chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2022 as dose 3 (booster), single (Lot number: FM0698) at the age of 25 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Mar2021 as dose 1, single (Lot number: 046A21A), in left arm and on 16Apr2021 as dose 2, single (Lot number: 046B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Major depression" (unspecified if ongoing); "known allergies Echineacea" (unspecified if ongoing), notes: known allergies Echineacea. Concomitant medication(s) included: LO LOESTRIN FE, start date: Aug2022, stop date: 08May2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08May2023 at 10:00, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were not taken as a result of drug ineffective, covid-19 included Paxlovid.
Per patient, he received Pffizer as first dose on April 12, 2021. We are unable to very this in database since alleged vaccination was given in another state. Patient insisted on getting 2nd dose as Morderna (mRNA) since we do not have Pfizer in the clinic at that time. Patient also said that he "is not always around" when the topic of getting 2nd vaccine as Pfizer on a different day from another site. Moderna vaccine was given as a 2nd dose per patient's requests.
COVID VACCINE SIDE EFFECT/HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (COVID VACCINE SIDE EFFECT/HEADACHE) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (COVID VACCINE SIDE EFFECT/HEADACHE). At the time of the report, HEADACHE (COVID VACCINE SIDE EFFECT/HEADACHE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was  provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The suspect drug daily dose was reported as citrate free.  No treatment medication information was provided.
Day of injection developed a nickel sized raised bump at injection site. 1 week after this red area began enlarging; did not start subsiding until 1/5/2021. See photo taken 1/3/2021: perimeter was red and raised. Itching started on 1/4/2021.
6/24  71-year-old female with a history of quadriplegia, dysphagia with PEG tube, bladder cancer history status postresection and chronic Foley, COPD, lung cancer status post radiation and chemotherapy. Has been less responsive to her family with low-grade fever, increasing congestion and rhinorrhea--brought into the emergency room.
REDNESS, SWELLING, FIRM, PAINFUL, WARM AT TOUCH; THIS STARTED ON DAY 1. BY DAY 4, 75% OF SKIN WAS COVERED. SHE WAS GIVEN TYLENOL AND MOTRIN, USED A COLD PACK TO AREA, AND I APPLIED ESSENTIAL OILS TO THE AREA TO HELP WITH THE PAIN. BY DAY 7, THERE IS ONLY A LITTLE FIRMNESS TO WHERE THE SHOT WAS GIVEN.
This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received the two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took the 2 doses of Pfizer's COVID-19 Vaccine but on an unspecified date the physician went and test self for antibody. The physician had negative IgG and positive IgM on an unspecified date. The physician asked, What the vaccine does, is that what it is supposed to do, just make IgM not IgG. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Tinnitus in bilateral ears, not improved.  Have had prednisone Corse without improvement.  Have followed with PCP.
Mom states pt started screaming 1 hr p/vax recvd & lasted x 5 hrs; t101; did not seek med attention; no c/o next day;
11 X 8 cm red indurated with ecchymosis at upper pole (left arm).
Patient was admitted to the hospital on 1/21/22 and discharged on 1/22/22. She was seen for seizure like activity. She was seen by neurology who recommended dilantin 100mg three times daily and can follow up in the office for seizure management. Outpatient EEG. She was also seen by cardiology. They recommended increasing her Toprol to 100mg daily for alleviation of palpitations of her ventricular bigeminy and discontinuation of lisinopril
Tightness in lungs immediately. Slight wheezing, stomach churning, pt turned bright red, Throat felt tight. Neck pain developed and hour later. Gave 25mg of diphenhydramine orally immediately.
FELT CRUDDY; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight was 309 pounds, and height was 65 inches. The patient's past medical history included: covid-19 infection (Patient stated that back in SEP-2020 he went to the hospital and almost died, CO2 level were through the roof. He sat down and looked at his hospital record and it said he had COVID. He assumed he had it.), and covid-19 infection (Patient stated he got Covid again in DEC-2020. Patient stated he still was not vaccinated either time), and concurrent conditions included: non-smoker, and non-alcoholic, and other pre-existing medical conditions included: The patient had no known allergies to vaccine, drug or food. The patient had no drug abuse or illicit drug usage. Patient did not have family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: unknown) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. Age at time of vaccination 51 years old. No concomitant medications were reported. On SEP-2020, Laboratory data included: CO2 Patient reported his CO2 level was through the roof. On 05-MAY-2021, the patient experienced felt cruddy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt cruddy. This report was non-serious. This case, involving the same patient is linked to 20220638632.
sustained high heart rate in the 160s 11/19/2021 - preworkout in system, went to er (blood drawn, ekg) sustained high heart rate in the 140s 11/22/2021 - preworkout not in system, went to doctors office (blood drawn) sustained high heart rate in the 160s-180s 11/25/2021 - no caffine, admitted to hospital for 2 days (triponine test, blood drawn, ekg, heart echo, heart monitor) sustained high heart rate in the 140s 11/29/2021 - (blood drawn, ekg)  All instances were with me standing still or sleeping.
Pneumonia; Blood clot in his lungs; Lack of appetite; Diarrhea; Headache; High Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and PULMONARY THROMBOSIS (Blood clot in his lungs) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L201) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant), PULMONARY THROMBOSIS (Blood clot in his lungs) (seriousness criteria hospitalization and medically significant), DECREASED APPETITE (Lack of appetite), DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (High Fever), CHILLS (Chills) and NAUSEA (Nausea). The patient was hospitalized from 22-Jan-2021 to 30-Jan-2021 due to PNEUMONIA and PULMONARY THROMBOSIS. At the time of the report, PNEUMONIA (Pneumonia), PULMONARY THROMBOSIS (Blood clot in his lungs), DECREASED APPETITE (Lack of appetite), DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (High Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood thinners, antibiotic and probiotics.  No treatment information was provided.  Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of fever, chills, headache, and nausea.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: New events and seriousness of hospitalization were added.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of fever, chills, headache, and nausea.
Pt presented to ED with Left facial numbness and concern for stroke. Observed over night. MRI brain negative for acute process. Stable at baseline neuro status 1/10/21, discharged home.
Parent states that (past 3 years) child has vomited for 3 days (starting 5-7 days after flu shot given).
3 weeks after the second dose I had fever, aches and pains, and fatigue. I decided to go to the walking clinic. They did a C reactive protein, CBC with auto differential, sedimentation rate. I took some Ibuprofen before going there. They encourage me to take some Ibuprofen. They said they wondered if it was related to the vaccine but they thought it could be a virus .
fever 105, hosp over noc scream for over 6hr;pt recovered;hosp for observation;
Felt very tired; Did not have the right amount of energy; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in Arm Left on 16Apr2021 11:00 (Batch/Lot Number: EW0153) (at the age of 66-years-old) as SINGLE for covid-19 immunization at hospital. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 17Mar2021 (Batch/Lot number: EP6955) as SINGLE for covid-19 immunization from which the patient felt a little tired that evening, and then felt fine and only slept about 12 hours. Another historical vaccine included swine flu vaccine from which the patient had a  slight temperature and every muscle in his body ached. Patient does not have NDC, lot or expiry as it was years and years ago. Within 4 weeks prior to the COVID vaccine, the patient received regular flu shot, had one Sep2020 and got one yesterday. Patient medical history included, IBSD from Sep2016 and his gastrointestinal doctor put him on the special diet, scar tissue (some hamburger broke off in his throat in 2009 and caused scar tissue and he can't stand heat and his food has to be soft and cold, he can't eat warm foods) from 2009 to an unknown date, acid reflux and took that medication and had problem with his throat from an unknown date and unknown if ongoing. Patient denied for any concomitant medications. On an unspecified date in May2021, the patient felt very tired for about 3 months and he did not have the right amount of energy and stated that he got up at 7am and is retired and by 2pm was laid out and resulted in patient to visit Physician Office. On 15Jul2021, the patient underwent lab tests and procedures which included Sugar, Iron, , Thyroid, B12, red blood cell and white blood cell which was found to be normal and On an unspecified date iron and B12 was found to be low and on 28Jul2021, his magnesium was found to be normal. On an unspecified date in Aug2021, the outcome of events was recovered.  Information on the lot/batch number has been requested.
Patient now presents with Guillain-Barre syndrome to Medical Center 1 week after flu vaccine. There is no other obvious source of infection, CSF cultures/tests are pending for viral/bacterial infections. The exact date and time of vaccination is unclear, but patient states roughly 1 week before symptoms started (which clearly started on 9/12/2013).
About an hour after first injection employee experienced foggyness for about an hour, day 2 - sore injection site.  Narrative:   Other Relevant History:
Information has been received from a physician concerning a female who on 07-NOV-2007 was vaccinated with the first dose of GARDASIL (659435/1265U). Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (-) tetanus toxoid. On 07-NOV-2007 the patient fainted and experienced headache, nausea and a sore arm. Subsequently, the patient recovered from the fainting, headache, nausea and sore arm. The patient sought unspecified medical attention. Additional information has been requested.
COVID-19 Vaccine EUA; fever, chills, joint intense pain in hip joints and neck, headache, exhaustion, loss of appetite, nausea,  heart fluttered for a few seconds at various times throughout the day, swelling and pain at injection site.  Symptoms started around 9PM on the 26th, started to feel better at 8AM morning of the 28th.  Could not work or focus at all for the 27th.  Took tylenol, motrin, and aleve for pain, which eased some pain, but not full relief, constantly felt pain.  By 8AM on the 28th, pain, headache, exhaustion, appetite loss, nausea, and heart flutters stopped.  Pain at arm shot site diminished to only when touched, discomfort shifted to  right side of rib cage under the armpit, and is still present at 12:15pm on Jan 29th.   Called primary physician to verify all was OK, and as predicted it passed within 24-48hrs.  No allergic reactions ever.
Fever, chills, achy. Received PREVNAR Friday 16/15. Received flu shot at Dr office a week before.
After receiving vaccine she started to have numbness in her tongue that lasted a few days and then it resolved.
Skipped July and August periods.  Got period 6/8/21 and then not until 8/23/21 after having regular monthly periods over 1 year.
On 12-19-08 increased temp 105.8 and febrile seizure.
Information regarding Prevnar was received from a healthcare professional regarding a 3 month old infant who experienced pneumococcal meningitis. The infant received the first done on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. The infant was hospitalized with pneumococcal meningitis on an unspecified date. No additional information was available at the time of this report.
shingles; I had severe nerve pain in my back and arms; numbness; tingling; itching; This is a spontaneous report from a non-contactable consumer (patient herself). A 49-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, administered in arm left on 31Mar2021 (Batch/Lot Number: ER8730) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Relevant medical history includes diabetes, fibromyalgia and known allergies to sulfa. The patient was not diagnosed with COVID- 19 prior to vaccination. The patient's concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient historically received flu vaccine for immunization on an unspecified date and experienced known allergies. On 01May2021, patient stated that she had severe nerve pain in my back and arms, numbness, tingling and itching on torso which then developed into shingles. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment for the adverse events was antiviral. The patient has not been tested for COVID-19 since the vaccination. Patient recovered with lasting effects on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Approximately 4 days post vax the pt became pregnant. 12 days post vax later the pt experienced 7-8 chickenpox marks.
Pt. received vaccine on 02/04/2019 stated on 02/05/2019 she woke up and it was tender 02/06/2019 it was red with a rash and hot to touch and swollen. Pt. was seen in clinic by staff who told pt. to ice her arm and take antihistamine. She also told pt. if it does not get any better an a couple of days to come back and been seen.
Moderna COVID-19 Vaccine EUA Vaccine shot at @ 10 am Monday , Febr uary 15. Minor soreness at vaccine  injection site. Symptoms started about 12 hours later.  10 pm same day. Left arm became very painful between elbow and shoulder joint. Injection  site became very painful.  Bec. ame nauseous. Headache  and feverish.. Theses symptoms continued for next 24 hours.. Temperature s taken were at 101.2 F and 102.6 F.  Oxygen levels (oxcimeter readings) bounced around from 95 to 92 and back to 95. This was during a 24 cycle . At about 9 am on Wednesday., arm soreness was almost completely gone , no nausea, no headache. . Only fatigue was left.  It felt like I had a 1 day .Covid attack.
A few months after the vaccine I went from a robust woman and becoming very weak and developed extreme pain down my clavicle, neck and from the waist down I was practically immobile and hurt all over and on the left side of my right hand I developed pain there as well. I began developing extreme lower back pain. I have a history of off/on pain but this pain was almost unbearable. 4/17 I visited my PCP who diagnosed me with Poly Myalgia Rheumatica/Temporal Arteritis and prescribed 20 mg of prednisone, which alleviated all symptoms, other than the lower back pain, immediately and I am still taking to date but it has been since lowered to 10mg. and will continue to be lowered as long as I remain asymptomatic and hopefully I will no longer have to take it soon. My immune system has been lowered resulting in various skin issues now that has developed as a result of the continued prednisone. My BP and glucose now is elevated as a result of the prednisone and I have no strength and has lost a lot of muscle mass.
injection site at the painful my arm still hurts; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (injection site at the painful my arm still hurts) 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 VACCINATION SITE PAIN (injection site at the painful my arm still hurts). At the time of the report, VACCINATION SITE PAIN (injection site at the painful my arm still hurts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment was reported by the reporter.   Reporter did not allow further contact
This case involves child (an unknown age and gender) patient who had pain following injection (injection site pain) and fever (pyrexia), after receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) [PREVNAR 13].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date: not reported) (suspension for injection) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect PREVNAR 13 not produced by Sanofi Pasteur (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious pain following injection (injection site pain) and fever (pyrexia) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and PREVNAR 13.  It was reported that, Pentacel is generally given at the same time and is likely cause of fever.  The patient was treated with TYLENOL [PARACETAMOL] and ADVIL [IBUPROFEN] for fever.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At time of reporting, the outcome was unknown for all the reported events.  There will be no information available on the batch number for this case.
WORSE CHILLS; WORSE HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. . The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced worse chills, and worse headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the worse chills and worse headache was not reported. This report was non-serious.
Inflammation in brain stem causing Internuclear Ophthalmoplegia, Bilateral. Eyes unable to focus together, resulting in blurred  vision, vertigo and nasea. Hospitalized 5 days and treated with three day course of solu medrol steroid and blood thinners.        Condition improved 5 days after discharge from hospital and daily thereafter. A recurrence of this adverse event is a distinct      possibility.
Patient developed a rash 7-10 days later.  Rash has been diagnosed as pityriasis rosea.  The dermatologist informed me that PR may be associated with vaccination.  Rash may last until mid February.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Expired Moderna vaccine that were given as booster shot to patients. No Treatment medication was provided.