chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ABOUT 15 MINUTES AFTER HER INJECTION, PT HAD SOME REDNESS AND ITCHING IN THE CREASE OF HER LEFT  ELBOW WHERE HER ARM BRACE WAS RUBBING.  WE CONTINUED TO MONITOR PATIENT AND ADMINISTERED A BENADRYL CAPSULE AT 11:59AM SINCE ITCHING CONTINUED AND SHE HAD MORE ITCHING ON RIGHT SIDE OF CHEST BELOW COLLAR BONE.   AT 12:05PM PATIENT INDICATED THE ITCHING WAS STARTING TO SUBSIDE.  WE CONTINUED TO MONITOR PATIENT FOR ANOTHER 45 MINUTES.  SHE INDICATED THE ITCHING WAS GOING AWAY AND THE REDNESS ON HER LEFT ELBOW CREASE WAS ALSO SUBSIDING.  WE INDICATED WE COULD CALL 911 FOR THE PATIENT BUT SHE DECLINED.  PATIENT INDICATED NO SHORTNESS OF BREATH AND NO SWELLING OF THE MOUTH, FACE, OR THROAT.  WE CALLED HER DOCTOR'S OFFICE AND THEY SCHEDULED A SAME DAY APPOINTMENT FOR HER.  PATIENT LEFT THE STORE AT 12:54PM AND INDICATED SHE HAD SOMEONE TO CONTINUE MONITORING HER UNTIL HER DOCTOR'S APPOINTMENT.
Fatique, joint pain, tunnel vision, memory fog. Bad tunnel vision (4 by 4 range) Severe memory fog (called doctor) Bad word recall, poor eye hand cordnation, poor cordnation, balance. 6/23/2021 went back to work, had trouble walk and stacking crates. Very tired, severe joint point. Had to leave work.  Felt disoriented
Pain in arm and unable to use arm.Went to my primary care physician who referred me to orthopedic doctor.Dr did steroid injection and i have had no more pain since then .
Heart rate and b/p extremely high, chills, chest tightness, headache, blurred vision, muscle weakness and dry cough and fatigue. It's been a week still has fatigue. Second booster. 4th shot.
Information has been received from a health professional concerning a female who on an unspecified date was vaccinated intramuscularly with her first dose of GARDASIL (Lot # not provided).  After receiving the vaccination, the patient "broke out in hives all over her body and had to be taken to the ER."  Specific information regarding the ER visit were not provided.  The reporter indicated that laboratory tests were performed; however, no specifics were provided.  On an unspecified date, the patient recovered from hives all over her body.  No additional information was provided.  Additional information has been requested.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients. On an unspecified date in 2012, the patient was vaccinated (route not provided) with GARDASIL dose 2 (lot number and expiry date not provided). The Licensed Practical Nurse reported that since an unspecified date in 2012, an unspecified number of patients were administered the second and third dose in the GARDASIL series later than the recommendation in the prescribing information. No adverse effects were reported. The outcome of administered the second and third doses in the GARDASIL series later than the recommendation in the prescribing information and no adverse effects is unknown. The reporter considered administered the second and third doses in the GARDASIL series later than recommendation in the prescribing information and no adverse effects to be not related to GARDASIL. Additional information has been requested.
Accidentally administered Pfizer vaccine as the second dose to the pt who got Moderna vaccine for the first dose on 08/11/2022.
No adverse event; GARDASIL 9 was administered to a patient in error instead of a flu shot from an unknown manufacturer; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapies details were not reported.  On 15-DEC-2022, the patient was vaccinated in error with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #W010661, expiration date: 19-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) instead of a flu shot vaccine of unknown manufacturer (Wrong product administered). No symptomatic side effect were reported. No additional adverse event or product quality complaint was reported.
Day after injection I had a 2-3 inch diameter swelling and redness near the injection. The swelling continued to increase in size toward my wrist and the whole arm began hurting. The swelling is still present and affects movement of my arm.
covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis.     The patient's past medical history included Chronic kidney disease stage 2 since an unknown date. Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (Lot: DIU20A) on 15-Jan-2021, COVID-19 VACCINE on 12-Feb-2021, COVID-19 VACCINE (Lot: 031D21A) on 21-Oct-2021, COVID-19 VACCINE (Lot: 0833214) on 29-Mar-2022 and Influenza. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE and Influenza.    On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Dec-2022,  after starting , the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Patient had symptoms like, sore throat, cough and runny nose.  No treatment information provided.
Mom reports on 10/26/09 that child started having sharp pains in head 1 day after receiving FLUMIST. States pains are sharp, cause him to abruptly stop activity. Has to lie down when pain occurs. Also had pain in legs for 2-3 days, but this has subsided. Pain in head continues. Advised see PCP.
Temperature 102.3, shaking, body aches, headache, weakness, fatigue. Rash and bruise at insertion site.
Patient stated that she is having sharp pain when she moves her arm, and numbness on arm and weird feeling on fingers , decreased range of motion.  Symptoms on fingers 4 & 5.  Recommended to see orthopedic surgeon and neurologist.
A serious post-marketed study report of dehydration, pneumonia and acute gastroenteritis has been received from a study investigator concerning a 36-month old female subject, patient ID 43450393, participating in a post marketing study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this subject. The subject received FLUMIST on 14-Dec-2007. On 09-Jan-2008, the subject was hospitalized for dehydration, pneumonia and acute gastroenteritis. The outcome is unknown. The investigator assessed the events of dehydration, pneumonia and acute gastroenteritis as not related to FLUMIST. The sponsor assessed the relationship of the events of FLUMIST as not related.
6 days after receiving the vaccine patient started having mouth problems, loss of taste and smell. Also had vision changes.
This spontaneous report was received from a physician, via company representative, regarding a 20 year old white female patient. The patient's medical history, concurrent conditions, or concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, lot number and expiration date were not reported) for prophylaxis. In approximately January 2017 (reported as "after the shot, about 2 months ago"), the patient presented with persistent low blood pressure. At the time of reporting, she was on an unspecified medication to keep her blood pressure up. The outcome of the event was unknown at the reporting time. The reporter did not provide a causality assessment between hypotension and the suspect therapy. Additional information has been requested.
Dizziness at first.  Warm red enlarged knot at injection site for 4 days now.  Next day fever, chills and fatigue
Dilated cardiomyopathy- right ventricle. CAUSED DEATH!!!!  Complained of a headache and tired two hours prior.
Approximately 1 week after getting the shot, the patient experienced a red, swollen, itchy arm.  Consulted with her doctor who then prescribed Keflex for Cellulitis
Systemic: Fainting / Unresponsive-Medium, Systemic: pt reported hurting ankle while getting up-Medium, Additional Details: On 03/31/2021 pt waa given covid vaccine by Technician at 12:11 pm, pt was seated in chair, fainted and rolled out of chair, pt reported twisting ankle when attempting to get up. Technician tended to pt until pt was well enough to leave the pharmacy on her own accord. After pt left Technician reported to Pharmacist, was told pt fainted but felt fine enough to leave. On 04/05 pt called store manager to report that she suffered from a broken wrist ankle and rib.
Information has been received from a nurse concerning a 23 year old female with a history of vaginal infection (treated for this in August 2007) and no drug reactions/allergies who 08-MAR-2007 was vaccinated with a first dose of GARDASIL (lot# unknown) 0.5mL IM. Concomitant therapy included hormonal contraceptives (unspecified). On 10-MAy-2007 the patient was vaccinated with a second dose of GARDASIL 0.5mL IM. There were no adverse events noted with the first and second dose. On 10-SEP-2007 the patient was vaccinated with third dose of GARDASIL (lot# 658558/1061U) 0.5mL IM. On 11-SEP-2007 the patient called the office and stated that in early AM she developed chills, fever and general aches. Medical attention was sought via phone. The patient's chills and fever and general aches persisted. no additional information at this time. Additional information has been requested.
Woke up with full body ache; Headache; Chills; A temp of 100.By 11:00am fever was up to 103.1, Fever went down around10pm, and was at 100.2 at 8am the following morning, which is today.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729), via an unspecified route of administration in the right arm on 07Apr2021 at 13:00 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease. The patient did not have any allergies to medications, food, or other products. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), tiotropium bromide monohydrate (SPIRIVA) and formoterol fumarate (SYMBICORT); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the right arm on 17Mar2021 at 13:00 (at the age of 43-years-old), as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 07:00, the patient woke up with full body ache, headache, chills and a temp of 100. By 11:00 fever was up to 103.1, pulse was steady at 115 beats per minute (bpm), and at one point the patient's blood o2  level was down to 91% and  fever went down around 22:00. On 09Apr2021 at 08:00, the following morning, the fever was at 100.2. At the time of reporting symptoms were improving, just a headache lingered. Therapeutic measures were not taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 08Apr2021 at 07:00, the  patient underwent lab test and procedure which included body temperature and result was shown as 100, on the same day at 11:00, the body temperature was shown as 103.1. On 08Apr2021, the  patient underwent lab test and procedure which included pulse rate, blood o2 level and results were shown as 115 bpm and 91% respectively. On 09Apr2021 at 08:00, the  patient underwent lab test and procedure which included body temperature and result was shown as 100.2. The clinical outcome of the events full body ache, headache, chills and fever were resolving at the time of reporting.   No follow-up attempts are needed. No further information is expected.
PATIENT RECEIVED THE SECOND VACINE ON DAY 23 NOT DAY 28     IT WAS 5 DAYS TOO EARLY.... THIS WAS DONE BY ACCIDENT
Patient received vaccine on 2/25/2021 from local health department clinic and presented to this reporter's facility ED on 02/26/2021 with generalized fatigue and body aches.
@ 3PM woke up screaming & scream unconsolable for 2 hrs; rt leg swollen to ankle, reddened & orange colored mom re ports; temp not taken-temp 11AM 24JUN 97.2;
Baby was babbling and starting to put together CVC sounds before MMR vaccine. Within two days he stopped at sounds. Evaluation at 18 months by county eating intervention program put him at the speech level of a 9 month old. Speech therapy begin at approximately 18 months, still working hard to regain speech.
Pt was diagnosed with full blown varicella, subsequent to receiving one dose of varicella virus vaccine live. Pt experienced a head to toe pruritic rash and a low grade fever.  Pts sibling had a similar experience.
after receiving vaccine on Wednesday 4/21, got positive pregnancy test on Saturday 4/24, 1 day after missed period. Estimated due date was 12/31/21. Began spotting on May 1 - approx 5 weeks pregnant. Spotted brown/pink with some clots until May 5, when I started lightly bleeding red.  Beta tests on May 5 and May 7 showed 6228.7 and 6529.0, respectively.  May 10 went in for viability scan - ultrasound showed gestational sac with 2 yolk sacs and 2 fetal poles, one measuring at 6 weeks and other measuring at 6w1d. No sign of misscarriage, no reason for bleeding was seen on the scan. Scan was perfect on paper. Bleeding picked up after scan and I lost the pregnancy on May 11 around 4:30pm. Bleeding continued for one week and HCG levels were low enough to show a negative test at my followup appointment 2 weeks later on May 26.
erythema and itching in both antecubital fossae extending superiorly and inferiorly on arms and forearms. Sensation of chest heaviness, light-headedness.  Treated with 25 mg po benadryl with resolution of itching and near dissipation of rash within 30 minutes.  Light-headedness responded to oral water.
That night I had an extremely fast and strong heart beat, unlike anything I have ever experienced. I couldn't calm it by deep breathing, relaxation exercises, or any method that usually helps calm a fast heart beat. It lasted for several hours, from around 11:30 p.m. to 3 a.m. My arm, back, and chest were also very sore (although they had been fine earlier in the day).
Approximately a week following the first injection, I developed soreness, itchiness, and a large red swelling around the injection site on my arm.  Area was approximately 6 long and 4 inches wide, warm to the touch and slightly swollen.  It was not too bothersome.
4 days following injection sore throat began. 6 days later fever began and continued for 10 days. 2 days into fever and 8 days from vaccination, fever spiked to 103.8.  Malaise, bilateral neck lymphadenopathy, shaking chills, loss of appetite and weight loss throughout the time of illness.
Since about 5 days after the second vaccine shot I have had heart inflammation.  Treating with ibuprofen.  At this point I have had it for 2 weeks.  When the ibuprofen wears off I can feel my heart pounding and I start to have chest pains.
Patient missed their 2nd dose; This case was reported by a other health professional and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (First dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. The reporter wanted to know if the patient missed their 2nd dose, whether he/she should restart the series of vaccination. The reporter consented to follow up.
vomiting; Diarrhea; Nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the right arm on 23Jan2021 16:00 at a single dose for COVID-19 immunization. The patient had no medical history. Concomitant medications included sea moss gel and elderberry syrup received within 2 weeks of vaccination. On 23Jan2021 07:00 PM, the patient experienced vomiting, diarrhea and nausea. No treatment was received for the events. There were no other vaccines administered on same date of Pfizer suspect. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was recovering.   Information on the Lot/Batch number has been requested.
STEMI; This is a spontaneous report from a contactable healthcare professional. An 80-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), intramuscularly, administered in the left arm on 29Mar2021 13:30 (at the age of 80 years old) at a single dose for COVID-19 immunization. Medical history included hypertension, hyperlipidemia, asthma, chronic kidney disease (CKD) 3, all from an unknown date and unknown if ongoing. Concomitant medications included tamsulosin, amlodipine, doxazosin mesilate (CARDURA), albuterol [salbutamol], umeclidinium bromide (INCRUSE ELLIPTA) atorvastatin (LIPITOR) and montelukast sodium (SINGULAIR), all taken for an unspecified indication, start and stop date were not reported. The patient previously took enalapril and augmentin [amoxicillin; clavulanic acid] and experienced allergies with both. The patient previously received first dose of BNT162B2 (lot number and expiry date were not reported), intramuscularly, administered in the left arm on 05Mar2021 13:00 (at the age of 80 years old) at a single dose for COVID-19 immunization. The patient experienced ST-elevation myocardial infarction (STEMI) on 31Mar2021. The event was reported to have resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization (also reported as number of days hospitalization: 0; pending clarification) and was reported as life threatening. Treatment included cardiac catheterization. There was no other vaccine in four weeks.  It was unknown if the patient had COVID prior vaccination and was not COVID tested post vaccination. The outcome of the event was recovering.  Information on the batch/lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pruritus, tenderness, 3 papules at injection site-left outer upper arm. Erythema also noted. One papule noted right forearm. Papules noted above lip.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX injection (dose, route of administration, anatomical location, lot # and expiry date were not specified). On an unknown date, the patient developed necrotizing fasciitis. The infection did not develop at the injection site. The patient sought medical attention and visited the physician's office on an unspecified date. Product quality complaint (PQC) was not involved. The outcome of the event was unknown. The reporter did not provide the causality assessment between the event and ZOSTAVAX. Upon internal review, the event of necrotizing fasciitis was determined to be medically significant. Additional information is not expected as there was no consent for further contact.
Near syncope with altered mental status.  Student vaccinated as part of meningococcal carriage study in high school gymnasium.  Student was standing in line~15 minutes after vaccination and became very pale and dizzy.  She was assisted to a mat and positioned supine with legs elevated.  Vital signs were normal.  She was awake and responsive but seemed to have slowed mentation and flat affect for ~20 minutes, after which spontaneous conversation returned.
Had finished me struck period the week prior to second shot. Day after second re-started menstrual period, and still bleeding today. Also noticed bleeding gums and bloody noses shortly after second vaccine. (Have never experienced these prior to second vaccine)
Patient called the day after immunization and stated her arm was sore. She has trouble moving her arm. She was going to call the Dr. and try to keep moving her arm.
Patient felt shortness of breath and "tingling", he then drove to urgent care and from there he was treated and then taken to Hospital by ambulance.
Diffuse myalgia and muscle weakness, worst in bilat hips and lower extremities beginning 1 wk post-vaccination; pt. subsequently also complained of short term memory loss which persists.
On day of vaccination I had a low grade fever of 99.6. Day 2 my arm was very painful, not like a normal pain after a shot. Day 8 I have developed a red, welted looking rash that is very itchy and painful to the touch. I searched it on the internet and I believe it may be "COVID Arm".
Case number PHHY2011US62732 is an initial spontaneous report received from a nurse on 12 Jul 2011. This report refers to an 11 year old boy. He was vaccinated with MENVEO (batch number: M10030) 0.5 ml, intramuscularly on 12 Jul 2011. However, the patient received only the Men CYW-135 liquid conjugate without reconstituting it with Men A powder conjugate. No adverse event was reported following this drug administration error.