chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experience constant tinnitus (high pitch, non-stopping ringing in both ears). It often results in increased anxiety and lack of sleep. It was not a condition I had experienced before.
patient experienced sore arm; hotness; pressure in the head (also said headache) at night; back ache; chest aches; flu-like; could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (patient experienced sore arm), VACCINATION SITE WARMTH (hotness), HEADACHE (pressure in the head (also said headache) at night), BACK PAIN (back ache) and CHEST PAIN (chest aches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (patient experienced sore arm), VACCINATION SITE WARMTH (hotness), HEADACHE (pressure in the head (also said headache) at night), BACK PAIN (back ache), CHEST PAIN (chest aches), INFLUENZA LIKE ILLNESS (flu-like) and INSOMNIA (could not sleep). On 19-Mar-2021, VACCINATION SITE PAIN (patient experienced sore arm) had resolved. On 21-Mar-2021, VACCINATION SITE WARMTH (hotness), HEADACHE (pressure in the head (also said headache) at night), BACK PAIN (back ache), CHEST PAIN (chest aches), INFLUENZA LIKE ILLNESS (flu-like) and INSOMNIA (could not sleep) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications of the patient included Naproxen and Tylenol. No concomitant medications of the patient were provided.
9" X 5" reddened, swollen, area around and under (L) deltoid.
extreme, heavy menstrual bleeding; I am still bleeding  going on 34 consecutive days; This is spontaneous report from a contactable consumer (patient). A 48-year-old female patient (age at vaccination: 48 years) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0187 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 22May2021 at 01.00 PM, as dose 1, single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0187 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 12Jun2021 at 12:45 PM, as dose 2, single dose for COVID-19 immunization at pharmacy or drug store. The patient was not pregnant at the time of vaccination. The patient's medical history included mild asthma and fibroids. The patient did not have any known allergies. Concomitant medications included norethisterone acetate (NORETHINDRONE) and sertraline (SETRALIN SANDOZ). The patient did receive any other vaccine in four weeks. It was unknown if the patient was diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient began with normal menstruation cycle two days before receiving first vaccine. Then extreme, heavy menstrual bleeding began around one week after that first vaccine on 29May2021 at 02:00 PM. She was still bleeding today, going on 34 consecutive days and counting. The patient did not receive any treatment for the events. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
No additional AE reported; VAQTA was inadvertently administered on 13 APR202 l after a temperature excursion occurred/Temperature 9.0C; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-APR-2021, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) pre-filled syringe, lot # T033304, expiration date reported as 23-JUN-2022, but upon internal validation process, it was established as 02-APR-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine was stored in the temperature of 9 degrees Celsius for 10 hours and 56 minutes.  There were no previous temperature excursions reported. The improper storage was recorded by digital data logger. There was no additional adverse event reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033304; expirationdate: 02-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA003667: US-009507513-2104USA003782: US-009507513-2104USA003622: US-009507513-2104USA003606:
Client was here for his first dose of Pfizer (lot number FJ5683, received to the LD at 1547 on 1-27-2022). Shortly after vaccination he complained of feeling dizzy. He did not present with pallor or diaphoresis and no LOC was noted. He denied vision or hearing changes. He reported that he?d been stressed all day and hadn?t had anything to eat or drink yet. He accepted juice and water and drank both without difficulty. At 1600, he laid down (after encouragement) and reported that he felt much better. VS at 1600 were: BP 120/80 laying, HR 64, SPO2 97% on RA.  He was allowed to rest/recuperate and continued to drink juice (after encouragement). VS at 1607: BP 118/76 laying, HR 77, SPO2 98% RA. At 1610, he sat at the edge of the cot without difficulty and reported that he felt ?normal?. His BP at this time was 124/84 sitting, HR 81, SPO2 99%.  At 1612, he stood and reported that he had no further dizziness. At 1612, his BP standing was 118/84, his HR was 89, and his SPO2 is 100% RA. He and his companion were provided education on vasovagal reactions, what to watch for, and when to seek out medical care. The client was also encouraged to make sure he has adequate fluid and food intake before injections and let his next vaccinator know that he had this reaction for his first dose.  Both verbalized understanding. The client reports that he will be monitored through the rest of the day and his companion will drive home. The client remained under observation without further reoccurrence of symptoms until 1621. He reported that he felt ?100% normal?. His VS at this time were: BP 118/84 standing, HR 83, SPO2 100% on RA. He stood and walked around the clinic without difficulty and without requiring assistance. He exited the facility at 1622 with his companion in a private vehicle.
arthralgia, myalgia, headache from 14 hr after vaccine until 32 hr after. rash on neck and torso days 3-5 after vaccine. redness, itching injection site days 4-6 swollen  lymph node armpit of injection arm  days 4-6 after vaccine.
Nausea, chest pain, difficulty breathing following first dose of Pfizer COVID-19 vaccine 0.3 mL IM in right deltoid. Went to outside ED and placed on BiPAP. Given diphenhydramine, epinephrine, and steroid (unknown doses). Prescribed outpatient epinephrine in case of flare of reaction once stabilized.
Arm numbness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Arm numbness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Arm numbness). At the time of the report, HYPOAESTHESIA (Arm numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
I have now have severe tinnitus in my left ear for the last several months.  I was having a bouts of insomnia so played rain sounds which must have masked the tinnitus. I joined a vitiligo research trial two months ago. They tested my hearing and TSH level before joining trial.  TSH level was137. I have had to increase strength from stable 150mcg to 200mcg.  I have been on 150mcg for at least 8 years.
She doesn't feel well; feels feverish; flu; lots of headache; running nose; her cheeks feel hot; back pain; chills; no appetite; coughing; nausea; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 23Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included COPD from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced flu, lots of headache, running nose, her cheeks feel hot, back pain, chills, no appetite, coughing and nausea on an unspecified date in Mar2021. The patient doesn't feel well and feels feverish on 27Mar2021. The patient took Ibuprofen to ease the pain. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Reddish whole body rash with severe itching; Reddish whole body rash with severe itching; This is a spontaneous report from a contactable nurse (patient). A 64-year-old patient of an unspecified gender received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9267), via an unspecified route of administration, administered in Arm Left on 22Mar2021 09:45 (received at the age of 64-years-old) as single dose for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any vaccine within 4 weeks prior to receiving BNT162B2. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. Medical history included known allergies: sulfa. Concomitant medication included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9269), via an unspecified route of administration, administered in Arm Left on 01Mar2021 09:45 (received at the age of 64-years-old) as single dose for COVID-19 immunization. The patient experienced reddish whole body rash with severe itching on 25Mar2021 03:30 PM. Therapeutic measures were taken as a result of reddish whole body rash with severe itching; the patient received oral Benadryl. Outcome of the events was not recovered. It was reported that events resulted into "congenital anomaly" (pending clarification).; Sender's Comments: Based on the information currently available and the product's known safety profile, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of "reddish whole body rash with severe itching" cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Acute pancreatitis lasting 3 days after injection. Normal normally last less than 20 minutes when they occur.
Therapy non-responder; wrong vaccine administration; Underdose; wrong vaccine administration; Underdose; wrong vaccine administration; Underdose; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a male patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis and HBV (Engerix B pediatric) (batch number 5R52M, expiry date 3rd October 2020) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B pediatric, the 2nd dose of Engerix B pediatric and the 3rd dose of Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, Engerix B pediatric and Engerix B pediatric, the patient experienced therapy non-responder, adult use of a child product, underdose, adult use of a child product, underdose, adult use of a child product and underdose. On an unknown date, the outcome of the therapy non-responder, adult use of a child product, underdose, adult use of a child product, underdose, adult use of a child product and underdose were unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B pediatric, Engerix B pediatric and Engerix B pediatric.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported the patient received Engerix-B series in pediatric doses, instead of adult doses, which led to adult use of a child product, underdose. The healthcare professional noted titers were drawn and show low to no response.      Lab Comments: On an unknown date, the lab test was performed.
Sore arm at site of injection, zero energy, feeling sick/weak without fever, and tiredness for three days. After the first few days I had stress/panic flashes in my chest randomly during the day for two weeks. Also had less common pain or twinge in chest during this time period.
diffuse polymorphic rash vesicles to large plaques on trunk arms & legs beginning 10 days p/vax;
Pregnant at the time of vaccination?: Yes; dermatitis rash on back of left shoulder; dispersed itchy rash in multiple locations (face, hands, and torso); This is a spontaneous report from a contactable consumer (Patient). A 34-year-old pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: ENG199 and Expiration date was not reported), via an unspecified route of administration in right arm on 09Mar2021 at 18:00 (at the age of 34-year-old ) as dose 1, single for Covid-19 Immunisation. The patient medical history was not reported. The patient had allergies to medications, food, or other products: Augmentin, Telfa bandages. The patient received concomitant medications within 2 weeks of vaccination included prenatal vitamins, probiotics, Colace. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021, the patient had experienced dermatitis rash on back of left shoulder, not directly at the vaccine site, followed by dispersed itchy rash in multiple locations (face, hands, and torso). Gestation period when reaction or event was observed in the fetus/unit: 28 weeks. Patient last menstrual period date on 22Aug2020. Pregnancy Due Date or delivery date on 29May2021. Adverse events resulted in doctor or other healthcare professional office or clinic visit. The patient received treatment which included antihistamines, steroid cream, oral steroids. The outcome of events was not recovered.  Follow-up attempts completed. No further information expected.
skin burning; dizzy; weak; high blood pressure (Higher than normal) headache, runny nose; head felt stopped up Believe it was an allergic reaction to Shingles vaccination felt "uncoordinated."  Started immediately - felt better each day - 5 days later felt "back to normal" however skin still bothered me a little
headache; has a history of cherry angioma but felt it became much more pronounced after vaccination.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EP7533) as dose 1, single for covid-19 immunisation. Relevant medical history included: "cherry angioma" (unspecified if ongoing), notes: she has a history of cherry angioma. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "has a history of cherry angioma but felt it became much more pronounced after vaccination.". The event "has a history of cherry angioma but felt it became much more pronounced after vaccination." was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated that she and a friend went together and received Pfizer Covid Vaccines (purple label). Reporter stated that this was her friends first dose, but this was her booster dose. Reporter states that she noticed they both had the same lot numbers. Reporter asked are all three doses of the Pfizer Covid vaccine the same formulation. During call Reporter mentioned that after her second dose of the Pfizer Covid Vaccine she had a fever of 103 degree. Reporter stated that symptoms began approximately 12 hours after injection and she had chills, muscle ache, joint pain and a mild fever that went up. Reporter stated she took Tylenol and Ibuprofen 3-4 times a day. Symptoms resolved in about 48 hours. Symptoms with her first Covid vaccination, Reporter stated, "It was a nightmare." Reporter said that she had a headache and that she has a history of cherry angioma but felt it became much more pronounced after vaccination. Reporter said because of this she went to the Emergency Room to have her platelets checked because she thought maybe they were going up, but they were fine. Reporter provided lot number of first vaccine as EP7533 and lot number of second vaccine as EW0153. Reporter comments that her booster dose was given about 20 min ago and at this point she feels fine.  Follow-up attempts completed. No further information expected.
Report A0370539A describes mercury poisoning in a male child, now four years old, who received hep B vaccine. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The child received an injection of hep B vaccine in September 1997, at 2 weeks of age. He also received hep B vaccine (Recombivax-HB) on 10/01/1997 and 01/27/1998; DTaP (Tripedia) on 10/01/1997, 11/19/1997, 01/27/1998, and 07/31/1998; ActHIB on 10/01/1997, 11/19/1997, 01/27/1998 and 07/31/1995; Orimune on 10/01/1997, 11/19/1997 and 11/06/1998; MMR II vaccine on 07/31/1998; and Varivax on 07/31/1998. The vaccinee's attorney alleged that the vaccinee experienced mercury poisoning due to vaccines administered "from July 1997 through at least November 1998." Time to onset from immunization and treatment were not provided. This report of mercury poisoning is considered medically serious.
Since the day after the second vaccine, I have had a rancid metallic taste and smell. It is so powerful that I am unable to consume food. Water is the only thing I can tolerate that does not taste rancid. Today is day 10 with the symptoms.
TOOK THIRD DOSE 24 HOURS AFTER THE SECOND DOSE; This spontaneous case (PVX2019-901) was received from a caregiver on 16-Apr-2019. It describes a female consumer who "took third dose 24 hours after the second dose". The consumer was receiving Vivotif for typhoid prophylaxis.  Case report: The consumer took third dose 24 hours after the second dose of Vivotif. The doses were taken on 11-Apr-2019, 13-Apr-2019, and 14-Apr-2019 respectively.  Action taken with Vivotif was unknown.   The clinical outcome of the event "took third dose 24 hours after the second dose" was unknown.   Company's Comment: The causality of the event "took third dose 24 hours after the second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose 24 hours after the second dose" was considered as not applicable.
This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received forst dose of JANSSEN COVID-19 VACCINE and second dose of Vaccine MRNA 1273 (Moderna)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. Previously administered products included for Prophylactic vaccination: JANSSEN COVID-19 VACCINE (Event Start Date : 12-Mar-2021;Event Stop Date : 15-Mar-2021;Duration : 3 D;Outcome: Recovered Causality: Possible; Action(s) taken with drug : Not Applicable) on 12-Mar-2021. Past adverse reactions to the above products included Tiredness with JANSSEN COVID-19 VACCINE. On 01-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received forst dose of JANSSEN COVID-19 VACCINE and second dose of Vaccine MRNA 1273 (Moderna)). On 01-Nov-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient received forst dose of JANSSEN COVID-19 VACCINE and second dose of Vaccine MRNA 1273 (Moderna)) had resolved. No concomitant medications reported. No Treatment medications reported. Patient reported no Adverse events after MRNA1273.
Slight swelling in my neck on the same site as the injection and one lump near the collar bone notice the day after the injection and a second lump noticed the next day in the same area.  First lump is about 1/2 inch long by 1/4 inch wide.  The second in about 1 inch long by about 1/2 inch wide.  Swelling is still there and lumps have not changed.
Acute diastolic congestive heart failure, Accelerated hypertension, Acute injury to kidney, Hypomagnesemia, Hyperkalemia,Syncope and collapse
Vaccine administer in her hip; This spontaneous report was received from a consumer concerning a 67-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and vaccine was administered in her hip.   The patient's medical history was not provided. Concomitant medications were not reported.  On 06 Jan 2021, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the hip (Lot number: 025J20-2A) for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient received the vaccine in hip instead of her deltoid.  Action taken with mRNA-1273 in response to the events was not reported.   The event vaccine administer in her hip was resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of product administered at inappropriate site for mRNA-1273.  There were no reported adverse events associated with this case.
Swelling in lymph nodes under left arm, low grade fever, headache, nausea, dry heaving, vomiting, diarrhea, muscle aches, fatigue all occurring Wednesday 15 Dec, and Thursday 16 December;  thought it was over Friday 17 December, and maintained fatigue, low grade fever, vomiting. Could not eat solid foods until Monday, 20 December, now experiencing acid reflux most likely from the vomiting.  Note: previously had doses 1&2 from Pfizer and did know know this would be a Moderna shot until arrival at Pharmacy.