chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seizure; A spontaneous report was received from a consumer concerning a 72-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed light headache/headache, fever/pyrexia and seizure.  Medical history or concomitant product use were not reported.  On 17 Jan 2021, the patient received her first of the two planned doses of mRNA-1273 (batch number: 013620A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 14 Feb 2021, the patient received her second of the two planned doses of mRNA-1273 (batch number: 013M20A) intramuscularly in the right arm. Soon, she had a light headache and fever. She took treatment with paracetamol  On 16 Feb 2021, the patient was hospitalized. She had her CT scan of the brain and was reported to have seizure because of the symptoms.   On 18 Feb 2021, the patient was discharged from the hospital.   The action was taken with mRNA-1273 in response to the events was not applicable since they developed after the second dose.  The outcomes of the event headache was resolved on 15 Feb 2021 and for other events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration of vial reported was 07-May-2021.  No concomitant medication was reported. No treatment information was reported.
pregnancy on week 28, patient has swelling, warm, redness on the injection site.  advised pt : cold pack for pain at the shot site, rest and protect sore area, sore area on pillows while apply cold pack, tylenol to help with the pain
low grade fever, h/a, overall bodyache, chills, nausea;recv inj in hip, had 4x8' redness, raised, sore & itching are of hip;called ER 28JUN98 was told to ingest DPH;29JUN98, no change in condition;called MD prescription for 5 days on pred;
Patient lost consciousness for approximately one minute right after administration of vaccines. Pt was hypotensive and had bradycardia  during recovery time. Pt was observed for approximately 15 minutes after event. Pt was discharged home in stable condition.
Cough, body aches, headaches, fever. The symptoms are still going on. They are moderate. The Dr. prescribed me PAXLOVID 5 day dose. I just started taking it today.
Narrative:  Pt received COVID-19 vaccine (1st dose) on 1/26/21 but developed pneumonia 2/22/21 and was treated with Augmentin but continued to be SOB and came to the ER 2/23/21 where the pt tested positive for COVID and passed away 2/24/21. Pt did not receive 2nd dose.
Face flushing; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and FLUSHING (Face flushing) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 21-Jan-2021, the patient experienced FLUSHING (Face flushing). At the time of the report, PAIN IN EXTREMITY (Arm soreness) and FLUSHING (Face flushing) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Given State Pediatric dose of Hep B - immediately gave private pay dose of Adult Hep B.
I received the J&J shot in the arm at 12:30 PM on 4/6.  At 7:00 PM -I started experiencing severe muscle cramping in both arms and both legs.  By 9:00 PM  chills started and were added to the severe muscle cramping experienced earlier. I took one Ibuprofen pill at 10:00 PM and tried going to sleep.  I was up all night with insomnia and muscular pain.  I had a low grade temperature of 100.3 starting around 12:30 AM.  Today, 4/7 I've had low grade temperature around 99 and severe muscle cramping in both legs early morning.  Right now at 4:30 PM on 4/7, my temp is gone but I remain extremely fatigued and have muscle cramping in both legs.  I tried taking a nap today and failed to sleep. The last time I was able to sleep was Monday night 4/5. I am hoping this will resolve itself by tomorrow 4/8.  If symptoms don't resolve by 4/8 I will contact my PCP on 4/9. Thank you hope this information helps. I didn't expect to have insomnia as a symptom of this vaccine.
on 3/24, she had decreased level of alertness, eating less, but continued to drink.  On 3/25, appeared a bit better, but still not at baseline.  drinking fluids but not eating.  she vomited up black material and then passed away on 3/25.
Received MMR#2 2/2/09 woke 2/3/09 with L shoulder, neck, upper arm pain/swelling ? and headache.  Self treated with IBUPROFEN 800 mg and TYLENOL 1000mg every 8 hours on Tues, Wed & Thurs.  Symptoms Improved Headache remains but is improved.  All reported to both clinics Thurs. 2/5/09.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 07-AUG-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a medical facility for a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the 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 significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient says he experienced nausea that was relieved upon eating, and redness/reaction at injection site.
admitted to local hospital on 10/21/22  until 11/10/2022 for chest pain, which was non-radiating, dyspnea, and dry cough. EKG showed diffuse ST elevations. TTE showed EF of 30-35% and evidence of myocarditis. Left heart cath showed normal coronary arteries. CTA ruled out a PE. Chest X ray showed pulmonary edema. infectious work-up negative including Influenza, COVID-19.  discharge diagnosis was Pericarditis, Myocarditis, and acute congestive heart failure.
flush in face; flu like symptoms; mild sinus congestion; lightheaded; chills with rigors; fatigue; low grade fever 99.8 f; This spontaneous case was reported by a physician and describes the occurrence of FLUSHING (flush in face), INFLUENZA LIKE ILLNESS (flu like symptoms), SINUS CONGESTION (mild sinus congestion), DIZZINESS (lightheaded) and CHILLS (chills with rigors) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced FLUSHING (flush in face), INFLUENZA LIKE ILLNESS (flu like symptoms), SINUS CONGESTION (mild sinus congestion), DIZZINESS (lightheaded), CHILLS (chills with rigors), FATIGUE (fatigue) and PYREXIA (low grade fever 99.8 f). On 13-Jan-2021, FLUSHING (flush in face), INFLUENZA LIKE ILLNESS (flu like symptoms), SINUS CONGESTION (mild sinus congestion), DIZZINESS (lightheaded), CHILLS (chills with rigors), FATIGUE (fatigue) and PYREXIA (low grade fever 99.8 f) had resolved.        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.   No concomitant medications reported. Treatment included Ibuprofen and Tylenol
Flu like side effects; Muscle pain; Dizziness; Weakness; Extreme tiredness; Chills; Stomach issues; Headaches; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In October 2019, 4 days after receiving Shingrix, the patient experienced influenza-like symptoms, muscle pain, dizziness, weakness, tiredness, chills, gastric disorder and headache. On an unknown date, the outcome of the influenza-like symptoms, muscle pain, dizziness, weakness, tiredness, chills, gastric disorder and headache were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, muscle pain, dizziness, weakness, tiredness, chills, gastric disorder and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a lot of flu like side effects, lots of muscle pain, dizziness, weakness, extreme tiredness, chills, stomach issues and headaches after vaccination. The patient asked whether it is normal to start events 4 to 5 days after shot and how many days does it usually last. The patient asked will experience the same side effects with the 2nd dose. The patient stated that her husband needs to get the shot but he cannot be out of work for 4 days. The patient asked how many days after shot and for how long events occur and why do people suffer from side effects.
Two of my friends have ended up with heart problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Two of my friends have ended up with heart problems".  Additional Information: Reporter stated that two of their friends have ended up with heart problems and four are now on blood thinners for the rest of their lives.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300035000 same reporter/drug, different patient/event;US-PFIZER INC-202300035001 same reporter/drug, different patient/event;US-PFIZER INC-202300035009 same reporter/drug, different patient/event;US-PFIZER INC-202300035010 same reporter/drug, different patient/event;US-PFIZER INC-202300035011 same reporter/drug, different patient/event;
It was discovered on 8/30/17 that we had PREVNAR in stock that had expired 5/31/17. We went through all immunizations given in the past year and discovered this one given 8/24/17. We also discovered 1 other patient (separate report completed). We contacted Pfizer, who deferred to the agency's recommendation to have the patient re-vaccinated. We contacted the patient to complete this. We also logged the error via STARS (Strategic Tracking and Reporting System).
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Additional Details: Patient scratched open a quarter sized wound into arm from the itching.
Patient received 3 doses of Hep A. The dose of Hep A given on 3/25/2013 was documented as HPV #2. This caused her to receive an extra dose of Hep A. Hep A #1 - 3/19/2012; Hep A #2 - 3/25/2013 (documented incorrectly); Hep A #3 - 4/15/2016.
breakthrough case, fully vaccinated in february, currently hospitalized for COVID-19,  has pneumonia spent three days in COVID ICU, is now on med/onc floor recovering. Being treated with remdesivir. significant history of current and chronic illnesses.
Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On 15-Dec-2021, the patient experienced SINUSITIS (Sinus infection). The patient was treated with PREDNISONE at an unspecified dose and frequency and AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) at an unspecified dose and frequency. At the time of the report, SINUSITIS (Sinus infection) was resolving.            No concomitant medications were reported.   Patient took booster dose of unspecified COVID-19 vaccine intramuscularly on 14-Dec-2021.  On 15 Dec 2021, the patient experienced sinus infection. Moderna vaccine were also considered suspect.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
5/11/2021 - Went for routine mammogram and they called me back that afternoon and  found abnormality. They wanted me to do an ultrasound. 5/28/2021 - ultrasound-multiple pictures and measurements - Doctor said it was a  benign cyst. He said they were seeing some of those at their center. I was told not to do anything different.
14 days post vax  pt exp 2-3 days fever, cough, coryza, conjunctivitis w/red maculopapular rash over entire body beginning on face-mild bronchitis w/LL rhonchi
Diffuse maculopapular rash starting 2 days after vaccine and persisting several days. No response to Benadryl. Prednisone prescribed 3/26/19 (date of report).
Additional information was received in event details. Information regarding PREVNAR 13 was received from a nurse regarding a 33-month-old female patient who experienced a febrile seizure and a viral infection. The patient received the first dose on 07-Jun-2010. No medical history of seizures. The patient experienced a febrile seizure on 07-Jun-2010. The febrile seizure occurred the evening that the patient was vaccinated, and the patient was taken to the Emergency Room and was later admitted to the hospital. Follow-up information revealed that the patient was found to have a viral infection (unknown date) in Jun-2010. The physician no longer believes that the febrile seizure was due to vaccination, but that febrile seizure was due to the viral infection. Neither diagnostic tests nor treatments were reported. Febrile seizure resolved. The outcome of viral infection is unknown. No additional information was available at the time of this report.
About an hour after, I felt slightly lightheaded.  About 4-6 hours after, I felt slightly achy,  slight headache,  slight nausea, and general mild unwellness.  All symptoms were resolved by the following morning.   I also had a very sore injection site the day of and day afterwards.
Had red eyes; extreme facial swelling; eyes swollen shut; lip swelling; Initial information was received on 03-Aug-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 48-year-old female patient who experienced red eyes (ocular hyperaemia), extreme facial swelling (swelling face), eyes swollen shut (eye swelling) and lip swelling, after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past vaccination(s) included FLU in 2015 which resulted in bilateral pink eyes.  At the time of the event, the patient had ongoing Cancer.   The patient's past medical treatment(s), concomitant medications and family history were not provided.  On 14-Dec-2016 at 6:00 pm, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot A4VN37333PAW3UX and expiry date was not reported) via an unknown route probably in left arm for prophylactic vaccination.  On 14-Dec-2016, the patient developed a non-serious red eye (ocular hyperaemia) (within an hour), at (11:30 pm) she had extreme facial swelling (swelling face), eyes swollen shut (eye swelling), lip swelling (Five hour 30 minutes) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported, that "call received from Patient reporting an adverse reaction to a flu shot received in 2015 (unknown which vaccine) as well as a reaction to FLUZONE QUADRIVALENT received in 2016. Patient reporting she has a history of cancer and had always gotten her flu shots at her oncologist without any adverse reactions until 2015. Caller reporting the flu shot in 2015 resulted in bilateral pink eyes which resolved on their own. Reporting she received the vaccine at pharmacy. Caller reporting in 2016 she received the FLUZONE QUADRIVALENT at 6:00pm and within an hour she had red eyes, and by 11:30pm she had extreme facial swelling, eyes swollen shut, and lip swelling. Caller with concerns on whether she should get the COVID vaccine based on her reaction to the flu vaccine. Caller with question on ingredients in the 2016 FLUZONE QUADRIVALENT to research whether she can receive a COVID vaccine."  Details of laboratory data were not reported.  The patient was treated with two ACRIVASTINE (BENADRYL [ACRIVASTINE]) and applied ice to affected areas, the doctor told that no further treatment required, patient was referred to allergist who recommended not to get the flu shot in the future.  On an unknown date, the patient was recovered from all the events.
HSP - dev. vomiting, viral exanthem on 1/4/08, received vaccine 1/9/08, dev. purpural petechiae subsequently - diagnosed with HSP 1/9/08; Also dev. Nephritis, including gross hematuria 1/14/08. Rx with steroids
Temperature of 95F, hypothermia; Diarrhea; left eye was twitching; Finger in the left and right hand where blue; Vomiting; Chills; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (Temperature of 95F, hypothermia) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Relevant medical history was not reported).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LIMB DISCOMFORT (sore arm). On 10-Apr-2021, the patient experienced CHILLS (Chills). On 11-Apr-2021, the patient experienced HYPOTHERMIA (Temperature of 95F, hypothermia) (seriousness criterion medically significant), DIARRHOEA (Diarrhea), BLEPHAROSPASM (left eye was twitching), CYANOSIS (Finger in the left and right hand where blue) and VOMITING (Vomiting). At the time of the report, HYPOTHERMIA (Temperature of 95F, hypothermia), DIARRHOEA (Diarrhea), BLEPHAROSPASM (left eye was twitching), CYANOSIS (Finger in the left and right hand where blue), LIMB DISCOMFORT (sore arm), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not reported.   Treatment for the events included acetaminophen and naproxen.   It was noted that the patient's HCP was aware of her symptoms.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Pfizer 3/17/21, 4/7/21. Positive on 12/14/22
Information has been received from a physician concerning a new female employee in her late 20's to early 30's, who in approximately October 2002 was vaccinated with her second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  In September 2002, on an employment physician a titer was drawn which was negative for measles.  Unspecified medical attention was sought.  Follow up information was received from the physician who reported that the patient did not come back for follow up.  The physician reported that the patient did not provide an immunization record and was not sure if the patient had received any vaccinations in the past.  The physician also reported that another new female employee who was vaccinated with the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) had a titer which was negative for rubella (WAES # 0210USA00516).  Additional information is not expected.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 05-OCT-2012 the patient was vaccinated with PNEUMOVAX 23 (lot # H013847, expiration date unknown) dose and route not reported. No concomitant medications were reported. The physician reported that the patient experienced adverse effects of malaise, fatigue, swelling, fever and under arm pain. The date of birth was not available for this patient nor was the specific information about the patient. The patient did not recover from the reported events at the time of this report. Treatment was not given for the events. The patient sought medical attention by notifying the physician. The physician was enquiring if there had been an increase in reports of adverse effects for this lot of PNEUMOVAX 23 and was it possible that this lot of PNEUMOVAX 23 was contaminated. This is one of the several reports from the same reporter. Additional information has been requested.
pt recv vax & about 4 hr p/vax pt exp fever;about 2 days p/vax pt devel joint swelling in the knee;
Had repetitive jerking of right arm with some jerking of head to the right, lasting a few seconds; occurred twice; patient remained alert during episode; parent called nurse line, advised to have child seen; child not seen until next well exam (at 6 months of age).
pt recv vax 27SEP95 & 20SEP97 pt devel shingles that started on the fingers of the lt hand, went up the lt arm & shoulder & then over to the back;