chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician for the Pregnancy Registry for HPV vaccine concerning a 15 year old female with no pertinent medical history who on 12-AUG-2008 was vaccinated with the first dose of GARDASIL and ADACEL. At the time of vaccination with  GARDASIL the patient was pregnant. On 02-SEP-2008, the patient came to the gynecologist office for annual physical exam and because she was missed her period, a pelvic ultrasound was performed that revealed a pregnancy of 14 weeks and 2 days. The patient's LMP was 9-JUN-2008 and EDD 16-MAR-2009. No adverse event occurred. Additional information has been received from a nurse concerning the patient. The nurse reported that the patient had a Cesarean section on 13-MAR-2009 and delivered a normal baby with "no problems", who weighed 9lbs, 13 oz. The nurse could not confirm the indication for the Cesarean. "It was possible it was due to the baby's size, but the nurse can't say for sure". The patient came back to the office at 2 weeks and 4 weeks postpartum for incision checks, but did not return for her "regular 6 week postpartum visit". The patient's incision was doing fine at the time and she was recovering from her Cesarean section. Upon internal review, Cesarean section was considered to be an other important medical event. Additional information is not expected.
the vial was initially stored in the refrigerator on 25-Mar-2022 and vaccine was administred on 25-Apr-2022; gave an expired dose of a Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave an expired dose of a Moderna vaccine) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25-Mar-2022 and vaccine was administred on 25-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave an expired dose of a Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25-Mar-2022 and vaccine was administered on 25-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave an expired dose of a Moderna vaccine) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25-Mar-2022 and vaccine was administered on 25-Apr-2022) outcome was unknown.    For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported Dose administered after manufacturer date of expiry. The vial does not undergo any temperature excursions. Treatment information was not reported
Information has been received from a healthcare worker concerning multiple unspecified patients. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates, the patients received doses of improperly stored GARDASIL (lot # K011325 with expire date 08-APR-2017, dosage and route not provided). The conditions storage was 32 F for 240 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PT FAINTED IN THE STORE WHILE SHOPPING WITH HER SPOUSE. PT STATED THAT SHE HAD BLOOD WORK AND HAS NO FOOD THE ENTIRE MORNING.
ER visit for seizure activity that occurred about 845am on 4/16/21.  Diagnosed with febrile seizure. Temperature in ER was 101.3 rectal pulse ox 99% on room air. He was treated with Tylenol and ibuprofen and observed. He was discharged about 12:28pm after no further seizure activity.
Two days post vax pt started crying as if he had colic. Pt was burped and suddenly eyes closed and body went limp. Pt stopped breathing and was taken to the ER.
Vomited and felt light-headed 5 minutes after the vaccine. no fainting.
RAPID DECLINE OF MOTOR SKILLS SINCE LAST OF MARCH. NO LONGER ABLE TO WALK OR STAND, CANNOT RAISE ARMS ABOVE SHOULDERS, SLURRED SPEECH
Chills, body and joint pain, spontaneous dislocation of left hand pinky joint, severve nausea, weakness, insomnia, sinus pain, injection site pain, loss is appetite.
Patient received 0.6 mls of pfizer booster after he got J&J vaccine as his first dose. This was administer based on the report the pharmacist had printed on the CDC website.
p/vax pt exp a varicella like rash approx 3wk p/1st dose;MD indicated indicated that did not see the pt & did not know details;
The pt experienced a localized reaction of welts to the injection site, the size of a silver dollar. Treated with Benadryl.
Received Tdap (ADACEL) 7/9/10 on 7/11/10 noticed quarter sized reddened area where given (L) deltoid.
First, pain at injection site. Then, increasing pain radiating throughout entire arm.  Swelling of entire arm and inability to move fingers wrist etc.  Excruciating pain ("worse than childbirth").  Shaky, near blackout several times, nausea, vomiting mucous. Fever.   Night sweats continue (night of May 3). Pain entirely resolved by May 3. No evidence of lasting disability at this time.
orange patch; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (orange patch) 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 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (orange patch). At the time of the report, SKIN DISCOLOURATION (orange patch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Began feeling achy at 7:00 pm and felt low grade fever.  By about 3:00am I was running a 102.1 fever.  I took Tylenol and the fever slowly came down.  I had body aches and lethargy and ran fever until about 7:00pm the next day, fever took all night and into 1/20/2020 to break the fever.  It fully broke by 10am on 1/20/2020 ( I sweated profusely)
Severe nausea; Vomiting; Diarrhea; Chills; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Apr2021 at 15:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patient had known allergy to nuts. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021, the patient experienced severe nausea and vomiting and diarrhea starting at 09:00, and on the same day the patient also experienced chills. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe nausea, vomiting, diarrhea and chills was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
headache; nausea; Fever 100 degrees; A spontaneous report  was received from a consumer concerning herself a male patient of age 78-years-old received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a headache, nausea and a fever 100 Degrees.  The patient's medical history was not provided. Concomitant medications were not reported by reporter.  On 24 Jan 2021, prior to the onset of the events the patient received his first of two planned doses of mRNA-1273 (lot/batch:030L20A) intramuscularly for prophylaxis of COVID-19 infection.   After vaccination he experienced headache, nausea and a fever 100 Degrees and   want to know whether he can take Tylenol, but he said he is feeling better now.  Action taken with mRNA-1273 in response to the events was unknown.   On unknown date the outcome of event(s), headache, nausea and a fever 100 Degrees was resolve
Patient has headaches resulting from MVA that took place May 2013 yet approx a wk and a half after vaccine headaches became worse and had all over body itching also.  The itching has resolved yet still has headaches managed with meds.
Pt given Tdap within 30 sec. pt. stated she didn't "feel" good. Within 2 min. passed out and had petit grand mal seizure. EMS arrived. Pt had another syncopal episode and seizure. Medics took to hospital.
syncope & very short episode of tonic-clonic movements lasting about 10 seconds; occurred about 1 minute p/vax; did well afterwards;
The COVID-19 Moderna Bivalent adult dose (0.5 ml) was administered to an 8 year old patient instead of the reduced dose (0.25 ml)
covid; covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "kidney stone" (unspecified if ongoing), notes: kidney stone in the past; "handicapped" (unspecified if ongoing), notes: left side weak (handicapped); "asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: need to watch for high blood pressure; "Grape Allergy" (unspecified if ongoing); "Pork allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "covid".  Clinical course: Patient didn't received other medication in 2 weeks. Adverse Event: Strong Stomach pain with hard time with bowel movement. Urine color bit dark even when drinking a lot water and color of poop is bit light. Adverse event start date: 01Jun2022. If patient recovered: Not Recovered. If treatment ae: No  No follow-up attempts are possible. No further information is expected.
Tested positive on 01/29/2021. Asymptomatic and tested positive again on 05/04/2021 was being tested for a surgical procedure.
No reactions.  Patient was inadvertently given varivax instead of Prevnar.  Mother notified on 03/23/2006 when mistake was discovered. Follow-up Information 19-APR-2006: To date, there has been no adverse reaction. There was an error in vaccine administration. Pt. inadvertently received Varivax at age 4 months.
HIGH FEVER 103+/EXTREME BODY ACHES FEVER BEGAN LESS THAN 24 HOURS AFTER INJECTION AND LASTED FOR APPROXIMATELY THREE DAYS. BODY ACHES SUBSIDED AFTER TWO DAYS. OVERALL FEELING OF TIREDNESS/ACHES THROUGHOUT BODY RASH AT AND AROUND INJECTION SITE/FELT WARM TO TOUCH FOR APPROXIMATELY FOUR DAYS AFTER INJECTION. I AM NOT SURE WHICH TYPE OF PNEUMOCOCCAL CONJUGATE VACCINE I RECEIVED AT THE OFFICE.  I AM GUESSING IT WAS THE PREVNAR 13 DUE TO MY ASTHAMA. I CALLED MY DOCTOR THE NEXT DAY AND ADVISED OF MY CONDITION.
tested positive result for Covid-19; Felt sick; Loss of Taste; Stuffy Nose; Congested Sinuses; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021. The most recent information was received on 03-Aug-2021 and was forwarded to Moderna on 04-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt sick), AGEUSIA (Loss of Taste), NASAL CONGESTION (Stuffy Nose), SINUS CONGESTION (Congested Sinuses) and COVID-19 (tested positive result for Covid-19) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced ILLNESS (Felt sick), AGEUSIA (Loss of Taste), NASAL CONGESTION (Stuffy Nose) and SINUS CONGESTION (Congested Sinuses). On an unknown date, the patient experienced COVID-19 (tested positive result for Covid-19). At the time of the report, ILLNESS (Felt sick), AGEUSIA (Loss of Taste), NASAL CONGESTION (Stuffy Nose) and SINUS CONGESTION (Congested Sinuses) was resolving and COVID-19 (tested positive result for Covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant F/U received : Lab data and additional event and event outcome are updated. 2nd dose information added.
virus in the mouth; This is a spontaneous report received from a contactable consumer (reporting for herself) via sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiry date not reported), via an unspecified route of administration on 18Jan2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient had the first dose of Covid 19 Vaccine 18Jan2021. and second dose was scheduled for 08Feb2021 and on the 30Jan2021 (Saturday), she experienced a problem with her mouth. Went to find out what was the problem, Dentist said that it was some kind of a virus in the mouth and it will clear up by itself and no medications needed, but the Caller (patient) was just letting us know about this situation because she really wants to take the second dose on the 08Feb2021. She was feeling good and no side effects just like what they read in the fact sheet. She was worried because there are enough doses left in their facility. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
henoch-Schonlein purpura; hospitalized for 5 days; sx started as extremely painful & swollen thigh w/ankle & test swelling; observed overnight, then discharged only to present w/purpuric rash which eventually coaleses into bruses;
Evening of immunization of varicella about 11PM noticed area burning. Woke up 10/22/02, hard reddened area; applied heat and felt better, but still hardened and reddened. 10/23/02 returned to clinic; area 2"x3" still hardened and slightly reddened.
developed flu-like symptoms after two weeks. Nausea. Loss of appetite. Wife admitted for renal failure. Patient admitted for acute on chronic heart failure. Now with gouty arthritis. Patient states it?s too much of a coincidence. They will not take another dose.
The day of receiving vax pt developed an injection site reaction characterized by burning, swelling, itching and warmth extending from clavicle area to antecubital. On 11/27/00 he was seen by MD and treated with cephalexin and loratadine. The pt had previously recvd an injection of Pnu-Imune-23 in 1994. This is 1 of 4 pts from this facility who had an adverse experience following receipt of 2 different lots of Pnu-Imune 23. Follow-up info recvd on 3/27/01 from the MD indicated that the pt recovered.
5 minutes following vaccine administration, developed itchy throat, which of 2 hour duration. Resolved without treatment.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (felt a pain/sensation from the top of his right arm to his right elbow) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011A21A) for COVID-19 immunization. Concomitant products included amlodipine, lisinopril and atenolol for an unknown indication. On Feb 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 26, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 26, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced pain in extremity (felt a pain/sensation from the top of his right arm to his right elbow). On Mar 31, 2021, pain in extremity (felt a pain/sensation from the top of his right arm to his right elbow) resolved. Treatment details not reported. This case linked to MOD-2021-070694 (patient link).
Long term pain in hips, joint pain and loss of mobility. (2nd Lymerix given on 9/10/99 and 3rd on 10/10/99).
about an hour after the vaccine I was feeling little dizzy and extreme fatigue. the following day i felt extreme tiredness and fell asleep after lunch. I  had dreams that were very short and back to back for only about a 20 min.  period  and this was on 3/26/2021 around 1:00 pm. I then woke in a panic gasping for air and quickly snapped out of it. I have had a Lingering headache since then.
First nausea starting on 5/14, then vomiting, then itching (5/23). Presented first to PCP, then to ER and subsequently admitted.
Information has been received on 08DEC2014 from a physician regarding a patient (gender not reported). The physician reported the patient received two doses of PNEUMOVAX 23 on unspecified dates, before age 65 years. This statement was unable to be further clarified. Physician additionally stated he knew of other unspecified physicians who routinely vaccinated their unspecified patients over 65 years with PNEUMOVAX 23 (every 5 years, regardless of their situation (see MARRS # 1412USA004604). No adverse effect reported. No additional information provided. Physician needed to disconnect call before AE collection was initiated, therefore all fields are NA. Additional information has been requested.
headache; body aches; sore arm; symptoms of L hand randomly jerking to were I could not hold my cell phon; visual abnormalities where my field of vision would shift; Vaccination was my third (booster); Vaccination was my third (booster); This is a spontaneous report from a contactable other hcp (patient). A 75-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FE3592), via an unspecified route of administration, administered in Arm Left on 11Sep2021 14:30 (at the age of 75-year-old) as dose 3, single for covid-19 immunisation. Medical history included connective tissue disorder from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration, on an unspecified date as dose 1, single and dose 2, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Sep2021, the patient experienced vaccination was my third. On 11Sep2021 21:00, patient experienced headache, body aches, sore arm, symptoms of l hand randomly jerking to were i could not hold cell phone, visual abnormalities where my field of vision would shift. Within 2-3 days, all symptoms were gone or reduced. No treatment was taken as a result of events. The outcome of the events headache, body aches, sore arm, symptoms of l hand randomly jerking to were i could not hold cell phone, visual abnormalities where my field of vision would shift was recovered on an unspecified date in Sep2021.   Follow-up attempts are completed. No further information is expected.
Immediately felt pain and burning at site and felt like nerve endings were on edge. Approx. 1 hour later, did not feel well and noticed her cheeks and upper neck were bright red and blotchy. Chest felt tight and had to use accessory muscles to breathe. BP 150/88, HR 109. Treated in ER with Solu-Medrol IV and Pepcid IV and given a prescription for Pepcid po and Medrol dose pack to take when discharged from the ER.
Initial report received from a healthcare professional on 08 December 2008. an adult female patient (age not reported) received a first intramuscular deltoid injection of ADACEL (lot number C3027BA) on 23 September 2008 and the following day, she developed a local reaction described as swelling, low grade fever and sore arm. No diagnostic tests or lab data were performed. The patient received treatment symptomatically and recovered. No additional details were reported. Follow-up information received 09 February 2009 from a health care professional. ADACEL had been administered in the patient's left deltoid. The injection site swelling was approximately one inch and the low grade fever approximately 100 degrees. the patient had no illness at the tome of vaccination and according to the reporter, the events resolved in five days. This patient's case was created as the result of follow-up received for a cluster of six patients. The other five patients were also identified and are recorded in cases 2008-02996, 2008-03924, 2008-03923, 2008-03926 and 2008-03927, all from the same reporter. Documents held by sender: None.
Person had a fever of 102.4, pulse rate of 118, he was non-responsive with edema of the right calf & ankle this morning when he was assessed.
Sleepy (After Second Vaccine); Body Aches (After Second Vaccine); Sore Left Arm (After Second Vaccine); Memory Pain in the Right Arm (After Second Vaccine); Muscle Aches (After Second Vaccine); Hip joint pain (After Second Vaccine); Chills (After Second Vaccine); Headache (After Second Vaccine); This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy (After Second Vaccine)), PAIN (Body Aches (After Second Vaccine)), PAIN (Sore Left Arm (After Second Vaccine)), PAIN IN EXTREMITY (Memory Pain in the Right Arm (After Second Vaccine)) and MYALGIA (Muscle Aches (After Second Vaccine)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced SOMNOLENCE (Sleepy (After Second Vaccine)), PAIN (Body Aches (After Second Vaccine)), PAIN (Sore Left Arm (After Second Vaccine)), PAIN IN EXTREMITY (Memory Pain in the Right Arm (After Second Vaccine)), MYALGIA (Muscle Aches (After Second Vaccine)), ARTHRALGIA (Hip joint pain (After Second Vaccine)), CHILLS (Chills (After Second Vaccine)) and HEADACHE (Headache (After Second Vaccine)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 30-Apr-2021, CHILLS (Chills (After Second Vaccine)) had resolved. On 01-May-2021, SOMNOLENCE (Sleepy (After Second Vaccine)), PAIN (Body Aches (After Second Vaccine)), PAIN (Sore Left Arm (After Second Vaccine)), PAIN IN EXTREMITY (Memory Pain in the Right Arm (After Second Vaccine)), MYALGIA (Muscle Aches (After Second Vaccine)), ARTHRALGIA (Hip joint pain (After Second Vaccine)) and HEADACHE (Headache (After Second Vaccine)) had resolved.            No concomitant details were provided