chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Could hardly stand; headache; fatigue; little dizzy; barley walk; was falling in the walls; frequently urinate; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (little dizzy), GAIT DISTURBANCE (barley walk), FALL (was falling in the walls), POLLAKIURIA (frequently urinate) and DYSSTASIA (Could hardly stand) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Liver transplant (12 year ago.) in November 2008. Concurrent medical conditions included Drug allergy (ciprofloxacin). Concomitant products included SIROLIMUS (RAPAMUNE) for Immunosuppressant drug level NOS, VITAMINS;MINERALS;LYSINE and CALCIUM for an unknown indication.    On 21-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced DIZZINESS (little dizzy), GAIT DISTURBANCE (barley walk), FALL (was falling in the walls) and POLLAKIURIA (frequently urinate). On 22-Aug-2021, the patient experienced HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced DYSSTASIA (Could hardly stand). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Fatigue, at an unspecified dose and frequency. On 22-Aug-2021, DIZZINESS (little dizzy), GAIT DISTURBANCE (barley walk), FALL (was falling in the walls) and HEADACHE (headache) had resolved. At the time of the report, POLLAKIURIA (frequently urinate) and DYSSTASIA (Could hardly stand) outcome was unknown and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: 34,37,23,1.43, 40, 31.3,13.3 (High) ALT-34,AGT-39, BUN-23,CREATINE-1.43, DIRECT BILLI..-40, MCH-31.3, MID-13.3 and 57.20,7.0 (Low) GRANULOCYTES-57.20, MPV-7.0.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter states that patient had blood test after 3 days of vaccination and liver and kidney level was elevated.  patient will  be going for another blood test after couple of days to see it return to normal.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Significant follow up events and new reporter and event outcome and tests are added , and I narrative updated.
For both vaccinations of SHINGRIX, patient reported fever and chills within 6 hours of vaccination and lasting about 24 hours with full recovery thereafter.
0 reaction- Pt received Fluzone MDV 0.5ml instead of 0.25ml.
Had a fever and chills for two days. Less than 72 hours after the vaccine, he started to get a small rash on a few different areas of his body. He took medicine to try to help, but by Sunday morning (the next morning) he had to go to the ER because the rash had spread over 90% of his body. Also, he had some chest pain.
generalized body ache which was worse in pelvis and knees; sick as a dog; her temperature went up to 101 degrees; This is a spontaneous case from a contactable consumer. A 63-year-old female patient receive dose 2 of COVID-19 vaccine (UNSPECIFIED TRADE NAME) via an unspecified route of administration in 2021 as a single dose for COVID-19 immunization. Medical history included ankylosing spondylitis. Concomitant medications included etanercept (ENBREL; Solution for injection in pre-filled pen; lot number 1124377) via an unspecified route of administration from Feb2021 at 50 mg frequency unknown for ankylosing spondylitis. The patient previously received dose 1 of COVID-19 vaccine on an unknown date. In 2021 after the second COVID-19 vaccine, the patient was sick as a dog . Her temperature went up to 101 degrees and stayed high for 12 hours. The patient had generalized body ache which was worse in pelvis and knees and had difficulty performing everyday tasks. The outcomes of sick, temperature went up, and generalized body ache were unknown.   No follow-up attempts are possible. No further information is expected.
I developed a left Internal Jugular vein thrombosis with supraclavicular inflammation and pain. I was diagnosed by CT scan and Doppler ultrasound. I have been started on Xarelto 1/11/2020.  Symptoms were localized and are slowly resolving.
1pm: Paresthesia throughout right arm & hand; lost feeling. 1:15pm - slight burning in right palm. 1:30pm - spreads to face. 2pm - elevated blood pressure (155/105), red splotches across chest & right shoulder, right side of face slightly swollen, pale. 2:15pm - blood pressure normalizes (110/75). 2:30pm - splotches go away & color returns. 2:45pm hot flash; feeling returns to fingertips & face, facial swelling gone. 3pm - some feeling returns to arm; burning sensation in palm lessens but remains. 5pm - slight burning sensation in palm remains; right arm tingles & has some lost sensitivity; feeling warm but no fever.
Received 2nd COVID Pfizer vaccine on 1/11/21 and 2 days later noted rash to bilateral arms that progressed to entire body (not hands/feet) within 12 hours.  Did itch.  Denies fever, myalgia, arthralgia, headaches, sob, swelling or any other systemic symptom.  Is self treating with oral benadryl - has not sought medical care with HCP.
pt recv vax; exp itching all over body;exp inflam & redness at inject site;inflam & redness resolved by 7feb96 and itching by 9feb96;
TUNNEL VISION; LACK OF ABILITY TO CONCENTRATE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, 1 total, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAY-2021, the patient experienced general side effects a kind of tunnel vision. Patient would not consider it dizziness, nausea or blurred vision. Patient had clear image of surroundings but it felt like vignette and another side effect was lack of ability to concentrate. Patient nearest experience like this was like being drunk or with anesthesia but with complete motor ability. After a good nap patient was ok, but the next day it went off again, less intense, but still annoying. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tunnel vision, and lack of ability to concentrate. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210550348-covid-19 vaccine ad26.cov2.s -Tunnel vision. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Fatigue directly after the shot, developing into chills at 11pm that evening. Injection site soreness. Woke up at 7am (8 hours later) with a low-grade fever (~99-100F), dizziness, nausea, and a terrible headache. Took an Aleve to help. Symptoms mostly went away by 11pm that evening (16 hours later, 48 hours from injection time). All symptoms besides minor muscle aches were gone by the follow morning.
Patient received the Covid-19 vaccine. He reports symptoms of sudden onset headache 10 minutes post vaccine administration.  Patient then disclosed that he had just had bilateral eye surgery a few days ago.  Slightly elevated blood pressure.  Patient later started profusely sweating and stated that his headache had worsened.  The sharp headache was localized to bilateral temple regions.   1436: BP 145/89 HR 71 O2 97 1445: BP 146/86 HR 65 O2 98   EMS called at 1450 when patient started profusely sweating and patient received the Covid-19 vaccine. He reports symptoms of sudden onset headache 10 minutes post vaccine administration.  Patient then disclosed that he had just had bilateral eye surgery a few days ago.  Slightly elevated blood pressure.  Patient later started profusely sweating and stated that his headache had worsened.  The sharp headache was localized to bilateral temple regions.   1436: BP 145/89 HR 71 O2 97 1445: BP 146/86 HR 65 O2 98   EMS called at 1450 when patient started profusely sweating and complained of worsening headache. Care endorsed to EMS -- patient then refused transport to hospital and left clinic after evaluation by EMS.mplained of worsening headache. Care endorsed to EMS -- patient then refused transport to hospital and left clinic after evaluation by EMS.
10 day menstural cycle (September 14-  10 days long - not when I was supposed to have it).  COVID positive 10/15/22 (cough, sore throat, fever, runny nose, headache, muscle aches, chills)
first dose was pfizer and second dose was moderna; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 IMMUNISATION (first dose was pfizer and second dose was moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced COVID-19 IMMUNISATION (first dose was pfizer and second dose was moderna). On 20-May-2021, COVID-19 IMMUNISATION (first dose was pfizer and second dose was moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: reporter information added On 25-May-2021: reporter information added
pt recv vax 12JUN96 & lab eval revealed a varicella antibody titer of less than 8;
Complained of body aches malaise on 1st day of sx with sudden onset of rash (shoulders, back, neck, back of head)the next day.  Gradual worsening with onset of HA and mild photophobia and admit to Tulane x 24 hrs.  No fever.  Supportive treatment.  Outpt follow-up showing gradual improvement with no rash as of 10 April.
Patient was running up steep incline when he had a syncopal episode on 11/27/2021. He reported feeling short of breath with prodromal symptoms of dizziness, lightheadedness, nausea, sweating and weakness. Patient reports feeling palpitations but denies having chest pain. Syncopal episode was witnessed by patient's mother.
Flu like symptoms; fever, chills, aches. Large, red, swollen, tender injection site.
COVID-19 symptoms started on 07/20/2022; tested positive on 07/25/2022. On the 20th I started with a migraine and vomiting. I went to the ER and they did an MRI and said they saw calcium build up on my brain so I was worried about that. They tested me for COVID-19, Strep, Flu, and RSV and they were all negative. Thursday it was the same thing with the nausea, vomiting, diarrhea, and migraine still. On Friday I started with sinus pressure and coughing and they had given me medications for the nausea which did help calm it down but then on Sunday night I started vomiting again and had a migraine again and started coughing and got hoarse and had a sore throat. Since those symptoms showed up I took a home test and it was positive. Monday I went to urgent care and at that point my oxygen levels dropped low and my blood pressure was going crazy and I got really weak because of the vomiting. They gave me antiviral IV and I immediately got better. Still, even now, I do get bad migraines and nausea time to time. I'm still not able to work because the migraine won't go away. Neurologist can't see me until the end of August.
Looks like a stroke; She became unresponsive; A spontaneous report was received from a consumer concerning a 80-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and she became unresponsive and it  looked like a stroke.  The patient's medical history was not provided. Concomitant medications reported included carvedilol, acetyl salicylic acid and an occasional injection for hives. The last injection for hives was administered a week and a half ago.  On 10 Mar 2021 at 4pm, approximately one day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 027A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 11 Mar 2021, it was reported that the patient became unresponsive and she appeared to be having a stroke. The patient was taken to the emergency room where she underwent treatment.  No other details were provided.  Treatment information were not provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken in response to the events was not applicable.   The outcome of events, became unresponsive and it looked like a stroke, was considered unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
This spontaneous report was received from a currently 87 year old male patient referring on himself. The patient's concurrent conditions included high blood pressure. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 25 mcg/0.5 ml injection, lot#, expiration date, route and dose were not reported. Concomitant therapies included Lisinopril (manufacturer unknown). On an unknown date, after vaccination, the patient began having pins and needles sensation in arm, back and shoulder. The pain started at injection site, and moved up the arm and shoulders. The pain became more intense in shoulder and upper arm. Pain was intermittent. The patient sought medical attention. An unspecified laboratory diagnostic was performed in approximately February 2015 (reported as '6 months ago'). The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Pharmacy administered 2nd dose Shingrix patient 24 hrs Later developed severe whole Body aches, weakness, aphasia, discoordingaiton - Entire episode Lasted 7 days.
Off balance - dx with Ataxia. Unsteady on her feet. Will f/u today? Refer to neuro.
Exposed to COVID19 at daycare on 8/21/22 Began feeling symptoms evening of 8/22/22 - did not want to eat dinner, was fussy, seemed like maybe having stomach pain Informed of positive case at daycare on 8/23/22 Positive home test 8/24/22
Received tetanus injection on 09/02/2001 in Emergency department following a traumatic injury to her left index finger. Pt seen 09/05/2001 in Wound clinic for follow up. Right upper arm red, hot, indurated and tender.
24 y.o. female who arrived  to the emergency department for an allergic reaction after receiving the COVID-19 vaccine today. Patient states she received the first dose of the Maderna vaccine in her left arm around 0910 hours this morning. Patient waited 15 minutes afterwards and within 30 minutes was back working in the trauma unit. However, she suddenly began to experience nausea, chest tightness, palpitations, shortness of breath, throat tightness, light headed, and overall shaky. Patient states she further went down to the vaccine clinic to inform them of her symptoms in which she was prompted to come to the ED for evaluation. She was not given an Epi pen prior to arrival. Patient reports overall feeling better now with only continued tingling in her tongue and fingers, as well as feeling mildly light headed. Patient also states her throat continues to feel tight, but denies any throat swelling. Chest tightness and palpitations have since improved, only with occasional flutters in her chest similar when feeling excited. Denies nausea, rash, itchy skin, or abdominal pain. No history of anaphylaxis or allergic reactions. Patient is prescribed Nexium, but denies taking any other daily medications.  Physical exam shows to be unremarkable with no rash or throat swelling/erythema. Patient does not appear in respiratory distress. Lung sounds are clear.   Will order an EKG. Will administer IV Epipen and IV Benadryl.   Differentials: Allergic Reaction   EKG shows NSR with sinus arrhythmia. Otherwise normal with a rate of 87 bpm.   Patient was observed in the ED for 3 hours with improvement of symptoms. Provided follow up instructions to clinic list. Discussed return precautions. Vital signs are stable at time of discharge  Initial Vital Signs [01/28/21 1019] Blood Pressure 132/91 Heart Rate 85 Respiratory Rate 24 Temp 36.6 °C (97.8 °F) Temp src Oral SpO2 99 %
Approximately 6 weeks post vax pt was diagnosed with varicella limited to left upper extremity.
Individual symptomatic with fatigue on 12/15/21 and sore throat, cough, body aches, HA, and n/v since 12/16/21. Went to local ED and tested negative for flu and positive for Covid on 12/18/21. Currently, in isolation for 10 days. She participated in the (PRIVACY) study and would like the antibody test done after isolation period ends.
This spontaneous report was received from a nurse practitioner referrin to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allegies, concurrent conditions and concomitant medications were not reported. In 2015, the patient was vaccinated with the first and second dose of GARDASIL 9 for prophylaxis (route of administration, lot # and expiration date were nott reported). It was reported that the patient did not receive the third dose. No adverse effects were reported.
Uncomfortable; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles, blister, pain and fear.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced discomfort (Verbatim: Uncomfortable). The outcome of the discomfort was not reported.   It was unknown if the reporter considered the discomfort to be related to Shingles vaccine.     It was unknown if the company considered the discomfort to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-MAR-2023 The case was received from the patient interactive digital media. The patient had shingles twice, first time blisters and sharp pain in legs could go on for 2 years and second time it was on one forth of face. The patient was scared for his/her eye but it was all ok so he/she had the Shingles shots. The patient stated that it was uncomfortable, but could had been much worse. The follow-up could not be possible as no contact details were available.
PATIENT WAS GIVEN AN EXPIRED DOSE PER POLICY. AFTER SPEAKING WITH PFIZER, THE DOSE HAD A 15 DAY GRACE PERIOD SO WAS STILL WITHIN THE TIME FRAME OF BEING GIVEN AND DOESN'T HAVE TO GET ANOTHER BOOSTER DOSE.  PATIENT WAS CALLED AND INFORMED BY DOCTOR ABOUT THE SITUATION THAT OCCURRED AND MADE SURE NO OTHER QUESTIONS WERE HAD BY THE PATIENT.
Vaccine was expired on 01 Apr 2022 and was stored in refrigerator on 04 Apr 2022 and was administered on 11 Apr 2022; Vaccine was expired on 01 Apr 2022 and was administered on 11 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was expired on 01 Apr 2022 and was stored in refrigerator on 04 Apr 2022 and was administered on 11 Apr 2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 11 Apr 2022) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 11 Apr 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01 Apr 2022 and was stored in refrigerator on 04 Apr 2022 and was administered on 11 Apr 2022). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was expired on 01 Apr 2022 and was stored in refrigerator on 04 Apr 2022 and was administered on 11 Apr 2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 11 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The pharmacist said that when the pharmacy received the vaccine on 23 feb 2022 that a staff member looked up the expiration date and came up with an expiration date of Jun 2022. However the expiration date of the moderna covid-19 and confirmed 01 Apr 2022. Date the vials was initially stored in refrigerator was 04 Apr2022. Vials did not undergone any temperature excursions.  No treatment information was reported.
3 cm area of erythema & induration appeared on right thigh within a few minutes of immunization, resolved within 30 minutes.
Pt recvd 3 doses of Engerix-B vax & titer were checked 6 months p/last dose; titer result was 6.2 indicating a low pos response;
Soreness in left arm near injection site; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in left arm on 23Mar2021 at 17:45, as a single dose for COVID-19 immunisation. The patients medical was not reported. The concomitant medications taken within two weeks of vaccination included escitalopram oxalate (LEXAPRO), atorvastatin calcium (LIPITOR), eszopiclone (LUNESTA), psyllium (METAMUCIL), omeprazole (PRILOSEC). No other vaccines are taken within four weeks of vaccination. Prior to vaccination, the patient did not have any symptoms associated with COVID-19. Since having the vaccine, patient had not tested positive for COVID-19. On 23Mar2021 at 17:45, the patient experienced soreness in left arm near injection site. No therapeutic measures were taken. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event vaccination site pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
positive for covid virus; positive for covid virus; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program COVAX US support. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was positive for covid virus. The patient on an unknown date underwent sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
VACCINE ADMINISTERED AFTER THE 31 DAY REFRIDGERATED BEYOND USE DATE BUT BEFORE THE 45 DAY EXCURSION DATE.
Left arm red, hot, swollen and itchy and rock hard.  Developed a cellulitis at the site, requiring antibiotics. Area was 6 inches by 6 inches