chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/01/2022, on Thursday evening, I had had sniffles and was sneezing and coughing quite a bit, that night I had chills, headache and I just went to bed. A week before I tested for COVID-19, and it was negative. I tested 2 days later, 12/03/2022 and the result was positive. Severe exhaustion and the next day I was in bed all day and coughing like crazy. I called the nurse line and they prescribed PAXLOVID. I picked up the PAXLOVID on Sunday 12/04/2022 and took the first dose in the late morning and I started feeling better within an hour or two of taking the first dose. I was feeling quite a bit better by the fifth day. I was still coughing and feeling crummy for at least another 5 days or so. The PAXLOVID had a metallic taste, lost my sense of smell and I am getting it better, I was told that loss of smell was a side effect of PAXLOVID. I also had diarrhea which was a side effect of the PAXLOVID. The metallic taste and the diarrhea went away when I completed taking the PAXLOVID. And my sense of smell is coming back.
Fever of 101 degrees, nausea, and skin felt hypersensitive to touch for about 48 hours. Ongoing symptom of intermittent sensations in arms and face that feels like quick "zings" of electricity. This happens usually when I am exercising or make fast movements. It seems to be improving over the weeks since I got the vaccine and is not impacting daily activities too much at the point.
RASH Narrative:  59 yo M patient s/o to me by Dr. as presenting with  the CC of having an allergic reaction to the Pneumonia vaccine received  yesterday, and awaiting re-evaluation after having been given IV dexamethasone, IV benadryl, and IV famotidine. Patient is currently resting comfortably in bed without any evidence of distress or discomfort. He denies any complaints or  concerns at this time, and states that the rash and itching have noticeably improved.
Burning sensation; This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bell's palsy.   In July 2020, the patient received the 2nd dose of Shingrix (intramuscular). In August 2020, between 1 and 2 months after receiving Shingrix, the patient experienced burning sensation. On an unknown date, the outcome of the burning sensation was recovering/resolving.   It was unknown if the reporter considered the burning sensation to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Consumer reported that she received 2nd dose of shingrix in july,2020 and at beginning of August she started having a Burning sensation on her right side at the waistband area. She describes it as "on fire, like a very bad sunburn.
terrible night; fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (terrible night), PYREXIA (fever) and VOMITING (vomiting) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced FEELING ABNORMAL (terrible night), PYREXIA (fever) and VOMITING (vomiting). At the time of the report, FEELING ABNORMAL (terrible night) outcome was unknown and PYREXIA (fever) and VOMITING (vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
I've experienced most of the symptoms described in the fact sheet.  Additionally, I have been experiencing tremendous, piercing pain in both ears.  It comes and goes.  I have been experiencing it 3-5 times a day.   The pain comes into both ears at the same time.  It is unlike any other discomfort and pain I've ever experienced.
Flu shot given in Lt. Deltoid.  Shot hurt at the time and has continued to be painful for a month.  Hurts to lift, push or pull.  Has appt. with physician on Nov. 4.
4-16-12 9:30am vaccinated. Irritable after vax, but no other negative responses. 4-17-12 AM. Clear, runny nose. No known elevated temp. 4-18-12 after afternoon nap - "green" runny nose. Bedtime: dry cough. 4-19-12 AM (restless night) cough stuff, "whiney" 4:15am Resp: 90-100/min Pulse 150-200 breathe from belly 5:30 - Gpa start O2 6:15 Emergency Room T = 100 when leave T = 100.5.
I immediately felt some discomfort in my uterus which increased the following day, which at that point felt like the onset of a huge period. Day 2 it subsided, though I've gotten  some random small sharp pains in the same area a couple of times now. Other symptoms were decreased appetite on day 1 and a little bit of lightheadedness, which has also dimished this evening of Day 2. I am hoping I do not get a heavier cycle than usual as some have reported. My next one is due in 4 days, and as it is they are usually heavy.
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 74A7L, expiry date 22nd July 2021) for prophylaxis.   On 5th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th August 2019, 1 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The healthcare professional consented to follow up regarding this case.
metallic taste; shellfish allergy; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A male patient (Age: 59, Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "metallic taste"; FOOD ALLERGY (non-serious), outcome "unknown", described as "shellfish allergy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
30Apr90 pt vax; 24May90 devel rash on buttocks & vomited lunch, purpura, ecchymosis, petechia on chest, temp of 98.8F.  Platelet count 25,000.  Hosp on 25May90.  Lowest platelet count <10,000.  Bone marrow & platelet antibodies neg.See worm
pt recv vax 21DEC98 & 23DEC98 pt devel painful swelling of a lt supraclavicular lymph node & an inj site rxn characterized by redness & induration;
Journal entry from 4/16/21:  "Got up at 7am after having trouble sleeping around 4 & 5 am.  Woke up feel sore all over, especially my right arm.  Rode bike & fixed toast for breakfast.  Felt achy all over, started getting a temp & headache.  Temp was 102.3 at highest.  Felt terrible all day & slept a lot in the recliner."       4/17/21:  No symptoms were reported.
Disruption to normal life functions, Headache, Tired, Muscle Aches, Nausea, Fever, unusual feeling on skin, tinnitus, shortness of breath, chest pain, leg swelling, abdominal pain, headache, blurred vision, dizziness, weakness, fast heart beat, difficulty breathing, difficulty walking, difficulty with facial movements/speaking, double vision, abnormal bowel function,
Information has been received from a registered nurse referring to a 12 month old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 16-SEP-2015 the patient inadvertently received a dose of PROQUADD (lot# K006218 with expiration date of 29-OCT-2015; strength, dosage, frequency and route unspecified) and a dose of (Oka/Merck) VARIVAX (lot# J012150 with expiration date of 28-SEP-2015; strength, dosage, frequency and route unspecified). Additional information has been requested.
At 6:50am on 02/26 (approximately 20 hours post immunization) patient was found by parents in bed with active seizures.  EMS arrived and found patient with seizures.  Transported to Medical Center.  On arrival intermittent seizures with Glascow Coma Scale of 3.  Electively intubated.  Mechanically ventilated for 36 hours.  Extubated on 02/27/22
experiencing red, itchy, softball sized blotches on their legs where quadracel was administered; experiencing red, itchy, softball sized blotches on their legs where quadracel was administered; experiencing red, itchy, softball sized blotches on their legs where quadracel was administered; Initial information received on 10-Feb-2023 regarding an unsolicited valid non-serious case received from  other health professional.  This case involves four patients (unknown age and gender) who experienced red, itchy, softball sized blotches on their legs where diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] was administered.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patients received unknown dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, Suspension for injection, (strength, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for immunisation.  On an unknown date the patient had experiencing red, itchy, softball sized blotches on their legs where quadracel was administered (vaccination site pruritus), (vaccination site erythema), (vaccination site rash) (unknown latency) following the administration of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine   No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all events.
Weak; Dizzy; Nauseous; This is a spontaneous report from a contactable Nurse. A contactable Nurse reported for a female patient.  A 53-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 (52-year-old at the time of vaccination) as Dose 1, single for covid-19 immunisation. Medical history included acquired absence of kidney, asthma, allergic rhinitis, disorder of brain, hypertension, hyperglycemia pruritus vulvae, type 2 diabetes mellitus unknown if ongoing. The patient pregnancy at the time of event  was reported as N/A. Concomitant medication(s) included axitinib (INLYTA, Batch/Lot number was not reported; Expiration Date: 31Jul2023), 5 mg, twice a day for mal neoplasm of rt kidney except renal pelvis 1 tab by mouth from 29Jan2021 to an unspecified date. rosuvastatin calcium (ROSUVASTATIN CALCIUM) taken for an unspecified indication, start and stop date were not reported; medroxyprogesterone (MEDROXYPROGESTERONE) taken for contraception, start and stop date were not reported; diphenhydramine hydrochloride (BANOPHEN) taken for an unspecified indication, start and stop date were not reported; prednisone (PREDNISONE) taken for an unspecified indication, start and stop date were not reported; potassium chloride (KLOR-CON) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported; famotidine (FAMOTIDINE) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (METOPROLOL SUCCINATE) taken for an unspecified indication, start and stop date were not reported; diltiazem (DILTIAZEM) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (MONTELUKAST SODIUM) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported; lidocaine hydrochloride (LIDOCAINE VISCOUS) taken for an unspecified indication, start and stop date were not reported; prochlorperazine (PROCHLORPERAZINE) taken for an unspecified indication, start and stop date were not reported; levetiracetam (LEVETIRACETAM) taken for an unspecified indication, start and stop date were not reported.  The patient previously took amoxicillin (AMOXICILLIN) and penicillin (PENICILLIN NOS) experienced allergy. On an unspecified date on Mar2021, the patient experienced nausea, weak and dizzy. The patient reported that she mentioned she took 1st dose of covid vaccine last weekend and notes she feels weak, dizzy and nauseous. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Febrile seizure approximately 7 hours after vaccines.  Temperature 39.7 - 40 for 4 days after vaccine.  Labs: OBC wnl, Flu negative, RSV negative, CRP 0.67, blood culture negative for 7 days.
Approximately 15 minutes after dose I experienced rapid and fluttering heart beat. I also expreienced fairly intense heat and forehead sweating. I notified the attending nurse and she said she would reccommend I stay in the lobby for an additional 15 minutes. She checked on me again, 15 minutes later, and my heart palpitations had slightly subsided. We agreed it was probably ok for me to go home.     This also occurred on my later second dose one month later but to a lesser degree.   In both vaccinations I had a fever for a few days and stayed in bed. No further complications continued.
Redness around the shot area The night of the shot, lip started to itchy during dinner After that,  hives on the edge of  the lips  showed up and itchy.  4 days later of the shot (5/3), rashes showed up on the right cheek and right side of the neck.  On the following day (5/4),  I woke up with swollen lips and the rash  showed all over the face and neck.   On 5/6, the rash spread down to the upper chest area.  Went to the doctor and got steroid medication.  On 5/7, an acne looking bumps showed up on the both palms.  As of today, I still have hives all over my face and neck and palms.  Lips are rough and dry and skins starts to peel off both on lips and face.
Patient developed hives several hours after receiving flu vaccine which persisted for 30 hours and subsequently resolved.
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004186, MCM-004183, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Pt diagnosed with chickenpox by doctor at hospital and medical center on 10/01/04. Had varicella vaccine on 2/11/02.
little red and hot to touch; sore arm; little red and hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH, PAIN IN EXTREMITY, and VACCINATION SITE ERYTHEMA in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included VITAMINS, LIPITOR, and LEXAPRO for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced VACCINATION SITE WARMTH, PAIN IN EXTREMITY, and VACCINATION SITE ERYTHEMA. The patient was treated with TYLENOL at a dose of UNK dosage form. At the time of the report, VACCINATION SITE WARMTH, PAIN IN EXTREMITY, and VACCINATION SITE ERYTHEMA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient wants to know if these symptoms are normal after two weeks of vaccination.
no addtional AE/PQC reported; an expired dose of ROTATEQ was administered; This spontaneous report was received from a medical assistant referring to a 6 months old patient of unknown gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 21-JAN-2022, at the age of 6 months old, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (strength and dose not reported, lot # U007860, expiration date 14-JAN-2022) (expired product administered). No additional adverse event was reported.
Per immunization and confirmed by patient today, she had received J&J vaccine on 4/1/21 and should not have received the first shot of Moderna on 7/1/21. Pt was given 1st Moderna vaccine in error. Pt was told today that she could not receive 2nd dose without further clarification by CDC guidelines.
Maculo papular erythemic rash on trunk. Low grade temperature approx 11 days after vaccine given pt given Zyrtec 1 tsp q HS A follow up report received 9/12/2002 adds: No site reaction. Dr thinks related to MMR.
Patient developed urticarial rash to stomach/ back/ and bilat upper arms beginning at approx. 3:30 PM 30 Nov 2007.  Treated with Bendryl 25 mg IM to Right Deltoid that evening.  01 Dec 2007 pt returned to medical at approx 1300 complaining that the "rash" was spreading.  Noted an increase of the urticarial rash to the same affected areas as the night prior.  Prescribed allegra 180mg take 1/2 tab by mouth every twelve hours.  Pt had no other complaints.  Followed up with patient this morning and patient states that "itching has diminished and rash is gone". Pt had no further complaints of additional symptoms this AM.
Hives-burning sensation. Tx: Prednisone 5mg (8 day supply), VISTARIL 25mg (10 day supply).
The area around the injection site swelled and turned red. The red area was probably around 2-3 inches wide and lasted until the morning of May 22. The area was sensitive and sore to the touch.
This spontaneous report as received from a other health care worker (C.M.A) who refers to a patient of unknown age. On 21APR2015, the patient was vaccinated with VARIVAX 0.5 ml/ a dose subcutaneous. The healthcare worker reported a single dose of VARIVAX that expired on 31JAN2015 (supported) was inadvertently administered to a patient. No adverse effects reported. The outcome of expired product administered and no adverse event is unknown. No further information was provided. Additional information was provided. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 31-AUG-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. "The vaccine did function as intended," and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 11-MAR-2014, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. 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 and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
admitted to the hospital with recurrent hypoxemic and hypercarbic respiratory failure.  discharged home.  passed away at home after discharge.
ACUTE ST ELEVATION MI, INFERIOR WALL 3/29/2023 HX OF ST ELEVATION MI
Initial report received on 18/Sep/2006 from a health care professional.  A 14-year-old female patient had received an intramuscular, first dose injection of Menactra, lot number U1860AA, on 12/Sep/2006.  The next day, she developed a rash at the injection site that progressed to the opposite bicep, neck, face, back and feet.  She was examined on 18/Sep/2006 for a systemic rash.  Concomitant medication included ZOLOFT.  At the time of this report, recovery status was unknown. Follow-up information received 4-10-08. Patient recovered.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 9:09 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 9:09 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  On 30-Mar-2021, Excursion time was 09 AM, temperature was 33, total doses given for the day was 173, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 3 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021 (Batch number: 019B21A). The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.