chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heavy vaginal bleeding one year post menopause. It lasted about 2.5 days, but not sure if this will reoccur or not.; This is a spontaneous report from a contactable consumer and other HCP. A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534 and Expiration date was not reported) via an unspecified route of administration, administered in Arm Right, on 01Apr2021 at 12:45 (at the age of 52-year-old), as single dose for COVID-19 immunisation. The patient medical history included thyroidectomy from 2006 to an unknown stop date, hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (LEVOXYL); ascorbic acid, betacarotene, biotin, calcium lactate, choline bitartrate, chromium nicotinate, colecalciferol, cyanocobalamin, dexpanthenol, dl-selenomethionine, folic acid, inositol, magnesium lactate, manganese gluconate, nicotinamide, potassium citrate, potassium iodide, pyridoxine hydrochloride, retinol palmitate, riboflavin phosphate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTI VITAMIN & MINERAL), probiotics, vit c (ASCORBIC ACID), vit d (ERGOCALCIFEROL), valtrex (VALACICLOVIR HYDROCHLORIDE) taken for an unspecified indication, start and stop date were not reported. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205) via an unspecified route of administration, administered in right arm, on 09Mar2021 at 12:30 PM (at the age of 52-year-old), as single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered reported as Pharmacy or Drug Store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not allergic to medications, food, or other products. On 10Apr2021, the patient had experienced heavy vaginal bleeding one year post menopause. it lasted about 2.5 days, but not sure if this will reoccur or not. The patient visited the physician office. The patient underwent lab tests and procedures which included peripheral nerve neurostimulation was normal on 13Apr2021. The outcome of the event was reported as unknown. It was reported that the Pfizer product had no causal effect to the adverse event.  Follow-up attempts are completed. No further information is expected
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 18-MAR-2013, the patient's healthcare provider at a medical center administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 10-DEC-2016, the patient was treated by a physician the same medical center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Information has been received from a Registered Pharmacist concerning a female patient with migraines who on 04-MAY-2011, was vaccinated subcutaneously in the right arm tricep with a dose of ZOSTAVAX (Merck) (lot # unspecified). Concomitant therapy included PAMELOR and IMITREX. The pharmacist reported that the "next evening" (on 05-MAY-2011), the patient called the pharmacy to report that she developed a swelling at the injection site that was the size of a "softball". The patient reported to the pharmacist over the phone that the injection site was warm to the touch and painful. On 06-MAY-2011, two days after she received the vaccine, the patient called to report that she was "not feeling well". She also reported nausea. No treatment was given to the patient. At the time of the report it was reported that the adverse events had not improved. The patient's outcome was not reported. Additional information has been requested.
Patient came in for booster shot and requested Janssen vaccine.  However, after vaccination realized patient had already received a booster shot of Janssen in November (his primary dose was also Janssen), so this would be his second booster.  Since patient getting 2nd booster he should have received either Moderna or Pfizer (since these are the 2 vaccinations approved for the 2nd booster).   Made patient aware of this  and at this point he was doing well--no adverse effects as of yet.
It started with being very itchy, two days later I saw my arm had a red rash and swollen. My arm was achy and I sprayed it Benadryl spray at night. The swelling went down after four days.
NAUSEAS, MUSCLE PAIN, FEVER, TIREDNESS, INJECTION SIDE PAIN,
MOM SAYS SEIZURE -LIKE EYE ROLLED BACK SHAKING,FAINTED,PALE PT WAS IN OBSERVATION AFTER PT WAS FASTING
Post vax, at 13:20, the pt's class went outside to run on track. Afterwards, he became diaphoretic, had increased heart rate (136); audible wheezing; hoarseness; rapid breathing and chest pains. Lungs were clear despite audible wheeze. He drank coke and blew into a paper bag. His heart rate eventually came down to 128, 104 and then to 82 after 20 minutes.
received 1st covid vaccine 2/12/21 2nd dose 3/5/21 at hospital admitted to medical center for covid symptoms including hypoxia, fever, and altered mental status testing positive for covid 5/4/2021
The morning after vaccination she had no strength in her legs. Could not walk.   Went to neurologist who examined and referred to hospital er. Admitted on Thursday and discharged following Tuesday.  Her condition was pre vaccination
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LISINOPRIL and METFORMIN for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 10-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       A consumer reported no thyroid.   This case was linked to MOD-2021-303744 (Patient Link).
Red, blotchy, hot to the touch rash on top of forearms.  Lasted 3 days.
11/3/2006:  PM hours following AM vaccination with influenza and PPV23 vaccines, patient reported the following symptoms:  generalized body shaking, fever, and pain.  Left arm red and warm to touch with swelling.  Duration of 2 days, after which she visited her family MD.  Prescribed Keflex 100 mg po bid for 7 days.  All symptoms subsided.
the patient presented with bruising on lower arm closer to elbow.  I could see the tiny bruise where her vaccine was administered and there were a couple of inches between where the vaccination was given and where this bruising occurred.  She wanted this reported; as such, i am reporting it since she believes it is from the vaccine.
This initial spontaneous report was received from a registered medical assistant referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL injection (lot # K010215 with expiration date 05-MAY-2017; dose and route were not provided). No adverse effect was reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Started with headache and chills at 10:00pm on 4/6/21(day of vaccine), fever greater than 102F starting at 1:30am 4/7/21 along with pounding headache and fatigue continuing until after 6:00pm when temp was 102.6F and Tylenol was taken.  Temperature reduced to 99F by 10:00pm and then returned to normal the next day.  On 4/8/21 left upper arm itchy and red area noted from injection site and covering an area approximately 4"x4".   Redness fading 4/11/21
I had the shot and I've had shingles on my back/ suspected vaccination failure; Shingles on back; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had the shot and I've had shingles on my back/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on back). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 25-MAR-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced shingles on his or her back for three times. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Expired vaccine administered. Covid vaccine lot number FM7553 expired 6/30/2022, administered 7/6/2022. Patient contacted, reports doing well, no adverse reactions post vaccination.
Pain; Little fever; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported for a male patient (husband). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Feb2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced pain, little fever. Verbatim and Event Description: Reporter calling in for her husband. Reporter said her husband got the vaccine yesterday and experienced pain and a little fever. Asking if her husband can take Tylenol. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
I had the normal, mild arm soreness after administration, Then two weeks and 2 days later, I had severe pain , swelling and pain at the injection site, and unable to move arm to the arm away to the side or forward of the body.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date, the unspecified patients were vaccinated with improperly stored PROQUAD (Merck) (therapy type: digital data logger). No adverse effects were reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). The vaccine for stored at -14 Celsius for an unspecified time and data logger was involved. This is one of the two reports from the same reporter. Additional information has been requested.
Patient received vaccine in early afternoon, had nausea and felt funny that night.   Friday morning felt funny then felt fine the rest of the day.   Saturday morning did not feel quite right but then better as the day went on.  Sunday night had sore throat.  Monday, patient had bad sore throat and could not swallow. Patient had to spit every few minutes, there were nodules of white stuff on spit and tongue was white.   On Tuesday went to doctor and given liquid to gargle with Novocain for pain; it was helpful.   Yesterday went to Urgent Care and doctor agreed but they did a culture to see if it was thrush or not; results come back on Monday.   Per reporter, she read that one of the vaccine ingredients from a bark of tree could cause problems with in lining of throat.   Patient went to Reporter spoke to Pharmacy on 6/7 and directed to call VAERS.  Currently, patient feels better when gargles because it helps with pain in throat. Aspirin also helps patient feel better. The symptoms are about the same--not improving.  Patient tested negative for strep and there is no fever.   Per doctor, it is not a bacterial infection--awaiting for results to see if fungal.
Patient complained of left arm pain that radiated down left shoulder in between the biceps and triceps muscles and down the extensor surface of the forearm into the left hand following administration of a flu shot.
transient facial palsy in conjunction w/insulin rxn (hypoglycemia) in type I diabetic;
Temp climbed to102; chills came on; Fever broke at 630 am; Continued having body aches and dry heaving; Continued having body aches and dry heaving; This is a spontaneous report from a non-contactable consumer. This consumer reported for female patient (reporter's daughter in law) that a 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history included rarely drinks. Concomitant medications was not reported. The reporter stated, the patient experienced, temperature started at 11:30, shot was given at 16:00. Temp climbed to 102 and then chills came on. Fever broke at 6:30 am with Tylenol. Continued having body aches and dry heaving. Her doctor Prescribed Zofrane because the nausea and dry heaving was awful. Down in bed for 2 days. (Missed 2 days of work). Has never smoked. She is in great shape. Rides her bike every day. Therapeutic measures were taken as a result of fever broke at 6:30 am, continued having body aches and dry heaving, continued having body aches and dry heaving and nausea. Outcome of events for body aches and dry heaving and nausea was not recovered and for the other events it was unknown.   No follow-up attempts are possible. Information about batch/Lot number cannot be obtained.
heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete: unknown manufacturer), for COVID-19 Immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitations".  Additional information: The patient reported that it reminded her of how hard it was to go through Covid. Also, the list of side effects reminded her that she had heart palpitations after her [Pfizer] booster. Age of the patient was also reported as 47 (unit not reported).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I got the shingles vaccine series (last year) and I currently have the shingles/suspected vaccination failure; and I currently have the shingles; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got the shingles vaccine series (last year) and I currently have the shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: and I currently have the shingles ).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-SEP-2023 This case was reported by a patient via interactive digital media. The patient received Shingles vaccine last year and currently have shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Pt of 16 years old was given booster dose of .25mL Moderna covid vaccine on 03/31/2022. Was not noted until audit on 4/12/22. Notified Moderna on 04/13/22, spoke with patients parent on 04/13/22 to assess for symptoms/side effects/adverse events which patient was negative for. Moderna response not received at time of VAERS report submission.
In the morning on 7/7/22 patient was on his way to baseball when he told dad, "I can't feel my legs". Mom states he lost feelings in his legs, arms & hands - said he could not move or use them. He became ashen, sweaty, & SOB. Also nauseous. Went to ER for eval & treat. Patient is an 8 year old male presented per ambulance for acute onset of sweats, cramping of arms and legs, lasting about 45 minutes per parent history.  Some shortness of breath.  No chest pain.  No rashes.  No syncope.  No noted fevers.  Symptoms have since resolved. The child has recently had his second immunization for coronavirus, Pfizer, 2 days ago.  Presents for evaluation. No sore throat, no stuffy nose, no cough.  Does carry diagnosis of asthma and is compliant with his inhalers. No wheezing respirations noted.
Side effect that can be spread to member  inside a family who did not recieve the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect that can be spread to member  inside a family who did not recieve the vaccine) in a patient of an unknown age and gender 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 VACCINATION COMPLICATION (Side effect that can be spread to member  inside a family who did not recieve the vaccine). At the time of the report, VACCINATION COMPLICATION (Side effect that can be spread to member  inside a family who did not recieve the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  The patient reported a side effect that can be spread to member inside a family who did not receive the vaccine.
pt c/o tingling hands and arms, chest pain 6/10 described as tightness and pressure; pt self medicated with Nitrogycerin SL 1 tab 0.6mg; advised by on site physician to go to the hospital, pt did not want to and sign AMA
Moderna vaccine given in error to 17 year old male. Per Mom, patient had no unusual adverse effects.
Patient presented to hospital with concerns of numbness in all extremities. Initial symptoms began two weeks prior to hospital admission when patient developed numbness in left arm following working out. Parenthesis progressed into right hand and arm and then finally to lower extremities which originated in feet and progress up the legs.
This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown ages. On an unknown date the unknown number of patients were vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date, strength, dose and frequency were not reported) which were improperly stored. No adverse effects were reported. This is one of several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information is not expected.
This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (really bad night sweats), FATIGUE (extreme tiredness) and CHILLS (Chills) 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 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced NIGHT SWEATS (really bad night sweats), FATIGUE (extreme tiredness) and CHILLS (Chills). At the time of the report, NIGHT SWEATS (really bad night sweats), FATIGUE (extreme tiredness) and CHILLS (Chills) outcome was unknown. The patient reported that she was waking up with wet spots on her bed sheet and she woke up 4-5 times a night to wipe sweat off her arms, chest, and legs. She was on her menstrual cycle and never had issues with night sweats before. She denied of taking any medications. She had not checked her temperature during those episodes. Concomitant medications were not provided. This case was linked to MOD-2021-064267.
Fatigue, loss of appetite, general feeling of unwellness, tired but not able to sleep easily or well, increase in sensory integration issues, increase in anxiety, crying, being upset, and other signs of sadness or frustration (inevitably from not feeling well), wanting to sit and not be up and active and playing like normal, increase in attachment to mother, also from not feeling well. Patient is unable to express specifically how he feels due to age, just that he doesn't feel well.
Rash on arm. Appeared 48 hours post vaccination, Present for 24 hours at time of reporting Body aches,  chills, fever, numbness of right side of face lasting  36 hours post vaccination