chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Passed Out; flushed; sleeping all day; kind of like a fever; nauseated; Headache; A spontaneous report was received from a healthcare professional (HCP) concerning a 72-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passing out (loss of consciousness), flushed, sleeping all day, kind of like a fever, nausea and headache.  The patient's medical history was not reported.  Concomitant products known to have been used by the patient, within two weeks prior to the event, included pantoprazole.  On 02 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 007M204) for prophylaxis of COVID-19 infection.  The patient stated that on 04 Feb 2021, the patient got up in the morning and didn't feel very well.  She stated that she was flushed, had a headache and a fever.  She had a coffee and sandwich and talked to her husband and then they got up and passed out.  They slept all day and did not feel well.  The patient stated that she was nauseated and felt like she had a fever and a real, dull headache.    Treatments for these events were not reported.  Action taken with mRNA-1273 in response to this event was not reported.  The outcome for the events passing out (loss of consciousness), flushed, sleeping all day, kind of like a fever, nausea and headache was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Patient was fine after the vaccination, however, patient became lethargic & "out of it" 30 minutes later. Nursing home staff contacted 911 & patient was brought to the ER.
Post vaccine patient became diaphoretic- felt dizzy. HR 170. Water given afterwards patient began to feel fatigued and have shortness of breath. EMS on site assessed and felt patient needed to be seen at local ED. Patient transported via ambulance.
had COVID in October and got doses of plasma.  started about midnight  after the vaccine: Fever 101.9, shaking, O2 sast 80s, hr 120, arms and leg joint ached terribly, headache.
Discharge summary states Guillain Barre Syndrome. Medical record states ptosis.   A follow up report received 8/5/2003 adds: Final diagnosis still is Guillain-Barre Syndrome (GBS), made by a neurologist.
This spontaneous report as received from a pharmacist refers to a adult patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. Pharmacist reported that the patient received the first dose of GARDASIL on 04-JUN-2007 and received the second dose of GARDASIL on 09-JUL-2007, at an unspecified healthcare provider. Pharmacist reported patient was 21 years of age, when patient received the first two doses of GARDASIL (inappropriate schedule of drug administration). No adverse effects were reported. No further information was provided.
Received 1st dose of MMR 04/17/2003.  Within 24 hours developed headache, lethargy, malaise, sore throat, and felt feverish.  Symptoms persisted 10 days then on 04/28/2003 developed itchy, prickly rash, rist on face, then neck, trunk, arms.  Examined 05/01/2003: Confllent erythematous macules and papules on face, discrete macules/papules on trunk, arms.  + Pharyngeal erythema, (-)Kopliks shots, (-)Lan.
Mom informed MD 8JAN92 mom had been to clinic 14NOV91 w/ pt who had temp of 105 @ home but 102.2 @ clinic; both tm appeared dark, landmarks not visible; pt given Amoxil, Pediolyte, H20;
After the first shot, I felt mildly dizzy / light-headed for a day. After the second one, following fever, exhaustion, nausea, vomiting, diarrhea the next day, dizziness / lightheadedness continued for around 5 days further. Since then, I started to have periodic bouts of feeling dizzy at random intervals. Initially 2-3 days a week with dizziness only lasting for a few seconds at a time, but several such times over a few hours in a given day.  I later started observing a position dependency when it seemed to get worse at certain positions of my neck, but present otherwise. I consulted with my PCP and had a general medical done, an ENT who did a quick check for BPPV, and then my vision - all normal. They advised that If it gets better over time it'll likely go away over a few months.  Since October, it started becoming worse where some days I can't move my head at all, and generally feel not confident enough to even drive my car. Went back to the ENT and had a full vestibular test done. Some issue has now been found in the left ear but full diagnosis and potential treatment is still underway along with consultations with a neurologist and cardiologist.
experienced rashes and today 04Apr2021 they're even more now.; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number and Expiration Date was not reported) via an unspecified route of administration on 31Mar2021, as a dose 2, single for COVID-19 immunisation. Medical history and Concomitant medications were not reported. Patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number and Expiration Date was not reported) via an unspecified route of administration on 10Mar2021, as a dose 1, single for COVID-19 immunisation. The patient experienced rashes and today 04Apr2021 they're even more now on 03Apr2021. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Patient was given vaccine with no initial side effects and was asked to wait for 15 minutes before leaving facility.  During that wait time patient started to develop blurred vision, and the pharmacist was alerted that the patient fell on the way to the bathroom.  Patient was then guided into the immunization room when he briefly lost consciousness. While patient was seated, pharmacist assessed for anaphylaxis reaction and contacted emergency services. Blood pressure was taken and noted to be elevated, other symptoms included blurred vision and sweating.  Patient denied itching, swelling, or trouble breathing. Patient did not receive epi-pen and was assessed by emergency services.  Patient recovered shortly after emergency services arrived, no further services were needed
Pt recv vax on 10/20/98; on 2/15/99 pt exp flu-like illness
Epilepsy; Device use error; Twitches; Generalized aching; This spontaneous case was reported by a physician and describes the occurrence of EPILEPSY (Epilepsy) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Plaque psoriasis.    Concurrent medical conditions included Seizures, Hypothyroidism, Sleep apnoea, Seasonal allergy and Non-tobacco user. Concomitant products included MONTELUKAST SODIUM for Allergy, LEVOTHYROXINE for Hypothyroidism, LAMOTRIGINE for Seizure.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN (Generalized aching). On 20-May-2021, the patient experienced EPILEPSY (Epilepsy) (seriousness criterion medically significant), DEVICE USE ERROR (Device use error) and MUSCLE TWITCHING (Twitches). In April 2021, PAIN (Generalized aching) had resolved. At the time of the report, EPILEPSY (Epilepsy) and DEVICE USE ERROR (Device use error) outcome was unknown and MUSCLE TWITCHING (Twitches) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was an non alcoholic.  No treatment medications were reported.  Very limited information regarding these events has been provided at this time. No further information is expected. The patient's medical history of seizures is a confounding factor that may play a possible contributory role.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected. The patient's medical history of seizures is a confounding factor that may play a possible contributory role.
Information has been received from a medical assistant concerning a 16 year old female who on 29-JAN-2007 was vaccinated IM in the right arm with a first 0.5mL dose of HPV. There was no concomitant medication. On approximately 31-JAN-2007 the developed bruises located on her right forearm and right upper arm. The reporter stated that "the patient noticed the bruises 2 days after the day of vaccination." At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Information has been received from a nurse referring to a few patients of unknown age and gender. No relevant medical history was reported. On unknown dates the patients were vaccinated with improperly stored PEDVAXHIB (lot # K016965, expiration date 20-JUL-2017, dose and route were unknown). No adverse effects were reported. This is one of two reports from the same reporter. Additional information is not expected as the reporter did not want to be contacted.
I had recently traveled out of state and attended a crowded ball game on 07/27/2022. I traveled home by flight on 07/28/2022. On 07/29/2022, I began developing symptoms in the late afternoon. Nothing major, but I knew something was wrong, so I took an at home COVID-19 test and it was negative. I woke up the next day, on 07/30/2022, and still didn't feel right so I took another test, and it was positive. I was incredibly fatigued, had no appetite, I had terrible back pain, along with the worst headache I've had in my life. I called my local hospital on 08/03/2022 because of the terrible headache that would not go away. They wanted me to come in to be seen, but I was concerned about going since my oxygen levels were fine. I ended up drinking two bottles of PEDIALYTE to rehydrate and the next morning my headache was gone. I was still fatigued for a good two weeks after that, but my appetite slowly came back, and my other symptoms dissipated in that time as well.
I stayed for 30 mins because after my first shot my arm ended up VERY swollen and I had a rash. So I was okay after the 30 minutes but when I started driving I felt like I was high on strong drugs. Like as if I?d taken an extremely strong marajuana edible and it just hit me. I had to pull over because my eyes wouldn?t stay open, my whole body was feeling very heavy and I was extremely tired and out of it. I didn?t have another way to get home (I had traveled about an hour) so I just kept driving and taking 15 min rests along the way. When I got home I fell asleep as soon as I sat down and slept for about four hours. I feel better now that I?m awake, still light headed but not near as bad.
Breakthrough case admission after 2 vaccines  Janssen 3/28/21 Lot# 1805020;  Pfizer 12/2/21 lot# 213D21A
Fever; Chills; Soreness; Chest Pain; Difficulty breathing; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero with an associated reaction of pyrexia (received 1st dose on an unknown date and experienced chills, difficulty in breathing, refer case US2019161286).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced fever, chills, pain, chest pain and difficulty breathing. Rechallenge with Bexsero was positive. On an unknown date, the outcome of the fever, chills, pain, chest pain and difficulty breathing were unknown.   It was unknown if the reporter considered the fever, chills, pain, chest pain and difficulty breathing to be related to Bexsero.  Additional details were provided as follows: This case was reported by patient's mother. The age at vaccination was not provided. The reporter stated that, after vaccination, the patient experienced fever of 103.4 degree C. The patient's physician recommended for emergency room visit. No further details were provided. The reporter did not want to provide any demographic or address information.      Lab Comments: on a unknown date, patient had fever
Vomiting; Diarrhea; Fatigue; Nausea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 79-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 23rd November 2022, the patient received the 1st dose of Flu vaccine (intramuscular) and the 1st dose of PNEUMONIA VACCINE (intramuscular). On 23rd November 2022, less than a day after receiving Flu vaccine, the patient experienced vomiting, diarrhea, fatigue and nausea. On 24th November 2022, the outcome of the vomiting, diarrhea and fatigue were recovered/resolved. On an unknown date, the outcome of the nausea was not recovered/not resolved.   It was unknown if the reporter considered the vomiting, diarrhea, fatigue and nausea to be related to Flu vaccine.     Additional Information: GSK receipt date:30-NOV-2022 Reporters comment: The reporter was the patient and he stated that he had a flu shot unknown manufacturer had a pneumonia shot which was unknown manufacturer and experienced vomiting, diarrhea, fatigue, and nausea. The patient planned to follow-up with his physician on an unknown date. The reporter given consent to follow-up. Additional Supportive information: It was unknown if the reporter considered the vomiting, diarrhea, fatigue and nausea to be related to pneumonia vaccine.
swollen eye's, severe redness (no white's) x 2wk;2wk appt MD office;
This spontaneous report as received from a male consumer of unknown age regarding himself. On 16-OCT-2014 the patient was vaccinated with ZOSTAVAX dose 1, 1 time vaccine. On 16-OCT-2014 the patient's hand had come in contact with the ZOSTAVAX. On 17-OCT-2014, the patient experienced itchiness at the site of exposure. The outcome of itchiness was reported as not recovered/not resolved. The outcome of his hand had come in contact with the ZOSTAVAX is unknown. The reporter considered his hand had come in contact with the ZOSTAVAX to be not related to ZOSTAVAX. Additional information has been requested.
This spontaneous report as received from a physician via a company representative refers to an 84 year old male patient. The patient received a dose of ZOSTAVAX (lot# not reported) about 5-6 years ago, in approximately March 2007. Concomitant therapies included PROTONIX and aspirin. The patient came down with shingles "recently". The patient contacted office on 07-MAR-2013 for pain and rash he was experiencing and he went to Emergency Room (ER) on 09-MAR-2013 with complaints of rash on his waist and groin and pain. Hospital name and location unspecified. The patient was diagnosed with shingles in Emergency Room (ER) and was prescribed acetaminophen, VICODIN and gabapentin but he was not admitted to hospital. Patient came into office for follow up visit on 18-MAR-2013 and physician reported that patient's rash was dried up by then but patient was still experiencing pain. Additional information has been requested.
(L) shoulder pain, especially with ROM in any place worse with lifting. Denies neurological symptoms, no neurological impairment found.
Diarrhea, fatigue, and confusion starting 3/24/21 with normal blood sugar levels (132). Morning of 3/25/21 pt disoriented, confused, fatigued (can't stay awake), dizzy, and has vomiting and diarrhea. No fever.
Information has been received from a pharmacist referring to 4 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 22-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 22Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 07Oct2021 at 15:45 as dose 3 (booster), single (Lot number: ff2589) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 20Sep2022 at 15:00 as dose 5 (booster), single (Lot number: AS7145B), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02May2022 as dose 4 (booster), single (Lot number: 049L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ASD w/right to left shunt" (unspecified if ongoing); "platypnea orthodeoxia with portable oxygen prescription for flights and elevations above 4000ft" (unspecified if ongoing), notes: platypnea orthodeoxia with portable oxygen prescription for flights and elevations above 4000ft; "history of bilateral pulmonary embolisms" (unspecified if ongoing); "DVT" (unspecified if ongoing); "inpatient MSSA staph blood infection" (unspecified if ongoing); "Former smoker" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Tetracycline" (unspecified if ongoing), notes: Known allergies: Tetracycline; "Known allergies: Bone cement monomer" (unspecified if ongoing); "Known allergies: Nitinol" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Titanium, reaction(s): "Known allergies: Titanium". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02May2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Nov2022) Positive; (02Dec2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: COVID Test was Positive (PCR) on 25Nov2022. Paxlovid started 25Nov2022. Paxlovid ended 30Nov2022. Tested negative for Covid (rapid test) and asymptomatic on 02Dec2022.
Headache, Myalgia & NauseaVomiting Narrative: body aches, fatigue, headache and nausea
Itchiness, red lines, hives on left arm starting 9/1/ 2022 shortly before midnight and continuing to worsen/spread through 9/3/2022.
her arm getting sore and stiff along with a painful sensation; her arm getting sore and stiff along with a painful sensation; This spontaneous report was received from a currently 80 year old female consumer concerning herself. Current conditions include: Allergy to pills, dust, mold and mildew; leukemia, congestion (unspecified). There was no information about the patient's concomitant medication.  On an unknown date, the patient was vaccinated with  a dose of vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in her right arm for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   On an unknown date, the patient experienced a reaction to it. It was reported that her reaction consisted of her arm getting sore and stiff along with a painful sensation (PT: pain in extremity, injected limb mobility decreased). No treatment was given for the events. A blood work was performed, on an unspecified date (data not showed).The outcome of pain in extremity and injected limb mobility decreased was reported as recovered, on an unknown date, reported as "4 or 5 days after she  received the injection" . It was mentioned that the patient seek unspecified medical attention.  The reporter considered pain in extremity and injected limb mobility decreased to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).
Information has been received from a nurse cornering an 11-12 year old female who was vaccinated with VARIVAX (Merck) (lot no., route and site of administration were not reported) 6-8 months ago.  At the same time the patient was vaccinated with GARDASIL (lot no., route and site of administration were not reported).  The vaccinations were given in the same arm.  The day after the patient received the vaccinations, the patient developed redness and swelling at the injection site.  It was reported that these events had an onset date of 6-8 months ago (approximately October 2007).  All symptoms resolved in a few days.  The patient sought unspecified medical attention.  This is one of several reports received from the same source.  Additional information has been requested.
06/18/02 developed a few vesicles on trunk 06/19/02 woke up at 30-40 chicken pox lesions on trunk, face, arms and buttocks. T 99.2.
5cm x 12cm indurated area-rt thigh w/erythematous blanching coalescing macular rash;
This case was reported by a consumer via other manufacturer and described the occurrence of adverse drug reaction in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of SHINGRIX and was looking for additional information due to possible unspecified reaction. The patient refused to provide additional information as she would like to share the information only with the manufacturer. This information had not been reported to the Food and Drug Administration. No further specifics or symptoms were provided. No further adverse event information was provided. The patient gave consent to be followed up.
Pt. was given PNEUMOVAX 23 vs. PPD. Pt. began with site reaction itching, swelling & pain at site approx. 10 hours after planted. Pt. had it noted on 11/24/10 was given CLARINEX.
Breakthrough; test positive for Covid19 on 6/4/22. Fever, chills, body aches, cough, etc, noticed onset on evening of 6/3/22.
Fever, rash and red spots 16 hrs after vaccination then resolved. Then a rash 4 week later with fever with rash.
Fever (101.5°F), body aches, nausea, swollen Scilla, swollen lymph nodes, pain at injection sore, redness at injection site
sz post vax x 2 13OCT-14OCT x2 17OCT;