chrisvoncsefalvay/vaers-outcomes huggingface dataset:
walked out of the building got into my car and noticed floaters in my left eye; see streaks of light in the corners of both eyes that I never had prior to the vaccine; black spots at times that are floaters in my eyes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 12:00 (Lot number: EW0161) as dose 2, single and administered in arm left, administration date 25Mar2021 12:00 (Lot number: ER8732) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHYROID. The following information was reported: VITREOUS FLOATERS (non-serious) with onset 25Mar2021 12:00, outcome "not recovered", described as "walked out of the building got into my car and noticed floaters in my left eye"; EYE DISORDER (non-serious) with onset 25Mar2021 12:00, outcome "not recovered", described as "see streaks of light in the corners of both eyes that I never had prior to the vaccine"; VISUAL IMPAIRMENT (non-serious) with onset 2021, outcome "not recovered", described as "black spots at times that are floaters in my eyes". Therapeutic measures were not taken as a result of vitreous floaters, eye disorder, visual impairment. Additional information: Clinical course includes After Patient received first vaccine she walked out of the building got into the car and noticed floaters in left eye. She thought it was a hair in her eye but it was not.  From that point on She see streaks of light in the corners of both eyes that she never had prior to the vaccine. She also now have black spots at times that are floaters in her eyes.Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/Military facility. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031220A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: On 29-JUL-2021, A follow up received where Outcome of event was updated from unknown to ongoing/Not recovered and reporter's demographics was added.; Sender's Comments: .
SHINGRIX antigen mixed with Merck sterile diluent and administered to patient Sub-Q. Pt contacted on 4-8-18 and came in to receive correct SHINGRIX vaccine IM.
Night of woke with extreme chills. Next day extremely Fatigued and an instant headache. Sleeping 12-14 hours a day. Continued fatigue for 3 months and daily head aches continue to date. No previous headaches, ever. MRI shows bone marrow abnormalities. Rferred to hematologist/ oncologist. High Blood pressure and continual UTI which is current. Treated twice, antibiotic resistant. Have only had 2 prior UTI twice in whole lifetime.
Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from non-health care professional. This case involves a 58 years old patient (gender was not reported) and caller stated that a 58 year old received the high dose and should have received the FLUBLOK, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 10-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UI995AA) (expiry date, dose in series and route was not reported) in the left deltoid. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. No adverse effects were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Severe Hives on face and neck.  Benadryl administered.  Hives continued throughout the evening.  She awoke and they were gone
HAVEN'T BEEN ABLE TO SLEEP FOR 2 DAYS; I AM IN SO MUCH PAIN/JOINTS FEEL LIKE THEY ARE ON  FIRE TO THE POINT WHERE I WANNA RIP MY ARMS OFF; This spontaneous report received from a patient via a company representative 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced haven't been able to sleep for 2 days, and i am in so much pain/joints feel like they are on fire to the point where i wanna rip my arms off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from haven't been able to sleep for 2 days, and the outcome of i am in so much pain/joints feel like they are on fire to the point where i wanna rip my arms off was not reported. This report was non-serious.
Patient has reported that on her Right arm where PNEUMOVAX 23 was administered, she has experienced swollen large area that was red with raised margins, and it was warm to touch. Patient had no fever. Patient took KEFLEX antibiotic that she had at home and symptoms were resolved over couple days.
Day after shot, daughter got light headed and dizzy at school, had to lie down. Became pale and a little sweaty. Blurry vision for a moment.
pt recv vax & appeared to be suffering from abd cramping & was irritable; mom also noted pt appeared to be in pain while nursing; pt did not receive any further doses of Hep B vax;
Temp. excursion lasted 13h, 35.7°F, Vx administered; This case was reported by a other health professional via other manufacturer and described the occurrence of intercepted product storage error in a patient who received Rota (Rotarix lyophilized formulation) (batch number 7L2D7, expiry date 24th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 3rd January 2023, the patient did not receive Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 3rd January 2023, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-JAN-2023, 11-JAN-2023 Reporter's comment: The reporter was certified MA (Medical assistant) called on behalf of facility. The temperature excursion lasted 13 hours and lowest temperature reached was 35.7 degrees Fahrenheit. The reporter clarified that patient did not receive the vaccine involved in the temperature excursion. Additional Supportive Information: The reporter was reporting that patient did not receive Rotarix after temperature excursion, which led to intercepted product storage error.; Sender's Comments:  US-GSK-US2023AMR001933:Same reporter
Patient reported some redness, pain and swelling around the injection site that developed the day after the injection. She initially thought it was from the bandaid but she did not have the same reaction on the other arm where she also had a bandaid from another injection.
10/1/2022 I had a sore throat, coughing, spitting clear mucous and was diagnosed with acute Bronchitis. I started an antibiotic and prednisone. I was sick for the entire month of October. Since then, I have been sick two more times with the same symptoms. I was prescribed antibiotics and prednisone for both times. The first night after starting these medications, I wake up soaking wet. Since the 4th vaccination, I have been sick with these symptoms every other month. On 5/22/23 I had a sore throat, nonstop coughing, spitting clear mucous at first then turned yellow. I went to the doctor yesterday. I was tested for Strep. The rapid test was negative, but am still waiting for the results of the one sent off. I was prescribed antibiotics and prednisone.
Patient received 2 vaccines. Patient fainted while sitting in chair in lobby. Family member notified pharmacist and parent in immunization room. Patient was moved from the floor back to the chair and vomited. He had a small cut on his right eyebrow. Patient stated he had not eaten. Patient was stable and left pharmacy 30 minutes later.
Information has been received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored PEDVAXHIB (lot# reported as M007762, expiration date 07-FEB-2018, strength, dose and route were not expected). There was no previous temperature excursion. Digital data logger involved. The vaccine had been stored under the lowest temperature of 0.8 Celsius degree for cumulative 2 hours 41 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The pt's mother noticed a reddened area that was 2x1 inch in diameter on his right thigh up to his buttocks on 12/28/00. On 12/29/00 this area became ecchymotic. On 1/4/01, the pt's mother noticed small slightly raised reddened bumps and red "lines" 1 inch long appearing randomly on the left thigh form mid thigh to the knee covering an area of 1 1/2/ in wide by 2 3/4 inches long. On 1/6/01, the mother noticed the rash and ecchymotic area had disappeared. No further symptoms noted.
Fever, malaise, decreased appetite for 1 day, responded very well to 1 dose of Tylenol and a good night sleep. No symptoms next day
The patient was given the Covid Pfizer BioNTech vaccine on 05/05/2021 with the incorrect diluent ( sterile water for injection was used instead of preservative-free normal saline) with no adverse outcome to the patient.    MD was notified and the patient was monitored.
This spontaneous report was received from a 53 year-old female licensed practical nurse referring to herself. There were no concurrent conditions or medical history reported. The patient presented an amoxicillin (+) clavulanate potassium (AUGMENTIN) and sulfonamide (SULFA) allergy/reaction. Her concomitant medication included an unspecified eye lubricant. On 17-APR-2017, the patient was twisting off a cap of a ROTATEQ when the vaccine splashed into her right eye, so she flushed her eye out right away. The patient's eye felt irritated but she did not sought medical attention and no laboratory diagnostic studies were performed. It was reported that the patient has been working at facility and "no other eye history" was noted. At the time of the report, she had not recovered from the adverse event. The causality between the adverse event and ROTATEQ was unknown.  Additional information is not expected, as no consent to contact the reporter was granted.
THAT EVENING SHARP KNIFE COMING OUT OF RIGHT BUTTOCK CHEEK SEVERAL TIMES OVER 15 MINUTES;  SO MUCH PAIN YELLED OUT EACH TIME;  STOPPED;  PAIN RIGHT HIP SPREAD ACROSS LOWER BACK TO LEFT HIP.  HORRIBLE PAIN.  COULDN'T STAND UP STRAIGHT IN THE AM FOR SEVERAL DAYS.   USED LIDOCANE PRESCRIPTION PATCHES AND HOT SHOWERS AND TYLENOL.  AFTER 2 WEEKS APPROX WENT AWAY;  CAME BACK A WEEK LATER. FOR 3 DAYS AND DISAPPEARED AGAIN
2/19/21 Seizure lasted >90 minutes. To hospital via ambulance then flew to another hospital. HR down to 60, complex status epilepticus, w/ fever. CT scan normal, Labs normal, EEG normal, no further seizures. He did develop a roseola rash
swollen lymph node, arm pain and loss of range of motion concluding to adhesive capsulitis
Approximately 9 days post vax the pt experienced an oblong red rash with 3 pin point sized bumps. The pt was afebrile The pt sought unspecified medical treatment. No further information is available.
Developed rash on the day after her vaccine, some swelling at injection site that lasted 1 day and then resolved; patient was seen for office visit and diagnosed with pityriasis rosea
Vaccine dose noted was second dose in earlier reporting.  Patient was admitted with GI symptoms and was found to have heart block with up to 12sec pauses, requiring transvenous pacemaker.  Patient did have dizziness, symptoms resolved with supportive treatment (transvenous pacing/NSAIDs and colchicine).  The patient does travel for work and had an intercurrent URI about 10/10 so a secondary workup was performed
Patient reported tightness in throat and swollen glands after injection.  Rapid response called.  Returned to work with a follow up check by rapid response.
I received a shingrix vaccination at Pharmacy approximately nov 10th, mild rash was noted on chest about nov. 18th. By November 20 the rash was prominent and pruritic and distributed thru my groin, arm pits, chest, scalp and back. On Thursday Nov. 21st I saw my pcp Dr. at Primary care who consulted with a dermatology practice. I then left for an immediate dermatology consultation. I was examined by PA-C on Nov. 22nd. Her diagnosis was hives, given no other changes in diet, household products, etc. we suspected my Shingrix vaccination and the proximate cause. PA-C started an immediate treatment with prednisone, cetirizine, montelukast. Additionally I applied generous OTC Benadryl gel to the affected areas. The hives are responding to this initial treatment. My only other allergy is to wasp / bee venom.
Bell's palsy; This is a spontaneous report from a contactable Nurse (patient).  A 64-year-old Female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Feb2021 at single dose in left deltoid for COVID-19 immunisation at the age of 64-year-old. Lot number was EN6200. Relevant medical history and concurrent conditions included Herpes zoster/ shingles, Bells palsy, overweight. Concomitant medications included ergocalciferol (Vitamin D) for her bones and that kind of stuff. First dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was received on 21Jan2021 for COVID-19 immunisation at the age of 64-year-old. Historical vaccine included typhoid, malaria and yellow jacket. Patient initially confirmed she has had no reactions after prior vaccinations. On 06Mar2021 at 02:30, the patient experienced Bells palsy; the event was considered Medically significant; the patient visited emergency room; the patient was given Zanamivir, antiviral in the Emergency Room. The patient had been told by other people that she should get started on a steroid, so she started prednisone, prescribed by the NP at her primary care. Patient had right facial paralysis right at the time of report, it was slightly worse than when she first noticed it. The patient did not think she has reached the maximum of the Bells Palsy and she had to drink coffee out to of a straw and issues with her words. The patient did not recover from the event. The reporter mentioned that she has had several family members who have had Bells Palsy. The odds that she received something that could trigger some kind of immune response, the time frame, the fact she got the vaccine, also fact she has a history of shingles she would have to associate with the vaccination. The reporter had done mission work and has never had a reaction to any of the vaccines that she received for that.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
HCP states that this vaccine was given subcutaneously instead of IM; A 12 month old child who was supposed to receive a VARIVAX vaccine, was accidentally given a VAXELIS vaccine.; the patient's injection site was red and swollen; the patient's injection site was red and swollen; This non-serious spontaneous safety report with reference number 02263229 was received by a partner on 06-OCT-2022 and forwarded to agency on 07-OCT-2022 from a physician. Additional information was received from a partner on 06-OCT-2022 (reference number 02263129) and on 07-OCT-2022.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "the patient's injection site was red and swollen".  Due to the nature of the event, the causality between Vaxelis and the reported events of "A 12-month-old child who was supposed to receive a VARIVAX vaccine, was accidentally given a VAXELIS vaccine and HCP states that this vaccine was given subcutaneously instead of IM" was not applicable.  Further information is expected.
sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient gargled with Listerine last night (11Apr2021) and the sore throat went away but returned the following day (12Apr2021).  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I was talking to my daughter on the phone and my right eye felt like I had something in it. My vision started getting dim. It would go back to normal, black, white, dim then back to normal. At one point I saw something round and white in my eye and a speck of blood attached. This last through the night into the next morning. In the afternoon, of the next morning, everything just stopped. I have not had any problems since that day.
At 3PM on 12-17-12 patient had fever (103 degrees), chills, & cough. Fever has gone but cough remains.
Information has been received from a consumer concerning a 12-month-old male who, on an unknown date, was vaccinated subcutaneous with 0.5 ml dose of MMR II. On an unspecified date, post vaccination, the patient developed a measles like rash. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. No further information is available.
Patient came to employee health for her Hep B series. She thought that she had completed her series when she worked at a nursing home. Unable to locate dates. Decision made to start series over instead of declining. Received the shot 3/5/08 about 10am and went home early that next morning from working 3rd shift with vomiting/diarrhea/hives and itching. Hospital has had many employees out with nausea, vomiting, and diarrhea.
weakness-fell to the ground stomach upset on Dec 6, 2008 and on Dec 7, 2008
pt recv vax 6NOV97 approx 730PM waited @ hlth dept approx 20min p/vax;went home & noticed hives on stomach;called hlth dept RN told to call 911 immed;approx 845PM;began to notice hives on back & arms, lips began to swell;
chills; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3249), via an unspecified route of administration in the left arm on 13Jan2021 10:00 at a single dose for COVID-19 immunisation. Medical history included Hypothyroidism controlled with meds. Concomitant medication included levothyroxine. On 14Jan2021 0130 (reported about 14 hours after injection), the patient experienced chills. The chills occurred about 2 in the morning and lasted only a short while. The patient had not tested for COVID post vaccination. The patient did not receive treatment for the event. The outcome of the event was recovered in Jan2021.
Generalized pain, intensified in neck. Headache. Fatigue. Feeling hot but no fever
experiencing a breakout of a rash; Hives; Swelling/My back is swollen, it is very itchy; Itching/My back is swollen, it is very itchy; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0217, expiration date: unknown), via an unspecified route of administration on 07Jun2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history included allergic to sea food and tomatoes and things. The patient's concomitant medications were not reported. On an unspecified date the patient experienced a breakout of a rash, hives, swelling/my back is swollen, it was very itchy. The patient wanted to know If she can take a Benadryl to relieve the itchiness for the allergy. She didn't know If she ate something or it's from the actual shot because she took this vaccine and this was her first shot. She doesn't want to take any kind of medication that might interact with it. So she called to get permission or find out if she can take the Benadryl to alleviate the hive that cause her skin is very itchy. Some kind of allergy medication to relieve the hive because her back was swollen, it was very itchy and don't want to keep scratching and make it bigger and bigger. Patient is scheduled for 2nd dose of vaccine on 02Jul2021. Outcome for the events was unknown.