chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medications and medical history was not provided. On unspecified dates, multiple, unspecified patients received improperly stored (Oka/Merck) VARIVAX (lot # M024677,expiration date 18-MAY-2018; lot # M02854, expiration date 07-JUN-2018; lot # M027347, expiration date 01-JUN-2018 and lot# M027885, expiration date 03-JUN-2018)(dose and frequency were not reported) subcutaneously. The (Oka/Merck) VARIVAX was stored at -9.7 C for 46 minutes with previous temperature excursion (Time Frame: 3 Hours and 9 Minutes at Temperature: 4.1C Time Frame: 31 Hours and 8 Minutes at Temperature: 4.6C). The temperature excursions were detected by a "data logger". No adverse effects reported. Additional information has been requested.
Experienced skipped heartbeats throughout the day that lasted for over a month.  Eventually stopped.  Not a problem now.  I was told during my doctor visit 3/31/21 that the problem was possibly caused by heart inflammation as the result of the Moderna injection.
Red, raised rash upper arms. Administered Benadryl 25 mg PO, talked to pt by phone at 4 PM: "rash gone and no other symptoms reported".
This initial spontaneous report was received on 06-NOV-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Medical history, concurrent conditions, and concomitant medications were not provided. On or about 17-OCT-2013, the patient was inoculated with ZOSTAVAX by an unspecified person at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-DEC-2015 the patient was treated by a physician/MD for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The female patient has been prescribed Acyclovir and pregabalin (LYRICA) for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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 not resolved. The lawyer felt the events were related to ZOSTAVAX.   Additional information has been requested.
Received vaccines on 4/26/21.  On 4/27/21 she began to have some pain, redness and swelling to left arm at injection site.  On 4/28/21 the arm was red and raised, then began to have tactile warmth.  Cold compress, IBU, Tylenol and Benadryl.
PER PATIENT, STATED BREAKING OUT ON ARMS AND BACK WITHIN A WEEK AFTER RECEIVING MODERNA, COULD HAVE BEEN REFERRING TO 6/3/21 DOSE, I DID NOT GIVE BOOSTER DOSE TODAY.  PATIENT STATED HE ALREADY REPORTED TO CDC
dizzy; Low grade fever; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th February 2020, the patient received Shingrix. On 14th February 2020, 1 days after receiving Shingrix, the patient experienced dizziness and low grade fever. On an unknown date, the outcome of the dizziness and low grade fever were unknown.   It was unknown if the reporter considered the dizziness and low grade fever to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received the vaccine and felt little dizzy and a low grade fever. The patient asked whether the events occurred are normal with the vaccine.
Shot site was fine. No soreness. About five days later, I noticed a rash - 4 inches below the shot site. Nothing bad but nothing around the shot site. No itching. No swelling. A little warm to the touch. No treatment. The rash was there for about a week and a half. - about 10 or 12 days.
Presented in ED with a reddened and swollen area of her  left deltoid region..  The patient states that she received the Madrona vaccine on 21 December in the left deltoid.  She states that she had no problem with the vaccine initially.  She states that she even hiked this last weekend and felt fine.  She states that she developed a reddened area of the skin 3 days ago that has been increasing in size.  It is now tender and somewhat warm to the touch.  She states that she also felt  some itchiness of her upper chest.  She is not sure if she has any true hives in this area.  She denies facial, tongue, or lip swelling.  She denies difficulty breathing.  She denies chest pain.  She denies abdominal pain, nausea, vomiting.  ASSESMENT and PLAN   Erythematous, hive-like region of the left deltoid that began 12 days after the Moderna vaccine.  This is likely a localized delayed type IV hypersensitivity reaction.  Bedside ultrasound performed by myself.  I do not note any pocket of fluid to indicate an abscess.  However, there is a small possibility that this could be cellulitis.  A cellulitis would be much more concerning.  From an allergic perspective, she has no evidence of anaphylaxis based on the timeframe and her current symptoms.  As a result, she will continue on Benadryl for now at 50 mg every 6 hours and will be placed on doxycycline 100 mg twice a day for 10 days.  May use prednisone taper but she should wait for 48 hours.  If she has improvement with doxycycline and Benadryl, she should continue with this.  The Benadryl is truly as needed and if it is improving, she does not need to continue on it.  She will.
Tingling or prickling sensation in right leg only at calf.  Frequency is about 5 times a day.  Also feels like: Pins & Needles and does not last long when it occurs, approximately a few seconds. But there was one yesterday (That felt stronger & lasted a  little longer.)
Patient arrived to observation area. Observation team noticed redness on left ear, left neck, and left flank. Patient denied itching, pain, nausea, vomiting, and chest pain, but did say he had "slurred vision" explained as delayed tunnel vision. Patient refused to have vital signs taken but agreed to 25mg of PO Benadryl. Observation staff asked patient if he would like to get out of the car to be more closely monitored--patient refused. Patient refused observation time and stated "I just want to go walk in a department store." Patient was educated to call 911/go to emergency room if condition worsened or new symptoms developed. Patient and family communicated understanding and left the site in stable condition.
This is a spontaneous report from a contactable physician via Pfizer sales representative. A 18-year-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration, on unspecified date single dose and MENACTRA, via an unspecified route of administration on an unspecified date. The patient medical history and the patient's concomitant medications were not reported. On unknown date the patient experienced could not see, face was pale, sweaty, dizzy, cold hands and nauseous. The outcome of the events was reported as unknown.
Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received HAV (Havrix) (batch number 72T95, expiry date 9th August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's Comments: The reporter reported that they inadvertently administered an expired Havrix dose to a patient.  Pharmacist called to inquire how to proceed. The reporter did not consent to follow-up. Additional Supportive Information: The vaccine was already expired and was administered to the patient, which led to expired vaccine used.
Approximately one week after receiving the 2nd dose, I noticed an increase in the number of angina events I was experiencing, and a corresponding increase in usage of Nitrostat. One 0.4 mg dose of sublingual Nitrostat stopped the angina symptoms. I have not been able to determine any trigger event for the angina attacks.
Patient notified me by telephone that during the night after her injection, she woke up with throbbing pain to her right arm and neck. Injection site was red and hot. The next day the area was bruised. When the bruising and pain went away, a rash started at the injection site and she described it as small raised bumps that itched. All symptoms have gone away today except there are still some raised bumps.
This spontaneous report was received from an epidemiologist who was also the patient's mother and refers to a 12 years old female patient with drug hypersensitivity (fever and nausea) following administration of unspecified vaccine (MARRS case 1601USA006994) and drug hypersensitivity (fever) following administration of MMR (manufacturer unknown) (MARRS case 1601USA006995). In November 2014, the patient was vaccinated with the first dose of GARDASIL (lot number, expiration date, dose and route of administration were not reported). In November 2015, the patient was vaccinated with the second dose of GARDASIL (lot number, expiration date, dose and route of administration were not reported). There was no concomitant medication reported. In approximately November 2015, reported as immediately following administration of the second dose, the patient experienced pyrexia (result and units were not reported). The patient did not seek medical attention and no product quality complain (PQC) was reported. At the reporting time, the outcome of pyrexia was recovered on an unspecified date. Additional information has been requested.
Febrile illness with abdominal pain elevate LFTs 2 weeks after ZOSTAVAX. Followed by prolonged recovery. Fatigue/weakness.
After first dose, developed SOB and dizziness ("similar to when I had arrhythmia ten years ago.") Hemodynamically stable, no improvement over 15" of monitoring,911 was called and he was transported to ED for urgent medical evaluation.  In ED, EKG was unrevealing. Patient rested comfortably. Patient's lab work is unrevealing.   Patient discharged home and advised to have PCP follow up.
Information has been received from a licensed practical nurse concerning a 25 year old female with no medical history and no known allergies, who on 25-OCT-2007 was vaccinated with a first dose of GARDASIL (lot and site unspecified).  On 10-JAN-2008 was vaccinated intramuscularly into the right deltoid with a second dose of GARDASIL (lot # 658560/1062U) and on 09-MAY-2008 was vaccinated intramuscularly into the left deltoid with a third dose of GARDASIL (lot # 659962/1740U).  Concomitant therapy included DEPO-PROVERA.  The patient reported that she developed shoulder and knee pain with numbness in her feet with an onset in April 2008.  The pain and numbness were described as  "off and on".  The pain was described as worsening with increased intensity and frequency.  On 11-AUG-2008 the pain was described as becoming more constant.  The patient saw an orthopedic physician and her primary care physician.  The orthopedic physician diagnosed the pain as "joint instability"  and no treatment was given.  The nurse noted that the patient started exercising in April 2008.  At the time of reporting the patient had not recovered.  The patient sought for medical attention: office call.  There was no product quality complaint.  Additional information has been requested.  12/19/2008 Patient does not recall having ortho consult & no f/u done w/PCP.  Has recovered completely w/o residual.
Pt recd vax early PM; began crying 45min p/shot; Screamed & warm w/vomiting & D; Fever climbed to 102F; Took to ER @ 7PM fever 102; High-pitched shrill cry continued until medicated @ ER; MD felt Pertussis caused rxn, told to avoid "P";
Information has been received from a nurse practitioner concerning a female who in October 2007, was vaccinated with the first dose of GARDASIL. Subsequently the patient developed swollen labia on both sides. The patient still had swollen labia but only on one side by the report time. The patient had sought medical attention. Follow up information has been received from this nurse practitioner concerning this 21 year old female who in October 2008 (not 2007 as previously reported) was vaccinated with the first dose of GARDASIL. Subsequently the patient had labia swelling on the left side and had no pain. The patient was treated with medication and had a follow-up visit scheduled with the nurse practitioner in two weeks. Additional information has been requested.
I have episodes of severe chills, shaking, fever, whole head and body.; I have episodes of severe chills, shaking, fever, whole head and body.; I have episodes of severe chills, shaking, fever, whole head and body.; I have episodes of severe chills, shaking, fever, whole head and body.; I have episodes of severe chills, shaking, fever, whole head and body.; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (I have episodes of severe chills, shaking, fever, whole head and body.), HEAD DISCOMFORT (I have episodes of severe chills, shaking, fever, whole head and body.), DISCOMFORT (I have episodes of severe chills, shaking, fever, whole head and body.), CHILLS (I have episodes of severe chills, shaking, fever, whole head and body.) and PYREXIA (I have episodes of severe chills, shaking, fever, whole head and body.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 012M20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (I have episodes of severe chills, shaking, fever, whole head and body.), HEAD DISCOMFORT (I have episodes of severe chills, shaking, fever, whole head and body.), DISCOMFORT (I have episodes of severe chills, shaking, fever, whole head and body.), CHILLS (I have episodes of severe chills, shaking, fever, whole head and body.) and PYREXIA (I have episodes of severe chills, shaking, fever, whole head and body.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, TREMOR (I have episodes of severe chills, shaking, fever, whole head and body.), HEAD DISCOMFORT (I have episodes of severe chills, shaking, fever, whole head and body.), DISCOMFORT (I have episodes of severe chills, shaking, fever, whole head and body.), CHILLS (I have episodes of severe chills, shaking, fever, whole head and body.) and PYREXIA (I have episodes of severe chills, shaking, fever, whole head and body.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza: negative (Negative) Patient tested flu negative.. On an unknown date, SARS-CoV-2 test: negative (Negative) Patient tested COVID-19 negative..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.
I had the Moderna booster shot. First day effects were tiredness. Second day were injection site pain, chills, bad muscle pain and headache. Third day were swollen lymph node on side of injection and clammy, sweaty skin. This is not an emergency but from my research, only Pfizer was reporting swollen lymph nodes. I though I should report that Moderna also had this as well. My side effects from the booster were far stronger than the first two shots.
Left axillary lymphadenopathy and breast pain. Second vaccine received 1/26/21. Symptoms persist through current time (2/27/21).  Symptoms checked by diagnostic mammogram and ultrasound, with findings consistent with lymphadenopathy. Symptoms include breast and axillary pain, swelling and itching.
Around the time I was going to sleep, I felt very nauseous and I was vomiting.  I also felt an electric jolt throughout my body. I tried to go to sleep afterwards, but I would still get these jolts on the right side of my chest. I didn't get much sleep that night.  On April 30, 2021, I went to the hospital. I took many tests. On May 2, 2021, I went back to the hospital because I was still experiencing chest problems. I took more tests. I am still dealing with chest pains and an electric jolt sensation in my chest. I am also dealing with shortness of breath, vomiting, and coughing. I also have a lump on my left breast and I have never had this before.
ICKY FEELING; DIGESTIVE UPSET; CHILLS; NAUSEA; SORENESS OF INJECTION SITE; TIREDNESS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced icky feeling. On MAR-2021, the subject experienced digestive upset. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced soreness of injection site. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced headache. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, icky feeling, soreness of injection site, tiredness, digestive upset, chills and headache was not reported. This report was non-serious.
Vomiting 1 daypost immunizations. Started just after dinner and continued over night.
Patient thinks she caught either the Delta Variance or COVID-19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Patient thinks she caught either the Delta Variance or COVID-19) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced EXPOSURE TO SARS-COV-2 (Patient thinks she caught either the Delta Variance or COVID-19). At the time of the report, EXPOSURE TO SARS-COV-2 (Patient thinks she caught either the Delta Variance or COVID-19) outcome was unknown.
pt devel redness, induration, warmth & hardness @ site of vax, cleared in 2wk;LMD did not see the rxn;pt on redux bid;
Instructed by CDC to report as pt was given this vaccine, which is meant for 12 and younger.
One day after receiving injection patient had localized pain at site, aches, drowsy, muscle soreness especially in back down to middle lower back. C/o fever, some headaches, trouble sleeping and hard time getting going in the am.
Redness with induration of about 4-5 cm. on right upper anterior thigh noted per mother 24 hrs. after vaccination
Patient says patient gets blurry vision from time to time and  cough with blood time to time which started about 2 months after getting J&J Covid Vaccine.
For 1 night, fever approximately 100 degrees F-101 degree F; aches, chills, N/V, malaise; pt. reported no issues with FLUZONE HD last year.
Pt developed fine macular papular rash on arms, abd and back. Pt given Benadryl and rash resolved.
pt recvd vax; 5 days later, devel pain in arm; pain persists to date of this rpt;
Initially had swelling the size of an egg at site of injection. 2 weeks afterwards, had red itchy welts on neck and front/back torso area. Contacted my doctor and she confirmed looked like an allergic reaction to something.
Patient tested for COVID-19 PCR on 4/10/21; >2 weeks after fully immunized w/ Pfizer on 3/18/21. Patient had cough, myalgia, anosmia, dysgeusia, fatigue. Hospitalized 4/14-4/19/21.   Received Remdesivir and monoclonal antibody treatment.
Mild localized injection site reaction appearing to be allergic in nature.  Treated with cold compress and Benadryl.
Patient received full dose of Moderna last Winter/early Spring, received a dose of Pfizer yesterday at the covid vaccine/flu clinic.  NO current symptoms
20-JAN-2021  - Dose 1 and 10-FEB-2021 - Dose 2; Stomach problems; Breathing problems; Diarrhea; Pain in arm / Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20-JAN-2021  - Dose 1 and 10-FEB-2021 - Dose 2), GASTRIC DISORDER (Stomach problems), RESPIRATORY DISORDER (Breathing problems), DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Pain in arm / Sore arm) in an 88-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) solution for injection for Crohn's disease.    No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-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) Citrate free. In 2021, the patient experienced GASTRIC DISORDER (Stomach problems), RESPIRATORY DISORDER (Breathing problems), DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Pain in arm / Sore arm). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20-JAN-2021  - Dose 1 and 10-FEB-2021 - Dose 2). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20-JAN-2021  - Dose 1 and 10-FEB-2021 - Dose 2) outcome was unknown and GASTRIC DISORDER (Stomach problems), RESPIRATORY DISORDER (Breathing problems), DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Pain in arm / Sore arm) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. 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.   This case was linked to MOD-2021-623847 (Patient Link).