chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling of lips; numbness of the face; Tingling of the face/ Tingling on scalp/ Tingling of fingers; Numbness of lips; Numbness on scalp; Numbness on fingers; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (Tingling of lips), HYPOAESTHESIA (numbness of the face), PARAESTHESIA (Tingling of the face/ Tingling on scalp/ Tingling of fingers), HYPOAESTHESIA ORAL (Numbness of lips) and HYPOAESTHESIA (Numbness on scalp) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling of lips), HYPOAESTHESIA (numbness of the face), PARAESTHESIA (Tingling of the face/ Tingling on scalp/ Tingling of fingers), HYPOAESTHESIA ORAL (Numbness of lips), HYPOAESTHESIA (Numbness on scalp) and HYPOAESTHESIA (Numbness on fingers). At the time of the report, PARAESTHESIA ORAL (Tingling of lips), HYPOAESTHESIA (numbness of the face), PARAESTHESIA (Tingling of the face/ Tingling on scalp/ Tingling of fingers), HYPOAESTHESIA ORAL (Numbness of lips), HYPOAESTHESIA (Numbness on scalp) and HYPOAESTHESIA (Numbness on fingers) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Arm falling asleep several times a day since vaccination on 1/14.  Mild Pain in clavicle area beginning yesterday 1/24 with increase in pain intensity today 1/25 along with radiating to lower portion of neck on right side.
Reaction was 4 mm with whitesh head-raised.  Has been warm to touch and area was knotted.
patient called and said he had a reaction to shingrix shot. fever, joint pain, muscle cramps and dizziness.  he said he will not get the second shot. he also mentioned that he already reported to FDA.
MYSATHENIA GRAVIS (AUTOIMMUNE DISORDER). Double vision, ptosis(drooping of the eyelid).
Hives on abdomen, neck, back, both arms, legs, hands and feet 30 minutes after receiving FLUMIST. At time of visit no hives, back was itchy.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EK 9231), in right arm, on 04Feb2021 as dose 2, single (Lot number: EN 5318), in right arm, on 29Sep2021 as dose 3 (booster), single (Lot number: 019F21H), in right arm and on 22Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 83 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN; FISH OIL; FINASTERIDE; GLUCOSAMINE; MONTELUKAST; OMEPRAZOLE; TAMULOSIN; SYMBICORT; VITAMIN C [ASCORBIC ACID]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (12Oct2022) Positive, notes: Retested positive 24 hours after last dose of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: The reporter stated, Patient received paxlovid  as treatment medication. The patient received vaccine and other medicines within in two weeks. The patient did not experienced any chronic health conditions as medical history.
SPOTTY RASH BOTH ARMS AND AROUND NECK , BLOTCHY, RED ITCHY, FLAT.     TREATED WITH BENADRYL 25MG 1 HS FOR A COUPLE OF NIGHTS.    RESOLVED.   SHE DIDN'T REPORT TO PHARMACIST BUT DID CONSULT WITH HER MEDICAL PROVIDER WHO TOLD HER SHE WAS OK THAT THEY HAD BEEN SEEING SUCH RASHES ESPECIALLY IN YOUNG, HEALTHY ADULTS.
Extreme tiredness  Body aches  Intense headache as it will explode  Chills
Sore upper arm muscle. Then swollen area and red itching too- one week later. Red, swollen area expanded some under the skin bacterial infection. Abxs presribed (4x a day) for 10 days.
Approximately a few months after my 2nd dose vaccination I experienced the following symptoms: Head pain (Back part of my head), Right eye pain, Right hand and arm numbness, Nausea and Headache. I was vomiting almost the whole night. Then the next day my symptoms subsided. I did not take anything for treatment and just decided to take a bed rest.
Within 15 minutes - Pounding heart beat, dizziness, pain at site of shot in left arm and heart pain Next two days - Pounding heart beat, fever, chest pain, weakness, dizziness, nausea, joint pain Within a week - Pounding heart beat and fast hear beat continues and shortness of breath
Admitted to hospital on 5/21/21 for hypotension and anemia. During screen for discharge, was found to be COVID-19 positive.  Is currently asymptomatic at time of writing. Patient remains admitted to hospital at this time, awaiting another COVID-19 test.
Upon beginning to administer the vaccine; the plunger stopped abruptly and I was unable to complete vaccine with that dose; after the patient left, when I tried pushing the plunger again, I had to use quite a bit of force to get it to move, and then only a little vaccine squirted out the needle. I had never encountered this issue and as a result I became a little flustered. The patient immediately began to bleed, which ran down her arm prior to me swabbing it up. The patient's arm started to swell and discolor almost immediately. The second vaccine that I prepared was compromised by me as I uncapped the needle and set it exposed on counter to go get another alcohol swab; the husband of the patient noticed this and pointed it out to me. I was obtained a new vaccine and successfully administered to patient.
Received dose on Friday, experienced a very sore arm and fatigue through Saturday evening.  Fatigue and sore arm dissipated by Sunday morning and random itching all over body became noticeable.  Itching became very intense on face along with a burning sensation on face. Itchy/ burning face continued though the next week along with tinging and numbness on the tongue and lips.  Antihistamines were taken but did not help very much.  A week after vaccine, extremely intense icy/hot burning sensations developed throughout body along with muscle tension in head, neck and jaw. Tension dissipated but burning sensation throughout body persisted.  Doctor prescribed 5 day prednisone treatment which did not alleviate symptoms. Now 26 days post 1st vaccine dose and neuropathic intense burning sensations throughout body have persisted for hours and days at a time.  Face/body itching  and burning has also retuned on day 25 post vaccine.
Patient refused to nurse following vaccine administration. Hives began to appear a few minutes after vaccines were given to bilateral legs as well as the patient's back. Patient was very warm to the touch and red. Very irritable. 9mg of Benadryl were given when this occurred. Patient began to improve around 15 min later.
Patient said that he had a mild headache immediately post vaccination, and about 5 minutes later, a red wheal of approximately 10x10cm noted on left anterior chest wall close to the vaccination site. Patient denied itching to the wheal, shortness of breath or any other symptom. BENADRYL offered to patient but he declined and said that he was okay. Patient was kept in the clinic for 30 minutes and monitored. Vital signs were 137/83, pulse 87, temp 97.1. 30 minutes after patient was given the vaccine, site of wheal was inspected, and the redness had reduced as well as the wheal. Patient denied any shortness of breath, wheezing, itching weakness. Patient said that he needed to go, and left the clinic. Patient informed that VAERS will be notified and that he should go to the emergency room if his reaction gets worse. Patient verbalized understanding.
Was not aware I was pregnant until shortly after my first vaccine dose.  Would have been between 3-5 weeks pregnant at first vaccine and 6-8 weeks at second vaccine. According to ultrasounds, my pregnancy never progressed beyond 6 weeks.
crohn's disease; immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (crohn's disease) and IMMUNODEFICIENCY (immunocompromised) in a 45-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch nos. ASKU, ASKU and ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CROHN'S DISEASE (crohn's disease) (seriousness criterion medically significant) and IMMUNODEFICIENCY (immunocompromised) (seriousness criterion medically significant). At the time of the report, CROHN'S DISEASE (crohn's disease) and IMMUNODEFICIENCY (immunocompromised) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  They recommended him to get another dose of COVID-19 Vaccine. Treatment medications were not reported.  Company comment:  This spontaneous case concerns a 45  year  old male patient, with no clear medical history reported, who received one dose with Janssen COVID  19 vaccine and 3 doses with Spikevax 2023-2024 vaccine, and experienced the unexpected, serious (medically significant) events of Crohn's disease and Immunodeficiency. Latency cannot be properly assessed since exact onset and vaccination dates were not provided. Patient stated he has Crohn's disease, and he is immunocompromised; however, it was not clarified if this condition started before or after any COVID-19 Vaccine. No further clinical details were provided for medical reviewing. The benefit-risk relationship of Spikevax 2023-2024 is not affected by this report.
An 18 hour bout of fever; cyclical vomiting; Lost 7 pounds in 72 hours. This is a spontaneous report from a contactable consumer (patient) reported for herself. A 49-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Ep7533, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 09Mar2021 at 14:00 pm (age at vaccination was 49 years) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The facility where the most recent COVID-19 vaccine was administered was  Health Clinic/ Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 16Mar2021 at 20:00 pm, the patient experienced an 18 hour bout of fever, cyclical vomiting and the patient lost 7 pounds in 72 hours. The patient received treatment with Phenegren. The patient recovered with lasting effects. The outcome of the events was resolved with sequel on an unspecified date in 2021.   No follow-up attempts are required. No further information is expected.
Diagnosed she has a lymph node in her neck that is filled, probably from infection; This is a spontaneous report from a non-contactable consumer (patient) via a REGULATORY authority. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown) via an unspecified route of administration, on an unknown date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient was diagnosed, she had a lymph node in her neck that was filled, probably from infection. The patient underwent lab tests and procedures which included investigation: resulted as she had a lymph node in her neck that was filled, probably from infection. Therapeutic measure was taken as a result of the event and patient was prescribed Amoxicillin for that. Inquiring if that would affect her Covid vaccine shot that she was scheduled to receive on Wednesday. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
This spontaneous report was received from a registered nurse and refers to a 12 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown dates, the patient was vaccinated with the first dose of RECOMBIVAX HB 10mcg/ml, 1 ml (route, lot number and expiration date were not provided). On an unknown date, reported as separated by three months from the first dose, the patient was vaccinated with the second dose of RECOMBIVAX HB 10mcg/ml, 1 ml (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. On an unknown date, there was an inappropriate schedule of drug administration as the patient received a RECOMBIVAX HB series of 2 doses separated by 3 months. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient took Booster dose.  On 06-DEC-2021,Lot 012H21B vials was placed in refrigerator.  No concomitant medication details was provided.  No treatment medication details was provided.
Sevire pain in left shoulder radiating down the chest, back and left arm.   Blood pressure shot up to 200 plus Temp shot up to over 104 Heart rate rapid PAIN! Left arm severely swollen for three weeks Terrible back muscle pain fit 5 days Shortness of breath Other flu like symptoms.
Symptoms started on May 1, 2022, I had a lot of stomach issues on Sunday, Monday & Tuesday. On Wednesday, my throat started bothering me so I tested a rapid home test which was positive. I had joint pain, chills, pain in throat, coughing worsened Thursday. On Friday, I got Paxlovid from my doctor and started that Friday night, my symptoms got better within 24hrs of starting meds. By Monday afternoon, my throat was better so I could talk and swallow again.
A non-serious spontaneous report of '29 patients received expired FLUMIST" was received from a physician concerning a six-year-old male. The patients' medical history included no history of asthma. Concomitant medication were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are
Pt pretreated with BENADRYL per MD orders. Itching began about 4 hrs after. Seen by MD next day b/c pt. reports darting pain in left breast region. Sent to ER given prednisone, VISTARIL, PEPCID. Also given CT scan with contrast then pain stopped.
Had the Pfizer shot (COVID shot), I have got COVID; I took the Pfizer vaccine both booster, I got COVID now; Had the Pfizer shot (COVID shot), I have got COVID; I took the Pfizer vaccine both booster, I got COVID now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune" (unspecified if ongoing), notes: she has an autoimmune. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had the Pfizer shot (COVID shot), I have got COVID; I took the Pfizer vaccine both booster, I got COVID now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.The patient was treated with Paxlovid.The NDC number of COVID Shot and UPC number of covid shot was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8x4 cm redness + swelling at injection site afebrile; no pain; warmth to touch
Headache severe to mild 5 days Nausea 5 days.      Extreme fatigue 5 days Vomiting 3 days Diarrhea 4 days Joint pain 3 days
Moderna vial was placed in fridge on 01/01/22. Moderna vial with the lot number of, 041J21A has not undergone a temperature excursion. Patient was administered Moderna booster(0.25ML) on 02/17/22 at 4:00PM. Patient has not reported to Medical Clinic with symptoms at this time.
I vomited several times; Severe headache; Muscle aches; Chills; Joint pain; Tiredness; Fever; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration from 07Jan2021 10:00 at left arm, at single dose for covid-19 immunization. Medical history included COVID 19 positive 12Dec2020, the patient was diagnosed with COVID-19 prior to vaccination. Allergies to medications, food, or other products was reported no. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient received vaccine at 07Han2021 10:00PM (as reported). 4 hours after receiving the vaccine 07Jan2021 14:00 the patient vomited several times, the patient had and still have severe headache, muscle aches, chills, joint pain, tiredness and fever. The patient realized that these are side effects and not adverse reactions but she felt that they were quite severe and she thought it was due to the fact that she so recently had COVID 19. OTC meds were received for all events. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
sent home from second dose, told too soon, unsuccessful at rescheduling appointment, no appointments on CDC page; Felt very sick; Fever; Bones ached horribly for three days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (sent home from second dose, told too soon, unsuccessful at rescheduling appointment, no appointments on CDC page), BONE PAIN (Bones ached horribly for three days) and PYREXIA (Fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID-19 twice before receiving the shot). Concurrent medical conditions included COPD.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (sent home from second dose, told too soon, unsuccessful at rescheduling appointment, no appointments on CDC page), BONE PAIN (Bones ached horribly for three days) and PYREXIA (Fever). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (sent home from second dose, told too soon, unsuccessful at rescheduling appointment, no appointments on CDC page), BONE PAIN (Bones ached horribly for three days) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.
Pt devel influenza A infect 2 months after vax, Dx was made using Directigen Flu A Test, performed at the MD office. This was 1 of 2 patient from this site to devel influenza A 2 months after vax with lot# 4978151.
Fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heartbeat) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEART RATE INCREASED (Fast heartbeat). At the time of the report, HEART RATE INCREASED (Fast heartbeat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Concomitant product use was unknown by the reporter
Pt presented for catch up schedule on DTaP and was given DTaP #5 at age 8, not recommended age.
Acute body aches, all over.  Elevated temperature.  Went to bed, drank a lot of water.  Slept through, until 7:00 pm.  Got up and ate a sandwich (tuna salad) and went back to bed.  Symptoms abated with no residual effect.
severe back pain next day, nausea, body ache before bed, legs would turn red when flareup occurs