chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Actos 100 mg, Metformin 500 mg, Losartan potassium 100 mg, Amlodipine 10 mg, Atenolol 25 mg, Isosorbide Mononitrate 30 mg, Atorvastatin (Lipitor) and Klor-Con 10 for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
sick to her stomach; arthritis, and the shot made it flare up; dizziness; fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to her stomach), ARTHRITIS (arthritis, and the shot made it flare up), DIZZINESS (dizziness) and PYREXIA (fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (surgery for intestinal blockage) in February 2021.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (sick to her stomach), ARTHRITIS (arthritis, and the shot made it flare up), DIZZINESS (dizziness) and PYREXIA (fever). At the time of the report, ABDOMINAL DISCOMFORT (sick to her stomach), ARTHRITIS (arthritis, and the shot made it flare up), DIZZINESS (dizziness) and PYREXIA (fever) outcome was unknown.            No concomitant medication was provided. No treatment medication was provided.   This case was linked to MOD-2021-051874 (Patient Link).
pt recvd vax & 10 days p/dose 2 dx w/erythema multiforme-like eruption; It was determined, states the reporter, that the eruption was due to nonsteroidal anti-inflammatory agents, not the Engerix-B;
Rheumatoid arthritis flare up; This is a solicited report based on information received by Pfizer from a company (MFR Control No. # 21K-163-4138978-00) from a contactable consumer(patient) reported for herself.  A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 25Feb2021 (at age of 67 years old, Batch/Lot number was not reported) as single dose, dose 2 intramuscular on 18Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rheumatoid arthritis flare up on an unspecified date. The action taken in response to the event for adalimumab was permanently withdrawn on an unspecified date. The outcome of event was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Rheumatoid arthritis flares was not provided. Causality for bnt162b2: The reporter's causality for the event of Rheumatoid arthritis flares was possible.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events RA  and suspect drug BNT162B2 cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient reports pain at injection site, feeling like she got bit by a tick. She has aches and pain all over her body described as in intense dull throb.
Swollen at injection area, red, pain dull ache, tingling - limited range of motion, sore - physical therapy assigned.
Information has been received from a registered nurse concerning a 22 year old female patient with no pertinent medical history and no known drug allergies who on 16-NOV-2011 was vaccinated SC with a dose of VARIVAX (Merck) (lot number: 669230/1682Z, exp. Date: 09-DEC-2012), 0.5 ml. There was no concomitant medication. On approximately 04-DEC-2011, about 2.5 weeks after administration of VARIVAX (Merck), the patient developed 5 to 6 varicella like lesions on head and body after administration of VARIVAX (Merck). The patient also developed urticaria at injection site. Unspecified antihistamine was given for the treatment of the adverse event. The patient sought medical by an office visit. No lab test was performed. At the time of the report, the patient's outcome was unknown. Follow up information has been received from the registered nurse concerning the student with no illness at the time of vaccination, no adverse events following prior vaccinations and not immune to varicella zoster (on 19-OCT-2011) who on 16-NOV-2011 at 10:41am, was vaccinated subcutaneously in the left arm with the first 0.5 ml dose of VARIVAX (Merck) (lot number: 669230/1682Z, exp. Date 09-DEC-2012). Secondary suspect vaccines included the first dose of MMR II (lot number 669517/0037AA, exp. date 01-FEB-2013), subcutaneously in the right arm on 16-NOV-2011, at 10:41am. Concomitant vaccines included the first dose of ENGERIX-B (lot number: AHBV009AA) intramuscularly in the left deltoid on 16-NOV-2011, at 10:41am. The registered nurse reported that on 05-DEC-2011 the patient developed itchy rash, 2 lesions on scalp, 2 lesions on chest, several vesicles on forehead, 3 cm urticarial type lesion on left arm and all spots were itchy and painful. The patient was given ZYRTEC for 10 days and advised to avoid contact with high risk people. On 17-JAN-2012 lab diagnostic tests were performed and the results were varicella zoster equivocal. The patient did not seek medical attention (previously reported by the registered nurse as sought medical attention by an office visit). At the time of the report the patient recovered from the event. Follow up information has been received from another registered nurse reported that "in 2011" the patient received the second dose of VARIVAX (merck) (lot number, expiry date and route was not reported) and on an unknown date developed "a varicella like syndrome with rash". She stated that it was like chicken pox. She stated it might have been reported at that time. An unspecified treatment was given for the event. The outcome of the event was recovered on an unknown date. The patient sought medical attention. It has been determined that case # {1309USA013858} is a duplicate of case # {1112USA01189} therefore, case # {1309USA013858} is being deleted from our files and the cases consolidated into case# {1112USA01189}. Additional information is not expected.
Patient reported developing hives and rash on bilateral forearms, anterior legs, chest and back. Reported going to emergency room for reaction.
Pt. states that after receiving the 1st dose of Shingrix 11/10/2021, started experiencing symptoms 11/14/2021 of facial swelling, Angioedema of the face, throat swelling (Anaphylaxis). Emergency Room visit 11/14/2021 discharged with Observation. 11/15/2021 self-treating with Benadryl, Emergency Room visit for continued symptoms. Admitted 11/15/2021 for Observation with Steroids and Pepcid. Still continuing to experience symptoms.
Asked if it was cyst; Swollen lymph node; A spontaneous report was received from a consumer concerning a 62-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swollen lymph node, asked if it was cyst.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection. On 31 Jan 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Swollen lymph node, Asked if it was cyst.  No treatment information provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), swollen lymph node, asked if it was cyst was unknown.
PATIENT PASSED AT HOME, BEGAN TO SWEAT COLD AND FELT UNCONSCIOUS. THE PATIENT WAS COLD TO THE TOUCH, GOT UP A LITTLE DAZED, HE WAS COLD HIS PULSE WAS LOW, THE BLOOD PRESSURE WAS OK. THE COUPLE REPORT THAT LOOKED LIKE A TYPE OF SEIZURE WHAT HAPPENED.
SWELLING OF HANDS, TONGUE & LIPS, GENERALIZED URTICARIA, PAINFUL SWALLOWING, TIGHTENING THROAT.
Muscle aches; This is a spontaneous report from a received from Pfizer colleagues Immediate Family and household Vaccination program. A contactable nurse reported that a patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced muscle aches on an unspecified date. Outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
originally after the shot I had slight discomfort at the injection site.  A week later, I had a red, raised, inflamed area--an  8 inch band around my upper left arm, over the injection site.  It itched.  I also had severe muscle aches in my neck and shoulders.  It lasted 2 days.
Pts arm was red around the injection site. She was checked up on several times and says the irritation is completely gone. She was just concerned.
Body burning inside, throat closed up,spinning to the point of passing out, rapid heart beat, body shakes with no fever present....symptoms continued for over week.
Lymph Node swelling under right arm pit and arm. Pain the radiated from there down to fingertips.
The 46yo patient came in to get his covid vaccine.  His parents reported he has a medical condition/disability that requires him to receive services in their home.  After receiving the vaccine the patient reported feeling lightheaded, dizzy, hot, and that his blood pressure felt abnormal.  He requested an ambulance and some water.  I called 911 and provided him water, but did not administer any epinephrine or any other medications.  The paramedics arrived and talked to him for about 15 minutes.  He then left on his own accord with his parents and declined further medical attention.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with ZOSTAVAX by a pharmacist as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date patient was diagnosed with shingles and/or other zoster-related injuries (herpes zoster) after and despite being inoculated with the ZOSTAVAX vaccine. In 2016, the patient was treated for shingles (herpes zoster). The lawyer reported that as a direct and proximate result of the ZOSTAVAX vaccine, patient has and will 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 because 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 reported as related for the events.
inappropriate duplication. Patient had no adverse effects. did not report previous vaccine at time of appointment. Discovered when entering info into system.
patient developed rash several days after vaccination, came to Clinic location and was diagnosed with shingles
Information has been received from a licensed practical nurse concerning a 65 year old female female with allergy to macrodantin, and no pertinent medical history, who on 25-JUL-2007 was vaccinated SC in the left arm with a 0.65 ml dose of ZOSTAVAX (Lot# 656858/0356U). Concomitant therapy included progesterone and TOFRANIL. On 26-JUL-2007 the patient developed shingles on her right great toe area. On 27-JUL-2007 the patient developed shingles on her face near her mouth. Medical attention was sought. The physician wrote in chart a painless cluster noted on foot. Office had not seen the patient's face yet. They are trying to get the patient to come back into the office. VZVID program offered to nurse and she will speak to the physician about it. Will send directions on specimen collection. No product quality was involved. Follow up information received from the physician indicated that the patient developed a cluster of blisters on the right great toe within 42 days of the vaccination. A rash did not occur at the site of injection post vaccination. There was no pain associated with the blisters (zero, on a scale of zero to ten, zero being the least). It was noted that the patient had no recent exposure to chicken pox or shingles. A direct fluorescent antibody was not done. A photo was taken. A specimen was obtain from a vesicle on 02-AUG-2007 for lab testing. Results reported the specimen to be inadequate ("all I got was a dried spot of blood-ran it twice"). No further information was provided. The patient was enrolled in the VZVIF program: the Varicella Zoster Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the OKA/MERCK VACCINE VZV strain. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Follow up information was received concerning a female with no pre-existing birth defects or medical conditions who on 02-AUG-2007 (previously reported as 26-Jul-2007) developed a fever blister on her left upper lip. There was no illness at the time of vaccination. She was treated for one week with VALTREX 500 milligrams, TID and CLEOCIN 300 milligrams, QID x 10 days. On an unspecified date, the patient recovered. The sample of the lesion was collected on 02-Aug-2007. The sample was taken from a vesicle (spot of blood). The results for the specimen from the vesicle were inadequate, ("all I got was a dried spot of blood-ran it twice"), no strain identified. Additional information is not expected.
After 2-3 mins in observation area.  I fainted.  came too, hot, sweating.  had to go to hospital.
I was vaccinated with the Pfizer COVID vaccine on 30Mar2021 and 20Apr2021 / COVID-19 Jul2021; I was vaccinated with the Pfizer COVID vaccine on 30Mar2021 and 20Apr2021 / COVID-19 Jul2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 20Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2021, outcome "unknown" and all described as "I was vaccinated with the Pfizer COVID vaccine on 30Mar2021 and 20Apr2021 / COVID-19 Jul2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.Name of Product (both commercial and generic names, if known), ritonavir (paxlovid).  Clinical information: No any other product(s) that were taken together with those indicated above. Paxlovid works great for me with no side effects. In 24 hours my symptoms subside and in 7 days I test negative. This drug is a life saver for me. I don't take my regular medications while on Paxlovid because it does not work well with my meds. I was vaccinated with the Pfizer COVID vaccine on 30Mar2021 and 20Apr2021. I have not had any boosters to date.
no additional AEs; it was reported multiple temperature excursion 16-NOV-2022 and 09-DEC-2022 and were administered PEDVAXHIB, ROTATEQ and VAQTA; This spontaneous report was received from a medical assistant and refers to an unspecified group of patients of unknown age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported.  On 16-NOV-2022 and 09-DEC-2022, the patients were vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number: U029144 and expiration date: 31-MAR-2024; with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023; and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number: U038854 and expiration date: 20-APR-2023. The vaccines were administered only once for prophylaxis, but dosage regimens, route of administrations and anatomical locations were not reported.  It was reported that the vaccines were administered after multiple temperature excursions (product storage error). Temperature was above 47 Fahrenheit (F) degree (50.0 F) for 0 hours 12 minutes and 0 seconds on 16-NOV-2022 and above 47 F (47.6F) for 0 hours 15 minutes and 0 seconds. Time frame was total 27 minutes. Additionally, no previous temperature excursion was reported. No other adverse event was reported (no adverse event).  Follow-up information was received from the medical assistant on 28-DEC-2022. This report refers to a 17 month old patient who was vaccinated on 29-NOV-2022 with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023, intramuscular (IM). The primary thermometer displayed out of range temperature for less than 15 minutes. The back-up thermometer did not display max. that was out of range. Log was ran and the temperatures were within range. The primary thermometer was re-calibrated.  Patients' identifiers were missing in the previous report but have now been provided.
pt recvd 3 doses of Engerix-B 25JUN92 found to be seronegative approx 13 months p/3rd dose;
AMENORRHEA/NOT HAVING PERIOD EVER SINCE VACCINATION; This spontaneous report received from a consumer concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced amenorrhea/not having period ever since vaccination. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from amenorrhea/not having period ever since vaccination. This report was non-serious.
Received vaccine on 6/23/07 gradually developed redness an induration. I saw her on 3.27. Pt had area of redness about 10.12 cm and induration about 2 cm. Symptoms control with Benadryl.
Appendicitis; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) 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 APPENDICITIS (Appendicitis) (seriousness criterion medically significant). At the time of the report, APPENDICITIS (Appendicitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.   This case was linked to MOD-2021-414613, MOD-2021-414673 (Patient Link).; Sender's Comments: This case concerns a  patient of an unknown age and gender, with no reported medical history, who experienced the serious, unexpected AESI event of appendicitis, after unspecified dose of mRNA 1273 Covid-19 vaccine. Onset latency is unknown as the dates of the vaccine and event was not specified.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Within an hour after taking the 2nd dose, I started running out of energy and strength. After trying to clean my church, I went home and I crawled into bed. I was shaking and freezing. After some time, I was running out of breath and could barely breathe. I went to my doctor and I took a breathing test. I was given an inhaler. The inhaler helped somewhat. I was getting a little better. But in July 2021, I became sick, my head was spinning, and I vomited. My heart went into Afib and I went to the hospital that evening. I was hospitalized for two nights. I also tested positive for Covid-19 in January 2022. I had a sinus headache, ear infection, and a nasty cough.
Booster shot (3rd dose) Soreness at injection site got progressively worse, wrapping under my arm and up my neck.  At 10:30p, I started trembling and i had chills. I also had a terrible headache.  At 5am the following morning, I awoke to take more headache medicine.
This infant received vaccines (listed below) on 04/18/01. Later that evening, he had a fever of 104 and possibly higher. He was taken to the ER after 12 midnight. The mother also noted " bumps on his chest". He was treated with Motrin and Tylenol in the ER and discharged at 4 AM. No explanation. On 4/23/01 the mom states the following day she noticed the infant making "jerking" movements. Denies fever or rash at this time. She states the jerking has continued since then. Instructed at this time to notify the child's pediatrician, explain to nursing personnel and ask for an appointment today. Will follow up in the AM. On 04/24/01, spoke with the mother today, she states the child saw a doctor on 04/23/01. She states that the baby is "fine". No problems noted on examination. The doctor stated some jerking movements are common after going to sleep. None noted excessively.
Rigors (4 hours), Fever to 101F (4 hours), muscle aches, fatigue, headache (ongoing)
Patient was seen in the ER 4 days after flu vaccine given. C/O numbness in feet. 6 days after flu vaccine numbness progressed to waist. 8 days after patient back in ER.