chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from nurse refers to a 12 year old female patient with asthma, allergic rhinitis, atopic dermatitis, chronic sinusitis and unspecified food allergies. The patient's medical history included recurrent staph dermatitis and headaches. On 16-Sep-2013 the patient was vaccinated with the first dose of GARDASIL (lot # J006236, exp. date 25-FEB-2016) 0.5 ml, intramuscular for standard vaccination. When the patient received dose 1 of GARDASIL, she also received MENACTRA (unspecified manufacturer), ADACEL (unspecified manufacturer) and Dose 2 of VAQTA (lot J002347, expiration date 04-SEP-2015, unspecified dose, unspecified therapy route) during the same visit. Concomitant therapies included ALLEGRA, VENTOLIN, SINGULAIR, FLOVENT, AUVI-Q and ZETONNA. The patient experienced hair loss beginning 20 days after vaccination (approximately 06-OCT-2013). The patient had balding areas, clumps of hair on her pillow, large hair loss in the shower and her hair was thinning. All of the patient's lab work, including complete blood count (CBC), ferritin levels, serum free triiodothyronine (FT)4 level, thyroid-stimulating hormone (TSH) level, c-reactive protein (CRP) level, comprehensive metabolic panel (CMP), came back normal. The patient sought medical attention by visiting office on 23-OCT-2013. The outcome of hair loss was reported as not recovered/not resolved. Additional information is not expected.
Lower than authorized dose volume was administered; Syringe was loose/cracked; A spontaneous report was received from a nurse concerning a patient (age and gender unspecified) who received Moderna's COVID-19 vaccine (mRNA-1273). It was observed that the syringe was loose/cracked and a lower than authorized dose volume was administered.  The patient's medical history and concomitant medications were not reported.  On 05 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 05 Mar 2021, while vaccine administration to a particular patient the syringe was loose/cracked and a lower than authorized dose volume was administered.  Treatment information were not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of events, were considered resolved on 05 Mar 2021.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # 011A21A) with no associated AEs reported.
pt recv vax & pt devel a mild generalized rash;also lab eval p/vax revealed a lack of seroconversion;
This spontaneous report was received from a pharmacist via a sales representative, refers to a female patient of unknown age. Pertinent medical history, concurrent conditions and drug reaction/allergies were unspecified by the reporter. On an unknown date, the patient was vaccinated with ZOSTAVAX vial, (lot number, strength, frequency, route and dose were not reported). Concomitant medications were unspecified by the reporter. On an unknown date, the patient developed shingles after receiving ZOSTAVAX. The outcome of shingles was unknown. Shingles did not require hospitalization or cause disability and no Product Quality Complaint (PQC) was involved. The relatedness between the adverse events and the therapy with ZOSTAVAX was not reported. Additional information has been requested.
A report has been received from a Health Professional concerning a 4 year old. Female subject, who had been receiving FLUMIST. FLUMIST started on 27-Jan-2014. On 27-Jan-2014, they inadvertently administered expired (expiration ate: 20-Jan-2014) FLUMIST. The outcome of the event of inadvertently administered expired FLUMIST is unknown. The report was considered to be non-serious.
I received the vaccination on my 2nd day menstrual cycle and following the vaccination I was heavily bleeding for 46 days and the large clots were coming out. I went to my doctor they did an internal vaginal ultrasound and lab work for bleeding disorders and they did hormonal test and everything was fine. The flow was the same throughout the period. The worst part was the clots at the end of the cycle.
whole body shaking; limping; his right arm doesn't swing anymore though it works good; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 13Dec2021 as dose 2 (booster), single (Lot number: 33030BD) at the age of 68 years, in the right arm for COVID-19 immunisation. The patient's relevant medical history included: "heart surgery", start date: 2001 (unspecified if ongoing), notes: He had been busted open and they fixed his heart for a while which he had for 22 years. The patient took concomitant medications. Vaccination history included: Janssen COVID-19 vaccine (dose 1, single), administration date: 17Mar2021, when the patient was 67-year-old, for COVID-19 immunisation. The following information was reported: TREMOR (hospitalization) with onset 26Dec2021, outcome "recovered", described as "whole body shaking"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "limping"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "his right arm doesn't swing anymore though it works good". The patient was hospitalized for tremor (start date: 26Dec2021, discharge date: 29Dec2021, hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: brain CT scan: Unknown results.  Clinical course details: Consumer said he got one before and the day after it put him in the hospital with his whole body shaking. He was in the hospital three days then they finally started pulling stuff out of him. Caller doesn't clarify this statement. They haven't helped anymore, he is not shaking, he is limping and his right arm doesn't swing anymore though it works good, it doesn't swing anymore when he walks. It was his second one, he had one almost a year ago, with one given as two shots at one time, which he was fine after that. Then he got this thing here, the Pfizer vaccine. He wants to know what to do, his doctor even done a check on his brain right side. His shaking is gone and he can hold his right hand out and it will shake and rock back and forth. His right leg limps a lot when he walks. He limps and has to go up steps one at a time, he can't put one down then one on the next, he has to pull himself up.
This spontaneous report as received from a registered nurse refers to a 64 year old female patient who was allergic to NASONEX (Marrs:1407USA011706, ALEVE, AMBIEN, MACRODANTIN, LEVAQUIN, probiotics, sulfa drugs and fish oil. On 11-DEC-2009 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous in the right arm, lot number: 665310/1195Y, expiration date 21-FEB-2011. Concomitant therapies included NEXIUM, CLARITIN. The reporter stated that a patient developed swelling of her right arm at the injection site that extended down to her fingers after receiving ZOSTAVAX. The patient sought medical attention via unspecified method. The outcome of the reported adverse events was reported as recovered (date unknown). The relatedness between reported adverse events and ZOSTAVAX was not reported. This report is linked with other report in MARRS:#1407USA011706 (same patient link). Additional information has been requested.
about 5" oval shaped itchy, hot, red rash appeared on upper left arm exactly 1 week after shot was injected
Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 28 year-old male patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. No other vaccine in four weeks. No covid prior vaccination. Vaccination history included: Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: CHEST PAIN (disability) with onset Dec2021, outcome "not recovered", described as "Chest pain". The event "chest pain" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: chest x-ray: unknown results; echocardiogram: unknown results; electrocardiogram: unknown results. Therapeutic measures were taken as a result of chest pain. No covid tested post vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient did not have an adverse event or reaction; however, she accidentally received a dose of Arexvy (which was a duplication as she previously had received a dose of an RSV vaccine 2 weeks prior to today's date) when she intended to have received Spikevax.  This was an error made by the vaccinator which has been reported accordingly.  Apologized to patient and after having spoke with her proceeded to give correct vaccine that she wanted to receive and administered Spikevax to her.
I noticed red rash over the fore arms, hands, legs and foot on 10/23/2011 eveing. It progressed over two weeks to lower abdomen and thighs. At day 3 its still continues to get worse. I do not have major itching after taking antihistamine.
pt recv vax 13OCT97 & 26NOV97 pt exp upper resp infect sx & devel varicella lesions on chest & in diaper area;tx w/calamine & camphor & avenge bath;& DPH & APAP;
Woke during the night with extreme muscular and joint pain.  Arm pain. Woke at 6:30 am with a heart rate of 120 bpm while still in bed.  Bad headache.  Came downstairs to take Tylenol for headache.  Took blood pressure which was  a little high. Broke out into a cold sweat so I sat down with head down.  Proceeded to pass out and hit my head on landing of steps and my daughter  had to call EMS.  Took me to the hospital, did bloodwork, CT scan of the head and gave fluids.  Released as per Primary Care Physician.  All tests came back normal.  Visited Dr. the next day for follow-up.
Body aches, pains and chills - 12 hours after vaccine until 24 hours after  Lower back pain, numb sensation in rectum and genitals - 36 hours after vaccination  Formation of genital ulcers on inner labia - 48 hours after vaccination Inflammation and irritation of genital ulcers - 48 hours after vaccination  Pain urinating - 48 hours after vaccination
Extreme swell of axillary lymph nodes at the inoculated arm and pain at the site.   Other normal known side effects: fever, chills, body aches, headache.
Immediately after vaccine was administered, entire arm went numb and tingled. Lasted for 2 hours. Days following had random minor muscle aches, weakness, and tingling (fingers), in forearm, palm; arm feels very tired. On day 9, arm began to ache continuously, felt very weak, swelling and redness at site, and tingling in hand and last two fingers.
10PM started crying p/temp taken pt was picked up from sleeping on couch; rt temp 104.8; high pitched scream x 2 hrs; settled down about MN whipmered most of noc;
12 hours post shot - fever  of 99 degrees and chills, muscle aches and cramps,  lasted approximately 24 hours. Slight redness and warmth on left arm ( injection arm) and some swelling.  Severe headache - it felt like my head would explode. A lot of pain on the back of my neck and down my back. Most of these symptoms were gone after 36 hours and then just generally weak and tired for an additional 24 hours.
Narrative: Patient developed injection site pain following administration of Pfizer Covid vaccine dose 2. Patient required no intervention and was able to leave following normal monitoring period.
Received vaccine dose on 4/2/2021, and found out three weeks later (on 4/22/2021) that I was pregnant. Most likely date of conception was 03/31/2021, two days before I received the vaccine. Estimated date of delivery is 12/24/2021. On August 6, 2021, I underwent the 20-wk ultrasound to check on the baby, and the baby was diagnosed with isolated dextrocardia (also known as uncomplicated dextroversion), which means his heart is on the right side of the chest (instead of on the left side). Various other scans indicate no additional complications, except for a potential ventricular septal defect (unconfirmed due to small size of defect)
I had an eye eczema flare up and there were more floaters in my eyes than usual. I contacted my doctor for a prescription and they were not able to give me the prescription and they told me to contact my eye doctor which I have not done yet. I have always had issue with floaters and flashing lights.
aches; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches) and FATIGUE (tiredness) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PAIN (aches) and FATIGUE (tiredness). At the time of the report, PAIN (aches) and FATIGUE (tiredness) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-424570, MOD-2021-424597 (Patient Link).
(R) arm injection site area red and swollen, hot to touch. Whealed a little bit. All around the redness is 10 1/2 cm and the middle is 3 1/2 cm with it being raised.
Pharmacist gave me a shot after prepping the site w/an alcohol wipe. I turned my  head away (I'm not fond of shots). A few seconds later, two streams of cold liquid flowed down my arm  & hand & dripped onto the floor. I told her liquid was running down my arm to which she replied, "l  know." She put a bandaid on my arm, & I asked her, "Was that vaccine running down my arm?" She  told me it was rubbing alcohol. I BELIEVE SHE LIED (no odor, no reason to be using alcohol during the  shot). I am fearful that I did not get a "valid" dose. She did not immediately give me another shot in the  other arm as recommended by CDC. No one can tell me what should now be done about it. CONT.  SECTION NOT WORKING
Participant noticed a  red area near injection site  that was rashy about 4 inches long  then developed another smaller rash. This happened 9 days following the vaccine. She had a sore arm and called in to her doctors office. She  was advised to treat with warm compress and an anti inflammatory. This lasted for about 5 days
Injection at 0800 at 1800 day of injection started feeling flushing, head pressure, and nausea. Day after immunization 1/5/2021 fever of 102.3 all day. Was able to be brought down using acetaminophen. She had what she described as severe hot and cold chills throughout the day. As of the time she reported to me 1/6/2021 @ approximately 1225 her fever had resolved. She still had slight lingering nausea and headache, but felt much better.
Moderns COVID-19 Vaccine EUA . BODY ACHES, HORRIBLE HEADACHE FATIGUE. DIARRHEA. SWELLING,PAIN,ITCHING AND REDNESS APPROXIMATELY 4 inches in diameter.
Sleepy; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy) and PAIN IN EXTREMITY (Sore arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21a) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepy) and PAIN IN EXTREMITY (Sore arm). At the time of the report, SOMNOLENCE (Sleepy) and PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: TCR attached
Information has been received from a pharmacist, for varicella virus vaccine live (Merck), a Pregnancy Registry Product, concerning a 32 year old female who on 03-OCT-2011 was vaccinated with first dose of virus vaccine live (Merck) (lot number unknown). The pharmacist reported that a female patient was approximately 3.5 weeks pregnant at the time of vaccination with varicella virus vaccine (Merck). The patient's last menstrual period (LMP) was approximately 08-SEP-2011 and estimated delivery date (EDD) would be 14-JUN-2011. The patient's pregnancy was confirmed by pregnancy test (type unspecified). At the time of reporting, the patient's pregnant gestation was 5 weeks. No adverse effect(s) reported. Pregnancy outcome was unknown. It was unspecified if the patient sought medical attention. No further information is available.
lymphadenopathy on left side (starting in axillary and progressing to supraclavicular and eventually neck as well.  swollen and extremely tender) in addition to normal side effects of chills, fatigue. also was having irregular heart rhythm (reason for hospitalization) do not know if the heart rhythms are related to the vaccine or not, onset was a few days after vaccination (ER 12/30/2020, then another hospital 1/1-1/2). but the hospitalization below is referring to the heart rhythm not the lymphadenopathy.
2hr p/vax babysitter phoned mom stating that pt had turned blue & began jerking all over;amb was called & arrived about 15-20min p/event started;pt was OK when EMT arrived;taken to ER 20-25min away;appeared OK in ER;t101
After vaccination: raised blood pressure. Severe anxiety. Bilateral tinnitus, constant. Dizziness, vertigo for the first 3 months, tapered down slowly. Seeing flashes of light in corner of eyes. Inability to sleep at first. Partially caused by uncontrollable body movements. Exploding head syndrome: hearing sounds that we?re not real when trying to sleep. Ear fullness. (Tinnitus has persisted 7 months at this time. Seems to get worse with sugar or salt ingestion. It has slowly gotten quieter but it is still constant. Still having occasional bouts of dizziness. Still have feeling of fullness in ears and fluid in ears.)
Approx. 8 hours after receiving Tdap pt. developed nausea then fever 100.4 degrees.  24 hours after injection chills, increased fever, myalgias, neck sore & stiff & HA & dizzy.
6 days p/vax 3NOV;pt woke up w/ diarrhea, slept most of day;10PM vomited once;/o h/a;c/o hands itching & swelling;pt taken to hosp;c/o feeling funny;29-20NOV96 c/o found & heavy & hurting;
Information has been received from a physician concerning a 73 year old female with rheumatoid arthritis and no allergies who on 20-MAR-2007 was vaccinated with a dose of Zostavax. concomitant therapy included prednisone and methotrexate. On 20-MAR-2007 the patient developed a red spot at the injection site (left posterior arm) immediately after vaccination. It was reported that over a short period of time the spot became larger and hard. The patient was prescribed unknown antibiotics by mouth which resulted in no improvement. The spot became "a little" itchy and pressure on the spot resulted in stinging. The spot became an 8mm erythematous, firm papule on patient's left upper posterior arm. On 22-MAY-2007, a biopsy was performed that resulted in diagnosis of necrotizing vasculitis and dermal necrosis. The patient recovered on 04-JUN-2007. A product quality complaint was not involved. The patient's experiences were considered to be other important medical events by the reporter. Additional information has been requested.
Presumed right arm muscle injury.  Several hours after the injection my arm was extremely sore and painful. The joint was painful as well. No redness or swelling. It was tender to touch. I was having difficulty reaching my arm up or moving it upward. Ex: it hurt to lift my hand to touch my face.  I also couldn?t let it fall. If I got my arm above my head I would have to assist it down. I couldn?t sleep that night because of the pain. I was having trouble with pushing movements in that arm. And also letting it hang dependently (like letting my arm hang when I hinged forward). I started taking Motrin 24 hours after the injection. Motrin helped, so I took it Friday and Saturday. Sunday, my arm felt 99% back to normal.  Monday and Tuesday I didn?t notice anything.   Wednesday  morning I woke up with the same pain again and difficulty moving my arm. Wednesday night, I couldn?t sleep again because of the pain/couldn?t get my arm in a comfortable position. I?m taking Motrin, with not as much relief as before. I?ve applied heat and I?ve tried to stretch it as well.   The only way i really know how to describe it? is that it feels as if my deltoid was injured. And my other muscles are fine. It?s hindering my movement in that arm. It is again, tender to touch my deltoid area. The tightness has extended in to my shoulder and neck. It has now been 8 days since my vaccination.
Pt vaccinated with DTP/OPV/Prohibit developed constant crying for about 5 hrs.
Positive for COVID-19 soon after 1st doseCOVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Positive for COVID-19 soon after 1st doseCOVID-19) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive for COVID-19 soon after 1st doseCOVID-19). At the time of the report, COVID-19 (Positive for COVID-19 soon after 1st doseCOVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: unknown (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.  Patient is due for the 2nd dose on 30Apr2021 and has been symptom free since 20Apr2021
Rashes on back, stomach, neck, ears, face, legs, arms and feet. My skin is scaly, dry and peeling. Flares up in heat which makes it unbearable. Been on all types of creams; no results. Diagnosis contact dermatitis.
On 3/8/15 late afternoon/evening patient was transported to hospital ED after experiencing a witnessed grand mal seizure. Pt has no hx of sz.
2/19: left arm, red spot approximately 2" in diameter at site of shot; itchy 2/20: left arm, redness increased to 3-4" in diameter; itchy; by evening increase to approximately 5" in diameter 2/21: left arm, redness area no change; itchy;  swelling increased after physical exertion; tender and warm to touch; 9:30pm  took 1 tablet Benedryl; 11:00pm  took 2nd tablet Benedryl 2/22: left arm, redness and swelling increased; approximately 5-6" in diameter11:00pm took 1 Benedryl tablet 2/23: left arm, redness and swelling diminish slightly, approximately 5" in diameter; 11:00pm took 1 Benedryl tablet 2/24:  left arm, swelling diminished; red area unchanged; 11:00 pm took 1 Benedryl tablet 2/25: left arm, swelling further diminished; red area unchanged - 5" diameter 2/26: left arm; no swelling; red area smaller - color changed lighter,  more pinkish, area 2-3" in diameter at shot site 2/27: left arm; pink at injection site; approximately 1-2" in diameter; slightly itchy