chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash to R lower ext. noted almost immediately after administering vaccines. Grandmother pointed out that patient was starting to get more red spots to face, arms, and abdomen. Provider notified immediately. As per provider, to give 4ml prednisolone and 5ml of Benadryl. Patient did vomit after administering medication. Provider notified. Patient seen by provider 15 minutes after medication. Patient ok to leave. Reaction noted to be going away. Mother advised to give patient 5ml Benadryl OTC every 6 hrs as needed if the rash returns. Verbalized understanding.
Varicella and Pneumococcal injections given in Left arm at approximately 1:45pm on July 23.  No adverse effects noted.  Nurse left to draw Gardasil vaccine and it was given approximately five minutes later in Right arm.  Syncope immediately after Gardasil injection, followed by a tonic clonic seizure.  Red non-raised rash present on neck and chest.  Given benadryl.  Pain in right arm still present 6 days after injection.
Information has been received from a physician concerning a 15 year old female patient with no known drug reactions/allergies or pertinent medical history who on 30-JUL-2009 was intramuscularly vaccinated with the first dose of GARDASIL (lot#662518/0087Y0 0.5 mL and also was vaccinated with a dose of MENACTRA on the same date. On 12-OCT-2009 the patient was intramuscularly vaccinated with a second dose of GARDASIL (lot#660612/0229Y) 0.5 mL. The physician reported that after the second dose of GARDASIL, the patient complained of blurred vision and increased loss of vision. The patient was seen by a neuro-ophthalmologist and was diagnosed with bilateral optic neuropathy with color loss (date unspecified). Lab test were performed that showed a vitamin B1 deficiency. The physician reported that the patient would not get the third dose of GARDASIL because she was uncertain that the patient's experience was not hypersensitivity reaction. It was noted that the physician did not feel that the patient's vision loss was disabling. The physician saw the patient on 03-NOV-2009 at which time she noted improvement of the patient's symptoms, but no resolutions as of yet. No further information is available.
Headache, Fever,  chills, fatigue  Narrative: employee states: he experienced fever 101.8/101.9 F he was light headed , fatigue, tired by 1/6/21 still fatigue but no  fever
"Moderna COVID-19 Vaccine EUA" Within 15 ins of injection throat was draining,  felt scratchy and sore. Headache, fatigue, joint pain, lymph nodes under arm were very painful for about week. And of course pain at injection site. On 09 Jan 2021  a red rash appeared and itching. It is also warm to the touch on left arm at or around the injection site. (concerned about this sense it appeared a week later.) Did not have this for a week.   After all the symptoms went away.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Moderna COVID19 Vaccine EUA  Hospitalized inpatient 2 days for bronchitis/COPD.
Patient reported feeling lightheaded and felt like her ?head was floating? Patient provided water and symptoms improved Patient refused medical transport and signed ama form
local urticaria @ inject site w/in 24 hrs-no reaction to prior 2 doses of vax;
Patient was biten by her dog while giving him oral medication for heart worm 05/29/2003.  she was given Td at that visit on 06/02, patient called and requested appt 06/03/2003: office visit and of no better patient to see a dermatologist.  Patient had round exats on lower extremity, upper extremity and buttocks.
patient report she felt anxious today and was unsure if she should receive the vaccine. She decided to come and get the vaccine, and following the injection, her anxiety return and she got upset. She walk over to the medical care area and was obviously anxious. This occurs around 4:20PM. She sat down and was given water and food. I talk with her during her 30 minutes observation period and she felt better at 4:50 PM. She is on an anxiety medication. No vitals were taken.
herpes zoster reaction after vaccination with Moderna COVID-19 vaccine; 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 HERPES ZOSTER (herpes zoster reaction after vaccination with Moderna COVID-19 vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (herpes zoster reaction after vaccination with Moderna COVID-19 vaccine). At the time of the report, HERPES ZOSTER (herpes zoster reaction after vaccination with Moderna COVID-19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not reported. No concomitant medications reported.
Bilateral facial numbness, persistent, unknown etiology, x2 normal MRI, normal MRA
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration 07-May-2021 No concomitant medication information was provided by the reporter No treatment information provided
DIZZINESS; HEADACHE; This spontaneous report received from a patient concerned an 84 year old female. 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: 0331211-1808980, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced dizziness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 01-APR-2021, and had not recovered from dizziness. This report was non-serious.
This case was reported by a physician, via a sales representative, and described the occurrence of decreased therapeutic response in a male subject of unspecified age who was vaccinated with Engerix B for prophylaxis.  On an unspecified date the subject received the Engerix B (unknown) series "years ago".  At an unspecified time after vaccination with Engerix B, the subject experienced decreased therapeutic response.  "Recently", the physician checked the subject's antibody levels for hepatitis B.  The subject's titre was 8 (units unspecified).  The sales representative believed that the titre should be at least 9 (units unspecified).  At the time of reporting, the sales representative had no further information.  At the time of reporting the event was unresolved.
Sore arm, headache, dizziness, fatigue, nausea, body aches, chills, low-grade fever
Information has been received from a Medical Assistant concerning a 36 year old female patient with "asthma years ago", allergic reaction to BENADRYL, neomycin, KEFLEX, CIPRO, loratadine and penicillin allergy, who on 24-MAY-2012 was vaccinated with a dose of MMR II (lot#, dose and route not reported). Concomitant therapy included tuberculin purified protein derivative, received on 22-MAY-2012 (reported as "received PPD two days ago"). It was reported that on 24-MAY-2012 after vaccination the patient almost immediately had an allergic reaction to the neomycin component of the vaccine. Reporter stated that the patient began to experience itching and then began breaking out in hives. Her tongue swelled and "it was that thick, dry prickly tongue, and she became heavy chested but not short of breath". The medical assistant reported that the patient received epinephrine 0.4ml immediately and "was sent to the emergency room". At the time of reporting the patient status was unknown. Almost immediately allergic reaction to the neomycin component of the vaccine was considered to be immediately life-threatening and other important medical event. Additional information has been requested.
Started with chills and upset stomach.  After about 30 minutes felt sick to my stomach, still chills and felt weak.  Went to bed with normal covers, spread and an extra quilt.  Temperature  was 101.0.  stayed  in bed  until noon then went to the couch.  Still felt weak and extremely tired.   Temp down to 99 but developed a bad headache.  Took Tylenol  and laid on the couch all day - did not eat still felt queasy.  Went to bed  around 8:00pm.  Got up about 10:00 on Friday and felt almost back to normal and got better as the day went on. I also noticed quite a bruise at the site.
Patient was given both immunizations on 9/16/17. Patient reports her arm became red and warm to the touch the day following the immunizations and continued. She sought treatment 2 days post vaccination on 9/18/17 where she was given a course of antibiotics (Keflex) to treat possible cellulitis. Diagnosis was cellulitis vs. very heightened immune response. Patient reported on 9/22/17 that redness is going down in arm but is still somewhat present and that it is still warm to the touch.
Potential administration of Bexsero, Menveo, Havrix, Kinrix, Pediarix, Shingrix, Boostrix, Infanrix, Engerix-B, Hiberix stored at -0.93C for an unknown amount of time; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Herpes zoster (Shingrix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Menveo, Havrix, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Shingrix, Boostrix, Infanrix, Infanrix Pre-Filled Syringe Device, Engerix B and Hiberix. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Menveo, Havrix, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Shingrix, Boostrix, Infanrix, Infanrix Pre-Filled Syringe Device, Engerix B and Hiberix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUL-2022 Reporter's comment: Registered nurse reported potential administration of Bexsero, Menveo, Havrix, Kinrix, Pediarix, Shingrix, Boostrix, Infanrix, Engerix-B, Hiberix stored at minus 0.93 degree Celsius for an unknown amount of time. Prior excursion on 27 March 2022 for minus 0.84 degree Celsius unknown time. Healthcare professional stated that 587 doses of vaccines had been administered from 27 March 2022 up until 13 July 2022 to 363 individual patients. It was unknown which vaccines had been administered. The consent to follow up was given. The reporter stated that once reports are available GSK would update with specific lot numbers and vaccines that was administered to patients. No additional details were available at this time. Additional supportive information: Registered nurse reported potential administration of Bexsero, Menveo, Havrix, Kinrix, Pediarix, Shingrix, Boostrix, Infanrix, Engerix-B, Hiberix stored at minus 0.93 degree Celsius for an unknown amount of time which led to incorrect storage of vaccine.
Pfizer 6/4 and 6/25. Positive on 1/2
pt recv vax 30JUN95 & was hosp 22DEC95 w/pneumonia;this is one of two pt from this site to devel pneumonia p/vax;
severe episode of recurrent HSV (ovalabial) 7 days p/vax; although pt has had minor orolabial HSV in past, this episode was markedly worse; entire lower lip was heavily involved w/heavy crusting, fissuring & bleeding w/extensive lesions
Information has been received from a physician and by telephone call to the doctor's office concerning a 70 year old white female patient who on 14-MAY-2007 (previously reported as 19-MAY-2007) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 655289/0958F not reported). On 19-MAY-2007, the patient experienced arm pain at injection site. No evidence of infection reported. The symptoms resolved approximately on 20-MAY-2007. Additional information is not expected.
On July 13, 2017, we reported a spike in temps refrigerator 60.6F and freezer unknown for 12.10 hours on July 9.
Information has been received from a health professional concerning a 25 year old female with a history of seasonal allergy who on 16-MAY-2007 was vaccinated IM with Gardasil (Lot #656051/0244U).  Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ).  On 16-MAY-2007 the patient developed a lump at the injection site.  As of 23-MAY-2007, the patient had not recovered.  Additional information has been requested.
Information has been received from a physician and a registered nurse (R.N.) concerning a 75-year-old female who during the week of 22-OCT-2007 was vaccinated subcutaneously with a dose of zoster vaccine live (Oka/Merck) (lot# 658604/1088U). During the week of 22-OCT-2007 the patient experienced a 2 inch round, red swelling at the injection site. It was unspecified if medical attention was sought. No outcome was reported for the patient. No quality quality complaint was involved. Additional information has been requested.
*knot at injection site - 24hr after shots warm compress to area *fever 104 24hr after sots. TYLENOL and MOTRIN given.
Unclear if directly related, however 48 hours after obtaining 3rd COVID booster, patient developed significant headaches and 5 days afterwards was diagnosed with a cerebral venous sinus thrombosis.
I have been in a lot of pain. Right arm turned red and swollen. The shot has caused to hurt my right shoulder and right arm.
itchy red rash, hot to touch, underlying tissue firmer than surrounding tissue beginning approx 3436 hours after vaccination; "covid arm" aka "moderna arm".  first time for patient. Itch and rash increased in severity for next 24+ hours; symptoms began to decrease slowly at about day 3; rash is still faint at day 8.    patient first, second, third vax were Pfizer;  4th, 5th, 6th vax doses  were Moderna with NO reaction reaction occurred with the new Vax approved Sept 12, 2023
Dizziness/lightheaded; mild nausea; patient received first dose on 22Dec2020 and second dose on 15Jan2021; This is a spontaneous report from a contactable physician (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 09:00 (at the age of 46-years-old) at a single dose for COVID-19 immunization. The patient had no medical history, concomitant medications within two weeks of vaccination, or known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), in the left arm, on 22Dec2020 (at the age of 46-years-old) for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced dizziness/lightheaded and mild nausea on 17Jan2021 at 06:00. The events were reported as non-serious. The patient received first dose on 22Dec2020 and second dose on 15Jan2021. The patient did not receive any treatment for the events. The clinical outcome of dizziness/lightheaded and mild nausea was not recovered and of patient received first dose on 22Dec2020 and second dose on 15Jan2021 was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
morning urine is dark like blood/ morning urine is being dark red/peeing out blood; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (morning urine is dark like blood/ morning urine is being dark red/peeing out blood) 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 CHROMATURIA (morning urine is dark like blood/ morning urine is being dark red/peeing out blood). At the time of the report, CHROMATURIA (morning urine is dark like blood/ morning urine is being dark red/peeing out blood) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  The patient reported having no fever or pain.  No treatment medications were reported.
woke from sleep cried had sz like jerking, eyes became very wide w/blinking, fists clenched, turned blue sz like jerking;mom noted hives on face, checked back which also had hives, episode of wide eyes w/blink & sz lik jerking & blue
Chest congestion; Hasn't felt great; Cough; Hoarseness; Chest tightness; Flushing; Sweats; Sore throat; Body ache; Sore arm; Fatigue; Chills; a low grade fever not getting over 100 F; sore arm; Asthama exaccerbated; This spontaneous case was reported by a consumer and describes the occurrence of LOWER RESPIRATORY TRACT CONGESTION (Chest congestion), FEELING ABNORMAL (Hasn't felt great), COUGH (Cough), DYSPHONIA (Hoarseness) and CHEST DISCOMFORT (Chest tightness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058C21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Asthma.   On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ASTHMA (Asthama exaccerbated). On 18-Sep-2021, the patient experienced LOWER RESPIRATORY TRACT CONGESTION (Chest congestion), FEELING ABNORMAL (Hasn't felt great), COUGH (Cough), DYSPHONIA (Hoarseness), CHEST DISCOMFORT (Chest tightness), FLUSHING (Flushing), HYPERHIDROSIS (Sweats), OROPHARYNGEAL PAIN (Sore throat), PAIN (Body ache), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), CHILLS (Chills), PYREXIA (a low grade fever not getting over 100 F) and VACCINATION SITE PAIN (sore arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 19-Sep-2021 for Adverse event following immunization, at a dose of 2 prescription per day. On 28-Sep-2021, COUGH (Cough), DYSPHONIA (Hoarseness), CHEST DISCOMFORT (Chest tightness), FLUSHING (Flushing), HYPERHIDROSIS (Sweats), OROPHARYNGEAL PAIN (Sore throat), PAIN (Body ache), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), CHILLS (Chills), PYREXIA (a low grade fever not getting over 100 F) and VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, LOWER RESPIRATORY TRACT CONGESTION (Chest congestion), FEELING ABNORMAL (Hasn't felt great) and ASTHMA (Asthama exaccerbated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: high (High) low grade fever not getting over 100 degree Fahrenheit.         No concomitant medication was provided y the reporter.  Patient had treatment of salt water gargling, lots of fluids, Fever lasted over a week did not exceed 100 but felt it. Patient had to take extra steroids.    Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Significant follow up received :- added events.
Patient was asked if he wanted to receive the covid vaccine since we had a cancellation of an appointment.  We asked about any other vaccines in the past 28 days, he said none. He received our vaccine-moderna, then after receiving the vaccine, he stated that he forgot he may have received another vaccine last month. After being referred to his friend, we discovered he received Pfizer vaccine on 2/24/21; We gave him moderna on 3/15/21; Patient was fine when he left our area after being there for over 30 minutes.
Pt recvd 2 doses of Engerix-B & had no problems p/1st dose; 22JUL92 devel swelling from elbow to neck; also devel black & blue marks @ inject site;
Light headedness  BP 120/60, RR 16, SO2 98%, HR 82 Signs and symptoms relieved within 5 min drinking water + pretzels 12:22 BP 110/70, SO2 99%, RR: 16, Discharge home/self.  Denies complaints
On April 2, 2022, developed large red wheals associate with severe itching & burning which was significantly worse at night. Each wheal remained for 5-7 days and each day developed additional wheals. They occurred on both arms, hands, fingers, lower legs and dorsum of both feet including ankles. Despite multiple biopsies and laboratory tests as well as consults with Rheumatology, Hematology and PCP, a diagnosis has not been determined. Treated with several courses of steroids, steroid creams, multiple H1 and H2 blockers, the wheals persist unabated. The itching and burning continues and is severe during the late evening and nighttime hours interrupting sleep. Currently taking multiple medications for sleep but cannot sleep for more than 1.5 hours at a time. Also started on Hydroxychloroquine with no effect on the daily eruption of wheals.