chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got the flu vaccine at ~ 5 pm.  Around 1 am she woke us up and was tossing and turning and burning up.  It is now 1 pm  and she is still running a fever of about 102, not eating, and generally miserable. Most years she has a fever with the flu vaccine so we are consulting her pediatrician about whether she should receive this vaccine in the future. We are not sure which brand of vaccine she got; I selected the first one since it is marked as an essential item..
About 4 hours after receiving the vaccine, I began to feel very nauseous and awful. I ended up throwing up twice. I went extremely pale. My lips and fingers were blue. I was incredibly cold, shaking and simultaneously felt hot. I also almost blacked-out. The shaking lasted for about an hour. I continued to feel sick and exhausted for about a week, but felt much better after the first day.
vaccine was reconstituted and drawn into a syringe, then by mistake another diluent was drawn in the same syringe; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted product preparation error in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted product preparation error (Verbatim: vaccine was reconstituted and drawn into a syringe, then by mistake another diluent was drawn in the same syringe). The outcome of the intercepted product preparation error was unknown.   Additional Information: GSK Receipt Date: 16-OCT-2023 The pharmacist called to report one Arexvy vaccine was reconstituted and drawn into a syringe, then by mistake another diluent was drawn in the same syringe with first vaccine still there (Intend was to reconstitute a second Arexvy vaccine) which led to intercepted product preparation error. Then pharmacist realized that the first vaccine was still in the syringe so called for guidance to what to do with the syringe that contains 1 Arexvy vaccine plus another diluent mixed together. The reporter did not consent to follow-up. The vaccine administration facility is the same as primary reporter. No lot number was reported. No patients were involved, the vaccine was not administered at the moment of call.
Information has been received from a registered nurse concerning a female who on unspecified dates was vaccinated with first and second doses, respectively, of GARDASIL vaccine (yeast) (lot#s not reported). Nurse reported that the patient fainted shortly after receiving her second dose of GARDASIL vaccine (yeast). Nurse reported that she gave the patient something to drink and then the patient "was fine". It was also reported that the patient had not eaten anything for several hours prior to her office visit. Unspecified medical attention was sought. No further information was provided. Additional information is not expected.
Injection site with severe erythema and severe edema and pain.  Rx: Ibuprofen 400 MG PO Q6hrs. RX: Benedryl 25 MG PO Q 6hrs. RX: Prelone 15/5 susp. 45mg po day #1 30mg po day #2 22.5mg po day #3 15mg po day #4.
vaccine administered to 16-year-old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 16-year-old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 16-year-old). On 03-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 16-year-old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Tightness and some tingling started in right shoulder/clavicle area spreading into neck and right cheek, and eventually in right hand. Has added layers of warmth around neck and torso has had on for about 3 and half hours. Tingling/tightness is decreasing.
high pitched screaming lasted 2 1/2 hrs, fussy & fever 101.8 for 12 hrs;
Swelling, redness, itching, hot to touch, swollen lymphnode in left underarm.
Two weeks after getting the second  Moderna COVID-19 vaccine I started to get chills, coughing, sneezing and feeling sluggish.  Water tasted terrible as the months continued, I began loosing weight because food was not appetizing and I cut back on eating.  I tried drinking water and then started drinking Gatorade.  I felt so bad on August 28, 2021 that I went to the Emergency room. Various tests were done and one test showed two nodules on my adrenal glands.  Still feeling terrible with chills, I went home.  I continued to loose weight and was getting weaker.  I had some doctor visits but nothing resulted.  I accompanied my partner to an orthopedic surgeon because he had a small fracture of the Tibia.  While in that doctors office I began sweating profusely and passed out.  I was told I was out for ABOUT 4/5 MINUTES.  That doctor called for various machines to be brought in and my blood pressure had dropped to 50/44 with 44 BPM.  Sugar and EKG were normal.  I turned down going to the Hospital at that time and my partner drove me home.   On December 6th, I was so weak I fell twice while trying to make my way to the bathroom.  In the bathroom I hit my head and passed out.  My partner called for the ambulance and I was taken to  Hospital.  They worked on me in the Hospital and I was admitted.  Many tests were taken and it was finally determined that I had ADRENAL INSUFFICIENCY.  I suspect the MODERNA vaccine led to this problem
headache; left arm pain; chills; body aches; This is a spontaneous report from a contactable consumer. A 45-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 17Feb2021 11:30 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. Medical history included irritable bowel syndrome and GERD (gastrooesophageal reflux disease) from an unknown date and unknown if ongoing. Concomitant medication(s) included probiotics taken for an unspecified indication, start and stop date were not reported; clotrimazole taken for an unspecified indication, start and stop date were not reported; diphenhydramine taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. The patient previously administered first of BNT162B2 (lot number :EL3247) on 27Jan2021 11:30 AM administered in Left arm for covid-19 immunisation. The patient experienced headache, left arm pain, chills and body aches on 17Feb2021 11:45. The patient did not received prior vaccination and covid tested post vaccination and also reported known allergies as no. Therapeutic measures were taken as a result of headache, left arm pain, chills and body aches and included treatment with acetaminophen 500 mg x 2 tablets. The outcome of the events was reported as not recovered.
A timing error occurred for a patient who got their second dose of Moderna COVID-19 vaccine 19 days after their first dose instead of 28 days after their initial dose.  The error was realized after the patient's appointment was completed. At our hospital we allow a window of at least 24 days from the initial Moderna dose and this was early in terms of this allowance as well.    A huddle occurred at the vaccination location where all staff (registrars, pharmacy, nurses/vaccinators) were informed of the acceptable time frame indicating the minimum date.  Signs were created for daily use.
This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 31-AUG-2016, the patient was vaccinated with ZOSTAVAX injection lot # K009769, expiration date 9-OCT-2015 (dose, strength, route of administration were not provided). There were no concomitant medications provided. No adverse effects were reported and product quality complain was not involved. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 2015, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 10-FEB-2015, the patient was treated at a physician office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Chills and hot flashes, stomach pains.  Reporting flu like symptoms, cotton mouth, and diarrhea.
pt recv vax & pt was tested for a varicella titer & the results showed a lack of seroconversion;
Slight headache in evening. Sore throat the next day (3year daughter also with runny nose. I got a head cold a week later).
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012488 with expiry date: 20-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
"Woke up with a rash on stomach, chest, neck, and back.  Rash does not itch."
Edema of lips, red eyes, hives on arms, back of head, chest tightness. Patient took BENADRYL. Rx for prednisone taper.
Fatigue, Nausea, Headache, Muscle Aches, Fever All symptoms were resolved by 4a 3/23/21
Flu like symptoms. Started about 4 days after injection, with fever (less than 100 degrees), nausea, malaise, frequent cough with thick white sputum. Took "MUCINEX" and "TYLENOL" for two days and symptoms persist. Dr. ordered by phone: "Amoxicillin" - 875 mg., 1 tablet every 12 hours, daily, for 10 days and "NYQUIL". Now, recovery with mild residual cough.
The first dose hit him the same way the second dose hit others who did not have COVID-19 before; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (The first dose hit him the same way the second dose hit others who did not have COVID-19 before) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042K21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (it came back positive) in November 2020 and Feeling unwell (wasn't feeling well) in November 2020.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (The first dose hit him the same way the second dose hit others who did not have COVID-19 before). At the time of the report, VACCINATION COMPLICATION (The first dose hit him the same way the second dose hit others who did not have COVID-19 before) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that they had hybrid immunity since the patient experienced COVID -19 in  Nov-2020 and then received the vaccine Concomitant medication use was unknown Treatment information was unknown   This case was linked to MOD-2021-409884, MOD-2021-409895 (Patient Link).
I woke up the next day I had body aches and felt really weak but that lasted about 2-3 days. A week later on the 17th I had a extreme headache and went to the ER my blood pressure was really high and my chest got really tight. I got a chest x-ray, EKG and lab work and everything came back fine. I went to the cardiologist 2/23/22 and they recommended I come back in March for a stress test.
Fever started in middle of the the night. 101.8 by 7.30am.  Headache, lethargic, and lack of appetite throughout the day of 4/14/21.  Treated with 500mg acetaminophen every 4 hours. Discounted after 3 doses.  Fever down to 100.1 at 8pm and other symptoms  were gone.  Sore arm started 5 hours after injection and continued for 48 hours - no treatment needed.
Moderna COVID-19 Vaccine EUA  I had two adverse events after my second dose: - rapid heartbeat for almost 2 hours starting about 16 hours after vaccination (ceased after this amount of time) - slightly over 48 hours after vaccination, I lost my sense of taste (I ate peanut butter) - not recovered yet, will consult doctor if doesn't resolve in one week
Pain, swelling, redness, warm to touch, hives or rash.  Symptoms improving slowly
no adverse event; I have a 4 year old who was supposed to receive a dose of the bivalent vaccine but received a monovalent vaccine instead; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (I have a 4 year old who was supposed to receive a dose of the bivalent vaccine but received a monovalent vaccine instead) and NO ADVERSE EVENT (no adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1415B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (lot number SL8095, Dose 1) on 29-Jun-2022, PFIZER BIONTECH COVID-19 VACCINE (lot number ST9142 and Dose 2) on 16-Sep-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 20-Apr-2023, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (I have a 4 year old who was supposed to receive a dose of the bivalent vaccine but received a monovalent vaccine instead). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (I have a 4 year old who was supposed to receive a dose of the bivalent vaccine but received a monovalent vaccine instead) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (I have a 4 year old who was supposed to receive a dose of the bivalent vaccine but received a monovalent vaccine instead).    No concomitant medications was reported. No symptoms was reported. No treatment drug details was reported.
Swollen and extremely tender lymph node under my left armpit, low grade fever and brain fog all which lasted 5 days. I didn?t get treatment and it went away on its own.
Pt received Dtap immunization in right arm deltoid. Pt developed swelling, pain and warmth from shoulder to elbow resulting in an ER visit.
Patient called stating she had a "bad rash" present "all over her body" for one week post vaccination. Scheduled patient with appointment with provider for further evaluation.
The patient is a 84 gentleman who presented to the hospital with chief complaints of worsening cough, sore throat and shortness of breath.  He has a past medical history significant for coronary disease status post quadruple bypass, hypertension, dyslipidemia, chronic renal disease, hypothyroidism, chronic microcytic anemia.  The patient was at his baseline health 3-4 days ago started having sore throat and cough that was productive of yellow to green phlegm.  Also noted some shortness of breath and exertion.  Symptoms have been getting worse gradually.  He did notice the low-grade temperature at home.  Denies any chest pain pressure or palpitations.  Denies nausea vomiting or any urinary symptoms.  The patient does reported in a awaiting prior to onset of symptoms.  He did a COVID-19 home test which resulted positive on Sundays the goal of view.  The patient has healed initial tumor no vaccines and a booster in November of 2021. Patient continued to have cough and therefore presented to the emergency department.  Pulse ox was found to be 88-89% with ambulation.  He was started on dexamethasone.  X-ray chest showed no acute process.  COVID-19 was positive in the ER.  Would also started on albuterol inhalers.  The patient responded well to conservative management.  His oxygenation improved and he was taken off oxygen and was able to ambulate.  He did have some cough that also got Norco improved.  He was given a prescription to complete 10 days of dexamethasone 6 mg at description for the inhaler.  The patient did well and was discharged home with recommendation to follow with the primary care physician.
Patient reported feeling "weird" in the evening of 7/7/20 after his injection.  He then had two full days of sickness: low-grade fever, chills, sweats, extreme fatigue.  He reported pain at the injection site and showed me redness at the site of injection and the redness spread around the left arm and deltoid area.  Today, 7/10/20, was the first day patient felt a little better.
Immediate dry mouth (under 1 minute). Watery eyes/pupils dilated (under 1 minute). Dizziness, light-headed (within 3 minutes). Hot flashes, severe sudden perspiration head/upper torso (within 10 mins). Severe sudden nausea, light-headed, muscle aches-- 5 hrs later. Fever, muscle/joint aches, sore throat-- 6 hrs later. Took 2 acetaminophen. Sore throat, muscle/joint aches next morning, continued throughout first 36 hrs. These symptoms returned every other day for first week, then a rash presented on Day 7 on chest and upper abdomen. Doctor visit on Day 7 (Mon, 5 April 2021).  Shingles on scalp presented on Day 9 (7 April 2021). Virtual Doctor visit on 8 April. Rx for 7-day course of Valtrex. Referral to Dermatology. Day 12--Crippling body aches on right side. Can hardly walk or move around the house. Severe muscle aches.
Administered only the liquid portion; Administered only the liquid portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA71QA, expiry date 31st May 2023) for prophylaxis.   On 1st September 2022, the patient received Menveo. On 1st September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-Sept-2022 Reporter's comment: No further details were provided. The reporter consented to follow-up. Additional supportive information: The patient was inadvertently given only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Burning eyes & swollen eyelids, numbness in left temple, pain in left jaw, swelling in left cheek & around eyes, numbness in chin
Information has been received from a medical assistant concerning a 40-60 year old patient who approximately 01-MAR-2010 ("within the past week") was vaccinated with a dose of PNEUMOVAX 23 (lot# 665270/1398Y). On the same night of the vaccination, the patient developed cellulitis at the injection site and was treated with an antibiotic. There were no laboratory diagnostics studies performed. At the time of this report, the patient's outcome was unknown. This is one of several reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received first dose of bnt162b2 (PFIZERBIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199), via an unspecified route of administration, administered in Arm Left on 07Mar2021 12:45 (age at the vaccination 56-year-old) as DOSE1, SINGLE for covid-19 immunisation. Medical history included ongoing high blood pressure (diagnosed with high blood pressure quite a while ago, Probably a good 15 years ago and ongoing). Concomitant medications included ongoing amlodipine at 10 mg, daily for blood pressure and hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. Historical vaccine included flu shot (Caller reported that just sometimes with the flu shot she would get a sore arm, but she does not have any details regarding vaccination dates). Patient reports she received her first dose on 07Mar2021 and then tested positive for Covid-19 infection on 28Mar2021. She reports her pharmacy spaced her second dose for 4 weeks after her first, but she never got the second dose. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 28Mar2021. The outcome of the events was unknown.  Follow-Up (26Jul2021): Follow-up attempts are completed. No further information is expected.
7 cm long mark that is hypopigmented x 1/2cm & slightly scaly. Does not hurt or itch. Mark has yet to go away.
COVID infection after completion of COVID vaccine series:  12/31/2020 COVID vaccine dose #1 01/25/2021 COVID vaccine dose #2 07/11/2021 Pt reported 2 days of rhinorrhea, chills, and myalgia along with close  contact exposure with COVID positive cases (relation unknown) 07/11/2021  COVID positive per nasopharyngeal swab
The pt experienced a severe local reaction (erythema and redness) 180mm x 200mm area at injection site.