chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL).    No concomitant information provided No treatment information provided HCP stated that they mistakenly provided patients with 0,25 mL doses of the Moderna Covid 19 Bivalent.   This case was linked to US-MODERNATX, INC.-MOD-2022-646299 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646299:Patient 3
Fever, chills, body ache, congestion, sore throat, cough, nausea, diarrhea, headache.
My daughter received vaccination on 11 Mar and on 17 Mar seemed sluggish, did a piercing cry at the time of her feeding. I put her to bed assuming she was tired. The mornign of March 18, I noticed that she was in the same position that I had previously left her. Possible seizure 4 months (glazed stare, staring, no response to voice for about 1 minute). Returned to normal state quickly so event was not reported. On the morning of Mar 18 at about 0655 my husband noticed that my daughter had vomit on her clothes and blanket. He put on her on the bed to gather her tub to give her a bath. He heard her scream and returned to find my daughter on the floor, lethargic and unresponsive, he immediately called me at work. I told him to call 911. She was rushed to hospital. She was unresponsive. She was helicoptered to hospital and diagnosed with severe brain damage.
My normal tDap side effect is a sore arm for a few days. On Aug 3, about four hours after I received the shot (8:30 am), I was overcome with fatigue and ended up sleeping until the next morning. The next day (Aug 4), I felt fine in the morning (except for the sore arm) and woke up to start my day at 5:30 am. At around 10 am, I started heating up. I took my temperature and it read 98.3. That afternoon, I went to grab dinner around 3 pm (fast food was 5 minutes away from the house). On the car ride home, I was again overcome with fatigue, and a migraine started to form. I drank a glass of cool water when I got home. I sat on the couch because I was a little dizzy (I have balance problems). I ended up falling asleep. My dog woke me up at 7 pm for her dinner. It took a while for me to get off the couch because everything hurt. I fed her and took my temperature and it read 102.7. I took a warm shower, and crawled into bed and slept until 9 am this morning (Aug 5). My temperature this morning was 100.3. I'm feeling better (except for the sore arm), but I'm still achy everywhere -- though not as bad as yesterday. The nurse at my PCP's office instructed me to report this to y'all.   I do not have redness or swelling in the shot area. I do not have nausea, vomiting, diarrhea. My stomach aches are usually IBS or Acid reflux-related.
had a rash covering the arm on the side where got the shot; This is a spontaneous report from a contactable consumer (patient) reported for self. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 30Mar2021 08:30 as dose number unknown, single (at the age of 58) for COVID-19 immunisation. The patient medical history reported as patient used to smoke for 10 years. There were no concomitant medications. The patient had a rash covering the arm on the side where got the shot on 30Mar2021 09:00. Event occurred about 30 minutes after the shot. It was not worse and was not increasing. Patient has not received any treatment for the event. The outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.
HEADACHE, FEVER (101.8 X 7DAYS), COUGH (2 MONTHS), CHEST CONGESTION (2 MONTHS).
patient noted left arm swollen and hot 24 hrs after receiving  flu vaccine. No shortness of breath or any other S/S
Woke up c/o feeling weak with chills and aches.  Presented pale with temp of 101.1, BP 104/48, Pulse 96.  Seen by Dr. Rx'd with Aleve/Advil OTC.  LMR
9/7/2022 Moderna Monovalent was given not Bivalent. We advised patient in 2 months they can return for a Bivalent shot. Patient tolerated well. No Adverse reactions.
Severe induration, weeping, has puritic rash, swelling shoulder - elbow.
12 x 10 cm lesion R thigh around shot sight. Red, hot, indurated, tender. Began around 1 day after shot. 1/21/09 decreased to 2 1/2 x 2 1/2 cm.
I experienced a strong case of diarrhea starting when I got up. on Sunday Jan. 21 and had 5 loose bowels between 7am and 2:30pm. I consider this episode a possible side effect of the vaccine because there were no other factors which could explain this episode--I did not eat any tainted or undercooked food. All food was prepared at home, properly stored and cooked. Usually when I have intestinal trouble, I take 1 tablet of Imodium and that stops it, but this was such a strong case of diarrhea that it took two tablets of Imodium to stop it.
Patient's estimated date of delivery is January 2022. Patient received Pfizer vaccine that had been mixed approximately 25.5 hours before administration. No other adverse effects to report. Patient will wait to repeat dose upon delivery.
Patient was given vaccination before her 12th birthday due to parent reporting her birthday incorrectly on purpose to get shot earlier.
Gave the vaccine to a 17 year old, the vaccine age requirement was 18 years or older
Patient reported having itchy tongue at 1450. Denied other symptoms/ side effects. Declined vitals/ medications and preferred to be observed longer. At 1500, client asked for medication. Administered cetrizine 10 mg PO at 1500 and had patient wait extra 30 minutes. At 1530, patient reported itchy tongue had resolved and had no further symptoms/ side effects. Client left clinic at 1530.
pain fever dizziness exhaustion joint/muscle aches migraine with numbness on right side of body mental confusion swelling at injection site the size of lemon then faded
Onset of fever, 103-104 degrees, 8 days post vax, lasting for 3 days. On the third day she broke out in a rash which lasted an additional 3 days. Given Tylenol for temperature. Rash primarily on trunk. Had appearance of heat rash. Symptoms abated by approximately 08/02/00.
ED visit for chronic respiratory failure. She was hospitalized almost every day between 9/7-10/26 after her COVID infection including heart issues, respiratory issues and infection issues. She is consistently needing high oxygen via HHF now, likely related to chronic conditions, including what is now a chronic Covid syndrome complicating her other multiple conditions.  And acute NSTEMI.  Patient died on 11/17/2021.
This spontaneous report as received from a pharmacist refers to an unspecified patient. On 19-AUG-2014, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX, (lot#, expiration date unspecified), subcutaneous that underwent a temperature excursion. No adverse effect reported. Additional information has been requested.
Patient reports known onset of right foot drop the following day of vaccination (time unknown, reported "Evening time"). Currently being worked up in the clinic, but now patient is day 12 of foot drop without any significant improvement. Unsure if vaccine reaction, reporting out of caution. Patient has no recent trauma or injury to spine.  Signs/Symptoms: Weakness in Dorsiflexion/Eversion of right foot, Mild weakness of right hip extension, Decreased sensation to right lateral lower leg, steppage gait
Booster; COVID-19 positive; COVID-19 positive; This is a spontaneous report received from a contactable reporter(s) (Consumer) from RA.  A 46-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Nov2021 (Lot number: EW0217) at the age of 46 years as dose 3, (booster) single, (Lot number: EL3247) as dose 2, single and (Lot number: EL3247) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 positive". The patient underwent the following laboratory tests and procedures: COVDI-19 test: positive.  No follow-up attempts are possible. No further information is expected.
On July 14, 2021 at approximately 2:21 pm  a 14 approached the mobile vaccination site located on. The patient spoke to a volunteer to assist in completing the registration form due to the patient only speaking Spanish. The volunteer completed the form and informed the vaccine administrator that the patient will be receiving the Jansen and Jansen. Upon handing the form to data entry specialist, it was informed by the data entry that the actual age of the patient was 14 and not 18. The vaccine administrator heard the actual age too late and completed the administration of the Jansen and Jansen Vaccine. The patient was informed of the potential side effects was directed to the nearest hospital in the event of a severe medical reaction. Patient waited 30 minutes for observation and reported no issues.
I want to report that the second dose was not administered through the same provider as the first dose. They ran out, so the second dose was given at pharmacy at 3:00pm.   1st dose - dizziness and racing heartbeat started 10 minutes after injection and subsided about 40 minutes after injection. THe 2nd dose the following symptoms started 45 minutes after the injection -shortness of breath, neck and chest flush, tingling on back of tongue, racing heartbeat, feeling extremely dizzy and feeling like I am going to pass out.  The symptoms subsided about 90 minutes after the injection.  The racing heartbeat and tingling on the tongue came and went off and on for 72 hours. I broke out with shingles about 48 hours after receiving the 2nd dose.
non contiguous papular rash on back and back of arms; excoriated and healing well without any s/sx of infection; no weeping; some early papules developing; pruritic; will treat with prednisone taper;
I am a healthcare worker and received my Pfizer COVID vaccines on 12/21/20 and 1/12/21. I had a routine annual primary care visit on 1/22/21 in which I obtained labs. For the past few years, my thyroid panel had always been within normal limits, however, this time my TSH was significantly out of range (low) and T4/T3 normal. We repeated thyroid labs again in two weeks on 2/5/21 to be sure, and my TSH was even lower (T4/T3 normal). I was symptomatic (fatigued more than usual) and was referred to an endocrinologist. At the endocrinologist visit, upon discussion of my history, physical exam, labs, and no recent viral illnesses, it was diagnosed that I had subclinical hyperthyroidism, due to thyroiditis, possibly due to the COVID vaccine. Treatment of thyroiditis is only supportive care to manage symptoms, but I had to let the thyroiditis run its course, in which I would go through a hyperthyroid phase, euthyroid phase, hypothyroid phase, then back to euthyroid. I started obtaining a monthly thyroid panel to monitor labs for the appropriate course of thyroiditis, and remained subclinical hyperthyroid for 4 months (TSH low, T4/T3 normal). My labs are finally back to normal/recovered per my endocrinologist as of 7/16/21, and I will continue with every 3 month monitoring for now. The facility I listed in this report is not the location where I received the vaccine. The listed facility is my endocriniologists' office. I received the vaccine at work.
Case number PHEH2014US019191 is an initial spontaneous report received from a nurse on 18 SEP 2014. This report refers to a 56 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. No adverse event was reported following the medication error (overdose).
Administered vaccine  that was above 8 degrees Celsius after 12 hours; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 Vaccine which was administered and was kept above 8 degrees Celsius after 12 hours.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an undisclosed date, 14 doses of vaccine were stored at a temperature excursion above 8 degrees Celsius.  On an undisclosed date, the patient received their planned doses of mRNA-1273 (Lot number 012L20A) intramuscularly for prophylaxis of COVID-19 infection. Vaccine doses were administered from a temperature excursion above 8 degrees Celsius for over 12 hours. There were no reported adverse events. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, a vaccine administered and kept above 8 degrees Celsius after 12 hours, was resolved.; Reporter's Comments: This case concerns a patient who received their planned doses of mRNA-1273 (Lot number 012L20A) intramuscularly for prophylaxis of COVID-19 infection and that the vaccine was kept a temperature excursion above 8 degrees Celsius for over 12 hours. There were no reported adverse events after the vaccine was administered in this case of out of specification product use.
It was reported that a female patient received an Imovax Rabies vaccination on Aug. 8th, 11, 15th and Sept. 5, 2000. The patient reportedly developed headache after each dose. Patient still experiencing headache, at least three times per week.
Initial misuse report received from a healthcare professional on 24 April 2014. A dose of YF-VAX was reconstituted with sterile water instead of supplied diluent (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Resident without complaints sitting up in wheelchair all evening. @ 2300 resident call light answered with resident c/o abdominal pain with watery uncontrollable diarrhea and nausea. Staff assisted to bed and assist with changing resident when vomiting started. Resident lethargic, diaphoretic, clammy. FSBG 256mg/dL. Resident requested to go to ER. Resident extremities cool. Staff had difficulty obtaining SpO2 HR with pulse weak and thready. SpO2 noted @ 84% RA and HR 43. . Upon arrival EMS had difficulty obtaining HR and SpO2 with their equipment. Resident OOF @ 2335 via gurney. Resident yelling out in pain upon discharge.
pt came back to pharmacy and complained of shortness of breath, arm pain in both arms and leg pain. I called ems and code white. i took her bp which was 120/83 and hr 45. ems got here and she was feeling better and gave her an aspiring. they were going to do a 12 lead. I tried calling pt several times and with no response
Follow-up info received provided the pt's date of birth, vaccinations receive within four weeks, medical history, and illness at the time of vaccination. Information regarding Flumist was received from a healthcare professional regarding a 9 year old male pt who experienced stuffy nose, runny nose. The pt received product that was stored at a temp that was higher than allowable and was not frozen. At 9 years of age, the pt received a dose on 10/18/03. The pt experienced stuffy nose and runny nose on 10/19/03. The pt's symptoms were treated with Triaminic. On 10/20/03, the pt had no complaints. The reporter indicated that the pt received product that was stored by the pharmacy at a temp that was higher than allowable and was not frozen.
Information has been received from a licensed practical nurse concerning an 18 year old female with no known allergies or medical history who, "above five years age," in approximately 2001 was vaccinated with a first dose of Recombivax HB. There was no concomitant medication. Shortly after being vaccinated, in approximately 2001, the patient developed a rash. Therapy with hepatitis B virus vaccine was discontinued. Unspecified medical attention was sought and the patient recovered. A product quality complaint was not involved. Additional information has been received from the nurse who reported that, to date, he was unable to get anymore information due to the patient not returning to the clinic for follow-up.
No adverse event; Patient received one dose of the bivalent Moderna COVID19 vaccine as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient received one dose of the bivalent Moderna COVID19 vaccine as a second dose) and NO ADVERSE EVENT (No adverse event) in a 41-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060f22a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Oct-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Patient received one dose of the bivalent Moderna COVID19 vaccine as a second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient received one dose of the bivalent Moderna COVID19 vaccine as a second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Patient received one dose of the bivalent Moderna COVID19 vaccine as a second dose).    No concomitant medications were reported. No treatment details were reported.
In April, 1999 and May, 1999, the pt received her 1st and 2nd dose of Lymerix vaccine and she immediately starting having pain in her right shoulder which then spread to her left shoulder and her hips. It was not clarified if these adverse events began after the 1st or 2nd injection. In the fall of 1999, the pt was dx'd with rheumatoid arthritis. Treatment includes Enbrel and Celebrex. Additional information has been requested.
Patient's mother arrived at the Health Department on 5/27/2010 to question the patient's blistered area on the left upper leg.  The area was the size of a quarter. The mother stated the child had a low grade fever and the leg was very sore.
1.20.2022 Employee called the Vaccine Support line to report symptoms post COVID-19 vaccination. Vaccine Name - Pfizer Vaccine Date - 1.10.2022 / Location: Right Deltoid Booster Dose - Yes Date of Symptom Onset - 1.11.2022 Symptoms - Fever (100.8F), Aches, Malaise Last Day of Work and Shift - 1.11.2022 / Works 12-Hour shifts (x3/week). Employee stated she only missed one shift (1.11.22)  and returned to work on 1.14.22. Home Remedies - Advil, 200 mg, 2 tablets, taken once Tuesday, 1.11.22 and once Wednesday, 1.12.22 Any Improvement - Yes (Symptoms resolved by 1.13.22)
large olive sized lump @ inject site immed p/inject; ice pack immed lessened swelling; 34 hrs p/inject pt reported eyes became red, swollen, watery; eyes were matted shut;
Swelling and rash at injection site. Boil on arm and chin after injection. Itching and pain all over.
This spontaneous case received from a physician via a field representative referred to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient received a GARDASIL (dose, frequency, lot number and expiry date not reported) and the patient became infertile. Outcome and causality for the event were not reported. Additional information has been requested.
little red bumps over his body and they itch/appear to be mosquito bites that itch appearing in several places on my body.; This is a Spontaneous report from a contactable consumer (patient) from a 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration in the left arm on 11Apr2021 at 10:00 as dose 1, single (at the age of 60-years-old) for COVID-19 immunization. Patient medical history include known allergies to peanuts and codeine. Concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and not received any other vaccines within 4 weeks. The patient not received any other medication within 2 weeks of vaccination. Since the vaccination, the patient not been tested for COVID-19. On 11Apr2021, after vaccination, the patient had what appear to be mosquito bites that itch appearing in several places on his body or had ittle red bumps over his body and they itch. And patient wants to know what they are and asking will he be okay getting the second shot. Treatment was not received for the adverse event. Outcome of the event was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.