chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mononucleosis; This is a spontaneous  report from a contactable consumer.   A 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced mononucleosis on an unspecified date with outcome of unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received 2 vaccinations left thigh and then right thigh. patient tolerated injection well.  After about 5 minutes, mom tried to get patient to stand up off the floor and noticed that patient looked pale.  At this time it was also noticed that patient's feet were weak like pt did not want to stand but I think that is when she began to have a reaction.  Mom picked up patient informed me patient looks pale, I had her bring pt over to injection table while mom was laying pt down pt went limp in her hands and eyes closed like she had passed out.  Lips were blueish in color as well.  This all happened approx at 1020 AM.  MD and RN were informed they came, oxygen per mask at 6 liters was administered to the patient, vitals taken at which time patient seemed to being going in and out of sleep/consciousness. she was unresponsive for about one minute.  then she recovered but was still cyanotic around her lips and pale for several minutes after that.   patient slowly pinked up and po2 was at 100 this entire time.  911 was called for patient and patient was transported to E.R.
Child received Hib in left thigh at an angle and a DTaP in right thigh. Had to restrict child - child moved and needle cam out. Area red, hot to touch and swelling.
This spontaneous report was received from a physician via a company representative and refers to a 66 year old female patient. The patient's medical history included fibromyalgia (reported as fibromyalgiam) and gastric bypass surgery. No drug reactions or allergies were reported. On 17-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not provided). Concomitant therapies included tramadol hydrochloride, SYNTHROI, fluticasone and duloxetine hydrochloride (also reported as "diloxiton"). On an unknown date in September 2015, the patient had a headache, both eyes swollen, right eye swollen shut, redness and swelling at injection site. The patient received BENADRYL, ZYRTEC (also reported as zyrtedc) and cold compresses to the eyes as the treatment for the events. The patient recovered on 29-SEP-2015. The patient sought medical attention. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Vaccine given at 4:30pm. Patient first states that her arm is numb; then she starts saying she is having trouble swallowing. Patient did not look like she was having difficulty breathing and no visible swelling. Gauze 25mg BENADRYL. Still no relief. Decided to call 911 at 5:00 pm. Patient returned to pharmacy at 7:30 w/2 scripts for prednisone and BENADRYL.
Information has been received from ah health professional concerning a 14 year old female who on 22-AUG-2007 was vaccinated with her second SC dose of varicella virus vaccine live (Oka/Merck) (lot # 658052/1008U) in the left arm. On 24-AUG-2007, the patient developed muscle aching, redness, bruising and mild swelling. No medical attention was sought. The patient's recovery status was unknown. Additional information has been requested.
Patient received 1st dose of Moderna  Covid  19 Vaccine on 06/24/2021,  Follow up appointment made for 2nd dose of Moderna  Covid  19 vaccine  on  07/22/2021 but Patient  presented too early for her second dose on 07/16/21 which was not caught. Patient received 2nd dose of Moderna Covid Vaccine on 06/16/2021.  No apparent injury or adverse reaction noted.
Mild injection site soreness; General Malaise; received both doses of the BNT162b2 SARS-CoV-2 vaccine at 29 0/7 weeks' and 32 0/7 weeks' gestation; This is a literature report.  This is a report of a 33-year-old physician who received both doses of the BNT162b2 SARS-CoV-2 vaccine at 29 0/7 weeks' and 32 0/7 weeks' gestation, respectively. She tolerated both doses well with only mild injection site soreness and general malaise with each. She had spontaneous labor at 38 5/7 weeks and delivered a healthy male infant with positive IgG SARS-CoV-2 antibodies in the umbilical vein blood sample at the time of birth. The mother also had IgG SARS-CoV-2 antibodies confirmed at the time of birth. She is healthy with no prior medical conditions and one prior term birth. There was no evidence of prior SARS-CoV-2 infection in the mother who had a negative SARS-CoV-2 IgG antibody test before vaccination, and two negative nasal swab PCR tests including one prenatally and at the time of delivery. Lab test included SARS-CoV-2 PCR (Maternal nasal swab) at 4 weeks' prenatal was negative; SARS-CoV-2 IgG (Maternal venous) at 12 weeks' gestation was negative; SARS-CoV-2 PCR (Maternal nasal swab) at 38 weeks' gestation was negative; SARS-CoV-2 IgG (Umbilical vein) at delivery was positive; SARS-CoV-2 IgG (Maternal venous) at delivery was positive.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 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.
Pt. mom called MD evening of 6/15 reports "involuntary shaking" x "few seconds" followed by "lethargy". T: 100 degrees. Same episode of shaking for a few seconds again on 6/16. Pt generally fussy and T 100 degrees until 6/18. Rash on neck noted 6/18 and increased rash on face and trunk and arms. Rash "rosacea-like" (pink M-P rash) seen by MD 6/19.
Patient was given 0.2mL of the adolescent Pfizer vaccine, instead of the 0.2 mL of the pediatric Pfizer vaccine that she should have received. Nurse was consulted. Additional safety measures have been taken so that this error does not occur again. Patient's mom was called on 11-23-21 to notify her of error and possible side effects to watch for. Patient's mom was also called on 11-24-21 to check on status of patient and mom stated patient had a sore arm but no other symptoms were reported.  No adverse effects reported at this time.
his arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (his arm was a little sore) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (his arm was a little sore). At the time of the report, VACCINATION SITE PAIN (his arm was a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication provided. no concomitant medication provided by reporter.   Reporter did not allow further contact
erythema; pain; swelling; This case was reported by a nurse via call center representative and described the occurrence of erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number KR7G2, expiry date 2nd June 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced erythema, pain and swelling. On an unknown date, the outcome of the erythema, pain and swelling were unknown.   It was unknown if the reporter considered the erythema, pain and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient experienced erythema, pain and swelling after getting a Shingrix vaccine.
Patient experienced shivers at night, she was too weak to sit up in bed, she was unable to reach for her lamp to turn the light on, she could not get out of bed, and she was fatigued for a week. She reported being too weak to get up at night to go to the restroom.
Started feeling funny, tightness in chest, numbness in face, light headed with visual changes. Then progressed to feelings of passing out.
Pt recvd 3 Engerix-B vax doses, 31AUG89, 9NOV89, 20FEB90 following these titer was neg; 4th dose vax given on 24APR91;
Per ED physician note (1/13/2022): Signs and symptoms seem most consistent with likely COVID-pneumonia. Patient appeared to be an excellent candidate for home O2 therapy and ongoing dexamethasone. While the chest x-ray showed streaky opacities, this is consistent with her COVID-19 diagnosis and does not appear to be a clear indication for admission at this time.  Patient was observed for more than an hour on her home oxygen without increased work of breathing, change in her respiratory status or desaturation events. Unfortunately, monoclonal antibody therapy has not shown to be effective with Omicron and is no longer accessible for patient. We discussed the above findings as well as ongoing management of COVID-19 symptoms and home oxygen use.  There does not appear to be any other indication for admission at this time. Patient appeared safe for discharge. We reviewed strict return precautions and follow-up options. At this point, we will plan for discharge home.
FEVER x 3 DAYS. INSOMNIA x 5 DAYS. REPORTED SIGNIFICANT PAIN AND INFLAMMATION IN THE JOINTS x 6 WEEKS.  SWELLING AND PAIN AFFECTED SHOULDERS, ELBOWS, WRISTS, FINGERS, HIPS, KNEES, ANKLES, NECK, ALONG THE SPINE, AND EVEN TOES.  PATIENT REPORTS WORST IN THE LT ARM, SHOULDER, TRICEPS, ELBOW, FOOT LT, AND BI-LATERALLY WITH HIS HANDS.  THE HANDS STILL PRESENTED WITH MILD EDEMA AND APPEARED SWOLLEN UPON INITIAL SIGHTING. THE PATIENT REPORTS THE PAIN AND SWELLING OF HIS JOINTS HAD PREVENTED HIM FROM EXCERCISING SINCE THE VACCINATIONS WERE RECIEVED.  ATTEMPTS TO EXCERCISE CAUSED HIM GREAT PHYSICAL DISCOMFORT AND PAIN IN THE JOINTS WHICH CAUSED CONTINUED PAIN AND INCREASED SWELLING INTO THE FOLLOWING DAY ACCORDING TO THE PATIENT.
Patient states that the area has felt sore since the vaccination, thrombing pain shoulder down to elbow. Worst at night, a deep tissue pain. Pt states "bone on bone."
On Day 9 after receiving the vaccine, I developed hives around the injection site. The affected area was approximately 4" diameter. The skin was raised with red  blisters that were extremely itchy.  The injection site also became tender to touch, as it did the first 36 hours after receiving the shot. I thought it strange to have a reaction so long after the initial shot.  I used anti-itch lotion and the hives   subsided completely in 3 days. I did not take any oral medication because I take several medications for Parkinson's and related conditions. I did not want to chance  another reaction.
Patient was given moderna vaccine on 8/6/22 by another health care facility.  He was then given pfizer by our office on 9/29/22. Parents in office today requesting third dose as recommended by pfizer.  No adverse side effects noted in our office.
About a month after 2nd vacine started to get headaches, light headed, dizzyness, with diarrhea.  Lated for about 10 minutes.  occured several time a day.  When getting up from a chair became dizzy and lightheaded. Currently waiting for doctor exam.
Pain and redness in the thigh following vaccination with Td toxoid. Severe pain and swelling of injections site on the following day. Rx Aleve, Tylenol. Swelling eventually subsided.
Injection site became red, warm, itchy, and swollen on 02/02 at night. On 02/03 the redness and puffiness went down but is still warm and slightly tender.
02/28/2021 the day after I got the vaccine, I had arm swelling, it was hot, and I had redness around lunch time. Monday 03/01/202I went to work and told my supervisor I was not feeling well around 9:00AM, I felt nauseous, I just did not feel "right". 03/02/2021 I developed a fever around 103.0, I called my PCP and was told to treat it with Tylenol and Advil, my fever ranged from 100.00 to 104.0. I began having hallucinations on 03/02/2021 which I believe was related to the fever. My daughter told me to call my doctor and I thought I did but later realized I did not. 03/03/2021, fever began increasing to 103 to 107 even on Tylenol and Advil. I went to ER hospital, city, state. Around 03:00PM I began to developed cyanosis, my wife found me in a confused state, dark purple in color, not responding well to questioning. Wife took me to hospital and my fever was around 107.1; they began an IV of antibiotic (unsure name). Was admitted to hospital around midnight 03/04/2021, between then and 03/06/2021, they ran a number of tests checking for various diseases, my liver enzymes began elevating, fever still had not broken; it was ranging from 103.0 to 105.0. 03/07/2021 After the hospital had ran every test, they could my fever did finally break, I was kept 24 hours after fever broke, they still could not give me a diagnosis, they said they did not believe it was due to the vaccine but recommended I not get 2nd vaccine. 03/09/2021 I was seen by my regular doctor who expressed my liver enzymes were so high it appeared within the range of an alcoholic, but I am not a drinker and doctor knows I don't drink so we ruled alcoholism. Since then, it has affected my memory, I have very large gaps rom 02/27/2021 until now. I have periods of hours and days that are gone. My liver enzymes have begun going down, but they are still not back to my baseline. I have tinnitus, fatigue, respiratory fatigue and muscular. Daughter began speaking on his behalf. His words are not correct, it's like he has a speech impediment, his words do not come out right or letters are jumbled with occasional slurring. He also bites his tongue a lot.
16hr p/vax hives on ankles & palms of hands, few hives on forearms;treated w/loratadine & steroids (unk);hives disappeared w/in 2hr;
received the first dose of the Pfizer covid vaccine on 12Mar2021 and tested positive for covid on 15Mar2021/not really feel anything, no signs; This is a spontaneous report from a contactable consumer (patient) via the sponsored program. A 54-year-old female patient received the first dose of bnt162b2, via an unspecified route of administration, administered in left arm on 12Mar2021 16:00 (Lot Number: EN6208) as single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient received the first dose of the pfizer covid vaccine on 12Mar2021 and tested positive for covid on 15Mar2021. The patient asked if she may get the second dose of the vaccine as scheduled on 02Apr2021. On 15Mar2021 she was diagnosed with COVID by COVID mouth swab test with positive for COVID result. She did not really feel anything, no signs. The outcome of the event was unknown.
Patient Received shot at 10:30 am  then while in the observation area , she began to experience itching . She noticed itching on her right arm at wrist area and on left arm and on area below left scapula. She noticed that the itching continued she also noted  some itching on her left upper lip area. She denied any sensation of shortness of breath or any feeling of throat closure. She denied any rash formation or any redness or any whelp formation.   she noted that the itching feeling continued for a approximately 15 min. She was given 25 mg Benadryl this help cease the itching sensation.  She was instructed that should the itching continue she should visit Emergency room . Her vital signs were 114/80 mmHg , heart rate 83 bpm ,oxygen saturation 99%. after 30 min her vital sign was 112/76mmHg, heart83bpm, temp 98.1 F . She was able to leave the facility  accompanying by spouse .
First dose went fine. Second dose resulted in swollen left arm at outside of elbow the next day. Now just over 2 weeks later swelling has gone down some but still present.  Suspect lymph node involved.
Racing heart; Face tingling; This is a spontaneous report received from a contactable health care professional. A 42-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6207) via an unspecified route of administration on 22Mar2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On 22Mar2021 during her 15-minute waiting period after the injection, the patient began to experience racing heart and face tingling. The patient denied rash, difficulty breathing, difficulty swallowing, throat tightness and facial swelling. Treatment included water and snacks. The follow up response to treatment was good. During discharge the patient was stable to go home and follow up with PCP (Primary Care Physician). The clinical outcome of the events racing heart and tingling were recovered on 22Mar2021.   No follow-up attempts are needed. No further information is expected.  Amendment (30Jun2021): This follow-up report is being submitted to amend previously reported: 1. Country added for patient in patient tab 2. Event Occurred Country of event Tingling updated from 3. Treatment received box checked for event Heart racing 4. Final sentence in analysis tab updated to No follow-up attempts needed. No further information expected
Fever starting around 8:00pm lasting approx 30 hours  Chills first noticed about 1:00am lasting about 17 hours  Swollen Lymph Nodes noted on February 18th during CT scan not related to shot symptoms.
Information has been received from a medical assistant (C.M.A.) concerning a female in her 60's who in about the week of 04-OCT-2010 was vaccinated IM with 0.5 ml dose of PNEUMOVAX 23 (lot # 665925/0932Z, expiration date 18-JUL-2011). On approximately 04-OCT-2010 the patient experienced warmth at the injection site that night and next day (approximately 05-OCT-2010) "her arm was blown up all the way down her arm" from her shoulder to her wrist. The patient was treated with ice and BENADRYL. Subsequently, the symptoms had completely resolved. The patient received PNEUMOVAX 23 (lot # and date not reported) in the past with no reaction noted. If was unspecified if the patient sought medical attention. This is one of several reports received from the same source. The doctor was requesting a lot check since each patient received the same lot number. The doses were administered by different staff members. The doctor had four more vials of the vaccine and was concerned about using them because of the above reactions. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Hives (urticaria) 1 1/2 - 2 hrs after vaccine - MMR/Varill/DTAP/IPV
Meningococcal B was given instead of Meningococcal Conjug. No adverse reaction.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified date, the patients received improperly stored doses of PNEUMOVAX 23 (dose and lot number were not reported). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
sore throat; Sneezing; Coughing; Runny nose; Headache; felt like mucus was running down the back of her throat; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EM9808) via an unspecified route of administration, administered in left arm on 05Feb2021 (at the age of 76-year-old) as dose 1, single for COVID-19 immunization. Medical history included blood pressure abnormal. There were no concomitant medications. The patient experienced sore throat on 08Feb2021. Patient also experienced sneezing, coughing, runny nose, headache and felt like mucus was running down the back of her throat on Feb2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 10Feb2021. Outcome of the event headache recovered on 15Feb2021; outcome of events sore throat and runny nose was recovering while the outcome of all other events was not recovered.  No follow-up attempts are possible. No further information is expected.
From correspondence received at manufacturer on 1/17/02, it was reported that a 68 year old female patient received a Fluzone SV 01-02 vaccination administered on 11/29/01. Painful at the time of injection. Immediately the patient lost range of motion of the right arm, unable to move arm towards back and unhook bra or fasten a seatbelt. She can't reach side (opposite), can raise arm straight up. Experiences pain in arm at right in muscle between shoulder and elbow. Physician thought injection hit a nerve. Treatment of using test exercises and prescribed VIOXX for 19 days. Flu shot was given high in deltoid, one finger below bone. Above treatments made no difference.
Sore arm started within 5 minutes and better after 2 days. Headache & low grade fever within 2 hours and lasted 2 days.
Both arms got very red/face and neck became very red; Neck started to swell; Face started to swell; Afluria TIV and Gardasil 9 were administered into the same (right) arm on the same day; The patient felt very run down; Ulcer like burns on his face and nose; Information was downloaded from Agency (US-SEQIRUS-202000368).  This spontaneous report as received from an other health professional refers to a 13-year-old male patient. The patient's concurrent conditions included asthma, allergy to dogs, seasonal allergy, food allergy and drug allergy.     On 08-OCT-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vial, right arm (lot #, expiration date, route of administration and dose were unknown) for prophylaxis.  Other suspect vaccination included influenza virus split virion 3v vaccine inactivated (AFLURIA) (lot #, expiration date, route of administration and dose were unknown) administered on the same date, in the same (right) arm (product administration error) for prophylaxis. Concomitant therapies included children vitamins (unspecified) and amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (ADDERALL TABLETS).     On 08-OCT-2019, patient's both arms got very red, face and neck became very red, his neck started to swell, and his face started to swell. On an unspecified date in October 2019, he experienced ulcer like burns on his face and nose and felt very run down. The outcome of the events was unknown.  The reporter did not provide relatedness between the events and the vaccinations with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and virus split virion 3v vaccine inactivated (AFLURIA).  The agency considered the events of swelling face, ulcer like burns on his face and nose, and neck swelling to be medically significant.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 29-JUL-2013, the patient was vaccinated with an expired dose of VARIVAX (Merck) (Lot # reported as G006861, expiration date 20-JUL-2013) (route not reported). No adverse effects were reported. Additional information has been requested.