chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came to receive booster dose of Pfizer (12+) purple cap. Patient had received 2 doses of Pfizer for primary series. Patient may have been given dose of vaccine that was beyond 6 hour puncture window. The vaccine manufacturer and BUD were in range and not expired. The vial was believed to have been punctured the previous day, and was kept from puncture time until use time at 2deg C to 8deg C. Pfizer Manufacturer stated that if vaccinated with in 24 hours of puncture, do not need to re dose.  There was no known signs or symptoms on site after dose given, and no know adverse reaction on site after dose given.
Fairly severe sore throat 2 days after 2nd injection; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: EP7533), via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not have any allergies to medications, food, or other products. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6207), via an unspecified route of administration in the left arm on 11Mar2021 at 09:00 (at the age of 72-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 03Apr2021 at 14:00, two days after the second vaccination, the patient experienced fairly severe sore throat. The patient did not receive any treatment for the event. The clinical outcome of the event fairly severe sore throat was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
I started experiencing a swelling of my left foot and ankle; my lower and upper left leg were swollen. I had a kidney stone operation in August of 2020 and one month later after that surgery I was first diagnosed with DVT and Pulmonary Embolism in September of last year. When it popped up again here, they don't know the reason why. I went to hospital ER after calling my doctor office. I was hospitalized for three days and two nights. They prescribed Eliquis for me. I had been given that last year but for 60 days only. But now that I have it again it will be for life. They monitored my heart and kept me an additional night because of testing that showed it may have initially strained my heart but everything was fine and they let me go. I can't tell if my blood clot has gone away. They still found evidence of a blood clot when they did the last test after I have been released from the hospital.
5 days after shot began post nasal drip and phlegm in throat. 8 days after shot began rash under armpits  10 days after shot began sore throat and dry cough  10 days after shot, rash has not improved with hydrocortisone or Allegra and appears to be spreading.
Tdap last administered 7/23/2021, not yet due for repeat. Patient not pregnant.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Additional information has been requested.
Pt and 2 sibs, came for 2nd COVID vaccine today. Vaccines given by nurse. After administration, it was noticed that the vaccine vial did not have the diluent added to it. It is estimated that each child got approx 25mcg rather than the intended 10 mcg dose. As soon as we noticed the mistake, I went in and told mom about the error with aid from an interpreter. The total dose given is below the 30mcg dose given to 12yo and above. I don't expect this to be dangerous in any way but did tell mom there may be an increased risk of s/e from the vaccine such as a fever. We discussed management if that should occur. Mom has the office contact number and knows how to have an MD paged after hours if questions or problems arise. Patient's were observed for approx 30 min after administration with no problems. I apologized to mom for the mistake.
Initial misuse report received from a nurse on 14 OCTOBER 2013. The patient had received FLUZONE. Nurse gave an expired dose from last season. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: None.
spontaneous abortion; booster; This is a spontaneous report from a contactable other hcp. This other hcp reported information for mother.This is a maternal report   A 32-years-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on 29Sep2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history was not reported. The patient did not have covid prior to vaccination. The patients concomitant medications were not reported. It was unknown that the patient received other vaccine in four weeks. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was, and expiration date were not reported), via an unspecified route of administration, on 10Jan2021 (Age at vaccination was 69 years) as dose 2, single and dose 1 via an unspecified route of administration (lot number was, and expiration date were not reported) on 20Dec2020 for COVID-19 immunization. Age at vaccination was 32 years. On 29Sep2021 the patient experienced booster. On an unspecified date patient also experienced spontaneous abortion. The last menstrual date was Nov2021. The mother reported she became pregnant while taking bnt162b2. It was unknown that therapeutic measures were taken or not. Adverse event resulted in doctor or other healthcare professional office. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test with unknown result (If COVID tested post vaccination: Yes, COVID test post vaccination: COVID test type post vaccination: Unknown). The outcome of event was unknown.  The lot number for BNT162B2 was not provided and will be request during follow-up.; Sender's Comments: Based on the available limited information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) booster and reported event abortion spontaneous cannot be fully assessed/exclude. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Fever and Chills - low grade up to 103 from the night of 3/13-evening of 3/14.  Fatigue all day 3/14 and light fatigue 3/15.  Fever broke by 6pm 3/14
loss of taste and smell; loss of taste and smell; had first dose of Shingrix on 23SEP2020 and second dose on 02APR2020; This case was reported by a consumer via call center representative and described the occurrence of taste loss in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd April 2020, the patient received the 2nd dose of Shingrix. On 2nd April 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced taste loss and loss of smell. The action taken with Shingrix was unknown. On an unknown date, the outcome of the taste loss, loss of smell and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the taste loss and loss of smell to be related to Shingrix.  Additional details were provided as follows: The patient reported that around the time of the first dose vaccination, she noted that she lost sense of smell and taste, noticed that especially with food. The patient received 2nd dose of Shingrix late, which led to lengthening of vaccination schedule. The reporter consented to follow up.
slight itch lower extremeties; Hives; stomach cramping; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives), ABDOMINAL PAIN UPPER (stomach cramping) and VACCINATION SITE PRURITUS (slight itch lower extremeties) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L2) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced URTICARIA (Hives) and ABDOMINAL PAIN UPPER (stomach cramping). On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (slight itch lower extremeties). The patient was treated with TRIAMCINOLONE at a dose of UNK,0.1% topical cream and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 04-Mar-2021, URTICARIA (Hives) and ABDOMINAL PAIN UPPER (stomach cramping) had resolved. At the time of the report, VACCINATION SITE PRURITUS (slight itch lower extremeties) outcome was unknown.            No concomitant medicines reported by reporter. Treatment medication includes shot of some sort of steroid(name unknown).
For 2 weeks after the shot, experienced 4" diameter rash at injection site, itching, hoarseness, swelling of mouth and tongue, muscle aches. Since then have experienced a feeling  that my mouth was on fire, diagnosed by physician as "Burning Mouth Syndrome."  I am also experiencing what I call brain fog. I exercise for 1 hour a day, 6 days per week, but for the last 6 months the exercise has been harder to perform. Have had to reduce weights and repetitions. Also have muscle aches (that I never had previously) in my left thigh.     I have never experienced anything like this before.  Before Shingrix I had NO medical issues, NO prescriptions, NO over the counter drugs (other than for the occasional headache). Now it is a 24/7 feeling of discomfort that prevents me from enjoying a meal at a restaurant, traveling, etc. Everything we eat is either fresh, or home made. Now, it also has to be without any seasoning (in order to avoid irritating my mouth).
About an hour after the Covid vaccine was given I experienced heart racing very rapidly, wave of nausea, feeling faint, knot in throat, this last about 5-10 minutes then passed, had knot in throat x 2 days.
PT WAS TO RECEIVE 2ND PFIZER VACCINE AND INADVERTENTLY RECEIVED APPROX 0.2ML OF AIR IN HIS LEFT DELTOID. AFTER DISCOVERY OF ERROR, PT RECEIVED VACCINE IN HIS RIGHT DELTOID, 30 MINUTES LATER. NO ADVERSE SIDE EFFECTS
Beginning on Saturday morning following the Friday morning shot, I began to have a sharp stabbing pain in my chest when I would take a deep breath.  This was in combination with the flu like symptoms the night before, which I had expected.  The troubling part was that from Saturday on I began having tightness in my chest and my heart would race.  I'm an avid distance runner, I have never had any health issues with my lungs or heart but could not take a deep breath for over a week.  At about day 8, I was at a xc race and tried to jog a little to the mile mark to watch and almost collapsed, incredibly light headed, my fellow coach said I looked like a ghost, I thought I was going to die.  it eventually subsided, but something was definitely not right. A week into these heart episodes I finally called my doctor but couldn't get in until well after Labor day.  They had me wear a heart rate monitor but I sweated it off a few days in.  Much of my symptoms had subsided by the time I was seen. The heart issues are still happening though they have gotten much less after the first 10 days.  Without sounding like a crazy person, I would describe it as a pain that crawls through my heart..like a worm now.
had both vaccinations now have shingles/suspected vaccination failure; shingles on face; raised welts; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: had both vaccinations now have shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles on face) and welts (Verbatim: raised welts). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the welts was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and welts to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure, shingles and welts to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that it was not necessarily.  The patient had both Shingrix vaccinations and now he/she had shingles on the left side of his/her face.  The reporter stated that it appeared that it was going to be a mild case, probably because of Shingrix. So far, he/she did not have blisters but rather, raised welts. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
My arm became sore more than when I first got the vaccine and I developed a large red rash on my arm.  It was also very hot to touch. It did not itch.
Cramping and pain began on Friday during the day, tiredness and some aching. (10/22) Severe Cramping and pain in uterus and abdomen. Worse than anything she has ever experienced before screaming and crying in pain. clots as big as 25c not ususal (usually dime size) Severe diarrhea and stomach pain. Lasted all day Saturday . Given tylenol and later ibubrofen to relieve pain, hot water bottle applied and rest. 10/23
patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 40-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
10 days post vax pt experienced 6 - 8 raised blister like clusters of vesicular lesions at the injection site with a low grade fever of 101.6F. 6 days later the pts swelling was reduced and the reaction was improving.
This spontaneous report as received from a physician refers to a 9 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 23-MAY-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # M046140 with expiration date on 27-SEP-2019 (dose and route of administration were not reported). Since 25-APR-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Mild headache on 3/9/2021 and light headed on 3/10/2021. All symptoms subsided by the evening of 3/10/2021
1 hour after receiving Anthrax and Tylenol vaccines, pt developed urticaria, treated with IM Solumedrol and Atarax, resolved.
Individual were administered Moderna vaccine booster dose after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Reporter has not yet contacted patients for follow up.
Breakthrough case admission after 4 vaccines  Moderna 1/12/21 Lot# 012L20A;  Moderna 2/9/21 Lot# 004M20A;  MOderna 12/15/21 Lot# 060H21A;  MOderna 12/15/22 Lot# 024H22A
WITHIN 5 MINUTES OF ADMINISTRATION PATIENT NOTED PAIN/TIGHTNESS IN LEFT SHOULDER JOINT. AFTER 10-15 MINUTES THE PAIN SPREAD TO BACK OF PT'S NECK. HE DESCRIBED THE PAIN AS A STABBING PAIN MIXED WITH A BURNING/STINGING SENSATION IN THE LEFT SHOULDER/NECK AREA.  AFTER THE INITIAL OBSERVATION PERIOD PATIENT SHOPPED IN THE STORE A BIT AND BEGAN TO EXPERIENCE TIGHTNESS IN THIGH MUSCLES, HEADACH, FATIGUE , AND MALAISE. THE PATIENT TOOK TYLENOL UPON ARRIVING HOME AND SAID THE SHOULDER PAIN WAS STARTING TO SUBSIDE. HE OBSERVED PAIN AND REDNESS AT VACCINATION SITE
onset 4OCT96 of discrete papular rash w/retro auricular macules & 1 large macule on rt thigh;rash worse on face & chest;mild URI sx;rhinorrhea;mild throat infect;
Menstrual cycle began again (started 9/27, start of previous menstrual cycle 9/20) extremely heavy flow, lasted for 4 days with many clots.
Pt came to pharmacy saying he was here for his second Moderna shot. A floater Tech ran the shot for Moderna. Also Floater Pharmacist on duty had the immunizing Technician give the shot. When patient was done he asked if he could get another vaccine card. The floater technician looked up the information this is when they discovered that he received Pfizer for his first dose
Flu clinic was performed in school 11/2/2021 and student was given vaccine along with schoolmates.  On 11/9 this facility returned to do a second flu clinic for the students who were out on 11/2.  This student was brought back in with a second signed permission form and given a second shot.  The parent reported the error this AM to the school.  The student was assessed by the school nurse who reported, "she shows no signs or symptoms of any issues but will continue to monitor."