chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Double vision after receiving first dose Pfizer vaccine 02/26/2021. Double vision first appeared 03/05/2021. First two weeks could not move around without patching one eye. That stopped double vision. Could see fine out of each eye as long as one remained shut. Vision improved over period of 4 to 5 months. No double vision in a 3 to 4 foot field of vision. Beyond 4 feet have to wear partial tape patch over glasses in order not to have double vision with both eyes open. No real improvement since July 2021.  On 09/12/2021 first office visit to doctor, Neuro Opthamologist. Diagnosed as 6th Nerve Palsy in Left eye. Same day blood lab work normal, ruled out inflammatory or bacterial problems. On next office visit with doctor 06/04/2021 showed improvement.  Set up for MRI  high resolution orbits with and without contrast on 06/10/2021. Results were normal. Next office visit with doctor 11/08/2021 showed no marked improvement with double vision. Gave me prescription for prism glasses. Will contact me for next appointment office visit in 6 months (April 2022). Have not done prism prescription yet. PLEASE NOT CORRECT BIRTHDATE IS 06/28/1950 AND NOT 06/27/1950 AS LISTED ON FORM. FOR SOME REASON CANNOT CORRECT ON FORM.
hives around the injection site, hives then moved to her back.  Fatigue, body aches, headache (also has sore throat, congestion and runny nose)
pt recv vax & devel urticarial rash developing w/in 5min of vax;no lip, tongue or eye swelling;
pt says about after taking 2nd dose she developed an intense headache.  She had severe joint pain and some gastro pain.  She felt like her skin was on fire.  There was no rash but her skin hurt to touch. Her right arm became very sore with shooting pain from the shoulder to her wrist.  She had a red spot under the injection site that was red and hot to touch.  She has no strength in right hand and pain in the elbow and shoulder.  She called her PCP and was prescribed steroids.  As of today 5/4/21 she still has the pain and weakness.  She has missed about 4 weeks of work and will maybe have to miss more.  Pt has an apt w/ PCP on 5/5/21 to get medical treatment.
lost consciousness and blacked out; In the process of her fall, she also hurt her back; felt foggy/it was as if a round black thing was coming at me in my brain/My feet and legs melted; bit confused; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (lost consciousness and blacked out) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced BACK INJURY (In the process of her fall, she also hurt her back), FEELING ABNORMAL (felt foggy/it was as if a round black thing was coming at me in my brain/My feet and legs melted) and CONFUSIONAL STATE (bit confused). On 23-Mar-2021 at 5:00 PM, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness and blacked out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (lost consciousness and blacked out), BACK INJURY (In the process of her fall, she also hurt her back), FEELING ABNORMAL (felt foggy/it was as if a round black thing was coming at me in my brain/My feet and legs melted) and CONFUSIONAL STATE (bit confused) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: covid19 (Positive) diagnosis of COVID19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient took Ibuprofen to relieve the pain after the fall. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. The patient received expired FLUMIST. The outcome of the event of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
About 25-30 minutes after my shot I had a histamine type reaction... itchy all over, creepy crawly feeling going up my scalp, hives. I took half a Xyzal which helped. About 3 hours later the feeling returned and I took another half of a Xyzal.
Second dose of vaccine given greater than 35 days; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine given greater than 35 days) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia. Concomitant products included LORAZEPAM (ATIVAN) from 23-Mar-2021 to an unknown date for Anxiety, DOCUSATE SODIUM, SENNOSIDE A+B (SENNA PLUS [DOCUSATE SODIUM;SENNOSIDE A+B]) from 23-Mar-2021 to an unknown date for Constipation, SERTRALINE HYDROCHLORIDE (ZOLOFT) from 23-Mar-2021 to an unknown date for Depression, AMMONIUM LACTATE (AMLACTIN) from 24-Mar-2021 to an unknown date for Dry skin, AMLODIPINE from 28-Apr-2021 to an unknown date for Hypertension, ACETAMINOPHEN from 28-Apr-2021 to an unknown date for Pain, VITAMIN D3 from 23-Mar-2021 to an unknown date for Vitamin D deficiency.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine given greater than 35 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine given greater than 35 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Amlodipine is on hold if Systolic Blood Pressure less than 110.  Treatment product details not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up received on 02-AUG-2021 contain no new information.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The medical history, concurrent condition and concomitant medications were not reported. On 07-APR-2016, the patient was vaccinated with an expired dose of PEDVAXHIB (lot # J006416, Expiry: 25-FEB-2016). No adverse effect was reported. Additional information has been requested.
Feeling druggy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling druggy) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling druggy). At the time of the report, FEELING ABNORMAL (Feeling druggy) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No Relevant concomitant medications was reported. Treatment information was not provided.
SORENESS THROUGHOUT BODY AND JOINTS; WORKING AND ACTIVITIES DIFFICULT; This spontaneous report received from a patient via a company representative concerned a 70 year old male. 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the patient experienced soreness throughout body and joints, and working and activities difficult. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soreness throughout body and joints, and had not recovered from working and activities difficult. This report was non-serious. This case, involving the same patient is linked to 20220320745.
Information has been received from a physician concerning current 16 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL  (dose, route and lot# not reported). Subsequently the patient developed a drug reaction/allergy. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The patient subsequently experienced shingles while on therapy with VARIVAX (Merck) (WAES 1101USA02404). Additional information has been requested.
Cervical and axillary lymphadenopathy with absence of fever, malaise, fatigue, headache or pharyngitis. x 3 days.
tachycardia; shortness of breath; dry cough; This spontaneous case was reported by a non-health professional and describes the occurrence of TACHYCARDIA (tachycardia), DYSPNOEA (shortness of breath) and COUGH (dry cough) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced TACHYCARDIA (tachycardia), DYSPNOEA (shortness of breath) and COUGH (dry cough). At the time of the report, TACHYCARDIA (tachycardia), DYSPNOEA (shortness of breath) and COUGH (dry cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Tinnitus; This is a spontaneous report from a contactable consumer.  A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0171, Expiry date: unknown), via unspecified route, administered on left arm, as dose 2, single, for covid-19 immunisation on 22Apr2021 at 09.00AM. Patient medical history was not reported. Concomitant medications included Bupropion, metformin, spironolactone and Prilosec (omeprazole). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8732 Expiry date: unknown), via unspecified route, administered on left arm, as dose 1, single, for covid-19 immunisation on 01Apr2021 at 02.00PM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No allergies. The patient experienced tinnitus on 29Apr2021. The patient did not receive any treatment for the event. The outcome of the event was not recovered.
There was an excursion from the freezer on 01 Oct 2021; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer on 01 Oct 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer on 01 Oct 2021). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer on 01 Oct 2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.  It was stated 10 Number of vials/doses were impacted. Storage condition at the time of the excursion was frozen and Minimum temperatures reached 4.2 degrees F and maximum was 5.7 degrees F and Excursion duration was 6 minutes.   .
SOB, weakness/faint, lt arm numbness, tired, rash blotching; pt recvd DPH, Solumedrol;
I had my 2nd vaccine administerd about 1015 hours on 01/20/2021.  About 11PM while I was sleeping, I awoke with shaking chills and a general unwell feeling.  I needed 2 additional blankets.
Covid Arm; arm was red/red area the size of a 3 by 5 card appeared in the area of the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE REACTION (Covid Arm) and VACCINATION SITE ERYTHEMA (arm was red/red area the size of a 3 by 5 card appeared in the area of the injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid Arm) and VACCINATION SITE ERYTHEMA (arm was red/red area the size of a 3 by 5 card appeared in the area of the injection site). At the time of the report, VACCINATION SITE REACTION (Covid Arm) and VACCINATION SITE ERYTHEMA (arm was red/red area the size of a 3 by 5 card appeared in the area of the injection site) outcome was unknown.            No concomitant medication was reported. Reporter did not remember which arm that the patient received Modern vaccine.  No treatment medication was reported.
My wife received 2 doses of the Pfizer shot, on February 9 and March 2. I have not received a Covid vaccination. However, beginning on March 17, I got a horrible painful and itchy rash on my left arm. I have heard that vaccinated people can shed and cause rashes and other problems for unvaccinated people. That rash has not improved, and continues to grow worse each day.
pt recv vax & 2 days p/vax c/o stiff neck which resolved in 2 days & later noted a tremor in both arms & hands;pt denied any visual changes, no rash or resp problems;pt stated legs became tired;
This spontaneous report has been received from a nurse practitioner concerning to a patient of unknown age and gender. Current conditions, medical history and drug reactions/allergies not reported. In October 2009 (reported as "four years ago"), the patient was vaccinated with GARDASIL first dose, (dose, route and lot# not provided) and in April 2012 the second dose was administered (dose, route and lot# not provided). Concomitant therapy not reported. No adverse effects were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Patient required hospitalization for altered mental status on 11/27 when patient could not be woken easily from a nap. Resolved same day.  Patient was monitored overnight and discharged on 11/28.   Patient did well overnight. Vitals wnl, no fevers overnight and saturating well on room air. Patient woke up with some congestion and cough, and a slight HA. HA resolved with Tylenol administration. Patient was tolerating diet and voiding well. Physical exam was wnl and neuro exam was normal.
Got shingles after 5 weeks of 2nd dose of COVID vaccine; This is a spontaneous report from a non-contactable consumer. A 34-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration on 25Mar2021 as single dose in arm for COVID-19 immunization. The patient past drug event included that Known Allergy: Pollen. Concomitant medications were not reported. Previously patient received of BNT162B2 (first dose) for COVID-19 immunization. Patient did not receive other vaccine in four weeks and no other medications in two weeks. The patient got shingles after 5 weeks of 2nd dose of COVID vaccine on 02May2021 and received unspecified treatment. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected. Lot/Batch number cannot be requested.
Arm pain, fever approx 101-102, upper respiratory, bronchitis, gastrointestinal- vomiting, diarrhea,  headache, body aches, etc ... worse than flu I had in 2002/3
This case was reported by a physician, via a GSK representative, and described the occurrence of acne type rash in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose of TWINRIX (details unknown). Seven days after vaccination with TWINRIX, the subject experienced acne type rash and cold. At the time of reporting the acne type rash was resolved and the outcome of the cold was unknown. The physician reported that the acne type rash took 1 month to go away.
Got COVID (Janssen) vaccine shot on April 6th at noon.  Felt fine Tuesday and went to bed as normal.  Woke up April 7th at 7AM with sharp pains in my left shoulder (same side as shot) and slight shortness of breath, and slight chest pain in the left quadrant of my torso (same side as shot).  Proceeded to take Advil and seemed to help a bit.  Minor aches/pains and shortness of breath throughout the day until about 8PM.  At this time shoulder chest pain became more severe, and breathing became very strained, short, and painful.  Pain and breathing kept getting worse and at midnight on Wednesday night thought I was having a heart attack due to extreme chest pain, couldn't breath, lightheaded, dizzy, tingly extremities.  My wife drove me to ER at 12:30 AM Thursday.
Within 10 minutes of vaccine the pt experienced a large red whelp. No systemic symptoms.
PATIENT  WITH CHILLS, HEADACHE , FEVER, THROAT INFLAMATION  AND RESPIRATORY DISTRESS.THIRD AND FOURTH DAY WAS WITHOUT VOICE. INJECTION SITE WITH REDNESS AND PAIN IN THE ARM.
Suspected COVID-19 virus infection -     POCT COVID-19 Antigen   Patient received her first dose of COVID-19 vaccine.  1 week later she developed symptoms starting with headache and now cough and tachycardia.  Due to her advanced age she is at risk for complications from COVID-19 including hospitalization and death. Patient was interested in monoclonal antibody treatments.  Risks and benefits were reviewed.  I discussed the case with the treatment navigator and also sent a message to our physician support team regarding when she should get her second dose of the vaccine.  I do believe it will likely occur on time.   Admission orders were placed for monoclonal antibody treatment   COVID-19 virus infection Dx Medication Infusion  Reason for Visit Progress Notes     Patient arrived at the ambulatory infusion site alone via car. Reports cough, fatigue, and diarrhea.  Patient stated she discussed Bamlanivimab infusion and associates risks with her doctor prior to this infusion. Reports all question were answered to her statisfaction. Denies any concerns or needs at this time.
I received the 1st Pfizer Covid vaccine and since 10 pm the night of my first vaccine I have had breathing problems.  I have seen my doctor.  She sent me for an x-ray because I had had a recent sinus/respiratory issue.  No pneumonia detected.  She put me on a 5 day dose of 40 mg per day of prednisone.  No change.  I am now having to use a nebulizer daily for breathing.  During the first two weeks following the first vaccine I smelled smoke to the point it woke me up in the middle of the night and I walked around my home to see if anything was on fire.
Break through infection. Sore throat, sinus congestion, productive cough, body aches, headache, dizziness, shortness of breath, fever, confusion.
SIRVA - range of motion limited, unable to raise elbow to be parallel to the ground, extreme pain, pt states has had history of soreness in arm and vaccine has accentuated the issues
Stated had a scratchy feeling in her throat. Was given Citirizine 10mg orally. Was sent home from the COVID vaccination site after observation at approximately 11:30am on same day as the vaccine.
numbness; itching; felt like Sandpaper rubbing on my stomach.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of numbness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles over a year ago).   On 14-DEC-2022, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced numbness (Verbatim: numbness), pruritus (Verbatim: itching) and skin irritation (Verbatim: felt like Sandpaper rubbing on my stomach.). The outcome of the numbness was not recovered/not resolved and the outcome of the pruritus and skin irritation were not reported.   It was unknown if the reporter considered the numbness, pruritus and skin irritation to be related to Shingles vaccine.     It was unknown if the company considered the numbness, pruritus and skin irritation to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Mar-2023 The case was received from the patient via interactive digital media. The patient got the first shingles shot and had numbness on his/her stomach from it. The patient stated that you could put an ice cube in the numb area, and he/she could not even felt it. The patient stated that plus his/her back was itching about all the time and when his/her shirt rubbed across his/her stomach, it felt like sandpaper rubbing on his/her stomach. The patient stated that numbness on his/her stomach was still there. The patient will be getting his/her second shingles shot in June 2023. The follow-up could not be possible as no contact details were available.
A non-serious spontaneous report of given half the dose of nasal H1N1 vaccine was received from a physician concerning approximately 40 children (between two to nine-year-old) at an urgent care clinic. The physician stated that approximately 40 children at the clinic were given half the dose of H1N1, Intranasal. A short pre-history screening was done on each child, and none of the children were on concomitant medications, and all were healthy children with no remarkable past medical history. The initial half-dosing of these children occurred between 28-Oct-2009 and 06-Nov-2009 into one nare. On an unknown date in 2009, the children were revaccinated. There were no adverse events associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 09-Dec-2009 and incorporated into the narrative: approximately age of all children, revaccination information, and period of vaccination.