chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe headache; Whole body pain; All day Vomiting; Nausea; Muscle Spasms; Intense Chills; fever cycle; Very High blood pressure; This is a spontaneous report from a contactable patient. A 52- year-old male patient received first dose of  BNT162B2 (Pfizer BioNTech covid 19 vaccine) (Lot no.: EN6207) via an unspecified route of administration  in right arm on 12Mar2021 at 12:00 PM (at the age of 52-years-old) as a single dose for COVID-19 vaccination. Medical history included high blood pressure and thyroid disorder. He also thought he had a false negative covid test in Jul2020, and actually did have covid in Jul2020. The patient did not have any allergies to medications, food and other products. Concomitant medication lexapro, losartan, DIM (as reported, unspecified), retinol (vitamin A), vitamin d and phytomenadione (VITAMIN K), trazadone within 2 weeks of vaccination for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, patient was not tested positive for COVID-19. On 13Mar2021, patient trip to the emergency room (ER) for severe headache, whole body pain, muscle spasms, intense chills and fever cycle, very high blood pressure, all-day vomiting and nausea. Nothing they tried eased any of the symptoms. There is no amount of ibuprofen or acetaminophen. He threw up nausea medicine. Two doses of morphine at the ER took the pain from a 10 to a 7. He had never, ever felt this badly. The clinical outcome of the events severe headache, body pain, muscle spasms, intense chills, fever, very high blood pressure, vomiting and nausea was not resolved. No follow-up attempts are possible. No further information is expected
aches; significant fatigue; chills; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), FATIGUE (significant fatigue), CHILLS (chills) and PYREXIA (low grade fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches), FATIGUE (significant fatigue), CHILLS (chills) and PYREXIA (low grade fever). At the time of the report, PAIN (aches), FATIGUE (significant fatigue), CHILLS (chills) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body/muscle aches) and PYREXIA (Feverish feeling) 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 05-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced MYALGIA (Body/muscle aches) and PYREXIA (Feverish feeling). At the time of the report, MYALGIA (Body/muscle aches) and PYREXIA (Feverish feeling) had not resolved.            No concomitant medications were reported. No treatment information was provided.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information of pertinent medical history and drug reactions/allergies of the patient were not reported. On 22-JUN-2015 the patient was vaccinated with expired M-M-R II (dose, strength and route unknown), lot # H016132 with expiration date of 31-AUG-2014. Concomitant medication was not reported. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
24hr post vax pt began itching in various places & broke out in hives on trunk;
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: EXTREME SWELLING IN THE ARM
I am a resident physician. I received my first two Moderna COVID-19 shots in January (1/2/2021, 1/30/21). With the first shot, I only had a sore arm for a few days. With the second shot, I develop fever, chills, headache that started 12 hours after the vaccine and lasted 36 hours. I received my booster shot with the Pfizer vaccine at a local pharmacy on 11/5/2021. I had taken the annual flu shot earlier in the week on 11/2/2021 at the Hospital, where I work, with only a sore arm as a side effect. Like my second Moderna shot, I experienced fever, night sweats, and headache 12 hours after the vaccine continuing through to 48 hours post-vaccine. I felt fatigued for the next week after the vaccine. I noticed a small bright spot in my center/slightly medial visual field on 11/8/21 evening and isolated the symptoms to my R eye. I presented to the ophthalmologist on 11/9/21 afternoon where I underwent visual field testing and retinal scans. I was noted to have a chorioretinal lesion in the R macula corresponding to a blind spot in my R central vision. I was referred to a uveitis specialist, who saw me on 11/30/21. He noted bilateral vitritis in addition to the findings mentioned earlier. I was started on prednisolone acetate 1% drops 4 times a day. A workup with lab testing and CXR was sent to rule out other etiologies for the development of this eye inflammation, which has all come back negative.  This event seems directly related to my booster vaccination. My follow up appointment is scheduled for 12/14/21.
She had swelling under her arm (near armpit) a few hours after her vaccine. She said it was the size of an egg. The swelling is almost gone now. She did not use any treatment.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 03-NOV-2015 06:00, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 10.7 and 2.3 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of rash mouth in a 60-year-old female patient who received Shingrix (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 27th July 2018, the patient received Shingrix (intramuscular) .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced rash mouth and rash. The patient was treated with emollients and protectives (Moisturizing Cream). On an unknown date, the outcome of the rash mouth and rash were not recovered/not resolved. The reporter considered the rash mouth and rash to be related to Shingrix. Additional details were provided as follows: Pharmacist reported that a patient was complaining of a rash around her lips and sometimes in her mouth since getting Shingrix. The patient thought it was caused by Shingrix. The patient had been treating the rash with moisturizing cream, but it was not going away.
This spontaneous report as received from a pharmacist refers to a 63 year old male patient with high blood pressure, diabetes and "other unknown pain related condition". On 30-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not provided). Concomitant therapies included amlodipine (manufacturer unknown), hydrocodone, VICTOZA, NOVOLOG, metformin, gabapentin, SINGULAR, PROTONIX, tizanidine (manufacturer unknown), atorvastatin (manufacturer unknown) and prednisone (manufacturer unknown). In 2015, the patient needed to take a higher dose of prednisone (manufacturer unknown) that what was prescribed on 09-MAY-2015 (adverse event). The reporter also mentioned that the patient went for a colonoscopy on an unspecified date after receiving vaccine ZOSTAVAX. At the time of this report, the outcome of adverse event and colonoscopy was not recovered. Additional information has been requested.
The adult patient was given a pediatric dose of Hepatitis A. She had already received her first dose of Hepatitis A. The error was caught after administration. The local health department was called for guidance and the patient contacted and notified of the error and that she would need an adult dose.
This spontaneous report as received from a physician and from a support services director via two company representatives refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 18-JUN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 mg/1ml injection (lot # J015547, expiry date 03-FEB-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two temperature excursions (dates unspecified), one lasting for 64 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius), and the second lasting for 16 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
On 3/1/19, I woke up with petechiae rash on my both arms and some tenderness in my left armpit. I scheduled my appointment with a PCP, Dr. who shares the practice with my PCP, Dr.. The rash worsen and appeared on my thighs and knee areas as well. On 3/20/19, I was seen by  Dr. and had a lab draw.  I had 10 + lab draws since then.  I also visited the urgent care, and I was also seen by doctors in hematology, dermatology, and rheumatology. The rash did not go away for two months.
From initial info received on 4/16/03 from a nurse regarding an adverse event, it was reported that a 29 year old male pt received his first dose of YF-VAX, and second dose of hep B vaccine on 4/16/03. The pt also received his first dose of hep B vaccine given IM in his right deltoid and his first dose of Pneumovax given IM in his left deltoid on 3/21/03. Upon receiving his second dose of hep B and first dose of YF-VAX, the pt developed difficulty swallowing, and irritated throat, nausea and a headache. The pt was transferred to the ER via ambulance and given 50mg of Benadryl. Reportedly, the pt recovered from these events.
stomach pains; nausea; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 10Mar2021 13:00 (Lot Number: EL 3247) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included anxiety and herniated disc in neck. Concomitant medications included gabapentin; escitalopram oxalate (LEXAPRO); and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Mar2021 13:30, the patient experienced stomach pains and nausea with outcome of recovered. The patient did not receive any treatment for the reported events.  No follow-up attempts are possible. No further information is expected.
body aches, chills, headache, and temp 100.6 for the first 24 hours. I rotated tylenol and ibuprofen and slept. I currently still have a headache and chills. I am very cold but sweating, today is 48 hours after.
Case number PHEH2015US002808, is a combined initial and follow up spontaneous report received from a nurse on 04 Feb 2015 and on 09 Feb 2015. This report refers to an 11 years old male patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with MENVEO (batch number: M14030) intramuscularly at a dose of 0.5 ml on 03 Dec 2014. It was reported that before administration, the MENVEO was stored at a temperature greater than 45 degree Fahrenheit for a total of 35 hours. On 17 Nov 2014 it was stored at 55.1 degree Fahrenheit for unknown period of time. The temperature excursion occurred in between 17 Nov 2014 to 03 Dec 2014. No adverse event was reported following this administration error.
About 2 minutes after receiving the injection - I went through 4 'waves' over the next 25 minutes - each wave lasted about 2 minutes.  During that time - I felt a wave/rush of lightheaded/disorientation feeling/ a cold sensation was rushing throughout my body internally/weak-shaky/ dry mouth/ and one of the waves I felt like I had to make myself swallow/like a rush of adrenaline.    These subsided - and started again with a couple minutes between each wave.     I took a Benadryl once I arrived home - only 2 very minor waves that morning.  No other treatment but now afraid and need guidance if I should get the 2nd injection in case the 2nd reaction is worse.
Got my yearly Mandatory flu shot. Each year I either have a terrible headache or severe backaches and body aches. This year, I had both. This caused me to feel pretty bad, but with no one to cover I went into work. At approximately 8 am, I began feeling dizzy and feeling like I was going to vomit. Shortly thereafter I vomited into my trash can which my manager witnessed and I then went home with a fever and basically slept for a day and a half.
pt recv vax 11AM 9MAY96 & middle of afternoon mom noted pt drowsy, feeling hot & dry;went to ER 5PM t105, alert, quiet, color good;given APAP;temp went down to 102.6 & pt was given advil; d/c 6PM w/t99.9;
had immediate reaction of heavy chest; trouble breathing; tightness in her throat; Her blood pressure went up; her face was red; she had blotches on her arms; This is a spontaneous report received from Pfizer sponsored program COVAX SUPPORT. A contactable consumer (patient) reported a female patient of an unspecified age received BNT162B2 (BNT162B2) (Batch/Lot number was not reported), dose 1, intramuscularly on 09Apr2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 09Apr2021 (reported as this morning), the patient had an immediate reaction of heavy chest, trouble breathing and tight in her throat following her first vaccination. Her blood pressure went up and her face was red and she had blotches on her arms. She stated she was immediately given Benadryl and took a hit from her inhaler and then was given another Benadryl. The patient stated they kept her there for 2 hours to make she would be alright. She stated the symptoms subsided but asked what she should do now. Clinical outcome of the events heavy chest, trouble breathing, tight in her throat, blood pressure went up, face was red and blotches on her arms was resolving.   No follow up attempts are needed. No further information is expected.
This spontaneous report was received from a pharmacist regarding a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On 24-AUG-2015, the patient was vaccinated with ZOSTAVAX of lot # L000461, expiry date: 08-MAR-2016 (dose and route were not reported). Other suspect therapy included Influenza virus vaccine (manufacturer unknown) which was also administered on 24-AUG-2015. Concomitant medications were not reported. On an unspecified date in AUG-2015 (also reported as approximately one week after vaccination) the patient was diagnosed with bronchitis and the patient was treated with an unspecified antibiotic. The outcome of bronchitis was reported as recovering. Causality assessment was not provided. Addditional information has been requested.
Hives, itching, warmth around injection site.  General ill feeling.  Given Motrin 600 mg at onset.  Applied OTC Cortisone 10 cream in late PM and in AM of 12/19/13.  Gave Benadryl 25 mg at bedtime on 12/18/13.
developed ulcers/blisters on the back of my tongue around 40 minutes after. Doctor diagnosed as pharyngitis, negative rapid strep a test, gave iv bag, benadryl, and a steroid.
got her 1st dose on 18MAR2021, and after 2 weeks she has rashes; This is a spontaneous report received from contactable consumer (patient ) via Pfizer sponsor program . A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection batch/Lot number was not reported ,expiry date was not reported), dose 1 via an unspecified route of administration on 18Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced got her first dose on 18mar2021, and after 2 weeks she has rashes .Patient asked if it is associated with the covid-19 vaccine because her second dose schedule is on 08Apr2021.Outcome of the event was unknown.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained.No further information is expected.
INADVERTENTLY VACCINATED BEFORE 12 YRS OF AGE. UNABLE TO CONTACT, WRONG DATA ENTRY.
Child jerked when vaccine administered the Hib vaccine causing the needle to be withdrawn while med was administered, and puncturing his leg again on 5/26/06.  Mother called on 5/30/06 stating site is inflamed, reddened, swollen and painful to touch.  Advised to apply warm packs and give Tylenol.  Mother took child to her family physician on 5/30/06 who prescribed an antibiotic in case of infection.
lungs feel tight, productive cough with severe burning sensation in lungs; mild sore throat;  no fever;  note: when instructed to sniff in when vaccine administered, I sniffed strongly, had funny taste in throat and back of mouth 15 minutes after.
presents the emergency department for evaluation of shortness of breath.  Patient received a diagnosis of COVID-19 infection 2 days ago.  Since that time, her condition has deteriorated resulting and difficulty with swallowing, progressive weakness and fluctuating mental status.  Patient also has a history of COPD and uses BiPAP at night and 2 L of oxygen during the day.  The patient is currently seeking care under hospice. We have escalated her respiratory support to now include high flow NC. It is effective and she is tolerating it well.
CELLULITS TO LEFT ARM. Sought care at neighborhood ER. Was given antibiotics and symptoms went away by the end of the treatment
Patient had a vaccine HPV or HPV9 I don't know. I would have to find out from the doctor. He woke up the next day with a few bumps on his forehead and by the evening he had bumps on his arms, neck, face. He was extremely itchy. I have him a BENADRYL and then called the doctor. It's day 2 and he woke up with a blister type on his earlobe. Still itchy. Still on BENADRYL and ZYRTEC and anti-itch cream. Item 21 doesn't not have a button to say I talked to the doctor and the nurse on the phone.
You experienced a bruise the size of a baseball that was yellow/brown in color and tender/irritating.
Information has been received from a physician concerning a 72 year old female with breast cancer, hypertension, high cholesterol and acyclovir, famciclovir, synthetic opiates allergies (diffused rash) who in December 2008, was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included AROMASIN, CRESTOR and atenolol. The physician reported the patient came down with shingles in January 2011. The physician stated that the onset of shingles was noticed on 24-JAN-2011. The patient complained of painful rash on her left chest. As per physician, the patient first thought that the chest pain was due to her hypertension and she went to ER to be examined. At present time, the patient had no active lesion but she suffers from post herpetic neuralgia (PHN). The physician prescribed acyclovir to the patient to treat shingles but the patient developed diffused rash and was not able to complete the treatment. Famciclovir was prescribed instead and the patient developed diffused rash with famciclovir as well and the treatment was discontinued. The patient was treated with gabapentin too. No lab diagnostics studies were performed. At the time of the report, the status of the patient was not reported. Additional information has been requested.
Few hours after administration of the vaccine, patient started c/o pain in area of injection (RT Deltoid) and noted area of redness on anterior aspect of right arm, which became more noticeable the following day (7/13/2010). No fever. No constitutional symptoms. Patient examined today in the office (7/14/2010): Area of erythema with increased local temperature on anterior aspect of right arm (extending from shoulder to elbow). No edema. Full R.O.M right upper extremity. Afebrile. Treatment: Cold compresses for 15-20 minutes every 4-6 hours. TYLENOL 500 mg PO Q 4-6 hours prn for pain, BENADRYL 25 mg po Q 8 hours. Follow up on 24 hours.
Child received DTaP with no immediate side effects.  Mother states child's leg was swollen in the evening at bath time.  Mother states the next day the R-leg was double in size and swelled into the hip with a "hugh" knot, red and warm to touch.  Mother states she contacted the doctor who instructed her to bring him to the office, but mother states she chose to take him to the emergency room.  Mother states the emergency room doctor told her the child had a "good" reaction to the shot, and to just give him Motrin and let it run its course.  I talked with mother today who states child is doing much better the leg is still swollen but the redness is gone.
2 episodes of less than 30 seconds duration where arms, legs, head had several rhythmic jerks as pt was breast feeding & falling asleep; both episodes occurred when pt was over tired & stopped when postion changed ?myolonic jerks;
8 doses given today after vial was punctured 30May2021. Technician did not know vial was from 30May2021".; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021. Technician did not know vial was from 30May2021".) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) 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 01-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021. Technician did not know vial was from 30May2021".). At the time of the report, EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021. Technician did not know vial was from 30May2021".) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD21-104754, MOD21-104756, MOD21-104758, MOD21-104759, MOD21-104760, MOD21-104761, MOD21-104762 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Contact information updated
Diarrhea q 2 hours x 4 days, as 4-29-10, improved but still several times q day, slowly recovering.
BODY RASH-HIVES, ITCHING, SWOLLEN THROAT, SWOLLEN FINGERS, TROUBLE BREATHING