chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's medical history information was not provided.  Concomitant products included SERTRALINE and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 03-Apr-2021. On 14-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 14-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Moderna COVID-19Vaccine  Injection site became hard, red, swollen and itchy 9 days after vaccination.  Same symptoms, though milder, persisted through 2/11 i.e. 10 days after vaccination. I am completing this form on behalf of my husband, who has vision problems.  We got our vaccination at the same time and place.  I had exactly the same symptoms at the same time, i.e. 9 and 10 days after vaccination.  (I don't plan to fill out a second report for myself - sorry!)
Immunizations given were part of a temperature excursion, no know adverse side effects known at this time.
dizziness, headache, nausea, "puffy thoat", BP 123/59, O2 sat 100%, HR 70
BOOSTRIX was given. INFANRIX was the immunization that was needed. No symptoms or adverse reaction.
COVID-19 antibody test negative for antibodies; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION FAILURE (COVID-19 antibody test negative for antibodies) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION FAILURE (COVID-19 antibody test negative for antibodies). On 03-Mar-2021, VACCINATION FAILURE (COVID-19 antibody test negative for antibodies) outcome was unknown.            Concomitant product used was not provided by the reporter.  Treatment information was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
patient was administered expired Pentacel vaccination, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional (medical assistant)(Reference number- 00669947) and transmitted to Sanofi on 06-Jul-2021.  This case involves a four month old patient (gender not rpeorted) who was administered an expired dose of suspect  DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 05-Jul-2021, the patient received a 0.5 mL expired dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE  (lot number: UJ334AA; expiry date: 17-JUN-2021) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  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 the 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.
Patient reported large red, hot area where pneumonia vaccine given. Fever of 105. Pt seen in local emergency room and diagnosed with cellulitis.
day p/vax pt had fever of 102 w/a sore arm, it lasted until next day;the school brought it to the nurse attention as seeming more significant than other students;took APAP during this time;
felt a lump and warmth at the injection site on 09/28 in the afternoon and 09/29 there was redness.
Sore arm within 6 hours of vaccination. Fever, chills, and body ache after waking up at 5am the following morning (3/31). Fever rose to 100.8 as indicated with ear thermometer and lasted until the morning of 4/1. Mild body ache and discomfort lasted until morning of 4/2.
Dizzy spells and fainting. No warning that it is coming and happens at random times of the day. One or twice daily thus far.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-AUG-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated by a family physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Local reaction, swelling (L) arm. Mild local warmth. Seen by covering MD. Rx with BENEDRYL 50mg PO BID, Prednisone 10mg PO qd x 3d then 1/2 tab x 3d. Cold compresses. Ibuprofen 600mg Bid.
4th day after vaccine(2/8/21): moderate headaches, tightness in chest (without difficulty breathing), higher than usual blood pressure (20 points higher systolic),  Continued through the 8th day.  After 8th day (on 2/12/21): BP returned to normal, headaches and chest tightness ceased.
Painful joints - ankles, knees, hips, shoulder, elbows, wrists, and fingers Fatigue Painful swelling of lower legs and ankles
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 03-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
client felt like heart was racing. EMT FD and RN did assessment on client. Witnessed someone else in observation begin to have a vaso-vagal reaction. Became anxious and sweaty. Taken to a cot in observation and feet elevated. Vitals checked and bp 150/92. HR 120. Rechecked vitals when away from situation in observation 5 minutes later and bp 153/93 and pulse 108. Client sat in cot for an additional 15 minutes. given juice and pretzels. Felt fine and refused further treatment.
Muscle aches; Also ran a temperature and didn't feel good; Flu like symptoms; Also ran a temperature and didn't feel good; Muscle aches in his arm for 2-3 days, which kind of radiated up into his neck and back of head; This is a spontaneous report from a contactable consumer (parent). This is Report 3 of 3. A 20-years-old male patient received bnt162b2 ((PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 26Aug2021 12:00 (at the age of 20-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing Neurofibromatosis (Verbatim: Neurofibromatosis, type 1 (von Recklinghausen's disease) diagnosed at 14 years old). There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0182) administered in left arm on 03Aug2021 11AM (at the age of 20-years-old) for covid-19 immunisation and patient experienced a dead arm in the injection arm, which was the right arm as reported. Could not lift arm because it hurt. Felt like was punched in the arm. Was continuous. It was reported that, second dose was administered a little over three weeks. On 26Aug2021, the patient experienced muscle aches in his arm for 2-3 days, which kind of radiated up into his neck and back of head. It was faded. Patient did break his arm in that area twice. Also ran a temperature and did not feel good. Felt Flu-ish or Flu-like symptoms on the same day. He never got sick. It was reported that all symptoms subsided in 48 hours. Outcome of events were recovered on an unspecified date in Aug2021.   Follow-up attempts are completed. No further information is expected.
Patient returned to the pharmacy on 10/6/23 and reported that she felt the vaccines may have been administered too high on her arm and too close together. Patient bruised at the site of injections and stated that she felt one bandaid would have covered both vaccine injections so she did not feel they were spaced appropriately. Lower down her left inside upper arm midway down between shoulder and elbow patient developed a bruise that began slight and then worsened. The patient said there was a bump under her skin there which I did feel. The area did not look infected and the patient had full range of her shoulder.  There was no residual bruising at the site of injections. The patient contacted her physician who ordered a regimen of oral Prednisone 20mg to be taken once a day for 3 days.
Vaccine given to patient after it had been expired for approx 6 weeks. Error noticed during request for vaccine records by patient's father this June 2023. Dr notified. Staff contacted patient's father. Notified him patient needs additional Hep A vaccine to complete series. Father verbalized understanding.
patient had recieved two doses of 0.5ml Fluzone HD Quad vaccinations, in the left deltoid on 10/27/20 and 11/16/2020 with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- US-SANOFI-00479869) and transmitted to Sanofi on 17-Feb-2021  This case involves a 80 year old male patient who was administered of 0.5 ml QUADRIVALENT INFLUENZA VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ536AA,expiry date: 30-JUN-2021) via unknown route in left deltoid for prophylactic vaccination (extra dose administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to extra dose administered (latency same day).  The caller stated that patient PH had recieved two doses of 0.5ml Fluzone HD Quad vaccinations, in the left deltoid on 10/27/20 and 11/16/2020. Staff person had administered the last vaccination.   At the time of report, no adverse event was reported.  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.
cough; nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and NASAL CONGESTION (nasal congestion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030620A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced COUGH (cough) and NASAL CONGESTION (nasal congestion). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. On 26-Jan-2021, COUGH (cough) and NASAL CONGESTION (nasal congestion) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, COVID-19: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included Acetamide Fen, Tylenol, Advil   Reporter did not allow further contact
Within hours of receiving the vaccine, my tinnitus, which began after the first dose of Moderna vaccine, increased to a 2-3 out of 10 and has continued to now. On 8/4/21, I developed severe, prolonged palpitations occurring several times a day until 8/17/21. During one episode, I felt dizzy, lightheaded, and slightly nauseous. A few more episodes occurred sporadically until 10/4/21. I have had no palpitations since then. I also developed palpitations 3.5 months after the first vaccine dose, but I was told they were not due to the vaccine. I went to see a cardiologist after the second set of palpitations on 8/18/21. He did not think they were due to the vaccine. He said that only young males get myocarditis from the COVID vaccine. I've never had palpitations like this before getting the Moderna vaccine and am afraid to get the booster shot. These incidents seem like too much to be a coincidence.
Headache; Fatigue; Pain at injection site (R); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), VACCINATION SITE PAIN (Pain at injection site (R)) and FATIGUE (Fatigue) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03TK20A and 043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported). Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included INSULIN for Diabetes, CARVEDILOL (COREG) and LISINOPRIL DIHYDRATE (PRINIVIL) for Hypertension.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site (R)). On 07-Feb-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, HEADACHE (Headache), VACCINATION SITE PAIN (Pain at injection site (R)) and FATIGUE (Fatigue) 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.
Moderate chills and joint aches, severe headache, feel feverish - temperature of 99°F
7JUL92 pt recvd a booster dose of Engerix-B; the day of the vax got sick, nauseated, achy all over, sore arm; went home p/receiving inject & went to bed; spent the next day in bed too; felt like was run over by a mack truck;
Developed hives on wrist within 5 minutes of Hep A #2 vaccines. Received Benadryl and hives progressed to face and other wrist. Received Prolone and observed for 1 hour with resolution of symptoms. No facial swelling, no wheeze, no shortness of breath.
1200 pt c/o lightheaded, vomit 1203.  Rapid response. NP saw pt.  VS, Bp 112/82, HR 58, o2 96% RA, @ 1209 to ED.
Since the second shot, on March 31st, I've had consistent pain and very limited movement in my left arm.  I went to urgent care on May 19th, where the attending physician told me that it was likely that injection had been too high, which caused inflammation between the the joints of my shoulder. She prescribed an anti-inflammatory, and said it's likely I'll need physical therapy. I have an appointment with my PCP on June 1st to get an ultrasound done (at her suggestion) and then plan a course of action.
got first dose of the vaccine on 20Jan2021 and second on 01Mar2021; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got first dose of the vaccine on 20Jan2021 and second on 01Mar2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got first dose of the vaccine on 20Jan2021 and second on 01Mar2021). On 01-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got first dose of the vaccine on 20Jan2021 and second on 01Mar2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-030370, MOD-2021-030416 (Patient Link).
Patient developed a loss of taste about 5 days after vaccine as well as headache and cough. He was tested for covid-19 and was negative. We prescribed a short course of steroids. All symptoms cleared up besides loss of taste which patient states has only returned to about 50%.
Pt had hives all over body and throat felt tight-mom gave Benadryl till symptoms resolved with first and second injections.
Patient called office 3/13/14 AM reporting she started experiencing left underarm pain early AM of 3/12/14 - Now has redness at site of injection and underarm. Adv. to take ibuprofen every 6 hours and apply cold compress to underarm and site.
Information has been received from a physician concerning a 22 year old female who on 23-APR-2009 was vaccinated with the second dose of GARDASIL. The patient received the first vaccination on 13-FEB-2009 (lot # reported as "660825/0423X"). After receiving the second dose on 23-APR-2009 the patient's face turned white, eyes rolled back in her head and she had a seizure. The physician reported that after the patient had a seizure she was sent to her primary care physician for further evaluation. The physician reported that the patient's primary care physician wanted the patient to go and have test done but the patient wanted the patient to go and have test done but the patient refused. The physician reported that the patient was still feeling tired and she was under a lot of stress but she was recovering. Follow-up information was received from a physician. The physician stated that the patient had a seizure that lasted 4-5 min with tonic, clonic posturing. The physician stated that the patient was "completely out". The patient "perked-up and came to with no postictal confusion". The physician stated that the patient had no history of seizures. The seizure occurred immediately after the patient received GARDASIL. The physician stated that he was not sure if the patient had the seizure due to GARDASIL or a drop in blood pressure. The physician did not know if the seizure was due to a neurological disorder. The physician stated that he thought the patient's Primary Care was another physician. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Pt w/ amoxicillin allergy unknown reaction. Flushing/sweating, dizziness, lightheadedness.  Pt had a near syncopal episode post vaccination.  Pt has a hx of "passing out" w/ shots.  Pt was laid down, given juice, and stable.  VSS BP 101/52, HR 74, RR 20 -- > 99/65, 82, 20.  Pt stable and released from the vaccination site.
She reported she started having a rash all over body reports she took Zyrtec and rash wen away.
kidney pain like she has a bladder infection; has pain in the injected arm that feels like someone used it as a punching bag; lung pain like she smoked a whole lot of cigarettes; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (lung pain like she smoked a whole lot of cigarettes), RENAL PAIN (kidney pain like she has a bladder infection) and VACCINATION SITE PAIN (has pain in the injected arm that feels like someone used it as a punching bag) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced PULMONARY PAIN (lung pain like she smoked a whole lot of cigarettes) and VACCINATION SITE PAIN (has pain in the injected arm that feels like someone used it as a punching bag). On 30-Jul-2021, the patient experienced RENAL PAIN (kidney pain like she has a bladder infection). At the time of the report, PULMONARY PAIN (lung pain like she smoked a whole lot of cigarettes), RENAL PAIN (kidney pain like she has a bladder infection) and VACCINATION SITE PAIN (has pain in the injected arm that feels like someone used it as a punching bag) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided by Reporter.  No treatment information provided by Reporter.
Woke up at aprx 2am with severe chills, nausea (102.5 fever). Vomiting and diarrhea. Fever lasted until aprx 8am. Random nausea continued for rest of the day.  Significant swelling at the injection site has developed and is extremely sensitive. Feeling of fatigue still exists.
On day 7 - started with rash on left arm, itchy and red, hot, left arm tenderness Day 8 - rash spreading, tender, hot, some edema, itchiness now into neck as well. Also axillary tenderness/adenopathy Day 9 - some resolution to pain in left arm, rash less red but more diffuse. Less itchy Day 10 - pain in left arm, swelling and tenderness at rash. More itchiness at night Day 11 - tender and warm, more diffuse rash that seems to be reabsorbing - less red, more itchy