chrisvoncsefalvay/vaers-outcomes huggingface dataset:
second dose made it worse; Redness; very inflamed; not been able to sleep; massive sweats; intense dreams; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (not been able to sleep), HYPERHIDROSIS (massive sweats), ABNORMAL DREAMS (intense dreams), CONDITION AGGRAVATED (second dose made it worse) and ERYTHEMA (Redness) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included COVID-19 in June 2020, Neurological symptoms NOS (amplified neurological effects) on 04-Jul-2020, Bug bite and Rash (had sever rashes all over leg and arm left marks due to bug). Concurrent medical conditions included Type 1 diabetes mellitus (type 1 diabetic with major neuropathic reaction). Concomitant products included INSULIN for an unknown indication.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced INSOMNIA (not been able to sleep), HYPERHIDROSIS (massive sweats), ABNORMAL DREAMS (intense dreams), ERYTHEMA (Redness) and INFLAMMATION (very inflamed). On an unknown date, the patient experienced CONDITION AGGRAVATED (second dose made it worse). At the time of the report, INSOMNIA (not been able to sleep), HYPERHIDROSIS (massive sweats), ABNORMAL DREAMS (intense dreams), CONDITION AGGRAVATED (second dose made it worse), ERYTHEMA (Redness) and INFLAMMATION (very inflamed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-337495 (Patient Link).
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.  It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated that the patient got a dose of SHINGRIX and complained of having a sore arm after administration of SHINGRIX. The healthcare professional said the patient was reluctant to get the 2nd dose due to the sore arm.
Very fatigued; slight headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Nov2021 10:00 (Lot number: 3302680) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRISTIQ; LIPITOR; LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number=FE3750, Prev dose lot unknown=False, Prev dose administrator route=Intramuscular, Prev dose administration date=21Oct2021 , Prev dose administration time=10:00AM, Prev dose dose number=1, Prev dose vaccine location=Left arm), administration date: 21Oct2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 11Nov2021, outcome "recovering", described as "Very fatigued"; HEADACHE (non-serious) with onset 11Nov2021, outcome "recovering", described as "slight headache". Therapeutic measures were not taken as a result of fatigue, headache.  Additional Information: The patient did not receive any other vaccine in four weeks. Patient did not get COVID prior to vaccination and was not COVID tested post vaccination. There are no known allergies or other medical history. The adverse event is reported as Not serious. After about two hours after second vaccine on 11Nov2021, patient became fatigued and had a slight headache. Patient was better next morning.   No follow-up attempts are possible. No further information is expected.
I went to bed with chills and a fever came overnight.  I thought that I was going to be sick and got out of bed for the toilet.  After using the toilet and proceeding to wash my hands, I collapsed, hit my chin on the bathroom counter and then fell to the floor.  I tried to get up again, only to fall again and hit my head in 2 places, on the tub and then the floor.  I was about to fall a third time, but crawled back to bed instead.
Forgot to release the muscle when he had the injection and a lot of the vaccine slipped through his arm; This spontaneous case was reported by a patient and describes the occurrence of UNDERDOSE (Forgot to release the muscle when he had the injection and a lot of the vaccine slipped through his arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LOSARTAN and EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced UNDERDOSE (Forgot to release the muscle when he had the injection and a lot of the vaccine slipped through his arm). On 24-Mar-2021, UNDERDOSE (Forgot to release the muscle when he had the injection and a lot of the vaccine slipped through his arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Batch number for Moderna Covid-19 vaccine is unknown; Sender's Comments: This report refers to a case of underdose for mRNA-1273, lot # unknown with no associated AEs.
I bled heavy clots for a week; A burning sensation throughout my entire body/burning of low back; numb hands and fingers but at times they tingle; numb hands and fingers but at times they tingle; migraine every morning; blurry vision; tachycard; severe nerve pain in my back; nausea; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: 301458A) as dose 1, single for COVID-19 immunization at pharmacy or drug store. Medical history was none. The patient did not receive any other vaccine within four weeks of Pfizer vaccine. There were no concomitant medications. The patient experienced a burning sensation throughout her entire body, burning of low back, numb hands and fingers but at times they tingle, severe nerve pain in her back, nausea and migraine every morning, blurry vision, tachycardia and she bled heavy clots for a week on 15Sep2021. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was received as a result of the events. The patient was not diagnosed with COVID prior to vaccination and had not been tested for COVID post vaccination. The outcome of the events was not recovered.
Patient got FLUZONE Intradermal shot on 1-20-14. Instead of typical welt, an red area about diameter of soda can appeared. At 11 AM 1-21-14 you could not see injection site, just a light reddish circle.
2-3 minutes after vaccine was administered, pt. complained she doesn't feel well and passed out. She was breathing and conscious but was very weak and was not able to move. Her pulse was normal but kept saying she doesn't feel well. I called 911 after 10 minutes of no change in pt.'s condition. Pt's BP was normal. She complained of being nauseated and threw up. She was taken by paramedics to hospital.
Screaming & crying for 2 days.Shakes.Swelling, knot @ injection site lasting up to 2 weeks. No family hx available.This was 1st DTP. Received DT 15Jun90, no problems
Severe anaphylaxis- Red on face and arm (hives/itching), severe shortness of breath, and severe swelling of face and under the arms.
fever 102.3 on day one, fever down on day two to 99.3, headache, and upper body aches (neck, shoulders, chest) due to the fever I assume.
PATIENT WAS INADVERTENTLY ADMINISTERED PFIZER VACCINE WHEN SHE IS TOO YOUNG TO RECEIVE IT. SHE DOES HAVE MEDICAL CONDITIONS THAT QUALIFIED HER FOR IT.
Consumer complained of swollen and painful arm following immunization. symptoms subsided, then developed a very itchy rash over the entire underside of right upper arm.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2018GSK191892). Concomitant products included Influenza vaccine Quadrivalent 2018-2019 season. On 4th October 2018, the patient received the 2nd dose of SHINGRIX. On 4th October 2018, less than an hour after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. On 7th October 2018, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX on an unknown deltoid. On 4th October 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season (intramuscular) on the opposite deltoid than that of SHINGRIX. The batch number and expiry date were not reported. Within 1 hour of vaccination, the patient experienced soreness in the injected arm. The soreness was lasted for 3 days. The reporter had denied permission to contact their physician.
One hr after second shot I became extremely tired. Had to go home and go to bed. Was there rest of that day and into second day. Few weeks later knees, fingers, back started locking up. Very weak. Muscles and joints painful. Unbelievable exhausted. Still going on. Getting worse
For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022; Expired doses administered beyond the BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered beyond the BUD) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered beyond the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered beyond the BUD) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient took 2nd booster of Moderna and took total 4 doses. Lot number 083J21A was refrigerated on 7-Feb-2022. Vial did not undergo any temperature excursion. No treatment information was reported .
ist vaccine, at 26 hours headache real bad, eyes movement , body aches..  And vaccine 1 month later.. at 33 hours chills, then fever of 102.. tylenol took temp down right away.. at 48 hours was doing well.. just tired from lack of sleep the night before..
Customer returned to pharmacy a few minutes after administration and stated the underside of her arm was itching. Had her remove her shirt to examine - did not seem red, no irritation at administration site. Advised to take 25mg of diphenhydramine. Was ok after that.
Approximately3 weeks post vaccine I began having GI upset, which in turn led to malabsorption and significant weight loss.  These symptoms led me to seek medical attention which resulted in screening for Celiac Disease, based on me having 2 other autoimmune diseases + symptoms.  Through serum testing, process of eliminating gluten from diet, and endoscopy I was diagnosed with Celiacs.  I am reporting because of the timing of symptoms post vaccination and the relation to autoimmune system.   While i do not consider CD to be disabling, it is permanent.
Mom called reports pt woke with small red bumps over chest arm & back "pen" prick type. Pt also has 3 raised bumps to injection reaction right leg pus/fluid filled. Pt had fever 3 day pain now onset of all on 3-16-04.
Body aches, severe arm soreness at sight of injection, 101 Fever, nausea.
VACCINATION ERROR: PARTIAL ADMINISTRATION. NEEDLE WAS NOT SECURED ON SYRINGE FROM MANUFACTURER RESULTING IN VACCINE LEAKING AT LEUR LOCK. THE PATIENT AND I PERCEIVE SIGNIFICANTLY LESS THAN HALF OF THE VACCINE WAS DELIVERED BUT WE CANNOT BE CERTAIN.
expired vaccine administered; No additional AEs; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 01-SEP-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S025157 with an expiration date on 13-AUG-2021) at a dose of 0.5 milliliters subcutaneously  (strength and anatomical location were not reported) for prophylaxis (expired product administered).         No additional adverse events were reported.
PATIENT INITIALLY REPORTED ITCHING ALL OVER HER BODY. SHE WAS ADMINISTERED 50MG OF BENADRYL BY MOUTH AND MONITORED. SHE WAS COUGHING AND HAD NO BEEN COUGHING PRIOR TO IMMUNIAATION. SHE STATED HER THROAT FELT DRY. HER BLOOD PRESSURE WAS SLIGHTLY ELEVATED OVER NORMAL. SHE BEGAN HAVING TREMORS AND ALSO BEGAN COMPLAINING OF EXTREME PAIN IN HER ABDOMEN. 911 WAS CALLED. SHE THEN SAID THE PAIN WAS IN HER BACK AS WELL AS HER ABDOMEN. SHE THEN STATED THAT BREATHING WAS BECOMING MORE DIFFICULT AND WAS THEN ADMINISTERED ONE 0.3MG DOSE OF EPINEPHRINE.  EMT'S THEN ARRIVED AND TRANSPORTED HER TO THE EMERGENCY ROOM.
Headache, Myalgia & Arthralgia Narrative: Other Relevant History:
Anaphylaxis throat itchiness, throat tightness, sinus swelling, ear fullness  Narrative:  Patient reported throat itchiness, throat tightness, sinus swelling, ear fullness. Transported via EMS to nearest ER
Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent condition were not provided. On unspecified dates the patients were vaccinated with RECOMBIVAX HB (dosage, strength, route and lot # were not reported), which had been improperly stored. At the time of the report, no adverse effects were reported. This is one of several report from the same reporter. Additional information is not expected as the reporter did not wish further contact.
When the vaccine went into my arm IT BURNED , I yelled out , " WHAT in the world was that, that BURNED."  AFTER  I've had pain at the base of my head , sores that appeared in my mouth ( of which I have pictures) , I had pink eye in both my eyes, ordered online eye drops for pink eye, ( also have pictures of my eyes, a tightness in my chest , I don't experience being tired I AM EXPERIENCING EXTREME FATIGUE, I GET READY TO GO OUT TO TAJE CARE OF ERRANDS ( pay a bill, get groceries etc.) when I'm done getting ready I'm extremely fatigued and instead lay down for the rest of the day, when I go to see one of my doctor's I get home so exhausted I'm laying down into the next day ( all day (
swelling & aching lt arm from elbow to inj site; began approx 1 hr p/inj; instructed to elevate & put ice on area; if no improvement to go to ER
My throat and mouth got itchy and EMT had me take a RX Benadryl that I had with me.  Otherwise, they were going to IV the Benadryl. They kept me 45 minutes and went home.  The itchiness stayed with me for the evening and intense headache came on board and petered out over the next few days.  Arm was extremely sore for 3 days and just feeling a bit punkish.
patient received his second dose of GARDASIL 9 five years ago and has not yet completed the series; No additional AE reported; This spontaneous report was received from a pharmacist referring to a currently 26-year-old male patient. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.   On approximately 2017, reported as five years ago, the patient received his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).   Reporter stated the patient had not yet completed the series (inappropriate schedule of product administration). No additional AE reported (no adverse event).
I had intensely itchy skin in isolated area for no apparent reason. I tried a topical cream until I realized it was systemic and probably a histamine over-reaction, then I took an over the counter anti-histamine and the symptoms went away. This has recurred several times over the summer but when I take an anti-histamine, it goes away.
Per mom, patient's right arm got swollen 2 hours after the vaccine. Came to the clinic a day after the vaccine. Pt not in distress No fever. Right upper arm is swollen, warm and tender to touch. No drainage noted.
Rash located on Right Upper Arm, noted on 7/11/2022, it is pink in color. it is associated with mild swelling but NO discharge, Itching, loss of sensation, numbness, pain, redness, pus, tingling sensation, fever and no Lymphadeopathy. Condition does not seem to get better with any measure. No prior consultation or treatment tried. No history of travel.
pt recv vax & became very ill;devel flu sx, weak, tired, lethargic, felt rotten;sx worsened over the next couple of months;hosp DEC or JAN for unspecified period of time;IV fluids;loss 35lbs;dx addison disease JUL97;
4 hours after the administration of her COVID-19 vaccine, she developed the onset of twitching of her left eyelid, some left-sided jaw pain, a cotton mouth sensation, and migratory left-sided facial paresthesias described as a tingling sensation that could involve the eyelid, nostril, scalp, cheek, or forehead.  These sensory symptoms feels somewhat like a Christmas tree with lights going on and off in different spots but always restricted to the left side of her face.  In addition she experience a mild headache but without associated scotoma, nausea, vomiting, or vertigo. Upon looking in the mirror she thought that perhaps there is some slight facial asymmetry on the left side.  In addition she reports feeling that her neck is weak on the left side and that she has to support her head in order to keep it from flopping further to the left.  The symptoms have been also associated with some pain in the left arm which has since improved as well as discomfort and achy sensation involving her left leg extending from the hip laterally down to the level of the knee. She was evaluated the next day by a neurologist. Her neurological examination demonstrates some subjective decrease in sensation involving the left V1 and V2 distribution but is otherwise normal.  Difficult to know to what extent the prior Botox injections could be contributing to her worsening left-sided neck weakness.  We are aware that the vaccine does induce a inflammatory cytokine response and it is conceivable that this is contributing to some of her symptoms.  MRI was obtained to exclude any underlying CNS pathology that could be conceivably exacerbated in the setting of an inflammatory micro environment induced by the vaccine.  There was no clear evidence of a new CNS lesion based upon the examination.
Breakthrough case admission after three vaccines Moderna 3/3/21 Lot# 029A21A;  Moderna 3/31/21 Lot# 028A21A;  Moderna 10/25/21 Lot# 039D21A
Blood in left leg.  Hospitalized for 3 days.  Now on Eliquist. Couldn't walk on left leg. Had to pull the cord and maintenance called the ambulance.  Still having pain in left leg even after a cortisone shot still not better and they don't know why.  Next appoint is on Thursday.   There is another appoint at the pain clinic for her back pain tomorrow
Both lower eyelids completely swollen. Burning, stinging sensation as well. Eye pain in addition to eyelid swelling. Began just over 24 hours after second Pfizer dose.
Patient developed rash and muscle tenderness, with burning sensation. Patient also had lightheadedness and dizziness for couple days.
07/23 frequent bowel movements,  Diarrhea  07/24 chills, fever of 102, Nausea, dizziness, throwing up, bed all day 07/25 chills, fever (no notation), very dizzy, difficulty walking to bathroom, in bed all day, throwing up, no appetite slept all day 07/26 all above but no fever and symptoms begin to lesson eating only liquids 07/27 able to get out of bed but nausea and dizziness present.  0
Arm soreness, Sleepy, lethargic, memory impairment, dizziness and light-headiness.
Patient received H1N1 lot 102141P exp 4/10 on 1-11-2010 in left deltoid. Returned on 1-21-10 with sore arm and bruise approx. 6 inches in diameter orange in color.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 74 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies. Antiviral details: Paxlovid was used from 25Aug2023 to 29Aug2023 for COVID-19 treatment.
9 to 10 days after administration I started with left shoulder and bicep pain.  vaccine was given low in the arm and away from the joint so I did not get concerned at the beginning.  The pain has progressed despite range of motion exercises, ibuprofen, heat and topical steroid cream.  It has affected the use of my arm and I started myself on 30 mg of prednisone today with concern of SIRVA.  I am unable to seek any medical care at this time as I am driving my husband for cancer treatment and won't be home until Saturday the 9th of January.  I wanted to report these symptoms so if anyone else has similar symptoms it can be counted.