chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment information was provided. Date the vial was initially stored in the refrigerator 08-Nov-2021.
Following vaccines, the pt experienced a worsening of liver function tests and was hospitalized. Therapy with tolterodine and atenolol were discontinued. The elevated LFT's persisted for two months before the pt recovered and the levels returned to baseline. No further information is available.
Patient fainted after receiving vaccines. Pt. was sitting and fell forward - hit nose on counter. Then; pt was layed back with legs elevated. Pt. came to in apprx 15-20 seconds *Pt immediately c/o (L) ankle pain, but ambulated out of clinic. Per mother, PT has swelling and aching in (L) ankle - starting later in the day. No trauma to (L) ankle @ time of visit.
Pt called on 11/3/10 and said she had a red rash on her back that is itchy and painful and it started on 11/2/10.  I called pt's primary care MD and they requested the pt to call the office to see the MD.  She thought it could be related to the flu vaccine.
Initial and follow-up information has been received from a 26 year old female pharmacist with coeliac disease who in the spring of 2004, was vaccinated with a dose of RECOMBIVAX HB. On a Sunday in June of 2006, the patient started to have distinct pain behind her left eye, this climaxed at 2 weeks. The patient lost 50% of her vision and had cloudy vision. This subsided in 4 weeks. The patient stated that a neuropathologist determined she had optic neuritis with no brain lesions. The patient stated that she did not develop numbness or tingling on her left side (previously reported as she did). At the time of the report the patient still had a "hot spot" on her left foot that "comes and goes periodically" but she considered herself recovered after therapy. Unspecified medical attention was sought, and MRI was performed and showed no multiple sclerosis lesions on her brain, eye exams with dilation and visual field tests were also performed. There was no product quality complaint involved. No further informtion was provided. No further information is expected.
large local react red itchy; 2 hot itchy red wheels size of orange on lt arm;
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided. On 11-DEC-2018, the patient was vaccinated with a dose of improperly stored VAQTA (dose not provided, lot # R009799, expiration date 02-JUN-2019) intramuscularly for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the multiple temperature excursions from 32 up to 35 (34.79) degrees Fahrenheit in a time frame of 6 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1901USA000392.
I started feeling like foggy vission. Use to read some things or use the phone without glasses but now have to use them more often.
April 30: Got vaccine in left arm. May3:Rash started on right arm, right shoulder pain. Called pharmacist said keep eye on it. It didn't make sense that you would get a rash from a dead virus. May 6: Blister started & rash was spreading. Stopped by and let pharmacist look at it. Still told me to keep eye on it. May 8:Rash & blisters spreading & more whelped up. Hand swollen, couldn't make a fist. May 9:My hand was more swollen, couldn't hardly bend fingers. Blisters & rash were more sensitive and spreading. Went to dr. He said he didn't know what it was and would be rare if I got the shingles form the vaccine since it was dead. Prescribed steroids. They didn't help at all. May11: Got up and in horrible pain. When my was down straight down it was throbbing.  I had to get a sling to keep my arm up. Went to the ER because I was in so much pain. Was seen first by an infectious disease nurse. She knew immediately it was shingles. When the doctor came in also knew immediately it was shingles. They were very worried about my well being because it was so bad. The doctor prescribed me lortab, gabapentin 300 mg, valacyclovir hcl 1 gram. Because of this I'm unable to work.
PATIENT CALLED THIS AM, STATING THAT HOURS AFTER ADMIN. SHE HAD REDNESS, SWELLING WITH A RIDGE AROUND THE SWELLING AND SEVERE ITCHING WHICH ALL STARTED BELOW THE INJECTION SIGHT.IT LOOKED LIKE A SAC. NOTHING AT THE SIGHT OF INJECTION AT ALL.  SOME SHORTNESS OF BREATH AND SWEATS DURING THE NIGHT AND THIS AM. SHE CAME INTO OFFICE THIS AM IT IS STILL RED AND WARM FEELING AND PAINFUL TO TOUCH BUT AGAIN NOT AT THE SIGHT OF INJECTION BUT BELOW AND AROUND TO THE BACK SIDE OF ARM
Within 24 hours, post vax, pt's personality drastically changed. She cried uncontrollably, could not sleep and within 48 hours, post vax, she developed a fever of 100.9F. Because she was only 1 week old when the vaccine was given and with the high fever, she was admitted to the hospital. She then had to endure a spinal tap, IV antibiotics for 3 days and having blood drawn. No one listened to us as parents when we repeatedly said it was a reaction to the vaccination. They insisted on doing all of the tests, admitted her to the hospital and said she had contracted a virus of some kind. (No one knows what virus, etc.).
Painful lymph nodes; lymph nodes are enlarged/swollen lymph nodes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LYMPH NODE PAIN (Painful lymph nodes) and LYMPHADENOPATHY (lymph nodes are enlarged/swollen lymph nodes) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPH NODE PAIN (Painful lymph nodes) and LYMPHADENOPATHY (lymph nodes are enlarged/swollen lymph nodes). At the time of the report, LYMPH NODE PAIN (Painful lymph nodes) and LYMPHADENOPATHY (lymph nodes are enlarged/swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient noticed swelling under his arm on the second week after receiving the vaccine. Patient stated he visited a health care provider for the events, who confirmed swollen lymph nodes. Patient was then prescribed Levocet (levocetirizine) for treatment of events.
About 24 hours after vaccine, achy joints began for about 12 hours, 36 hours after vaccination I developed a rash on my neck and chest, and later experienced vertigo
Patient got his Covid vaccine this past Thursday, 2 days ago.  He experienced typical side effects of a sore left shoulder and some fatigue but was feeling well until this afternoon around 1:55 PM when he noticed throbbing of his left hand.  He looked down and noticed that there was a purple discoloration to his middle finger and distal palmar aspect of his hand.  He felt like there was maybe some swelling as well and that he might have been having an allergic reaction so called the emergency department for further advice and came in for evaluation.  By the time I arrived to the emergency department the patient's left hand was no longer swollen and there was only a small purple discoloration to the palmar proximal middle finger.  I was concerned that the patient developed a small blood clot that was resolved upon evaluation.
INJECTION SITE PAIN, SHORTNESS OF BREATH, CHEST PAIN, FATIGUE, MUSCLE WEAKNESS, HEADACHES Narrative:  SYMPTOMS LASTED 2 DAYS; EMPLOYEE MISSED WORK 1/26/21-1/27/21
Information has been received from a physician concerning a female patient who on 17-APR-2007 was vaccinated with a dose of ProQuad (Lot # 656312/0297U). It was reported that the patient developed redness, swelling, tenderness and induration at injection site on an unspecified date after vaccination, approximately April 2007. Additional information has been requested. This is one of several reports received from the same source.
BRIEF OVERVIEW: Admission Date: 9/10/2023 Discharge Date: Sep 11, 2023 Discharge Disposition:  home or self care      Active Issues Requiring Follow-up: None No future appointments.   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Weakness generalized [R53.1] AKI (acute kidney injury) (HCC) [N17.9] Syncope, unspecified syncope type [R55] COVID-19 [U07.1]   HOSPITAL COURSE: Patient was admitted for observation and evaluation for her falls.  On telemetry there was no a arrhythmias noted.  PT was not performed, but OT saw patient and found her to be strong enough to go home.  Her diet was improved while she was here in the hospital.  IV fluids were again not required.  No symptomatic treatments were necessary for COVID as she had no pulmonary or GI symptoms.   This patient was medically stable at discharge to go home.  She will have a tenuous course of caution with mobilization and daughter will be with.  Would consider her contagious for a 7 day.  Which is nearly up at this time.
node on the back side of her shoulder; This is a spontaneous report from Pfizer-sponsored program via a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on 01Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 01Mar2021, 4 hours ago, the patient experienced node on the back side of her shoulder. caller wants to know if it is normal. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
30 minutes after vaccination he did not feel good, has droopy eyes , slurred speech, numbness of left arm.  high blood pressure, headach, shortness of breath 2 days after vaccination  he feels better but still has mild headache , pressure behind eye, Rt eyelid ptosis,  numbness of left upper arm and slight shortness of breath
Director for children's clinic reported a patient receiving only half the dose of the required dose of VAXELIS.; Director for clinic reported a patient receiving only half the dose of the required dose of VAXELIS.; This spontaneous safety report, with reference number 2023SA185923 (Interaction # 01657028), was received by the partner on 16-JUN-2023 and forwarded to agency on 19-JUN-2023, from a health professional.  Due to the nature of the event, the causality between the events "Director for children's clinic reported a patient receiving only half the dose of the required dose of VAXELIS." and Vaxelis was not applicable."  Further information is expected.
My sight started to go; started getting blurry and I can't see my phone to find number and it lasted about an hour my sight came back; sudden my sight started to go; blurry; ever since then my smell has been back; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: E9262), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included high blood pressure, over weight, lost my sense of smell, border line diabetic and a heart condition that is hereditary it has to deal with the elasticity of the vessels; all from unspecified date and unknown if ongoing. The patient was administered first dose of BNT162B2 (lot number: EH9899) on unspecified date for COVID-19 immunization and experienced the regular signs, a little bit of a headache, little dizziness in the morning, and cognitively was little not there for about an hour. Concomitant medication included lisinopril, metformin hydrochloride (ROBUSTIN) and vitamins. The patient stated, "for the second shot the 2nd day I was at school letting kids out and all of a sudden my sight started to go. It started getting blurry and I got back into the building and my Principal said let's just call the doctors, I said I can't see my phone to get, find his number. They took care of that for me and it lasted about an hour and hour and half and my sight came back. That's was the only negative and the positive thing happened, I have lost my sense of smell 10 years ago from taking a prescription for high blood pressure I mean diabetes (unspecified medication). Within a month I lost complete smell of everything, for 10 years I have not been able to smell a thing. The day I lost my lost my sight for little while, that day on the way home I was driving pass a restaurant with my windows up and I could smell barbeque sauce, pass an Italian restaurant and I could smell Italian food, and ever since then my smell has been back. I don't know I am not complaining at all, I am just telling something that, the doctors says I haven't heard of that, so that I thought you should know." The patient had bloodwork done with unknown results on unspecified date. The outcome of the events was unknown.
My arm was extremely sore for a week at the injection site, I developed an itchy and burning rash localized on  the right side of my spine, I developed a fever blister on my right lip, I had a very painful headache for 1 1/2 weeks, and worst of all I developed constant tinnitus.
Red rash, itch, progressive at site of injection. Rash progressed for 3 days, then resolved.
onset fever on evening of 28OCT92 fever persisted & on 29OCT92 @ 1700 hrs pt had brief generalized tonic seizure lasting 5 mins & was adm to hosp;
In observation patient noticed a new onset of tingling and itching on her upper extremities.  Administered benadryl with no relief and subsequently given epi pen. Patient has prior allergy to flu and pneumonia vaccine. Advised by PCP to take benadryl prior to COVID vaccine which patient took. Patient presented to ED subsequent day as itching continued. No lip swelling or tongue swelling or difficulty breathing.
On the 20th, patient had a low grade fever (100.7 F).  This morning, 21st, he woke up with spot on his face, chest, back and torso.    We are waiting to see how the rash develops before contacting the doctor.
Initial report was received from a health care professional on 17 August 2012. A 31-year-old male patient had received an injection in the left arm of FLUZONE, Sanofi Pasteur Inc. (lot number, route and site not reported) on 07 August 2012. On 09 August 2012, the patient experienced right wrist pain which got better then left wrist pain. The patient ran and experienced ankle pain. The patient got better and experienced muscle contractions, difficulty holding dental instruments and reduced reflex action which "leveled off on 20 August 2012" (future date). The physician first thought it was GBS but "then didn't really think so." The patient's outcome was not recovered. Documents held by sender: None.
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unspecified dates in 2016, the patients were vaccinated with improperly stored ZOSTAVAX lot # L039096, expiry date 08-JAN-2017 (dose, route and site of administration were not reported). No adverse effects were reported. The temperature excursion was noted at 5.7 degrees Fahrenheit for 18 hours. Previous temperature excursion was at 18 degrees Fahrenheit which lasted for 3 hours. Data logger was not involved. Additional information has been requested.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) .5 ml, administered on 17-MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 11-JUN-2021, the subject experienced suspected covid-19 infection. Laboratory data included: Laboratory test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint: 90000182971 The suspected product quality complaint has been confirmed to be not voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious
Patient developed Immune Thrombocytopenic Purpura- bleeding gums, bleeding lip, petechia all over body and bruising, fatigue, abdominal pain...2 weeks after 2nd COVID Moderna vaccine.
Three days post injection pt became weak, shaking, cold, runny nose mild fever, HTN increased, heart flutter increased, HR increased, then all 3 fluctuated. Pt. was seen on 8-6-18 by regular physician and advised to not take second SHINGRIX.
Thirty pox lesions  - solid on face and torso. Temperature 99.3.
Systemic: Body Aches Generalized-Severe, Systemic: Fever-Medium, Additional Details: pt came into a different sotre  to get her second booster.  she had received 2 primary doses reported she got 0.5 ml of Moderna even though she is not immunocompromised.  she admitted to making the online appoinment herself.  She communicated that she felt she experienced stronger side effects because of the incorrect dose which she herself made an appointment for.
Employee c/o skin flushing, itching, scratchy throat and ears, shortness of breath shortly after receiving the Influenza vaccine. Employee treated at emergency room with Epi 1:1000 0.5 SQ left arm;benedryl 50 mg. IVSP; Solumedrol 125 mg IVP; Zofran 4 mg IVP. Employee sent home on Benedryl P.O. 4 times daily for next five days and Prdnisone dose pack. Employee to follow-up with primary care physician.
2"x3" welt over injection site 7 days after injection, resolved over the course  of 7 days
COVID Vaccine #1 on 3/9/2021; Unusual Menstrual spotting began 3/27/2021; Early Heavy Menstrual Bleeding Began on 3/31/2021; COVID Vaccine #2 on 4/1/2021; Heavy Menstrual Bleeding Continues daily through today's date 4/29/2021
Severe headache, palpitations, chills  - started at 3am - lasted till 9pm
Fever of 39C, intense headache, joint and muscle pain, fatigue; patient remained in bed for two days with flu-like symptoms. Third day experienced mild headache and muscle pain; significant fatigue extended out through fifth day after vaccination and has not fully abated 12 days later. Asthma intensified to require round-the-clock use of rescue inhaler and has continued to be nearly uncontrollable, similar to one month after last year's illness with COVID-19.
About 10:30PM 8/22/01 the mother noted swelling at the injection sites in left deltoid. the pt complained of itching. Mother took him to ER immediately where he was Rx'd with 12.5 mg of Benadryl Elixir po and given 10 cc to take 1 tsp every 4-6 hrs as needed.
Chills, shivering, headache, injection site soreness, fever (102.4),  GI upset, muscle soreness
PATIENT CAME INTO OFFICE ON 10-11-2008 DESCRIBING COMPLAINT OF COUGH, SLIGHT SWELLING AND DIFFICULTY SWALLOWING AFTER RECEIVING FLU SHOT ON 10-10-2008.  THE SYMPTOMS STARTED WITHIN A FEW HOURS OF RECEIVING HIS FLU SHOT. PATIENT STATES HE TOOK AN OVER-THE-COUNTER ANTIHISTAMINE AND REPORTS FEELING BETTER AT APPT ON 10-11-08.
1st covid shot:  extremely sore at injection site.  Achy joints and fatigue. 2nd covid shot:  extremely sore at injection site, fatigue, joint pain, headache, fever of 101, golf ball size swollen lymph node in left armpit.
pt recv vax; lt upper arm red approx size of 3x4"; c/o feeling n; no vomiting;epi given; observed for 30 min;
Patient received 0.5ml of Moderna for booster instead of 0.25ml. No adverse reaction on date of administration
7 cm x 6 cm indurated, erythematous lesion around site of vaccine (R) thigh-warm to touch.
Beginning on Tuesday, April 6, I began with a fever of 100.2 off and on (normal always 97) each day and night until this morning (Fri). Still have an accompanying headache and slight nausea all this time (4/6-9). Taken one 500 mg acetaminophen when gets bad, which lessens headache.
pt recvd vax & 2 days later devel red strawberry rash on 90% of body; seen by MD;
Myocarditis in 2 days - diuretics,  Respiratory Failure in 2 days Bipap and Airvo, Clotted off leg in a few weeks Angiogram and Fascitomy, Ischemic gut weeks - comfort care orders, DVT in arm in weeks could have been due to PICC also - Elquis
Received vaccine below on 7/19/06. 7/26/06 had temp of 103.9. Taken to ER. Daiagnosed wit Bronchitis and sinus infeciton. Given Rocephin inj. Rx issued for Biaxin, then changed to amoxcillin.  Father read VIS #5 and thinks t his could have caused child to become ill.
Swollen lymph node underarm; Nausea; Fatigue; Fever; Backache; Joint pain; Chills; Hot flashes; Taste off; Nose bleed; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration on the left arm on 12Apr2021 at 10:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8730) via an unspecified route of administration on the left arm on 22Mar2021 at 15:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 01:00, the patient experienced swollen lymph node underarm, nausea, fatigue, fever, backache, joint pain, chills, hot flashes, taste off and nose bleed. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph node underarm, nausea, fatigue, fever, backache, joint pain, chills, hot flashes, taste off and nose bleed was recovered on an unspecified date in Apr2021.   No follow-up attempts are possible. No further information is expected.