chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for Covid-19; This is a spontaneous report received from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 25Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated she had the first dose of the vaccine on 25Mar2021 and is scheduled for the second dose on 15Apr2021. She has tested positive for COVID-19 since the first dose and asked if she can get the second dose? She asked if it is safe for someone to get the second dose if they have had Covid recently (she asked this multiple times). She stated she is almost symptom free now but the second dose is just a week after she recovers. She stated she doesn't think she should not get it just because she has antibodies. She also asked if she could get the second dose late because she isn't sure if it is too soon to get it after recovering. The reporter classified the event as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Had mild fatigue and developed a rash ( similar to a heat rash) on my torso (back, chest, neck).  The rash cleared up in three days.
Patient received his 2nd dose of Moderna 5 days early from 1st dose, but really 1 day early with the buffer time frame. Patient completed his 207 and scheduled his appointment with the date of 5 April 2021, Patients vaccine card and electronic record stated 7 April 2021. The form screener and vaccinator did not catch the discrepancy and patient was given vaccine. Error was caught when administrative personnel  documented vaccine into electronic record.  Patient was still at the vaccine site and notified.
face, neck red, left arm inflammation,dizziness, naseau, pins an needles in legs, arm pain, flushed face
Redness, heat, swelling, itchy injection site 9 days after vaccine was administered.  Did not see physician
Approximately 9 days prior to ED presentation, the patient began having sore throat, nasal congestion, diaphoresis, and progressively had a cough and shortness of breath. The patient had a positive COVID-19 test prior to ED presentation. On presentation to the ED, the patient had an O2 saturation of 82% on room air. Patient is on 5L O2 by nasal cannula and has improved to 94%. The patient is receiving dexamethasone. The patient will be admitted to the hospital.
Moderate  joint pain in both knees; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 30Mar2021 at 13:30 (at the age of 67-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications included rivaroxaban (XARELTO) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 67-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced no effect after the first dose. On 11Apr2021 at 15:00, 12 days after second vaccination, the patient experienced moderate joint pain in both knees. The patient still enduring moderate pain at the 15-day point. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event joint pain in both knees. On an unknown date, the patient underwent lab test and procedure which included blood test and the result was no indicated problems or abnormalities found. The clinical outcome of the event joint pain in both knees was not resolved at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
She saw a physician the next day, who said she had chickenpox. Mild case for about 1 1/2 weeks.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
This spontaneous report was received from a nurse practitioner, via a company representative, referring to a 14 year old female patient. No medical history, concurrent conditions or drug reactions/allergies were reported. On 15-FEB-2016, the patient was vaccinated with a dose of GARDASIL 9 (lot # reported as 013429, expiration date 21-JUL-2017) intramuscularly (strength was not provided) in the right deltoid. This dose was reported as "the third dose", the first two doses were of the original GARDASIL. On an unknown date, she also received the flu vaccine (manufactured by sanofi) and the hepatitis A vaccine (manufactured by GlaxoSmithKline) at different injection sites. On 15-FEB-2016, on the same day of vaccination, the patient experienced syncope and tonic-clonic motions, the patient was observed by a doctor for about 30 minutes and once symptoms resolved, she was sent home from the office. It was also reported that the adverse events improved on therapy, the patient did not receive any treatment and there was not product quality complaint involved. The outcome of syncope and tonic-clonic motions was reported as recovered on 15-FEB-2016. Lot number 013429 is an invalid lot number for GARDASIL 9. The causality assessment was not provided. Additional information has been requested.
Pt. states that her right arm swole up into twice it's size & there were striations. The swelling began the evening the shot was given. She took anti-inflammatories, so the swelling had gone down to moderate swelling on 10/31 when the patient came to the pharmacy. The patient wanted more info on what to do about swelling other than anti-inflammatories, so she was referred to her primary MD.
5-19-11 - vaccination. 5-20-11 - raised red area, tender noted. 5-24-11 - raised red area increased to 4 cm diameter with tender erythematous area 11 x 16 cm - started prednisone taper.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: Patient had some chest pain & dyspnea the day after the shot. It was sporadic throughout the whole day & came in waves. She had COVID a year ago & experienced moderate chest pain & dyspnea back then. Recent chest pain wasn't as bad as the COVID pain. All symptoms resolved the following day. Chest pain lasted 1 day.
Both times.was in bed several days felt so like really bad flu; Both times.was in bed several days felt so like really bad flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a 57-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of bedridden (1st dose received last year, refer case US2023AMR067490).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza-like symptoms (Verbatim: Both times.was in bed several days felt so like really bad flu) and bedridden (Verbatim: Both times.was in bed several days felt so like really bad flu). Rechallenge with Shingles vaccine was positive. The outcome of the influenza-like symptoms and bedridden were resolved.   It was unknown if the reporter considered the influenza-like symptoms and bedridden to be related to Shingles vaccine.     It was unknown if the company considered the influenza-like symptoms and bedridden to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR067490   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. Last year the patient got Shingles shot vaccine. Both times the patient was in bed several days felt so like really bad flu. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR067490:same patient
She received her first shingrix vaccine in approx April or May of 2023 - she can't remember the date - at pharmacy. States she hasn't felt well since then (mostly fatigue, nausea, vomiting, and pain), and has had numerous shingles flare-ups to her left buttocks since receiving the vaccine. Tried valtrex and acyclovir with no improvement. Has an upcoming appt scheduled with GI to eval and treat ongoing nausea and vomiting. Most recent shingles rash flared up again 7/8/23. She is being referred to Internal Medicine for evaluation and treatment of her ongoing symptoms that started shortly after receiving her first shingles vaccine.
Shortly after she developed tingling sensation; This is a spontaneous report from a contactable consumer (mother/caregiver). A 38-years-old female patient (daughter) received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration in left arm on 30Sep2021 at 12:15 (at the age of 38-year-old) as dose 2, single for COVID-19 immunization. Medical history included eye disorder and sinus disorder. Patient previously took Novocaine and experienced numbness and tingling (Shortly after she developed tingling sensation (similar to when Novocain wears off; like when you had novocaine, there's feeling of numbness). Concomitant medications were not reported. The patient previously received bnt162 (COMIRNATY, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On 30Sep2021, shortly after the administration of vaccine, the patient experienced tingling sensation under her left eye left sinus. It was reported that the tingling sensation (similar to when Novocain wears off; was like when you had novocaine, there's feeling of numbness) under her left eye left sinus after her second vaccine. Outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (Prolonged dizziness like orthostatic hypotension) and ORTHOSTATIC HYPOTENSION (Prolonged dizziness like orthostatic hypotension) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DIZZINESS (Prolonged dizziness like orthostatic hypotension) and ORTHOSTATIC HYPOTENSION (Prolonged dizziness like orthostatic hypotension). At the time of the report, DIZZINESS (Prolonged dizziness like orthostatic hypotension) and ORTHOSTATIC HYPOTENSION (Prolonged dizziness like orthostatic hypotension) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.
Left Deltoid Region, circular skin erythema size 8x9 cm, tender, warm to touch, no discharge.
Uncontrollable Diarrhea, migraine, night sweats, cough, Cardiac Tamponade, cardiac rupture, and cardiac clots.    Symptoms  started hours after shot.   Eventually Death on day 6 post shot.
Fully vaccinated and boosted 11/1/21.   COVID breakthrough infection with inpatient hospital stay
Varicella given on Aug 23, 07. On Aug 31 child presented with approx 50 "chicken pox" lesions.
Information has been received from a registered nurse concerning a female patient who on 05/07/1991 was vaccinated with her second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # not reported).  The patient had previously received a rubella vaccine (Manufacturer unknown) in 1984, mumps vaccine (manufacturer unknown) in 1985 and measles vaccine (manufacturer unknown) in 1986.  Upon entering college, titers were drawn and she was found to have a negative titer.  Unspecified medical attention was sought.  Additional information has been requested.
This spontaneous report was received from other health professional (nurse) refers to an unspecified number of patients of unknown demographics. The patient's past medical history and concomitant medications were not reported. On unknown dates the patients received improperly stored GARDASIL 9 lot # M042853 expiry date 17-JUL-2019 (Dose, frequency, route unknown) for prophylaxis. No adverse effects reported. This one of the 3 reports. Additional information has been requested. .
I had a fever and chills and was very weak and dizzy from late evening of the day I received the vaccination and then for two complete days after that - basically bed bond.  On the third day the fever broke but I was still very weak and dizzy and at least could get out of bed and walk around somewhat.
Vaccines were administered on 10/14/08. Pt is on Enbrel; now having rash, itching, swelling.
headache; fatigue; slight swelling at the injection site; redness; very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE SWELLING (slight swelling at the injection site), VACCINATION SITE ERYTHEMA (redness) and MYALGIA (very sore arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FLUOXETINE, AMLODIPINE and ATORVASTATIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE SWELLING (slight swelling at the injection site), VACCINATION SITE ERYTHEMA (redness) and MYALGIA (very sore arm). At the time of the report, HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE SWELLING (slight swelling at the injection site), VACCINATION SITE ERYTHEMA (redness) and MYALGIA (very sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided
Soreness of injection site. Inflammation/ red. Recommend patient to take an acetaminophen or ibuprofen. Also recommend Benadryl.
4 and a half-year-old girl with a known allergy to dogs presented to the ER for lip  swelling, eye swelling and hives all over her body.  Child had her well-child care visit at which she received DTaP/IPV and MMRV, all antigens she has received before.  Child went to bed and then parents heard her scratching furiously with a very mild cough and when they went to check on her they saw that she had "welts" all over her body.  She also felt very hot so they took her temperature and found it to be 104.  She was not given  any Tylenol or Motrin but given the eye swelling, parents called EMS who responded and gave  child an EpiPen Junior on route to the ED.   Child has been referred to an allergist and is awaiting appointment.
Client reports left arm swelling at injection site sates now size of her palm and "feels hot".
pt recv vax 13MAY96 & 2-3wk post vax exp abd discomfort;later devel nausea & dark stools & was examined by MD;test & exam @ this time did not reveal a specific dx;all test were negative;also exp itching or nerve pain over abd;
father called 26APR96 & states 2hr p/vax pt started screaming & holding head;father states gave pt 3 APAP which relieved the pain;pt taken to PMD for eval that evening;MD felt h/a was probably a side effect of the inj;
At 11:10 AM the vaccinator attempted to inject 0.1 mL of the Jynneos vaccine intradermally into the left forearm. The needle used leaked around the hub and the full dose could not be given. The vaccinator reported this to the event leads. The patient was counseled and the 0.1 mL was administered intradermally into the right forearm successfully. A wheal was formed. This is presumed to be an error with the needle in question.
flu sx, anxiety, drowsiness, fatigue, h/a, pain, tinnitus, SOB, dry mouth, diarrhea, flatulence, myalgia, arthralgia;
I felt fine after the first shot.  The second shot brought me chills, headache, and severe body aches approximately 24 hours after receiving it.
About five hours later I had a 102 fever, I developed bronchitis and my oxygen level was down to 86. I did not feel good at all so I went to the ER. They checked my heart and took my temperature and just gave me some Tylenol and Mucinex and then I was breathing ok so I went home. My oxygen also went back up, they were monitoring that as well as my pulse. The next late morning it was all resolved, after about ten hours of sleep.
Fever 101 F not responsive to acetaminophen; localized swelling, erythema, hot and painful to touch; Treated with continued acetaminophen, oxycodone, and hot packs.
Fever of 101.8 at highest for 36 hours, head pain, eye sensitivity, severe muscle joint pain, severe chills, fatigue, appetite loss. Worse symptom was profuse and urgent bouts of  urination every 30-60 minutes for about 24 hours straight . I also had bad heart palpitations for about 24 hours.
Arm pain, body aches, severe headache, extreme thirst, chest pain, brain fog, fatigue, swollen lymph nodes. Side effects still apparent 72 hours after booster
PTSD response with severe anxiety, depression, and hyperarousal. Pain at injection site, joint pain systemic, weakness, exhaustion.
Sore Throat, Sneezing violently, Stuffiness, Runny Nose, Severe Weakness, Fatigue, Headache, General Aches all over body. Has been going on since about 10/11/2018.
pt recvd vax & exp very brief inject pain; pain was described as short lived irritating & transient; No further info available;
Pt vaccinated with DTP developed persistent fever of 103, redness which resolved, swelling & "lime, green, flourescent stools".
Migraine; nausea; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 05Feb2021 13:30 (at the age of 23-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the hospital. The patient was not pregnant at the time of vaccination. The patient had known allergies with penicillin. Concomitant medication included methylphenidate hydrochloride (CONCERTA) taken for an unspecified indication, start and stop date were not reported. The patient experienced migraine and nausea both on 06Feb2021 09:30 with outcome of recovering. The patient did not received treatment for the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After the shot he was very sick; red leg, rash, crying, would wake at night from this day on and stare into space. Walk around and not know it. Scared me. Fever 103. After vaccination has high pitched screaming, allergy to milk, collapse/unconsciousness, frequent ear infections and frequent sore throats, respiratory infections, frequent fevers, chronically overweight, convulsions with fever, paralysis, joint pain/stiffness(arthritis), and swollen lymph nodes
Patient is a 49 y.o. female with a PMHx of AAT deficiency, HPV infection, DVT, Vitamin D Deficiency, Hypercholesterolemia and Anxiety with complaints of acute left arm numbness that radiates into her left digits and chest tightness that began 12-13 min after receipt of the COVID-19 vaccine. She noted numbness radiation into the left side of the neck and the bilateral ears. She voices she has also developed chest tightness and wheezing. Evaluated in the emergency department treated with diphenhydramine 25mg, epinephrine 0.3mg and dexamethasone 10mg
Nausea; Vomiting; Headache; Body ache; Exhaustion; Mood swing; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Apr2021 at 20:00 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic sinus infection. The patient had unspecified known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. On 27Apr2021 at 00:00, the patient experienced nausea, vomiting, headache, body ache, exhaustion and mood swing that just keep going two weeks later (at the time of report). The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event nausea, vomiting, headache, body ache, exhaustion and mood swing was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Big mouth sore, Rash on her face, heavy around the eyes; face especially eyes swollen, lymph nodes enlarged, body rash (neck, back, chest, arms, thighs, back of the knees) 1/6/21-Pediatrician visit -COVID negative, comprehensive metabolic panel ok, Valtrex cream for possible eczema prescribed. 1/8/21-Dermatologist visit -Nizoral shampoo 2% for scalp and face, TAC 0.1% ointment for eyelids and posterior scalp; Cerave cleanser; anti-histamines, Benadryl, mupirocin topical 2%, skin biopsy and auto immune panel bloodwork 1/20/21-Face rash better; body rash worse-Another Dermatologist appt. Autoimmune bloodwork showed positive ANA of 1:320; skin biopsy possible psoriasis 2/1/21-Rheumatologist visit
This spontaneous report was received from a Licensed Vocational Nurse (LVN) referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (lot # L011085, expiry date: 01-APR-2017; lot# L012036, expiry date: 07-APR-2017; lot# L016126, expiry date: 06-MAY-2017, dose, route and frequency unspecified). Other suspect and concomitant therapies were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.