chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 hours after I received the vaccination, I came down with severe chills.  My entire body was shaking and I could not get warm.  I got extremely fatigued to the point that I could not get out of bed.  I got a severe headache (and I get headaches a lot...this one lasted for almost 10 days).  It seemed that every bone and muscle in my body began aching, from head to toes.  My fever went up to almost 102.  These symptoms continued for a course of four days, except the headache and fatigue (which lasted for approximately 6 days and the headache for 10 days).  I alternated Tylenol, Advil and Alleve.  They did not help hardly at all, unfortunately.  2 weeks later, I developed lymph node swelling in my right arm pit and alongside my right breast.  Today, these lymph nodes are still swollen and are painful to the touch.  I experienced pain at the injection site and if I touch it, it is still painful today, but does not ache like it did initially.
Large area of erythema that begins 1 1/2"-2" distal to insertion site & progresses laterally & medially (mostly medially) & distally. Edema at most distal-medial portion. Warm to the touch, left deltoid.
5:20 Pt had syncope episode.  Taken to Observation area via w/c to lay down.  BP 80/52 P62 R20 5:35 BP 90/62 P 60 R 16 No nausea.  skin warm & dry. 6:05 Sitting up drinking juice.  6:35 Pt left with parents w/o assistance.
Headache, Sedation, Myalgia, nausea, pain at injection site Narrative:  Onset of headache evening of date of vaccination (1/13/21). On 1/14/21 noted fatigue, sore arm and headache, with onset of myalgias and nausea noted that evening. On 1/15/21 noted fever, chills, and sweats - but improvement in headache. Symptoms improved towards end of day on 1/15/21. Missed work half day 1/14/21 and all day 1/15/21 due to symptoms. No history of known COVID infection.
Dizziness; This is a spontaneous report from a contactable consumer reporting for herself. An 84-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021, at single dose, for COVID-19 immunisation. Medical history included sinus disorder. Concomitant medications were not reported. The patient experienced dizziness in Feb2021, 3-4 days after vaccination. on an unspecified date with outcome of recovering. The patient did not know if the dizziness was due to the COVID-19 vaccine or her sinus disorder.  The information on the lot/batch number has been requested.
received all 5 Pfizer covid shots and has got covid about 3-4 days ago / and is not feeling so good; received all 5 Pfizer covid shots and has got covid about 3-4 days ago / and is not feeling so good; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "received all 5 Pfizer covid shots and has got covid about 3-4 days ago / and is not feeling so good". Clinical course: The patient received all 5 of his Pfizer covid shots and has got covid about 3-4 days ago and is not feeling so good. He said his daughter called and was recommended to try a product that could ease the problems with covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever of 102 nite of vax; mom considered nl & treated w/APAP fever dec; by next AM inc size of lt delt @ site of DTP; by 3 day later 31OCT when seen @ clinic arm was hard, swollen 1 1/2 x size of rt arm, red & hot to touch; fever resolved;
Vaccine 10/28/2003-Pneumococcal sore ness the same day, painful could not lay on right arm.  10/29 @ 17:00: noticed redness elbow to mid upper arm, very warm circulation good.  Advised to see MD if becomes worse and to call tomorrow to report.
5-11 Pfizer primary vaccine dose given undiluted, so he received 0.2 ml non diluted dose
Fatigue; Flu-like symtoms; This is a spontaneous report from a contactable consumer (patient, reported for self). A 39-year-old (non pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247, Expiration date: Not reported), via an unspecified route of administration, administered in the left arm on 26Mar2021 15:00 (at 03:00 PM) (at the age of 39-years-old) as dose 2, single in left arm for COVID-19 immunization. Patient had no allergies to medications, food, or other products. The patient concomitant medications were not reported. The patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247, Expiration date: Not reported), via an unspecified route of administration, administered in the left arm on 04Mar2021 (03:00 PM) as dose 1, single for COVID-19 Immunization. Prior to vaccination, patient was not diagnosed with COVID-19 prior to the COVID vaccine. No other medical history reported. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 07:00 AM patient experienced fatigue, and flu like symptoms. Adverse event did not result in Physician office visit or emergency visit. Patient had received treatment for the adverse events which included acetaminophen. Since the vaccination the patient has not been tested for COVID-19. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
This case was reported by a physician and described the occurrence of elevated direct bilirubin in a 1-day-old male subject who was vaccinated with Engerix B (GlaxoSmithKline).  There were no concurrent medications.  On 8 April 2008 the subject received 1st dose of Engerix B at 0.5 ml in an unknown thigh.  On 8 April 2008, less than one day after vaccination with Engerix B, the subject experienced elevated direct bilirubin.  On 14 April 2008, 6 days after administration of Engerix B, the subject tested positive for hepatitis B surface antigen.  The baby was to be hospitalized on 22 April 2008 for further evaluation.  At the time of reporting the events were unresolved.
Received Vaccine set on 7/21/023 with no preceding symptoms. Day after 7/22/2023 began to develop fevers at home. Appearing well otherwise, but mother of child was giving Tylenol with improvement of fevers. Developed red well delineated circular raised rash on bilateral cheeks. Never previously had this rash. Fevers continued intermittently for the next 48 hour then self resolved. Rash slowly resolved over the next 24 hours with no additional symptoms. Family did not seek medical attention as the patient symptoms resolved
headache; muscle pain; stuffy nose; "woozy"; sore neck; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced headache, muscle pain, nasal stuffiness, woozy and neck pain. On an unknown date, the outcome of the headache, muscle pain, nasal stuffiness, woozy and neck pain were unknown.   It was unknown if the reporter considered the headache, muscle pain, nasal stuffiness, woozy and neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced headache, muscle pain, stuffy nose, woozy and sore neck. The reporter did not consent to follow up.
approx 10min after injection patient reported difficulty breathing and dizziness. b/p elevated @ 140/100. HR 64. sent to ER for evaluation
Approx 1 hour after vaccine c/o hot flashes, sweating with pain radiating from vaccine site down to above wrist. Swelling between both thumbs and forefinger noted, greater on right. Symptoms lasted approximately 8 hours with no further complaints.
1st shot about 20 minuets later started felling flushed and temp fluctuated for about two hours.  Then a day or two later started getting left arm rash then on to the right arm a few days later.  Don't know if rash was caused by that.  Went for 2nd shot today and rejected when I told them about fluctuation of temperatures at fist shot.  How can I get second shot??
nosebleeds X 3  12/31, 1/1 and 1/2  treated with pressure and ice
CHILLS; FEVER; TIRED; MUSCLE PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced chills, fever, tired, and muscle pain. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 96 F, 98 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, tired and muscle pain was not reported. This report was non-serious.
-  Symptoms:  bodily aches & pains, headache, feverish, nausea, weakness -  Note: I do not know which Zoster vaccine I received (Shingrix or Zostavax).
Sore throat; Feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and FEELING ABNORMAL (Feeling bad) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and AZATHIOPRINE for an unknown indication.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) CF, UNK and AZATHIOPRINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and FEELING ABNORMAL (Feeling bad). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) had resolved with sequelae and FEELING ABNORMAL (Feeling bad) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter assessed the events as not related with Humira. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Hives, facial swelling; injection of methylprednisolone sodium succinate  and Rx for prednisone.  Some itching still present.
Rec'd meningococcal B. recombinant 0.5 ml Intramuscular Deltoid (L) S58878 Pfizer, Inc Exp: 6/01/19 HPI: Patient is a pleasant 18 year old female that is here today with clinical complaints of rash on left upper arm after getting a vaccination. ROS: Patient reports rash but reports no abnormal mole, no jaundice, no laceration, no non-healing areas, no changes in hair/nails, no psoriasis, no change in skin color, and no breast lump. She reports no fever, no night sweats, no significant weight gain, no significant weight loss, no exercise intolerance, no chills, and no malaise. She reports no dry eyes, no vision change, no irritation, and no eye disease/injury. She reports no difficulty hearing and no ear pain. She reports no frequent nosebleeds, no nose problems, and no sinus problems. She reports no sore throat, no bleeding gums, no snoring, no dry mouth, no mouth ulcers, no oral abnormalities, no teeth problems, no ringing in the ears, and no sinusitis. She reports no chest pain, no arm pain on exertion, no shortness of breath when walking, no shortness of breath when lying down, no palpitations, no known heart murmur, and no ankle swelling. She reports no cough, no wheezing, no shortness of breath, no coughing up blood, and no sleep apnea. She reports no abdominal pain, no nausea, no vomiting, no constipation, normal appetite, no diarrhea, not vomiting blood, no dyspepsia, and no GERD. She reports no incontinence, no difficulty urinating, no hematuria, and no increased frequency. She reports no muscle aches, no muscle weakness, no arthralgias/joint pain, no back pain, no swelling in the extremities, no neck pain, no difficulty walking, no cramps, no osteoporosis, and no fractures. She reports no loss of consciousness, no weakness, no numbness, no seizures, no dizziness, no migraines, no headaches, no tremor, no gait dysfunction, and no paralysis. She reports no depression, no sleep disturbances, feeling safe in a relationship, no alcohol abuse, no anxiety, no hallucinations, no suicidal thoughts, no mood swings, no memory loss, no agitation, no dementia, and no delirium. She reports no fatigue. She report no swollen glands, no bruising, no excessive bleeding, no anemia, and no phlebitis. She reports no runny nose, no sinus pressure, no itching, no hives, and no frequent sneezing.
I had COVID symptoms including a fever for 3 days. I had ongoing chest pain and shortness of breath, I had wheezing and breathing problems. I went to the doctor within 1 week of having the vaccine. He referred me to a cardiologist who ran a number of test on me including ekg, echocardiogram, and a stress test.  I still have some shortness of breath and chest pain and feel I am 90% better.
skin is itchy everyday; sleep is disturbed 1-2 days; skin is cracked and dry 1-2 days of the week.; skin is cracked and dry 1-2 days of the week.; flare up; This is a spontaneous report from a contactable other hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2,Solution for injection,Batch/Lot number was not reported, Expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1,SINGLE,and bnt162b2 (BNT162B2,Solution for injection, Batch/Lot number was not reported, Expiry date was not reported dose 2 via an unspecified route of administration on an unspecified date DOSE 2,SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced skin is itchy, sleep is disturbed, skin is cracked and dry 1-2 days of the week (skin dry),skin is cracked and dry 1-2 days of the week, flare up.The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Reporter state that her husband recv "double dose" of vax & exp pain at inj site. He recovered by 05/28/97. This is 1 of 3 family members to have adverse rxn following "double dose"  of vax.
This spontaneous report as received from a physician via a company representative refers to an 18 year old female patient. On 04-JUN-2014 the patient was vaccinated with GARDASIL dose 1. On 04-DEC-2014 the patient received her third dose and at that time told her physician that she lactates for 7 days after each dose. The outcome of patient lactates after each GARDASIL dose was reported as recovered/resolved. No treatment was given. Additional information has been requested.
Approximately 28min after vaccine administration, pt. was noted to have red/swollen face & SOB. Pt reported hx of severe asthma. Epi pen administered by clinic RN and pt took own albuterol inhaler at 1322. 911 called. pt reported some improvement of SOB after meds, but continued w/cough and increased work of breathing. VS showed tachycardia and hypertension after epi administration.  Pt reported improvements in face swelling and throat tightness after epi administration but still appeared to have labored and tachypneic breathing despite O2 sats 98-100%. Pt placed on 2L O2 via face mask to decrease work of breathing. Pt remained A&O, but developed rigors after epi administration. Paramedics and EMS arrived at approx 1328. Pt was subsequently transported to ED for further eval per EMS report.
No additional AE reported; improperly stored vaccines administered; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided. On 29-SEP-2021, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), 0.5 milliliter (lot number T035389, expiration date 14-APR-2022) (strength, frequency and route of administration were not provided) for prophylaxis. No adverse event was reported. According to the reporter, the temperature excursions were -14 to -10 (-13.7) degrees Celsius for a time frame of 30 minutes; -10 to 8 (-2.8) degrees Celsius for a time frame of 30 minutes and -10 to 8 (7.9) degrees Celsius for a time frame of 30 minutes, all temperature excursions on 20-SEP-2021, without any previous temperature excursion
102 Fever; headache; joint pain; back pain; nausea; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution). A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11Mar2021 08:15 (lot number: EN6203; expiry date: unknown) at the age of 19-years-old, as dose 1, single for COVID-19 immunisation. Medical history included Crohn's disease, polycystic ovarian syndrome (PCOS), migraines, and epilepsy. There were no concomitant medications. The patient previously received Cefcil and experienced allergies. The patient was not diagnosed with Covid-19 prior vaccination. The patient was not pregnant at the time of vaccination. The vaccine was administered in Public Health Clinic/Veterans Administration facility. The patient did not receive other vaccines in four weeks, or other medications in two weeks. On 11Mar2021 at 23:00, the patient experienced 102 fever, headache, joint pain, back pain, and nausea. The patient did not receive treatment for the events. Outcome of the events was recovering. The patient has not been tested for Covid-19 post vaccination.   No follow-up attempts are possible. No further information is expected.
Throat felt tight Narrative:  Throat felt tight. No wheezes/rhonci. Tongue without edema. Able to swallow. O2SAT 100% Vitals wnl
Patient passed away on April 27, 2021, which was two weeks after receiving second dose of Moderna Covid-19 vaccine.
Hot to the touch Injection Site; Swollen Injection Site; Red about 4" Injection Site; Itching Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE ERYTHEMA (Red about 4" Injection Site) and VACCINATION SITE PRURITUS (Itching Injection Site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE ERYTHEMA (Red about 4" Injection Site) and VACCINATION SITE PRURITUS (Itching Injection Site). At the time of the report, VACCINATION SITE WARMTH (Hot to the touch Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE ERYTHEMA (Red about 4" Injection Site) and VACCINATION SITE PRURITUS (Itching Injection Site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Expired vial was initially stored in the refrigerator; No adverse event; Patient received an expired dose of the monovalent Moderna COVID19 vaccine as a first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the monovalent Moderna COVID19 vaccine as a first dose), PRODUCT STORAGE ERROR (Expired vial was initially stored in the refrigerator) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 26-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the monovalent Moderna COVID19 vaccine as a first dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was initially stored in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the monovalent Moderna COVID19 vaccine as a first dose), PRODUCT STORAGE ERROR (Expired vial was initially stored in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the monovalent Moderna COVID19 vaccine as a first dose) and PRODUCT STORAGE ERROR (Expired vial was initially stored in the refrigerator).    No concomitant medications were reported.  The patient did not report side effects.  The vial was initially stored in the refrigerator on 26-Feb- 2023.  The vial did not undergo any temperature excursions.  No treatment medications were reported.
Mother called had immunization Tuesday 8/22/06.  Fussy, temperature 100.8.