drug allergy (levaquin). Concomitant products included CARVEDILOL and LEVOTHYROXINE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Body aches). 23-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (chills), HEADACHE (headaches), NAUSEA (nausea) and LYMPHADENOPATHY (swollen lymph node under the left arm). On 09-Mar-2021, the patient experienced FATIGUE (felt tired). On 19-Mar-2021, the patient experienced FEELING ABNORMAL (felt "overall icky") and PYREXIA (feverish feeling). On 25-Feb-2021, PAIN (Body aches), PYREXIA (fever), CHILLS (chills), HEADACHE (headaches), NAUSEA (nausea) and LYMPHADENOPATHY (swollen lymph node under the left arm) had resolved. On 20-Mar-2021, PYREXIA (feverish feeling) had resolved. At the time of the report, FEELING ABNORMAL (felt "overall icky") and FATIGUE (felt tired) outcome was unknown.            Past medical history includes four surgeries Treatment information was not provided.
Patient was fine at the time of administration, we sat and chat for a few minutes. We both went to waiting room to meet his wife and chatted for a few minutes. Patient reported feeling weird and fainted. Later reported not having eaten all day and having phobias of needles and a history of syncope. The patient wat stabilized in the seated position, head down between his knees, blood pressure taken 3 times and orange juice and a banana was give to him to boost his blood sugar. I stayed with him for half hour; his wife then drove hime home. I followed up with the patient the next day,he is fine. The incident was reported to his primary care so that the history of syncopes is noted.
Severe pain on right rib; traveling pain from mid back to under breast; traveling pain from mid back to under breast; Shingles; Dose Number: 3; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number was Unknown, Expiration Date: Unknown) dose 3 via an unspecified route of administration, administered in Arm Right on 30Oct2021 at 12:00 as Dose 3 (Booster), single (age at vaccination 68 years) for covid-19 immunisation administered in Health Clinic. Medical history included high bp, cholesterol, hypothyroidism from an unknown date and unknown if ongoing. No known allergies were reported. The patient was not pregnant at the time of vaccination. Concomitant medication(s) included atorvastatin taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium taken for an unspecified indication, start and stop date were not reported; valsartan taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (Batch/Lot Number was Unknown, Expiration Date: Unknown) dose 2 via an unspecified route of administration, administered in Left arm on 05Mar2021 at 01:00pm (age at vaccination 68 years) as dose 2, single for covid-19 immunisation and dose 1 of BNT162B2 (Batch/Lot Number was Unknown, Expiration Date: Unknown) via an unspecified route of administration, administered in right arm on 08Feb2021 at 02:00pm (age at vaccination 68 years) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient did not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Oct2021, the patient received dose number: 3 (booster). On 01Nov2021 the patient experienced severe pain on right rib, traveling pain from mid back to under breast. Then the patient states that her doctor diagnosed her with Shingles, however, she still don't have a rash 6 days later. Therapeutic measures were taken for all events with antivirals and pain medication. The patient visited Doctor or other healthcare professional office/clinic visit due to all events. The outcome of all the events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
red to blue rash on thigh; short of breath; headache; could hardly walk; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable 75-year-old female consumer (Patient) received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME) (lot number/expiration date: unknown), via unknown route of administration, on 25Jan2021 as a single dose for COVID-19 immunization. Relevant medical history was unknown. Concomitant medications was unknown. On 26Jan2021 patient was admitted to hospital for red to blue rash on thigh and short of breath. She stated she got headache after injection and 2 hrs later she could hardly walk. She was in the hospital for 3 days. Complete cardiac work up and CT scans performed which were all negative. The patient inquired if she should take the second covax. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 20-MAR-2014, a healthcare provider administered the ZOSTAVAX (dose, route, and lot # not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 10-OCT-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, 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, the patient had and would continue 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 include 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; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
3/23/2021Started feeling short of breath and very winded. I kept thinking it was just a passing issue and if I took a few pounds off, I would feel better. My back started to hurt as well, so I decided to see a pain specialist. Upon going to the pain clinic, and taking my vitals, they discovered my heart rate was elevated to 150's. Being an RN, I contributed it to my busy and hectic work schedule along with life itself. I was highly advised to go to the closest ER. Upon going, they admitted me and immediately put me on a Cardizem drip, along with admitting me to the telemetry floor.
got the Flu shot once in patients life, got it perfectly well & got the sickest patient had ever been for over a week; Initial information received on 09-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involved a patient of unknown age who get the flu shot once in patients life, got it perfectly well and got the sickest patient had ever been for over a week  (illness), while patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient get the flu shot once in patients life, got it perfectly well and got the sickest patient had ever been for over a week  (illness), (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  Outcome of the events were unknown.  There will be no information available regarding batch number in this case.
Thursday night I had intense burning/ heaviness numbness on my wrist and hands. Next day nerve pain from my hands to my shoulder/ armpit area. Proceeding to my chest then looser extremities (including groin, genital area).
Like when I've had the flu in the past. Hot/cold chills (chills, yet hot to the touch--didn't take temp), All-over body ache, severe aching when got up to use the restroom, etc. Could not get comfortable in any position. The injection site hurt like a bad charliehorse. Pounding headache. Eyes felt hot. This was a booster to the Pfizer vaccine, and I had no such reaction to the first two, other than I slept about 30 hours in a weekend following the first, and slight headache. ALSO, as a patient, I do not have manufacturer information for my influenza vaccine I rec'd less than a  month ago, however, I had to select one from the drop-down on the next page.
hypoglycemia; hypotensive; dizziness; significant local reaction; Initial information received on 30-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2019SA210290 and 2019SA209569.  This case involves an unknown age female patient who experienced hypoglycemia, hypotensive, dizziness and significant local reaction, while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PARACETAMOL (TYLENOL [PARACETAMOL]) and MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA).  On an unknown date, the patient received a 0.5ml second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6522AB, expiry date: 29-Jan-2021 via unknown route in the right deltoid.  On an unknown date, the patient experienced a non-serious hypoglycemia (hypoglycemia), hypotensive (hypotension), dizziness and significant local reaction (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was significant local reaction, dizziness, hypotensive and hypoglycemia.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for the events.   List of documents held by sender: none.
On 09/30 onset of parathesias hands feet arms and legs, urinary retention, constipation, facial flushing, and elevated BP, Seen at ED  on 10/3 MRI C/T/L wnl, CT C/T wnl. On 10/13 noted difficulty walking, weakness of rt leg. Admitted to Hospital with presumptive DX of Gillian Barre. Neuro exam showed absent achilles tendon reflex, hypersensitivity of all extremities, and decreased vibratory sensation of feet. CSF showed protein of 42, WBC 0.  Other labs wnl. Given 3 day protocol of IVIG 2mgm/kg with dramatic improvement of sx. discharged on 10/18. EMG and other lab performed as OP.
At approximately 2:43 PM patient slipped off of chair in observation area of clinic and fell face-down unconscious. As patient was turned over, it was noted that he seemed to be experiencing a seizure. Seizure activity lasted for approximately 3 seconds. Upon resolution of the seizure activity, patient began to regain consciousness, alert but not oriented at first. Vital signs were conducted, blood pressure 163/83, pulse regular 62 beats per minute. EMS notified. Patient complained of head pain (occipital region) and was diaphoretic. No apparent trauma to head noted, full extraocular movement. Patient began to regain more consciousness. EMS arrived on scene @ approximately 3 PM. EMS further evaluated patient. Repeat vital signs, blood pressure 147/80, pulse 60 beats per minute, respiratory rate 18 breaths per minute, oxygen saturation within normal limits. EMS also performed an EKG which was found to be normal. Patient refused any further treatment and signed AMA (against medical advice). Ultimately patient was going to be transported home by a fellow co-worker.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and on 04Oct2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Erthromyicine, reaction(s): "Known allergies: Erthromyicine". 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: (unspecified date) Positive, notes: Treatment of COVID-19; (17Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and Paxlovid was used for treatment of COVID-19 from 08Oct2022 to 12Oct2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
A report has been received from a Health Professional concerning a 32 year old, female patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. On 15-Jan-2014 the patient received nasal FLUMIST QUADRIVALENT, but the vaccine was expired on November 25, 2013. At the time of reporting, the outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Uncontrollable flatulence; This spontaneous case was reported by a consumer and describes the occurrence of FLATULENCE (Uncontrollable flatulence) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced FLATULENCE (Uncontrollable flatulence). At the time of the report, FLATULENCE (Uncontrollable flatulence) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Gas-X. No concomitant medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up information received on 11-MAY-2021, contains non-significant information.
Patient came home and slept all day. The following day she complained of headache and the arm injected was very swollen. She had no "knot" in the arm, but it was hot, had a red appearance around the injection site, much larger than the site, and when I measured her arm, it was almost 2" larger than her other arm (the arm injected was her L arm; the left side of her body is smaller and has more atrophy than the R, as it is). By the evening, her headache was severe and all she wanted to do was sleep. Patient continued to have severe headaches, almost daily, for 3 months and was very exhausted and intolerant (this was not her typical disposition or pattern).
No adverse event; Dose administered after more than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 055a22a, 012l20a, 015m20a and 048f) for COVID-19 vaccination.     The patient was not immunocompromised.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture).    No concomitant medication information was provided.  The vial was initially stored in the refrigerator on 10-Aug-2022. The vial was first punctured at 12 TM on 11-Aug-2022. The vial did not undergo any temperature excursions.  Post puncture, the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius equal to 46 degree Fahrenheit to 77 degree Fahrenheit) for 13 hours and 23 minutes prior to administration on 12-Aug-2022.  No treatment information was provided.   This case was linked to MOD-2022-628872 (Patient Link).
No additional AE/no PQC.; Nurse called and reported that a dose of PROQUAD was administered to a 15 year old on 8/18/2023.; This spontaneous report was received from a nurse referring to a 15-year-old female  patient. The patient's concurrent conditions, medical history, concomitant therapies and historical drugs were not reported.  On 18-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 1 dose, lot #X007356, expiration date: 08-SEP-2024, administered subcutaneously for prophylaxis at left arm (strength was not provided) (inappropriate age at vaccine administration). No additional adverse event (no AE).
Fever over 103, extreme abdominal pain, shooting pain down both legs, vomiting, diarrhea, migraine headache with photophobia, extreme anxiety with impending sense of doom.  Symptoms lasted 12 hours (3pm -3am) and migraine with photophobia lasted another 8 hours with extreme fatigue (slept on / off for 24 hours straight). All symptoms resolved within 2 days.