chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lightheadedness/dizziness; Vaccine-Related Anxiety; This is a spontaneous report from a non-contactable healthcare professional.  A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  During her 30-minute waiting period after the injection, the patient began to experience lightheadedness and dizziness. Treatment included water and snacks. Follow-up response to treatment was excellent. Patient discharged (pending clarification), she was stable to go home and follow-up with PCP. Differential diagnosis reported as vaccine-related anxiety (include misc mental health) and systemic reaction (hypoglycemia, hypotension, generalized rash). Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Client returned to site c/o n/v, throat pain and swelling, acute headache, hands swelling and numb and "feel like on fire", tachycardia and tachypnea.  No acute wheezing or respiratory distress.  Benadryl 50 mg IM administered.  Transported via ambulance to hospital.
Sore arm Headache- took 600mg Ibuprofen, still headache next day Fatigue Numb face/lips (The feeling after you visit the dentist) about 45 minutes after vaccine. 12 hours later, started to   feel normal. Very slight numb feeling 22 hr later.
Temporary Sensation of numbness in left side of neck. New and Persistent tinnitus in both ears.  New and continued chest pains in both left and right sides.
Patient states that her right eye was swollen and blood shot the day after she received vaccine. She also had trouble breathing and had to use her oxygen more than usual for the next 2 or 3 days.
I have noticed a change in my menstrual cycle for 2 cycles post the vaccine 1st and 2nd docse The 2 cycles have had reduced flows, a reduction of approximately 50%.  I will continue to monitor if the change persists.
No adverse effects to note, but wrong vaccine administered. Patient came in for a Pfizer COVID bivalent booster and was administered a dose of the original Pfizer vaccine instead.
Pt. states that after receiving the 1st dose of Phizer 08/30/2021, started experiencing symptoms 09/02/2021 of Red rash developed with pain right throughout the arm and underneath, Dermatologist?s Biopsy done 09/09/2021 After Biopsy done rash has spread to the hand. 09/17/2021 expected Results of Biopsy.
This spontaneous report was received from a physician through email via healthcare worker refers to a patient of unknown demography. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # J009833 (Expiry: 25-JAN-2015) (dose, route and frequency was not reported). On an unknown date the patient experienced significant pain, redness and swelling at the injection site. The outcome of the event significant pain, redness and swelling at the injection site was unknown. The reporter did not provide the causality between the event of significant pain, redness and swelling at the injection site and the suspect drug. The case is linked to the case 1402USA006209, 1402USA007454 and 1402USA007456 (same reporter link). Additional information has been requested.
Nauseated after receiving vaccine, patient asked to sit in the wheel chair and accompanied by nurse to observation area. Patient feels better. Patient was observed for 30mins
Soreness at injection site. Lasted 3 days. Used arnicare cream & naproxen sodium tabs as directed.
day of shot, no adverse symptoms. second day extreme dizziness . day three mild dizziness and nausea.
Patient recieved a Pfizer monovalent instead of Pfizer Bivalent  on 10/04/22.
Patient presented to the ED with cellulitis of the left lower extremity within 6 weeks of receiving COVID vaccination. She was hospitalized on 5/28/2021 for diabetic infection of left foot.
A week and a half after receiving the Pfizer Booster shot, she began experiencing pain in her groin area, swelling of the right leg, and cramping in the leg. Ultrasound and CT scan done at the hospital on 9/8/21 showed a large blood clot in the groin area as well as 2 smaller clots in each lung.
Patient was scheduled to receive the second dose of Pfizer 5-11 years monovalent vaccine.  Pfizer 5-11 years Bivalent Booster vaccine dose was  incorrectly administered for the second dose in the primary series.  Patient observed for 15 minutes post vaccine administration and no adverse reaction noted upon departure.
Loose stools; stomach ache; body became hot up to her head then red haze seen in room/Body became hot like a hot flash again; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration at Left arm on 21Jan2021 15:45 at SINGLE DOSE for COVID-19 immunization. The patient was not pregnant. Medical history included high blood pressure, arthritis, known allergies: sulfa drugs, dust, mold. Concomitant medication included atenolol, atorvastatin, lactobacillus nos (CULTURELLE), ascorbic acid, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol acetate, riboflavin, selenium, silicon dioxide, sodium metavanadate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc (CENTRUM SILVER ADULTS 50+). No other vaccine in four weeks. The patient's body became hot up to her head then red haze seen in room on first day 21Jan2021 07:00 PM. Body became hot like a hot flash again, no color haze on the second day (22Jan2021). Loose stools and stomach ache on third day (23Jan2021). No treatment received for the events. No COVID prior vaccination, no COVID tested post vaccination. The outcome of the events was recovered in Jan2021.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 12-NOV-2015 the patient was vaccinated with ROTATEQ (lot # L008057, expiration date 01-DEC-2016, oral, dose not reported), which was exposed to temperatures outside of the recommended temperature. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a 85 years old male patient with leukemia refers to himself. The patient did not have any drug reactions/allergies. The patient was vaccinate with ZOSTAVAX (1 time injection, route, dose and lot # and expiration date were unknown) on 03-SEP-2012. No other co-suspects were reported. Concomitant medications included LIPITOR, metformin, BENICAR (reported as BENECAR) and heart medication (unspecified). On 06-NOV-2012 the patient experienced a rash around the injection site and soreness in his shoulder. He stated that the rash extends down to his elbow. No treatment was given for adverse events. The outcome of events were reported as recovering/resolving. The patient did the blood tests for leukemia. The patient had sought unspecified medical attention. Additional information is not expected.
In May 2001, the patient experienced severe arm soreness and general weakness. Subsequently, the patient recovered within 2 days. Additional information has been requested. The medical assistant also reported on 2 additional patients, one patient experienced injection site swelling and redness and cellulitis and the other patient experienced severe arm soreness.
Expired beyond use date from removal of freezer which was on 11/16/21. No treatment needed No adverse s/s
DOSE GIVEN BEYOND 2 HOURS AT ROOM TEMPERATURE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 14:40 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced dose given beyond 2 hours at room temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose given beyond 2 hours at room temperature was not reported. This report was non-serious.
Petechial Rash entire body. Fever to 102 degrees on day 13 post MMR. With possible insect bite day of rash.
for three days post 2nd vaccination, patient broke out in line rashes across the ribs and lower back, neck and shoulders bilaterally.  The rash was raw feeling and at times itchy.  It was criss crossed lines of rash that were within raised whelps.   Benadryl helped relieve the symptoms of discomfort and the raised rash within an hour each time it occurred.
Immediate flushing of face, swelling of throat, nausea,  short of breath, dizzy, blurred vision , increase heart rate
Vaccine breakthrough. Seen in our office 2/28/05 with fever and rash onset 2/26/05. Had maculo papular rash head to toe. Over 200 lesions. Also about 10 vesicles, itchy. All lesions scabbed by 3/2/05. Diagnosed by PNP with varicella at visit.
This spontaneous report as received from a pharmacist refers to a 75 year old male patient. No concurrent conditions, medical history and concomitant medications were reported. The temperature excursion occurred on 26-SEP-2016; the vaccine was exposed to a maximum temperature of 11.6 F for 7 hours and 30 minutes, and a maximum temperature of 6.2 F for 20 minutes. On 28-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX lot # M020902,expiry date:18-JUL-2017 (dosing details was not reported)  subcutaneously for prophylaxis. No adverse event was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1609USA012216:
Moderna COVID-19 Vaccine EUA The area around the injection site is itchy and the redness around it is the size of the palm of my hand. My family doctor wasn?t worried about it and told me to take Benadryl and use Benadryl cream.
36 week pregnant  patient Staff administered Arexvy instead of Abrysvo; Inappropriate age at vaccine administration; 36 week pregnant  patient Staff administered Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a nurse via sales rep and described the occurrence of vaccine exposure during pregnancy in a 26-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 18-OCT-2023, the patient received Arexvy (left arm). On 18-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration) and wrong vaccine administered (Verbatim: 36 week pregnant  patient Staff administered Arexvy instead of Abrysvo). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 36 week pregnant  patient Staff administered Arexvy instead of Abrysvo). The outcome of the vaccine exposure during pregnancy, inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 18-Oct-2023 26 year old female who was 36 week pregnant (4th pregnancy) received Arexvy instead of Abrysvo on the day of reporting about 8:30 am.  Patient identified the error when given the VIS form.   Patient was not upset with them and was willing to do whatever was best for her baby. The reporter did not consent to follow-up. A pregnant patient received a dose of Arexvy instead of Abrysvo at an inappropriate age, which led to vaccine exposure during pregnancy,  inappropriate age at vaccine administration and wrong vaccine administered.
11/26/07 Seen by PCP-for headache with watery eyes, skin rash. 11/27/07 weakness in facial and lip area, (L) eye would not shut. 12/3/07 Headache, insomnia, 12/7/07 weakness, earache, 12/10/07 weakness, 12/14/07 weakness; 1/4/08 weakness; 2/4/08 Idiopathic peripheral neuropathy 5/7/08-records received for DOS 12/14-12/21/07-DC DX: Guillain-Barre syndrome. Onset of left side of face Bell's palsy on 11/25/07. Day before experienced bifrontal headache. Two weeks ago experienced weakness of lower extremities and became progressive to point he could no longer ambulate. Difficult time standing from sitting . Now has mild weakness in upper extremities. Paresthesias of all four extremities. Fell recently. DTRs absent throughout. Lumbar puncture unremarkable. IVIG treatment.
Immunization given 3/10/04. On 3/12/04 pt seen with 12cmx4cm edema/erythema right upper arm. Given Benadryl and Motrin. Pt returned on 3/24- Rx gone right arm within normal limits. Pt without complaint.
05/21/2021 Shingles shot 1st 05/21/2021 arm couldn?t move it, 2 weeks elbow pain. Pain eventually subsided.
Four days later, patient developed single blisters on her right side of body.  Valacyclovir is being used to treat shingles.
I first noticed a pronounced rash and swollen lymph nodes under my left arm within 72 hours of my second vaccination. Within 24 hours of that, I noticed that I also had swollen lymph nodes and a rash under my right arm. The rashes were especially sensitive to the touch. The swelling and redness of the rashes became more pronounced over the following days and weeks, and then they gradually began to subside until they finally resolved themselves about 3 or 4 months after the vaccination. During this time, I corresponded with Dr. via email. He advised me that the rashes were likely a result of the vaccination and that they should resolve over time. However, if they got worse, I was to notify him. Since the rashes eventually resolved themselves, I never had to make any in-person visits to the doctor's office.
Fever, headache, nausea, pain all over body, muscle spasms, feeling weak.
Per parent 9 days after MMR, VUX, PCV, H1N1 vaccine. Pt had a febrile seizure was seen & hospital per mom. We have no records from Hosp. - Mom just informed us 3-2-10.
CC - redness, soreness, hot to touch, pain, difficult to move arm - referred to PCP which referred her to ER. Treat with Antibiotics and discharged with DX of cellulitis.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: swollen eyes only, still swollen, pt calling pcp
Exposed to COVID before first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Exposed to COVID before first dose of vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Exposed to COVID before first dose of vaccine). At the time of the report, COVID-19 (Exposed to COVID before first dose of vaccine) outcome was unknown. Split for coding      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Patient stated that she is using Monocrobial Antibiotic Treatment for COVID-19
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2014, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date later in 2014, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Herpes zoster. The patient claims damages including: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown. Additional information has been requested.
Patient age 17 was administered Moderna vaccine on the Red mobile unit.  Age limit for Moderna is 18.
COAGULOPATHY, UNSPECIFIED TYPE OBSTRUCTIVE SLEEP APNEA
DID NOT COMPLETE DOSES ONE WEEK PRIOR TO TRAVEL; This spontaneous case report was received from a consumer (PVX2019-392) on 12-Feb-2018. The report describes a 23-year-old female consumer who "did not complete her doses one week prior to travel". The consumer was receiving Vivotif (lot number: 3003239 and expiry date: Oct 2019) for an unknown indication.  It was reported that the consumer started Vivotif yesterday and she will be going out of the country tomorrow. She would be arriving in foreign country in about two days.  The action taken with Vivotif with respect to the event "did not complete her doses one week prior to travel" was not applicable.  The clinical outcome of the event "did not complete her doses one week prior to travel" was unknown.  Company's Comment: The causality of the event "did not complete her doses one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete her doses one week prior to travel" was considered as not applicable.
Swelling to leg "mom states 2" above". Taken to ER and was put on antibiotic and instructed to give Benadryl. It is still swollen.
Arm sore for one day, for three days I have ran a temperature (101) every six to eight hours I've had to take tylenol, I'm weak, my body aches, I've had a severe headache, a slight runny nose, a slight cough, and a runny nose, and my hands have a tingling feeling.
Patient was supposed to commence series with DOSE 1 MODERNA RED CAP MONOVALENT. Patient received MODERNA BIVALENT BOOSTER. Patient denies any adverse symptoms; to return to this clinic to receive the appropriate Covid vaccine.
Patient was vaccinated on Sunday; by Wednesday she was noting some redness under her arms and breasts. By Thursday she had welts in those areas in addition to her legs. They were somewhat relieved by calamine lotion, but she contacted us on Friday for further consultation. She did not have a reaction to her primary series. She does not report any new source of allergens such as laundry detergent or soap. Advised patient to take OTC diphenhydramine and contact her PCP if they were not relieved in 24 hours.
Rash on neck, inner aspect of biceps bilaterally, erythematous papular 2-5cm, consistency, pruritic. No fever - hx of chicken pox as child.
Patient reported swollen, red, chapped lips after both doses of Covid-19, commencing one day after each vaccine. Condition improved several days after first dose, then recurred and improved again before second dose, after which it once again flared. Doctor prescribed triamcinolone to treat.  Second dose administered 12/10/21 lot FD7218.
Patient called on 11/12/2020 around 11am to report of adverse events related to her vaccination on 11/11/2020.  She reported swelling at both injection sites on the left arm.  Patient said in the evening she developed a headache and body pain.  She had arm soreness in the evening and into the night which caused her not to sleep well.  This morning she wasn't able to move her arm (lift arm up) and had to call out of work.  Patient took a dose of ibuprofen 600mg which she had in the house to help with the pain.  She also had starting placing an ice pack at the site of injection before calling the pharmacy.  Patient will contact her doctor if the pain and arm soreness continues.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    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 HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided
Temp of 101.4 Achiness  Right arm is so sore unable to lift it  Nasal congestion Lethargy Exhaustion  Loss of appetite  Basically feel like I have COVID all over again except I have not had diff breathing at this time
Around the end of January 2023, I started getting a black spot in my vision on my right eye and it would dance around. I spoke to my primary doctor, and she referred to the eye clinic. Teh eye clinic diagnosed me with a retinol tear. They had to a laser treatment around the area to ensure it didn't tear further. I'm still in the recovery process. I will have to see them a couple times this year and then yearly visits after that. Still have the dark spot but it is stable for now.
having some adverse reactions; numbness and tingling in arm; tingling in arm; fever 102.3; chills; fatigue; myalgia; nausea; vomiting; diarrhea; A spontaneous report was received from a nurse concerning Unknown patient, participating in the Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  experienced sme adverse reactions.   The patient's medical history, is npt provided by the reporter.  Concomitant medications were not reported.   The patient received their first of two planned dose of mRNA-1273 on 19JAN2021.The patient received their first of two planned doses of mRNA-1273 in(Lot number: Unknown) for prophylaxis of COVID-19 infection.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events were unknown.   The reporter did not provide an assessment for the events.  Since no Seriousness criteria is reported , hence the case is considered to be Non-serious.
pt recv vax; 4 days later; T spiked to 101; fever; mild sz; mom has had febrile sz & epilepsy' dx of febrile sz;