chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed Shingles, trigeminal nerve left side. Ophthalmic and maxillary portions. Placed on Valacyclovir, Prednisone and Zirgan for the left eye. Responding to treatment slowly.
pt recvd vax 1PM, 9:30pm t 104 R-hypotonic, limp by mom report; talke do MD 1030-given APAP;
w/in 45min of vax pt started getting red splotches on face;they were like hives;burning & itching;w/in 1 1/2hr whole face & neck was involved;took DPH & applied ATB ointment;
Headache (akin to a tension headache, forehead location) almost instantly after injection that has persisted but lessened in severity since injection over the course of one week.
Fever (100.6), chills, body aches began at 1:00am on 1/19/21. Body aches, headache and fatigue continued until 3:00am on 1/20/21. Swelling and redness at the injection site noted shortly after vaccination and has continued to grow.
Severe left shoulder pain, with severe limitation to range of motion that lasted from Oct 12 around 10 am until Oct 15. Unable to raise left arm higher than 3 inches from side without severe pain. No tenderness at site of injection. No redness. No swelling. Nov fever. Ibuprofen 400 mg taken twice on Oct 13 with no affect on pain. Ibuprofen 400 mg taken 3x/day on Oct 14 resulted in decrease in pain and return of 50% of range of motion.
aches and pains across shoulders and neck; aches and pains across shoulders and neck; periodic Headaches; In bed for 3 days; This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received historical first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) for covid-19 immunisation. On an unspecified date, patient was in bed for 3 days with aches and pains across shoulders and neck, periodic headaches since the second dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
go to the continuation page  Prior to getting the 1st Moderna vaccine I could eat all citrus fruits without a problem and no skin reactions.    2/3/21  -   Moderna  012M20A        10:10 am      2/18/21  I had a Minneola tangelo but didn't connect until it happened again on 2/25/21 2/19/21 - Early morning around 2 am on 2/19/21 I had few hive bumps on my buttocks, a couple on the very top of my legs and one on my lip and then my chin. 2/20/21  I took one antihistamine and the hives went away for a couple of days.   2/22/21  The hives were back but not as bad.  They seemed to be going away. 2/24/21  I had a Minneola tangelo from and had hives around 8 hours later.  Just bumps but there were more of them this time. Stayed away from all acidic foods. 2/25/21 to 3/2/21  Took a 24 hour antihistamine and the hives went away.   3/3/21 -   Moderna  027A21A        11:34 am      Was sick with the chills and body aches on 3/4/21 but by Friday 3/5/21 morning was fine.     3/3/21 to 3/5/21  I didn't take an antihistamine and things were fine.   3/5/21 -  Hives started around 8 pm by 4 am they were pink bumps on my buttocks, legs and arms.  One hive on the side of my forhead and none on my neck.  Worst then when I had them on 2/24/21.  I had no citrus, including juices, or acidic foods of any kind since 2/24/21.  3/6/21  took an antihistamine at 4:30 am for the hives and they are calming down.
RespDepression & HYPERtension Narrative: Employee reported difficulty breathing within 15 minutes of vaccine administration. She was given oral Benadryl and one dose of epinephrine per epi pen. She was taken to the ER for further evaluation.
Chills, fevers, sweating, severe pain R arm (4"x 7") w/ swelling, redness, pt. couldn't use R arm, systemic deep muscle pain, rapid temperature shifts, sx resolved by 1200pm 8/27/09, lost appetite.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N031002, expiration date 03-NOV-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA007385: US-009507513-1806USA007386: US-009507513-1806USA007387: US-009507513-1806USA007388: US-009507513-1806USA007389: US-009507513-1806USA007390: US-009507513-1806USA007392: US-009507513-1806USA007393: US-009507513-1806USA001032.
Site: Pain at Injection Site-Severe, Additional Details: Patient came in on 11/15 to pick up a prescription. She complained that she was still having moderate-severe arm pain from her covid injection on 10/20/22. She had had Pfizer previously and not reacted to other immunizations. I advised her if it continues she may want to have it evaluated for shoulder impingement/injury.
Information has been received from a medical assistant referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 16-DEC-2015 the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (lot # K007262, expiration date 25-NOV-2015; route not reported). No adverse effects were reported. Additional information has been requested.
pt recv vax & exp a low titer level;7JUL95 1hr p/vax pt exp dizziness, lightheadedness, & nausea which became more pronounced p/2hrs;
Developed a red vesicular rash on right thigh and buttock. He has also been more irritable, not sleeping or eating as well, and had a runny nose.
Slight headache near left temple short duration; rapid heart beat, short duration, sore area of shot, then up to shoulder. Lightheaded for brief moment 3 times. Blood pressure systolic 113 then up to 170 for 24 hrs.
p/vax pt arm &site tender; area of redness; 50x50mm area of erythema w/tenderness at site; warm to touch;
t102.2 x 24 hrs, vomited 1-2 x  in 24 hrs; irritability 24 hrs;
Patient states she has a  vasovagal reaction to needels/injections. After vaccine was administered patient was askied how she was feeling. She stated she felt the vaccination but felt fine. She proceeded to sit in the seat in the lobby , but then fainted a few minutes later
Left arm swelling, induration, pain radiating up neck on left side, blotchy redness to left upper arm.
Fever & UrticariaPruritus Narrative:  Reported fever day following injection. Reported itching sensation that kept him up at night 2/21/2021 and into the day 2/22/2021  Other Relevant History:
This spontaneous case was reported by a patient family member or friend and describes the occurrence of URTICARIA (Systemic Hives) in a 16-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. A51414B) for COVID-19 vaccination. The patient had no allergies. Patient has never had COVID positive test or diagnosis. Patient had no history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. On 30-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced URTICARIA (Systemic Hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Systemic Hives) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient's height was reported as 30 inches (but reporter was not sure). Patient was not taking any concomitant medication. Reporter wanted to report Moderna Covid-19 vaccine side effects for the son. The adverse event caused patient to seek medical care and Doctor gave Benadryl. Hives were on and off, symptoms improved after taking Benadryl but they come back.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. The medical assistant reported that an excursion of SF for up to 3 minutes each day over the past 30 days, totaling 90 minutes. The product affected was VARIVAX (Merck) (dose and route not reported), lot numbers of product involved in the excursion(s), and which may have been administered, are as follows: lot J009989 expiration date 12-AUG-2015; lot J012210 expiration date 28-SEP-2015; lot reported as J013730 expiration date 30-OCT-2015; lot reported as J014229 expiration date 08-NOV-2015. The product was also involved in a supported excursion on 13-JUN-2014 of 7F for up to 16 minutes. The reporter presumes that the vaccine had been administered post excursion but is not 100% sure. She states that no one has reported any adverse effects post receipt of any vaccination administered at her office. This is one of several reports from the same reporter. Additional information has been requested.
Whole body itching, resulting in intense rash. Scabbing due to itching while sleeping.
Hot, flushed face and ?stuffy? nose within 20 minutes  of vaccine. Abated within two hours. Extreme fatigue within 7 hours of vaccine. Woke up next day with burst blood vessels in R eye.
Shoulder joint pain.  No muscle pain, but pain when rotating joint, lifting arm.  At time of vaccine, patient thought the vaccine site was too far up on the arm - more in joint and not muscle.
51yo M with preDM, hld presents to ED with hypoxia, O2 sat in the low 90s at home. Pt has URI sxs x 5 days and was tested positive for Covid on 10/8.  He was vaccinated.  In ED, pt ambulated on RA with O2 sat in the low 90s and appeared shortness of breath.  Temp was 100.3 in ED.  93-95% on RA at rest    Pt was admitted and started on Decadron and Remdesivir.    Pt does not respike temp in house.  He is also not hypoxic.  O2 sat 94-97% on RA.  Pt feels stronger and can ambulate to BR today.  He could not do it yesterda    He will be d/c home today on cough medications: Tessalon Perles and Robitussin AC    Will not continue Decadron or Remdesivir as pt has not been hypoxic.  Discussed plan with ID and Pulm.
No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medications were reported. 27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                 No treatment information was reported. This case is for the 5th patient out of 27 adult patients described by the reporter.
Initial and follow up information has been received from a registered nurse, concerning a 24 year old female patient with no known drug allergies, who on 26-JUL-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot #658222/0927U). There was no concomitant medication. On 28-JUL-2007, two days after the vaccination, the patient developed itchiness and a rash on the palms of both hands. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. On 30-JUL-2007, the patient was seen by the physician, and treatment included MEDROL dose pack. At the time of this report, the patient had recovered from the rash (duration not specified). The nurse stated that the physician did not feel the rash and itching was related to the immunization. Follow up information received from the nurse indicated that on 24-SEP-2007, the patient was vaccinated with the second dose of GARDASIL (lot #658560/1062U), and she next day, 25-SEP-2007 she again experienced itchy hands. Treatment again included steroids (unspecified), and at the time of this report, the patient had recovered. No further information is expected.
No treatment from medical professional. I took Tylenol and drank water.  I had the vaccine at 10 am.  I felt perfect as I did with the first vaccine until I woke at midnight with a high fever , diarrhea, severe fatigue and muscle aches. Hard for me to move or walk. Needed assistance from husband to get to the bathroom. The symptoms lasted until approximately 9 am. Then I felt tired but fine. Today I feel tired but no symptoms. Back to normal.
13SEP fever 103/mom-rash, afebrile x 3 days; 20SEP fever 3 days/mom 102 R, rash on face, trunk itching-rx DPH; 26SEP rash fading; 30SEP rash very faint;
Injection site pain, headache, chills, nausea, feeling unwell , right eye began having specs as if there were floaters in my eye Lasted for 3 days
pt recvd 1 dose of Engerix-B & had an inc in bilirubin;
My head started hurting really badly and I started getting pain in my left arm. I then became nauseated and vomited. I felt so ill that I went to sleep and when I woke up I did not feel like myself and started having heart palpitations and my headache was terrible. I still had pain in my arm and felt chest pains so bad I almost went to the emergency room. I had no choice but to go to work and I was sick all day long and I also started feeling numbness in my extremities. I have also had blurred vison, loss of appetite, and shortness of breath. The crazy thing was I had covid and did not feel half as bad as I do now.  I was forced to get this vaccine because of a job and now everyday I feel myself getting worse and worse since taking it. I am really worried I am going to have a heart attack as my heart has not stopped doing strange things since I got the shot. I am not sure what to do, I guess there is nothing I can do now.
COVID-19; Pain; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4327066-00 (Company).  A 64-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years and on 18May2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 11463448) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2021, outcome "recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19"; PAIN (non-serious), outcome "not recovered". The action taken for adalimumab was unknown.  Clinical course: On an unknown date, the patient experienced PAIN/STILL HURT EVERYWHERE. In 2021, the patient experienced COVID-19. On 14Feb2022, the patient experienced COVID-19 and Pneumonia in left lung then entered right. In 2022, the COVID-19 and Pneumonia in left lung then entered right resolved. Pfizer BioNTech COVID-19 Vaccine (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of COVID-19 onset 14Feb2022 and Pneumonia in left lung then entered right with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of COVID-19 onset in 2021 and Pain/still hurt everywhere was not provided.  Relevant Laboratory & Other Diagnostic Tests: 14Feb2022 COVID-19 TEST: positive. Change History: On 26Apr2022, received updates to event information, reporter opinion of causality, concomitant drug information and narrative description. On 29Jun2022, received updates to patient demographics, event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. The event of "Pain/still hurt everywhere" was added  The reporter's assessment of the causal relationship of "covid-19" and "pain" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on possible temporal association the causal role of  reported events cannot be excluded for  suspect product  .Case will be reviewed further on receipt of FU information.
My arm is still sore.  It is swollen around the injection site.  It has spread out about 2 inches from center.  It is warm to the touch.  Today, 3/9/2021, I marked the parameter  with a sharpie pen.
Localized, redness, swelling, erythema, fever, chills, mental status change.
Site pain for both doses for less than 48 hours.; Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02May2021 08:30 (Lot number: Ew0167) as dose , 2 single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Chronic UTI" (unspecified if ongoing); "Lumbar Radiculopathy" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Sulfonamide, reaction(s): "Known allergies:Sulfa", notes: Macrobid & sulfa; Macrobid, reaction(s): "known allergies: Macrobid". Vaccination history included: Bnt162b2 (Dose number-01, Lot no-EW0158, Vaccination site-Left arm, Administration Time-08:30Am), administration date: 08Apr2021, when the patient was 49 years old, for Covid-19 immunisation, reaction(s): "Vaccination site pain". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04May2021, outcome "not recovered", described as "Site pain for both doses for less than 48 hours."; TINNITUS (non-serious) with onset 04May2021, outcome "not recovered", described as "Tinnitus". No follow-up attempts are possible. No further information is expected.  Additional Information: Patient did not have covid prior vaccination. She did not tested for covid post vaccination.  NoFollow-up activities are required, and no further information expected
WRONG TECHNIQUE WAS USED TO ADMINISTER THE VACCINE; NERVOUS SYSTEM SYMPTOMS; LOTS OF PAIN THAT WOULD NOT GO AWAY; HARDLY LEFT HER ARM; DIZZINESS; ALMOST PASSED OUT; HEADACHE; A MEDICAL ASSISTANT ADMINISTERED THE VACCINE AND SHE IMMEDIATELY FELT EXCRUCIATING PAIN (PAIN IN HER DELTOID); This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced wrong technique was used to administer the vaccine, nervous system symptoms, lots of pain that would not go away, hardly lift her arm, dizziness, almost passed out, headache, and a medical assistant administered the vaccine and she immediately felt excruciating pain (pain in her deltoid). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a medical assistant administered the vaccine and she immediately felt excruciating pain (pain in her deltoid), almost passed out, headache, dizziness, nervous system symptoms, wrong technique was used to administer the vaccine, lots of pain that would not go away and hardly left her arm was not reported. This report was non-serious.
PER PATIENT THE ARM WAS NO MORE SORE THAN USUAL. SHE TOOK OFF HER SLEEVE TO SHOW ME HER ARM AND VERY DARK BRUISE COVERING WHOLE ARM TO THE ELBOW. SHE GOT THE VACCINE ON THURSDAY AND BRUISING COVERED ARM BY SATURDAY.
Started as a cold the first day or so. Then started getting slight fever spikes. OTC meds at this point were treating my symptoms. Then on 11/28/2013 I ended up being taken to the ER for intense dizziness, nausea, and vomiting. Was released same day with RX meds to treat symptoms. Less then 24 hrs. later back in ER with even more intense dizziness, vomiting, and dehydration.
This patient received an influenza vaccination in accordance with standard protocol procedures early in the season. She describes pain at the injection site days later to pharmacist on duty. Pharmacist  explained that one of the most common side effects in short term pain at the injection site. She then followed up many weeks later stating she sought medical attention and her physician said it was because of the flu shot.
pt recvd vax & lost consciousness & was found to be in insulin shock;spent one day int he ICU;sugars had been erratic since that day; addtl info has been requested
pt recvd vax  & later became pale (white) having often trembling & very hard breathing; no loss of consciousness; no sz; episode lasted 20 mins;
noc sweats, hallucinations, head pain, heavy legs, behavior changes;pt reported hypochondriac;pt informed by ER MD that had a vaccine allerg rxn & it would resolve on its own;pt disch from ER w/no tx or tests;
Full body hives developed hours later per pt, lasted about 2 days. Abd pain, sharp for 2 days as well.
Nurse verified if patient had any reaction to 1st dose but did not verify when it was. Dose was given before 28 days at day 14.  Patient was observed for 30 minutes after vaccination- no reaction noted. Advised to contact her doctor or call 911 should she have any harsh  side effects- Patient verbalized understanding.
Pfizer vaccine given. Patient was waiting 15 minutes after vaccine before departing. Patient was accompanied by father and two siblings. Patient fainted while sitting.
Onset: 10 minutes after vaccination Dizziness with no other symptoms.  Assessed every 5 minutes for 20 minutes.  Clt felt better, stated "not dizzy anymore" and walked out with a stead gait