chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse effect reported; The vaccine was not fully administered due to the child moving the leg while getting the injection; needle was bent; This spontaneous report was received from a registered nurse, referring to a 3-year-old female patient. The patient's current condition included autism spectrum disorder. Information regarding the patient's pertinent drug reactions/allergies and concomitant medication was not provided.   On 26-JUL-2021, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # V005271, was evaluated and changed to the valid lot # U005271, expiration date 21-NOV-2022, 0.5 milliliter, intramuscular in the left thigh) for prophylaxis. During vaccine administration, the patient removed needle from leg due to movement, needle was bent (needle issue). The vaccine was not fully administered due to the child moving the leg while getting the injection (incorrect dose administered). The operator was a trained healthcare professional. There was no treatment for the events. Re-dosing was recommended, and the patient's mother declined at this time. No additional adverse effect reported.  The outcome of the events was also reported as recovered. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: U005271; expirationdate: 21-NOV-2022; deviceage and unit: 0 ; operatorofdevice: Other Health Care Professional; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
pt recvd vax 14MAR93 during evening of 14MAR93, pt exp screaming x 2 hrs, staring, body stiffness;
Pt. complained of headache, arm hurts from shoulder to hand, neck pain, no fever.  Tingling in arm and hand.  Pain in left elbow.  Flu -like symptoms, arm swollen and reddened at injection site.  Treatment: Celestone 2cc, Keflex, Atarax, Tylenol.
Rash; itching; Red; swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), PRURITUS (itching), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (swollen) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included VITAMIN B12 NOS for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced RASH (Rash), PRURITUS (itching), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH (Rash), PRURITUS (itching), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient received on 7/14/23. On 7/15/23, she noticed redness to her left upper arm. She went to the ED later in the day on 7/15/23. She was diagnosed with Left arm cellulitis. She was prescribed two different antibiotics, Keflex and Bactrim x 7 days. Patient still taking medications.
achy arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP).  A 45-years-old female patient received BNT162b2 (BNT162B2), on 11Aug2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Aug2021, outcome "unknown", described as "achy arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
She was given the HPV Vaccine and passed out. She never fell or hit anything. she came to and had sever pain in her ankle. she has had xrays and a MRI and they show nothing wrong BUT she still has the pain.
This spontaneous report as received from a healthcare worker/office manager via a company representative refers to a patient of unknown age and gender. Healthcare worker reported that the patients had received the first three doses of GARDASIL on a schedule that was outside the prescribing information and also a fourth dose of GARDASIL (strength, dose, route and lot # unspecified). Patient was administered doses on 16-MAY-2012, 08-AUG-2013, 12-AUG-2014 and 22-OCT-2014. No adverse events were reported. The outcome of event was unknown. This is one of several reports received from the same source. Additional information has been requested.
01/29/22 presents to ED for "shortness of breath". PMHx of "asthma, PSVT, IDDM, HTN, HLD, hepatic steatosis, psoriatic arthritis, chronic headaches, morbid obesity"
I have had dizziness/vertigo, which began a week after the vaccine shot, each day, and which seems to be getting worse. I am at 9 days after the shot, and woke up dizzy when I reorient my body.
From initial information received on 9/7/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a female patient (age unknown) received a TD ADS ADULT vaccination, lot number U1347AA, administered in the left upper deltoid on 9/30/04. The same day, the patient developed soreness and stiffness of the left arm and neck. She also experienced a flushed face and a local reaction of a granuloma formation at the injection site. From additional information received on 10/19/04 from the responsible physician, it was reported that the patient was 39 years old at the time of the event. No new medical information was provided and it was not reported whether the patient recovered from these events. The reporter of this case is the same reporter as case 200402989.
Patient received COVID vaccine on 10/27/2021. Patient called on 11/20/21 stating that she developed a mass next to her arm pit 4 days after receiving her first shot. Patient stated that she had typical arm pain associate with the shot but also swelling and hardness to the side of the armpit. Patient did receive a lymphatic massage and the swelling did decrease. Patient did seek advice from her medical doctor on Saturday 11/20/21 who was unsure of the cause of the mass but did suggest the patient complete the Pfizer regimen and get second dose in the opposite arm. Patient came on 11/22/21 and received 2nd Pfizer dose in opposite arm. Patient will follow up with pharmacist next week.
Day 8 after the first shot of  vaccine, I awakened to pain in my upper left arm that I was lying on.  Right around the injection site was very red (about 3" in diameter), very hot and very sore and hard to the touch. It was itchy and there was a small red rash.  It felt good to put a cold compress on it, but that only temporarily alleviated the pain. I put Triamcinolone Acetonide Cream  0.1% on the rash to relieve itchiness and went on a 6 mile hike that day.  End of day, red blotch extended down arm towards elbow. Symptoms persisted for about 3 days until resolving.    Mind you, I had none of this when first inoculated other than a slightly sore upper arm, not unlike having a flu shot.
My hands began to swell, turned red, itched, and felt a burning sensation, and it hurt but then it went away. I don?t know what happened.
T78.3XXA ANGIOEDEMA, INIT 5/31/2022 ANEMIA DUE TO BLOOD LOSS T78.3XXS ANGIOEDEMA, SEQUELA 6/6/2022 ANEMIA DUE TO BLOOD LOSS
Patient was accidentally given the Rotarix vaccine IM instead of oral. The patient did not have an immediate reaction.
Patient said her arm (at the site of injection) began itching and was swollen and slightly red.  Patient woke up this morning to find that the area was better. The swelling had reduced and the itching was mostly gone. She was going to apply ice to help with the swelling and redness.
Approximately 60 hours after my second Moderna shot, I woke up at 7am with extreme dizziness and sweating.  I couldn't walk to the bathroom by myself.  I had nausea and vomiting, severe sweating, chills and LOW body temperature (around 91 degrees) for 5 hours.  Rapid breathing also....so much so that my ribs and abdomen were sore for the next several days.  Around noon, I went to sleep in bed - I was exhausted - and when I woke up, I wasn't dizzy any longer.  Mostly only chills after that and fatigue that lasted a couple weeks.  Entire event seemed to be around 5 hours.  My doctor only told me that he has "heard of many different types of reactions"....but I hadn't heard of any other people with these side effects.
Acute onset of LUQ abdominal pain, 2 hrs. after vax, lasting about 10 hrs. No nausea, vomiting, diarrhea or fever. Symptoms resolved spontaneously without sequelae.
Arm swelling, tenderness - decreased strength and ROM - 10/27/09 - 11am - talked with pt, she stated "(L)" arm still sore and can't pick up son without having pain still.
I had pain in  left arm , headache and fatigue starting the night I received the vaccine.  I missed the rest of the week from work. On Oct 1 I had redness and tingling in my left foot that lasted a few minutes.  The headache and fatigue continued on . On Oct 7 both of my legs went numb my toes on right foot turned white and I could not walk very well.  I went to the Er. Lab work was done to rule out a DVT and an neurological exam was done. It was very obvious to the eye I had weakness in both of my  legs and could not stand on my toes or walk without my legs shaking . They did not have a neurologist on staff so they advised me to go to another hospital which was an hour away that night or the next morning if symptoms continued.  The next day I had more control of my legs the numbness continued w/ tingling , by the end of that day they symptoms had gone away so I did not receive any further treatment
had a mini stroke; I have an injury with chronic pain; I have an injury with chronic pain; vitamin D deficiency; This is a spontaneous report from a contactable consumer (patient). A 61-years-old patient of an unspecified gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 61-Years-old) as dose number unknown, single for COVID-19 immunization. Medical history included hydrocephalus, reported that, part of patient's disability is memory; from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified dates, the patient had a mini stroke, and also an injury with chronic pain, and experienced vitamin d deficiency. It was reported that, patient had predicament with health they automatically gave Medicare and patient did not provide the name of the medication they are seeking assistance with. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Modern COVID-19 Vaccine EUA Days 1-2, I had a hot hard red lump at the site of the injection. Approximately 2" by 3".   It resolved completely. Then, on Day 8, I developed a hot red itchy lump at the injection site.  This delayed reaction was approximately 4" by 8" and steadily worsened over the day on Day 8.  It was completely resolved by Day 14.
2 x 2 cm firm, indurated subq nodule on Lt upper arm at previous injection site per pt was given in Lt (injection is documented as Rt deltoid). BACTRIM BID x 7 days f/u in 3 days.
Stabbing pain under her left breast that came frequently and very short.  It only lasted a second or two but they occurred frequently for 3 days.  She was taken to the emergency room to make sure she was not having a heart attack.  She was cleared of any heart problems.  I took her to the doctor on Tuesday and the doctor said it was possible it was a side effect from the shot.  The pains eventually went away.
This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 03Feb2021 at 13:00 (at the age of 73-years-old) as a single dose for COVID-19 immunization. Medical history included dialysis for past four and half years, colon cancer since 2008, multiple myeloma and chemotherapy. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN), colecalciferol (D 3), cyanocobalamin (B 12), nasal sprays (MANUFACTURER UNKNOWN) and unknown renal so medications, all from an unknown date, for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the right arm on 13Jan2021 at 13:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 27Mar2021 at 20:00, the Saturday evening, the patient experienced terribly itched head through the Sunday morning and patient stopped taking some chemo related medications, which were started on 24Mar2021. On28Mar2021, the patient experienced forehead swelling by the dinner time. On 29Mar2021, Monday, the patient experienced swollen eye lid, it was very swollen. On 30Mar2021, Tuesday, the patient experienced swelling moved to the area under the eye. The patient visited oncologist office on Monday, Tuesday and they said they never saw this type of reaction to chemotherapy.  Began medications on 29Mar2021, Tuesday and was suspecting if this could this be related to the vaccine and if she was a part of the clinical trials as she was a chemotherapy patient. The event resulted in doctor or other healthcare professional office/clinic visit on 29Mar2021. Therapeutic measures were taken as a result of adverse events included treatment with Benadryl for itching and cold compression to reduce swelling. The patient underwent lab tests and procedures, which included COVID-19 test on an unknown date and was found to be negative. The clinical outcome of head itching was recovered on Mar2021 and forehead swelling, eyelid swollen and swelling of under eye area was unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
lost of taste; change of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost of taste) and TASTE DISORDER (change of taste) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced AGEUSIA (lost of taste) and TASTE DISORDER (change of taste). On 28-Mar-2021, AGEUSIA (lost of taste) and TASTE DISORDER (change of taste) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided.
Patient presented to hospital with Positive breakthrough case. Came to ED no feeling well, SOB, vomiting.  97% on 4 L NC.
Received 1st dose of Moderna COVID 19 vaccine from expired vial; This case was received via an unknown source no reference has been entered for a health authority on 29-Apr-2021 and was forwarded to Moderna on 29-Apr-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 1st dose of Moderna COVID 19 vaccine from expired vial) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for an unknown indication.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 1st dose of Moderna COVID 19 vaccine from expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received 1st dose of Moderna COVID 19 vaccine from expired vial) outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC-MOD-2021-097935.   Reporter did not allow further contact. Sender's Comments:  US-MODERNATX, INC-MOD-2021-097935.
S swelling/ orally with T 101 F at home per client. O T 98.8 po 1.2 cm x 0.9cm erythema at site of injection L deltoid slightly.
4 vaccines administered. After 4th injection child stiffened, eyes squeezed closed. Assisted to exam table, alert, crying, circumoral cyanosis, Dr summoned. O2 0.5 l face mask applied. Pulse Ox 98% R.A, conversing appropriately throughout. Offered rice cakes and water, child ate and enjoyed. Pallor and cyanosis resolved. Observed for 25 min, then DR discharged to home.
pt prev healthy recv vax 26SEP97 & during routine physical 12-24hr p/vax pt started devel maculopapular exanthem over face & torso which progressed to stevens-johnson synd on 1OCT97;multiple mucosal surface w/ulcerations;pt still hosp;
Swelling at injection site with pain and redness (diameter 3") On day following injection. Two days after injection the following symptoms occurred: intense pain at site, axillary area and chest, large swelling beneath axilla and over chest, mild fever, nausea, chills. The swelling under the axilla radiating over the chest involved about an 8" diameter. The swelling seemed to very fluid like. The pain mostly occurred deep in the axillary area. Three days after injection, the swelling and pain persisted in all areas. From the second day after, the patient was medicated with 600mg of Advil three times a day, which gave some relief. On the evening of the third day, taken to the ER where he was diagnosed with a severe reaction to the tetanus booster. The physician who examined him prescribed Benadryl for that evening (50mg) and Allegra (180mg) for the next four days. Days five and six showed a decrease in swelling but pain still persists deep in the axilla and now radiates over the left anterior deltoid area and over the left latissimus dorsi. The patient is a competitive swimmer and during practice and competition, he experiences muscle spasms and pain.
shoulder stiffness/stiff upto ear/Stiff left arm where she received her vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (shoulder stiffness/stiff upto ear/Stiff left arm where she received her vaccine) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (shoulder stiffness/stiff upto ear/Stiff left arm where she received her vaccine). At the time of the report, MUSCULOSKELETAL STIFFNESS (shoulder stiffness/stiff upto ear/Stiff left arm where she received her vaccine) had resolved.            No concomitant medications were reported.  On 6-AUG-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) in unknown route with batch no.007B21A  Patient received compresses and pain relievers as treatment medications but they did not help. Patient went to the ER and they gave her a muscle relaxer and she is fine now.   This case was linked to MOD-2021-274267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Added event and treatment information. On 23-Sep-2021: Follow up document received contains event coding and outcome of event updated
HIVES; CHILLS; NAUSEA; FEVER; ACHE; RAPID HEART RATE; RASH ACROSS CHEST; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, Laboratory data included: Antibody test (NR: not provided) negative.  On 02-APR-2021, the subject experienced ache. On 02-APR-2021, the subject experienced rapid heart rate. On 02-APR-2021, the subject experienced rash across chest. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced fever. On 14-APR-2021, the subject experienced hives. Laboratory data (dates unspecified) included: PCR (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache, and chills on 04-APR-2021, and rapid heart rate, nausea, and fever on 06-APR-2021, was recovering from hives, and had not recovered from rash across chest. This report was non-serious.
Fatigue, nausea, diarrhea, headache, bodyaches, sweats Rectal bleeding.
Pt received varivax on 9/11/00 and dx'd with chickenpox on 12/12/00.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history was not provided. On 26-NOV-2013 the patient was inadvertently administered a dose of RECOMBIVAX HB (lot # J000722) that had been improperly stored. Dose and route were not reported. No adverse effects were reported. Additional information has been requested.
Woke up on 6/18/21 with notable vision impairment upper left quadrant of right eye went to eye doctor on 6/19/21 was examined after consultation with her college it was determined I suffered a branch retinal artery occlusion in the right eye was immediately sent to ER for a stroke work up
Dizziness, difficulty breathing, hoarseness, wheezing, weakness, severe sore throat, tachycardia, SOB to the point I had to be nebulized.
Information has been received from a medical assistant referring to a 1 month old patient of unknown gender. Information about concurrent condition, drug reactions/allergies, concomitant therapies and medical history was unknown. On 27-NOV-2017, the patient was vaccinated with AN improperly stored dose of RECOMBIVAX HB (lot # M036156 with expiration date 23-FEB-2019, 1 dose, strength unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported. The vaccines were exposure at the temperature of 55.2 Fahrenheit (47 to 77 Fahrenheit) for 2 hours and 41 minutes. There was no previous temperature excursion. A data logger was involved. This is one of 4 reports received from the same reporter.; Sender's Comments: US-009507513-1712USA005650: US-009507513-1712USA005651: US-009507513-1711USA012903:
Began high pitched about 1 to 1.5 hours after vaccines and was unconsolable for about 4-5 hours later.
it started one hour after injections. painful, red and swallow. about 4x6 wide. warm and hard.
Vaccine administered 9/18/2013 patient started to break out with rash 9/19 and by 9/21 rash spread over body (streaks of rash) and became itchy and hot. Patient saw PCP on 9/23 and PCP indicated reaction was from flu vaccine. Started BENADRYL and famotidine.
Patient felt tender and warm at the injection site first then rash developed and spread to the elbow and even under arm in 1 - 2 days. Doctor. Dx: cellulitis and prescribed KEFLEX. Pt. felt better after 1 week.