chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right ear Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Feb2021 17:00 (Lot number: EL9269) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Previous dose details:, Prev dose product=COVID 19, Prev dose brand= Pfizer, Prev dose lot unknown=False, Prev dose lot number= EL0142, Prev dose administration date: 14Jan2021, Prev dose administration time=05:00 PM, Prev dose vaccine location=Right arm, Prev dose dose number=1), administration date: 14Jan2021, when the patient was 54 years old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 06Feb2021, outcome "not recovered", described as "Right ear Tinnitus". The event "right ear tinnitus" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: The event was treated with Antibiotics and steroids. Facility type vaccine was Hospital. The patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. The patient did not have Covid prior vaccination and did not Covid tested post vaccination. The patient did not have known allergies. Other medical history was none.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. The patients' concurrent conditions, medical history and concomitant medications were not reported. Since 19-JUN-2016, the patients' were vaccinated with improperly stored doses of GARDASIL from lot # L040459 with expiry date of 06-AP-2017 (dose, dose number and route not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
within a few minutes patient became dizzy, hypertensive (202/104) and tachycardic (139). Over ~45 minutes blood pressure down to 130/79 and HR to 81.   Released patient per his request.
Treatment of COVID-19/Positive for covid 19; Treatment of COVID-19/Positive for covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: Oj2524) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EL9266) at the age of 67 years, in left arm, on 29Mar2021 as dose 2, single (Lot number: Er8730) at the age of 67 years, in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: Ff2587) at the age of 68 years, in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: Fk9895) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2017; ATORVASTATIN, start date: 01Jan2006, stop date: 29Dec2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2022, outcome "unknown" and all described as "Treatment of COVID-19/Positive for covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2022) Positive, notes: Positive for covid 19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  No follow-up attempts are possible. No further information is expected.
big bump below her arm; itchy; rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (big bump below her arm), PRURITUS (itchy) and RASH (rash) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (big bump below her arm), PRURITUS (itchy) and RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (big bump below her arm), PRURITUS (itchy) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Approx 4 rhs p/immun had high pitched cry & became limp & unresponsive; color gray;
SYSTEMIC JOINT SWELLING IN ALL JOINTS, LOSS OF MUSCLE MASS DUE TO IMMOBILITY, THORASIC  BURNING PAIN BETWEEN SHOULDERS, NOW HAVE CARPEL TUNNEL IN BOTH WRISTS, CHRONIC PAIN, HANDS ARE NUMB AND CLAWLIKE.  GOING ON 6 MONTHS WITH THESE SIDE EFFECTS.
This spontaneous reported by a consumer, describes the occurrence of pain in extremity (sore arm, achy arm) and tenderness (tender arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 011M21A and 002B21A) for COVID-19 immunization. No medical history reported. On Feb 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 15, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 25, 2021, patient experienced pain in extremity (sore arm, achy arm). On an unknown date, patient experienced  tenderness (tender arm). At the time of the report, pain in extremity (sore arm, achy arm) and tenderness (tender arm): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Patient took Tylenol for prophylaxis. This case linked to MOD-2021-060931 (patient link).
Resident was tested on April 12, 2021,  Results came back detected for COVID.  Resident is asymtomatic at the time of this report.
Pre-exposure rabies-48 hrs post vaccine-left (side vaccine administered) axillary lymphadenopathy, slight fever and lightheadedness-lightheadedness & fever went away w/in 3 days, still had lympadenopathy 1 week later (time for 2nd dose); administered 2nd dose after evaluating risk with CDC on the right side-36 hrs post 2nd vaccine no right sided lymphadenopathy, but the left is larger and feels as though skin is sensitive.  Client currently also receiving tattoos.  Referred client to PMD
With in a few hours of the shot I had pain up and down my right arm, up and down my right side and into my shoulder/ neck.  I went to home and had a slight fever with chills and could not sleep that night. I called off from work and stayed home. Over the weekend the pain in my neck. shoulder and arm continued.  I went to a chiropractor treatment that Tuesday 3/2/21. He made some adjustments and the shoulder / upper arm still did not feel better.  My right arm became more numb and weak on Thursday 3/4/2021 . My wife was sitting next me on our couch when I suddenly had a spasm in the upper arm.  The next morning I waking and had even more trouble lifting the arm or moving it. I attempted to suffer through it thinking it would get better.  Over that weekend conditions with the arm became even worse and was unable to lift it. I returned to chiropractor. He evaluated me and i described what had happened after the second covid shot.  He  recommend an MRI and I attempted to contact my PCP. With no answer from the PCP i went to the ED who said My PCP would need to order a MRI. I was then sent to physical  therapy and Orthopedics. They ordered an X ray and MRI. Both showed nothing.  Still seeing physical therapy with some improvement and movement. Have a EMG scheduled for April 22,2021
Patient describes nausea and mild dizziness . Patient being sent home with mother who is driver . ER precautions given . Patient advised to follow-up with PCM for persistent symptoms.
Starting around the beginning of May, I realized I had a receding hairline especially above my ears. I went to see the physician 5/21/2021 and the Doctor said it could be an autoimmune response. Unknown reason for the hair loss at the moment. It hasn't been progressing now that I have noticed it. It seems to have stabilized. Topical - Minoxidil - liquid OTC to use for it (apply to scalp) and I have been using it somewhat inconsistently. It is still present - the loss.
Severe bodyaches Headache  Diarrhea Chills Sweating Metal taste in mouth Severe fatigue
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 02-MAY-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0079AE, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
5 patients were vaccinated on 13 Apr 2022,expiration date was on 02 Apr 2022; Expired dose administered to 5 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 5 patients) and PRODUCT STORAGE ERROR (5 patients were vaccinated on 13 Apr 2022,expiration date was on 02 Apr 2022) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 5 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (5 patients were vaccinated on 13 Apr 2022,expiration date was on 02 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 5 patients) and PRODUCT STORAGE ERROR (5 patients were vaccinated on 13 Apr 2022,expiration date was on 02 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.    The vial was initially stored in the refrigerator on 14-Mar-2022.  No treatment information was reported.
Fever (103), chills, body aches, dizziness, headache, nausea, fatigue, headache, and mensural period stopped.  I was on the day two of my period which is regular and follows a normal cycle.  It stopped while I was having the reaction to the vaccine and then started again 48 hours later.
Dermatitis and herpes zoster.; Dermatitis and herpes zoster.; Information has been received from a lawyer referring to a patient of unknown age and gender. Information regrading the patient's pertinent medical history, known allergies, concurrent conditions and concomitant medications was not provided. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date ,the patient experienced dermatitis and herpes zoster. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of  zoster vaccine live (ZOSTAVAX) vaccination, symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. Furthermore, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of dermatitis and herpes zoster was determined to be not recovered.     The reporter considered dermatitis and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Cellulitis of left deltoid 8 cm x 6 cm  Tx: Cephalexin 500mg TID x 7 days
Was given Varicella vaccine in RA sub-q.  1 day later he had a very large 1" blister at site of injection and within 1 week had scarring, which he still has.
Patient with cognitive impairment presented for a booster dose of Moderna with a picture of some of his doses on a COVID card on his phone. Unknowingly, a 5th dose was given.
Pt fully vaccinated in February 2021 and admitted to hospital for fatigue and weakness.  Found to be positive for COVID-19.  Discharge on 6/28/2021.  Pt previously had COVID-19 in September 2020.
Bleeding in stool; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 26Mar2021 10:30 am (Batch/Lot Number: Er8733) as single dose for covid-19 immunisation. The patient medical history was none. Concomitant medications within 2 weeks included amlodipine; cetirizine hydrochloride (CETRIZINE); carvedilol; oxymetazoline hydrochloride (AFRIN); diclofenac; and diclofeafrin, diclofe. Patient previously received first dose of bnt162b2 on 03Mar2021 10:00 AM at age of 61-year-old for covid-19 immunisation. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The patient experienced bleeding in stool on 26Mar2021 with outcome of not recovered. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient didn't receive treatment for the event. The report was considered as non-serious.
Pneumonia; Feeling weird; Stomach problems; Sinus problems; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ulcers aphthous oral and Hernia.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling weird), ABDOMINAL DISCOMFORT (Stomach problems) and SINUS DISORDER (Sinus problems). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia), FEELING ABNORMAL (Feeling weird) and SINUS DISORDER (Sinus problems) outcome was unknown and ABDOMINAL DISCOMFORT (Stomach problems) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt was brought to hosp by squad; DOA; pt apparently was healthy & put to bed by mom & found unresponsive @ approx 11PM & squad was called;
21FEB92 830PM pt had high pitched cry the evening p/vax x 2 hrs cried to sleep, t101 no seizures; 22FEB92 withdrawn poor appetite no seizure;
Fever of 102F beginning exactly 1 week after MMR vaccine, lasting 3 days, followed by aching for 3 days.  Abdominal rash beginning 12 days after vaccine, lasting 3 days.
they gave daptacel on yesterday and just discovered that the vaccine had expired; Initial information received on 30-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a female patient of unknown age who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that they gave Daptacel on yesterday and just discovered that the vaccine had expired.  The patient's past vaccination(s) included PEDIARIX. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A).  On an unknown date, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5206AA and expiry date: 17-May-2019 via intramuscular route in the left thigh.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Vertigo, after the first and second vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 15:30 (Lot number: ER8734) at the age of 64 years as dose 1, single and administered in arm left, administration date 22Apr2021 10:15 (Lot number: ER8735) as dose 2, single for covid-19 immunisation. Family history included: "Covid virus" (unspecified if ongoing), notes: Verbatim: Her daughter got the Covid virus. The patient's concomitant medications were not reported. The following information was reported: VERTIGO (non-serious) with onset 04Apr2021, outcome "not recovered", described as "Vertigo, after the first and second vaccine". The event "vertigo, after the first and second vaccine" was evaluated at the physician office visit. Additional information: NDC number and Expiry Date of the vaccine were Unknown. The Patient did not have any Medical History (including any illness at time of vaccination). There was not any Family Medical History Relevant to Adverse Event. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Adverse Event following prior vaccinations. Additional Context: The reporter stated that she is calling about the Pfizer and confirmed as Covid shot. She reported after the first vaccine she had Vertigo. She also stated that a couple of days before the second shot, she felt better, and before the second shot, she got over, the Vertigo. She also reported that she had the second vaccine, and she has had vertigo ever since.  she was fine in the afternoon of the second vaccine and the next morning when she got up, she had the Vertigo again. She also was agreeing to fill out a safety report. Initially she also stated that she did not know the date that it started after the first vaccine. Later in the call, she reported the date as 04Apr2021. She has health problems, and her daughter got the Covid virus. She stated her daughter had a rough time and she felt, because of that, she should get the Covid vaccine. She also stated s initially, she was not planning on getting the vaccine. She is on all the same medications and does not feel they are relevant to the report. She saw her doctor twice, on the phone, once after the first vaccine and once after the second vaccine.  She reported that some days are worse than others.  She did not have Relevant Tests.   No follow-up attempts are possible. No further information is expected.
Patients face was red starting the day of her second vaccine. The next day she reports welts on her face and neck. I recommended that she take Benadryl to contact her primary care physician.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 20-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Patient had a few hives, discussed that since they didn't occur until over a week later did not appear to be related. Patient received the second dose, and had hives a few days later, at one week post reaction patient began to have a lump in her throat and went to hospital, patient was given prednisone, patient had to go to days in a row.
At 9pm went to bed early. Just felt crummy. Slept poorly. Temperature at 3:30 am on 2/25/2021 was 101.4. F. Took one 500mg Tylenol. Slept better. Fatigue all day. By 2/26/2021 I?m feeling back to normal.
The first day after vaccine I began to have a severe headache a few hours later that turned into a migraine. The following weekend I had mirgaine, sore throat, body aches, chills, hot flashes, loss of appetite which lasted until Tuesday of the following week.
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a four months old female patient who was vaccinated with the components of PENTACEL separately and mixed the HIB with sterile water rather than 0.4% saline on 13-Nov-2018 (HIB batch number: C55428A, Expiry date: 08-SEP-2019 and IPV lot number: C5408AA, expiry date: 08-Sep-2019). The subject received the vaccine in the left thigh The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. It was an actual medication error due to inappropriate reconstitution technique. The patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
The following day I had a fever (100.7), headache and fatigue. It was gone by the next morning.
Had numbness in left and right arm and hand and left leg and foot - it was off and on and has started to subside but do get occasional tingling in both hands
Patient came to ED with shortness of breath and chest pain.  Patient admitted to hospital with Covid.
Pt recv vax on 11/4/98; 1 hr post vax pt exp vax site pain w/ swelling, whelps, raised; developed blisters in mouth; aching all over