chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client called and reported about 11 pm the night of the vaccine waking up with severe nausea and little vomiting (described vomiting more as spitting up). Client had experienced severe nausea for about 3-4 days, but without vomiting (described if she could vomit thinking it would have helped). Client also experienced; body aches, low grade fevers the first two days, and headache. Client called doctor and was prescribed Ondansetron (Zofran). Client reports that is helping with the nausea. Client reported on day seven finally able to resume normal daily activities. Client reported daughter in law came over to feed dogs and assist with daily activities during this time.
Left chest wall pain with movement of left arm and palpation. Redness around smallpox vax site. Dx musculo skeletal pain / chest wall pain.
Sweats; Covid 19 immnunization; Interchange of vaccine products; Dizziness; Nausea; Fatigue; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (Sweats), COVID-19 IMMUNISATION (Covid 19 immnunization), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), DIZZINESS (Dizziness) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051f21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient was plenty healthy. Her auto immune markers have diminished.  The patient's past medical history included Walker user (had to use back in 2016 when she first came down with autoimmune issues) in 2016, Lyme disease (She was pretty healthy until she got what considered to be Lyme disease on 2015) in 2015 and Near death experience (she really was dying in 2016 and had to be hospitalized for a month) in 2016. Previously administered products included for Product used for unknown indication: J and J (Lot#1805025 and first dose) on 13-Mar-2021. Past adverse reactions to the above products included No adverse event with J and J. Concurrent medical conditions included Asthma, Pollen allergy (allergic to tree pollen), Allergy to molds and Antiphospholipid syndrome (complex of autoimmune disorders back in 2016, a serious heart autoimmune disorder or a blood autoimmune disorder called APS antiphospholipid syndrome) since 2016.    On 11-Apr-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 HYPERHIDROSIS (Sweats), COVID-19 IMMUNISATION (Covid 19 immnunization), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), DIZZINESS (Dizziness), NAUSEA (Nausea), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Sweats), DIZZINESS (Dizziness), NAUSEA (Nausea), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) had resolved and COVID-19 IMMUNISATION (Covid 19 immnunization) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            No concomitant medications were reported.   It was reported that patient experienced life threatening adverse reaction to Moderna's Boosters.  Following vaccination with the 1st Moderna booster patient experienced adverse reaction of nausea, fatigue, fever, sweats, chills, dizziness and it went away by the 3rd day.  Patient did not had COVID positive test or diagnosis and never had symptoms for COVID.   No treatment medication was provided.   This case was linked to MOD-2022-674780, MOD-2022-674779 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2022: Follow-up received included added.
The pt was found unresponsive/apneic by parents around 4:00pm on 2/10/01. The pt was transported to the ER. The pt died in the ER.
I started having symptoms May of 2021 one month after the vaccine. My symptoms are off balance, weakness, hyper reflexes (both knees ), spasticity in my ankle and hip,  and inflammation in both hips. By August of 2021 my left leg developed the same issues as the right. As of today, March 14, 2023, I have been diagnosed with brisk deep tendon reflexes, gait difficulty/ disorder, drop-foot and Myelitis. I have had 4 MRI's and two nerve conduction tests done, results came back with issues but none are causing my ailments. My Neurologist can't figure out what is wrong with me, which makes me believe that I may have had an adverse reaction to the Janssen vaccine.
Headache, cold chills, body ache started about 10:00am on 1/29/2021.  It is now 1/30/2021 @ 7:56pm and still have a headache and feel tired as have been all day.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: FP7534), in left arm, on 07Apr2021 as dose 2, single (Lot number: ER8737), in left arm, on 23Aug2021 as dose 3 (booster), single (Lot number: FW0177), in left arm and on 06Feb2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease (on immunosuppressant Stelara)" (unspecified if ongoing). Concomitant medication(s) included: PENTASA, start date: Feb2018; GABAPENTIN, start date: Apr2022; ALBUTEROL SULFATE HFA, start date: Apr2022, stop date: 20May2022; WIXELA INHUB, start date: Mar2022, stop date: 20May2022; FLUOXETINE, start date: Sep2021; STELARA, start date: Oct2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Positive, notes: Positive tests on 04May2022 and then again on 16May2022; (10May2022) Negative, notes: negative tests in between on 10May2022 and 11May2022; (11May2022) Negative, notes: negative tests in between on 10May2022 and 11May2022; (16May2022) Positive, notes: Positive tests on 04May2022 and then again on 16May2022; (18May2022) Positive, notes: I also tested positive on a PCR on 18May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergy. Rebound Covid - Positive tests on 04May and then again on 16May, with negative tests in between on 10May and 11May. I tested positive (antigen) for Covid the first time on 04May2022, got a prescription for Paxlovid that day, and took the full dose on schedule. I tested negative (antigen) on both 10May2022 and 11May2022 and had limited remaining symptoms. I woke up with a bad runny nose and cough again on 16May2022 and tested positive again immediately on two different antigen tests. I also tested positive on a PCR on 18May2022. I was initially told by my PCP not to do another round of Paxlovid, but when my cough got worse and into my chest, I was prescribed a second round of Paxlovid beginning 20May2022. Additionally, my son developed Covid symptoms on 17May2022 and tested positive (PCR) on 18May2022. I assume he caught it from my rebound covid, but he could have caught it elsewhere.
Patient was given vaccine in her left arm on 9/21/10. She came back into the store on 9/28/10 and showed me her arm which was bruised. Pt takes COUMADIN had bleeding under her skin. No office visit was needed.
The next day after my first shot, my left leg felt heavy, numb, tingling, and sore
This spontaneous report as received from a pharmacist refers to 18 year old male patient (at the time of event). Patients current conditions and historical conditions were not reported. No Known allergies. Approximately in 1970 (at the age of 18 years), the patient was vaccinated with the first dose of MMR II. No concomitant medications were reported. Approximately in 1970, immediately after receiving the first dose of MMR II, the patient went into anaphylactic shock (medically significant) and lost consciousness (unspecified duration of loss of consciousness or date of administration). Patient received unspecified treatment for the event. the patient had limited information about the adverse event reaction at the time of the call. No PQC was involved. The outcome of anaphylactic shock was reported as recovered. The reporters causality for the event anaphylactic shock with the therapy of MMR II was not reported. Upon internal review the event anaphylactic shock was considered as medically significant event. Additional information has been requested.
"passed out" within 4 minutes of receiving vaccination; patient then had a seizure that lasted 15 seconds; his blood pressure was taken (BP 95/52); The patient was tired; This spontaneous report was received from an office manager and refers to a 13-year-old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. His drug reactions or allergies included dextromethorphan polistirex (DELSYM 12 HOURS).   On 03-FEB-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, prefilled syringe, intramuscularly in the left arm lot # 1687292, expiration date 25-AUG-2022 (dose was not reported) for prophylaxis.  On the same date, within 4 minutes of receiving vaccination, the patient "passed out" and than he had a seizure that lasted 15 seconds. After regaining consciousness (reported as "came to"), his blood pressure was taken, which showed 95/52 (units not provided), and he was monitored for 30 minutes. He did not received any treatment for the events. The patient was tired but okay when he left the office. The outcome of the events was reported as recovered.  The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the events of passed out and seizure were determined to be medically significant. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Chills for about 2 hrs; body soreness; light headache; This is a spontaneous report from a contactable consumer (patient). A 50-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EL3248; Expiration date was not reported), via an unspecified route of administration, administered in left arm on 01Feb2021 08:00 hr (at the age of 50-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included none. The patient previously took erythromycin and experienced drug hypersensitivity. Concomitant medication included sumatriptan (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number EL3248; Expiration date was not reported) via an unspecified route of administration, administered in left arm on 12Jan2021 16:00 hr for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 02Feb2021 01:00, the patient experienced chills for about 2 hrs, body soreness and light headache for about 4 hours. Patient received no treatment for the events. The clinical outcome of the chills for about 2 hrs, body soreness and light headache were recovered on 02Feb2021.  Follow-Up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This spontaneous report as received from a consumer via Clinic refers to a currently 7 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2017, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # M005733, Expiry date: 01-OCT-2017), subsequently on 29-SEP-2017 and 28-MAY-2017, the patient was vaccinated with second and third doses of improperly stored ROTATEQ (lot # M005733 and M031650, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Patient said her arm was really sore after injection. She said her arm swelled later that evening. She went to her family doctor 10/27/23 because swelling was worse and he told her to stop Xarelto and continue to keep an ice pak on it. Patient  said he thought it was a hemotoma.
Developed left inguinal lymphadenopathy and subsequent left lower extremity cellulitis for which hospitalization was required.  The pt received antibiotics and was discharged from the hospital.  As of June 8, 2021, she has persisting lymphadenopathy.
I have not had any TMJ for thirty years. After I got the first dose of the vaccine I started to have jaw pain and discomfort and headaches. After I got the second dose of the vaccine the jaw pain and headaches got worse. My headaches happened daily and over time I had gotten used to it. I was using Advil and Tylenol. After the third dose of the vaccine I was in severe pain within a week. The pain was so much worse that the pain relievers were not working. I consulted with my dentist and he suggested I see a Chiropractor. I have been receiving treatment twice weekly and it has been seven weeks since my Booster and the pain and discomfort have not improved. I have some temporary relief after my Chiropractic treatment but it always returns.
not feeling well; no appetite; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling well), DECREASED APPETITE (no appetite) and HEADACHE (headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced FEELING ABNORMAL (not feeling well), DECREASED APPETITE (no appetite) and HEADACHE (headache). At the time of the report, FEELING ABNORMAL (not feeling well), DECREASED APPETITE (no appetite) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information included Tylenol.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: If vaccine received: Yes, Other medication in 2weeks: No, Known allergies: No  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
8 days p/vax t101 rash (mild) erythematous papular face & trunk; mild crabbiness-no intervention x/APAP;
Large 3" swelling, redness 4", raised, warm and painful at right lower leg where IVP site is. DTAP site is ok, no swelling.
VARIVAX was given after having a temperature excursion/ The vaccin had been storage in the refrigerator; No other issues reported; This spontaneous report has been received from a pharmacist concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On an unspecified date, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number T036561, expiration date 28-OCT-2022, which upon internal validation was determined to be valid) (dose, vaccination scheme frequency, routes and anatomical locations of administration were not reported) as prophylaxis (product storage error).   The involved vaccine was stored in the refrigerator and underwent a temperature excursion (exact temperature not provided) for approximately 2 days (not dates specified) per caller; also recorded by a data logger. Was unknown if underwent previous temperature excursions. The reporter inquired about the vaccine storage information. No other issues reported (no adverse event).  This case has been classified as non-valid due to the lack of patient's identifiers.
Immediate redness not only at site but distally with tenderness and erythema. Dx Cephalepan 500 bid x 7 days.
This spontaneous report was received from medical assistant refers to 3 unspecified patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 10-MAR-2016, 3 patients were inadvertently administered with ROTATEQ suspension 2, that had been improperly stored, lot # L037921 (expiry date: 31-MAY-2017), orally (dosage not reported). The vaccine was stored at a temperature 30.2F and time frame included cumulative time of 132 hours. No previous temperature excursion was reported. No adverse effects reported. No product quality complaint (PQC) involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
She has not been eating; Walking lop-sided; Down and out on Friday; Pain; Dizzy; chills; headache; Nauseous; Very sick; Legs are weak; Vomited x1; Fever - feverish - temperature of 103'; Aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick), MUSCULAR WEAKNESS (Legs are weak), FEEDING DISORDER (She has not been eating), GAIT DISTURBANCE (Walking lop-sided) and VACCINATION COMPLICATION (Down and out on Friday) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was given.  Concurrent medical conditions included Blood pressure high. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced ILLNESS (Very sick), MUSCULAR WEAKNESS (Legs are weak), VOMITING (Vomited x1), PYREXIA (Fever - feverish - temperature of 103') and MYALGIA (Aches and pain). On an unknown date, the patient experienced FEEDING DISORDER (She has not been eating), GAIT DISTURBANCE (Walking lop-sided), VACCINATION COMPLICATION (Down and out on Friday), PAIN (Pain), DIZZINESS (Dizzy), CHILLS (chills), HEADACHE (headache) and NAUSEA (Nauseous). The patient was treated with IBUPROFEN for Adverse event, at a dose of alternating dose; ACEBUTOLOL (oral) ongoing from 2018 for Blood pressure, at a dose of 800 milligram; VALSARTAN (VALSACOR) (oral) ongoing from 2018 for Blood pressure, at a dose of 320 milligram; HYDRALAZINE (oral) ongoing from 2018 for Blood pressure, at a dose of 400 milligram and GUANFACINE (oral) ongoing from 2018 for Blood pressure, at a dose of 3 milligram. On 05-Sep-2021, MYALGIA (Aches and pain) had resolved. At the time of the report, ILLNESS (Very sick), MUSCULAR WEAKNESS (Legs are weak), FEEDING DISORDER (She has not been eating), GAIT DISTURBANCE (Walking lop-sided), VACCINATION COMPLICATION (Down and out on Friday), PAIN (Pain), DIZZINESS (Dizzy), VOMITING (Vomited x1), CHILLS (chills), HEADACHE (headache) and NAUSEA (Nauseous) outcome was unknown and PYREXIA (Fever - feverish - temperature of 103') had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2021, Body temperature: 104 (High) 104 F.         Concomitant medications include blood pressure medications. Took alternating dose of Ibuprofen and Advil.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Significant follow-up appended
This 8 year old girl was vaccinated with Vivotif on 7/22/03 and 7/24/03. One day after the intake of the second dose she experienced weakness, fatigue and pain in arms and legs. At the time of the onset of the symptoms she was at the airport with her mother on the way overseas to move there for three years. The mother called the physician who prescribed the vaccine and was told that this reaction would be over when they left the plane. One week later, the symptoms were still present and they visited a western health service department. An allergic reaction was diagnosed and medication with an antihistaminic and paracetamol was prescribed. Another week later the patient additionally experienced serious abdominal pain, strong enough to wake her up in the night and lasting for 10 days. The consulted physician interpreted the abdominal pain as a consequence of the paracetamol therapy. Then the patient developed further symptoms such as respiratory and eye infections. They visited a medical center. Antibiotic treatment for the eye and respiratory infections was started. Since the hospital staff was not aware of the seriousness of the symptoms they looked for other treatment possibilities. The strength in the patient's arms was close to normal, no more pain, but hips and legs were still very weak and painful, so she hardly could not walk. The patient then visited a hospital on 9/18/03 and was admitted on 9/19/03. Blood tests, urine tests, stools tests, brain CT scan and chest x-ray were normal, only the spinal fluid was a little high. On 9/26/03 the patient had cranial and full spinal MRI and additional blood tests performed at the hospital. The tests were normal. An EMG performed on 10/11/03 was positive for mild chronic polyradiculoneuropathy. At the time of reporting, the patient is still hospitalized. Follow up information: Despite of repeated queries for follow up information on this case we could not obtain any further information and therefore closed this case on 04May04.  This case was received by e-mail from the patient's mother, who had access to the relevant medical records.
6:30am 8/15/02 awoke with hives, had coughed during night of 8/13/02 and 8/14/02. Hives on torso, legs, neck, face. Referred to PCP for evaluation.
The next day I had some aches and pains and felt rundown with a bit of a law intensity nahhing headache. Injection was 4:30 PM Friday. Symptoms completely cleared by 9:00 AM Monday