chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderate Facial Swelling; This is a spontaneous report from a contactable other hcp. A 41-year-old male patient received second dose of bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EW0185), dose 2 via an un-specified route of administration, administered in Arm Left on 25May2021 09:45 (Batch/Lot Number: EW0185) as DOSE 2, SINGLE for covid-19 immunisation (at the age of 41-year-old). Medical history included cancer and BRCA from an unknown date and unknown if ongoing. Not known allergies. Concomitant medications included alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (Lot number EW0176) in Left arm on 04May2021 12:00PM for Covid-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. On 25May2021 09:45 PM patient experienced Moderate Facial Swelling. The event was not required the initiation of new medication/other treatment/Procedure. The outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.
Client reports "brachial neuritis". Onset of pain was immediate, has had pain, weakness, limited ROM since.
Started out with immense headache which proceeded to chills and full body aches. Body aches were the worst part of it - they were so bad I could not get up or walk. They started middle of the night I received the vaccine, lasted all the next day and into the next morning. By that evening I felt much better with just a headache and by the following day all symptoms subsided    I had hardly any Odin at the injection site unless I pushed or laid on it and no swelling or rash at all.
MAJOR ADVERSE REACTION; FEELS LIKE THE WALKING  DEAD; WORSE ADVERSE REACTION; CHRONIC FATIGUE; INSOMNIA; MENOPAUSE; This spontaneous report received from a patient via social media a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total administered on 01-APR-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, within two weeks after receiving the vaccine, the patient experienced insomnia, and chronic fatigue (dose number in series: 1). On an unspecified date, the patient experienced major adverse reaction feels like the walking dead, (dose number in series: 1) and it was reported as Woman Feels Like the Walking Dead' After COVID9Vaccine Injuries 1st JandJ jab caused major adverse reaction" and " I went to a couple of doctors and they just said it was menopause that was causing it."  The patient received, Non-company suspect vaccine tozinameran (pfizer) (dose number in series: 2) ( form of admin, route of admin, and batch number, expiry were not reported) dose was not reported, administered on NOV-2021 for covid-19 prophylaxis.  On an unspecified date, following vaccination with tozinameran (pfizer), the patient experienced worse adverse reaction (Dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the major adverse reaction, chronic fatigue, insomnia, menopause, feels like the walking dead and worse adverse reaction was not reported. This report was non-serious.
Developed wheezing, ocular hyperemia and orbital edema.  She denies dyspnea or dysphagia. At 11:55 pm developed fever of 101.3 F and myalgias.  Wheezing subsided at 11:55 pm.
FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced fever, and headache. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever and headache was not reported. This report was non-serious.
Feeling of lump in throat and slight headache that subsided before I got back there.  Lower lip on right side was visibly  swollen.  Blood pressure and O2 were in normal range.    had here stay an additional 10 minutes after she was evaluated.  she felt good and left
35-year-old female came in for Flushot and HPV on 09/16/2023. After reviewing patient profile and form, Flublok (NDC 49281072310, Lot QFAA2313, exp 06/2024) was given IM to patient Left Arm,  and Gardasil 9 (NDC 00006412102, Lot W014209, exp 01/06/2025) was given IM to patient Right Arm. Approximately 5 minutes later, patient stated that she did not feel very well and would like a glass of water. At this time, patient looked pale to pharmacist. She began sweating and became nauseous. Pharmacist checked, and no sign of anaphylaxis, injection sites looked clean and clear. Patient remained consciousness and fully alert. Pharmacist recommended patient to stay at the pharmacy for observation. After ~ 5 minutes of resting, patient began to feel better. No medication was given to patient. Patient had called her mother to pick her up from pharmacy after 15 minutes. Follow up with patient on Sunday 09/17/2023 around 10:15am via phone, patient stated that she felt better, no other symptoms/issue.
Sore arm. Headache, dizziness, fever (treated with Tylenol), fatigue. Sore arm a few hours after injection worsening the next day (not treated). Headache starting about 8am the next morning. Fever starting about 9am. Did not slow down or rest all day. Performed mentally challenging tasks. Drank plenty of fluids. Fatigue hit hard about 8pm.
Dizziness, Diarrhea, Palpitations & Tachycardia Narrative:  Patient remained in facility for 15 minutes after receiving vaccination. Upon ambulating to depart facility, patient returned to area complaining of dizziness and fast heart beat. Patient was immediately seated and vital signs were obtained. 0954- BP 150/82, pulse 80, Oxygen saturation 95%, and temp 97.8. Patient drank 8 ounces water. Patient reported feeling better after 10 minutes. Repeat vital signs at 1007 BP 127/74, pulse 80, oxygen saturation 95%. Patient with no further complaints of dizziness or fast heart beat. Patient did not verbalize any other complaints. Patient denied escalation to emergency department. Condition was resolved prior to leaving facility. Patient left facility ambulatory without any difficultly, and was accompanied by family member. Patient instructed to call 911 and report to nearest emergency room for any further issues or complaints. Patient verbalized understanding of instructions in her own words.
Dose Expired on 3/12/2023 and was given to the patient on 3/17/2023  spoke with the Manufatcurer they advised they will need to check the stability of the Dose that will take 3-5 days, they advised they will let us know and we can determine whether we should provide the dose again
pt recv vax 10JUN98 &  15JUN98 pt devel achiness, nausea, diarrhea & cramping;pt was not treated for the event;
mom describes prolonged crying beginning 445PM until 8 or 815PM inconsolable;begin 20min p/vax;mom had not contact office,info offered on inquiry re any problems p/prev vax;
Left side numbness. Tests pointed to possible blood clot. Still don?t have feeling in left arm. Having to continue to see neurologist.
fine rash, diarrhea, vomiting x1 for 2 days;
Patient returned to the pharmacy two days after injection. Injection site had "hard bump", was warm, itching and localized.
Randomly get surges of pain in joints, muscles, head, legs, arms hurt. Neck feels tense. Lightheaded, dizzy. Hurts to even move fingers. Dehydrated and disoriented. Insides feel hot. Hurts to move anything.
12/12/05, C/O of pain at time of injection.  1/20/06 C/O continual pain in left deltoid since time of injection.  He rates pain as 1 which increases to 3 when he lifts or moves his arm.  There is no redness or swelling.  He denies pain in the elbow.  He is always aware of the pain and at times it wakes him at night.  When lying on his left shoulder he does not experience pain.  He believes the strength in his left arm is less then before the injection.  He states he has had slight numbness in his 1st and 2nd fingers but thinks it may be attributed to an injury he sustained to his wrist some time ago.  He was advised to be seen for an evaluation.  Name and number of contact person was provided.  Follow up phone and email contact were made to inquire about his arm.  He stated symptoms are the same but he does not care to seek medical evaluation or treatment at this time.
I currently have an outbreak of shingles(herpes zoster) covering my left lower back and stomach.  I have never had shingles before.  I am young (35), have no medical problems and have rarely been sick a day in my life. This started approximately 3 weeks after receiving the booster(3rd shot) of the Pfizer vaccine. I am currently taking antiviral medication, steroids and gabapentin to manage the outbreak and symptoms.
There is a discrepancy from the chart notes from the visit on 6/21/11. Per MOC when I asked her last week, patient began to have redness of chest, possible urticarial rash, and facial angioedema within hours of IPV administration. Per chart notes, this began the following morning after the vaccine was administered. There is no mention of redness to chest or urticaria in the chart notes, just mild-moderate angioedema of upper eyelids.
pt recvd vax 5JUL94 w/vax & the following day pt began fever & mom adm to hosp 10PM; MD said pt had an infection but could not find anything else wrong;
This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (decreased Appetite), MYALGIA (sore arm, arm pain), CHILLS (severe chills), FATIGUE (fatigue) and NAUSEA (nausea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Breast cancer, Penicillin allergy and Allergy to antibiotic (Erythromycin). Concomitant products included OMEPRAZOLE for GERD, CHLORDIAZEPOXIDE;CLIDINIUM, METHYLCELLULOSE (CITRUCEL) and LACTOBACILLUS ACIDOPHILUS (FLORASTOR [LACTOBACILLUS ACIDOPHILUS]) for Irritable bowel syndrome, RALOXIFENE for Osteoporosis NOS, VITAMIN 15, PRAVASTATIN, PYRIDOXINE, VITAMIN D3, UBIDECARENONE (CO-Q10-CHLORELLA), MACROGOL 400, PROPYLENE GLYCOL (SYSTANE) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced MYALGIA (sore arm, arm pain), CHILLS (severe chills), FATIGUE (fatigue) and NAUSEA (nausea). On an unknown date, the patient experienced DECREASED APPETITE (decreased Appetite). On 17-Jan-2021, MYALGIA (sore arm, arm pain), CHILLS (severe chills), FATIGUE (fatigue) and NAUSEA (nausea) had resolved. At the time of the report, DECREASED APPETITE (decreased Appetite) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Blood glucose: high (High) high blood sugar.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported for mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment   This case was linked to MOD-2021-252848 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Significant follow-up received and concomitant medications, Medical history was updated. Patient demographics was added. Recovery date of all the events was added. New event added.
I had sore throat, congestive in my sinus, and coughing on Dec 3rd. Then, I had fever, headache and body aches all over my body on Dec 4th. I was test on positive for Dec 5th for Covid-19. On Dec 6th, they gave me the antibody fusion. They did blood work, the DE dimer was very evaluated. This shows that, I am a risk for a DTV. I am on blood thinners now. I had to have a IMR done to see how thick my blood is.
This spontaneous report as receive from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that the patient received a dose of ZOSTAVAX (dose, route, site of administration, indication and lot number were not reported) on an unspecified date in December 2012 at an unspecified physician's office. The patient received a second dose of ZOSTAVAX (dose, route, site of administration, indication and lot number were not reported) on 31-AUG-2013. No adverse events were reported. Additional information has been requested.
arm has really sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm has really sore) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm has really sore). At the time of the report, VACCINATION SITE PAIN (arm has really sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medication provided no treatment was reported
Blurred vision; Muscle weakness; Nausea; headache; Exposure to COVID-19 by family; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision), MUSCULAR WEAKNESS (Muscle weakness), NAUSEA (Nausea), HEADACHE (headache) and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19 by family) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 18-May-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposure to COVID-19 by family). On 12-Aug-2021, the patient experienced VISION BLURRED (Blurred vision), MUSCULAR WEAKNESS (Muscle weakness), NAUSEA (Nausea) and HEADACHE (headache). At the time of the report, VISION BLURRED (Blurred vision), MUSCULAR WEAKNESS (Muscle weakness), NAUSEA (Nausea) and HEADACHE (headache) was resolving and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19 by family) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jul-2021, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  The patient was exposed to Covid-19 by family in his home around 23-Jul-2021. Patient did move to hotel and self-quarantine. The patient was feeling better however, still unable to work. No other information reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the event of blurred vision, muscle weakness, exposed to covid-19 by family, nausea and headache was not provided for co-suspect drug Skyrizi.
Fever, Aches, Pain, Chills, Nausea, headache, Dizziness, Weakness, Fatigue,Somnolent. Arm pain, arm swelling, Arm Redness like a second degree burn on the left arm
After the 2nd shot listed above in #5, I had high blood pressure and heart palpitations that developed gradually over five months and ended up in the Emergency Room in July.  I was referred to a cardiologist and had a series of cardiac testing of which nothing significant resulted.  I then had my booster on 11 Dec 21, and within one month had the following symptoms:  High blood pressure, heart palpitations, 24/7 headache, extreme 24/7 dizziness, 24/7 ear pressure,24/7 eye pressure, 24/7 eye pain when moved eyes, chocking sensation in throat for one month, neckache, runny odd colored diarrhea, weak body muscles, couldn't move left leg/walk for two days, shortness of breath, prickly/tingling in both hands and feet,
Redness and swelling and pain at site. Fever chills headache - could not hold urine not sleeping.
30JAN98 mom reported child unable to walk for 3hr;fine since;pt recv typhoid #2 on 13MAR98 w/no known difficulty;
Roughly 5 minutes after the shot patient fainted while checking out and her entire body started twitching. She was taken by ambulance from doctors office to emergency room where she continued to shake but it was mainly right arm. Major headache and numbness followed by pain in legs. The twitching did finally stop and we were discharged. As of today, 10/13, when patient woke up and started moving around her right arm began twitching severely again and has yet to stop.
Tightness of chest; Severe headaches; Rashes on skin; Feverish ness; This is a spontaneous report from contactable consumer (patient). A 13-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176), via an unspecified route on 04Jun2021 (at the age of 13-years) as dose number unknown, single in the left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had known allergic to Aspirin and Ibuprofen. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Jun2021 at 13:15, the patient experienced tightness of chest for about 15 minutes. Happened again on 06Jun2021 for 5mins and on 07Jun2021 for about 3 minutes. Also experienced severe headaches, rashes on skin and feverish ness. The patient did not received treatment for events. The events was assessed as serious Life threatening illness. The outcome of the events was recovering.  Information on the lot/batch was available, further information has been requested.
Patient developed fever (15 days after vaccination) that persisted for about 2 months, also developed cough, and anorexia as well as fatigue.
0931 patient received vaccination within 60 second she verbalized  sensation to the right side  body; chest itchy, felt throat closing Ice pack provided 1950 pt states throat feels better, not as constricted ; hot under mask area only;  denied itching  1000 patient reports the feels "perfectly normal" ER precautions provided for follow-up if symptoms return
PATIENT GOT HER INFLUENZA AND AABRYSVO VACCINE ON 10/12/23 AT 12:15PM. AFTER THE INJECTION, THERE WAS NO SERIOUS SIDE EFFECT OR PATIENT HAD ANY SYMPTOM SUCH AS SHORT OF BREATH, RASH, HIVE, STROKE OR HEART PROBLEM AFTER 5-15 MINUTES WAITING IN THE PHARMACY AFTER THE SHOT. ON 10/13/23 PATIENT'S SON COME TO THE PHARMACY TO PICK UP HIS MEDICATION AND INFORM US THAT HIS MOM HAS PASSED AWAY ON 10/12/23 NIGHT. THERE WAS UNKNOWN IF THE VACCINE HAS CORRELATION FOR THE PATIENT PASSING OUTCOME OR NOT. CONTACT DISTRICT MANAGER AND FILE AN INCIDENT REPORT FOR THE CASE TO REPORT WHAT HAPPENED,  WILL CALL TO INFORM THE CASE ON THE SAME DAY.
Welts to body and swelling of tongue around 1800 that evening after the injection at 900 am. Patient was seen at primary doctor and was given an steroid injection and a steroid to take at home.
pt recv vax 10DEC96 & 6DEC97 pt devel chickenpox;pt has approx 15 lesion face, stomach & extremities;
no further ae reported; Temp excursion occurred; This spontaneous report was received from a nurse referring to a 25 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  Temperature excursion occurred on an unspecified date. On 30-NOV-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the right arm (lot U020244, expiration date 28-JUN-2023) (strength and dose were not provided).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
PATIENT RECEIVED MMR II VACCINE AND VERY SOON AFTER FELT DIZZY. PATIENT THEN PASSED OUT BUT REGAINED CONSCIOUSNESS WITHIN A MINUTE. EMERGENCY SERVICES WERE CALLED AND ARRIVED WITHIN 5 MINUTES. THEY ASSESSED HER  ON SITE. BLOOD PRESSURE WAS EXTREMELY LOW. EKG WAS NORMAL. PATIENT STATED SHE HAD NOT EATEN OR HAD ANYTHING TO DRINK BEFORE THE SHOT. EMT ATTRIBUTED EVENT TO PATIENT DEHYDRATION WITH POSSIBLE HYPOGLYCEMIA. PATIENT WAS TAKEN TO ER..
I HAD SEVERE PAIN AT THE SITE OF INJETION FROM 1/13/09(DAY OF VACCINATION) TO 1/14/09...MORE THAN 36 HRS....WITH SITE (LEFT DELTOID)PAIN , I HAD MODERATE TO SEVERE HEAD ACHE AND WHOLE BODY PAIN. I HAD TO STAY HOME 1/14/09 ALL DAY TOOK TYLENOL EVERY 4 HRS. WENT TO SLEEP 1/14 FELT MUCH BETTER ON 1/15/09. VACCINE MANUFACTURER: sanofi pasteur
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an unknown date in 2016, the patients were vaccinated with the improperly stored dose of PROQUAD (Merck) (lot # L024123, expiration date 30-DEC-2016; dose and route were not provided). No adverse effects were reported. The vaccines were exposed to 17.2 Fahrenheit (F) for 2 hours on 12-JAN-2016 and to 8.1 F for 12 hours on an unknown date in 2016. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a male patient of unknown age. The patient was administered the first dose of GARDASIL, intramuscularly (lot number and site of administration were not reported) in August 2012 and the second dose of GARDASIL on 27-AUG-2013. No adverse effects were reported. Therapy with GARDASIL was not discontinued. Additional information has been requested.
Tingling started in hand of vaccination arm that evening and spread to the other hand as well as both legs and feet under the knee
Pain in abdomen started at 10:00 PM that night. Later hospitalized for appendicitis and had appendix removed.
Fever, chills, fatigue, brain fog, sore, achy, sore at injection site,
Chronic shingles outbreak; Information has been received regarding a case in litigation from a lawyer referring a female patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 01-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for prophylaxis.         On 01-AUG-2012, (reported as "since she received the vaccination"), she had experienced chronic shingles outbreaks.  The outcome of the shingles was unknown.     The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).