chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight fever; headache; body aches; diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 48-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm on 29Mar2021 at 11:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and central sleep apnea syndrome. The patient did not have a history of allergies to any food products, medications or others. Concomitant medications included losartan (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO), atorvastatin (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN) for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in left arm on 08Mar2021 at 10:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. 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 30Mar2021 at 06:00, the patient experienced flu-like symptoms such as slight fever, headache, body aches and diarrhea. The patient did not receive any treatment for the reported events. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event slight fever, headache, body aches and diarrhea was resolving.   No follow-up attempts are needed. No further information is expected.
rash; balance problems; This spontaneous report was received from a lawyer rand refers to a currently 66 year old patient.  The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.    On 17-SEP-2013, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, the patient was treated for the following injuries resulting from Plaintiff's zoster vaccine live(ZOSTAVAX) use: balance problems and rash.      The outcome of rash and balance disorder was unknown. The reporter considered rash and balance disorder to be related to Zoster Vaccine Live(ZOSTAVAX).
chest pressure, paleness, clammy, hot, faster heart beat, fainting - layed down, clammyness subsided, heart beat and chest pressure continued less severe for 4 more hours. - chest pressure returned briefly 6:00 pm 02/04/2010
Death occurred at night in home, unwitnessed, possible SIDS, previously healthy with mild CER, autopsy performed, genetics involved second to strong family history of developmental delay and psychiatric d/o. Pt in phase III clinical trial of HibMency, received vaccine 8/9/06
7 days after second shot I have headache, chills, and temp of 101.6
Fully vaccinated.  Vaccine breakthrough with inpatient hospital stay on a med surg unit.
patient recieved his bi-valent covid booster yesterday. presenting now today with HTN emergency: new HTN, frontal HA, chest tightness. Negative ED workup including EKG, CXR, basic labs, troponin, however HTN is new and symptoms were concerning.  responded to 2 doses of IV labetalol 10mg each.  recommended hospitalization but patient left AMA. because this SHOULD have been a hospitalization i will mark it as such below
I got notified the day after attending a party with some friends that someone was positive for COVID-19, the next day I started not feeling well. The first test came back negative then took more the next day that were positive. From there I was sick, this is my second time I had COVID, symptoms were fever, sore throat and cough started testing after 10 days they were positive and on the 11th day negative. Since then, I am feeling much better. Took about 3 weeks to feel completely better.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jan2022 as dose 3 (booster), single (Lot number: 059H21A) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Htn" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "obesity" (unspecified if ongoing); "fmd" (unspecified if ongoing); "ACE inhibitors allergies" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE; ROSUVASTATIN; VIT D3; VIT B6. Past drug history included: Amlodipine, reaction(s): "Known allergies: Amlodipine"; Keflex, reaction(s): "Known allergies: keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
No ADR Resident was given Pfizer bivalent dose prior to receiving any primary series doses
This spontaneous report as received from a pharmacy technician refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 24-JAN-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA001558:
Patient receive vaccine, was very sick the first 3 days after getting it started to feel better for two more days and then died suddenly around 3 p.m.
pt allergic to shellfish, pt immediately reported tingling of tongue, lips, tingling of hands and feet 50 mg of Benadryl given EMS on site EpiPen given by EMS and transported to Hospital
Tenderness at injection site; Swelling at injection site; Fever; Body aches; Bedridden; This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number HM3NC, expiry date 13th April 2021) for prophylaxis.   In December 2018, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site tenderness, injection site swelling, fever, general body pain and bedridden. In December 2018, the outcome of the bedridden was recovered/resolved. On an unknown date, the outcome of the injection site tenderness, injection site swelling, fever and general body pain were unknown.   It was unknown if the reporter considered the injection site tenderness, injection site swelling, fever, general body pain and bedridden to be related to Shingrix.  Additional case details were reported as follows: In December 2018, the patient experienced fever, full body aches, swelling at the injection site, tenderness at the injection site, and had to stay in bed for 3 days.
Information has been received from a nurse concerning a 23 month old patient who on 26-JUL-2011 was vaccinated with a dose of VARIVAX (Merck) (lot# 669684/0088AA). The nurse mentioned that on 05-JUN-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. A lot check has been initiated. Follow up information has been received from a registered nurse refers to a 2 year old female patient. The patient's medical history included wheezing and none illness at time of vaccination. The patient was vaccinated subcutaneously in left leg with a first dose of VARIVAX (Merck), (dose not reported, lot # (669684/0088AA) on 26-JUL-2011. It was reported that the patient came to the clinic on 05-JUL-2012 with a rash described as "vesicles noted on trunk upper extremities. Patient had some crusted lesions in the popliteal area of both legs." The patient was diagnosed with varicella. No lab diagnostic tests were performed. At the time of the report the patient's status was recovered (recovery date was reported as 22-JUN-2012, when patient was seen without rash). This is one of several reports from the same source. Additional information is not expected.
It was reported that a 41 year old female received a TD Adult vaccination on 11 Apr 2000. Reportedly on 12 Apr 2000, the patient complained of pain and redness at the injection site of the left deltoid, as well as nausea. The left arm pain and redness was diagnosed as cellulitis. The patient was placed on antibiotics, pain-killers and something for the nausea (not specified). The symptoms seemed to become better in a few days. The patient returned on April 14th for checkup. Further information requested. From additional information received on 7 Jun 2000, it was reported that the patient recovered from this experience. Additional vaccine, patient and responsible physician information was also provided.
light menstrual bleeding everyday since her last period; Irregular menstrual bleeding; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (light menstrual bleeding everyday since her last period) and MENSTRUATION IRREGULAR (Irregular menstrual bleeding) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy, Drug allergy, Depression and ADHD. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) from 2015 to an unknown date for ADHD, FLUOXETINE from 2014 to an unknown date for Depression.    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 experienced INTERMENSTRUAL BLEEDING (light menstrual bleeding everyday since her last period) and MENSTRUATION IRREGULAR (Irregular menstrual bleeding). At the time of the report, INTERMENSTRUAL BLEEDING (light menstrual bleeding everyday since her last period) and MENSTRUATION IRREGULAR (Irregular menstrual bleeding) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Labs were done in 2020, indicated normal hormonal levels.   This case was linked to MOD-2021-103545 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow up received, concomitant medication , medical history and event updated.
Patient said she felt hot after injection. Then she drove herself to work  , and when she returned to work she felt a burning sensation in her body , itching and broke out in a rash.  She took Benadryl and has taken Benadryl every other day since the vaccine. The Benadryl helps her symptoms of burning and itching.   She does not want to take the 2 nd vaccine for COVID 19 , especially since she had COVID 19 at the end of August 2021
Woke Monday, Sep 19th with swollen, red, itchy, irritated left eye.  Sought treatment at Medical Center Emergency where Doctor diagnosed me with periorbital cellulitis of left eye.  Given prescription for amoxicillin-clavulanate 875-125mg twice daily for 7 days and started it right away.  By late Monday morning my right eye was exhibiting the same symptoms.  Throughout Monday I applied warm compresses to my eyes as directed by the Doctor and took 25mg Diphenhydramine HCl for the itching, irritated feeling.  Tuesday morning the redness and swelling was reduced and still taking prescription along with the Diphenhydramine.
I got up to use the bathroom about 4am. I got dizzy and the next thing I know I was on the floor in extreme pain in my left shoulder and arm. I was also hurting in my ribs. When my wife heard the fall, she rushed in to the bathroom to see what happened. She checked on me to see what was wrong. Within a minute or two she also  got very dizzy and sick to her stomach. She sat down on the commode and put her head down between her knees. The next thing I know she is falling off the commode. I called to her several times before she answered. She finally got up but got dizzy again. I took several minutes before it began to wear off. We had to figure out how to get me off the floor as I am twice the size of my wife. I propped my foot against the door. I was finally able to get on one knee. There was no way I was going to use my left arm/shoulder. I was in too much pain. I was eventually able to get up on both knees and then to my feet. She helped me back to the bed. We both laid back down. That morning (~10am) we went to Hospital ER to get checked out. I was still in extreme pain. My wife seemed to be doing okay. She also filed an adverse reaction report.
10 minutes post vaccine: lightheaded, lost color in her face, needed to lay down and take her mask off to breathe deeper....laid her flat, called over the nurse practision in our building, placed cool compresses on wrists and foread, at 20 minutes post vaccine, tried to sit up, but still dizzy, so continued to lay down, asked if she wanted EMS or family notified, but she declines.  This has occurrd before...at 25 minutes post vaccine...feeling better, color returned to face, drank 2 bottels of water and one sugar lollipop.  Stayed another 15 minutes before  leaving store
Pt vaccinated was under the age of 18 and received the Janssen vaccine which is not approved for those under 18
Presented with worsening SOB/cough, hypoxia; initially dx + Covid 1/10 and improved, now worse; CXR: Bilat PNA; Dx Covid PNA; Labs: D-dimer 1.0, CRP 8.17; Ferritin 355; Tx:  continued on IV steroids and Lovenox, zinc; oxygen requirements increased and placed on Airvo on 1/25.  Received a dose of Actrema (1/25).  Pulmonary consult requested from Dr. in view of persistent high oxygen requirements.  CT angio showed no signs of any pulmonary embolism.  Patient received 2nd dose of Bactrim on 02/05/22.  Patient is a DNR and as long discussed with patient and she does not want intubation.  Symptoms got worse and remained on BiPAP continuously and unable to oxygen at on Airvo and non-rebreather.  Patient and family d
Phstyngeal Edema, Fever, Tongue Disorder - Information has been received from a registered nurse for an employee health center concerning a 29 year old caucasian female with codeine allergy exposure results in fever and vomiting, adhesive tape allergy exposure results in local rash and a local reaction swelling to be stings.  On approximately 02 Nov 2000, the patient was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  On 08 Nov 2000, the patient noted spots on her tongue, fever, and swollen throat.  The patient's fever resolved in three days and she returned to work.  The patient also recovered from the spots on her tongue and swollen throat.  Additional information has been requested.
low grade fever; A spontaneous report was received from a Healthcare Professional concerning a 65-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events low grade fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced the events low grade fever.  Treatment details included Tylenol  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, low grade fever was not reported.
pt in clinic 5SEP96 w/ c/o swelling & redness;instructed to put compresses as prev instructed p/initial inj;recv phone call from infect control nurse stating site very red & hot to touch;pt instructed to go to pvt MD for eval;dx cellulitis
This spontaneous report as received from a physician refers to a two male patients currently over 71 years old. One of the patients (unspecified which patient) had a past medical history of polymyalgia rheumatica that was being treated with chronic steroid treatment (steroid name, dose, and manufacturer were unspecified). No medication history of medical history was unspecified for the other patient. The patients had no known drug reactions or allergies. Approximately in 2007 (reported as "about 7 to 8 years ago"), the patients were vaccinated with a doses of ZOSTAVAX (lot number and expiration date were not reported), subcutaneously to prevent shingles. Secondary suspects and concomitant therapies were not reported. Approximately in 2012 (reported as "during the past 3 years") the patients experienced outbreak of shingles. Each patient was given FAMVIR, ZOVIRAX ointment, and prednisone (manufacturer unknown) on unspecified dates to resolve the shingles. There was no lab diagnostic studies performed. The outcome of herpes zoster was reported as recovering (also reported as "recovered"). The patients sought medical attention via visiting the physician. The relatedness between outbreak of shingles and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot# K011077, expiration date 30-MAR-2017; K015462, expiration date 10-JUL-2017; K026532, expiration date 07-AUG-2017; L006545, expiration date 16-NOV-2017; L012838, expiration date 10-MAR-2018; strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PFIZER VACCINE PLACED IN FREEZER 050621 AND DUE TO BE MOVED TO REFRIGERATOR 05192021.  PFIZER VACCINE WAS USED 05212021 AFTER BEING THAWED FROM FREEZER.
Headache; chills; Fever; Body aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (chills), PYREXIA (Fever), PAIN (Body aches) and FATIGUE (Fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE (Headache), CHILLS (chills), PYREXIA (Fever), PAIN (Body aches) and FATIGUE (Fatigue). At the time of the report, HEADACHE (Headache), CHILLS (chills), PYREXIA (Fever), PAIN (Body aches) and FATIGUE (Fatigue) outcome was unknown. Not Provided  No treatment information was provided.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
All of my muscles were sore, my skin was extremely sensitive to touch, severe headache, and felt feverish - though my actual temperature was only 0.6 above my normal.
Erythematous indurated area on (L) upper arm, from 1" below injection site (not involving actual site) to elbow. Painful, not warm. No pustules or other breaks in skin.
Two hours post vax, the pt began developing hives and itching on arms, chest and hands. Subsequently the pts lips became swollen, left eyelid was swollen and pt experienced a sore throat. There was no shortness of breath. The pt was treated with 2 doses of Benadryl. The hives continued to progress and pt was treated with Atarax every 6 hours and started Medrol dose pak. The pt then saw improvement.
Gave Rotateq at 14 weeks of age.  no side effects noted.  Gave vaccination orally.  Client had normal infant behavior prior to and after the vaccination.
had a rash on both elbows like eczema; a rash on both elbows like eczema. Stated that it was  bumpy and itchy; This is a spontaneous report from a contactable Consumer. This Consumer(Patient) reported that.  A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8734), via an unspecified route of administration, administered in left arm (as reported left shoulder) as dose 1, single on 08Apr2021 10:30 (at the age of 63-year-old) for covid-19 immunisation. No medical history reported. The patient's concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Stated that he got the first 08Apr2021 and the second on 29Apr2021. Provided a lot number for the second shot of EW0153. Stated that both shots were to the left shoulder. Caller stated that he received both shots and the first time he had a rash on both elbows like eczema and was bumpy and itchy on 09Apr2021 06:00. Stated that after the second shot it continued on both elbows and to the groin and belly area. Stated that it was clearing up and was not getting any worse. Stated that he had a wellness check on 28Apr2021. Stated that he showed the doctor his elbows. Stated that the doctor stated that it looked like psoriasis. Stated that the doctor told him that he could prescribe something. Therapeutic measures were taken as a result of events with Gold Bond lotion on it which makes the itching better. Event eczema (rash) both elbows were resulted in physician office. At the time of this report, the outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
Information has been received from the pregnancy registry from a physician concerning a 33 year old pregnant female with no pertinent medical history and no drug reactions/allergies who on 10-SEP-2006 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) at another health clinic. There was no concomitant medication. On 10-SEP-2006 the patient was 4.5 weeks pregnant at the time of her vaccination with varicella virus vaccine live (Oka/Merck). On 20-DEC-2006 an ultrasound was completed for dating/placenta placement. On 09-JAN-2007 an amniocentesis was done and the result was abnormal serum screen. No further information is available. Unspecified medical attention was sought. There were no previous pregnancies. It is unknown if the patient was not tested for varicella antibodies before vaccination with VZV containing vaccine. The pregnancy outcome was a live birth, female born on 24-APR-2007, birth weight 6 lbs, 10 oz. The infant was normal. During the pregnancy the patient experienced insomnia and was treated Phenergan 25mg 1/2-1/1 PO Q prn. In addition, during pregnancy, the patient was taking PNV 1/1 PO daily. There was no product quality complaint. Additional information has been requested.