chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 29-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: EW0162), in right arm, on 07May2021 as dose 2, single (Lot number: EW017D), in right arm and on 22Dec2021 as dose 3 (booster), single (Lot number: FP080D) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "moderate-severe asthma" (unspecified if ongoing), notes: moderate-severe asthma; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jun2022) Negative, notes: I tested negative for COVID on 12Jun; (Jun2022) Rebound COVID, notes: Rebound COVID symptoms. My COVID symptoms started 04Jun; (16Jun2022) rebound COVID, notes: On 16Jun, I began having rebound COVID symptoms; (17Jun2022) positive, notes: On 17Jun, I tested positive again for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19.No Other medication in 2weeks. Rebound COVID symptoms. COVID symptoms started 04Jun. Symptoms consisted of upper respiratory congestion, cough, fever, sore throat, headache, fatigue. However did not test positive for COVID until 07Jun. Started Paxlovid on 07Jun My symptoms greatly improved by 09Jun. Last day of Paxlovid was 11Jun. The patient tested negative for COVID on 12Jun. On 16Jun, began having rebound COVID symptoms. On 17Jun, tested positive again for COVID. Rebound symptoms consist of sinus congestion, headache, sore throat.
215PM 29JUN95 pt recv vax 11AM 28JUN95 spiked 104 temp @ MN; 28JUN95 arm very swollen APAP given 3AM; 29JUN95 none since T remains 104; pt irritable, no appetite; called MD instructed to give Ibuprofen; 30JUN05 feeling better fever gone
Red, itching rash after administration of second dose of Moderna Covid-19.  Rash / itching on head, neck, shoulders, back and partial chest for approximately 2 weeks after dose.   In addition, itching rash has periodically re-appeared on lower legs since that time.  No previous history of rash/skin issues.
That day just felt sick and then next day could hardly lift arm and felt very sick, sat I looked like someone beat me . The pictures look like I was beat to death my skin was all purple went to urgicare they sent me hime , went Er Sunday and the Dilantin wouldn?t kill the pain, dehydrated Gabe me fluids and did a Doppler, then sent me hime on oxi which did nothing but dull pain went from Sunday since so tired and still in pain and sick , he send mye for labs on Friday. It came back iron was low. My arms are both blotchy and sore and black n blue .
lost weight; I am exhausted/I am very tired; I was really sick; not feeling great; extra dose administered; This is a spontaneous report from a contactable consumer (patient, self-reported). A patient of unspecified age and gender received third dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 18Aug2021, as a single dose for COVID-19 immunization, second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an un-specified route of administration, on an unspecified date, as a single dose for COVID-19 immunization and after second shot had a reaction and you know it felt, flu like symptoms, and first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that the patient had third shot (further clarification unknown hence not captured in tab) and after second shot the patient had a reaction and you know it felt, flu like symptoms whatever and the patient was anticipating the same type of thing when the patient had the shot last Wednesday and today on Monday was the first day actually feel somewhat decent and other than fact that the patient was exhausted, lost weight, everything on 23Aug2021. The patient wanted to know like has this happened before the people the patient like felt like the patient was really sick and had it for so long, was that something that has happened before. The patient stated that the patient was concerned the patient mean it was possible to get sick at same time that seems strange and was perfectly fine you know when got it and right now the patient felt like the patient didn't have fever today (further not clarified hence not captured in tab), it was the first time the patient was very tired and all wanted to know was if you supposed to documenting this all but I also wanted to know the patient was sure you have heard many thousands of peoples and the patient wanted to know if this was that something unusual obviously it was not the usual thing ok you wanna connect me to with them. The patient stated that the patient was not feeling great so did not feel like doing that. The patient underwent lab test and procedure included weight which was decreased on an unspecified date. Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2 was not provided and will be re-quested during follow up.
Joint aches, headache, fatigue-  Motrin. Lasted 3 days
Sore arm; mild headache; strange dreams/disturbed sleep; occasional body aches; strange dreams/disturbed sleep,; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 at 19:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, irritable bowel syndrome, GERD and gastritis, allergy to certain soy sauces but not all, and no other soy products. Concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX), levothyroxine sodium (EUTHYROX), loratadine (CLARITIN), ibuprofen (ADVIL), and doxycycline (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took Cephalexin (MANAFACTURER UNKNOWN), acetaminophen; hydrocodone (VICODIN), hydrocodone bitartrate; acetaminophen (LORTAB), hydrocodone bitartrate (NORCO) all from an unknown date for an unspecified indication and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 22:00 the patient experienced sore arm, mild headache, strange dreams/disturbed sleep, occasional body aches. Patient did not receive treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events pain in arm, headache, sleep disturbance, general body pain, abnormal dreams was resolving at the time of reporting.  No follow-up attempts are needed. No further information is expected.
flu-like symptoms; Diarrhea; Weak; unstable; Blisters around mouth and in the nose; chills; fever does not know how high but get very hot; tired of being sick; Sleeps alot; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (Diarrhea), ASTHENIA (Weak), FEELING ABNORMAL (unstable) and BLISTER (Blisters around mouth and in the nose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19, Heart attack (COVID-19 virus which gave her a massive heart attack) and Hospitalization (between the hospital and rehab) from 15-Mar-2020 to May 2020. Concurrent medical conditions included Asthma, Stevens Johnson syndrome (dry mouth from SJS), Osteoarthritis (left shoulder injury) and Bursitis. Concomitant products included PILOCARPINE for Dry mouth, MENTHOL, METHYL SALICYLATE (BEN GAY) for Shoulder pain, ACETYLSALICYLIC ACID (ASPIRIN CUPAL [ACETYLSALICYLIC ACID]), MONTELUKAST, BUSPIRONE, METOPROLOL SUCCINATE, ESTRADIOL, DIAZEPAM, ATORVASTATIN, ESOMEPRAZOLE, LISINOPRIL, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), MELATONIN, AZELASTINE HYDROCHLORIDE (AZELASTINE [AZELASTINE HYDROCHLORIDE]), CORTICOSTEROID NOS, TICAGRELOR (BRILINTA) and FESOTERODINE FUMARATE (TOVIAZ) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (Diarrhea), ASTHENIA (Weak), FEELING ABNORMAL (unstable), BLISTER (Blisters around mouth and in the nose), CHILLS (chills), PYREXIA (fever does not know how high but get very hot), MALAISE (tired of being sick), HYPERSOMNIA (Sleeps alot) and FATIGUE (Tired). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) ongoing since an unknown date for Diarrhea, at a dose of UNK dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (Diarrhea), ASTHENIA (Weak), FEELING ABNORMAL (unstable), BLISTER (Blisters around mouth and in the nose), CHILLS (chills), PYREXIA (fever does not know how high but get very hot), MALAISE (tired of being sick), HYPERSOMNIA (Sleeps alot) and FATIGUE (Tired) outcome was unknown.            Patient reported that she had no side effects from the first dose of vaccine. Patient was instructed to not to take Montelukast 7 days before the shot.
After shot given 9/23/09 had increased headache. Saw her PMD, was given TYLENOL with CODEINE to relieve. He stated no more GARDASIL.
On September 16, at approximately 12:00 pm I went into Atrial Fibulation.  I was wearing an I-watch and it confirmed I was in A-Fib, so I called my cardiologist's office and spoke to a nurse.  She told me to call an ambulance, which I did.  Paramedics arrived four minutes later, hooked me up to an EKG to confirm A-Fib, which is was, was taken to hospital via ambulance.  Shortly after arriving, my heart went back into normal sinus rhythm on its own.  No medication was needed or other treatment.  Resident Doctor spoke to my cardiologist via telephone and they decided on a course of treatment which was Eloquis and Bystolic.  Followed up with doctor a week later.  I am a 60 year old female who exercises 5-6 days a week for the last 40 years.  Cardio, yoga, weight training.  Not over weight, eat fairly healthy.  Never had any heart issues my entire life until this.
Flu-like malaise, weakness, low grade fever, headache - Painful rash across left breast.
11/21 evening: upset stomach, diarrhea. 11/22: diarrhea, fever, treatment: Immodium. 11/23: diarrhea and sore throat, fever, treatment: Immodium and ibuprofen. 11/24: sore throat and nasal drainage, fever, treatment: ibuprofen and Sudafed. 11/25: sore throat, nasal drainage, fever, coughing, treatment: ibuprofen and Sudafed. 11/26: nasal drainage, coughing treatment: Mucinex DM and ibuprofen 11/27: coughing, treatment: Mucinex DM.
FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a female of unspecified age. 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 was not reported, administered on 02-APR-2021 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 APR-2021, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms was not reported. This report was non-serious.
PATIENT STATED HE FELT FAINT AND NAUSEOUS ABOUT 5 MIN AFTER RECEIVING HIS FIRST DOSE OF PFIZER COVID-19 VACCINE.  HE WAS SITTING IN THE OBSERVATION AREA. WE HAD HIM LIE DOWN ON THE FLOOR,  GAVE HIM FRESH COLD WATER AND MONITORED HIM. AFTER 5 MIN OF LYING DOWN HE BEGAN TO FEEL BETTER AND AGAIN SAT UP IN A CHAIR FOR AN ADDITIONAL 15 MIN. WE CONTINUED TO MONITOR HIM AND VERIFIED HE WAS FULLY RECOVERED BEFORE LEAVING. PATIENT STATED AT THE BEGINNING THAT HE HAS THIS REACTION TO ALL VACCINES/SHOTS
Aching with low grade temp initially with swelling and redness and pain at the (10 cm diameter) site of injection without blister formation. Treated with cephalexin 250mg every 6 hours for 5 days. Cool compresses for 10-15 minutes 3x/day.
It was reported that a 45 year old female patient received a Fluzone SV 2001-2002 vaccination, administered on 11/19/01. The patient developed pain in upper and lower arm and shoulder area one week after vaccination. These symptoms are currently unresolved.
COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total, administered on 31-MAR-2021 for covid-19 prophylaxis. The patient did not experience any adverse event with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total, administered on 03-DEC-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On 22-JAN-2022, the patient experienced covid-19 test positive. The patient did not have any symptoms like fever, cough, congestion, chills. Laboratory data included: COVID-19 virus test Positive. On 01-FEB-2022, Laboratory data included: COVID-19 virus test showed a slight marker (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 test positive. This report was non-serious. This case, from the same reporter is linked to 20230157110.
I passed out in my living room, landing on my leg, damaging both my knee and ankle.  I had to go to emergency room, and follow up doctor appointments.
Muscle aches, sore throat, sinus drainage and injection, headache, lack of appetite, slight redness on both forearms (not in area of injection) -- lasted for 5 days.
Was brought to the attention of EMS related to patient feeling "dizzy, lightheaded" and almost passing out. patient blood pressure low, diaphoretic. He remained alert and oriented during observation period. patient resting in stretched with improvement in vitals signs. patient left ambulatory, denies any chest pain, difficulty breathing, no hives noted, no tongue swelling noted.
EXTREME reaction of fever, chills, body aches, fatigue, headache,  & nausea.  Completely bedridden for over 24 hours, crying, begging for life. For the following 72 hours:  normal fatigue and nausea plus shortness of breath
Patient reported becoming dizzy 12 minutes after receiving injection. Patient felt like she was going to faint. Patient was placed on floor with legs elevated and given a snack and a sugary drink. Felt better left facility and called in reporting when she got down to go inside her home she had a repeat episode of vertigo.
This patient had a 10cm circular red induration around the site of injection. No secondary infection. Resolved with rest, oral Benadryl.
Vaccine site is swollen and red, and tender lymph node in armpit. Left arm is where injection was given.
Extremely weak; I was so weak that I actually fell; Reaction; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Extremely weak), FALL (I was so weak that I actually fell) and VACCINATION COMPLICATION (Reaction) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Extremely weak), FALL (I was so weak that I actually fell) and VACCINATION COMPLICATION (Reaction). At the time of the report, ASTHENIA (Extremely weak), FALL (I was so weak that I actually fell) and VACCINATION COMPLICATION (Reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatments medications was reported.   This case was linked to MOD-2021-250426 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-JUL-2021 contains: No new information regarding first dose On 10-Aug-2021: Follow up received and does not contain any new information. On 12-Aug-2021: Follow up included no new information On 25-Aug-2021: Follow up contains additional dose 2 events reported.
Patient presented to the Health Department wanting a booster shot. Patient stated he last had her booster in September 2022. Secretary double checked and confirmed date. Bivalent Booster given on 01/20/2023, however it was then learned his last booster in September of 2022 was also a Bivalent so patient has received 2 bivalent boosters.  After learning this patient has not reported any adverse reactions
Administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported that the vaccine was stored in freezer, one of two vials were taken out and placed in fridge each day as needed.  No treatment given to the patient.
Chief Complaint   Altered mentation, Behavioral changes  History of Present Illness     Patient is a 23-year-old male transferred from outside hospital after being in the ICU for 14 days.  Most of the history obtained from chart review and outside records.    Summary of his treatment from outside hospital:   Patient was initially admitted for hypoxic respiratory failure most likely second Covid infection diagnosed on 7/19/2021 (first time infected in August 2020) that was treated with IV high-dose steroids, remdesivir, N-acetylcysteine, ivermectin and therapeutic anticoagulation.  He also developed E. coli pneumonia during this hospitalization and was treated with IV antibiotics for 8 days.  He was found to have worsening agitation and aggressive behavior.  He has history of autism and has been followed by psychiatry.  At the hospital he received IV Precedex, fentanyl, propofol for sedation.  He will also receive the scheduled Haldol and Zyprexa in addition to Depakene and Ativan as needed every 4-6 hours.  Patient underwent an MRI and was found to have diffusion restriction and splenium of corpus callosum that resolved eventually in the second MRI that was obtained few days later.  For this he was treated with IV steroids as well as IVIG for total of 5 days.  Continues EEG that performed did not show any evidence of seizures just generalized showing indicating moderate to severe encephalopathy.  Patient also underwent LP, CSF analysis were not indicated of any bacterial/viral or fungal infection.  The autoimmune panel was negative.   During this hospitalization he was also hyperglycemic requiring sliding scale insulin, developed ileus secondary to continuous IV fentanyl drip requiring stool softeners, MiraLAX as well as naloxegol following which patient had a bowel movement and his symptoms and x-ray findings resolved.   Prior to transfer patient underwent bronchoscopy as he had increased requirement of FiO2 and was found to have right lower lobe atelectasis secondary to mucous plug.