chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 23-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381: Original Case: 1808USA001261; US-009507513-1808USA004382: Original Case: 1808USA001261; US-009507513-1808USA004383: Original Case: 1808USA001261; US-009507513-1808USA004384: Original Case: 1808USA001261; US-009507513-1808USA004385: Original Case: 1808USA001261; US-009507513-1808USA004380: Original Case: 1808USA001261; US-009507513-1808USA004379: Original Case: 1808USA001261; US-009507513-1808USA004376: Original Case: 1808USA001261; US-009507513-1808USA004377: Original Case: 1808USA001261; US-009507513-1808USA004378: Original Case: 1808USA001261; US-009507513-1808USA004386: Original Case: 1808USA001261; US-009507513-1808USA004387: Original Case: 1808USA001261; US-009507513-1808USA004388: Original Case: 1808USA001261; US-009507513-1808USA004362: Original Case: 1808USA001261; US-009507513-1808USA004363: Original Case: 1808USA001261; US-009507513-1808USA004364: Original Case: 1808USA001261; US-009507513-1808USA004390: Original Case: 1808USA001261; US-009507513-1808USA004391: Original Case: 1808USA001261; US-009507513-1808USA004392: Original Case: 1808USA001261; US-009507513-1808USA004393: Original Case: 1808USA001261; US-009507513-1808USA004394: Original Case: 1808USA001261; US-009507513-1808USA004395: Original Case: 1808USA001261; US-009507513-1808USA004396: Original Case: 1808USA001261; US-009507513-1808USA004365: Original Case: 1808USA001261; US-009507513-1808USA004366: Original Case: 1808USA001261; US-009507513-1808USA004367: Original Case: 1808USA001261; US-009507513-1808USA004397: Original Case: 1808USA001261; US-009507513-1808USA004398: Original Case: 1808USA001261; US-009507513-1808USA004399: Original Case: 1808USA001261; US-009507513-1808USA004368: Original Case: 1808USA001261; US-009507513-1808USA004369: Original Case: 1808USA001261; US-009507513-1808USA004400: Original Case: 1808USA001261; US-009507513-1808USA004401: Original Case: 1808USA001261; US-009507513-1808USA004370: Original Case: 1808USA00126.
I was fine Saturday after the shot.  Sunday I was completely enervated.  I had a bad headache and zero energy and a little bit of nausea.  I started feeling better around 6:00 pm, but went to bed at 8:30 pm and slept 9 hours (which is very long for me).
On 3/15/02 at 04:30, pt developed a fever of 102F, swollen lymph nodes and a sore throat. Went to PMD on 3/15/02 and PMD not sure if related to vaccine or virus. No treatment.
sore and aching all over; soreness is down in his abdominal area; soreness is down in his abdominal area and the base of his spine; This is a spontaneous report from a contactable consumer (patient). A 90-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL5318), via an unspecified route of administration in left arm on 31Jan2021 12:30 at single dose for COVID-19 immunization. Medical history included blood thinner  (doctor basically wants to thin his blood due to his age and so forth) from an unknown date and unknown if ongoing, the patient mentioned this to his doctor did want him taking the baby aspirin every day of the week but he told his doctor he bled too much and his doctor "well oh okay". Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) as blood thinner, lisinopril, metoprolol succinate and amlodipine besilate. The patient previously took flu vaccine. The patient received his COVID vaccination around 12:30 Sunday afternoon. He felt fine for the next 2 hours and then he started feeling a little sore and so forth. By evening, the patient was sore and aching all over on 31Jan2021. This is the only side effect he had, everything else went fine. He could hardly get out of bed yesterday because he was so sore all over and it was the same today. The patient stated, "I keep shrinking at this age". The patient found that when he gets out of bed and forces himself to walk around very carefully, it seems to get a little better. Today, the soreness was down in his abdominal area and the base of his spine. The rest has seemed to clear up. The patient confirmed it has improved some. The doctor did a blood test about two weeks ago prior to the vaccine and it came back excellent in Jan2021. The patient wants to know if it is okay to take Advil or something like that to reduce the pain. The outcome of the events was recovering.
Site: Pain at Injection Site-Mild, Additional Details: discomfort in shoulder lasting weeks after injection, but felt immediately at injection time that something was wrong. discomfort doesn't limit range of motion, no tingling or numbness. dr advised him it might take several weeks or mothns to go away. no further follow up at this time.
ON 01-11-08 PAIN AFTER INJECTION AND LATE AFTERNOON NOTED REDNESS, WARM TO TOUCH, PAINFUL, RAISED AREA SIZE OF HER PALM. NO MEDICATION WAS TAKEN ON 01-11-08.  ON 01-12-08 AREA WORSEN WITH PAIN, REDNESS, EDEMA, AND RED STREAK TOWARDS LEFT BREAST.  PT. WENT TO MEDICAL CENTER AND TREATED WITH DOXYCYCLINE 100MG ONE TABLET EVERY 12 HOURS. PT WITH FEVER, NAUSEA OR VOMITING.  ER MD INFORMED PT TO TAKE OTC BENADRYL. S/S IMPROVED SLIGHTLY AND SEEN BY DR. ON 01-15-08.  PAIN, EDEMA, REDNESS, AND RED STREAK TO LEFT BREAST IMPROVED.  DR. INFORMED PT TO D/C DOXYCYCLINE R/T POSSIBLE ALLERGIC REACTION.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) 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) (Intramuscular) 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 CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown. Not Provided          Reporter did not allow further contact
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT, UNSPECIFIED VEIN ACUTE DVT OF LEFT FEMORAL VEIN
painful sensation on her nose; swelling on the left part of the nose; inhaled she feel everything irritated within; malaise; She had her throat dry; This is a spontaneous report from a contactable consumer. This female consumer reported for herself.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number was not reported), dose 1 via an unspecified route of administration on 25Feb2021 as 1 ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 03Mar2021 the patient experienced painful sensation on her nose, swelling on the left part of the nose and it began to drop liquid out of it, she had her throat dry and when she inhaled she feel everything irritated within and also she had malaise. On the day of report (09Mar2021), the patient did not have the symptoms anymore, but her nose ended up a little sensitive. The patient mentioned that she had the same pain on the same side of the nose cartilage. She would like to know if this might be caused by the vaccine. The patient was scheduled to get the second dose on 18Mar. The patient was recovered from the events in Mar2021 where as painful sensation on her nose was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
received a dose of the vaccine past expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine past expiration date) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine past expiration date). On 18-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine past expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter.
Patient found down at home with agonal respirations and per EMS asystole, received 2 rounds of epi at her house with return of spontaneous pulses, lost pulse again in route to ER and another round of epi was given, CPR in progress when arrived at hospital.  Prior to this patient's husband states he heard her fall in the bathroom but did not immediately check on her as he states that this has happened before.  He checked on her 10 min later and that's when he found her unconscious.  Daughter called 911 and she began CPR.  No previous complaints of headache, chest pain, back pain, fever or chills.  Husband states patient was drinking that evening which is not unusual for her.  Patient died at hospital.
onset of drowsiness, fatigue, throbbing h/a, generalized aches & chills, myalgias; no skin rash or urticaria;
had some of the side effects headache; had some of the side effects fever; had some of the side effects shivering; neck ache the night of the shot.; next day my stomach was upset; Slight diarrhea; I noticed a couple bumps / one of my right arm one of my left arm and one on my back below my neck; I noticed a couple bumps that itch; small blister / one was like three little blisters; I must have scratched so they were scabs; shingles; This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced headache, fever, chills, neck pain, upset stomach, diarrhea, vesicular rash, itchy rash, blister, scab and shingles. On an unknown date, the outcome of the headache, fever, chills, neck pain, upset stomach, diarrhea, vesicular rash, itchy rash, blister, scab and shingles were unknown.   It was unknown if the reporter considered the headache, fever, chills, neck pain, upset stomach, diarrhea, vesicular rash, itchy rash, blister, scab and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had headache, fever, shivering and neck ache the night of the shot. The patient also had  upset stomach, diarrhea, couple bumps that itch to little on right arm and left arm and one on back and below neck, small blister scratched so they were scabs. The patient asked is it possible aving a mild chicken pox like outbreak from the shot or these just belittle shingles and asked is this contagious.
Swelling of B hands and feet, macular rash on trunk and exts c/w serum sickness. Treating w/ H2 blocker and corticosteroids.
Developed cancer in right earlobe after first dose; A spontaneous report was received from a consumer concerning himself, a 68 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cancer in right earlobe/neoplasm malignant.  The patient's medical history was not provided by the reporter. Products known to have been used by the patient, within two weeks prior to the event include tacrolimus, metoprolol, losartan, apixaban and vitamins.  On 16 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 16M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.   On an unspecified date after receiving mRNA-1273, the patient developed cancer in his right earlobe. The patient mentioned that he is on immunosuppresants.   Action taken with mRNA -1273 in response to the event was not reported.  Outcome of the event, cancer in the right earlobe was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This case was reported by a pharmacist and described the occurrence of wrong vaccine administered in a 64-year-old female patient who received BOOSTRIX (batch number 4SY79, expiry date May 2016). On 3rd February 2015, the patient received BOOSTRIX. On 3rd February 2015, an unknown time after receiving BOOSTRIX, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown. Additional information: The pharmacist reported that BOOSTRIX was placed in the freezer and accidentally given to the patient instead of ZOSTAVAX. The pharmacist was not aware of any issues that were experienced by the patient.
101 Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (101 Fever) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PYREXIA (101 Fever). At the time of the report, PYREXIA (101 Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication provided by Reporter.  No treatment information provided by Reporter.
Study conducted to determine Ab response to PEDVAXHIB in 30 consecutive premature infants who required supplemental O2 because of chronic lung disease; 6 failed to complete study, 2 died; chronically ill premature infants don't respond as..
This case was reported by a nurse and described the occurrence of expired vaccine used in a 15-year-old patient who received HAVRIX 1440. On an unknown date, the patient received HAVRIX 1440 at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX 1440, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details provided: This was one of the two cases received from the same reporter.
Within 10 minutes of receiving vaccine, Pt c/o abrupt severe H/A 0 SOB 0 hives 0 local reaction.
Patient received first dose of Moderna on 7/6/21.  Patient then received first dose of Pfizer on 7/12/21.
6 inch raised area, with redness, and warm to touch, Patient noted as well having a Fever.
Strong reaction / A week of fever; Strong reaction / A week of / chills; Strong reaction / A week of / body aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, chills and general body pain. On an unknown date, the outcome of the fever, chills and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had  a week of fever, chills and body aches.  The reporter said that because of this the patient might not want to get the second shot.  The reporter asked would only one dose provide any protection against shingles.
3 cm liver enlargement in months following Moderna  2nd dose administered on 02/16/2021
very slight runny nose/Little bit of the drippy nose; tiredness; sneeze; cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious), outcome "unknown", described as "very slight runny nose/Little bit of the drippy nose"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; SNEEZING (non-serious), outcome "unknown", described as "sneeze"; COUGH (non-serious), outcome "unknown", described as "cough".  Additional Information: he was experiencing the signs and symptoms of a very slight runny nose and also tiredness and sometimes he sneeze and cough also. And one of his friend was also experiencing the same signs and symptoms after getting the vaccine. Had all three shots and that the booster shot also. Wanted to know if these are after effects to vaccine.  Follow-up attempts completed. No further information is expected.
Site: Pain at Injection Site-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: RPh was alerted by seatedpatient 10min after injection that she was lightheaded, then patient's head fell back, her arms strongly shook two times Rph went to her but she was unconscious. Rph place her hand on the back of her head for support patients eyes were opn Rph asked if she was ok she then "woke up" a bit dazed gave her apple juice and fan- episode 10 sec
Per nurse "when injecting patient with vaccine, needle was not on syringe appropriately and the majority of the medication was running down patient's arm therefore proper dose was not administered. The patient was informed of the situation. Doctor of the day was notified and advised to administer another full dose. Patient was given another dose of Janssen vaccine."
Nausea and Severe Emesis. Gave patient some meclizine. Patient requested we call EMS.
6/04/14 2:00 PM mom called to say child got up about 7:00 AM today, ate breakfast, then went back to bed at 10:00 AM and slept for next 4 hrs so soundly she didn't hear environmental noises she normally would hear. Aroused, but promptly went to sleep; this uncharacteristic for her. After 5 hrs, she awoke and began to act normally. 6/05/14 Phone call to mom -> acting normally. Child afebrile per mom's history.
Starting at 10:00 AM the next day after being vaccinated I started to get the chills, headache, and extremely fatigued. I checked my temperature and it was 101.3.  The temperature continued into the next morning but did break by Friday.  On Thursday the injection site was very swollen to size of golf ball.  It was hot to the touch. The swelling has gone down but on 1/19/21 the injection spot had hives and was very itchy.  There are no hives as of today 1/20/21.
Woke up at 2:00am with a sore arm and could not lift arm without pain. By 10am had fever, chills and body aches. Alternating Tylenol and Advil for pain and fever
Pt recvd vax on 18MAY92 & pt felt perfectly well until that evening when took allerest; w/in a few ins pt became cold & clammy & said that teeth chattered; also devel nausea & diarrhea;
Information has been received from a registered pharmacist concerning an approximately 5 year old child who on an unspecified date was vaccinated with a 0.5ml dose of ZOSTAVAX (Merck) (lot # 669538/1390Z) (only 0.5ml was given not the 0.65ml) instead of VARIVAX (Merck) in error. The pharmacist stated that this was suppose to be child's second dose of VARIVAX (Merck). Pharmacist stated that the child received the first dose of VARIVAX (Merck) on 23-MAR-2007. No adverse event reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
pt recvd vax & devel 6-cm by 7-cm area of induration at inj site. Seen by MD & tx w/Allegra. Is 1 of 2 pt from this site to have inj site rxn p/vax w/lot# 4978061.
My hands itch a lot/ it's a little each day/ is very itchy for hours/ my arms also itch.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 13:00 (Lot number: EW0171) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing); "known allergies: Nuts" (unspecified if ongoing). Concomitant medication(s) included: METHIMAZOLE; VALSARTAN. Vaccination history included: Bnt162b2 (product: COVID 19, brand: Pfizer, lot number: ER8737, lot unknown: False, administration date: 01Apr2021, administration time: 12:30 PM, dose number: 1, vaccine location: Right arm), administration date: 01Apr2021, when the patient was 62 years old, for COVID-19 Immunisation. The following information was reported: PRURITUS (non-serious) with onset 04May2021, outcome "not recovered", described as "My hands itch a lot/ it's a little each day/ is very itchy for hours/ my arms also itch.". Therapeutic measures were not taken as a result of pruritus. Additional information Covid vaccine details: Lot unknown: False If other vaccine in four weeks: No Other medications in two weeks: Valsartan, Methimazole. The patient did not have Covid prior vaccination. The patient had not Covid tested post vaccination. Adverse events start date: 04May2021   Adverse event: My hands itch a lot. Sometimes it's a little each day. Sometimes is very itchy for hours. Sometimes my arms also itch. Follow-up attempts are completed. No further information is expected.
severe chills. shivering at night for 2 hours. no fever, some aching and malaise. this was  4 days after shot. all previous days was fatigued alittle chilled and arm sore. taking alot of tylenol drinking alot of water. things did not get worse.