chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from healthcare professional on 18 November 2013. A 27-year female patient, who has no relevant medical history and concomitant medications were not reported, had received intradermal dose of TENIVAC vaccine, batch number C4403AA in left forearm on 18 November 2013. It was reported that on 18 November, after receiving TENIVAC vaccine, the patient experienced site reaction of redness and itching. The patient received steroids as a corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow up information was received on 17 January 2014: On an unspecified date, the events of vaccination site redness and vaccinations site pruritus was recovered.
Right-sided facial swelling and numbness which began a few hours after receiving flu vaccine. The patient noticed a little bit of swelling inside her right cheek. The symptoms started approximately two hours prior to been seeing in the Emergency Department.
This spontaneous report as received from a nurse practitioner refers to a 40 year old female patient with Crohn's disease. On 28-APR-2014, the patient was vaccinated with the first dose of PNEUMOVAX23 injection (lot#, expiration date, dose, strength, route and indication not reported). On 24-JUL-2014, the patient was vaccinated with the second dose of PNEUMOVAX23 injection, in the arm (lot#, expiration date, dose, strength, route and indication not reported). The nurse practitioner reported that the patient developed pain and swelling of her arm where PNEUMOVAX was administered on 24-JUL-2014. The patient sought medical attention by office visit. At the time of reporting, the outcome of the events was not recovered. Additional information has been requested.
patient experience syncope ( feeling faint, dizzy, nauseated, sweating) and had a headache
Increased temperature 105 degrees/ seizure activity. Fever started day of vaccine 6/26/2009 seizure started 6/27/2009.
pain on injection side of body; head pain; difficulty taking a deep breath; injection arm ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain on injection side of body), DYSPNOEA (difficulty taking a deep breath), VACCINATION SITE PAIN (injection arm ache) and HEADACHE (head pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced DYSPNOEA (difficulty taking a deep breath) and VACCINATION SITE PAIN (injection arm ache). On 26-May-2021, the patient experienced PAIN (pain on injection side of body) and HEADACHE (head pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (pain on injection side of body), DYSPNOEA (difficulty taking a deep breath), VACCINATION SITE PAIN (injection arm ache) and HEADACHE (head pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product include inhaler.
My heart went into v-fib flurry and the AICD I have went off 5 times in 3 days. I had a bio-polar v-tach ablation in 2018 that was successful and had no V-fib since May 2019. The symptoms cause my heart rate to elevate 300 bpm in a fraction of a second and passed out each time. I was hospitalized and had to have amiodarone added to my system to get it to stop. Since I have had no v-fib and the only change in my life was the vaccine I received just 1 week prior.
Shingles; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 3 patients. This is one of 3 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101473796 same reporter/drug/event, different patient;US-PFIZER INC-202101473797 same reporter/drug/event, different patient
Patient was ordered Pfizer Bivalent Booster vaccine before going to home  Patient was inadvertently administered the Monovalent Vaccine which is for Primary Immunization only.  Both Vials look very similar, they are separated and labeled for primary vaccination only.  Case Management informed to contact home of error, so patient can be scheduled to get the bivalent vaccine in 2 months. Report also to be filed for error.  This formulation is no longer approved for booster vaccinations.  Discovered when viewing data
After less than a day i feel hot; tingly; sun burn not registering a fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (After less than a day i feel hot), PARAESTHESIA (tingly) and THERMAL BURN (sun burn not registering a fever) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (After less than a day i feel hot), PARAESTHESIA (tingly) and THERMAL BURN (sun burn not registering a fever). At the time of the report, FEELING HOT (After less than a day i feel hot), PARAESTHESIA (tingly) and THERMAL BURN (sun burn not registering a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
The patient states that the morning after receiving her second dose of the Shingrix vaccination, she had fainted. This resulted in hitting a hard surface near her eye which caused bruising near the orbital area.
Two days following vaccination with DTaP to right thigh, pt. developed 4 x 5 cm area of erythema, 2x3cm area of induration, hot to touch, tender to palpation
Had immediate tingling in left arm, fast heart beat. Lymph nodes swelled very large in neck.  Exactly 1 wk later right knee swelled & was unable to bend. By next morning couldn?t feel leg was numb & tingling. Next day broke out in rash all around trunk area.
Guardian reports patient experience redness and warmth to area 48 hours post injection.  Guardian reports patient was given Benadryl in case of allergic reaction to medication.  Patient noted to have discoloration approximately 2 and one half cm around injection site.  Patient denies any discomfort at time of visit today.
Patient received second dose 1 day earlier than 4 day grace period. No adverse effects noted.
Information has been received from a certified medical assistant concerning a 64 year old female patient, with diabetes, hypertension, diverticulosis, haemorrhoid, colonic polyps, anxiety, sulfa allergy and penicillin allergies and a history of stroke, who on 19-SEP-2011 was vaccinated subcutaneously on the back of the right arm with a dose of PNEUMOVAX 23 (lot # 668008/1157Z, expiration date 08-MAR-2012) (dose not reported). Suspect therapy included influenza virus vaccine inactivated (unspecified), on 19-SEP-2011 on the left arm. Concomitant therapy included glimepiride, alprazolam, LIPITOR, lisinopril (manufacturer unspecified), metformin hydrochloride (+) sitagliptin phosphate, dipyridamole and amlodipine. The certified medical assistant reported that after one day, on 20-Sep-2011 (also reported as on 23-SEP-2011) the patient started to swell, the back of the right arm was red and hot. Each day it kept getting bigger and then it covered the entire back side of her arm from the elbow to her shoulder. The patient sought unspecified medical attention and she was told to take BENADRYL and to put ice on it; no lab diagnostic tests were performed. The physician said it was the dorsal surface of the upper right arm, 10 cm red, warm "succular" and progressing from injection site. At the time of the report the patient was recovering from the adverse events but her anxiety increased. Anxiety, redness, swelling and warmth were considered to be an other important medical event by the certified medical assistant. Additional information has been requested.
Client came in to show us her arm.  Stated she woke up with reaction.  Left deltoid area where shot was given was noticibly red, raised, firm and very warm- about 3inch x3inch circumference. Client states it is bothersome and itchy. Client also states she has mild systemic type illness.  Discussed relief options and to let us know if site did not improve.   Dec. 14, 2020- follow up call with client- she reports vast improvement of local symptoms- no swelling, slightly pink , some itching at times.
shaky; not feeling well; achy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (shaky), MALAISE (not feeling well) and MYALGIA (achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced TREMOR (shaky), MALAISE (not feeling well) and MYALGIA (achy). At the time of the report, TREMOR (shaky), MALAISE (not feeling well) and MYALGIA (achy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow-up information updated outcome of events to Recovered; the patient stated that he is fine and does not want additional follow-up
Discomfort and decreased range of motion in injected arm. Cannot lift arm above a certain point and with difficulty. Has currently lasted about 6 weeks. Unknown if considered disability/permanent.
Chills cough runny nose headache body aches weak. Last  about 18 hours.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 78-year-old male patient who received SHINGRIX for prophylaxis. On 14th May 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th May 2018, less than a day after receiving SHINGRIX, the patient experienced chills and injection site pain. On an unknown date, the outcome of the chills and injection site pain were recovered/resolved. The reporter considered the chills and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the wife of the patient. The patient experienced some pain at the injection site and had chills that night. The symptoms were resolved. This is 1 of 3 cases, reported by the same reporter.
Fever started 11-4-17, cough, chills, H/a, stomach ache.
Body aches began at 11pm night of receiving vaccine.  Headache, chills and low grade fever (up to 100.1) developed following day.  48 hours after vaccine headache and body aches persist, chills and fever resolved
Gut  in chaos One hour after the 2nd shot / Gut in turmoil after 2nd shot ' Barely made it home and to the bathroom 1 hour after 2nd shot; This spontaneous case was reported by a non-health professional and describes the occurrence of GASTROINTESTINAL DISORDER (Gut  in chaos One hour after the 2nd shot / Gut in turmoil after 2nd shot ' Barely made it home and to the bathroom 1 hour after 2nd shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included Irritable bowel syndrome (IBS).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced GASTROINTESTINAL DISORDER (Gut  in chaos One hour after the 2nd shot / Gut in turmoil after 2nd shot ' Barely made it home and to the bathroom 1 hour after 2nd shot). At the time of the report, GASTROINTESTINAL DISORDER (Gut  in chaos One hour after the 2nd shot / Gut in turmoil after 2nd shot ' Barely made it home and to the bathroom 1 hour after 2nd shot) had not resolved.            No concomitant medication was provided by the reporter No treatment information was provided by the reporter Patient had a little stomach issue and IBS about 20 years ago.   This case was linked to MOD-2022-452389, MOD-2022-451586 (Patient Link).
got ill; she started to feel her heart properly, and she got burning all over; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing), notes: she used to have migraines years ago. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got ill"; BURNING SENSATION (non-serious), outcome "unknown", described as "she started to feel her heart properly, and she got burning all over".  Additional information: Reporter who was calling on behalf of his wife, mentioned that his wife got ill when she took the Pfizer COVID vaccines 2 years ago. Reporter reported that a week after his wife took the Pfizer COVID-19 vaccine, she got ill, and he would like to speak to someone regarding legal matters regarding what happened. He also said that his wife has been sick for more than two years, and his wife writes everything down because she used to have migraines years ago, and all of a sudden, a week after she took that COVID shot, she started to feel her heart properly, and she got burning all over. Also stated his wife has been sick for two years after taking the Pfizer covid-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201020700 same reporter/patient, different dose/event;
walking difficulty; arthritis; sciatic nerve pain/knees and shoulders are bone on bone; difficulty standing and walking; pain/more pain than she normally had; muscle pain; joint pain/more joint pain; fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fall), GAIT DISTURBANCE (walking difficulty), ARTHRITIS (arthritis), SCIATICA (sciatic nerve pain/knees and shoulders are bone on bone) and DYSSTASIA (difficulty standing and walking) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced FALL (fall). On an unknown date, the patient experienced GAIT DISTURBANCE (walking difficulty), ARTHRITIS (arthritis), SCIATICA (sciatic nerve pain/knees and shoulders are bone on bone), DYSSTASIA (difficulty standing and walking), PAIN (pain/more pain than she normally had), MYALGIA (muscle pain) and ARTHRALGIA (joint pain/more joint pain). The patient was treated with CORTISONE in July 2021 for Adverse event, at a dose of cortisone injection in both knees. At the time of the report, FALL (fall), GAIT DISTURBANCE (walking difficulty), ARTHRITIS (arthritis), SCIATICA (sciatic nerve pain/knees and shoulders are bone on bone), DYSSTASIA (difficulty standing and walking), PAIN (pain/more pain than she normally had), MYALGIA (muscle pain) and ARTHRALGIA (joint pain/more joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: revealed arthritis (abnormal) revealed arthritis.         Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up contains additional events difficulty in standing, sciatic nerve pain and treatment product.
Strong flu-like symptoms, severe joint aches, chills, headache,exhaustion, soreness at location of the shot, this has lasted 2 days, though abating today after 49 hours still have mild joint aches, lack of energy.
Information has been received from a certified medical assistant concerning a 25 year old female patient with no pertinent medical history and no drug reactions or allergies who on 17-JAN-2011 was vaccinated with the first dose of GARDASIL (Lot # and expired date not reported), prefilled syringe, intramuscularly. On 29-MAR-2011, the patient was vaccinated with the second dose of GARDASIL (Lot # 666596/0097Z and expiration date 15-OCT-2012), prefilled syringe, intramuscularly. There was no concomitant medication. The certified medical assistant stated that on an unspecified date, the patient developed a rash. The patient went to an emergency room. The certified medical assistant mentioned that the patient was treated with SOLU-MEDROL and BENADRYL. On an unspecified date, the patient recovered. Follow up information has been received from certified medical assistant concerning a 25 year old female registered nurse with no illness at the time of vaccination who on 29-MAR-2011 was vaccinated intramuscularly in the left deltoid with the second dose of GARDASIL (Lot # 666596/0097Z). It was reported that on 29-MAR-2011 the patient experienced tongue swelled. The patient sought medical attention. The patient was treated with SOLU-MEDROL and BENADRYL. At the time of reporting the patient's outcome was unknown. Additional information has been requested.
SEVERE PAIN AT THE SITE (RIGHT DELTOID) OF MENACTRA VACCINE.
Tiredness; Sore right injection site arm; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Tiredness) and VACCINATION SITE PAIN (Sore right injection site arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced FATIGUE (Tiredness) and VACCINATION SITE PAIN (Sore right injection site arm). At the time of the report, FATIGUE (Tiredness) and VACCINATION SITE PAIN (Sore right injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2021-279875 (Patient Link).   Reporter did not allow further contact
Large red area  around injection site with a lot of swelling, some tenderness  and hardness. Very itchy. Started a day and a half after the injection and has continued for 10 days.  Applied hydrocortisone cream, ice, Claritin.
Wife reported that day after receiving vaccines, her husband started feeling very dizzy, and like having vertigo with position changes. These symptoms disrupted his ability to conduct normal daily functions for days. He had never complained of dizziness or vertigo before. He had continued experiencing the symptoms but already feeling better by the day it was reported. He never went to the doctor or hospital.
12 hours after vaccine delivery(primary recipent)with swelling of soft palate, uvula, and hoarseness. No other signs of anaphylaxis-hypotension, urticaria, wheezing, etc.  Did self-treat with bronchodilators(Ventolin/Atrovent)at home with some respiratory distress.  Works in ER, went to see physician; large uvula, swollen tonsils, some edema of soft palate remaing. No wheezing, vaccine site clean, no derm lesions, normal vital signs.   Place on antihistamines--chose atarax to avoid somnolence of benadryl.  Offered urticaria dosing of alternating benadryl (4-6mg/kg/day)--physician and patient chose atarax alone.  Spoke with CDC about use of corticosteriods if fails antihistamines.  CDC concurred with use needed, use traditional dosing but limit # of days once symptoms resolve.  Exposure to adults at work with respiratory illness.  Never with symptoms like this before, no history of aeroallergens, no consistent use of medications, no current medications.  No contraindication to vaccine delivery.  No family history angioedema. Only intermittently with wheeze-Nebmask 1-2 times/quarter.  No known vaccine adverse events . No known sensitivity to phenol, thimerosal, polymyxin, neomycin, or streptomycin.  Works with many aerolized medications on a daily basis, no problems.
4 mo 13 day infant with no medical problems was vaccinated on 10/19/09 with oral rotavirus vaccine -RotaTeq-R--, standard dose, 2 ml. On 10/21/09 the infant's mother related the child had a rectal temperature of 101.5 degrees F. She had a rectal 98.9 degree temp on 10/21 and no temperature on 10/21. This was a mild AE on the protocol. This AE may have been related to the vaccine. The patient recovered without effects. This serves as the initial and 15 day report.
1 day after recieving vaccine - fever, chills 3 days after recieving vaccine - anxiety, racing heart, tingling nerves
Fever btw 100.5 to 102.5 F , chills, feeling hot, runny nose congestion, slightly productive cough. Extreme head ache, feeling weak and awful all over, light sensitivity., nausea and vomiting, hard to focus, joints and body ache. Inability to sleep. Irritability.
Vaccines given 11/24/09-Rash onset 12-4-09. "Doesn't seem sick" described as "prickly" from trunk to extremities, afebrile.
Sore arm where vaccine given, swelling, a lump at site. Body aches, headaches. Pt has eczema flare-up, thinks its due to the vaccine. Nausea.
Flu like symptoms day after 2nd injection, 24 hour bug.  One week later, my menstrual cycle arrived one week early. My typical cycle lasts 3-4 days with light to medium flow/blood loss. Beginning 5/29, my menstrual cycle was 6 days long, had heavy cramping throughout my abdomen, back, and legs, and a continuously heavy flow all 6 days.
T 101.5 w/swelling of lt arm from hand to elbow & warm to touch; 5SEP91 PMD dx cellulitis; rx Augmentin; dec rx p/1 day (gave PT diarrhea) & mom stated arm was OK next day p/seeing MD;
Patient report body rash of upper torso a day after receiving the vaccine. Rash resolved by time of reporting to pharmacy on 11/19/19
Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient had no issues during 15 minute wait period, but informed MD that experienced facial flushing, numbness, and warmness for total of 30 minutes on way home. Symptoms have resolved without any treatment.