chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day 1: Felt normal until the night.  Overnight developed a fever, nausea, muscle aches, sore throat, cough, Diarrhea   Day 2: Bed ridden - unable to work, get out of bed, do anything.  Diarrhea   Day 3 - Throwing up after meals uncontrollably. Able to get out of bed but still feel horrible. Diarrhea   Day 4- Day 7 (Current) - Lethargic, wake up feeling exhausted, Shaky, Mild Fever in the morning and at night, Nausea, Diarrhea . Have no energy.  Pre vaccine never felt like this before
11:27am vaccine given 0.5ml R deltoid IM 11:55am patient started complaining of R upper arm pain; reluctant to move arm - cold pack to injection site.  12:05pm patient complaining of shortness of breath; voice changes noted; shaking.  911 called. 12:07pm 1st dose of epinephrine pen given L thigh 12:12pm No improvement noted per patient statement 12:13pm epinephrine pen given R thigh - patient anxious, tearful; reassured by translator.   12:20 paramedics arrived and patient transported.
Moderate pain in the injection site (upper right arm) followed by severe fatigue, back ache,  and a slight fever (37.8 Celsius). Symptoms started 8 hours after the vaccination. No treatment other than strict rest and ibuprofen taken once (600 mg).
5 days after the shot- Body aches, headache. Mostly body aches in the legs, Same body aches that I had 24 hours after the shot. Ended up getting rapid and PCR tested- both negative. 6 days after the shot- body aches turned to sore and tired. 7 days after- gone.
Intense chest cramps. Seemed to be pericarditis... Pain went away but I went to the doctor with deep concerns over heart issues.
2nd dose of Moderna vaccine given too close to first dose - outside of recommended dosing spacing per CDC guidelines.  Gave a second dose vaccine to a patient who was only 3-weeks out from his first dose of Moderna.
diagnosed with COVID-19/tested positive for COVID; diagnosed with COVID-19/tested positive for COVID; she was tired; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.  A 58-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration in left arm on 17Mar2021 06:40 (at the age of 58-years-old) as single dose for covid-19 immunisation. The patient received first dose of bnt162b2 (lot: EL9266) in left arm on 22Feb2021 at about 07:30 (at the age of 58-years-old) for covid-19 immunisation. The vaccination facility type was stated that was like a wellness center, an urgent care, hospital clinic and the vaccine was not administered at military facility. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). There were no primary infection site, no predisposing factors, no culture performed and no antipyretic Use (around the date of vaccination). Medical history included did not have the best immune system and has some vitamin deficiencies. Concomitant medication included bamlanivimab. The patient's second vaccine was 23 days after the first vaccine. The patient received the second dose on 17Mar2021 and tested positive 20Mar2021 for the Covid virus. The patient stated that her husband tested positive for the Covid virus as well. The patient asked if she will need to get another vaccine. This Saturday (20Mar2021 at 18:00), they were diagnosed with COVID-19 and they were currently still battling it. The patient got the result on 20Mar2021 at 18:00, and describes as it got worse, but then it plateaued. The patient wanted to know if having COVID-19 at the time of vaccination lessen the efficacy of the vaccine. The patient wanted to know if she should take another shot because she has COVID-19 at the time of vaccination. The patient was not going to fill out her husband's report, she was tired. The height reported as 5 foot 1 and a half. The events did not require emergency room visit, no hospitalization as of yet. They gave her monoclonal antibodies at the Urgent Care. They scheduled that at the Urgent Care. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021336109 same reporter/drug/event, different patient
severe dizziness, constant tinnitus / ringing in ears, feeling of fullness in ears
Pt received Moderna Vaccines on 01/19/2021 and 02/16/2021. Pt came to the ED on 11/24/21 with complaints of AMS and hypoxia. Pt required supplemental oxygen and was found to be COVID positive.
fussy pm p/vax;T101.5 w/in 20hr p/vax;seen MD ofc w/in 24hr. exp episode of apnea;adm hosp- exp multiple sz 3 days p/ adm;transfer to another hosp on life support; sz cont for 48hr;dx meningoencephalitis, has permanent brain damage;Annual follow-up dated 10/2/00 states that the pt had neurological damage, cerebral palsy and global developmental delays.
Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a two-months old male patient who received a first dose of 0.5 ml of PENTACEL, lot C5324AC, exp date: 05-Sep-2019, via intramuscular route in the left thigh on 10-Sep-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. This was actual medication error case due to product preparation error (it was reported that a dose was given to a patient of the DTaP and IPV but the ACT-HIB was not given. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Went limp; Noticed the bottoms of her feet were red, swollen, and hot; Noticed the bottoms of her feet were red, swollen, and hot; Noticed the bottoms of her feet were red, swollen, and hot; Noticed the bottoms of her feet were red, swollen, and hot; She was still unresponsive; Retching; She had a fever of 100.3 at the time; Electrocardiogram normal; Turned grey; She was still unresponsive; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2555808-1. The original narrative from the sender is as follows:   At 8:45pm Pt started sounding like she was trying to vomit, turned grey and went limp. We rushed her to the ER at the medical center. When we got there, she was still unresponsive and she started to come to while we were being triaged. She had a fever of 100.3 at the time. We were sent to the waiting room; after an hour or two, she was fully alert and back to her normal color. We decided to go home and monitor her because there was a very long wait time at the ER and a lot of sick people and we were uncomfortable keeping her around that many sick people. Saturday morning, she had a fever of 103, we gave her Tylenol and it came down. She didn't have a fever the rest of the day. That afternoon, I went to change her diaper and noticed the bottoms of her feet were red, swollen and hot to the touch. She was then inconsolable for 4-5 hours and I spoke to the after hours nurse and the on call provider at pediatrics clinic and they said we needed to go back to the ER. We packed up and went to the hospital and they did a chest X-ray, labs, and EKG and all came back normal. They called it a brief resolved unexplained event.   The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Went limp", "Noticed the bottoms of her feet were red, swollen, and hot", "Retching, and "She was still unresponsive".  Due to the nature of the event, the causal relationship between Vaxelis and the events "She had a fever of 100.3 at the time", "Electrocardiogram normal", "Turned grey", and, "She was still unresponsive" is not applicable.   No further information is expected.
Four vesicles, R/thigh, at injection site. Tx: Benadryl 2.5 for pruritis.
Ot felt faint, cold clammy hands, sweating, pale, dizzy.
Large red, slightly raised area 4" x 5".  A second area 1" x 1" beside it. Patient denies itching or pain. Notice last night. Given 25mg PO x 2.
Breaking out in red itchy hives under each arm and along left flank.  Also some hives in groin area near lymph nodes.
Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Body aches). The patient was treated with PARACETAMOL (TYLENOL) for General body pain, at an unspecified dose and frequency. On 13-Mar-2021, PAIN (Body aches) had resolved.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up information received on 29 Jun 2021 contains non-significant information.
Hemodialysis pt recvd 1 dose of Engerix-B; 2 days later pt tested pos by acid neutralization for Hep B suface antigen & neg for anti-HBSAB antibody;
This spontaneous report was received from a healthcare worker refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # K002926, expiry date: 26-FEB-2016; lot # L016125, expiry date: 06-MAY-2017). Healthcare worker stated that the vaccine underwent a temperature excursion at 9 degree Fahrenheit for 666.5 hours. There were no previous temperature excursions. Healthcare worker confirmed that the vaccine was administered on unspecified dates before their expiration dates. No adverse effects were reported. This is one of the six reports received from the same reporter. Additional information has been requested.
103 fever and urticaria, given tylenol for infants At 8am 02/18/2022 had 'hives' on back, stomach, and arms; red spots; unknown if itchy Seems resolved now Breathing 'looked a little funny yesterday'-no wheezing 'or anything like that' but later mom said she seemed like trying to catch her breath but breathing fine Diarrhea on 02/17/2022 after vaccines
Left arm/Left shoulder pain, red, swollen warm, to the touch.  Upset stomach
15 minutes following vaccination, pt c/o "face burning and L arm burning". Pt given Benadryl 50mg PO x 1 at 1900. Pt was monitored, o2 sats 100% and HR 77 BPM. At 1922 pt's symptoms had not resolved and pt stated her legs felt like they were also "on fire". Pt sent to ER at at 1922 and she felt okay to drive herself when asked. Called pt at 2030 and she stated she left the ER and they said they couldn't really do anything for her even though she had heavy breathing but O2 was normal. She asked if it was okay to take Benadryl again. Told her she was given 50mg and to follow directions on the bottle if she would like to take it again later on if symptoms had not resolved. She voiced understanding.
3/6/14 (L) upper arm swollen and draining clear fluid. Given BENADRYL and Rx for prednisone.
This case was reported by a healthcare professional and described the occurrence of paresthesia in a 35-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). There were no concurrent medications. In November 2010 the subject received 2nd dose of HAVRIX (unknown). In November 2010, at an unspecified time after vaccination with HAVRIX, the subject experienced paresthesia (all over). At the time of reporting the outcome of the event was unspecified.
Pt recvd vax 9MAR91; mom reported 12MAR91 that pt had welts, hives, difficulty walking & moving extremities; tx included DPH; 13MAR pt turning "purple"; office visit required; marked purpura on buttocks, legs & ankles; tx Pred;
Pt had swelling, redness at injection site. Area warm to the touch. Pt at OB GYN office and MD informed her it was infected and started antibiotic therapy.
headache, excess mucus, fatigue, slight cough, difficulty concentrating, swollen neck glands, chills, fever (101 at highest), aching muscles.  Started Fri. afternoon (tested negative). Worst Saturday, slightly better Sunday (tested positive), improved Monday, Wed. (today) a few mild symptoms, no fever since Monday afternoon; tested positive again.
2 hr. post inj pt. c/o redness and pain rt. shoulder to elbow. Tx: 1 wk of Prednisone and TYLENOL and return in 1 wk.
Doctor appointment on Sat. Sept. 29, 2012. Pharyngitis caused by a virus. Very very bad sore throat that I feel in my ears and painful when I would swallow; could not sleep, throat drainage; temperature high; still have mild drainage.
Cold lower legs (rest of body and head felt hot), shooting pain left leg, throbbing left knee (though had broke that patella 6 years ago). Lightheaded at times (bending over or exertion).  Joint pain. Tired.These symptoms lasted on and off for weeks and months and continued after 2nd shot and booster.  Especially cold lower legs. During August, For about 10 days, the pain in left leg was so bad at times I couldn't put weight on it.  Mild fever for very limited time (couple days at most) Chest pain (not excruciating, but unsettling) and slight short of breath...... these started end of July and continue, though chest pain happens less often now. Not sure of Diagnosis or cause. No treatment other than some testing. Moderna second vaccine (lot 039B21A) was ON 4/30/2021 And Booster Moderna (lot 029H21B) was on 12/07/2021 (with some reservation. because of the chest pains and leg issues). And again, still, cold lower legs.  Have had  a few episodes of the chest pains, and have had joint pain.
patient developed a rash that appeared to look like a viral rash.  flat and red. not raised.  warm to touch.  rash went from right arm at injection site, to shoulder, front neck down to bra line, and posterior neck and down back to back of pants waist area. tender and painful.
no adverse reaction to vaccine, but tested positive for COVID on 9/30/2023 upon presentation to the ED with symptoms of  nausea, nonproductive coughing, rhinorrhea, congestion and generalized weakness.  Admitted to the Adult Care unit x 2 days due to her age, weakness, and mild hypoxia.
cough began 630PM 27JUN94 by 9PM had watery eyes & runny nose-c/o feeling bad w/cold sx today 28OCT94; states had similar react p/flu vax approx 4 yrs ago; non since & has taken it even year; t99;
Information has been received from a physician concerning a 7-year-old white female with no pre-existing allergies, birth defects, or medical conditions who on 01-MAY-2000 was vaccinated IM in the right leg with first dose of Varivax (Lot # 632049/1365J). There was no illness at the time of vaccination. On 31-MAY-2006, the mother brought the child to the physician for what she thought was a rash of poison ivy over her left leg which started about 72 hours prior to the visit. The mother was treating the rash with calamine lotion and TYLENOL for discomfort. The physician diagnosed the patient with clinical zoster. Vesicles were noted on the left buttocks and anterior left upper leg. There was a 50-cent sized patch of erythema with some slight vesiculation over the high buttocks stopping at the midline. There was a larger patch, perhaps 8x6-cm over the anterior left thigh, which contained some coalesced vesicles and then a few scattered vesicles down over the lower leg anteriorly. The patient walked well. There was no motor deficit. The remainder of the skin was clear. She was afebrile, alert, interactive, and nontoxic. No significant inguinal lymphadenopathy was noted. The physician provided the mother with mimix and adaptic dressing to put on the zoster. Subsequently the patient recovered from clinical zoster. There were no relevant diagnostic tests or laboratory data. No additional information is expected.
Rash, itching, pain throughout whole body. No treatment reported/For 4 months.
Patient was + covid first on 7-17-22 , expired on 8-1-22.  According to records had pneumonia , resp distress , abn cxr , cough, fever and chills and shortness of breath.   DX-   MYOCARDIAL INFARCTION SEPSIS COVID-19 __ CIRROHSIS, COPD
Pulled muscle that was very painful; Sore arm; Very tired for a few days; Fever; Headache; Increased feeling of dizziness; Worsening loss of balance; Feeling sleepy; bad strain on the left side; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE STRAIN (Pulled muscle that was very painful), PAIN IN EXTREMITY (Sore arm), FATIGUE (Very tired for a few days), MUSCLE STRAIN (bad strain on the left side) and DIZZINESS (Increased feeling of dizziness) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included PRAVASTATIN, LISINOPRIL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and FISH OIL for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced MUSCLE STRAIN (bad strain on the left side) and SOMNOLENCE (Feeling sleepy). On 23-Apr-2021, the patient experienced DIZZINESS (Increased feeling of dizziness) and BALANCE DISORDER (Worsening loss of balance). On an unknown date, the patient experienced MUSCLE STRAIN (Pulled muscle that was very painful), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Very tired for a few days). At the time of the report, MUSCLE STRAIN (Pulled muscle that was very painful), PAIN IN EXTREMITY (Sore arm), FATIGUE (Very tired for a few days), MUSCLE STRAIN (bad strain on the left side), DIZZINESS (Increased feeling of dizziness), BALANCE DISORDER (Worsening loss of balance) and SOMNOLENCE (Feeling sleepy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication include generic MEDROL dose pak.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: reporter details  .new concomitants ,events were updated.Route of administration was updated On 27-May-2021: TCR form, patient has no email or fax. Son will call on her behalf.
Starting yesterday afternoon my child got a nasty rash on her back and bottom, and the injection site swelled, fevered and turned beet red. Her doctor's office was contacted, they told me just keep an eye out. The rash continued to spread up the back and the leg became more inflamed. She became agitated, restless, irritable and couldn't sleep. She woke at 4 am the day before, and didn't sleep until 1230 am the following day. She sobbed inconsolable in pain with her back arched from 9-11 pm. This has never happened in her life. She woke at 6. The leg is still swollen, rash is still visible, and my child is still irritable and acting unlike herself.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This initial study case was received from the investigator in a trial on 24 October 2014. A 21-year-old male subject, with no reported medical history, received the following vaccines on 09 January 2014: ACAM2000; Typhoid, ViCPs; ANTHRAX VACCINE (1) (other manufacturer); MMR (2) (other manufacturer); lot numbers, routes, and sites of administration were not reported. On 21 January 2014, 12 days post-vaccination, the subject was diagnosed with subendocardial infarction and non-specific myocarditis. On 29 January 2014, 20 days post-vaccination, he was diagnosed with unspecified disease of the pericardium. An echocardiogram was normal. Outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
1st shots 9/21/06, crying x 3 hours ER visit DR said constipated and gave enema or lax ok afterwards per dad.
Fever, body aches, headache, daughter fatigue, arm pain. Arm pain started and still continues at time of this report. Fever was noticed the morning after receiving the vaccination and led to a much earlier wake-up than usual. Fever was roughly 100 degrees F. Patient took 1g acetaminophen to address headache, which is typical as patient takes NSAIDs regularly to address headache. Fever went down to 98.5 within a few hours, returned to 99.5 by afternoon. Patient took another 1g of acetaminophen and fever was down to 97.5 by evening. Side effects led to patient functional ability being significantly reduced for the day.
Swollen axillary lymph node in left arm, extending from axilla down side and back
On the same day after injection, I felt muscle pain around the injection site in the arm and difficult to sleep at night  due to the pain. From yesterday, my mouth lip (upper left) started swelling and became worse today. I feel difficult to open mouth and eat food.
PATIENT HAD FIRST DOSE OF MODERNA VACCINE ON 9/15/21, AND DEVELOPED CHEST PAINS AND DIFFICULTY BREATHING. PATIENT WENT TO CAMBRIDGE MEDICAL CENTER DUE TO HER SYMPTOMS.
12 hours after injection, developed swelling at injection site that increased over two days to be about 1 1/2 inch in diameter that slowly decreased over 1 week.  Developed muscle pain in left jaw, left neck, left chest for two days.   Itching at site of injection lasted about 2 weeks.
At site of DTAP vaccine, within 5 minutes, developed localized swelling, red, and puritis. Rx with Benadryl po.
W/in 20 min of 5th DTP, pt devel episode of hypotension & pallor w/loss of muscle tone; pt was undergoing fingerstick for CBC, placed in Trendelenburg position given fluids until normal color, BP was noted p/approx 20 min;
This report was received from the investigator in the trial on 20 May 2010. Additional information was received on 24 May 2010 from the investigator. A 29 year-old male subject whose medical history was not available received the following vaccines: ACAM2000 (lot number not reported) on 18 December 2008; and anthrax vaccine (other manufacturer and lot number not reported), and Hep B vaccine (other manufacturer and lot number not reported) on 09 December 2008. Nine days after receipt of smallpox, the subject was diagnosed with unspecified disease of the pericardium. Results of diagnostic testing were not available. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.
The pt experienced a rash at injection site and diarrhea, ear infection, runny nose, fever and cough.