chrisvoncsefalvay/vaers-outcomes huggingface dataset:
With the second Moderna vaccine shot, I became very ill (side effects) (03-01-2021). This was the same for the third Moderna vaccine shot (booster) as well (01-26-2022). However, I developed heart palpitations after my second dose. As time moved on, they became more consistent and frequent. On average, it was happening approximately once per month. Then after my booster shot, they started occurring multiple times per week. I have no prior medical history of this. I have no family history of this either. After I received the booster shot, I started keeping track of the dates and times when this instances happen (when I am able to). They happen at any given point in time. I have had no treatment given to me yet for this issue. The outcome is still pending with medical professionals.
Sore arm; Patient may have only received the adjuvant; Patient may have only received the adjuvant; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the pain in arm, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was wife of the patient. The age at vaccination was not reported. The reporter stated that, the patient only received the adjuvant, instead of the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient had sore arm after vaccination with Shingrix. The reporter did not consent to follow up.
evaluation and management of symptomatic COVID-19 infection with acute hypoxic respiratory failure.  Symptom onset occurred on 11/24/21 with positive SARS-CoV-2 testing on 11/24/21.  He had not been in contact with known COVID-19 positive individual(s) prior to being hospitalized.
pt recvd 5 doses of Rabies vax & approx 1 month p/last dose pt began exp muscle spasms that felt like an ache 1-2 times a day, lasting about 30-60 seconds, in the lt arm @ the inject site;
Report A0371232A describes the occurrence of injection site cellulitis in an eleven year old male who received hep B vaccine recombinant (Engerix B). This report was received from a nurse practitioner. The subject has no known drug allergies, relevant medical history, concurrent conditions or concomitant medications. The subject had no adverse experiences following receipt of the first injection of Engerix B. On 5/28/02, the subject received his second injection of Engerix B in the right deltoid. Post-vaccination, the subject developed an injection site reaction characterized by mild bruising, swelling the size of a baseball, and pain. Additionally, the subject experienced decreased mobility of his right arm. Onset of these events was initially reported to have started the next day, however on follow-up the events were noted to have started the same day of the injection. On 5/30/02, two days post-vaccination, the subject was seen by a nurse practitioner and was diagnosed with injection site cellulitis. Treatment included Augmentin 400mg twice daily by mouth for 10 days, ice to be applied four times daily and Tylenol or ibuprofen for pain and swelling. The events resolved in June 2002. The reporter considered the events to be related to the second injection of Engerix B. On 8/15/02, a hep B surface antibody titer was drawn which reflected a "positive" result. It was reported that "no additional hep B vaccine needed." This case is considered serious as the reporter stated that the pt was jeopardized or required intervention.
Pt began running a temp about 6 hrs post/vax. Tylenol was given but did not reduce temp. By 11:00 PM, 1/26/00, temp was 105 & she was taken to ER. Pt was given Motrin & temp came down. She still has congested cough.
08/18/2010 Father brought patient into health department  reporting a swollen, red, painful left arm. Had shots on 8/16/10 about 10 AM. Pain and redness and rash started about 2 pm same day. Area of about 5" x 4" on (L) arm erythemic with about 20 small and one 3/4" fluid filled pustule around site of injection. Referred to PMD. TC to Father 8/18 at 2pm doctor prescribed antibiotic and BENADRYL.
This case was reported by a nurse and described the occurrence of left brachial vein thrombosis in a 22 year old male patient who received hepatitis B vaccine recombinant. On 5/3/04, the patient received the first dose of Engerix B vaccine (lot ENG5588A4) in the left arm. On 5/6/04, the patient was seen in an emergency room and underwent a doppler ultrasound of the left arm. The ultrasound revealed left brachial vein thrombosis. The patient reported to the nurse that the adverse event began the day after receiving the injection. The event improved. Comment: Vein thrombosis was assessed as medically serious (OMIC). Follow UP: The immunization series with Engerix B was discontinued. The events resolved on 21MAY2004. The nurse considered the events to possibly be related to vaccination with Engerix B.
Shortly following the second dose, I experienced chest pain and elevated heart rate (no medical history of either), noticeable decrease in exercise capacity, and fatigue/shortness of breath. I am now about 2.5 months post-second-dose and while the chest pains have subsided somewhat, the elevated heart rate, fatigue, shortness of breath, and reduced capacity to exercise have persisted to this day.
JOINT ACHES; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient concerned a 47 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: 041A21A, expiry: 19-SEP-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, treatment medications included: ibuprofen, and paracetamol. On 11-APR-2021, the patient experienced joint aches. On 11-APR-2021, the patient experienced low grade fever. On 11-APR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint aches, low grade fever, and headache on 11-APR-2021. This report was non-serious. This case, involving the same patient is linked to 20111208304 and 20140118303. This case, from the same reporter is linked to 20210832767.
Administered MCV4 (R) delt followed by Hep A (L) delt. Pt became disoriented, rigid, ashen x 30-40 seconds. Relaxed, responded then developed same sx x 30-40 sec. EMTs called. Pt remained ashen in color but responsive. Stated he did not feel well. Transported to local ER.
Near syncope day of injection while at rest in seated position. Subsequently recurring idiopathic angioedema in several months following injections. I did do series and had second injection 2/2/21 from same lot number at same location/site, but without alternative explanation for these symptoms I did discuss it with my allergist who felt like more than likely related to mast cell destabilizing effects of that particular vaccine.
5-6 hours after getting the shot I started to feel a low fever, started having a dry cough, had full body muscle aches. The next day (12/4) all symptoms continued, with the addition of headache and feeling dehydrated. I noticed a red welt at the injection site with a diameter of about 2 inches. The full body aches continued but a new specific/sharper pain at the left lateral chest appeared as well, along with some swelling; also headache, and pain in the muscle at medial base of R palm. Rapid test on both Friday and Saturday were negative (I just wanted to make sure I hadn't coincidentaly been reinfected at the same time).
Patient received the 2nd booster dose 1 month too soon. Patient had last booster on 1/5/22 and should have been due on 5/5/22. Received a booster 0.25mL dose of Moderna today 4/7/22.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved. The reporter considered the injection site reaction to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient demographic details (date of birth or initials) were unknown. The batch number and expiry date of suspect vaccine were unknown. The injection site reaction was lasted for 3 to 4 days.
Got sick; Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Lot number: ER2613) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Got sick"; MALAISE (non-serious), outcome "unknown", described as "Not feeling well".  Additional information: The patient had chemo next day after the vaccination.   No follow-up attempts are possible. No further information is expected.
Typical varicella exanthem, 750 lesions mostly on trunk, some scattered on extremities & face.
Initial and follow-up information has been received from a pharmacist concerning a 39 (also reported as 35) year old female patient, who on 10-OCT-2007 (also reported as 12-OCT-2007), was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (Lot# 657040/0859U). Concomitant therapy given in the same deltoid, about 2 to 3 inches from the first site, included a dose of influenza virus split virion 3v vaccine inactivated (Lot# "U2453AA"), administered intramuscularly. There were no illness at the time of the vaccinations. On 12-OCT-2007, the patient developed swelling up to 4 times the baseline at the injection site within 24 hours from the time of vaccination. It was reported that the patient felt lethargic and "like she was about to die." The patient went to the hospital and was diagnosed with cellulitis at the site of the PNEUMOVAX 23, which spread to the rest of her body. The emergency room doctor stated that the cellulitis was due to the vaccination with PNEUMOVAX 23. She was put on Cephalexin and sent home. On 14-OCT-2007, the patient was reported to be feeling much better. On 15-OCT-2007, it was reported that the patient was going to see a physician at a Hospital. The reporter is requesting a lot check for PNEUMOVAX 23 (Lot# 657040/0859U). A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
gave an expired dose of PENTACEL, with no reproted adverse event; Initial information received on 14-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 weeks old male patient who was administered an expired dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero), with no reproted adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine Live Reassort Oral 5V (Rotateq); and Hepatitis B Vaccine (Hep [Hepatitis B Vaccine]) for Prophylactic vaccination (Immunisation).  On 14-Jul-2022, the patient received a 0.5 ml dose once of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine (Suspension for injection) (lot: UJ528AAA; expiry date -10-Jul-22) via intramuscular route in the right thigh for prophylactic vaccination.   On 14-Jul-2022 the patient was administered an expired dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine, with no reproted adverse event (expired product administered) (latency: same day).  Action taken with Diphtheria,Tetanus, AC Pertussis, IPV AND HIB Vaccine (Pentacel (Vero)) was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 guidelines. 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.
Pt is a 81 y.o. female with PMH of RA (on methotrexate), PAF, HTN, Hx of Colon cancer (s/p resection and chemo), CKD, that was diagnosed with COVID on 11/19 ( test by PCP s/p monoclonal infusion) presented to local ED with worsening cough and diarrhea. She is fully vaccinated with Pfizer (second dose in 3/21 and booster in 10/21). The patient was seen in local ED two days ago. She states since then her cough has gotten worse, it is both dry and productive and her diarrhea has increased. Her only pain is in her throat. She is short of breath with ambulation. Her husband also has covid and is recovering from at home. In the ED, she is sat 95 % on room air. Her lactic acid is 3, procal is 1.51 and BNP is 15,029. The patient will be admitted to the hospitalist service for further treatment and evaluation
I got the shot on 3-20-21 at school. My vaccine card says moderna 003B21A. It has been my first dose in my right arm. It wasn't painful and there was no reaction until out of nowhere, the morning of 3-28-21. The injection site and the area around it was raised, red and really hot to the touch. The area has been itchy. I am still currently dealing with the issue... I don't receive my second shot until 4-17-21 so we'll see how that goes. I haven't went to the doctor because when I do a search online it says people are dubbing this "covid arm". It is still concerning me though because it is itchy and the area is very hot. Prior to getting the shot I was not told of any such reaction would be delayed an entire week.
she gets a chemical breath/Smell was particularly bad/Smell from her breath comes and go's; Doctor said that the caller's wife may be having a reaction to the Moderna Covid-19 vaccine.; blood pressure runs up; This spontaneous case was reported by a consumer and describes the occurrence of BREATH ODOUR (she gets a chemical breath/Smell was particularly bad/Smell from her breath comes and go's), VACCINATION COMPLICATION (Doctor said that the caller's wife may be having a reaction to the Moderna Covid-19 vaccine.) and HYPERTENSION (blood pressure runs up) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (prior to receiving the vaccine).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced BREATH ODOUR (she gets a chemical breath/Smell was particularly bad/Smell from her breath comes and go's), VACCINATION COMPLICATION (Doctor said that the caller's wife may be having a reaction to the Moderna Covid-19 vaccine.) and HYPERTENSION (blood pressure runs up). At the time of the report, BREATH ODOUR (she gets a chemical breath/Smell was particularly bad/Smell from her breath comes and go's), VACCINATION COMPLICATION (Doctor said that the caller's wife may be having a reaction to the Moderna Covid-19 vaccine.) and HYPERTENSION (blood pressure runs up) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Blood pressure measurement: high (High) blood pressure runs up. In February 2022, Blood test: results not provided Results not provided. In February 2022, Chest X-ray: returned negative (Negative) returned negative.         No history of Myocarditis/pericarditis. No concomitant medications were reported.  The caller's wife received her booster dose about two months ago. Smell was particularly bad on 16-Feb-2022. The caller's wife went to the hospital about one week ago. The hospital discharged her after doing blood work and chest x-rays. The patient was discharged from the emergency room. Patient developed a smell of chemicals when she breaths out through her nose. The caller's wife also developed higher blood pressure than her normal baseline blood pressure. Cause was not determined. Chest x-rays taken at the hospital returned negative.  No Treatment was given.
Day 1: Flu-like symptoms day after. Fatigue; nausea; headache; slight fever Day 2: Diminished almost completely except for slight fatigue Day 3: slight fatigue Day 4: slight fatigue; headache
pt recvd DTP/OPV on 28FEB92; mom reported that pt had poss sz on 2MAR; taken to ER t103; tx w/APAP 7 scheduled for eval by neurologist; 3MAR asymptomatic;
Patient reported continued pain on touch at injection site 2 weeks post vaccination. Patient was notified could make nursing appt for eval. Never made. And no further complaints as of 3 months out.
4/26/2021 - 14:00  Fatigue set in about 4 hours after the injection and continued for 2 days. 4/27/2021 - 17:00 fever of 100 - 101 lasting a few hours. Subsided somewhat with Tylenol.
Information has been received from a physician concerning a 15 year old male with asthma and "cardiac history" (unspecified) who on 30-AUG-2010 was vaccinated with GARDASIL (Lot number 665607/1333Y). Concomitant therapy included LIPITOR. On 27-SEP-2010 the patient died while playing hockey. The physician reported "awaiting autopsy results". At the time of report no further information was available. The reporter considered death to be life-threatening. A lot check has been initiated. Additional information has been requested.
1 week after getting my first dose of the  Moderna Vaccine,  I developed  redness and itching at the site.  The  redness is about 3 inches in diameter.
sore injection site injection sight red and swollen hours after injection stomach slight burning sensation  day after injection tired and overall not feeling well day after injection
No additional AE details; Improperly stored vaccine was administered to this patient on 8/24/2021.; This spontaneous report was received from a nurse, referring to 6 months old male patient. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 24-AUG-2021, the patient was administered Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, dose, route were not reported; lot# 1742470 has been verified to be a valid lot number, expiration date 16-MAR-2022) for prophylaxis that had undergone a temperature excursion (product storage error). No additional adverse events were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006895: US-009507513-2108USA007324:
Extremely heavy (irregular) period with continual bleeding which has with in the last week stopped; Extreme lasting fatigue; Muscle Soreness; Tingling Skin; This is a spontaneous report from a contactable consumer (patient). A 21 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  dose 1 via an unspecified route of administration, administered in Arm Right on 25Mar2021 14:00 (Lot Number: EN6207) as SINGLE DOSE (at the age of 21 years old) for covid-19 immunisation.  Medical history included ventricular septal defect (VSD) from an unknown date and unknown if ongoing, heart murmur from an unknown date and unknown if ongoing.    There were no concomitant medications.  The patient did not have any known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  It was also reported that since the vaccination, the patient had not been tested for COVID-19. On unknown date, the patient experienced Extremely heavy (irregular) period with continual bleeding which has with in the last week stopped, Extreme lasting fatigue, Muscle Soreness, Tingling Skin. No treatment was received. Outcome of the events was Recovered/Resolved with Sequel.
Pt had a 99.5 degrees F fever and started feeling itchy and achy all over.
About 6 PM on 10/30/2001 pt had an episode of bradycardia. On apnea monitor.
since the booster dose experiencing hair loss/strands of hair are coming in my hands/hair loss/hair falling few strands at a time; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (since the booster dose experiencing hair loss/strands of hair are coming in my hands/hair loss/hair falling few strands at a time) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ALOPECIA (since the booster dose experiencing hair loss/strands of hair are coming in my hands/hair loss/hair falling few strands at a time). The patient was treated with FINASTERIDE on 11-Nov-2021 for Hair loss, at an unspecified dose and frequency. At the time of the report, ALOPECIA (since the booster dose experiencing hair loss/strands of hair are coming in my hands/hair loss/hair falling few strands at a time) had not resolved.            Concomitant product use was not provided by the reporter.  Patient's dermatologist gave her a steroid medication for her scalp.  Reporter stated that the blood work would be performed to see if there were any other reason for the hair loss. She did not get COVID.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Added date of birth and added treatment. On 23-Nov-2021: Updated reporter details and added event verbatim
Patient states felt very fatigued the evening of 11/6/2018. Did not sleep well, restless. Felt very fatigued the next day, 11/7/18 and had trouble focusing, concentrating in class and her finger joints felt stiff, but did not note swelling. States felt "disconnected". Denies headache, f/c, dizziness, rash, visual sx. States slept well that night. Symptoms were essentially resolved 11/8/2018 except mild fatigue. Has never had an influenza vaccine