chrisvoncsefalvay/vaers-outcomes huggingface dataset:
brother passed away of unknown circumstances on 04Jan2022; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (brother passed away of unknown circumstances on 04Jan2022) in a 70-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on 04-Jan-2022 The patient died on 04-Jan-2022. The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  It was reported that patient was now deceased who was in a Moderna Covid-19 vaccine clinical study in 2020. The trial was conducted by the Medical Center. It was reported that the patient passed away due to unknown circumstances on 04Jan2022.  The patient received a placebo injection in the study.  After the trial ended, patient got unblinded and then received the Moderna Covid-19 vaccine. The reporter did not report any side effects or adverse reactions to Moderna Covid-19 vaccine. The reporter did not had dates of administration or lot numbers for the patient's Moderna Covid-19 vaccines. Deceased patient was listed as a contact in the case. On 05May2022 the reported answered the phone and said that he would try to call Moderna back with the information about vaccine lot numbers and dates of administration of the vaccine.  Company comment: This Spontaneous case concerns a 70-year-old male patient, with no reported medical history, who had a serious, unexpected fatal outcome unspecified day, after receiving a dose of mRNA-1273 vaccine.  Patient had passed away due to unknown circumstances and the cause of death was not reported.  It is unknown if an autopsy was performed.  The patient was reported to have been included in a clinical trial and have received a placebo injection while in the study.  After the trial ended, the patient received a dose of mRNA-1273 vaccine on unknown date.  Clinical course, circumstances surrounding the event and treatment details were not reported in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-56043.; Sender's Comments: This Spontaneous case concerns a 70-year-old male patient, with no reported medical history, who had a serious, unexpected fatal outcome unspecified day, after receiving a dose of mRNA-1273 vaccine.  Patient had passed away due to unknown circumstances and the cause of death was not reported.  It is unknown if an autopsy was performed.  The patient was reported to have been included in a clinical trial and have received a placebo injection while in the study.  After the trial ended, the patient received a dose of mRNA-1273 vaccine on unknown date.  Clinical course, circumstances surrounding the event and treatment details were not reported in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: his brother passed away of unknown circumstances
No additional AE; a patient received an expired dose of GARDASIL 9; This spontaneous report was received from a pharmacist, physician (from the office where the vaccine was given) and from a 36-year-old male patient, who was a nurse working for the physician's office and was reporting on himself. The patient's medical history and concurrent conditions were not reported. On 09-SEP-2020, reported as yesterday (also reported as on 10-SEP-2020), the patient was vaccinated with the third expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (vial, lot # N023828, expiry date: 25-JUN-2020, route of administration not reported). No adverse event was reported. It was reported that, the vaccine had never gone temperature excursion. The patient wanted to know whether, the vaccine was viable after expiration date and if he needed additional dose.
exactly 24hr later, p/recv vax ran fever & had a sz that lasted 1 1/2hr;rash existed for about 1/2in over neck, chest back & arms;pt is now Dilantin;
10:30 pm 03/26/2019: fatigue. 11:00 pm 03/26/2019: face feeling flushed. 11:30 pm 03/26/2019: headache, chills, body aches, fever of 100.1 degrees, fast pulse (109). Still feeling all symptoms 11:30 am 03/27/2019, but to lesser degree.
Right arm swollen and painful starting 10 hours after vaccination. Cortisone injection given by MD, referred to rheumatologist. Fluid removed from both shoulders. Not rheumatoid arthritis, gout or lyme.
Vertigo; tinnitus; nausea; middle ear inflammation; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 44-year-old male patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: EP6955) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sciatica" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: bnt162b2 (Dose 1, single (Lot Number: EN6202)), administration date: 03Mar2021, when the patient was 43 years old, for COVID-19 immunisation, reaction: "High blood pressure". The following information was reported: VERTIGO (non-serious) with onset Mar2021, outcome "not recovered", described as "Vertigo"; TINNITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "tinnitus"; NAUSEA (non-serious) with onset Mar2021, outcome "not recovered", described as "nausea"; MIDDLE EAR INFLAMMATION (non-serious) with onset Mar2021, outcome "not recovered", described as "middle ear inflammation". The events "vertigo", "tinnitus", "nausea" and "middle ear inflammation" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of vertigo, tinnitus, nausea, middle ear inflammation.  Additional Information: After second dose, the patient experienced vertigo, tinnitus, nausea, all probably due to the sudden middle ear inflammation after the shot. The patient received meclizine and dexamethasone as treatment for the adverse events. The patient did not receive other vaccine in four weeks. The patient received other medications in two weeks. The patient did not have COVID prior vaccination, was not tested for COVID post vaccination, and had no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021350614 Same patient and drug; Different dose and event
The caller stated she has vertigo and the doctor says it is a viral ear infection; The caller stated she has vertigo and the doctor says it is a viral ear infection; This is a spontaneous report from a contactable consumer(patient). A 66-year-old female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: not reported) via an unspecified route of administration as a single dose for COVID-19 immunization on an unspecified date in 2021. The medical history and concomitant medications were not reported. On an unknown date, the patient stated that she had vertigo and the doctor told it as a viral ear infection. He prescribed an antiviral and anti-inflammatory medications that she was picking up. The doctor said she cannot get the second dose when it is scheduled on 27th because she will be taking these medications. She asked if these symptoms are from the vaccine. She stated she asked the doctor and he said no one knows. She stated she has never had vertigo or an ear infection but 12 days after the vaccine this happened but it could be a coincidence.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Watery eyes; Runny nose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Lot number: ep7533) at the age of 68 years 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: LACRIMATION INCREASED (non-serious) with onset 22Apr2021, outcome "unknown", described as "Watery eyes"; RHINORRHOEA (non-serious) with onset 22Apr2021, outcome "unknown", described as "Runny nose".  Additional information:Patient was receive dose 1 on 01Apr2021 (Lot - ep7533) and she was due for her second dose today, but yesterday began having watery eyes and a runny nose and isn't sure if they will let her with those symptoms. Patient wanted to know Should I get the second dose because she experienced side effect after the first dose of the vaccine.    No follow-up attempts are possible. No further information is expected.
Pt presents to the ED with chest pain and shortness of breath. Patient was hospitalized for Covid evaluation and treated with Remdesivir.
The patient received 7 vaccines. Immediately after the 7th vaccines which was HPV. The patient complained of blurry vision and fainted. She jerked for a few seconds around at 10:39 AM and awake again. She was alert and oriented. BP= 107/65, P=70 at 10:39 AM. She was observed for 20 mins. BP= 109/87, P= 68 at 11:01 AM. The patient left the clinic in a stable condition.
Skin got real leathery, like lizard skin and was peeling and was horrible; severe rash; painful/the pain wasn't even that bad; painful and burned, itched, was swelling and weepy; painful and burned, itched, was swelling and weepy; painful and burned, itched, was swelling and weepy; painful and burned, itched, was swelling and weepy; Skin got real leathery, like lizard skin and was peeling and was horrible; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 18Jul2021 as dose 2, single (Lot number: EW0181) in arm left at the age of 68 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE NUMBER 1, SINGEL, EW0178), administration date: 27Jun2021, for COVID-19 immunization.  The following information was reported: SKIN EXFOLIATION (non-serious), SKIN DISORDER (non-serious), outcome "unknown" and all described as "Skin got real leathery, like lizard skin and was peeling and was horrible"; RASH (non-serious), outcome "unknown", described as "severe rash"; PAIN (non-serious), outcome "unknown", described as "painful/the pain wasn't even that bad"; THERMAL BURN (non-serious), PRURITUS (non-serious), SWELLING (non-serious), CRYING (non-serious), outcome "unknown" and all described as "painful and burned, itched, was swelling and weepy".  Additional Information: Patient did not required a visit to: Emergency Room. Patient had no prior Vaccinations (within 4 weeks). Did not even get flu vaccine. Has not had flu vaccine since 70's when swine flu was out. Had no prior vaccinations. Patient had no medical History. Family Medical History Relevant to AE: Not that she knows of. Time of Onset: about 7 or 10 days after second vaccine, 18Jul2022. Had both vaccines at Pharmacy, different pharmacists did each injection.  She is actually one of those people who don't do medications. Does a lot of juice and exercises, is a very healthy person. It wasn't something where she could use anything topical either. Severe rash and reaction: It felt like she had razor blades or glass coming out from inside the skin. It was that painful and  burned, itched, was swelling and weepy. Skin got real leathery, like lizard skin and was peeling and was horrible. Lasted 3 or 4 months. Started tapering off toward the end, then would flare a little bit. When flares were farther apart finally it did slow down. Last part to heal were her knuckles. Was both arms, under her arms, worst was rash in the trunk and had rash on legs. Was not as severe but was behind her knees. Arms were the worst.
THE PARENTS LIED ABOUT THE DAUGHTER AGE REAL DOB IS 7/6/2010 BUT STATED ON CONSENT FORM AS OF 7/6/2009. Pt RECEIVED BOTH DOSES OF PFIZER COVID VACCINE. Local COUNTY PUBLIC HEALTH INFORMED US ABOUT THE PATIENT AGE.
I noticed it when I was getting dressed around 10am.  Where I had the shot looks like a big bug bite.  About 3? in diameter, a red welt.  It itches and is sore.   I took Tylenol, wiped it with alcohol, and put some ice on it.     It?s still red and welted right now.
Now has discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Now has discomfort) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DISCOMFORT (Now has discomfort). At the time of the report, DISCOMFORT (Now has discomfort) outcome was unknown.
Student had fever 100.1 and chills. Student took Advil and an hour later felt fine. T.100.1 BP 130/80 P100 029690 CNRA
Back muscle pain and tiredness the day of the shot. Within 24 hours of the vaccine, anxiety, depression, lack of focus. It was like a severe PMS in the mental sense, and two weeks of it, and the tiredness worsened over the two weeks. I am not someone who suffers from PMS like in general, it was exceptional, and the only difference in my routine was the shot precisely the two weeks before a cycle.
Felt hot, really tired, and headache the morning after the vaccine.  Symptoms began when he woke up- he woke up about 30 minutes earlier than normal saying he did not feel well.  Stayed home from school to rest. Felt better a few hours later, but did take Tylenol to help (only needed one dose).  He felt better by evening and eturned to school the next day.
Pt received smallpox vaccine on 2/13/03.  Pt received a tattoo on opposite arm on 2/15/03. Pt had a localized rash on arm which received the tattoo on 2/15/03.  No fever or bodyaches.
Clinician prepared vial with 1.3ml Normal Saline diluent rather than 1.8ml Normal Saline. During conversation of being notified of VAERS report she reported experiencing Nausea & vomiting  with a migraine evening after injection. She stated she missed 3 days of work. Reports feeling well now with no clinical concerns
Patient developed shortness of breath, hives, urticaria to anterior chest, back and neck, and numbness in mouth during the observation period after receiving her first Moderna COVID-19 Vaccination. She was given Epinephrine 0.3 mg IM x1 in the vaccination clinic prior to transfer to the Emergency Department. In the  ED the patient was given IV fluids, diphenhydramine, famotidine, and methylprednisolone. Symptoms were alleviated and patient was discharged with a prescription for 4 additional days of oral prednisone.
diffuse fuzziness, tired, mild headache, some increase in blood pressure.  Slept 12 hours  second day of symptoms.  Symptoms waxed and waned, worse in mornings. Finally cleared completely Jan 27(onset Jan 10) Treatment occasional acetaminophen although no fever.
Information has been received from a registered nurse concerning a 4 year old white female with no known allergies who on 2/12/01 was vaccinated in the left upper extremity with a first dose of varicella virus vaccine live (lot # 635461/1246K). Illness at the time of vaccination included a rash. On 10/18/04 (also reported as 10/19/04), the patient developed an outbreak of varicella (also reported as varicella rash). The patient recovered on 10/26/04. Additional information has been requested.
Has a sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Has a sore throat) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Has a sore throat). At the time of the report, OROPHARYNGEAL PAIN (Has a sore throat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
no adverse event; PROQUAD in combination with VARIVAX; Wrong vaccine administered; This spontaneous report was received from a nurse referring to an unknown gender 12-month-old patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  The patient was intended to be administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) in combination with varicella virus vaccine live (oka/merck) (VARIVAX) but on 26-SEP-2022, the patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection rHA (recombinant Human albumin), lot #W020548, expiration date: 26-DEC-2023, administered for prophylaxis (strength, dose and route of administration were not provided) with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W016746, expiration date: 23-MAY-2024, administered for prophylaxis (strength, dose and route of administration were not provided) (overdose, wrong product administered). The patient had never been administered corresponding measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) prior to or at current call time. The reporter was unable to further clarify these statements at current call time. No adverse event was reported.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 09-DEC-2015 the patient was vaccinated with dose of improperly stored VARIVAX (Merck) (incorrect product storage) (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
Approximately one minute after receiving vaccine, patient began feeling flushed. He had a syncope episode immediately afterwards. Patient received epinephrine 0.6 ml IM to right thigh, cool compress, Trendelenburg  position, and oxygen at 3L/nc. Patient complained of chest tightness, shortness of breath, temporary hearing loss, and numbness/tingling of arms and feet. Patient reports feeling 80% back to normal; alert, oriented x 4. Patient began feeling flush again and complained of chest tightness and feeling flush again after placed in sitting position. Ambulance transported to
Redness at injecton site, warm to touch, swollen painful arm, tingling in fingers of injection arm. Advised BENADRYL. Call MD if worse.
On monitoring for declining in condition, loss of appetite and generalized body weakness on2/1/2021. Was confirmed COVID-19 positive 4/23/2020.
Syncope episode with convulsions Underwent cardiovascular and brain scanning and imaging Treated with Keppra x 3 days Determined to be a non-seizure event
Patient presented to pharmacy and asked pharmacist to look at arm which she had Shingrix administered in 2 days prior.  Patient reported redness, warmth and tenderness at injection site. Pharmacist verified redness and warm in approximately 2 inch circle surrounding injection site. Pharmacist recommended patient follow up with PCP to see if it may be infected and if so how to proceed. Patient agreed to check with Doctor.
I had my first Covid vaccine on 11/20/21 at Pharmacy. The vaccine provided was Moderna. I have never had bad reactions to vaccines in the past. However 10 minutes after the vaccine was administered I started feeling dizzy. About 20 minutes later it was hard to see, my tongue started to feel numb, my skin felt like it was on fire, my throat started swelling and it was harder to breathe. My husband rushed me to the ER and when we arrived it was still getting worse, but I was shaking very badly. At the hospital, I was given a steroid shot and a shot of Benadryl to counteract the vaccine. This stopped the symptoms and I started to feel better. I was later discharged and did not have anymore allergic reaction symptoms. I am however experiencing severe flu like symptoms and fever that started on 11/22.
Got period 10 days after the start of previous cycle and much heavier flow and clotting than usual; Menstrual cycle changes one week after receiving Covid vaccine booster; Got period 10 days after the start of previous cycle; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "Got period 10 days after the start of previous cycle and much heavier flow and clotting than usual"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "Menstrual cycle changes one week after receiving Covid vaccine booster"; OLIGOMENORRHOEA (non-serious), outcome "unknown", described as "Got period 10 days after the start of previous cycle"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster".  Additional information: No known underlying conditions or concomitant medication. Experienced menstrual cycle changes one week after receiving Covid vaccine booster. Got period 10 days after the start of previous cycle and much heavier flow and clotting than usual. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Hives on chest and back arms legs and face.  flat, no allergic reaction otherwise,
sore arm; Initial information was received on 24-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient) via social media.  This case was linked to 2020SA308167, 2020SA308168, 2020SA308169, 2020SA308170, 2020SA308171, 2020SA308163, 2020SA308173, 2020SA308174, 2020SA308175 and 2020SA308176 (same reporter).  This case involves a patient of unknown demographics who had sore arm (pain in extremity), when received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient complained of a non-serious sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE. The patient did not get flu.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.