chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Morning after receiving vaccine, awoke with severe malaise, fatigue, aches and fever of 101. These symptoms continued and worsened throughout the day and at 5:30 PM fever shot up to 104.7, at that time I took 600mg of ibuprofen, then 30 minutes later began to feel face and eyelids burning, fever now 106.4. I undressed and used cool clothes in armpits and fever began to come down gradually. The following day had temp of 100.-100.4 all day, and other symptoms had subsided. Then on 3/9/21 began to have right leg pain that 5 days later when rash appeared was diagnosed as shingles. I had never had an outbreak of shingles before.
Headache, Fever, NauseaVomiting, Local Symptoms: Pain- discomfort. General Symptoms: Fever, headaches, fatigue, nausea.  Narrative:
Vomiting several times a day causing burning sensation in chest and across both shoulders, muscle stiffness in left and right arms, right chest pain.
Shortly after receiving second dose vaccine, she begin to have a fever and headache.RN recommendation is for patient to cont Ibuprofen for headache, if headache cont. beyond 48hrs,  please make an appt. with her PCP.  She was agreeable with recommendation.
pt says the next day after taking the vax when he woke up next day he had a low grade fever, chills, fatigue, and left arm is sore.  Pt says he is taking Tylenol as well as his Naproxen for the pain.  He said his symptoms are getting better.
Approx 2 wks ago, exposed to chickenpox. 2 hrs post/vax, started to break out, temp started to go up from 99, then at 6:30, to 108, within 1/2 hr. Taken to ER by EMS, but had a seizure before their arrival. ER checked for Pneumonia.
Patient c/o intense shoulder pain and neck pain post vaccine. MD evaluated 48 hours post vaccine. Supportive care recommended.
Patient was given a second dose.   Had previously received on 10-1-2015 at another facility, but indicated they had not  been given one.
lt arm red, swollen, & hot from inj site in deltoid to elbow;warm pack placed to arm next AM p/inj;
Pt recv vax on 4/19/99; 1 hr post vax pt exp fever, shaking chills, nausea, headache, sharp shooting joint pain x 3 hr
Has bronchitis; A spontaneous report was received from a consumer concerning a 67-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bronchitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the event, the patient received their dose of mRNA-1273 (Batch Number: 025S20A or 025520A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced bronchitis.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event bronchitis was not reported.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
12/16/20- body aches, chills. congestion, stuffy, runny nose, occasional cough from drainage, fatigue 12/17/20- congestion, stuffy, runny nose, some cough and drainage.
Tight knees and weakness in legs. Causing knees  to buckle resulting in a fall
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  On an unspecified date in Mar-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) frequency 1 total, dose was not reported, administered 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 an unspecified date in Jun-2021, the patient experienced suspected covid-19 infection. The patient stated that she still had symptoms four weeks after getting COVID while working (suspected covid-19 infection). On an unspecified date, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210708714- covid-19 vaccine ad26.cov2.s -Suspected vaccine failure, suspected covid-19 infection. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
passed out/ woke up on the bathroom floor.; only received one dose; cramp behind her leg; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out/ woke up on the bathroom floor.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out/ woke up on the bathroom floor.) (seriousness criterion medically significant), PRODUCT DOSE OMISSION ISSUE (only received one dose), MUSCLE SPASMS (cramp behind her leg) and PAIN IN EXTREMITY (arm was a little sore). At the time of the report, LOSS OF CONSCIOUSNESS (passed out/ woke up on the bathroom floor.), MUSCLE SPASMS (cramp behind her leg) and PAIN IN EXTREMITY (arm was a little sore) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (only received one dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Electrocardiogram: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  After the patient received her first dose her arm was a little sore but two days later she passed out in her house.  She got up in the early morning, remembers going into the bathroom woke up on the bathroom floor.  She was not sure how long she was on the floor.  When she woke up she crawled to her bed.  She went to the doctor two days later and they did an electrocardiogram (EKG) and it came back normal.  She also mentioned she had a cramp behind her leg the night she was in bed and then passed out.  The patient was scheduled for the second dose but appointment was cancelled by the facility and the patient doesn't want to get the second dose after what had happened in the first dose administration.  No treatment information was provided.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
I had a rash, my chest tightened up, I had a very bad headache for 3 days, a fever, my body ached all over, diarrhea and decreased of appetite.
A non serious spontaneous report of "administration to a child of 1 year and 11 months of age" was received from a registered nurse concerning a 23- month old male patient. No medical history or medication history was reported for this patient. The patient received FLUMIST on 15-Oct-2008. The patient will not be turning two until 02-Nov-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
tingling in face, muscle  pain right thigh, chills, fever, elevated heart rate and blood pressure
This spontaneous report was received from a pharmacist refers to a 67 year old male patient. No medical history or drug allergies were reported. On 07-OCT-2013 the patient was vaccinated with dose 1 of ZOSTAVAX, subcutaneously. Concomitant therapies included GLUMETZA, ALTACE, COREG, aspirin, PLAVIX and niacin. On 11-OCT-2013, the patient experienced lip swelling, which went away on an unknown date in 2013 with use of BENADRYL. On an unknown date in 2013, the lip swelling returned along with numbness and tingling in his lips and gums. It was reported that the numbness and tingling goes up the patient's ear and nasal passage. Laboratory tests performed were reported as none. The outcome of the recurred event of lip swelling along with numbness and tingling on the lips and gums and the numbness and tingling reaching up to the patient's ear and nasal passage was reported as not recovered. The relatedness of the events with ZOSTAVAX was not reported. Additional information has been requested.
My sinuses were burning really bad, I had thought it was from the dry air and cigarettes from being in a dry climate. A couple of days later I got a sore throat and cough. I did an at home COVID-19 test that came back negative. After a couple of days of feeling bad and my at home COVID-19 test coming back negative I went to the doctor. My doctor did a rapid COVID-19 test that came back positive. He prescribed me some benzonatate for the cough. I started to feel better in five days and tested negative on 06/0/2022.
Redness and swelling (entire length of upper arm to elbow-larger than the size of a tennis ball); lots of pain; warmth.
18 minutes after receiving vaccine, I became dizzy, hot, and nauseous. Nurses put me in a wheel chair. Heart rate was 55 and I was admitted into urgent care for monitoring.
This spontaneous report as received from a medical assistant refers to a 22-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On 30-NOV-2017, the patient was vaccinated with a dose of improperly VARIVAX, lot # M017292, expiration date 07-APR-2018 (route of administration was not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine experienced a temperature excursion of 23.2 degrees Fahrenheit for 8 hours. There were no previous temperature excursion reported. The digital data logger was involved in recording the temperature excursion details. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA002139: US-009507513-1801USA002137: US-009507513-1801USA002138.
Patient is a 96 y.o.  male to pass medically significant for Corey or disease, hyperlipidemia, hypertension, who presented after sudden onset of lower extremity weakness. Patient reports that last night that he suddenly felt heavy and that he couldn't stand.  He managed to gently take himself down to the floor. He wasn't able to get up. He feels that both his RUE and RLE are weaker.  he denies change in vision, changing speech or loss of sensation. He was found to have UTI , he uses a super pubic character for urination. Denies any sensory symptoms including saddle anesthesia. Denies back pain.   Had 2 booster on 4/6/22.
Employee reported hives, chest tightness, rash, pruritus and lip tingling 2 hours post injection.  She was given Benadryl 50 mg IM at 1117
This spontaneous report was received from a healthcare worker refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # K010224, expiry date: 13-MAY-2016) orally (start date and dosage not reported). No adverse effect reported. No further details provided This is one of the several reports received from the same reporter. Additional information has been requested.
The next day, I had headache, fever, and felt like throwing up. I felt fine afterwards. I went to the doctor because I had an ear infection and it was really bad - 4/28/2021 - gave me some ear drops. The ear drops helped with it. I had the ear infection for about five or six days before I went to the doctor and it lasted three or four more days after I saw the doctor.
red and swollen at site, hard and warm to touch, child screams when you touch site.
This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 16-SEP-2017, the patient was vaccinated with an expired dose of with ZOSTAVAX, lot # reported as L00722, expiration date 03-JUN-2016 (dose, dose number, route of administration were not provided) for prophylaxis. On the same date, within 15 minutes of receiving the vaccine, the patient experienced some numbness and tingling on right side of head down to the cheeks, and redness at the site of injection. On 18-SEP-2017, the patient had a headache. At the time of report, the outcome of hypoaesthesia, paraesthesia, injection site erythema and headache was unknown. The causality assessment between the events and the vaccination with ZOSTAVAX was not reported. Lot number L00722 is an invalid lot number for ZOSTAVAX.
RECOMBIVAX 5mcg administered IM on 7/29/12 then again on 8/15/12.
Pt. left tent 9 to observation and started feeling lightheaded and heart fluttering.  Paramedics assessed EKG (PAC) on monito,  It subsided once patient relaxed.  Paramedics cleared pt. and let her leave,
Initial report received from a health care professional on 08 October 2013. The patient had received expired FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Had same reaction w/both shots...Left arm on 6/29/18, Right arm on 9/15/18. Slight ache in area of shot, progressing over the course of a week to shoulder, then upper back, front upper chest, then continuing to elbow and lower arm on top. Deep burning nerve pain. Pain lasted the first time for about a month, in my 2nd week of pain after the 2nd shot now. First time, they thought I might be having a heart attack and advised me to go to the ER, cardiac workout done, no problems found, referred to my PCP. She diagnosed me w/trigger pain in my uper back radiating to the other areas, referred me to PT for 4 weeks, and a lidocaine injection(never got the injection as the doc couldn't get me in for a month and pain was improving by then. She also prescribed me Flexeril, but that gave me no relief, neither did Tylenol or Motrin. After 2 weeks of PT it was improving, but wasn't sure if it was just time or the PT that helped. I was discharged from PT after 3 weeks when it was feeling a bit better. Kept asking if it could be vaccine related and ER doc, PCP, and PT all said probably not, because it wasn't immediate. Forgot all about it, until I got the 2nd shot, then realized it was starting all over again on the other side. Since nothing helped before, this time I told my doctor about it, but am just doing the PT exercises on my own and using heat which either masks it, or helps relieve the pain a bit. Never had a reaction to any vaccine previously.
Lump at injection site, left arm. Doctor prescribed Cephalexin 500mg oral, 4 times daily for 10 days.
About 7 days after injection, injection site became reddened, about 3? in diameter and itchy with slight ache - much like the 48 hours after the injection, but that had resolved within 48 hours of receiving injection.
Severe posterior headache and lower midline back pain. 68 yo female with PMH cognitive changes since admission for Sepsis (6/2020), chronic headaches, right sided HL, GAD, NA fatty liver disease, Osteoporosis p/w headache back of her head after receiving the COVID immunization.  Per Daughter CO reported feeling unwell while leaving the vaccination clinic. They wet back to the clinic and CO laid down for a while and was given a snack. She then reported she felt well and wanted to go home. Between the clinic and the car she felt unwell again and was directed to the ED.  Per CO HA at back of head along with mild dizziness initially. Dizziness has now resolved.  She took Tylenol at 1100 today for HA but does not remember if she took any more Tylenol since then. CO does not remember when she last ate. Per Daughter she last ate at 1030 today. She was supposed to have lunch at one but someone forgot. CO has a family member with her at all times since her cognitive impairment this past summer. She reports regular HAs are usual for her ever since her "brain injury" (CO hospitalized for Sepsis July 2020) Denies dizziness, denies visual changes, no photophobia. Given Acetaminophen and some food. RBS: 94 CO reports that the headache is now at the front of her head.  CO eating a sandwich, calm, in a good mood. Feels much better. Headache resolved prior to discharge.
7/19/2022 - @545pm received booster                             @ 6:30pm chills, body aches, headache 7/20/2022 -  chills, body aches, headache, 103 fever, left arm small tingle, left leg feels like losing circulation when bent 7/21/2022 - NO CHILLS, BODY ACHES OR FEVER ; headache still present, small tingle in left leg starts at knee then ankle then hips (does not stay all day, does go away but comes back), dizziness and fast heart rate 7/22/2022 - no changes from 7/21/2022 , all symptoms still present
Pt received shot on 6/28/21. Pt's grandmother contacted pharmacy on 6/30/21 stating patient had broken out in hives over her face and hands. Pharmacy advised to start taking Benadryl for the hives and to not get the second shot due to concern the allergic reaction could escalate. Grandma will follow up with pharmacy in 24 hours to update on pt's condition.
A few minutes after the patient had received her vaccine, her mother came up to the counter and stated the patient was not feeling well. The patient was nauseous, pale, and dizzy. She was sitting in a chair. I put an ice pack on the patient's neck and wrists. After 5 minutes or so, she started feeling better. I gave her some water. Within 15 minutes, she was feeling back to normal and the color had returned to her face. Her mother stated the patient has had this happen before at the doctor's office due to anxiety around immunizations. Patient and her mother waited around 20 minutes before leaving. Patient was back to baseline before leaving the store.
Fatigue, lightheadedness, achiness, left arm soreness and pain at the site for 48 + hours.
Patient had 30 minute observation period and departed. Returned approximately 15 minutes later (45 minutes after vaccine) c/o rash on back, chest and legs. No angioedema, lungs cear 16:15BP 194/116 P101 R 19 O2 100% Benedryl 50mg Transfer to EMS, to ED.
Patient developed headache, nausea and palpitations 02/12/22. Palpitations continue intermittently lasting 5-10 min.
Three and a half months after vaccination, I started having a cough, runny nose, and fever (did not measure). I took a home Covid test on 5-8-2022 and it was positive. I then went to the Hospital on 5-9-2022 and had a positive Covid test. I had it at the lab, no ER visit. I took no medications for the positive Covid result. I am alot better today with no symptoms. I am reporting my breakthru case of Covid.  .
12/30/2020 about 7 pm started with head,body aches 12/31/2020  Nausea, body aches, headaches fatigue sore arm cannot lift (R)
pt recvd vax; exp fever approx 24 hrs after vax; febrile szs x 2 36-48 hrs after vax; irritability x 4-5 days, began 24 hrs after vax; rash x 5-6 days; scleral injection bilaterally 6-7 days; tx w/ IV & atb to r/o sepsis;
This spontaneous report as received from a registered pharmacist refers to a male patient of unknown age. On approximately 20-DEC-2014, "about one and a half week ago", the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported that beginning on an unspecified date in December 2014, the patient developed shingles-like rash. The patient was prescribed unspecified antiviral therapy as treatment. The outcome of shingles-like rash was unknown. Additional information has been requested.
coughing up flehm; throwing up; dizziness/light headed when stands; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing up flehm), VOMITING (throwing up) and DIZZINESS (dizziness/light headed when stands) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (coughing up flehm), VOMITING (throwing up) and DIZZINESS (dizziness/light headed when stands). At the time of the report, COUGH (coughing up flehm), VOMITING (throwing up) and DIZZINESS (dizziness/light headed when stands) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications are listed. The Patient is scheduled to receive her second dose of Moderna Vaccine on 12Apr2021 at 3:00
Went to school from office accompanied by mother. When got to school had rash all over. Stated when at school, throat started to close, 911 called, taken to ER by ambulance.
Erythematous macules and papules on face, chest, abdomen, and back. None of arms or legs. Woke up with the rash the morning following the vaccine. Itchy. No pain, no fever, no congestion, no runny nose.
Per mom, on 11/13/10 2 pm, child felt hot, tired, in pain and had difficulty breathing. Mom gave 2 puffs of her own albuterol inhaler, child slept and woke up better.
Absence & Tonic Clonic Seizures & blackouts, memory loss, sleep walking, excessively fatigued & stressed, confusion, unexplained stiffness & soreness, irritability, anxiety, shaky hands & repetitive hand motions, acne, complains of being cold even when room temp is 74 degrees, sinus infections, vision problems, 1 hallucination. She was diagnosed with Epilepsy 10-19-11. Neurologist gave no info with the diagnosis. 2nd Neurologist we saw said that the Epilepsy was caused by a genetic mutation and told her that she needed to have an eye exam after looking at her eyes. She is now seeing a 3rd Neurologist & taking Lamictal XR 300mg twice daily & Aptiom 600mg once daily. She has had a few break-thru seizures even while taking her meds.
Itchy Eyes, Red Raised Bumps around Eyes, Scratchy Throat & inside  ears, wheeze & tightness when breathing , itchy neck red face, started around 1 hour 45 minutes after injection
Patient reportedly fainted after receiving the flu vaccination. She regained consciousness within a few seconds per my technician that administered the vaccine and the mother. When I came into the pharmacy she was completely alert and able to talk with me. She stated she was scared of needles and had just watched her mother and then her vaccine was too much. I had them wait out in the pharmacy to make sure she was still good and offered water or crackers to help her out. They left with no further issues.