chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; sweats; tired; This is a spontaneous report received from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:00 (Batch/Lot Number: EP6955) at the age of 54-years-old as single dose for covid-19 immunisation. Patient was not pregnant. Medical history included hypertension, osteo-arthritis. Concomitant medications included candesartan cilexetil (ATACAND) taken for an unspecified indication, start and stop date were not reported; vitamin B2 [riboflavin] taken for an unspecified indication, start and stop date were not reported; vitamin D2 taken for an unspecified indication, start and stop date were not reported; ubidecarenone (COQ10) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (Lot number: EL3247) on 03Mar2021 10:00 AM at left arm for covid-19 immunization. The patient had chills and sweats and was really tired on 25Mar2021 07:30 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
Sweating; Hot Flashes; Diarrhea x1 time; Dizziness; Sleepy; Body Ache; Headache; Vomiting; Little Pain Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), HOT FLUSH (Hot Flashes), DIARRHOEA (Diarrhea x1 time), DIZZINESS (Dizziness) and SOMNOLENCE (Sleepy) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (Little Pain Injection Site). On 05-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating), HOT FLUSH (Hot Flashes), DIARRHOEA (Diarrhea x1 time), DIZZINESS (Dizziness), SOMNOLENCE (Sleepy), MYALGIA (Body Ache), HEADACHE (Headache) and VOMITING (Vomiting). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 04-Feb-2021, VACCINATION SITE PAIN (Little Pain Injection Site) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), HOT FLUSH (Hot Flashes), DIARRHOEA (Diarrhea x1 time), DIZZINESS (Dizziness), SOMNOLENCE (Sleepy), MYALGIA (Body Ache), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.            No relevant concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received on 09-JUL-2021 and does not contain any new information.
This spontaneous report as received from allergist via company representative refers to a 13 year old female patient. On 12-DEC-2013 the patient was vaccinated with GARDASIL injection 120 y (dose number, dose units, route, lot number and expiry date unknown). Other suspect therapy included influenza virus vaccine (also reported as flu vaccine) (manufacture unknown) (dose number, dose units, route, lot number and expiry date unknown). Concomitant therapy included CORTISPORIN OTIC drops. On 16-DEC-2013, 4 days after administration of GARDASIL patient developed hives on her trunk. The patient was treated with BENADRYL and CLARITIN and the hives resolved within 24 hours. It was reported that he has not seen the patient in his office yet, but was informed by her unspecified healthcare provider that the patient was treated with BENADRYL and CLARITIN. It was reported that laboratory diagnostics studies were not performed. The outcome of hives on trunk was reported as recovered/resolved. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 07Feb2021 as dose 2, single (Lot number: EL9269), in left arm and on 26Aug2021 as dose 3 (booster), single (Lot number: FA6780) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03May2022 as dose 4 (booster), single (Lot number: 057M21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019, lot N002720, expiration date 12-MAY-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. The vaccine was exposed from 32°F to 35°F for 1 hour. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Red swollen lump on injection site .; Itchy lump; Red swollen lump on injection site .; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (Red swollen lump on injection site .), VACCINATION SITE PRURITUS (Itchy lump) and VACCINATION SITE ERYTHEMA (Red swollen lump on injection site .) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, the patient experienced VACCINATION SITE MASS (Red swollen lump on injection site .), VACCINATION SITE PRURITUS (Itchy lump) and VACCINATION SITE ERYTHEMA (Red swollen lump on injection site .). At the time of the report, VACCINATION SITE MASS (Red swollen lump on injection site .), VACCINATION SITE PRURITUS (Itchy lump) and VACCINATION SITE ERYTHEMA (Red swollen lump on injection site .) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Med Info Agent: Patient called and reported the Adverse event , experienced after the first dose of Moderna vaccine on 8May 2021. After one week of getting the shot on 16 May 2021, patient developed  red swollen lump on injection site which continued  to grow and got bigger. Lump is itchy. Injection was given on the left upper arm , intramuscular .Caller did not provide the expiration for the vaccine .Consent for safety follow up was given via email
Per internal reported event - Pt stated he was experiencing SOB after vaccine. BP was 146/80 in left arm. He did not appear to be in distress; he was alert and oriented. Pt was given 50mg of Benadryl, requested per mother. He felt improved after Benadryl. Pt and Mother denied additional care and wanted to go home after the additional monitoring of 15 min (total of 30 min).
Patient c/o throat thickness.  Osat 96%, BP 132/98, HR 72.  Pt states she is back to baseline.  S/S similar to GERD pt stated.  Pt with in normal limits upon discharge.
1-03-2021dose at 9:30 arm pain 6:00 pm went to bed 11:00 woke up around 5:00 with significant breathing problems. Did not improve with albuterol. called 911 and was taken to the hospital ER. Loss of memory for 4-5 hours. don't know what happened
C/o pain 8/14/14 at night, dragging legs and limping 8/15/14. On Sat 8/16/14 pt unable to walk. Currently still in ER.
Tender at site 10/13/18. L upper arm reddened and tender to touch. Redness from a couple inches below shoulder joint to a couple inches above elbow joint, covering about 1/3-1/2 of upper arm. Resolved by dinnertime 10/16/18
Patient states he starting having symptoms like Bell's Palsy one week after receiving the flu vaccine, Fluad.  He started having  face drooping on the right side of his face, eye is dry and mouth would not close all the way on the right side on 11-17-2020.   Patient said it is not debilitating but noticeable.  He had a phone conference with his dr on 11-19-2020 and he was advised to monitor and be seen if symptoms worsen but should improve.
a small nosebleed; Felt very fatigued for the following 2 days(stayed home); experienced mild nausea; dizziness; This is a spontaneous report from a contactable other healthcare professional (Patient). A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, on 16Feb2021 at 10:00 (at the age of 27-year-old), as dose 2, single in left arm for COVID-19 immunization at Workplace clinic. The patient's medical history was not reported. Patient had no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, on 25Jan2021 at 11:15 AM (at the age of 27-year-old), as single dose in left arm for COVID-19 immunization. Concomitant medications in two weeks were reported as daily multivitamin, ibuprofen; taken for unspecified indications, start and stop dates were not reported. Patient did not receive any other vaccine in four weeks after COVID vaccination. On 16Feb2021 at 12:00 PM, 2 hours after second dose of vaccine, the patient felt very fatigued for the following 2 days (stayed home), experienced mild nausea and dizziness. On 17Feb2021 morning, on second day after dose 2, the patient experienced a small nosebleed. Patient still felt fatigued on day 3, although much better. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was recovering.  Follow-up attempts completed. No further information expected.
Two days after vaccination, pt was driving to work and developed a severe headache, heard the sound of "nails" being shaken in her head, and "shocking" sensation in her head (from shoulders up to top of head). The sound as well as the shock sensation occurred frequently, every 10 seconds, and caused severe pain. She had CT brain as well as MRI of brain done = both were normal. Treated with 100mg carbamazepine BID (for possible trigeminal neuralgia) and symptoms resolved completely within 4 days of treatment.
It was noticed that patient was administered PCV 13 1 year after 1st dose of PCV 13 after the age of 65 instead of the follow up PPSV23.
she came out with a rash in the upper chest, on the collar bone area near neck and and on her back; it was itching; pain in right arm at injection site; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 40-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE mRNA, Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration, administered in right arm on 29Apr2021 at 11:30 (at the age of 40-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history reported as none. Family medical history was none. The patient's concomitant medications were not reported. She did not receive any prior vaccine (within 4 weeks) and not received any other vaccinations within four weeks prior to the first administration date of the suspect. On 29Apr2021, there was pain in right arm at injection site. She had the first shot of Pfizer Covid-19 vaccine on Thursday morning and yesterday at mid-afternoon on 02May2021, she came out with a rash in the upper chest, on the collar bone area near neck and on her back, it was a small rash at night it was itching. The events did not result in emergency room or physician office. Outcome of the event pain in right arm at injection site was recovered on 30Apr2021, for itching it was unknown and for a small rash in the front near her neck and on the back, it was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Neck hurt bad; Neck started bothering her; Arthritis in the neck; Pre-diabetic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Neck started bothering her), ARTHRITIS (Arthritis in the neck), NECK PAIN (Neck hurt bad) and GLUCOSE TOLERANCE IMPAIRED (Pre-diabetic) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pre-diabetic, Glaucoma, High cholesterol, Hypertension and Arthritis. Concomitant products included BIMATOPROST (LUMIGAN) for Glaucoma, PRAVASTATIN for High cholesterol, CHLORTHALIDONE for Hypertension, POTASSIUM for Potassium replacement.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced GLUCOSE TOLERANCE IMPAIRED (Pre-diabetic). On 05-Feb-2021, the patient experienced NECK PAIN (Neck started bothering her) and ARTHRITIS (Arthritis in the neck). On 08-Feb-2021, the patient experienced NECK PAIN (Neck hurt bad). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) at an unspecified dose and frequency. At the time of the report, NECK PAIN (Neck started bothering her), ARTHRITIS (Arthritis in the neck), NECK PAIN (Neck hurt bad) and GLUCOSE TOLERANCE IMPAIRED (Pre-diabetic) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: arthritis in the neck.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever chills, swollen lymph nodes Narrative:  Fever 102, chills, lymph node swollen in left axilla; taking Tylenol. No reaction previously, no recent vaccine.
distal and medial  to injection site (about 7 cm away) developed a raised, red, warm slightly tender/slightly itchy papule 15 mm by 4 mm with 2 separate smaller (several mm each)  similar areas distal
Pt received Tdap dose (Adacel) at advice of her MD due to a cut on her hand to protect against tetanus. The Tdap has given her arm swelling, rash on arm, neck pain, vision problems.
ON 1/29/13 PAPIENT CAME IN FOR HER WELL CHILD EXAM AND RECEIVED 2 SHOTS IN EACH UPPER ARM'S: HEP A #1 AND MENINGITIS SHOT. AND MOTHER WAS TO RETURN PATIENT BACK TO START THE RECOMMENDATIONS OF HPV AND TO FINISH THE VARICELLA SERIES SHOTS. MOTHER CALLED ON 1/31/2013 @ 4:43PM, SAYING PT'S LEFT ARM HURTS WHERE PT HAD THE A SHOT, IT IS ITCHY, RED, SWOLLEN, IT STARTED SINCE YESTERDAY SHE THOUGHT IT WAS IRRITATED, BUT TODAY WAS MORE. PER MEDICAL DOCTOR: MOTHER WAS TO HAVE PT USE COOL COMPRESSORS AND TYLENOL OR IBUPROFEN FOR PAIN AND TO SCHEDULE AN APPT FOR THE NEXT DAY.  On 2/1/2013: WHEN MOTHER BROUGHT IN PATIENT TO HER APPOINTMENT HER LEFT DELTOID WAS SWOLLEN AND SLIGHTLY TENDER A FEW HOURS AFTER THE SHOT AND WAS RESOLVING BY IT ITSELF, AT THAT TIME. THE MD MEASURED 6CM OF INDURATION OF THE LEFT DELTOID. NO RASH. DIAGNOSIS CODE: E949.6 VACCINE REACTION TO MENACTRA. PATIENT'S RECOMMENDATION WERE TO CONTINUE THE COOL COMPRESSES AND IF NEEDED TO TAKE THE TYLENOL FOR PAIN AND to CALL IF IT GET WORST.
Severe arm pain from the shoulder down to the fingers, joint pain, nausea, vomiting, dizziness, fever
This is a spontaneous report from a contactable consumer. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at the left arm on 13Jan2021 at a single dose to protect against COVID.  Medical history included under active thyroid in Jul2019. There were no concomitant medications. The patient woke during the night feeling like she was on fire feeling prickly throughout her body/her whole body got really hot and she had to cool with a rag on 19Jan2021 03:00. Outcome of the events was unknown.
Starting the following day after receiving the vaccine (04/29/2021), I woke up feeling very achy with chills and my temperature was just over 102. I tried to eat a bite and took some ibuprofen. I tried to sleep it off, but the symptoms continued for about 24 hours then gradually got better, and within 2 days I was back to normal other than being slightly sore at the injection site.
This spontaneous report as received from a physician refers to an approximately 3 month old patient of unspecified gender. The patient had no allergies. No concurrent conditions, and medical history were reported. Concomitant therapies included ranitidine hydrochloride(ZANTAC). On 19-JUN-2017, the patient was vaccinated with ROTATEQ lot M043836 with expiry date: 17-JUN-2018, dose 1 (dosing detail, route were unknown) for prophylaxis. On the same day, the patient experienced severe diarrhea. A stool culture performed at physician's medical practice and the results of the culture was negative. On an unknown date approximately in 2017 (reported as a few days later), the patient was taken to pediatric emergency room and stool culture was performed in the pediatric emergency room showed white blood cells and mucus in the patient's stool; positive for occult blood. No treatment was given for diarrhea. As of 10-JUL-2017, the patient does not have blood in stool but continues to have diarrhea containing mucus. The outcome of diarrhea was not recovered and that of occult blood was unknown. The reporter did not provide the causality between the events and ROTATEQ. There were no product quality complaints (PQC) involved.
Fatigue on-going. Retinal/occular migraine - left eye sight blurry, flashing, spinning zig zag lights without bad headache. Never experienced the vision issue before.
Headache, Fever, NauseaVomiting, ARM REDNESS Narrative:
My goal was to get a vaccine from each manufacturer. I accidentally ended up with multiple sets of pfizer.  Pfizer #1  on 02/12/2021 at 3pm, in right arm Pfizer #2 on 03/06/2021 at 1 pm. In left arm  Had the Johnson and Johnson vaccine  04/12/2021 at 1 pm. On 04/14/2021 at 3:30 pm - 9 pm nose bleed occurred.   Had Pfizer #1 on 04/18/2021 at 8:30 pm, Pfizer #2 on 05/02/2021 at 6:30 pm  Sex on 04/22/2021.  Not on any birth control.  Taking 50 MG each day of serialize. Period started on 04/29/2021 and continues today, 05/13/2021.  I made an appointment to see my obgyn next week. Mild cramping everyday.  Cannot take birth control as I am supposed to take leviteracem 250mg every night, but am lucky if I remember to take it 3nights a week
Information has been received from a physician concerning a 5 yr old male who on his 12 month visit, in approx 2001, was vaccinated with a dose of varicella virus vaccine live. Recently, in 2005, the pt experienced breakthrough varicella of about fifty lesions or less with no fever. Subsequently, the pt recovered. No treatment was given. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Narrative: 71 yo M Patient with PMH of thrombocytopenic disorder, large prostate, HLD, viral hep C, and HTN who developed a diffuse rash on upper arms, upper thighs, and buttocks after receiving the Pfizer COVID vaccine first dose. Patient reports that "There are little red bumps the size of 1-2 pinhead's light red in color, no pain, no fever, no sore throat, no cough, no contact with anything new other than Vaccine. Does not do any outdoor activities. Overall, itchiness is getting better." Patient was given hyrocortisone cream. Per 3/1/21 note, rash appears to be improving and provider advised to get the 2nd dose of the COVID vaccine.
I woke up around four in the morning on November 3rd, just feeling very itchy and I realized that I had some hives. I went into the bathroom and checked myself out. I wasn't experiencing anything else other than the itching and took a Zyrtec. It seemed to resolve, but then it came back around 7-8pm that night and I started to get itchy again with increasing hives. There was no trouble breathing, etc. So, I took Benadryl that night and took 50 mgs. And that didn't seem to help much. So, Thursday November 4th, I again woke up at four in the morning and woke up itchy and took another Zyrtec and it was widespread and moving hives. So, the hives continued throughout the day, and I was very itchy and it was moving around. Took Zyrtec again and even tried Pepcid for a histamine block without much relief. Friday morning November 5th, continuing hives over most of my body besides my face. So, I reached out to my Primary Care Physician, and she prescribed Hydroxyzine and continued to do what I was already doing. I did not pick up the medication because of timing and didn't want to take too much antihistamine. Friday evening 7-8pm, I started to feel like when I swallowed it felt like I was going to choke on something, felt like it was towards my breast. It would be uncomfortable, and it felt like a spasm of my esophagus. By Saturday morning it was still happening, so I was seen virtually Saturday morning November 6th with doctor, and we couldn't come up with any new triggers. So, she basically recommended antihistamine twice a day, Pepcid and she suggested to take Omeprazole for the esophagus feeling. She also prescribed a steroid, but we talked about not taking it just yet. So, Saturday and Sunday were the worst with hives, and it was all over my legs, back and abdomen. It was super itchy. I did get the Hydroxyzine and it didn't feel like it was doing anything. Since yesterday, it was less dramatic. Saturday night, esophagus hasn't been as intense, feels like a sensation but it did get better. Hives did improve yesterday, still present, and visible. Still need to take Zyrtec twice a day. Calms down after a dose. Still itchy and still present. I still have not started the steroids.
Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and needed to be returned to VFC. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been identify the 12 patients who administered HPV vaccine between the dates of 2/12 - 2/18/14 under lot number (J012212).