chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NAUSEA; LOW GRADE FEVER; BODY ACHE (AROUND THE NECK); CHILLS; HEADACHE; This spontaneous report received from a consumer concerned a 49 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 31-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021 23:00, the subject experienced body ache (around the neck). On 31-MAR-2021 23:00, the subject experienced chills. On 31-MAR-2021 23:00, the subject experienced headache. On an unspecified date, the subject experienced nausea, and low grade fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, body ache (around the neck), chills, low grade fever and nausea was not reported. This report was non-serious.
This spontaneous case reported by a consumer, describes the occurrence of mild pain, very mild dizziness and balance disorder (trouble of equilibrium) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 039B21A and 048A21A) for COVID-19 immunization. Concurrent medical conditions included heartburn. On Mar 17, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 14, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 15, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient had mild pain. On an unknown date, patient experienced very mild dizziness and balance disorder (trouble of equilibrium). At the time of the report, mild pain, very mild dizziness and balance disorder (trouble of equilibrium) outcome: unknown/not provided. The reporter did not provide any causality assessments, concomitant medications or treatment medications. This case linked to MOD-2021-053448 (patient link).
This spontaneous report as received from a nurse refers to a 3-year-old male patient. The patient had no pertinent medical history, drug reactions or allergies or concomitant medications. On 23-APR-2019, the patient was vaccinated with M-M-R II lot # R024907, expiration date: 30-AUG-2020, subcutaneously (dose was not reported), for prevention of measles,mumps and rubella which was reconstituted in sterile diluent (STERILE DILUENT), lot # S002623, expiration date 28-OCT-2021. On 01-MAY-2019, the patient experienced seizure lasting 10 to 15 minutes. On the same day, the patient recovered from seizure. The patient sought medical attention by calling a physician. No treatment was given for the event. No lab diagnostics or studies were performed. The causality assessment was not provided. Upon internal review, the event of seizure was determined to be medically significant.
45 minutes after the shot, patient felt "sicker than a dog", puking with a headache.  Patient laid down and slept for 4 hours.  Patient woke up, her left leg was tingling with heat waves going down the left leg.  Her left side was droopy including her face and arm.  She went to the ER and they sent her to a larger hospital thinking she was having a stroke.  Symptoms resolved by the next day
Pt broke out with raised rash on neck, trunk & facial area. Pustules present, but not open. Eyes red & blood shot. Taken to hospital 10/24/11 - started on DURACEF & gentamycin. Patient not getting better rash getting worse & eyes not clearing. Taken to doctor, optometrist. Started on TOBRADEX. Taken to MD again started on prednisone. Rash still visible but fading with time.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 05-JUL-2017 the patient was vaccinated with GARDASIL 9 lot # N004799 dose 4 for prophylaxis. On 05-JUL-2017, 1 year 1 month 27 days after onset of therapy the patient experienced extra dose administered. On an unknown date the patient experienced no adverse event. The outcome of extra dose administered and no adverse event is unknown. The reporter considered extra dose administered and no adverse event to be not related to GARDASIL 9.
Patient called today (12/18/2018) to report since getting the 1st dose of SHINGRIX on 06/10/18 he had mobility issues. He said he had a scan done and a micrographic report showed that the vaccine had hit a nerve and that was the cause of the mobility issues.
4-5 hours after vaccine asministration, child developed a rash on the face.  Pediatrician notified.  Instruced to observe child.  Respirations OK, Behaviour as usual.
After I administered the ZOSTAVAX vaccine, I noticed the vaccine was expired by 5 days.
Information has been received from a registered nurse concerning a 18 week old infant who was vaccinated on 30-NOV-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product complaint involved. Additional information is not expected.
Gi problems , loose stools up to 10 a day  . stomach pain  . hand and leg pain . fatigue
inadvertently administered an expired dose of Shingrix to a patient yesterday; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number LG2XJ, expiry date 10-SEP-2023) for prophylaxis.   On 15-OCT-2023, the patient received Shingrix. On 15-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired dose of Shingrix to a patient yesterday). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 16-Oct-2023 The registered pharmacist reported that street address provided was in adverse event form but might be the same as in health care professional's contact record. The reporter consented to follow-up. The patient received an expire dose of Shingrix, which led to expired vaccine used.
Myalgia PAIN IN RIGHT ARM, NECK AND UPPER BACK  Narrative:
p/vax rt arm swollen-hot all way to elbow-pain;to ER given ATB x 7 days;
Patient hospitalized due to breakthrough covid-19 infection on 7/24/21 with complaints of cough, SOB, generalized weakness, myalgias, fevers, chills and lightheadedness x 1 week. Patient was pronounced deceased on 7/25/2021 @ 8:52am. Patient completed the Moderna vaccination series in March/April. Information below is copied from the discharge summary:   Summary of stay below:   PNA present on admission- COVID 19 - cap - CXR bl infiltrates - high risk - o2 supplement, bipap at max settings, DNR - therapeutic ac renally adjusted -statin -recommended voluntary prone positioning 8hrs per day - solumedrol bid -procalcitonin elevated given abx for pna  -borderline benefit for remdesivir, given    Acute respiratory failure w hypoxia - setting of PNA - o2 supplement - as above    Sepsis- sec to above - cultures were negative  - lactic acid 6-2 - ivf for hydration given     HTN- fairly controlled -  home meds   Hypothyroidism -synthroid    BPH - flomax
pt vax'd w/3 doses hepatits B vac & experienced after each dose tiredness, light-headedness,weakness, & nausea.
do know 3 other women who developed breast cysts after a Pfizer vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: BREAST CYST (non-serious), outcome "unknown", described as "do know 3 other women who developed breast cysts after a Pfizer vaccine.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101193629 same reporter/product/event, different patient.;US-PFIZER INC-202101193630 same reporter/product/event, different patient.
Vomiting, diarrhea, chills, muscle soreness, nausea, dizziness, and sore arm  These symptoms started in 21 hours after I had taken the second vaccine. They lasted for about 12 hours.
For 48 hours I experienced pain at the injection site, aches of the entire body, fatigue, and low-grade fever. After 48 hours only the pain at the injection site persisted for another 3 days. I was previously tested positive for Covid-19 in early January with symptoms starting on 12/29/20.
fever last PM p/receiving vax; sleeping in parents/bed; 630AM pt was sitting up, jerking & eyes began rolling back; no emesis, cyanosis; parent took pt into showere jerky movement stopped;
When I caught COVID-19 I had mucus in my throat, and I had a little coughing. A couple of hours later I felt tired. I had a little headache. The next day I felt relatively okay. I just had some intense sneezing and coughing for the first couple of days. In the middle of the day I had joint pain, a headache, and fatigue. I called my doctor, and I was prescribed paxlovid. I had mostly coughing and sneezing for a couple of days. I also had a little fatigue but nothing bad. After finishing paxlovid on July 4, 2022 I had a stuffy nose through that night. It got worse during the day. I had nasal congestion and more coughing. I had tested positive for COVID-19 again. A couple days after that I felt fine. After that I had an occasional soggy throat and cough. My joint pain went away after that as well. I had a never had a fever. I used some saline nose spray and congestion nose spray. I also took Advil.
Fever up to 100 degrees, chills, body aches, lasting 3 days.
female child received a dose of expired Ipol / no AE; Initial information received on 14-Jul-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 years old female patient who was vaccinated with once 0.5 ml third dose of expired vaccine IPV (VERO) [IPOL (lot number unknown ) Expiry date-May-2020 via unknown route in the left thigh on 14-Jul-2020 for Prophylactic vaccination.  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications were also not provided.  It was an actual medication error case due to expired vaccine used.  No reported side effects.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  There will be no information available on the batch number for this case.
pt exp swelling & redness & tenderness tricep & elbow area; beginning approx 1 day p/pt recvd vax;
Heart flutters and tickling in bronchial tube for several hours.  In the past when I had this reaction to a different combination of medications, it progressed to spasms and I couldn't get my breath for several minutes.   My reaction to the covid vaccine didn't progress to that degree, so I didn't report it.  A friend suggested that I contact you to see if it is safe for me to take the second shot since the reaction is often stronger after the second dose.  I am scheduled to receive that second shot Monday. My only other reactions to the first dose were chills and fatigue, and minor soreness at site of injection.
A couple weeks after the shot I was getting pain in my leg and butt. Muscle pain in my back.
Pt. developed bilat numbness tingling hands/feet (digits), then poor focus , HA, 2d later, (L) cheek swollen, (R) facial droop, (R) side of tongue tingling: slurred speech. Seen at ER 11/2/11 & admitted & evaluated also HTN, presumed Guillain-Barre.
Fever lasting 2 weeks, but most importantly leg/joint pain a day after shots. Child began kicking legs and becoming restless at night complaining of leg pain, could not pinpoint exact spot but rather and all over pain in both legs (top/bottom). It is now October and child has complained every single night since her immunizations took place.
arm pain / really sore arm / uses his arm a lot because he does a lot of physical work; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) (batch number 3NY5G, expiry date 7th March 2021) for prophylaxis.   Concomitant products included fluticasone furoate, vilanterol trifenatate (Breo Ellipta).   On 25th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient himself. The patient mentioned that, he was on Breo ellipta and he did not state that his condition had worsened or that he experienced any adverse event while using the Breo ellipta. The patient received 1st dose of Shingrix in his left arm and experienced left arm pain that lasted for 8 to 9 months. The patient had a really sore arm and because of the arm pain, he had never received the 2nd dose. The patient was claiming that, he uses his arm a lot for physical work and therefore, he elected not getting the 2nd dose. The reporter consented to follow up. The batch number was updated from 3MY56 to 3NY5G, as per the sales data sheet.  Note: The 2nd dose was not captured as suspect for 'incomplete course', as the patient didn't want to take the 2nd dose due to medical reasons.
Patient received his immunization about 11:15 am.  He was sent to the observation area.  about 1:10 pm the nurse informed me patient had developed a rash on the left side of his face.  I administered Chewable Diphenhydramine and kept patient for 30 minutes of further observation.  Patient improved and was discharged to his home.
Facial/lip swelling,chills, body aches, some difficulty breathing. Hives on neck and trunk. Took benadryl,24 hr. swollen face/lips. Report To regular Dr. told pt continue benadryl.x 1 week hives on trunk, flare-up Asthma.
LYING ALL THE TIME; SEVER HEADACHE (FELT LIKE HEAD IS GOING TO EXPLODE AND BLOOD VESSELS WERE BREAKING IN HEAD); This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: 23-AUG-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced lying all the time. On 06-MAR-2021, the patient experienced sever headache (felt like head is going to explode and blood vessels were breaking in head). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lying all the time, and sever headache (felt like head is going to explode and blood vessels were breaking in head) on 09-MAR-2021. This report was non-serious.
Patient states started itching a few hours after receiving the shot but didn't think anything about it. Later, noticed small red bumps/blisters covering most of body and began coughing. Went to an urgent care facility and received a shot, oral medication and a Rx to take medication for several days.
Starting with redness and pressure in right eye, then pressure in upper jaw and ear. Diagnosed as sinus infection at doctor's visit. Z-Pac and antibiotic eye drops were prescribed and currently taken.
I noticed patient was covered in petechiae and bruises that were popping up like crazy.  I called pediatric hematologist and headed to the ER right away.  Platelet count was found to be 7,000.  Returned to clinic on 7/25/11, 8/1/11, 8/9/11, 8/18/11 (received IVIG infusion), 8/19/11(had to return to clinic for side effects of IVIG including high fever, severe headache, and pain.  Was given IV fluids, pain medicine, and started on oral steroids.  Followed up 8/31/11, 9/12/11, and 9/28/11 for blood count checks.
hernia; anemia; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer sponsored program. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got his first dose but then was diagnosed with a hernia and had to have emergency surgery with a blood transfusion for anemia.  Therapeutic measures were taken as a result of hernia which included surgery and anemia which included blood transfusion. The patient's second dose was due today and the reporter asks if he should get it or if should be delayed due to getting transfusion. The outcome of the events was unknown.  Information on Lot/Batch has been requested.
Mom called to report a rash about 48 hours post vaccination with Pfizer COVID vaccine. Reported that patient received the IMZ in left deltoid at about 6pm Thursday 11/18/21. At about 10pm Saturday 11/20/21 patient showed her a rash on her RIGHT arm and RIGHT leg. Described as red dots in a line from shoulder to elbow and hip to knee. Overnight a few more had appeared in each area.  Each compromised of 10-12 "dots". Mom denies any report of itching, burning, erythema, involvement of the chest, jaw, lips or tongue or difficulty breathing.  Recommended monitoring, diphenhydramine for worsening localized reaction and inform doctor in morning
12 hrs p/vax 3rd dose pt devel abd cramps w/episodes of diarrhea x 2 days, t100.4, sneezing, runny nose, lightheaded x 3-4 days; nausea, chills, h/a, pain in rt deltoid area;
third shot of Moderna, 2 Pfizer shots previously; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (third shot of Moderna, 2 Pfizer shots previously) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Immunocompromised.   On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to at an unspecified dose. On 30-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (third shot of Moderna, 2 Pfizer shots previously). On 30-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (third shot of Moderna, 2 Pfizer shots previously) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment history was reported.  Patient took modern third dose on 30 aug2021. One of the patient got their 2 shots of Pfizer previously, 2nd Pfizer shot on 25 aug2021, and took modern booster after 5 days.
Tingling and numbness, pins and needles in my hands and lower arms. Not weakness. Just asleep all the time. Started day after vaccine and is still ongoing. It has not gotten any better, if anything it?s worse.
Had sot at 4:00 PM about 10:00 PM started getting severe chills. Didn't stop seemed to be getting worse so I called ask for nurse she said take 2 TYLENOL. I went to bed woke up at 1:30 running fever 102.1 took 2 more TYLENOL went back to bed woke up at 7:00 tem was 100.2.
Extreme pain in arm and part of back; Extreme pain in arm and part of back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Extreme pain in arm and part of back) and BACK PAIN (Extreme pain in arm and part of back) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (Extreme pain in arm and part of back) and BACK PAIN (Extreme pain in arm and part of back). At the time of the report, PAIN IN EXTREMITY (Extreme pain in arm and part of back) and BACK PAIN (Extreme pain in arm and part of back) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that it was just a little pain and that he was fine. No concomitant medications were provided  by the reporter. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: TCR Added. Event outcome updated. Consent for further FU was declined by reporter.
Headache and vomiting for 2.5 days -symptoms resolved without additional treatment.
Patient says he cannot raise arm easily above shoulder. He had not come by earlier but does say it's getting better. He demonstrated that he could raise his arm but said it had mild pain.
This is a medication error.  Directed to complete VAERS.  Marcelina came in to get 2nd dose of Moderna vaccine. She accidently received the pfizer vaccine instead.  no adverse reaction at time of observation at covid clinic.