chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got his retina detached; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization), for COVID-19 immunization. The following information was reported: RETINAL DETACHMENT (medically significant), outcome "not recovered", described as "got his retina detached". Therapeutic measures were taken as a result of retinal detachment. Additional information: The reporter states that the reporter has a friend who got a dose of the Pfizer Covid 19 vaccine and got his retina detached, she further shares that they had to fly to (State name withheld) to get it reattached. The reporter asking for information regarding retinal dettachment and/or retinal problems being reported as adverse events when taking the vaccine. Reporter also states that reporter himself has not experienced any problems with the vaccine. Is report related to a study or programme: No. The reporter states a patient reporter knows got a detached retina in patient eye when patient got the booster. Reporter states that reporter doesn't know if the guy was joking or not since people make covid jokes all the time, but he said that was a side effects of the booster shot. The guy was on vacation and had to be flown home and have emergency surgery on patient eye, they fixed it but then 2 weeks later it detached again. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Obtained both Tdap & PNEUMOVAX 9/10/12. Reports hard, hot lump upper lateral (R) arm, swelling, pain. Redness/swelling moving inferiorly. Rx: OTC ZYRTEC as directed on bottle; warm packs to site qid.
atrial fibrillation; hear started racing; shakiness; didn't feel good; fever; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation), PALPITATIONS (hear started racing), TREMOR (shakiness), MALAISE (didn't feel good) and PYREXIA (fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 013M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced TREMOR (shakiness), MALAISE (didn't feel good) and PYREXIA (fever). On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) and PALPITATIONS (hear started racing). In October 2021, TREMOR (shakiness), MALAISE (didn't feel good) and PYREXIA (fever) had resolved. At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation) and PALPITATIONS (hear started racing) had resolved.            Concomitant medications included were cholesterol medication, sinuses medication (allergies). No treatment information was provided.  Company comment This case concerns  a 71 year old male , with no reported medical history , who experienced , Non-serious  , unexpected. AESI  event of Atrial fibrillation , which occurred  2 days after vaccination with the 3rd dose (Booster dose) of mRNA-1273 vaccine (Moderna Covid 19 Vaccine). The re-challenge for this case is not applicable since the event occurred on the 3rd dose and no additional doses will be given. The benefit risk relationship of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) is not affected by this report. This case was downgraded from serious : Medically Significant to non-serious .   This case was linked to MOD-2021-377177 (Patient Link).; Sender's Comments: This case concerns  a 71 year old male , with no reported medical history , who experienced , Non-serious  , unexpected. AESI  event of Atrial fibrillation , which occurred  2 days after vaccination with the 3rd dose (Booster dose) of mRNA-1273 vaccine (Moderna Covid 19 Vaccine). The re-challenge for this case is not applicable since the event occurred on the 3rd dose and no additional doses will be given. The benefit risk relationship of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) is not affected by this report. This case was downgraded from serious : Medically Significant to non-serious .
Two days after patient's first vaccine@ about 4 pm, I could tell that something was wrong with her. Every day she and I play cards, but this day she was really struggling. She couldn't figure out where any of the cards went, and was missing every play. I tool her up to lay down. At about 6pm, her eyes looked really glassy and she was unable to speak clearly. Her words were very slurred, and her sentences did not make any sense. I called 911, and they came and took her to the ER. The doctors said that she had a small stroke. She was put on a low dosage of blood pressure medicine, and was hospitalized for 6 days to monitor her. During that time many tests were run on her.  2nd Vaccine- 2-24-21 Two hours after returning from getting the second vaccine, the patient went upstairs to go to the bathroom and she passed out onto the bathroom floor. Again, when talking to her, her words were slurred. She was very weak. I called 911 again. Initially they were not going to take her, but when she went to get up she fell back down. She was too weak to walk, so they took her to the ER again. She was released to go home that evening. Sher saw her primary doctor and was referred by her oncologist to see a hematologist. She endured a three month waiting period until she could be tested for APLS. She will go this Friday to find out the reslts of that test. Additionally, she saw her vascular neurologist, Dr. He looked at her scans and said it was NOT a stroke. He said that  her body basically had a surge as a result of trying to fight off the vaccine. He said that the CAT scan that was done at the time she went to the ER the first time did NOT indicate signs of a new stroke, but that what they were seeing on the scans was from her past stroke. Dr. said that he saw no indication that she had another stroke and that her body was just reacting to the vaccine. He said that all of the symptoms that she had were all things that could happen because of the surge.
got their second shots today (7 days early); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got their second shots today (7 days early)) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form(s). On 04-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got their second shots today (7 days early)). On 04-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got their second shots today (7 days early)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-102768 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-102768:
The patient did not experience any other AE; caller said the patient received a dose after a temperature excursion occurred.; This spontaneous report was received from medical assistant, referring to patient of unknown date and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-JUN-2022, the patient was vaccinated with one dose rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #1858935 has been verified to be a valid lot, expiration date: 25-MAR-2023), administered orally for prophylaxis (strength, route of administration and anatomical location was not provided).   Additionally, it was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent to a temperature excursion of 9.8 degree Celsius (°C) for 47 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported
pt experienced itching in upper torso area starting 2-3 days after vaccination, splotches appeared at this time and have not resolved at this time Pt also experienced blurred vision in her right eye with eye twitch starting 5 days after vaccination
Two days after administration developed erythema multiforms with red rash on ankle and wrist edema.
I had a stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 16:45 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing). No known allergies reported. The patient took concomitant medication included Zquil medications in two weeks. Patient did not have covid prior vaccination. Patient was tested for covid post vaccination. Patient did not receive any other vaccine in four weeks. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, medically significant, life threatening) with onset 09Sep2021, outcome "recovered with sequelae", described as "I had a stroke". Adverse event: Patient had a stroke 9 days after vaccine. The patient was hospitalized for cerebrovascular accident (hospitalization duration: 2 day(s)). The event "i had a stroke" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: echocardiogram: (unspecified date) unknown results; electrocardiogram: (unspecified date) unknown results; heart rate: (unspecified date) unknown results; laboratory test: (unspecified date) unknown results, notes: Many Tests; magnetic resonance imaging: (unspecified date) unknown results; sars-cov-2 test: (12Oct2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of cerebrovascular accident included many tests, MRI, EKG, heart monitor, ECHO.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Patient was given vaccines that system showed  were due. When entering vaccines into system  there were some previous vaccines given on the date of 7/14/21 that were showing "not valid". Once it was researched we found the date was entered wrong into system and should have been 7/14/2022.  So the vaccines that were given on 10/18/2022  were not due and the vaccines were repeated.  Mom notified to contact clinic or go to ER if any reaction occurs. Patient is well with no reaction or adverse affects of vaccines given.
48 hours after vaccine administration developed facial swelling, facial rash, and dyspnea.  Given epi pen x 2 and transported to hospital.
Pt recv vax on 1/25/99;  pt exp painful, stinging upon injection; immediate queasiness; red line on skin-knuckles of left hand up arm; headache
This spontaneous report was received from a register nurse, concerning an unknown number of patients  of an unknown gender and age. Medical history and concurrent conditions were  not reported. The register nurse reported that on unspecified dates between 22-AUG-2014 and 10-SEP-2014, up to 27 doses of vaccinated with (Oka/Merck) VARIVAX (dose number and route were not reported), 0.5 ml, lot number K006137 expiration date 29-APR-2016, K002923 expiration date 26-FEB-2016 and J005253 expiration date 26-APR-2015 underwent an unsupported temperature excursion were received by unspecified patients. No adverse experiences reported. Co-suspect and concomitant therapies were  not reported. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Nausea without vomiting, fever to 102F first night. Right deltoid warm to touch and had difficulty moving the arm. Had tenderness under arm (axillary) and "difficulty breathing that night". Pt was given 2 aspirin X 3 in 24 hours. Follow-yp with MD office on call MD and use Advil, ice and Tylenol.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-MAY-2015, the patient was vaccinated with improperly stored MMR II lot # K008814 and 19-JUN-2016 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
None of the patients reported symptoms. No Additional AE's/PQC's were reported.; Improperly stored PEDVAXHIB has been administered to patients; This spontaneous report was received from a staff from an outpatient care, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  From 24-MAY-2021 to 25-MAY-2021, a temperature excursion occurred as haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T026067 has been verified to be a valid lot number, expiration date was reported as 01-APR-2023) was stored under 54.3 Fahrenheit (F) for 1 hour and 20 minutes, 55.0 F for 7 hours and 10 minutes and 56.8 F for 2 hours and 35 minutes. The temperature excursion was recorded by digital data logger. There was no previous temperature excursion. On 22-JUN-2021, the patient was vaccinated with the improperly stored vaccine (strength and route were not reported) 1 (unit not provided) for prophylaxis. The patient did not report symptoms. No additional adverse events (AE) or product quality complaints (PQC) were reported.  This is one of several reports received from the same reporter.
Pt vaccinated w/DTP/OPV developed fever 103-107 w/convulsions 2JAN91, 12 Midnight -taken to ER was treated w/Tylenol supp.
fever; muscle pain; headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever), MYALGIA (muscle pain) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Breast cancer and on chemotherapy treatment).    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), MYALGIA (muscle pain) and HEADACHE (headache). At the time of the report, PYREXIA (fever), MYALGIA (muscle pain) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were not reported. No treatment information was provided.
After Dose #1 (04/30/2021) - mild expected symptoms plus muscle tension; pain in both hands; After Dose #2 (06/30/2021) - increasingly unwell as the day went by, fever 104, high blood pressure; Was seen in Emergency room of hospital 6pm (day of shot) and kept there until dawn of next day.  Diagnosis: allergic reaction to shingles shot.  Gradually, as the days went by pain in both arm increased, numbness and tingling, and burning pain, neck pain, Left arm near lymph node stabbing--shooting pains, inability to sleep through the night due to pain; Fingers lost strength; unable to twist jar tops off; generally painful to use hands.  Was seen in doctors office and also by physical therapist.   16 Sessions PT.
This spontaneous report was received from a consumer and refers to a female patient of unknown age. The patient was allergic to sulfa drugs and unknown antibiotics. No information regarding the patient's medical history or concomitant medications was provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route of administration, lot # and expiration date were not reported) to prevent pneumonia. On an unknown date, after receiving the vaccine, the patient experienced headache, swollen arm and rash no legs. No lab test were performed. The patient did not seek medical attention. An unspecified treatment was given for the adverse events. The outcome of all adverse events was reported as not recovered/not resolved. The relatedness between all adverse events and PNEUMOVAX 23 was not reported.
The patient was given KINRIX instead of separate vaccine DTAP and IPV. Which the doctor ordered separate vaccines. I made the error and combined both vaccines instead. Pt. has not called with any complaints.
Client was given booster dose of Pfizer on 12/29/2021. Client has already received 3 doses of Pfizer and last dose of Pfizer was given on 08/27/2021. Booster dose administered on 12/29/2021 was administered too early according to protocol. Supervisor spoke to the client on 12/29/2021 and client was made aware of this error.
Large local reaction and persistent headaches with vertigo, fatigue, memory changes and tinnitus. Pt reports she had her first anthrax vaccine in FEB2003 without any significant local reaction and without significant systemic systems. She received her second anthrax vaccine on PM of 2/28/03 over her right deltoid area. That night, she noted increased redness, swelling, warmth and tenderness at the vaccination site. She felt feverish with a headache and generalized body aches, so she took Tylenol before going to bed. She recalls not sleeping well through the night, primarily due to her headaches She had gone to Tampa for the weekend. On Saturday, she had planned to go to amusement park, but cancelled secondary to feeling bad. She continued to feel feverish, with chills, and complained of a headache, generalized body aches and fatigue over the weekend. The vaccination site was surrounded with redness, swelling and increased warmth and was significantly tender. on Monday, 3/3/03, she went to the clinic for evaluation of her anthrax  vaccination reaction. the clinic note form her evaluation on 3/3/03 states that her smallpox site (received 2/20/03) was evaluated and felt to be a major take. She had no axillary lymph nodes. Her temp was 97.1. Her anthrax vaccination site was surrounded by an 8cmx5cm area of swelling and erythema on the right arm. She was given 48 hours quarters and instructed to take Motrin for pain and Zyrtec for pruritus due to local irritation. She noted the local reaction diminished over the next 1-2 weeks, except she still has a small, nontender knot at the vaccination site. She was given an exemption for her third anthrax vaccine. Prior to March 2003, pt considered herself to be in good health. Since that time, she has continued to experience chronic headaches with vertigo, fatigue, memory changes and tinnitus.
Fever started 7 hr after immunization & peaked at 102 degrees (15 hrs after immunization). Tingling both legs from 3-11pm on 9/13. Pt reported being very tired from 11 am-3pm on 9/13 slept overnight & felt fine on 9/14.
Soreness in arm soon after shot.  Fatigue, mental fogginess,  body aches at joints and back, insomnia, night sweats. All began that evening and continued.  I expected them to moderate but they continue.  Also experiencing  stomach queziness intermittently.
No adverse event. No reaction reported from patient at this time  Reason for the form is Moderna COVID vaccine given to 16 year old,  not authorized to give under age 18.
4 mo old given imm 3/9/06 at 9:30 am given Pediarix/Hib/Prevnar given Tylenol at 10 am and 8 pm. Got fussy during day, at 3 or 4 pm, mom noticed red splotches appearing to body, hands, finger and feet. Mildly swollen and reddened, several area to arms with macular papular rash. Given Benadryl 3/10/06-rash begin to fade.
I have had Chronic Regional Pain Syndrome for 11 years and have been in remission for about 9 years. One day after the vaccine I am now in a flare up of my CRPS for the first time in many years.
In order. Weak legs. Heavy breath and rush of heat. I started skipping beats and my heart and breath weren't keeping up. Headache and gradual sense of vertigo. When medical staff realized I was about to collapse after 2 minutes they had me stand up to go lay on the stretcher. I realized I couldn't stand on my feet and sit on a near bench. My ears were obtunded as if I couldn't hear properly anymore. When I laid down with my legs up I started feeling blood flowing again on my face and my ears regained sensibility. After ten minutes I was almost all right. I felt tired the rest of the day but I worked my shift as usual. Next day I couldn't lift my left arm and I was just a little tired. The day after it was manageable.
Past six weeks; Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and PRODUCT DOSE OMISSION ISSUE (Past six weeks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced COVID-19 (Covid-19). On 31-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past six weeks). On 31-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Past six weeks) had resolved. At the time of the report, COVID-19 (Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information received on 24-JUN-2021 contains No new information
This spontaneous report was received from a 36 year old nurse prescriber (also reported as a nurse practitioner) who is also the patient via a company representative. The patient's concurrent conditions included an immunodeficiency. Other pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the immunocompromised patient was vaccinated with a dose of ZOSTAVAX 19400 plaque forming units (PFU), as prophylaxis (Strength, dose, frequency, lot # and expiration date were not reported). No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.