chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After patient was given shot, chest and throat felt tight. Went to ER after 45 minutes. Was given BENADRYL and STEROID at ER had some swelling and hives.
He passed out after the vaccine and fell to the floor. He has a history of syncope with previous blood draws and vaccinations.
Pulmonary Embolisms diagnosis via CT scan with contrast dye on 2/3/2022. Trouble breathing for at least two weeks prior to diagnosis. Blood clot in right calf diagnosis via ultrasound on 2/3/2022.
Chronic redness and Hives all over my body with severe itching.  These episodes will come and go through out  the day and appear on different parts of my body. Antihistamines are helping to control the episodes, but the duration and severity have not subsided since the initial episode.
L leg began to swell and get red at approx 1 pm.  Mom calls 2/7/06 seen pt. at 9:30 am on 2/7/06 leg measured 3.5 x 4.5 and circumference 12 1/4.
Mother of patient called the clinic on 6/14 to report swelling and redness at the site of injection
slight chills; fever, maybe a degree; Muscle ache; Joint ache; she ached all over; Headache; Nausea; she sleeping around the clock. She would wake up and fall back asleep; felt tired/Exhaustion; This is a spontaneous report from a contactable nurse (Patient).  A 77-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6200, expiration date: not reported) via an unspecified route of administration, administered in left arm on 02Mar2021 at 09:15 (at the age of 77-years-old) as dose 2, single for covid-19 immunization. Medical history included Chronic Lyme disease, she got it again in 2018 she thinks, she had it in 2017. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number: EL9264, expiry date: not reported), via an unspecified route of administration on unspecified date (at the age of 77-years-old) as a single dose for COVID-19 immunization and she takes a flu vaccine every and it's fine. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for chronic lime disease, start and stop date were not reported. On 18Mar2021, patient experienced slight chills, fever, maybe a degree, muscle ache, joint ache, exhaustion, headache, nausea, she sleeping around the clock. she would wake up and fall back asleep and felt tired. Patient took ibuprofen for events chills and fever maybe a degree. On 18Mar2021, patient underwent lab tests and procedures which included body temperature resulted fever maybe a degree. At the time of reporting, the outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 21-JUN-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot#  N024562 and expiration date 06-MAR-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
Monthly period came 6 days earlier than normal.  Period is extremely heavy than normal and more painful and extremely thick.
INDIVIDUAL RECEIVED VACCINE STORED PAST THE BEYOND USE DATE (FOR REFRIGERATION) AND THE ADDITIONAL 14 DAY STABILITY DATE (OFF LABEL). INDIVIDUAL TO BE REVACCINATED.
She had very little hives and it went away by itself.; This spontaneous case was reported by a non-health professional and describes the occurrence of URTICARIA (She had very little hives and it went away by itself.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced URTICARIA (She had very little hives and it went away by itself.). On 31-Jan-2021, URTICARIA (She had very little hives and it went away by itself.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-315301 (Patient Link).
Extreme lower abdominal pain the first 72 hours. I was in such distress that I could not sleep. Also joint and muscular pain well above average. Fatigue continues in day 4. My daily activities have been severely limited.
Patient passed out without warning (fell) and hit ceramic floor; Patient passed out without warning (fell) and hit ceramic floor; Black eye; bruised extremities; Been "out of it" since then; A spontaneous report was received from a consumer concerning a 59 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed out and hit a ceramic floor causing a black eye, bruised extremities, and the patient was been out of it since the event ( feeling abnormal ).  The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 01 Feb 2021, approximately one day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot number 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient passed out without warning and hit a ceramic floor, which cased a black eye, bruised extremities, and the patient has been out of it since the event.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events passed out and hit a ceramic floor causing a black eye, bruised extremities, and the patient was been out of it since the event ( feeling abnormal ) were unknown.; Reporter's Comments: This case concerns a 59 year old female subject, who experienced a serious unexpected event of loss of consciousness after second dose of mRNA1273 (Lot# 028L20A). Very limited information has been provided at this time. Further information has been requested.
I had the shot and each day thereafter, I had more and more trouble breathing. One week later, I had Pneumonia and was admitted to ER.
Disorder aggravation; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Disorder aggravation) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa and Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (Disorder aggravation). At the time of the report, CONDITION AGGRAVATED (Disorder aggravation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment medications was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-FEB-2023, the patient received the 1st dose of Shingrix. On 02-APR-2023, 59 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced mild case of Shingles. The patient stated that he or she was recovered from shingles and now been 6 weeks since being diagnosed. The reporter wanted to know when should he or she receive the second dose of Shingrix after he or she recovered from shingles. Follow-up would not possible as no contact details were available.
4 inch circular redness with warmth. no s/s infection. supportive care : compresses and motrin prn.
Pt recv vax on 11/9/98; on same day pt exp myoclonic jerks of  extremities, unable to walk or move legs, swelling of neck; tx=Benadryl
Fever, chills, cough, heavy feeling chest, joint pain in wrists, knees, elbows, runny nose. Took MOTRIN. Pt states (11-21-12) he began feeling better about 6am this morning.
Chix Pox diagnosed 03/24/2003 and Zoervax 400mg po qld x 5-7. Fever central
I had tingling in the lips, tongue, fingers & toes. I also had dizziness and flushing of my face starting approx 15 minutes after receiving the vaccination.  I took Benadryl & Famotidine and symptoms resolved over an hour.
Gave NOVARTIS H1N1 vaccine (4yrs and older) 0.5ml IM. Should have given Sanofi Pasteur vaccine (6 months and older) 0.5ml IM. No signs or symptoms of distress noted.
Pt walked over and sat down in waiting area.  Within 2 minutes he lost consciousness, fell out of his chair, hit his head on the floor. this lead to bleeding/ bump on left eyebrow.  Pt was hot, sweaty, clammy, and  pale. he laid on floor with feet raised for a few minutes. He felt better in about 15 minutes, parents arrived to drive him home.
Pt admit 6/20/22 positive with COVID19 s/p 3 doses of COVID vaccine (1/20/21, 3/17/21, 4/14/21). Pt had elevated ddimer and required supplemental O2 during stay.
Pt received two doses of IPV on accident. Patient was given 1 dose from the multi-dose vial of IPV administered to her right thigh and an additional dose of IPV from a combination vaccine of Dtap/HepB/IPV in her left thigh. Patient appeared well after vaccines were administered. Mother was informed of what happened. Doctor assessed patient and agreed that she was doing well.
Tested positive for COVID after full vaccination. Test on 5/17/21 by PCR.
This spontaneous report as received from a pharmacy technician refers to unspecified patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not provided by the reporter. On an unknown date in 2017(reported as from 24-JUL-2017 to 07-AUG-2017), the patients were vaccinated with PNEUMOVAX 23 (strength, dose and route of administration were not reported) lot # M043424, expiration date 06-JUN-2018, for prophylaxis. The vaccine was exposed to a temperature of 47 degree fahrenheit to 77 degree Fahrenheit for 5 hours (incorrect product storage). There was no previous temperature excursion. Digital data logger was involved. There was no adverse effects.There was no product quality complaint (PQC) involved.
53 yo male with no chronic medical conditions.  Pt recently  visited his home country.  While he was there he started having cough.  He had a rapid antigen test which showe3d detectable antigen,.  he then had a PCR test which came back negative.  Because of the negative PCR test he was able to fly back where he lives.  Pt continued to have symptoms with cough and increased dyspnea.  He denies any nausea vomiting diarrhea.  He had no voiding issues.  He then presented to the ED for further evaluation.
exposure to someone that tested positive; This is a spontaneous report from a contactable pharmacist, who is also the patient. This male pharmacist of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced exposure to someone that tested positive. The outcome of the event was unknown.  The information on the Batch number has been requested.
Delayed rash bumps on both lower arms & hands also on lower legs.  Extremely itchy.
Background: Hesperia pharmacy received 49 vials of Pfizer COVID vaccine (Lot number EN6199) on 5 March 2021 and stored them in the pharmacy refrigerator.   The doses were labeled with an expiration date of 10 March 2021 at 0701.   Since starting the COVID-19 vaccine program, the Hesperia MOB has always used the doses before they approached the expiration date.  This time, there were 16 vials of the Pfizer vaccine that had not been used and set to expire. The labeled expiration date and time were clearly present on the outside of the bag containing the doses.  On the morning of 10 March 2021, a pharmacist retrieved 1 vial at 0754 and 7 vials at 1138 from that allocation and provided them to nursing for the day?s administrations.  The pharmacy placed those doses in a new amber bag and did not label the bag with an expiration date and time.   The nursing team received the vials, diluted and drew up 20 doses that were administered to patients before 1230.    The charge nurse did not question the expiration date until after 20 patients had been vaccinated.  At that time she messaged the pharmacist to verify the expiration date.  The pharmacist indicated that the label did not state am or pm and misinterpreted the expiration time for the doses as 7:01 PM rather than 7:01 AM.  There was not a defined double check at the time of distribution from the pharmacy to nursing  The remaining 11 vials were quarantined.  The pharmacy manager contacted the manufacturer.  According to Pfizer it?s recommended to use the thawed vaccine within 120 hours, but can be used up to 144 hours.  The doses in question were administered before 125 hours after they were thawed.  The remaining expired vials will be wasted and appropriate notifications sent.  Assessment: Twenty patients received Pfizer COVID vaccine 5 hours passed the labeled expiration date and time.  While exceeding the manufacturer?s recommended beyond use dating, the doses were within the acceptable 144 hours post thaw period and still safe for patient administration.  There was misinterpretation of the labeled expiration time by the dispensing pharmacist, the container of COVID vaccine vials provided to nursing was not labeled with an expiration date or time, there was not a double check on hand off, the nursing team did not double check the expiration date/time before dilution or administration.  Recommendation:  When repackaging COVID Vaccine vials for distribution to vaccination centers, a label including the expiration date and time should be placed on the new container.    When COVID vaccine is transferred from one location or department to the next, a double check of the product, quantity, integrity and expiration date and time may prevent a recurrence of this situation.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling for vaccinated limb in a adult female patient who received Influenza vaccine Quadrivalent. Concurrent medical conditions included splenectomy and idiopathic thrombocytopenic purpura. Concomitant products included TYLENOL. On an unknown date, the patient received Influenza vaccine Quadrivalent (intramuscular). On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent, the patient experienced swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach to be related to Influenza vaccine Quadrivalent. Additional details reported as follows: The age at vaccination was not reported. The reporter approximates that within the past five years there were three yearly occasions in which the symptoms occurred within a few hours after receiving a flu vaccine of unknown name and manufacturer. The patient always had the vaccines administered into her left arm muscle, as she was right-handed. The patient cannot recall exact dosing details. The left arm would be swollen and red around the site of injection, and the area would be 4 inches or greater in diameter. That arm area was painful and could feel hot like it had a fever. The symptoms would last for another day and then resolve. In addition to the left arm symptoms, she also fell sick to her stomach described as feeling like she was getting the flu on one of the three occasions. That symptom diminished the next day after receiving the vaccine. The patient went to the doctor the day after receiving the vaccine when she had the stomach upset. The doctor told her that symptom was likely to have been caused by food poisoning instead of the flu. Once she changed and started getting her annual flu shot at a different retail pharmacy location, she did not have these symptoms and was told that the previous symptoms which had followed her previous flu vaccinations had been due to the preservatives in the vaccine products she had previously received which were no longer now included in the vaccine provided at the retail location. The patient thought the symptoms were due to the preservatives in those past flu vaccine products.
Rash on both arms, started the next day,  still there a week later.  no treatment Sore throat, next day still happening.  Nausea started next day. went away two days after  Fatigue. day after and  went away after that.
Soft tissue swelling/redness that began approx 10-12 hrs after injection. Now starting to itch; now decrease in swelling and redness (site of injection in mid LUE).
This spontaneous report as received from a healthcare worker refers to an unspecified amount of patients. Concomitant medication and pertinent medical history were not provided. The healthcare worker reported that the ROTATEQ (lot number, dose, route and frequency were not provided) was exposed to a lowest temperature of 32F for a total of 136 hours over 17 days occurring since 01-JAN-2014. There was also a nurse reported that she was unsure if the ROTATEQ had undergone excursions since 01-JAN-2014 because she stated that they ordered products on a weekly basis. She reported that "some" may have undergone multiple excursions and "others" may have undergone no excursions but she was not exactly sure of which ones. On an unknown dates an unspecified amount of patients were vaccinated with ROTATEQ which were improperly stored. No adverse effect reported. The outcome of the events was unknown. This is one of several reports received from the same source (MARRS# 1406USA006824). Additional information has been requested.
My mother got the vaccination on March 14 about a week later she started to feel numbness/pain from her toes to her stomach and on the back of my arm. She the second shot April 3, 2021. She went to the ER twice and was sent back home because they did not know what it was. Her doctor recommended cooper sock which didn?t work.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medications. On 21-JUN-2018, the patient was inadvertently vaccinated with the expired M-M-R II lot # M029230 with expiration date of 08-JUN-2018 and Albumin status of rHA, for prophylaxis (dose and route of administration). The vaccine was reconstituted with sterile diluent MRK INJ lot # M029230 with expiration date of 19-JUL-2018. No adverse effects were reported.
Redness, swelling, itchy, pain 4 inches wide by 3 inches height at vaccine site.  10 days after vaccination. Taking cortisone cream OTC, and Muciprocin 2%.  For 2 days
Some of the vaccine, medicines spurt it out did not get the full dose; Some of the vaccine, medicines spurt it out did not get the full dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Some of the vaccine, medicines spurt it out did not get the full dose), PRODUCT ADMINISTRATION ERROR (Some of the vaccine, medicines spurt it out did not get the full dose) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Some of the vaccine, medicines spurt it out did not get the full dose), PRODUCT ADMINISTRATION ERROR (Some of the vaccine, medicines spurt it out did not get the full dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Some of the vaccine, medicines spurt it out did not get the full dose), PRODUCT ADMINISTRATION ERROR (Some of the vaccine, medicines spurt it out did not get the full dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for ACCIDENTAL UNDERDOSE (Some of the vaccine, medicines spurt it out did not get the full dose) and PRODUCT ADMINISTRATION ERROR (Some of the vaccine, medicines spurt it out did not get the full dose).    Concomitant medication was not provided. Treatment information was not reported.
Patient was reported to have possible seizure.  She reportedly went to floor on her own . Seizure had ended and had gotten back to her feet by the time pharmacy personnel arrived.  Patient seemed not to want to stay in store and left with a family member about 5 minutes after event was reported.