chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu shot given. Approximately 9 minutes later, pt reported, "felt funny, heart racing" BP 174/94, P 126, R 12. Skin warm, dry, pink, ho SOB. At 6:24 AM 160/90-92-12. Nose stuffy, feels better 6:23 AM 134/90-92-12 better 6:32 AM 132/86-80-12. No heart racing, calmer. 6:38 AM 126/82-76-12, okay back to work. 6:46 AM 16/82-124-24 back hurts, racing heart and throat slight tightness. Gave Epi. 0.5cc SQ. Skin cool and dry pt fearful, medic called, arrived 6:53 AM BP 170/100-140 lungs clear. Medic feels reaction is anxiety, leave 7:11 AM. 7:13 AM 140/82-92-12. Pt back to work. 7:40 AM working, no symptoms or complaints. 140/82-88, color pink, skin warm and dry. This was the pt's first time getting a flu shot.
Patient received a third dose of Janssen.  Patient was fully vaccinated at the time of injection with two previous doses of Janssen. Patient was asymptomatic. No treatment needed
Had puncture wound (deep) of left thumb. Asked for tetanus injection and received Tdap.
Chest pain, unable to fully inflate lungs, fever for 12 days, temporary loss of vision on 8/11/21, severe diarrhea for 3 weeks, hallucinations at night for about 7 days, loss of kidney function, fatigue for 3 weeks, extreme dizziness for 2 weeks which is now finally going away, heart rate went into the 90's and stayed there for the first 3 days, heart fluttering and skipping beats.
This spontaneous report as received from a certified medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL lot# K023432, expiration date: 18-JUN-2016 and lot# K007828, expiration date: 03-MAR-2017 (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Red 5 1/2" x 2 1/2" LD no swelling warm to touch. 10/2/02 saw MD this am-advised Benadryl po qid x 5 days and ice per mom.
Pt pale, sweaty, weak/lightheaded after HPV vaccine #2 of 2.
Pt started to feel unwell, said I feel like I'm going to faint. Nursing staff reclined pt on exam table to supine position. Within 5 sec of GARDASIL vaccine administration. Pt remained conscious for 15 sec talking w/nurse, then proceeded to have stiffening of body flexion and jerking of arms and legs, incontinence of urine. Episode lasted 45 sec. Pt woke, drowsy and gradually recovered over 20 mins.
Sore arm that night.   Body ache, stifness, nausea by 8 AM.   Feels like a very bad flu.
CHILD 5 YEARS OF AGE RECEIVED ADULT LOT# AND DOSE OF PFIZER AS FIRST DOSE
Left arm reddened, swelling, hot, tender elbow to shoulder. Augmentin 500 BID for 10 days.
Rash developed at site of inject a week after injection. Fatigue, headache, body aches and lightheaded episodes.
aches and tired but most important is a body odor about 3 days later and still present 11 days later
Chest pain; Nervousness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NERVOUSNESS (Nervousness) and CHEST PAIN (Chest pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.  No Medical History information was reported.  On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced NERVOUSNESS (Nervousness) and CHEST PAIN (Chest pain). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) at an unspecified dose and frequency. On 01-Mar-2021, NERVOUSNESS (Nervousness) and CHEST PAIN (Chest pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Heart rate: increased (High) Heart Racing. On an unknown date, Heart rate: normal (normal) She saw the cardiologist and was told her heart is functioning normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Developed cellulitis around injection site.  Had erythema, tenderness, warmth.  Resolved with course of antibiotics (oral), over 3 days.
Urticarial rash around injection site that started 8 days after injection; site is warm to touch, raised, and itchy. Area of reaction extends approx. 2 inches x 3 inches over the left deltoid area. Raised rash resolved approx. 24 hrs later, but itchiness remain.
Arm soreness at injection site, chills, fever, migraine, muscle pain, fatigue, cough, wheezing, pain in lymph nodes in right armpit and right side of neck
Woke up in AM w/nausea and vomiting. Unable to eat or drink w/o vomiting.
This spontaneous report as received from a physician refers to a male patient of unknown age with hypertension and drug hypersensitivity. On an unknown date in 2010, the patient was vaccinated with  ZOSTAVAX, unknown for prophylaxis. Concomitant therapies included ramipril (RAMIPRIL). On an unknown date, the patient experienced herpes zoster and inappropriate schedule of drug administration. The outcome of herpes zoster and inappropriate schedule of drug administration is unknown. The reporter considered inappropriate schedule of drug administration to be not related to ZOSTAVAX.
Information has been received from a registered nurse concerning a 4 year old female with no pertinent medical history or allergies who on 28-OCT-2008 was vaccinated subcutaneously with a second 0.5ml dose of VARIVAX (Merck) (lot# 661444/0529X). There was no concomitant medication. On 16-JUL-2009 the patient developed a mild case of chickenpox. She visited the office and the physician prescribed acyclovir to her. No lab diagnostics studies were performed. At the time of reporting the patient was not recovered. Follow up information has been received from the registered nurse concerning the 4 year old female child with no pre-existing allergies, birth defects or medical conditions who on 18-OCT-2005 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot# 661444/0529X) into the left arm and the first dose of MMR II (lot# 658156/0215X) into the right arm. Concomitant therapy included DTAP (lot # C2957AA, schedule: 21-DEC-2004, 08-DEC-2005, 12-APR-2005, 10-APR-2006) IM into the right arm and IPV (lot#A1060, schedule: 21-DEC-2004, 08-FEB-2005, 10-APR-2006) IM into the left arm. On 17-JUL-2009 the patient came into the physician's office with rash and low-grade fever. She was diagnosed with chickenpox and the illness was mild. The patient was treated with acyclovir, 200mg/5ml; sig: 400mg, oral administration, q8 hours for 4 days. There was no illness at the time of vaccination. No relevant diagnostic tests were performed. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Tdap administered IM in L deltoid 8/15. 8am 8/17 L deltoid very tight and firm ,warm to touch, 1pm fever 101.6 w/ chills and generally body aches, ice applied,600mg ibuprofen administered.employee told to come to ED if any increase in fever. 8/20 she reports fever and chills 8/18 and 8/19 and increasing erythema. Left upper arm w/ 19cm X 17 cm erythema and very warm to touch. No fever. Arm remains tender to touch but overall less painful. ice continued. 8/22 erythema gone,she reports feeling tired but overall improved. herpes simplex on upper lip noted today.
On the day that I receieved my flu shot I developed aches and pain by that afternoon. The following day I hurt even worse and I started coughing. That day I aslo, lost my voice and have since not gotten it back to normal. I still have a cough and aches. Today would be the seventh day since I received the shot.
Starting 8 hours after vaccine: severe fatigue lasting 24 hours, moderate bone and muscle pain lasting 12 hours, moderate chills lasting 3 hours. Mild headache intermittently for 24 hours.
Excruciating pain in her whole left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Excruciating pain in her whole left arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Excruciating pain in her whole left arm). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of UNK dosage form and IBUPROFEN at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Excruciating pain in her whole left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. The patient could barely raise her arm to drive. It was also hard for her to sleep on the left side because of the pain.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Redness/swelling 30.5cm x 40cm at injection site. (7-20 12 - pt was given script for KEFLEX 500).
Upper left arm at site of DTaP red, swollen, warm.  Area 13x10 cm.  Vaccine given at about 0945 on 08/25/05. Complained of her arm hurting that day and also during the middle of the night.  Report called from Dr.'s office at about 1445 on 08/26/05.
No additional adverse effects were reported; the patient received improperly stored VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 23-JUL-2020, the patient was vaccinated with a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided) vial (upon internal validation process, the formulation was established as prefilled syringe) (lot# T008698, was established as valid, with expiration date: 04-JUN-2021) (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis.  The temperature to which the vaccines was exposed was 62.2 degrees of Fahrenheit and the time frame was reported as 3 hours 50 minutes. No previous temperature excursion was reported. A digital data logger was involved. No additional adverse effects were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA010267: US-009507513-2007USA010268: US-009507513-2007USA009779:
Patient was given a Moderna booster- Patient not eligable for moderna due to age. No symptoms
After receiving my third dose, I experienced shortness of breath, a kidney infection, hematuria, and sciatica in my leg. I'm going to have a cystoscopy this month to look for tumors or infections.
My Epstein Barr flared and I got a cold sore within 5 days, one again a month later. I had trouble sleeping for 5 nights and all of my allergies/strep symptoms flared. I got a nose polyp.
pt recv vax;exposed to shingles 2 wk prior to onset of chicken pox lesions;pt has many vesicles in groin area;vaccine failure
having trouble thinking from migraine; sore arm; swollen up; lymph nodes swollen, but went down; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (having trouble thinking from migraine), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen up) and LYMPHADENOPATHY (lymph nodes swollen, but went down) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 24-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENTAL IMPAIRMENT (having trouble thinking from migraine), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen up) and LYMPHADENOPATHY (lymph nodes swollen, but went down). At the time of the report, MENTAL IMPAIRMENT (having trouble thinking from migraine) outcome was unknown and PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen up) and LYMPHADENOPATHY (lymph nodes swollen, but went down) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication reported as migraine medication, it is also a blood thinner, and is a natural medication that also has magnesium for migraine. No treatment medications were reported.  Company comment - This case concerns a 78-year-old male patient with relevant medical history of Migraine, who experienced the non-serious unexpected events of Mental Impairment, Pain in Extremity, Peripheral Swelling, and Lymphadenopathy. The events occurred on an unknown date after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The medical history of Migraine remains a confounder for the event Mental Impairment. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 78-year-old male patient with relevant medical history of Migraine, who experienced the non-serious unexpected events of Mental Impairment, Pain in Extremity, Peripheral Swelling, and Lymphadenopathy. The events occurred on an unknown date after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The medical history of Migraine remains a confounder for the event Mental Impairment. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
First sign developed 8 days after initial dose of Pfizer vaccine. Symptom was moderate leg pain on standing/walking, both legs. Following day(s) through this notice, Tuesday, March 9-2021, increased to constant, excruciating, severe pain advancing to arms and hands. Difficult to move, rise from laying, sitting position, climbing stairs (almost impossible without extreme and constant pain) and accompanying overall fatigue. Little or no appetite. Went to ER . All tests run showed no adversity and no treatment offered other than pain meds. Outcome still pending as symptoms persist. Self treat for pain with 500 mg Tylenol extra strength (generic). Began with 2 and went to 3. Currently providing moderate comfort but no real pain relief, as yet. Symptoms increase each day.
Pain & stiffness in muscle 1st -3rd day.  Redness & heat right earlobe 3-4th day.  Swollen/painful lymph nodes right armpit 5th & 6th day.
Raised red hive/itching half-dollar size around injection site.  Treating with hydrocortizone.  Has not yet been 24 hours--I am certain reaction will subside, just wanted to make report.
During the waiting period (about 5 minutes after receiving vaccine) the patient passed out for a moment and fell out of her chair. 911 was called and the patient remained laying on the floor due to feeling a bit anxious and overwhelmed. Patient stated she was not having trouble breathing but had a slight headache from hitting her head. Patient walked out of pharmacy with paramedics.
Patient had an injection site reaction - redness around site, hard/lump under injection site, pain upon touch and warm
an improperly stored dose of GARDASIL9 was administered to the patient; No adverse effects; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N022952, expiration date: 14-JUN-2020, dose detail and route were not reported) for prophylaxis (product storage error). The vaccine was exposed below 36 Fahrenheit degrees (32.1 Fahrenheit degrees) for 8 hours. There was no previous temperature excursion and the call was because of data logger involved. No adverse effects were reported.
pt recvd vax; n, v, lightheadiness, dizziness, some fever soon p/ vax;lasted into eve;
Minor kidney problems; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (Minor kidney problems) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL DISORDER (Minor kidney problems). At the time of the report, RENAL DISORDER (Minor kidney problems) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
Provider hospital summary "Patient is a 67-year-old female with history of diabetes, hypertension, thrombocytopenia presented with shortness of breath with exertion.  Patient's symptoms started 11 days prior to admission.  Patient is vaccinated for COVID-19.  Patient was found to be positive on 11/18 and she was being quarantined at home.  Due to worsening shortness of breath she went to a walk-in clinic and her oxygen saturation was 88%.  Patient was initially sent to ER.  Later on she was transferred to Hospital for further monitoring.  Patient improved rapidly.  Next morning she was insisting to go home.  She will be provided a course of dexamethasone on discharge.  Home oxygen will be arranged."
Redness, swelling, and pain over injection site and extending 4-5 centimeters out from injection site.
MVCC transferred customer who had questions on appropriateness of receiving PNEUMOVAX 23 vaccine after she's already had 3 previous unspecified pneumonia vaccines. She states she is 78 years old and her healthcare provider chose to give her 3 previo; This spontaneous report was received from a 78-year-old female patient, who was referring to herself. Her concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (strength, vaccination schedule, lot #, expiry date, site and route of administration were not provided) for prophylaxis. The patient had questions on appropriateness of receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) after she already had 3 previous unspecified pneumonia vaccines, suspected to be pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (strengths, vaccination schedules, lot #, expiry dates, sites and routes of administration were not provided), or pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (formulation, strength, vaccination schedule, lot #, expiry date, site and route of administration were not provided), administered for prophylaxis (Extra dose administered). The patient reported she received 3 previous doses due to her health history as per healthcare provider's decision. No additional information was provided.
PERSISTENT SORENESS AT SITE, SHOOTING PAIN DOWN ARM (right) TO MIDDLE FINGER AREA.
Patient had History of Reaction to Flu Vaccine. Patient administered own Epipen once reactions started. Used personal Epipen.
Shortness of breath starting 12:50 on 12/22/20 lasting up to the 5pm hour. Shortness of breath.  Monitored O2 sats and deep breathing supine on sofa.  Sats stayed in 90s and only for about a 30 min period, sats dropped to 88-93 percent.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history or concomitant medications were not reported. On unknown dates, unspecified patients were vaccinated with improperly stored GARDASIL 9 lot # reported as L043214; expiration date 28-AUG-2017, dose and route of administration were unspecified. The vaccines had been exposed to 32 degrees Fahrenheit for 11 hours. There was no previous temperature excursion. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous retrospective pregnancy report was received from a physician and refers to a 28-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included latent tuberculosis. The patient's concomitant medications included unspecified vitamins and ferrous sulfate. The patient did not have any drug reactions or allergies. On 24-APR-2017, the pregnant patient was vaccinated with a first dose of VARIVAX subcutaneously, lot# M028552 and expiration date 07-JUN-2018 (dose was not reported) for prevention of varicella. The patient's gestational age on the date of administration was 13 weeks, 1 day. The last menstrual period date was estimated on 22-JAN-2017, date of conception on 05-FEB-2017 and estimated date of delivery on 29-OCT-2017. On an unknown date in 2017, the patient had routine fetal anatomy ultrasounds, all of which were normal. The patient did not spontaneously go into labor after 40 weeks of pregnancy, so she was admitted to the medical center at 41 weeks on 06-NOV-2017 for induction of labor. On 06-NOV-2017, the patient delivered a baby with no complications. The baby was born with congenial anomaly, an "ear pit" in the right ear. The physician reported no treatment was necessary for the "ear pit." The outcome of the events was reported as resolved. The relatedness between the events and VARIVAX was not reported. The child's case was captured into MARRS# 1711USA004413. Sender's Comments:  US-009507513-1711USA004413.
Patient had a 50mm oval shape of redness and tenderness at the site of S.C. injection.  Area of concern is also identical to that of erythema migrans.