chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous consumer report (initial receipt 20-Jul-2011) concerns a male patient with a medical history of stroke. Concomitant medications included unknown blood thinners. On an unknown date 3 years ago (??-???-2008), the patient received a flu vaccine. At the same time, the patient also received additional suspect drug, ZOSTAVAX, for prevention of shingles. On an unknown date 3 years ago (??-???-2008), the patient then experienced vertigo in which he became hospitalised. The patient sought medical attention and was hospitalised for one week. The patient still experiences vertigo once in a while as a result. The event outcome was recovering. The suspect drug ZOSTAVAX was not re-introduced. The reporter considered events serious due to hospitalisation.
p/vax pt lt thigh appeared swollen, erythema noted tenderness @ inj site per mom;lt thigh measurement 14 1/2inches;rt thigh 12 1/2inches;pt afeb;T98.4;pt appeared happy;mom instructed to give APAP PRN & ice pack;cellulitis lt thigh;
This spontaneous report was received from a physician, via a company representative, referring to an unknown number of child patients between 7-10 years old of unknown gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (manufacturer unknown) for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients were hospitalized for an unknown reason (adverse event). At the reporting time, the outcome of adverse event was unknown. The causality assessment was not provided. Sender's Comments: US-009507513-1905USA004181: US-009507513-1904USA013391: US-009507513-1905USA004179: US-009507513-1905USA004178: US-009507513-1905USA004182: US-009507513-1905USA004177.
Initially experienced severe B elbow pain on anterior side that resolved within 48 hours. Noted that clothing seemed tight- especially underwear, bras, and shirts, arms and breasts visibly swollen on both sides. Breasts itchy. Some shortness of breath noticed that was surprising x3 during week. I am 1 week post vaccine and put 2+2 together this AM. Initially thought that I must have put something in the dryer for too long, but EVERYTHING fits tightly. I recently had shoulder surgery and purchased clothing that was loosely fitting and It is now tight.  My BP on home machine is 133/86, which is generally normal for me. No fever. Fatigued all week that could be attributed to this or heavy workload. Generally feel good. Distal extremities normal in size.
Severe itching at site of injection immediately after booster was given. Severe swelling occured approximately 24 hours after shot was given, with large red spot (about size of softball), heat and itching at/around site of injection. No pain in arm. After 48 hours, swelling has substantially reduced, with site at injection hard and red. Site still itches and red spot is same size.
have 2 shots & still got shingles/Suspected vaccination failure; shingles; Very painful; burning; blisters; still off for 3 weeks; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, burning sensation, blister and malaise. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, burning sensation, blister and malaise were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, burning sensation, blister and malaise to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the 2 shingles shot and still got shingles. The patient reported that it was very painful & burning blisters but it could had been worse without the shots. The patient was still off for 3 weeks. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report as received from a 66 year old male patient refers to himself. No medical history and drug reactions/allergies were reported. On 21-AUG-2013, the patient was vaccinated with ZOSTAVAX (lot # J000495, expiration date 14-APR-2014) vial injection (dose and route not provided). 12 hrs after receiving ZOSTAVAX on 21 or 22-AUG-2013, the patient experienced flu-like symptoms and elevated body temperature. The patient's overall symptoms included upset digestive system, joint discomfort and extremely hyper-sensitive skin. The patient self medicated with TAGAMET. The outcome of the events was unknown. The causality between the events and therapy with ZOSTAVAX was unknown. Additional information is not expected.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 21-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Information has been received from a consumer concerning a 7 year old male with no known medical history or allergies who on 10/15/98 was vaccinated in his right arm with a first dose of varicella virus vaccine live (lot # 627747/1058H). There was no illness at the time of vaccination. Two weeks following his infant sister's immunization with varicella virus vaccine live, the patient developed a mild, atypical case of varicella with approximately 10 lesions. No fever was noted. Follow up information from the physician indicated that on 10/5/04 the patient developed varicella disease with a fever of 102 degrees F and a rash. No other adverse events were noted. Additional information is not expected.
pt recvd vax 2MAR93 & woke up 3MAR93 w/swollen area & couldn't move rt arm by last noc are tender-difficult to move arm; This AM 4MAR93 tender red approx 4" diameter swollen-below area of inject; no fever;
Pt recv vax and became ill promptly after. A diagnosis of giant cell arteritis was made and patient was treated w/prednisone.
Splotchy, raised, itchy red bump on arm around injection site ... maybe 5x5.:General itchiness.
felt off in the middle of the night; migraine; 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 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 (Lot number: EW0181) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "essential tremors" (unspecified if ongoing); "deep brain stimulator" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2, for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "felt off in the middle of the night"; MIGRAINE (non-serious) with onset 23Jul2021, outcome "recovered" (24Jul2021), described as "migraine".  Additional Information:  Caller stated she developed a migraine and felt off in the middle of the night and she was bouncing off the wall to get to the bathroom, lying down helped this. The off feeling lasted all day Saturday and her family wanted her to go to the ER but she called an after hours surgeon who comforted her. On Sunday she reports she still wasn't steady, but today is back to normal. Caller is stressed and seeking information if she should receieve her second dose of the vaccination series.  Clinical course: The caller called into her newer surgeon. The caller states she has a condition similar to Parkinson's, but it is called essential tremors. The caller has a DBS, deep brain stimulator in her brain and batteries in the caller's chest. The caller was hesitant to receive the first dose Pfizer Covid 19 Vaccine due to having these pre-existing conditions. The caller had the instruction sheet from Rite Aid and saw that the migraine can happen. The caller is currently 71 years old, turned 71 on Sunday, 25Jul2021. Everything was on and was okay with the battery. The feeling off only seemed to last maybe 24 hours. The caller's weight is probably right now what it was when the caller was pregnant 47 years ago. The caller is about 190lbs. The caller clarifies the surgeries referenced occurred prior to receiving the first dose Pfizer Covid 19 Vaccine, like 2 years ago. The caller states in the past she has had the shingles and the flu vaccines. AE(s) did not require a visit to Emergency Room or Physician Office. Everybody in caller's family was worried and need to go to ER and caller didn't want to go to the emergency room, the patient called the newer surgeon, even though she knew they weren't in, given an emergency number. Prior Vaccinations (within 4 weeks) no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Even after new shingle vaccine, had two of them, no reaction. The caller states these vaccines occurred when the caller did not have her deep brain stimulator.  Follow-up (11Aug2021): Follow-up attempts are completed. No further information is expected.
Large red area to right thigh approximately 5 inch in diameter; warm to touch. Benadryl 1-2 teaspoons ever 6 hours. Pediapred 5/5 1 teaspoon PO TID for 4 days.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 70 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Pneumonia shot (my arm hurt a little bit, I've had other shots that hurt 10x worse), for immunisation, reaction(s): "my arm hurt"; Tetanus shot (his arm was much more sore after the tetanus shot), for immunisation, reaction(s): "arm was much more sore". The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my arm hurt a little bit". Additional information: The patient is taking blood thinners before taking the first dose until now and wanted to know if it was okay. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna COVID-19 Vaccine  Suddenly developed extreme dryness and itchiness which only mildly responded to lotion and body oil. Did not contact dr as I had no shortness of breath or hives. My sister told me she had experienced the same thing after being vaccinated.  We both are reporting it. I had thought it was due to an antibiotic until she described her symptoms to me.
PATIENT RECEIVED A SUBCUTANEOU INJECTION TO HER LEFT ARM. NO ADVERSE EVENTS OCCURRED. PATIENT WAS UNABLE TO RECEIVE AN INTRADERMAL INJECTION, THEREFORE VACCINE WAS ADMINISTERED SUBCUTANEOUSLY.
Right side of the head has pressure, ringing in the right ear, right arm sore, and no energy. Was provided medication by healthcare professional. (Prednisone 10mg)
I had a slight headache while at work but was fine. I was home and was a little cold and my throat was scratchy. . Then about 9pm all of a sudden I started to get waves of chills. My hand were cold and my feet were frozen. I layered up with sweater and sweatpants to go to bed with a heavy comforter. I just could not get warm. About 1am, I woke up and put on my thick winter socks on because my feet were still frozen. I kept reminding myself to breathe in deeply.  I checked my BPM and it was 80-82 and normally its about low  70s. I woke up about 5:30am and had a really bad headache, injection area and arm hurt, my  body hurt and felt like I weighed several tons making me so slow. I didn't go to work the next day. My husband took my son to school and I took ibuprofen and went back to bed. Woke up again about 12:30 and felt better.
A cyst appeared on my right breast; primary cutaneous small/medium cd4+ t-cell lymphoproliferative disorder; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 as dose 2, single (Lot number: FK4554) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "known allergies Sulfa" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: Prior vaccination. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, lot number: FK9895), administration date: 19Mar2022, when the patient was 31-year-old, for COVID-19 immunization. No other vaccine in four weeks. The following information was reported: BREAST CYST (medically significant) with onset 14May2022, outcome "unknown", described as "A cyst appeared on my right breast"; LYMPHOPROLIFERATIVE DISORDER (medically significant) with onset 14May2022, outcome "unknown", described as "primary cutaneous small/medium cd4+ t-cell lymphoproliferative disorder". The events "a cyst appeared on my right breast" and "primary cutaneous small/medium cd4+ t-cell lymphoproliferative disorder" required physician office visit. A cyst appeared on right breast that was tested at various labs and ultimately determined to be primary cutaneous small/medium cd4+ t-cell lymphoproliferative disorder. Dermatology journal found indicated, "This case series found cutaneous T-cell-rich lymphoid infiltrates to be rare but potential complications after Pfizer/BioNTech COVID-19 mRNA vaccination." Therapeutic measures were taken as a result of breast cyst, lymphoproliferative disorder. Adverse events treatment included surgical removal of cyst, oncologist visit and labs. The patient was not covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Local swelling & redness noted 5/14/11 better by 5/17/11 only minimal itching used BENADRYL orally & oral MOTRIN .
1707- Patient in observation area and vomited on floor. Emesis white. Mask removed. Patient's lips appeared pale. Communicare team called for assistance. BP 128/88, HR 111, O2 sat 97%. Patient denies headache or dizziness. Denies further nausea. Reports feeling 'anxious'. Patient offered juice.    1711- HR 104,O2 sat 99%, RR 18.  denies nausea, continues to report anxiety, patient sipping juice.    1718- Lips and skin pink and dry, denies further nausea. BP 118/82 HR 100, O2 sat 98%. Patient reports feeling better.   1720- HR 100, O2 sat 99%. Denies dizziness. Communicare provider discussed with family that reaction likely from being nervous and that he would 'do fine with his next shot".    1728- HR 100, ambulated to private vehicle with parent and this provider. HR after ambulation 104, no dizziness, O2 sat 99%. ER precautions reviewed via interpreter. Father stated understanding.
Fever; sick two weeks after getting the first dose; soreness; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via unspecified route of administration on an unknown date about two weeks ago from the date of report, in Jan2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. After receiving the vaccine, patient had some soreness. On 27Jan2021 (a day prior to the report), patient had a fever and was sick two weeks after getting the first dose. The patient thought he had COVID and underwent COVID-19 test and it was revealed that the patient was negative. The patient wanted to know if side effects appear that long after getting the vaccine and the time frame to get the second dose was 3 weeks or shorter. Outcome of the events was reported as unknown.  No follow-up attempts were possible. Information on Lot/batch number cannot be obtained. No further information was expected
1) Arm muscle soreness at injection site & generalized fatigue for 2-3 days after vaccine; 2) REASON FOR THIS REPORT: then onset 1 week after vaccine of severe spinal pain radiating down both legs, severe headache, low grade fever, night sweat X 1 night, chills & fatigue progressively worsening over 3 days with no known exposure to meningitis or any other viral illness. Symptoms peaked in severity from 11/13pm-11/14pm and relieved after acupuncture and several days of ibuprofen and rest.
on 12/8 I noticed a tiny itchy hive by my right eye. That night the soles of my feet and palms of my hands started itching intensely. The next night it itched so much it woke me up in the middle of the night. On 12/12 I noticed a tiny hive or more on other areas of my body that started itching. Random places that seem to be covered by clothing or accessories. Took Benadryl the night of 12/12 and it seemed to help. Took another Benadryl this morning when I saw more random hives. Seeing my dermatologist later today.
Patient initially felt dizzy which resolved after a couple of minutes. Patient stated she felt better, just "tired". She went to her locker, felt dizzy and went to Nursing office at 10:57 pm via wheelchair.
Local erythema at least 2" x 2" mottled, no edema. 15 hrs later, pt has erythematous slightly raised circle over injection site with warmth. The next morning noted palpitations they resolved.
We report a rapid onset of severe diabetes ketoacidosis (DKA) and transient profound insulin resistance in a 24-year-old female with type 1 diabetes after administration of the second dose of the COVID-19 vaccine.  Patient required ICU admission
The patient referred that has no symptoms. POC was with her, until she died. She died of Alzheimer's, diabetes and a sacral ulcer that she brought when she was admitted.
Immediately following injection, patient developed a golf-ball sized hard mass around the injection site. There was a little blood, but the mass didn't appear red or warm after 10 minutes of monitoring. Advised patient to go home and ice injection site, and take some ibuprofen.
tightness in chest and feeling of swelling in neck. wheezing r/t SOB. 1L NS bolus IV, Decadron 8mg po, Benadryl 25mg IVP, O2
Arm very sore, feeling weaker and weaker, aching, migraine, fever 101, vomiting -- visit MD on Monday.
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from non-healthcare professional (reported as Pharmacy technician). This case involves a 65 years old patient who received 0.5ml of vaccine FLUZONE HIGH DOSE (batch number: UJ044AB) (expiry date and site of administration were not reported) via intramuscular route in the left deltoid on 29-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunization. It was case of actual medication error due to incorrect product storage. No adverse event was reported. 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.
Large red area on front side of arm; wife states redness started at site of injection and moved down arm; looks blistered/blood and inflamed, some skin peeling at site.
fever; chills; rashes; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and RASH (rashes) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 16M220A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and RASH (rashes). At the time of the report, PYREXIA (fever), CHILLS (chills) and RASH (rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Significant histamine reaction, fatigue, general malaise lasting 5-6 days. If these are not considered adverse events, please disregard this report.
Intense muscle aches, fatigue, injection site pain, headache,  brain fog, low grade fever.
Patient tested positive for COVID a week and a half after having received BNT162b2; This is a spontaneous report from a contactable consumer (patient), via the Pfizer sponsored program   A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID a week and a half after having received BNT162b2. No further information was reported.    Information on the lot/batch number has been requested.
administered on 19Oct2022, expiration 30Sep2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 65-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 19th October 2022, the patient received the 2nd dose of Havrix. On 19th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: This was the patient's second dose in the series. At the time of reporting, a repeat dose has not been administered. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havirx, which led to expired vaccine used.