chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 vaccine administered to patient post temperature excursion; No adverse event; Wrong dose was given to adult mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong dose was given to adult mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong dose was given to adult mistakenly) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong dose was given to adult mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) 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 assessments were provided for WRONG PRODUCT ADMINISTERED (Wrong dose was given to adult mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion).    This case contains information for the 87th patient out of 104 adult patients described by the reporter.  Concomitant medication information was not provided.  It was reported there was a temperature excursion issue in the vials from 26-May-2022 to 30-Sep-2022 and the vial with lot number AR5186C had undergone temperature excursion issue between a period of 08-Sep-2022 to 27-Sep-2022. AR5186C was previously reported. Wrong dose was given to adults mistakenly and was reported to VAERS and each patient who received the error dose, was instructed to re-vaccinate 2 months from the initial error dose.  The vial with lot number 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:
Information has been rec'd from the father of a child who was vaccinated as a toddler with a dose of MMR. Subsequently, the pt was diagnosed with autism. The pt's autism persisted. At the time of this report the pt was 10 yrs old. Upon internal review, autism was considered an other medical event. Additional info has been requested.
Patient fainted 15 mins after receiving the flu shot. She became conscious pretty fast within 2 approximately 3 minutes. First she fainted in her mother's arm then we laid her on the floor and kept calling her name to get a response. She became conscious within 2 approximately 3 minutes, pharmacist asked her if she had difficulty breathing which she said she didn't have. Patient did not have seizure, no allergy reaction. She was given a bottled water and candies, then watched for approximately 20 mins while she was resting in the cubicle. After 20 minutes of monitoring her, mother said she seemed fine and said they were going to leave. Pharmacist gave her our pharmacy phone number for her to call back if there were any further problems or for update.
This 88  year old white  male received the Covid shot on  1/26/21    and went to the ED on  2/17/21     and was admitted  on 2/17/21 with the following diagnoses listed below. U07.1 - COVID-19
A non-serious spontaneous report of expired FLUMIST was given was received from a health professional concerning an adult female patient. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 12-Dec-2010. On 16-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information received on 03-Mar-2011 and incorporated into case: no late occurring adverse events.
24hrs p/vax pt became limp, pale, lethargic & clammy; taken by ambulance to ER; w/u w/blood, EKG, etc-neg; recovery in 3 hrs;
Headache, Myalgia, Fever, "Felt like I had the flu" Narrative:
Injection site soreness; This is a spontaneous report from a contactable consumer. This is 2 of 3 report. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), single dose in upper right arm via an unspecified route of administration on an unknown date for COVID-19 immunisation. Medical history included diabetic. . The patient's concomitant medications were not reported. Reporter was a consumer reporting she knew a person who had the Pfizer Covid 19 Vaccine and said they only had injection site soreness. Reporter stated all these people caller reports had soreness at injection site after receiving Pfizer Covid Vaccine didn't have anything other than injection site pain, Reporter would assume this would be all she had also. Reports these said persons were on various prescription medications and the caller was not. Reports they were all about the same age group. Reporter was surprised she would have all the reactions reported and the said persons did not. Caller did not know if any rhyme or reason but was trying to find out. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Unconsolable crying from time of administration( 9:30 a.m.) of the vaccines until present time (4:00 p.m.). Mom had not given any tylenol. Advised to give tylenol and apply cool compresses to the site. Mom denies fever,denies that the site is swollen red or hot to the touch.
My first dose was administered on Mar. 5th, 2021.  On March 18th, 2021 I had a spontaneous anaphylactic reaction requiring the use of Benadryl and an inhaler. 40 minutes after second injection (Apr. 2nd, 2021) my face became bright red - which is usually the beginnings of an allergic or non-tolerant reaction to something to which I've come in contact.  A Benadryl dose resolved this reaction within 20 minutes. On April 10th I had a spontaneous anaphylactic reaction requiring the use of Benadryl. 12 Days after second dose I noticed my tongue feeling raw and started feeling a UTI beginning.  By 14 days after second dose I had approximately 14 pea sized lumps on the back and back sides of my tongue, the gums of my teeth were very swollen and sore. The roots of my teeth ached terribly, chewing was very difficult.  My ears were both very itchy deep within.  I was seen my my physician on  April 20th, 2021 and diagnosed with Candida Overgrowth.
Client presented to the Health Department on 01/18/2023  to receive Moderna Bivalent, after reviewing client's vaccination record it was determined that he had received Moderna Bivalent on 09/26/2022 and 11/21/2022.  Second dose given on 11/21/2022 was not needed as client was up-to-date with dose given on 09/26/2022.
Information has been received from a nurse practitioner referring to 4 year old female patient with no known drug allergy. The patient had no illness at time of vaccination. Concomitant therapies included (Oka/Merck) VARIVAX and KINRIX. On 09-MAY-2016 at 11:59, the patient was vaccinated with (wistar ra 27-3) M-M-R II lot # L042818 dose 2, subcutaneously in the right thigh. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received rom the same reporter. Additional information has been requested.
Feeling crappy too; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling crappy too) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling crappy too). At the time of the report, MALAISE (Feeling crappy too) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were reported.  The patient did not clarify if the patient received Moderna COVID-19 Vaccine. The patient was in close proximity with a positive case of COVID.   This case was linked to US-MODERNATX, INC.-MOD-2021-126915 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-126915:(MOD-2021-126915) The reporter from same case reported that a relative was feeling crappy too
Fever 103 Tylenol able to control fevers. Dizziness when standing headache and cough.  Fever lasted 48 hours, Dizziness and cough lasted 1 day longer
Fever, rash, fever x 2 days then rash/hives. Please read included ER document. Pt is a 1-year-old female who had her MMR II and hepatitis A shot yesterday. Last night, she developed a hive-like rash over her back that progressively worsened over the course of today. The parents called the primary care physician who recommended p.o. BENADRYL. However, she has also developed a low grade fever, in addition to the rash today, so she came in to be evaluated. There has been no vomiting. There has been no coughing. There has been good p.o. intake and good urine output. There has been no lethargy or irritability.
This case was reported by a consumer via patient support programs and described the occurrence of pain in arm in a 81-year-old female patient who received SHINGRIX for prophylaxis. On 26th December 2018 10:00, the patient received the 1st dose of SHINGRIX. On 26th December 2018 13:00, 3 hrs after receiving SHINGRIX, the patient experienced pain in arm (serious criteria hospitalization), shoulder muscle stiffness (serious criteria hospitalization) and muscle tightness (serious criteria hospitalization). On an unknown date, the patient experienced pharmaceutical product complaint. The patient was treated with tramadol and (NOS) BENADRYL. On an unknown date, the outcome of the pain in arm, shoulder muscle stiffness, muscle tightness and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the pain in arm, shoulder muscle stiffness and muscle tightness to be related to SHINGRIX. Additional details were reported as follows: After vaccination the patient experienced tightness around the shoulder and left arm, which escalated to immense pain. On the same day, the patient went to hospital on the around 5:15 PM.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients), POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and NO ADVERSE EVENT (No adverse event) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.       For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients).    No concomitant medications were reported.   It was unknown that the patient ever been diagnosed with/ tested positive for COVID-19.  The patient took 1, 2, and 3 doses intramuscularly and at the deltoid site of the body.  Dose 4 vaccine administered through deltoid.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. No adverse reactions reported for any of these patients.    No treatment medications were reported.
Initial report received from the patient's daughter on 29 November 2010; and follow-up information was received via telephone call to the patient's daughter on 01 December 2010. A female patient had received a dose of Influenza vaccine (trade name, manufacturer name, lot number, route and site of administration unknown) on an unknown day in September 2010 and one month later was diagnosed with influenza Type A. It was unknown if the patient had any illnesses, pre-existing medical conditions, or use of other medications at the time of vaccination; nor was it known if the patient required any treatment for the influenza. Recovery status was unknown. Documents held by sender: None.
fever, malaise, rhinitis, cough, urticarial rash, slapped cheek appearance, began about 20 hours after vaccine administration.  Augmentin had been started morning of symptoms. Treatment was to stop vaccine doses, stop augmentin, use tylenol, zyrtec, benadryl for syptomatic care.
Started running a high temp early Saturday morning temp anywhere from 103-105 degrees. Went to doctor and started on Z-pack for ear infection. No other symptoms noted. Still having temp. Started ATB on 7/27/14.
I am allergic to latex. Did inform nurse of it.Began to swell around throat and neck and face three days after injection. Difficulty breathing, hoarseness in voice. Wheezing, very weak could not stay awake. Cough, headache and blurred vision. Treated by self as a cold, once the breathing worsened went to see physician.
COVID vaccinated 12/18/2020 and 1/8/2021.  Positive COVID test 4/1/21
This case involves an unknown age male patient who had flu shot a week later he had the flu while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE unknown formulation and strength produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event, "had flu shot a week later he had the flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (had flu shot a week later he had the flu). At time of reporting, the outcome was Unknown for the event had flu shot a week later he had the flu.
(the second vaccine in the form above was a mistaken button press) I have suffered and lived with an extreme brain injury ever since the event.  This began three days after the first dose.  I am an ivy league physics phd in the prime of my life, and I can barely fill out this form.  The wave that came over my brain 3 days after the first vaccine was extremely foreign and unlike anything I have ever experienced.  I don't have words to fully describe it.  After a few weeks it got somewhat better, so I tried the second vaccine.  Again, exactly three days after the second vaccine, the same thing happened to my brain, and it has not stopped since.  Because I am now disabled, I can't adequately describe this to anybody.  My verbal abilities have been greatly limited.  My working memory, (using the technical term) is gone.  I have none.  If I am speaking to you and you ask me what I just said, I will not be able to answer.  I am in a constant fight with my brain to just function, and I have nobody to turn to for help.    It is also important to note that the effects that the vaccine had on my brain are in no way related to long-covid brain fog.  It is a completely different experience.  In addition to the extreme brain impairment, my body is unable to regulate temperature effectively.  This has been most pronounced in my genital area, where my testicles spent an entire year shrunk up inside of my body.  They have finally dropped again, but things are not normal.
4 hours after vaccine, had the following Reaction :  -Big Chills -Nausea -Small amount of swelling on Face, Ankles, & Wrists -Very tired = fatigue / sleep
ARM BECAME RED, SWOLLEN, AND PAINFUL TO TOUCH. FROM INJECTION SITE TO ELBOW.
My right hand started hurting in the afternoon where it would hurt when I closed my hand; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; batch/lot number and expiration date were not reported) via an unspecified route of administration in the morning of 16Mar2021 (at the age of 76-years-old) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. In the afternoon of 16Mar2021, the patient's right hand started hurting where it would hurt when she closed her hand and it has not gone away. The patient asked how long for the pain to go away. The patient was referred to health care practitioner(HCP) provider for additional guidance. The outcome of this event was not recovered.  Information on the lot/batch number has been requested.
Pt began crying, was very uncomfortable, would wake frequently when trying to sleep; Seen by MD given APAP w/codeine, cold pack to inject site Lt deltoid; MD states severe local rxn to DTP;
PT STATES RECEIVED COVID-19 (PFIZER) VACCINE ON 10/19/21 FELT FATIGUED, SORE & TENDERNESS AT INJ SITE YESTERDAY & STARTED WHEEZING THIS MORNING.
Pain in the arm, neck and back. Fever of 100.1 starting 3/10/21.
Redness at least 3 inches in diameter, swelling, pain, itch and one small blister. Patient denied any warmth, dizziness, weakness, headche, shivering/chills, fever, stomach pain or nausea.
Arm slightly achy the evening of administration; as to be expected. The following morning, pt woke up with arm very sore, swollen, visibly red, and hot to the touch. All-over muscle aches; felt like she "had the flu." Joints also affected/very stiff, especially knees & ankles. Lower back/hip pain forced pt to stretch/reposition stance at work every 3-5 mins. Took 800mg of ibuprofen around 10:15am; gelcap form. No noticeable difference. By 1pm, pt's oral temp was 101.8F and she felt very tired and nauseous. Pt complained of being "freezing cold" despite other coworkers in the area feeling hot and it being a +80F day. Heat from injection site could be felt by coworkers through uniform scrubs. Large knot had formed around injection site, approx. 2.5" diameter. By 4pm, pt's mobility had become limited due to pain/swelling at injection site. Pt was very weak/lethargic, had a headache, and was extremely thirsty, almost as if dehydrated. Sent home from work early. Pt applied ice to arm at home and went to bed around 8pm. Woke several times throughout the night due to arm pain when shifting/repositioning during sleep. The following morning, 6/9/2018, two days post-vaccine, pt woke feeling even worse. Body aches, headache, arm pain, redness, swelling, etc all worse than previous day. Knot on arm approx. 4" diameter, dark red/purple, and extremely hot. Pt. could barely move arm to dress self, drive, etc. Oral temp 99.3F upon arrival at immediate care center. Pt. given shot of TORADOL and ODT ZOFRAN. Sent home with Rx for 4mg ZOFRAN, 650mg TYLENOL, 600mg ibuprofen. Improvement of body aches, headache, and arm mobility after TORADOL shot by that afternoon. Injection site knot, redness, heat, and pain persist despite treatment.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: ~10 min after covid vax, pt reports she believes briefly passed out, as she dropped her phone, and then felt very dizzy and "out of it".  She was able to walk to the pharmacy.  We had her sit, gave her Orange juice, and checked her BP (72/50).  Pt stated both of her hands felt numb.  She said she had no trouble breathing, no itching, no facial numbness.  Pt looked flushed and said she felt warm/sweaty/clammy.  EMS was called to check on patient at patient's request.  All vitals were normal at that time
Nephrotic Syndrome symptoms (swelling throughout body and increased protein in urine. 1 month after vaccine parents started noticing weight gain until it reach a point of concern, i.e. swelling of entire body.  At that time 9/15/21 she was taken to ER which transferred her to Hospital.  She was tested for Lupus, and other auto immune disease which were negative. Patient was treated with prednisone and lasix for 5 days and then released after symptoms subsided.  Patient is presently being treated with prednisone 60mg daily and is due next week to taper to predisone 60mg every other day.
On the 12th day following immunization with Smallpox , pt noticed a red spot on his right lower eyelid. On day 17 he had significant swelling and erythema of right lowere eyelid and was sent to an opthemologist for examination. He was diagnosed with a RLL coalization and treated with Tobradex ung q hs x 2 weeks.
This spontaneous report was received from a physician refers to a 65 year old female patient. On 15-AUG-2013, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously. On an unknown date in August 2013, the patient developed a, not major but noticeable, rash on both arms, after receiving ZOSTAVAX. The patient sought medical attention: office visit on an unspecified date. The outcome of noticeable rash on both arms was reported as recovering. Additional information has been requested.
spotting; having cramps like contractions; This is a spontaneous report from a contactable Consumer (patient's husband). A 24-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date in 2021 (about two weeks ago from the report date) as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On an unspecified date in 2021, after receiving second dose of vaccination, patient experienced spotting and was having cramps like contraction. As per reporter patient was patient was supposed to be starting her period but was spotting and was having cramps like contraction. Reporter asked could this be from the vaccine. Outcome of the events were unknown. Reporter declined transfer to safety.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.