chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was offered booster dose for Pfizer.  Patient was given Monovalent instead of Bivalent vaccination.  He had completed all primary series.  No adverse reactions.
pupils were abnormally small/ Both pupils were constricted and fixed; Had a headache; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 29Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included migraines, endometriosis, allergic reaction to sulfa (both hives and skin flushing, elevated heartrate) and anaphylactic sting allergy. The patient is not pregnant. Concomitant medication included estradiol (VIVELLE DOT) and estradiol (IMVEXXY). The patient previously took codeine and experienced allergies (hives, skin flushing and elevated heart rate). It was reported that about 2 hours (reported as "11:45") after vaccination a coworker noticed that the patient's pupils were abnormally small for the lighting in the room. She had a headache as suggested with typical side effects. The patient took a picture. Both pupils were constricted and fixed. They have remained this way since that time. The patient have taken pictures periodically since it was noticed. The headache remains, but all other (typical) side effects have abated. No treatment was received for the events. The outcome of the event pupils were constricted was recovered on an unspecified date, while the event headache was not recovered.
2cm x 2 cm, red, raised, warm to touch Treat with ice and Tylenol
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Rash/hives on face
DVT IN LEFT LEG; SORE ARM; This spontaneous report received from a consumer (wife) concerned a 54 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: unknown, expiry: unknown) dose was not reported, 1 total, administered on 25-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 25-APR-2021, the patient had sore arm. On 17-MAY-2021, the patient noticed that his left leg got bigger and ignored it, he measured his calf which was 2 inch wider and elevated his feet. On 24-MAY-2021, it was really big and then the doctor sent him to urgent care and it was confirmed a case of deep vein thrombosis (DVT) and he was treated with blood thinner. Still his calf, ankle and foot looks bigger. The patient's wife did not have the lot number. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 28-APR-2021, and had not recovered from DVT in left leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210556854 -Covid-19 vaccine ad26.cov2.s - DVT IN LEFT LEG . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient had onset of throat pain about 15 mintues after receiving vaccines. His mother gave him Benadryl 2 tablets, and they returned to clinic. He was monitored in clinic for about 20 minutes, and had normal vital signs and his throat pain resolved.
The day of receiving the vaccine I experienced severe chills and a fever the next day. I had an ongoing headache and my arm was hurting. What concerns me is I've had intermittent lightheadedness since receiving the 2nd vaccine on May 1st.
Narrative: SVHC acute on chronic resp failure; SOB, weakness, fatigue, myalgia, pneumonia, discharged to home
noted 2 days later red & hard local rxn;7x5cm oval area of redness w/sl induration on anterior lateral thigh;
Had High blood pressure and pulse.  went to ER, diagnosed with pneumonia. confirmed by x-ray
Rash at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the arm left on 13Apr2021 at 11:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included mild TBI (traumatic brain injury), aneurysm, craniotomy (for aneurysm) and brain swelling in 2014. Concomitant medications included levetiracetam (KEPPRA), cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR), norethisterone (NORETHINDRONE) and hydrochlorothiazide (HYDROCHLOROTH), all started from an unspecified date and for an unknown indication, and taken within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient previously received doxycycline (MANUFACTURER UNKNOWN) and  sulfamethoxazole; trimethoprim(BACTRIM) on unknown dates and for unknown indications which caused drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 12:00, the patient developed a rash at the injection site. The rash had progressively gotten larger over the past few days since receiving the shot. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the event rash at the injection site was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
exacerbation of chronic graft versus host disease; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "haematopoietic stem cell transplantation (HSCT)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for COVID-19 immunisation.  The following information was reported: CHRONIC GRAFT VERSUS HOST DISEASE (medically significant), outcome "unknown", described as "exacerbation of chronic graft versus host disease".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely excluded.  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.,Linked Report(s) : US-PFIZER INC-202200611693 Same reporter/product/event, different patient
W/in 1hrs of receiving vax, pt developed flu-like sx w/malaise, fatigue, nausea & fever; Tx included isonicotinic acid hydrazide; Lab testing revealed PPD positive; Pt rec'd 1st dose w/out adverse experience;
The events were partial loss of vision in the left eye.  On October 27 or 28 I was working on my computer and noticed a jagged area in the upper right where there was no vision and also no aura.  Since I do have ocular migraines and this seemed different I covered up my left eye and had no vision problems, but when I covered my right eye I did.  It only lasted a few minutes, again different from the usually 20 minutes of an ocular migraine.  The same thing happened again a couple of days later - again I was at my computer, again it was the upper right area in my left eye.  The second time I did check my watch and it lasted about 2 minutes.  I didn't take it as seriously as I probably should have, but I had an appointment for my annual checkup with my ophthalmologist on November 8.  When I met with her she was quite concerned that there might be blood clots in the retinal arteries, felt that I really should take it seriously as a possible early warning sign, and gave me a list of tests she thought I should take.  I reported it to my primary care physician and scheduled additional blood tests, an MRI, an echo cardiogram and a carotid artery scan.  After completing the testing, as well as the testing from my annual physical on November 18, my physician found "nothing worrisome" and it has not happened again.
Not Received a Second Dose (About 3 months post first shot); Ski Accident after first dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not Received a Second Dose (About 3 months post first shot)) and ACCIDENT (Ski Accident after first dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Accident (ski accident) since 20-Mar-2021.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced ACCIDENT (Ski Accident after first dose). On 23-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not Received a Second Dose (About 3 months post first shot)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Not Received a Second Dose (About 3 months post first shot)) and ACCIDENT (Ski Accident after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication provided by reporter. No concomitant medication provided by reporter.
First vaccine on 1/26/21 began taking three naps a day and arm pain. Given Ibuprofen. Seemed to resolve after 5 days, but continued to nap three times a day sometimes. No fever, but hot flashes at times. Booster given 2/23/21. Began to nap again three times a day or want to stay in his dark room. Began to have a lot of sinus drainage. Gagging at times. Pain over right eye area. Pain in right flank and stomach area. Severe headaches and possible body aches. No fever, but increased and more severe hot flashes that would wake him. 2/28 had a tonic clonic seizure after presenting with a distressed look throughout the day. Slept and upon waking began vomiting until 3am. Was at the ER and given many tests, pain meds and nausea meds. Ruled out kidney stones with CT scan and urinalysis. No fever, but hot flashing continued. ER visit lasted from 2/28/21 through 3/1/21 ER Physician suspects possible reaction to vaccine. Followed up with Neurologist and General Practitioner and both suspect reaction to vaccine.
BLOOD PRESSURE INCREASED; INCREASE GLUCOSE LEVEL; DIZZINESS; This spontaneous report received from a physician concerned an adult of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced blood pressure increased. On 06-APR-2021, the subject experienced increase glucose level. On 06-APR-2021, the subject experienced dizziness. Laboratory data included: Blood pressure (NR: not provided) Increased, and Glucose (NR: not provided) Increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, blood pressure increased, and increase glucose level. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Hard breast; Tingling Tongue; Tingling mouth; Knee arthritis; Tingling lips; Extremely painful along with entire body; entire body inflamed with arthritis; Breast Swelling,Breast engorged , enlarged,areola very enlarged; This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (Breast Swelling,Breast engorged , enlarged,areola very enlarged), BREAST TENDERNESS (Hard breast), PARAESTHESIA ORAL (Tingling Tongue), PARAESTHESIA ORAL (Tingling mouth) and ARTHRITIS (Knee arthritis) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast reduction (Patient had a breast reduction 32 years ago). Concurrent medical conditions included Acid reflux (esophageal), Drug allergy (Morphine), Drug allergy (Protonix) and Drug allergy (Reglan). Concomitant products included FAMOTIDINE and CALCIUM for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced BREAST SWELLING (Breast Swelling,Breast engorged , enlarged,areola very enlarged), PARAESTHESIA ORAL (Tingling mouth), ARTHRITIS (Knee arthritis), PARAESTHESIA ORAL (Tingling lips), MYALGIA (Extremely painful along with entire body) and ARTHRITIS (entire body inflamed with arthritis). On 13-Feb-2021, the patient experienced BREAST TENDERNESS (Hard breast) and PARAESTHESIA ORAL (Tingling Tongue). At the time of the report, BREAST SWELLING (Breast Swelling,Breast engorged , enlarged,areola very enlarged), BREAST TENDERNESS (Hard breast), PARAESTHESIA ORAL (Tingling Tongue), PARAESTHESIA ORAL (Tingling mouth), ARTHRITIS (Knee arthritis), PARAESTHESIA ORAL (Tingling lips), MYALGIA (Extremely painful along with entire body) and ARTHRITIS (entire body inflamed with arthritis) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On Saturday Patient took Famotidine and antacid tablet for 2 days.  Patient feels Constantly thirsty.  Patient used ice pack and heating pads for months and continues today on breast and knees  No Treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Medical history updated in patient tab, New events are added in events tab. On 11-Jul-2021: Non significant follow up-adr form copies updated
pt was shaking w/eye rolling back in eye sockets w/a questionable cessation of breathing; entire episode lasted aprpox 1 min
high pitched screams & crying starting about 2 hrs p/vax, would stop when held but would continue when laid down; this lasted all day & through the following day; only slept short intervals during the noc; seen by MD 24SEP92 & ear infect;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 82-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 12th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 12th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site itching, fever and chills. On an unknown date, the outcome of the injection site pain, injection site itching, fever and chills were recovering/resolving. The reporter considered the injection site pain, injection site itching, fever and chills to be related to SHINGRIX. Additional details were provided as follows: On the day of vaccination, the patient experienced pain and itching at the injection site, fever and chills and worsened overnight. The patient went to urgent care four days later to be evaluated. The events had gotten better but had not resolved.
2/15 11am- vaccines, evening-fussy. 2/16- fussy/sleepy. 2/17- sleepy 9pm-extreme fussiness, inconsolable screaming all night into the morning. 2/18 1am-100.3 temp, inconsolable crying/ screaming. 9am-100.4 temp/TYLENOL, 10am-called pediatrician nurse line and she said no need to take him in until 105 temp. (Ummm No thanks), 2pm-102.2 temp/ give TYLENOL, 2:45pm-100.6 temp 330pm- arrive at urgent care & Dr sends us straight to childrens ER due to HR in 200s. Would have been sent by ambulance but said I could take him since he was alert. 4pm-100 temp at ER, flu, rsv, uti test (all negative), HR gone down to 180s. 6pm-discharged saying it's probably viral. 9pm-101 temp, inconsolable, refuses to lift head from belly position. 2/19 11am-follow up appt at ped, said ears looked great, sent back to ER for labs. 12pm-ER says ears appear a little red and diagnose as viral ear infection, no rx and to follow up with ped, labs all normal. 8pm- inconsolable, gave TYLENOL, up all night crying, rapid/darting eye movements. Still refusing to lift head from belly position. 2/20 5am- 101.6 temp/TYLENOL. Fever continues through the day w/fussiness, diarrhea. I stop TYLENOL and use cool cloths and bath, fever gone by early evening. Night- fever free, extremely fussy, diarrhea. Refuses to lift head from belly position. 2/21-diarrhea, vomiting, fussy, sleepy. Cries at breast and refuses to nurse, jerky movements different than the typical newborn stuff, 6 wet diapers between 6am-9pm, tries to sleep at night but his body won't stop moving even if his eyes are closed trying to sleep, extremely gassy. 2/22 am- jerky movements, more alert, gassy, fussy. 2/23 follow up with pediatrician, no evidence of an ear infection, small appetite. 2/24 happy in the am, inconsolable crying afternoon/pm, just wants to sleep and nurse.
On 3/19 have what is described as Covid arm. Swelling, redness and itchiness at injection site. Had Moderna vaccine, first shot, 3/10.
received a 3rd dose of Shingrix; This case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019) and Shingrix (received 2nd dose in 2019).   On 10th March 2022, the patient received the 3rd dose of Shingrix. On 10th March 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The case was reported by Registered Nurse. The age at vaccination was not reported. The patient received 3rd dose of Shingrix on the day of reporting, which led to extra dose administered.  The reporter requested information on safety in patients receiving three doses of Shingrix.  The request was submitted to Medical Affairs. The reporter did not consent to follow up.
Administrative deviation only; no adverse event resulted from this deviation.This patient received a  mixed series of COVID-19 vaccine (one dose of Moderna and one dose of Pfizer-box #4 reflects the date of the second dose).The decision to administer a mixed series to the patient was due to an " exceptional circumstance "  stemming from the unavailability of the first vaccine product (Moderna) at the time the second dose was due.We understand that although CDC provides considerations for a  mixed series in exceptional circumstances (such as a vaccine shortage, which was the case here),a mixed series is still considered an administration deviation that requires VAERS reporting.Note second vaccination date is listed.
ED/Hospitalization within 6 weeks of receiving first COVID vaccine. First dose received 3/10/2021. Hospitalization 3/13/2021. Second dose received 3/31/2021.
Starting 10/18/2022, I had congestion and a cough and a fever of around 100. My HR was elevated and I did an at home COVID-19 test which was positive. I contacted my doctors office and they recommended Paxlovid. After speaking with my regular doctor, she said I didn't necessarily need it so I did not take it. I basically had a lingering cough for a few weeks and that's about it. The fever resolved after the day and the congestion lasted for about a week. I am feeling fine and do not have any lingering symptoms.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration: 07-May-2021 No relevant concomitant medications were reported. No treatment information was provided.
20 min after the vaccine became lightheaded.  EMT took vitals- all fine.  4 hours after vaccine my ears became dark red and very hot.  My age spots on my legs and arms became raised, darker red and extremely itchy!  I also became very cold and started shaking .   I called my doctors office, the Doctor on call told me to take benadryl and if not better go to ER.   Within 30 minuets everything calmed down.  Did not go to ER.  Felt weak, lightheaded and shaky for 3 days.   I have had "Red Man syndrome" and all love body rashes from antibiotics in the past.    I am very nervous to get 2nd shot!!!  Please tell me what to do.
Information has been received on 15-JAN-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 12-MAR-2007, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a county health department. On or about 07-AUG-2012, the patient was treated by a healthcare provider at an eye care center for the following injuries resulting from the patient's ZOSTAVAX use: herpes zoster. The patient claims damages as a result of injury to herself and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
redness, itching and warmth at site of injection which spread down the upper left arm, redness improved by 10-30-09 pt used OTC Benadryl and helped, did not recommended antibiotics or any further treatment but could continue benadryl prn itch - did not suspect cellulitis