chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm is sore at injection site; This is a spontaneous report received from a sponsored program. A contactable consumer (patient) reported that a 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1284, Expiry date 01Apr2021), via an unspecified route of administration on 19Jan2021 as single dose for COVID-19 immunization. Medical history included Cancer. Concomitant medication included palbociclib (IBRANCE) taken for neoplasm malignant, start and stop date were not reported. It was reported that patient had the first injection yesterday (19Jan2021) and she was doing great. She did not had any kind of reaction from it except her arm was a little bit sore. That was all, no big deal. But she have cancer and she was on old chemo called Ibrance and she did not inform vaccination providers of her taking Ibrance regularly wanted to know if she should have informed them. And was asking that, should she have to tell them and does it matter. When informed about Medical Information department, consumer stated, "That was okay. She mean, she was not going to sit and wait on the phone call any more. She was not having any kind of reaction or anything. Oncologist wanted her to have the shot. So, she guess she would have told. As such no treatment she just massaged it and she have taken Tylenol. No big deal. It was just barely sore. Patient stated, she do not know what they were. She just had to go to her oncologist. She had cancer. They always draw blood. she has no idea what it for was. The outcome of the event was unknown.
arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.
I did not have to go to the doctor. My symptoms started about a day and a half after getting the vaccine. I had a pounding headache at the base of my skull. It was not a normal headache like I usually get. There was a slight fever, body aches, and exhaustion. The symptoms lasted about two days and then I felt fine.
C/O pain and swelling x 2 days after receiving DTaP/IPV. Erythema, warmth, mild swelling upper half of (L) arm, approx. 10 cm x 9 cm diameter, limited to the extensor aspect of the arm.
Inconsolable fussiness, crying, and vomiting x 3 days after receiving the vaccines.
Hives/red splotches around the shoulder area and underarm of the arm vaccinated. Itchy and sore to the touch.
3 days with fever, body aches, chills 5 days and counting of headache, tiredness, nausea, and heavy night sweats.
Symptoms began 11/15/99 with 2 red bumps on neck and spread to arms, thigh, trunk. Pt is afebrile still breaking out with lesions. (now 25), no known exposure.
HIVES ON CHEST, ARMS, HANDS,  UPPER THIGHS AND OVER A FEW DAYS FACE AND TOES AND BACK.  DIZZINESS, WEAKNESS. I WENT TO PHARMACY  10/21/23 TO REPORT SYMTOMS AND BOUGHT SOME ANTI ITCH GEL AND WAS ADVISED TO TAKE BENADRYL. I DIDN'T GET THE BENADRYL AS I WAS TRAVELING TO SEE FAMILY. I DID GET IT THAT EVENING AND TOOK ONE PILL THAT EVENING. 10/22/2023 I WENT TO URGENT CARE. PHARMACY FILLED PRESCRIPTION: PREDNISONE NDC 59651-0489-01 1 DOSE DAILY FOR 6 DAYS . BENADRYL 1 EVERY NIGHT AND CONTINUE ANTI ITCH GEL AS DIRECTED. EACH DAY IMPROVEMENT OF ALL SYMTOMS.
9 patients were all given vaccines past the 30 days expiration mark; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients were all given vaccines past the 30 days expiration mark) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients were all given vaccines past the 30 days expiration mark). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (9 patients were all given vaccines past the 30 days expiration mark) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information provided.
Fever of 99.5 overnight after vaccination. Fatigue starting about 11 hours after injection and lasting the entire day after that.
urticaria rash given DPH, t98 x 5d-rash cleared on 3rd day of treatment;
Treatment of COVID-19/ Rebound testing positive after 10 days; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 at 09:30 as dose 1, single (Lot number: EL1283), in right arm, on 13Feb2021 at 09:00 as dose 2, single (Lot number: EN5318), in right arm and on 14Dec2021 at 09:45 as dose 3 (booster), single (Lot number: 33BoBA) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05May2022 at 10:00 as dose 4 (booster), single (Lot number: 049231A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma and breast cancer; "breast cancer" (unspecified if ongoing), notes: Other medical history: Asthma and breast cancer; "Known allergies: Eggs" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered", described as "Treatment of COVID-19/ Rebound testing positive after 10 days"; COVID-19 (medically significant), outcome "not recovered", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (Aug2022) Positive, notes: Rebound testing positive after 10 days after paxlovid meds. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Rebound testing positive after 10 days after paxlovid meds. Still unable to breathe. AE treatment: Breathing treatments and steroids. Known allergies: Eggs. Other medical history: Asthma and breast cancer. COVID 19 Treatment start ate 24Jul2022 and Stop date of treatment 28Jul2022, Lot number GE1498. The patient did not took any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine.
On6/25/20 around 2AM patient had a temp of 103'F and experienced 10 seconds of seizure activity.
COVID-19/sore throat and coughing a lot in bed and so forth; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19/sore throat and coughing a lot in bed and so forth) in an 84-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     Patient had no Allergies.  Previously administered products included for Product used for unknown indication: Flu vaccine (Flu yearly around the same time as with the reporter). Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Hypertension and AFib. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 16-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Nov-2022, the patient experienced COVID-19 (COVID-19/sore throat and coughing a lot in bed and so forth). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19/sore throat and coughing a lot in bed and so forth) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2022, SARS-CoV-2 test: Positive.         Concomitant medications also includes high blood medications and other medications for male stuff.  The patient received first dose on 26-Jan-2021 with lot number 030L20A, second dose on 23-Feb-2021 with lot number 031L20A, 1st booster dose on 3-Nov-2021 with lot number 032F21 and 2nd booster dose on 8-Apr-2022 with lot number 002M21A.  It was reported that initially, patient had sore throat then on (08-Nov-2022) coughing a lot in bed and so forth and did a home test on 09-Nov-2022 and it came out positive.   The AE did not cause patient to seek medical care.  The patient does not experienced a similar event in the past.  The symptoms were getting better.  Patient was prescribed with Paxlovid.   This case was linked to US-MODERNATX, INC.-MOD-2022-672556, US-MODERNATX, INC.-MOD-2022-672560 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-672556:Wife's bivalent dose US-MODERNATX, INC.-MOD-2022-672560:Wife's second booster
Six to eight hours after vaccines, MMR, Varicella, he started vomiting every half hour for five hours. Gradually kept down gatorade and by the next day he was acting fine.
Patient developed a local skin reaction today at the site the vaccine was given (right deltoid).  Skin is hot to touch, slightly erythematous, slightly tender only when palpated.  No pain otherwise.
pt pregnant, last menstrual period 5FEB98;recv vax 15JAN98;
This patient is a 16 year old male who had a syncopal episode in the clinic today with his mother present. He received 3 vaccines during this visit, immediately after the 3rd vaccine (HPV9) he slumped over at 10:51am , was caught by the nurse, had convulsion-like movements for 10 seconds at 10:52am, and was safely brought to the ground by 10:53am for continued recovery with the assistance of a second nurse. He regained consciousness before moving him to the ground, he laid with elevated feet and drank juice and was breathing normally. His perfusion improved, color returned to his face, and he showed no other abnormalities. He sat up slowly and waited in the chair, drank water, and conversed normally with the nurses for 15 more minutes before leaving. He was discharged 11:14am accompanied by his mother and stated he ?felt much better?. The client recovered quickly <15 minutes.
Patient states that the day after she received the vaccine she noticed a red rash that started at the injection site and spread around to the back of her arm. She states that it is not itchy and since it's initial appearance it has decreased in size. I recommended she take a Benadryl and continue to monitor it.
Random headaches on daily basis; my cycle is back in full swing day after my second dose; Bottom number of BP rising; Swelling in feet and legs.; Lightheartedness; I really feel that something is just not right; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot umber: EV0164, patient was 51-year-old and not pregnant at the time of vaccination) via an unspecified route of administration, administered in arm left on 23Mar2021 as dose 2, single for COVID-19 immunization. Medical history included ADHD, bipolar, depression, anxiety, colon cancer, migraines, bananas tree nuts, premenopausal. Concomitant medications included amlodipine besilate (5mg); ascorbic acid, ferrous fumarate (VITRON C) both was taken within 2 weeks of vaccination. The patient previously took dilantin [phenytoin] and experienced Allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot umber: EN6208) via an unspecified route of administration, administered in arm left on an unspecified date as dose 1, single for COVID-19 immunization. Patient does not receive other vaccine in four weeks. Reported that never had an issue with bottom number before only top. No COVID prior vaccination. Patient was not tested COVID post vaccination. On 16Apr2021 at 12:00, the patient experienced random headaches on daily basis, my cycle is back in full swing day after my second dose, bottom number of bp rising, swelling in feet and legs, lightheartedness, I really feel that something is just not right. The patient underwent lab tests and procedures which included blood pressure measurement resulted as bp rising on 16Apr2021 as bottom number of BP rising. Patient received treatment for events and increased BP medication. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
No immediate response,  approx 4 hours after dose started not feeling well passed out 3 times with 5 minute time frame, EMS called, became coherent while they were route, continue to improve and vitals were checked and advised to monitor.  Currently experiencing dizziness when standing from a seated position consistently with no improvement, also fatigued as well.  In touch with Primary Care Physician and am monitoring .
the patient was only given the liquid CYW portion; the patient was only given the liquid CYW portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA723Z, expiry date 31st August 2023) for prophylaxis.   On 10th October 2022, the patient received Menveo. On 10th October 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-Oct-2022 Reporter's comment: The clinic supervisor reported the patient was administered with a dose of Menveo on 10th October 2022. The reporter stated that the provider was not aware there were two vials to reconstitute before administration, and the patient was only given the liquid CYW portion. At the time of reporting, the dose had not been repeated. The reporter gave permission for follow-up. Additional Supportive Information: The patient was only given the liquid CYW portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. There was discrepancy in the vaccination date reported in source document which was future date, hence it was captured as per narrative.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), on 16Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
MD ordered HD Fluzone to be given to patient. Vaxelis was given instead.
Infant received routine vaccines at 6 week well check. Within 12 hours of vaccination, had one episode where baby moaned then turned head to the left, become very tight, accompanied by bilateral eye deviation to the left, staring off unresponsive to sound or movement. No generalized convulsion. Episode lasted 1-1.5 minutes. No repeat episodes.
Received the flu vaccine on 10/30/18 at 1955. Started to cough within 5 mins of receiving the vaccine started experiencing tightness in her throat and was drinking water after 10 to 15 mins At 2028 took her inhaler Albuterol At 2031 50mg BENADRYL IM was given to RT Deltoid by nurse Lot #6400145 exp 4/1/2019 D1021L01 Needed to go to the ER for SOLUMEDEROL injection Has taken FLUBLOK in the past without issues In ED received Famotidine 40 mg 10/30/18 21:11 and methylprednisolone 125 mg IM 10/30/18 at 21:11. Was on steroids 20 mg PO X 4 days.
Pt. reported feeling dizzy, palpitations, sweaty hands, pain throbbing down arm to fingers and up to neck.
swelling/hot/red/tender lt arm swollen @ axilla 22 3/4cm @ mid arm 20 1/2cm;sx occurred approx 40hr p/vax;no fever;WBC 12,600;
Fever 103.8.; 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 PYREXIA (Fever 103.8.) 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) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fever 103.8.). At the time of the report, PYREXIA (Fever 103.8.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.8 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment information provided.
Patient requested that all her shots were to be given in her left arm only because she needed her right arm pain-free. Shots were given at least 2 inches apart on left upper arm intramuscularly. Patient complains of pain and rashes at the site of vaccination and a slightly elevated but flat swollen raised round patch of skin at site of vaccination. Patient called her doctor on 03/16/2016 but doctor told her to call the pharmacy and did not recommend anything. She came to the pharmacy on 03/17/2016 and spoke with another pharmacist who told her to take Benadryl and use cortisone cream on the swollen site over-the-counter until she could see the doctor, if the swelling does not resolve. I called her today (03/17/2016) at about 6:15pm and spoke with her, she admits to the pain subsiding somewhat and the swelling going down, but she would make an appointment with the doctor in the morning of 03/18/2016.
Patient became lightheaeded shortly after receiving the vaccine and then approached the MA letting her know that he felt like he was going to faint. We elevated his legs up on another chair and lowered him slowly to the ground so he could lie flat on a yoga mat, applied cool compresses to the back of his neck and took his vitals.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 2017 (reported as between the dates of 31-JUL-2017 through 04-AUG-2017), the patient was vaccinated with GARDASIL 9 for prophylaxis. On 2017 the patient experienced expired product administered. On an unknown date the patient experienced no adverse event.
Got it in her eyes from the shot/Suspected vaccination failure; Got it in her eyes; Losing her sight, something similar to macular degeneration; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and loss of vision (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and loss of vision were not recovered/not resolved.   The reporter considered the vaccination failure, ophthalmic herpes zoster and loss of vision to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comments: This case was received from patient's parent via interactive digital media. The patient got shingles in her eyes from the stinking shingle shot and she was losing her sight. The patient now had something similar to macular degeneration.  The patient had been getting injections in both eyes to stop it (over 2 years now) but it was not helping. The reporter stated that of course, patient could not get help with the cost of trying to save her sight. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
my tongue got all swollen; my chest got like a big hive/rash/  I saw the hives on my chest.; my chest got like a big hive/rash; my tongue start hurting and tingle; my tongue start hurting and tingle; I couldn't breath properly; felt pressure on my chest; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jul2021 12:00 (Lot Number: ewo173) at 48 years old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included rheumatoid arthritis, patient diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included unspecified vitamins. The patient previously took humera and experienced drug allergy.  Soon after vaccine (02Jul2021 12:00 PM), the patient experienced felt pressure on her chest, then felt that she couldn't breath properly on the following days then nothing change but she didn't think it was an emergency then on Tuesday (06Jul2021) her tongue got all swollen and her chest got like a big hive/rash . The patient didn't figure it out till her tongue start hurting and tingle and then she saw the hives on her chest. Since the vaccination, the patient has not been tested for COVID-19. The outcome was unknown.   Follow-up attempts are completed. No further information is expected.
Swelling in whole left arm, rash, shoulder joint pain and felt loose, hand pain and swelling