chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a cluster headache - that started the day of (started as a dull headache) and it continued throughout the next day. The next night it woke me up in the middle of night - terrible pain in my head. And continued for three weeks. I called my PCP - He said take Tylenol and drink water. Went to Urgent care on January 4 and they prescribed Imitrex for migraines and an antibiotic for double ear infection .I still have a little headache. I have an appt to go back to check my ears because they are still draining.
Weakness, trouble breathing, heart pain.  Went to doc and had CT scan and blood work.
Arm became extremely sore then swelling began. The entire area from my elbow to my shoulder became rock hard. The pain was excruciating. I also began to itch all over and had nasal congestion and a sore throat.
h/a; severe enough that needed to lie down in the evening of 7NOV994; also had general malaise; c/o h/a started the same day of vax 4NOV94; 10NOV94 pt exp sz, then passed out; sx ruptured cerebral aneurysm; pt had surgery 11NOV94 & died;
Patient called about 24 hours after the immunization and complained of trouble sleeping due to "unbearable" pain in the arm.  Said that he has taken Hydrocodone for the pain, as well as applying ice.  He does not have trouble moving the arm and confirmed that the pain was at the injection site only, saying that the muscle felt bruised.
Within 15-20 minutes of injection; full body rash; red skin; sensation was burning.  Light headedness.  In three days; ringing in ears.
Did Not Seroconvert After 2 Doses; Given Heplisav-B on 3/3/20 and 7/13/20; Initial Report Received on 02-Oct-2020.  Follow-up Report Received on 28-Oct-2020 and 02-Nov-2020 included provision of lot numbers, age group, and titer information.  A supervisor at a blood center reported to an account manager that an adult male patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and did not seroconvert after receiving the second dose of HEPLISAV-B outside the dosing schedule.  No medical history was reported. The reporter was unsure if the patient had any immune issues.  No concomitant medications were reported.  On 03-Mar-2020, the patient received the first dose of HEPLISAV-B.  On 13-Jul-2020, 133 days after receiving the first dose, the patient received the second dose of HEPLISAV-B outside the dosing window.   HEPLISAV-B lot numbers were 933839 and 933634. Expiration date and NDC # were not available.  A month after the last dose was administered, a titer was drawn. The reporter was not sure how the antibody levels were determined. The patient was determined to not have seroconverted after the two doses of HEPLISAV-B.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Pt developed "2/12" area of redness around injection site, was cranky, had fever. Now 3 days later area improving. Given Tylenol.
temperature excursion/ABOVE 46F (46.73F) for 46 hours 5 minutes and 0 seconds; No additional AE/PQC reported at this time; This spontaneous report was received from a nurse and refers to a 23-month-old patient of unknown gender.  The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant human albumin) (M-M-R II) subcutaneous injection (lot number S039319 and expiration date 04-DEC-2021 were verified as valid) (dose and vaccination scheme frequency were unknown; route and anatomical location of vaccination were not reported) for prophylaxis. It was reported that this was the first dose of the vaccine administered to the patient. The vaccine was exposed to a temperature excursion as it was improperly stored at 46.73 Fahrenheit degrees for 46 hours, 5 minutes (product storage error), which was detected by digital data logger. The recommended range temperature was minus 58 Fahrenheit degrees to 46 Fahrenheit degrees. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001947:
at 11pm on 4/6/21, 12 hours after my shot, I began to get chills, sweats, and a fever (ranging from 100-105F) and vomiting. I had a mild headache. I vomited routinely until 4pm on 4/7/21. I called my Oncologist and  I was very close to going to the ER due to dehydration when I took a Zofran (waited 10 min), then took 25 MG liquid THC (waited 20 min) and then 2 Tylenol. The vomited ceased, the sweats/chills stopped, and I was able to sleep to begin healing.
First dose- barely had chills ( I am usually cold so this may not be a side effect except for the goosebumps that came and went once or twice) and goosebumps for an hour in the evening and arm soreness for 24 hours. Second dose - barely had chills with goosebumps again for an hour or two in the evening in the evening and arm soreness for 24 hours. I typically have a body temperature of 97.4 and this evening it went to 98.1 for the hour or two.  Had I not been monitoring due to the vaccine I would have chalked it up to tiredness or just cold as usual. The unexpected side effect which is why I am filling this  form out was very bad dreams on both nights 4/9 and 4/10 and more than one bad dream on 4/9.
8 hours after shot I became nauseous. Was shaking, major chills, 2 large hives on face, accelerated heart beat and had little bit issue breathing. Took benadryl. Started feel good after 20 minutes
Pain at the site of injection, shivering, headache, swelling and a hot red rash at the site of injection that became larger over next 4 days and completely disappeared after 6 days.
redness, swelling, Pt. did a follow up visit on 3/14/2020 and given Ibuprofen & advise to - to do cool compression.
Patient stated bed rest was required the day after the shot for flu-like symptoms. Approximately 24 hours post injection patient reported tenderness, redness, and swelling/irregular shape at injection site. Patient reported 48 hours after injection tenderness had gone down and generalized symptoms had been under control with acetaminophen usage. Patient states 48 hours after that tenderness had decreased but pink/red area has gotten larger about 4 inches in size with irregular border and still warmth at injection site.
My daughter had all 3 shots in the Gardasil series. 1st shot 12/6/07, also had the Meningococcal that day, no problems noticed until 2nd shot which was on 1/9/08, she started to complain the next day of nausea, headaches and body aches. 3rd shot 6/20/08. symptoms of headache, body aches and dizziness, flashes of color at times have continued on almost a daily basis.
constant feeling of going to throw up. Did throw up many times. But it wasn?t a deep purge from the bottom of the stomach. It felt like more of a shallow purge from the top of stomach or bottom of esophagus. This condition lasted 2 days and was accompanied by fever and was completely debilitating, affecting lucidity. When the nauseous sensation finally subsided, esophagus felt like there was a hole burned through it. It took 11 or 12 days to fully recover.
After vaccination patient felt dizzy, diaphoretic  Nurse stated patients ?eyes  rolled back? Patient stated he was still awake during episode Patient given water and stated he felt ?shaky? Patient denied medical transport or evaluation and signed AMA form
It started with a bruise that slowly got bigger. When he came to our office on 04/20/18 the bruise was 4 cm in size with significant tenderness throughout his deltoid. He experienced an ache in his arm that increased over time to the point where he could not raise his arm due to soreness. The pain finally resolved around the beginning of May.
Information has been received from a physician concerning a patient who on 19-DEC-2007 was vaccinated with a first dose of ROTATEQ.  On 15-APR-2008 the patient was vaccinated with a second dose of ROTATEQ.  It is unknown if medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
p/vax pt exp fever; body aches; a localized react going from inj site to upper arm down to elbow & upset stomach;
Headache Pain at inj site, Chills, Exhausted, hot and cold sweats, HA Narrative:
Suspected febrile seizure. Parents report the patient stopped responding and was not breathing, but also describes the patient as crying and gasping.  Denies any tonic-clonic activity.  Reports confusion for several minutes afterwards
It has been over 10 days, Friday the 20th of August will be 2 weeks since I received first dose. I got my vaccine and  about 8 hrs later had a fever of 100 exactly, my norm is 97.4-97.6. The 3rd day on the 9th of August 2021, I started getting red bumps that looked like mosquito bites that had been itched and swollen. These bumps were behind  knee on right leg and on the side of left leg near the knee, I had smaller bumps all over. The bigger bump sites are now bruises. Although, there is no visible signs, I CAN'T STOP ITCHING, I itch from the top of my head to my feet, everywhere in between including vagina. I have not went to my Dr. But have been advised to. I know it's a reaction to the vaccine because nothing else has changed in my life. I've called the cdc, 2 pharmacies and 2 Dr's offices with the same answers to get to Dr. I cant take benadryl as I get heart palpitations, afraid to go to a Dr because of of covid 19 prevelance. I'm really scared, and have no guidance. Maybe when I go to Dr, I'll get relief but fear they won't know why this is happening. I assume I should not get 2nd dose as I know this is an allergic reaction, it has all the symtoms of allergic reaction, jyst lasting a long time and it is a severe itch.
Pt. reports fatigue, headache, chills, nausea, decreased appetite, and generalized muscle pain.
Eye swollen; nauseated; Fever; chills; coughing; Body ache; Muscle ache; Tired; Ear ache; This is a spontaneous report was received from a contactable other hcp. A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported), via intramuscular route of administration, administered in arm left on 27Jan2021 12:00 as single dose for covid-19 immunisation.  The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient had history of promethazine allergy. The patient was not pregnant at the time of vaccination. The patient did not take any other vaccine in four weeks and did not take other medications in two weeks. On 27Jan2021 at 20:15, the patient was feeling nauseated, fever, chills, coughing, body ache, muscle ache, tired, earache, eye swollen. The patient did not take any treatment. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported), via intramuscular route of administration, administered in arm left on 06Jan2021 12:00 as single dose for covid-19 immunisation. The patient had no covid prior vaccination. On 28Jan2021, (post vaccination), the patient underwent lab tests and procedures which included covid-19 and the results were pending. The outcome of the events was recovering.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
had a little bit of issues with the first one, but she already had respiratory issues before; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from agent. The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Aug2021 (Lot number: FC3181, Expiration Date: 28Feb2022) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: H1n1 vaccine (In past about 10 years with the H1N1 vaccine she ended up in the ICU and with neuropathy and myopathy.), for Influenza immunisation, reaction(s): "myopathy", "neuropathy". The following information was reported: RESPIRATORY DISORDER (non-serious) with onset Aug2021, outcome "unknown", described as "had a little bit of issues with the first one, but she already had respiratory issues before".  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was taking medications prior to the event being reported (details not reported). Patient received no other vaccines on the same day. No investigation assessment. Vaccine was not administered at facility.  No follow-up attempts are possible. No further information is expected.
Father reported that pt developed fever of 103 -104 deg F 3 hours after injection. Father denied giving pt medication at home. Four days later, father reported that they called pt's PCP regarding fever, and provider advised to take pt to ER. Pt was taken to ER on 7/1/23, and pt was given prescription for Motrin and father was told fever should resolve in 2-3 days. Pt arrived to clinic on 7/5/23, pt with no fever (temp 98.8 tympanic) and in no apparent distress, but presented with generalized rash all over face and body. Father denied taking pt back to ER for rash when it developed. Father reports that rash started after ER visit, but does not know what day exactly. Advised father to take pt back to ER to get evaluated for rash, get blood tests, and treated for rash.
ZOSTAVAX vaccine administered 4/11/08; 4/12/08 pt reported onset of dryness followed by itching, blisters perioral left upper eyelid. No fever, No mucosal; rash persists 2-3 days, followed by dryness for 1 week. Recurred 5/29, 5/24.
Symptoms/reactions started one week after I received the vaccine.  I stated having severe pains in my left arm from the elbow up to my shoulder and left side of neck, with the site of the shot/vaccine being very tender and extremely painful.  I can't hold my hand down, it is very sensitive, I can't turn my head around or even tilt my head back to gargle my throat..  I have to hold my hand in a certain way because it hurts terribly.
As per patient's daughter she had swelling in her arm, severe fatigue and difficulty breathing. Patient rested stayed at home and used an extra dose of Albuterol
Nasal drainage, cough and hoarseness. No treatment, outcome symptoms persist beyond 3 days.  Patient will be tested for flu and COVID-19.
COVID-related death, hospital admission  2/19/22-3/4/22, readmitted 3/8/22, expired 3/10/22
16 year old patient received the first Pfizer dose and full dose of Moderna as the second dose; accidentally received a full dose of Moderna as second dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (16 year old patient received the first Pfizer dose and full dose of Moderna as the second dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally received a full dose of Moderna as second dose) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (received the first Pfizer dose) on 27-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 08-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (16 year old patient received the first Pfizer dose and full dose of Moderna as the second dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally received a full dose of Moderna as second dose). On 08-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (16 year old patient received the first Pfizer dose and full dose of Moderna as the second dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally received a full dose of Moderna as second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Patient was admitted to hospital on 01/04/2022.  There are no records charted in database for this patient regarding symptoms, tests or pre-existing conditions
Site: Pain at Injection Site-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium
Patient experienced a headache and a warm red and swelling whelt, persisting over night into the next day. Soreness is noticed on touch. Final size about 1 inch in diameter.
severe headache with light sensitivity and ear ringing. lightheaded, dizzy, clammy, flush  and collapsed
Have not gotten my second vaccine yet; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Have not gotten my second vaccine yet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Have not gotten my second vaccine yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Have not gotten my second vaccine yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment medications were provided
4 hr fl Dtap had tremor of hand/feet. Eye rolled back, had diff breathing for 20-30 sec. Spontaneous restored, see in ER.
RASH ON LEFT SIDE OF NECK FROM CHIN TO COLLAR BONE AND SWELLING OF LYMPH NODE AT EDGE OF COLLAR BONE AND NECK.
Patient fainted a few minutes after injection while waiting in the waiting area.  I got him some water, an ice pack for the back of his neck because he was hot and clammy, and he also sucked on a hard candy.  Patient admitted he had not eaten all day.  I made him stay in the observation area longer to make sure he was going to be ok.  He was there for about 45 minutes after the fainting spell and left with his mom and grandma on his own accord.
COLD/HOT FLASHES; RESPIRATORY ISSUES; SHORTNESS OF BREATH; TIRED; This spontaneous report received from a patient concerned a male 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: Unknown) dose, (Dose number in series:1), start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced cold/hot flashes, shortness of breath, tired and respiratory issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold/hot flashes, shortness of breath, tired and respiratory issues were not reported. This report was non-serious. This case, involving the same patient is linked to 20211241171 (dose number in series was 2).
Large swelling on the arm injection was given. Red, itchy, and painful. About the size of a small fist. Was advised by doctor to take allergy medicine (like Benadryl) as she felt given the description I had given her I was having an allergic reaction. Advised to keep an eye out but felt arm would be back to normal within a day or two.
awoke 10PM on 18JUL95 w/fever & stiffening then began seizing off & on 15-15mins;transported to ER by ambulnce & had a sz in ambulance upon arrival to ER listless, screamed
Red raised rash/hives on trunk, neck, face, hot, prickly sensation.
Elevated heart rate and blood pressure for four whole days following vaccination. Resting heart rate reached as high as 130. Also elevated blood pressure when I have always had normal blood pressure. Sore arm for one day, the day after.
0300 7/27/2018 Temp of 104.2, then episode of glazed eyes and not moving extremities, making funny noises and was stiff. Was taken to ER. Treated with TYLENOL/MOTRIN, unable to start IV therapy - labs done - PO intake encouraged - per mom fever started after immunization but had been continuing.
Massive bruising on legs morning post receiving vax. Bruises disappeared about 30 days after. No Tx.
0953 received 1st dose Moderna to rt. deltoid. @1010 employee c/o tongue tingling and throat tingling.  Denies SOB, chest pain and difficulty breathing.  V.S. 139/82, HR 96,  O2 sat- 100% on RA.  No chronic conditions.  No hx of allergic reactions to vaccines.  Med allergy: Tramadol;   Food allergies:  pineapple, corn, grapes @1019 Benadryl 50 mg given IM to Left deltoid.   Lungs clear to auscultation.  No wheezing.  No WOB noted. @1036 per employee, tingly throat improved but tongue still remains tingly. V.S. 131/83, HR 91.    @ 1053 updated Dr. and awaiting recommendations.   @ 1102 Ok per Dr.  to release employee from observation.  Employee instructed to call and notify her PCP.
Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004A21A, 002A21A and 030L20A) for COVID-19 vaccination.     The patient did not had known allergies to medications, food and other products.  Concurrent medical conditions included High cholesterol (Started 5 years ago, recent status: Stable). Concomitant products included PITAVASTATIN CALCIUM (LIVALO) for Cholesterol.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            The patient never had COVID positive test or diagnosed.  The patient received 4 doses of the Moderna COVID-19 vaccine and not experienced any severe reactions except may be a sore arm.  The patient received flu shot on 03-Oct-2022 and Bivalent booster on 14-oct-2022.  No treatment information was provided.   This case was linked to MOD-2022-659961 (Patient Link).
Bilateral shoulder and upper arm pain (and burning sensation), with limitation of range of motion due to pain.
Herpes Zoster (Unilateral band of red papules, painful, dermatomaz approximately T11) onset 12/18/2001. Culture obtained 12/19/2001, started on Acyclovir.