chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the 7th day after the vaccine, patient developed a red, warm to touch, swollen, itchy area slightly below where the shot was given.  It started out at  about 2" in diameter and continued to spread on the upper arm  up to today,  3-4 days later.  It increased in size to about 6X6" in diameter.  Patient saw his primary care MD today who said to take Benadryl, use cold compresses and prescribed a Medrol Dose Pack.  We will phone the doctor two days from now with an update.
Received her first Covid-19 Vaccine Pfizer on 10/30/21. The day after (10/31/2021) she started experiencing allergic reaction (mild skin bumps only similar to hives but without redness or welts) through out her chest, arms and legs. Bumps were itchy, but no color and lasted for 24 hours. She received her 2nd dose 11/23/2021. During vaccination, patient was given loratadine 10mg  tablet. She was also given diphenhydramine 25mg cap for night time with proper counseling (drowsiness). She was instructed to seek medical help as necessary. She waited 30 minutes in the pharmacy and experienced no symptoms. Upon follow up night of 11/23/21 and morning of 11/24/21, she mentioned no allergic reaction occurred.
Swelling at site of injection. C/O difficulty bearing weight. No redness noted. Advised ADVIL cool compresses call if worse.
It started 30 mins after I got the shot on my way home. I felt like the tip of my tongue was swelling and my breathing was started to act weird. I called the pharmacy and the told me to take Benadryl and it went away.
MY ARM STARTED SWELLING, TURNED RED, ITCHED, AND WAS TENDER TO TOUCH. I ALSO HAD A LOW GRADE FEVER. I WENT TO APRN AND SHE MEASURED THE SWELLING AND I HAVE TAKEN PICTURES AND MEASURED ALMOST EVERYDAY SINCE THE VACCINATION.
Pt says his arm became sore like he had strained it about 2 hours after receiving  the immunization. He says it is not getting better and it has been a month.
After receiving the 4th shot, the student fainted and began seizing on the floor. Had tonic/clonic generalized movements, eyes rolled up, lasting less than 1 minute. No incontinence. No history of previous seizures. Vital signs are stable after seizure.
A reaction; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a reaction/adverse reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the experienced a reaction. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event a reaction was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Pt recvd measles vax approx NOV90 & 3 wks later pt exp fever to 103, followed in 48 hrs by a rash involving the trunk, back, face & scalp; As of 4DEC90 sx had resolved; No further details were provided;
received both doses, then had shingles/suspected vaccination failure; shingles; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In 2020, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 07-JUL-2022 Reporter's Comments: The reporter was a GSK employee. The physician reported that the patient received first and second dose of Shingrix vaccine and then had a case of shingles. The HCP (health care professional) reported event but was not clear from records when it happened. The HCP (health care professional) considered it a breakthrough case in a patient that had been refractory to several treatments for her condition. The reporter agrees to follow up from GlaxoSmithKline. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test confirming of shingles were unknown at the time of reporting.
5/3/07 developed rash 4 1/2 x 5 1/2 cm at site of varicella vaccination (booster dose), erythematous sl rash and diffuse sl raised vesicular rash on ant chest, bilat arms not itchy (+) F/C on 5/2 had recurrent migraine on 5/2 and received ibuprofen
On 03/06/2021, Severe Left groin, thigh and knee pain, numbness in left shin at around 11:30 pm. I went to ER around 6am on3/7/2021. I was treated with dilaudid iv for pain.
Felt off like light headed; Heart was racing; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt off like light headed) and HEART RATE INCREASED (Heart was racing) 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 No adverse event.    On 05-Feb-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Felt off like light headed) and HEART RATE INCREASED (Heart was racing). At the time of the report, DIZZINESS (Felt off like light headed) and HEART RATE INCREASED (Heart was racing) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure increased: Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Mild to moderate body rash on arms and trunk starting 3 days after administration of flu shot.
on and off stomach pain and heart burn; Tingling in hand; on and off stomach pain and heart burn; Headache as well a bit.; This is a spontaneous report received from a contactable consumer (patient herself). A 36-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0162) via an unspecified route of administration in left arm on 16Apr2021 08:15 as dose 1, single (at the age of 36-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history and concomitant medications were not reported. Patient did not had any allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. On 16Apr2021 at 08:15 patient experienced tingling in hand, on and off stomach pain and heart burn, headache. Patient did not receive any treatment for the adverse events. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200411140 (Pfizer). A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 (Lot number: FC3183) at the age of 77 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Allergy" (ongoing); "Bladder" (ongoing), notes: Verbatim: Helps Bladder; "Hernia", start date: 2016 (unspecified if ongoing), notes: Pertinent details: Surgery 2016; "Removal of stone in bile over" (unspecified if ongoing), notes: Verbatim: Removal of stone in bile over, Pertinent details: Surgery 2016; "Enlarged Prostate" (ongoing), notes: Medication. Concomitant medication(s) included: ALLEGRA taken for hypersensitivity (ongoing); TAMSULOSIN taken for bladder disorder (ongoing); ROSUVASTATIN (ongoing); FINASTERIDE taken for prostatomegaly (ongoing). Vaccination history included: Bnt162b2 (Lot/Batch number: EN6203, Anatomical location: Left arm, Dose no: 1), administration date: 26Feb2021, when the patient was 77 years old, for Covid-19 immunization, reaction(s): "No adverse reaction"; Bnt162b2 (Lot/Batch number: EN6209, Anatomical location: Left arm, Dose no: 2), administration date: 19Mar2021, when the patient was 77 years old, for Covid-19 immunization, reaction(s): "No adverse reaction". The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 31Aug2021, outcome "unknown" and all described as "he received his first booster dose at the end of August"; BLOOD PRESSURE INCREASED (medically significant), outcome "unknown", described as "triple BP"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "I had symptoms of Covid but test was OK". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) ok, notes: Nasopharyngeal swab, Ms2 ort s gene; blood pressure measurement: (unspecified date) increased. Patient asks Its been Six months when will she be able to take another booster. Patient had symptoms of Covid but test was ok. Relevant family medical history was Metoprolol blood pressure oral ongoing ipratropium bromide spray for nasal. Follow-up (07Feb2022): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected. Follow-up (02Mar2022): This is a follow up spontaneous report from a same contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included: Case was upgraded to serious, CC reporter, RMH, lab data, Vaccine details, New AE and concomitant drugs details was added. Follow-up attempts have been completed and no further information is expected.
Reaction was first noticed the day after administration, starting as an approximately 3" diameter area of red, inflamed tissue around the site of administration on the right deltoid. Pt thought this was a normal reaction until the inflammation spread, and came in 2 days after administration at which time the irritated area was an approximately 5" by 6.5" area of cellulitis. Diagnosis was cellulitis. Treated by 20 capsules of 500mg Cephalexin BID x 10 days paired with 24 tablets of 325mg acetaminophin Q4H PRN.
Too many to count eryth lesions with central small fluid filled vesicles, mostly pencil eraser size some with eryth up to 1 cm, non tender, none crusted.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given >12 hour post-puncture) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2022 at 11:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 13-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given >12 hour post-puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given >12 hour post-puncture) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that the date and time vial was first punctured was on 12 Mar 2022 at 10:18 AM. The vial was stored at room temperature post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 to 25 degree Celsius = 46 to 77 degree Fahrenheit ) was 24 hours. No concomitant medications information was reported.
Onset 12 hours after IM vaccination SHINGRIX. Flu-like symptoms of myalgia, shivers, low grade fever, malaise and insomnia. Stayed in bed next day and night. Symptoms resolved gradually. Able to resume normal activity about 36 hours later, though quite fatigued.
Fatigue, headache, soreness, aches and pains, fever, chills, chest pain, dizziness, eye blurriness
Patient had fever and nausea with some vomiting roughly 5-10 minutes after receiving vaccine.  Patient also had some trouble breathing but it resolved within a five minutes.  Gave patient cold compress over her neck and monitored her breathing and nausea.  All symptoms resolved and she was able to leave facility.
Autism/PDD-NOS (symptoms began shortly after MMR).  Child also received over 100 micrograms of thimerosal contained in vaccines administered prior to MMR.
shooting joint pain in both hands both wrists when moving, lifting small items, finger and wrist joints "lock"; finger and wrist joints "lock" during routine tasks; during routine tasks followed by radiating pain; This is a spontaneous report from a contactable consumer reported for himself. A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, lot number: en6198), dose 2 via an unspecified route of administration, administered in arm left on 26Feb2021 as a single dose for COVID-19 immunisation. The patient previously took first dose of bnt162b2 via an unspecified route of administration, administered in arm right on 05Feb2021 12:15 (lot number: el3246) as a single dose for COVID-19 immunisation. Medical history included known allergy to lithium, meloxicam, nightshade vegetables. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications in two weeks included losartan 100, spironolactone 50, loratadine 5, all taken for an unspecified indication, start and stop date were not reported. On 27Feb2021 08:00, the patient experienced shooting joint pain in both hands both wrists when moving, lifting small items, finger and wrist joints "lock" during routine tasks followed by radiating pain. No treatment received for the adverse event. This is a non-serious report. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was unknown.
About 8hrs after vaccine developed tenderness, swelling, erythemas warmth. Symptoms from elbow to upper arm with SOB T98 BP 120/84 P66. PE: NAD non toxic. Left upper ext: with edema, warmth, erythema over lateral portion. No ulcers. no target lesions imp: Cl oral: no lesions. Tx = NAPROSYN, prednisone taper.
Fever of 102 degrees, chills, body aches, lost 5 lbs over 5 days, injection site pain, redness, warm to touch. (All since injection on 8/5/15).
Pt vaccinated with influenza 11/20/03, on 11/24/03 c/o headache and continued soreness,
Pt woke up this AM with 101 temp and feeling "sore all over her body". No redness and no swelling noted to the site of injection. Mom gave some Acetaminophen and the fever came down by 9 AM.
Four hours post vax, pt developed big blotches over entire body, on soles of feet and palms. Her face became swollen and she had a temp of 103. She was treated in the ER with oral Benadryl and the blotches began to subside.
I had the Johnson & Johnson/Janssen vaccine on August 12th, 2021.  I had THE worst muscle aches humanly possible which lasted 2 days.  From the 3rd day until the writing of this email on September 16th, 2021, more than a month, I have muscle aches all day every day.  My doctor has recommended that I take 1000 mg tylenol every 4 hours with 800 mg of Ibuprofen every 8 hours.  While that does diminish the pain somewhat, it does not completely relieve it.  That dosage is not sustainable.  I will end up in worse shape if I try to keep taking that dosage daily.  Even Flexeril doesn't completely relieve it.  My life has become a living misery.  I wish I had known ahead of time what my reaction would have been.  I hope that my story may save even one person from making the wrong decision.
customer passed out and or had seizure and EMS was called. customer is alert and fine now.
no adverse event; A HCP called and reported that an expired dose of MMR II was administered to a patient. The caller refused to provide a first and last name. No adverse effects were noted. No additional AE reported. No PQC; This spontaneous report was received from a Registered Nurse (RN)and refers to a 58-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-MAY-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, once, lot #U011995, expiration date: 15-APR-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event reported.
DEVELOPED RED RASH ON UPPER RIGHT CHEST (17CMX13CM), WARM TO TOUCH AND ITCHES. BY NEXT MORNING COLOR HAD FADED AND RASH WAS NOT AS ITCHY.
Nurse was called to the pts car by the traffic controller. Pt stated " she became dizzy after receiving the vaccine. On Assessment pts skin was pale and diaphoretic. She reports that she has not eaten since breakfast. Pt also stated that she has  HX of syncope or vaso-vagal syncope when getting blood drawn.
the patient reported that two days after he received the vaccine he created a spot on his right arm near his elbow that looked like a blood spot. since the vaccination date the spot hasn't removed. Also,  the patient reported that the area was tender and at times felt pain.
Patient received a covid booster on 11/10/21.  Patient came in today complaining of numbness and tingling that began one day after receiving the vaccine and has not subsided for the last 10 days. she explains the tingling starts at the injection site and radiates down into her palm and all fingers.
SEVERE PAINS ACROSS SHOULDER, IN ALL JOINTS, NECK, KNEES ANKLES, WRISTS FINGERS, FEET AND SWELLING IN THOSE AREAS UNABLE TO WALK 9/22/2023 ON RISING FOR SEVERAL DAYS FLU ON 9/15/2023
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Patient developed rash/hives on one leg about one hour after receiving vaccines. Rash appeared on chest a few hours later. Took Benadryl, and this resolved rash.
This spontaneous case was reported by a patient and describes the occurrence of COUGH (started coughing), LARYNGEAL DISCOMFORT (woke up with congestion  centered at my larynx), DYSPHONIA (am very hoarse) and MYALGIA (sore arm) 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 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced MYALGIA (sore arm). On 29-May-2021, the patient experienced COUGH (started coughing), LARYNGEAL DISCOMFORT (woke up with congestion  centered at my larynx) and DYSPHONIA (am very hoarse). On 28-May-2021, MYALGIA (sore arm) had resolved. At the time of the report, COUGH (started coughing), LARYNGEAL DISCOMFORT (woke up with congestion  centered at my larynx) and DYSPHONIA (am very hoarse) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
PATIENT STATES THAT HER ARM IS SWELLING UP STARTING TO TRAVEL TOWARD ELBOW.
Information has been received from a consumer concerning her brother who on an unspecified date was vaccinated with MMR II and then developed autism on an unknown date. It is unknown if the patient sought medical attention. Upon internal review, autism was determined to be an other important medical event. This is one of several reports received from the same source. Additional information is not expected.
broke out in rash from head to toe in approx 1wk; MD seen pt & saw reaction was due to MMR;
Pt recvd vax 2OCT91 in afternoon; mom called 3OCT91 AM pt was very lethargic & difficult to arouse, t102; mom attempted to stimulate w/in 5-10 min pt was alert, responsive & t101R;
vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks; Dose 1 received was on 22-Feb-2022 , while dose 2 received on 17-May-2022; Patient received vaccine that had been expired for 2 weeks; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that had been expired for 2 weeks), PRODUCT STORAGE ERROR (vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received was on 22-Feb-2022 , while dose 2 received on 17-May-2022) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 083J21A and 027L21A) for COVID-19 vaccination.     Patient do not have any allergies.    On 22-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that had been expired for 2 weeks) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received was on 22-Feb-2022 , while dose 2 received on 17-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that had been expired for 2 weeks), PRODUCT STORAGE ERROR (vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received was on 22-Feb-2022 , while dose 2 received on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Number of doses/vials: 26 doses some were primary doses and some boosters .  The health care professional (HCP) states that they administered the Moderna COVID 19 vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks. The HCP explains that since the expiration date was not written on the vial, they did not notice it had already expired.  On 17-May-2022, the vial was initially stored in the refrigerator and the vial did not undergo any temperature excursions.  Reporter stated that none of them had reported side effects.  No treatment medications were reported.