chrisvoncsefalvay/vaers-outcomes huggingface dataset:
really sick; shortness of breath; fever; diarrhea; hot and cold chills; headache; really tired; she can't talk very long nor walk very long; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (Patient's mother). A female patient (daughter) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. Medical history included Covid in Aug2020. The patient's concomitant medications were not reported. Consumer and daughter got their 1st dose of Covid-19 vaccine. Daughter was really sick, it seems like she got it all over again. Because they got covid back in August. Patient was experiencing a lot, shortness of breath, fever, diarrhea, hot and cold chills, headache, really tired, she can't talk very long nor walk very long. The event outcome was unknown.  Information on the lot/batch number has been requested.
pt recvd vax 23OCT95 & 3 to 4 hrs later pt turned blue, quit breathing & had a sz;pt was taken by amb to ER & was later sent home;24OCT95 exp another sz & was hosp;pt found to have congenital Wolff-Parkinson-White synd & gastroesophageal DO
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 18-JUL-2016 a dose of improperly stored M-M-R II (lot# L027591, rHA, expiration date 23-JUL-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
C/O Sore arm at site of vaccination on the evening of the vaccination.  Then arm sore and painful into ring finger.  TC 12-03-03 in AM reported noted s/s as above says is improving.
On 4/24/00, she developed a "tremendous" papular rash, which was not pruritic on the top and bottom surfaces of her hands, feet, which blistered and turned black and blue; buttocks and thighs. She also developed an erythematous rash on her hard palate, lips and tongue, and described the rash as erythema multiforme. She also developed a fever of 100.6. She recovered.
On approximately 10/08/97, about two weeks after vaccination, the child "was found limp in her crib". The child was then hospitalized for an irregular heart beat. No further info was provided.
No additional adverse events reported; an expired dose of GARDASIL 9 was administered; This spontaneous report was received from a healthcare worker referring to an 18 years old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 09-JUL-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml; lot # R029515, expiration date 08-JUL-2021; strength, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). This dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was found supported by memo with no temperature excursion. No other information given. No additional adverse events were reported (no adverse event). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R029515; expirationdate: 08-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Fever, dizziness, vomiting clear liquid, chills.   Started about 10 hours after shot.  Lasted only about an hour.   Fine after that.
pt recvd 3 doses of Engerix-B & titer report dated 7JAN91 indicated pt did not respond;
Pt developed suppurative draining R otitis media on 1/25/02. Fever on 1/28/02. Pneumococcal meningitis on 1/29/02. Not adverse event but possible vaccine failure.
Rash on his right upper extremity and chest and partially on his trunk started approximately 3.5 hours after vaccines given. Patient was given BENADRYL 25 mg by mouth. Instructed to continue BENADRYL as needed. Instructed to go to Emergency department for any facial swelling, tongue swelling, throat tightness or sore throat.
Pt reports bleeding for 24 hours starting at time of vaccination. She presents 12 days post vaccination with bruised area on deltoid area; no obvious swelling or redness. She reports still having tenderness in the area. Medical F/U was recommended.
p/vax pt devel small red half moon shaped area w/light center @ inj site;also had a small knot @ the site;
Pt. had major swelling of left arm, warmth to touch, red, severe arm pain that kept her up all night and is still bothering her.
Chills, myalgia and fatigue starting around 12 hours after vaccine dose. Nausea, photophobia  and fever starting around 24 hours after vaccine dose, subsiding with medication after about 8 hours. Diarrhea and blanching red rash at chest, shoulders and back starting 48 hours after vaccine dose.
Pt walked into clinic at 10:00 am on 11-3-08.  She reported 4-5 hrs after getting vaccines pt noted redness, warmth, soreness and itching on upper left arm and pulse went to 1:15 & returned to normal w/5 min after doing valsalua movement - hx of evt.  The next day 11-1-08, the redness had spread to up her neck to the side of her face & was warm/itchy.  At night 11-1-09 pt had constant cough, phlegm production, wheezing when she layed down .  The redness is now decreased to 6" & 0 soreness and itching 0 cough.  Pt did not seek medical care with acute sx.
Allergic reaction; splotchy rashes on face and chest, large rash on cheek, with splotchy rashes on forehead; Hands appear red as well; This is a spontaneous report from a contactable consumer (patient). This 21-year-old non-pregnant female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 25Mar2021 at 15:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included glycerin allergy from an unknown date and unknown if ongoing. Concomitant medications included medical marijuana from an unknown date for an unknown indication. The patient was not diagnosed with COVID-19 prior to vaccination and had not received any other vaccines within 4 weeks prior to vaccination. On 26Mar2021 at 22:30 the patient experienced what appeared to be an allergic reaction, splotchy rashes on face and chest, large rash on cheek, with splotchy rashes on forehead, and her hands appeared red as well. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of allergic reaction; splotchy rashes on face and chest, large rash on cheek, with splotchy rashes on forehead; and her hands appeared red as well were unknown. It was also reported that since vaccination the patient had not been tested for COVID.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
About 3-4 hrs. after the shot, I had a feeling like my throat was closing up.  I could breathe ok, but felt when I swallowed that there were 2 "boulders" in my throat.  I also started coughing, like there was a tickle in my throat. My throat was not sore. One other symptom was that my eyes were both red and had yellow puss in the corners.  Within the next hour, I went to be examined and treated.  The doctor prescribed Hydroxyzine- 25 mg and also 150 mg zantac.  I took both and within the next hour felt totally better.  The closing of the throat and the cough went away.  And my eyes cleared up. I slept fine.  Today I woke up with a headache which was helped by Tylenol.  All day I felt lethargic and slept but no other symptoms.  Did not need to take any further medication.
This spontaneous report was received from a nurse practitioner concerning an unspecified number of patients of unknown demographics. It was reported that on an unknown date, unspecified number of unspecified patients may have received doses of GARDASIL (lot number, expiry date, dose and route unspecified) that were exposed to an unsupported temperature excursion of 27 degrees Fahrenheit (F) for 2 hours. Nurse practitioner was unsure if any patients actually received the unsupported doses. No concomitant therapy was reported. No adverse effects was reported. Additional information has been requested.
NDC # 58160-828-03; exp date 5/13/22; Dilutant lot number ZS3FY Vaccine given at medical Clinic  Rash starting within 24 hours which subsequently generalized, fever , arthralgias.  Required hospitalization 10/6/ 22 - 10/8/22
Redness, warmth and swelling on posterior left arm at site of Zoster vaccine - redness is 1.5 x 2 inches in size.
pt recv vax 5FEB96 & 7FEB96 pt was covered w/a macular-papular rash which was very pruritic;therapy w/DPH was initiated;reporter was uncertain if the rash was a vaccine rxn versus an allerg rxn;
PPD test given on (L) deltoid (partial) (wrong route) instead of intradermal. Patient was very nervous about getting vaccine after the vaccine was a bit dizzy-recovered in approx 10 min.
Left leg with erythema 9cm X 14cm around injection sites of DTAP and IPV, puffy and warm to touch.
I got the shot Saturday around noon and by midnight Monday night I had huge welts/hives all over my body and scratching. I called a 24 hr pharmacy and the man told me to take a benedryl and/or antihistamine. I took a Zyrtek and the intense itching subsided, and by morning my welts/hives appeared to be improving. By the next morning I was much, much worse and went to the minor emergency, around 11 AM, whereby the doctor advised both the Benedryl & Steroid shot. I accepted the benedryl shot. By the time late afternoon arrived I noticed my hives getting better. Then shortly after noticing the improvement, my hands started swelling like sausages. It appeared that the swelling in the hands were caused by the bendryl injection. I called the urgent care facility towards evening.  They said I could take a benedryl tablet every 8 hrs. So that is what I have been doing.
within two days of first injection, patient woke with foggy mind that lasted about two weeks.   Significant fatigue started a day after first injection became worse after second injection and that lasted until today.
Started with fever morning of 7/24/2012 up to 103.2 axillary. Temp max 104.3 at 3 am on 7/25/12.
my arm was very red (rash like); severely itchy; I'm in the middle of a flare; fatigued; This is a spontaneous report from a contactable other HCP (patient). A 36-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 20Feb2021 at 01:00 PM as a single dose for COVID-19 immunization (at the age of 36-years-old). Medical history included covid-19 (Under investigation for a year and a half, after a client gave me a virus and I developed symptoms similar to post covid syndrome), food allergy (Chemical produced by fresh pineapple and some tropical fruits), and arthropathy for joint issues. Concomitant medication(s) included hydroxychloroquine (HYDROXYCHLOROQUINE) taken for arthropathy. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. On 27Feb2021 (at 10:00 AM), the patient experienced my arm was very red, severely itchy, I am in the middle of a flare, and fatigued. The outcome of all the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
-Fever, dizziness, no appetite, nausea, fatigue, body aches, headache, whole body hurts to the touch., I'm freezing
rash, paleness, weakness, hoarseness, wheezing;tx w/med;
L upper arm cellulitis (erythema, warmth and tenderness over L deltoid region) @ injection site noted 1 day after receiving the vax, started on Cipro 500mg po bid on 5/22/2000. Scheduled for re-evaluation on 5/26/00.
Ongoing severe cognitive impairment; Heart rate > 100; Lethargic; Not functioning, Patient does not know how to wash soap off of hands; weak; Extreme exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of COGNITIVE DISORDER (Ongoing severe cognitive impairment), HEART RATE INCREASED (Heart rate > 100), LETHARGY (Lethargic), FEELING ABNORMAL (Not functioning, Patient does not know how to wash soap off of hands) and ASTHENIA (weak) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation and Vaccination site reaction (had a strong reaction to a flu vaccine 30 years ago and hasn't gotten one since was reported.). Concurrent medical conditions included Heart failure. Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]), PROBIOTICS NOS, FISH OIL and VITAMIN D NOS for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced COGNITIVE DISORDER (Ongoing severe cognitive impairment), HEART RATE INCREASED (Heart rate > 100), LETHARGY (Lethargic), FEELING ABNORMAL (Not functioning, Patient does not know how to wash soap off of hands), ASTHENIA (weak) and FATIGUE (Extreme exhaustion). At the time of the report, COGNITIVE DISORDER (Ongoing severe cognitive impairment), HEART RATE INCREASED (Heart rate > 100), LETHARGY (Lethargic), FEELING ABNORMAL (Not functioning, Patient does not know how to wash soap off of hands), ASTHENIA (weak) and FATIGUE (Extreme exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Heart rate: 100 (High) heart rate  greater than 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
The patient was given the vaccination and told to wait 15 minutes in the recovery area to observe for signs of adverse reactions. The patient had syncope about 2 minutes after sitting and fell from a seated position on his chair to the ground. He had a brief seizure (unresponsive, tense muscles, open eyes) for about 2-5 seconds. He then became responsive and was able to respond to prompts and questions. He was given water. an ice pack (for injured spot on forehead), and told to wait for 30 minutes for further observation. He arranged to have a friend pick him up to take him home from the pharmacy and was told that he could not drive himself home after this adverse reaction. The patient stated that he otherwise felt normal afterwards (aside from some ache from the forehead after falling).
Hives, angioedema, fever, nausea, diarrhea, chills, headaches
Fatigue and aching left lower lateral leg in the evening.  Progressing to bilateral legs aching.  Back aching, joint aching with fatigue, nausea and headaches over the next 3 days.  Relieved with Advil.  Onset on 04/17/2003. fOLLOW UP: The initial complaint was low blood pressure,headache and weakness. His vital signs were stable on admission to the emergency department. His mother stated to me that he had gotten very hot and tired when he was working in the yard after his visit to our clinic. He has a history of asthma. During the assessment a rash was noted. The diagnosis was allergic reaction, acute; uticaria rash, general weakness, heache and dizziness. I also noted that there was a change in the lab values from when he was at the clinic and hten at the Emergency Department that PM. I suspect that he may also have become somewhat dehydrated.
pt recv vax & 10 days p/vax pt exp bell's palsy w/facial weakness, drooling trouble closing eyelids & some sensitivity around ears;sx have resolved w/the exception of sl sensitivity around ears;
Rec'd shot & by evening was screaming, crying; Mom stated was shaking & jumpy; Child irritable & crying since this PM;
One week after vaccination, I experienced itching and a rash around injection site. It is about 4 inches long by about 3 inches wide. Treated with topical anti itch ointment...gives temporary relief.
Began experiencing fast heartbeat at approx 1730. Sought care at urgent care/ED. Heart rate continued to increase along with elevated blood pressure. Was treated with Benadryl, Epi, Zofran, and Ativan. Transferred to local hospital for observation and continued montioring.
Beyond 42 days and No second dose yet; Rash (left  thigh); Shingles (left  thigh); Blisters (left  thigh); Numb Left Leg; Full Blown Allergy; Nasal symptoms; Cough; Tired; Left Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles (left  thigh)), BLISTER (Blisters (left  thigh)), HYPOAESTHESIA (Numb Left Leg) and RASH (Rash (left  thigh)) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left Arm hurt) and FATIGUE (Tired). On 10-Apr-2021, the patient experienced HYPERSENSITIVITY (Full Blown Allergy), NASAL DISORDER (Nasal symptoms) and COUGH (Cough). On 16-Apr-2021, the patient experienced HERPES ZOSTER (Shingles (left  thigh)) (seriousness criterion medically significant), BLISTER (Blisters (left  thigh)) (seriousness criterion medically significant), HYPOAESTHESIA (Numb Left Leg) (seriousness criterion medically significant) and RASH (Rash (left  thigh)) (seriousness criterion medically significant). On 02-Jun-2021, the patient experienced OFF LABEL USE (Beyond 42 days and No second dose yet). On 16-Apr-2021, PAIN IN EXTREMITY (Left Arm hurt) had resolved. On 31-May-2021, HERPES ZOSTER (Shingles (left  thigh)), BLISTER (Blisters (left  thigh)), NASAL DISORDER (Nasal symptoms), COUGH (Cough) and FATIGUE (Tired) had resolved, HYPERSENSITIVITY (Full Blown Allergy) outcome was unknown. On 02-Jun-2021, OFF LABEL USE (Beyond 42 days and No second dose yet) had resolved. At the time of the report, HYPOAESTHESIA (Numb Left Leg) had not resolved and RASH (Rash (left  thigh)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter  Patient reported that after taking vaccine her arm hurt and she was tired. On 10-Apr-2021 she had allergy, Cough, Nasal symptoms. She again had Rash, blister and diagnosed with shingles on left thigh. her left leg felt numb and feeling till at the time of report. Doctor advised her do not took 2nd dose until she has totally recovered.  Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Live follow up received on 02-Jun-2021.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Urticaria - seen by doctor.  Gave Adarax.  Symptoms worsened same day.  Referred to Hospital.
Severe pain in left upper arm and shoulder with ROM decreased due to pain. Now c/o pain bilateral shoulders.
Patient has had no adverse events. Patient received the primary series of Moderna Covid 19 instead of the updated bivalent moderna booster for little ones.
Pt awoke in afternoon w/fever 104.8; Very restless & cranky, definite personality change, per mom; Didn't want to move; Given APAP & cool baths per advise of clinic, also applied cool compress to site (swollen & warm, tender);
Redness/erythema; probably 3 by 3 inches; rashes on the arm; Itchy little bit but not that bad; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy little bit but not that bad), ERYTHEMA (Redness/erythema), RASH (probably 3 by 3 inches) and VACCINATION SITE RASH (rashes on the arm) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014m20a and 031a21a) for COVID-19 vaccination.     Concurrent medical conditions included Drug hypersensitivity (allegic to penicillian drugs, gets body rash.) and Drug hypersensitivity (allergic to sulfa drugs,gets  body rashes.). Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (LILLOW) for Birth control.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced RASH PRURITIC (Itchy little bit but not that bad), RASH (probably 3 by 3 inches) and VACCINATION SITE RASH (rashes on the arm). On an unknown date, the patient experienced ERYTHEMA (Redness/erythema). At the time of the report, RASH PRURITIC (Itchy little bit but not that bad), ERYTHEMA (Redness/erythema), RASH (probably 3 by 3 inches) and VACCINATION SITE RASH (rashes on the arm) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Significant FU contained Medical history includes allergic to penicillin and sulfa drugs. 2nd dose was updated. Concomitant medication LILLOW(birth control pills) added. Adverse event Redness/erythema, rash reported.
Starting after I received the flu shot in January, I had some pain in my right upper arm.  I informed may physician in February at which time she told me not to be concerned. over the months I continued to mention to her.  She prescribed me neuroton and told me to take ibruprofen, until I got my ultrasound and blood work.  In April I had both done and nothing came back.  She ordered an CT Scan for me which I took today, 5/9/23. Still awaiting results.  Symptoms:  pain, mobility issues, tingling and numbness in arm and hang
It was reported that a 35 year old female pt received a TD Adult vaccination on 08/24/2000. Reportedly on 08/26/2000, the pt developed a severe localized reaction of redness, warmth and induration. Reportedly the pt recovered from this experience.
Pt admitted to hospital from 5/21 to 5/22 discharged home, dehydration, atrial fibrillation, malaise, had second moderna covid vaccine 5/21, became ill 5/22 woke up with low grade fever, generalized weakness, malaise, no appetite, lightheaded, fall to ground stricking righ cheek, no LOC, baselilne memory losse, confusion improved, better on 5/22 morning, no need for follow up clinic visit. Can't get to fill in hospital information to unshade to fill in