chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives throughout body within 6-7 hours after seasonal influenza vaccination.  C/O itching, headach, nausea, along with hives.
Patient had typical side effects for 1-2 days after the vaccine and then recovered. Then a week or two later was exhibiting increased thirst (nursing much more frequently than usual) and fussiness. This was not recognized at early signs of diabetes yet. He developed a fever in late 11/2022. The fever resolved but he remained lethargic. Flu, covid, and rsv were ruled out on 11/30/22. He deteriorated further and then developed DKA and was admitted and diagnosed with Type 1 diabetes on 12/7/22.
A VACCINE WAS ADMINISTERED PAST ITS BEYOND USE DATE. THE BEYOND USE DATE WAS 7/1/22 BUT THE PHARMACIST LOOKED AT THE EXPIRATION DATE (8/31/22) WHEN DETERMINING IF IT WAS OKAY TO GIVE.
415PM 1hive on rt side of abd;mom refused DPH-requested DPh PO;MD paged;mom called pvt MD to arrange child being seen @ ER 4:55Pm transported to ER by mom child had hive on forehead & rt temporal area;
VISUAL IMPAIRMENT; DOES NOT FEEL AS MENTALLY ALERT OR AS FAST AS SHE WAS BEFORE THE VACCINATION; COGNITIVE DELAY BETWEEN HER THINKING AND ABILITY TO FORMULATE WORDS; DISORIENTED WHILE WALKING; BODY ACHES; FEEL UNBALANCED; WEAKNESS; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 APR-2021, the subject experienced body aches. On APR-2021, the subject experienced feel unbalanced. On APR-2021, the subject experienced weakness. On 06-APR-2021, the subject experienced does not feel as mentally alert or as fast as she was before the vaccination. On 06-APR-2021, the subject experienced cognitive delay between her thinking and ability to formulate words. On 06-APR-2021, the subject experienced disoriented while walking. On an unspecified date, the subject experienced visual impairment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from visual impairment, and the outcome of cognitive delay between her thinking and ability to formulate words, does not feel as mentally alert or as fast as she was before the vaccination, disoriented while walking, body aches, weakness and feel unbalanced was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
C/O HEADACHE, NAUSEA. RESTED IN CLINIC, PROVIDED SNACK AND LUNCH. CONTACTED FATHER. CONTINUED TO OBSERVE STUDENT UNTIL END OF SCHOOL DAY AT 1:32 PM. RELEASED TO FATHER.
Patient developed acute onset of severe blurry vision in R eye on 9/29/21.  He reports being diagnosed with "clot" in eye that "dissolved"--was seen by an Ophthalmologist while traveling.  He also underwent hospital work up for CVA that was normal (initial CT apparently showed possible areas of concern but MRI was reassuring as per carotid ultrasound and ECHO per patient).  No other associated neurologic symptoms.  Vision back to baseline on 9/30/21.
New onset motor tics involving bobbing of head about 3 days after vaccination, still persistent today
Feeling very on edge; Short tempered; This spontaneous case was reported by a consumer and describes the occurrence of HYPERVIGILANCE (Feeling very on edge) and ANGER (Short tempered) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERVIGILANCE (Feeling very on edge) and ANGER (Short tempered). At the time of the report, HYPERVIGILANCE (Feeling very on edge) and ANGER (Short tempered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported
Severe body aches/chills and 101 fever for about 8 hours had to be in bed couldn?t function This occurred with the 2 nd shot also
This spontaneous report has been received from a pharmacist referring to a 24 years old male patient. The patient's medical history included nephrotic syndrome, unspecified dates onset when he was a child. The patient had no concomitant medication or drug reactions/allergies. Information about concurrent condition was unknown. On 31-MAY-2018 the patient was vaccinated with the first dose of GARDASIL 9 (lot # N000326, Expiration Date: 14-OCT-2019, 0.5 ml, intramuscular) for HPV prevention. On 31-MAY-2018, three hours after the vaccination of GARDASIL 9, the patient experienced rash on both arms. On the same date, the patient took BENADRYL, and the rash went away (unknown date in 2018). On approximately 02-JUN-2018 (reported as two to three days after vaccination), the patient experienced nephrotic syndrome with symptoms of accumulating fluid (unknown where in the body the fluid was accumulated). The patient had seen by the physician. The patient received treatment for the events and no lab diagnostics/studies was performed. This was the first time the patient exhibited symptoms of nephrotic syndrome since he had it as a child. The outcome of nephrotic syndrome was unknown. The outcome of rash was reported as recovered. The causality between GARDASIL 9 with all the events was unknown. Upon internal review, the event of nephrotic syndrome was considered to be medically significant.
feeling very tired, more so than after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling very tired, more so than after the first dose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (feeling very tired, more so than after the first dose). At the time of the report, FATIGUE (feeling very tired, more so than after the first dose) outcome was unknown.            No concomitant medications reported by reporter. Treatment medication not reported. Action taken with mRNA-1273 was not applicable.   This case was linked to MOD-2021-051704 (Patient Link).
Sneezing, sore throat, congestion , mucous & thickness in throat, wheezing, loss of taste & appetite, loss of energy, fever. My usually excellent lung capacity felt diminished worst respiratory experience in memory.
Had rash on top of head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:   A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "Had rash on top of head".  Additional Information: The report was cross referenced to report ID:  Other friends mentioned having rashes associated with unknown Vaccine. Caller declined to complete report regarding other friends. Thought one friend had called Pfizer. The patient is the person who urged caller to contact Pfizer.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : PFIZER INC-202201169888 same reporter/drug/event, different patient; PFIZER INC-202201169912 same reporter/drug/event, different patient;
stomach pain; nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain) and NAUSEA (nausea) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and NAUSEA (nausea). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication history not provided. Treatment information was unknown.
3 in diameter, raised patch of redness at sight of injection. Tender and warm to touch. Appeared around 8-9 days after injection.
Vaccinator did not successfully make a weak. Dose administered  in other forearm and weal was successful.
red rash began to appear at injection site approximately 3 days after injection; slightly itchy and hot to touch; lessened but still red and itchy currently
Immunization was administered at 1pm, and patient started to go into anaphylaxis at 10:00pm. He swelled up, and had trouble breathing. He received epinephrine, steroids and breathing treatments in the ER.
Child had FLUMIST on 9/29/10 - 10/3/10 started with wheeze and cough. ? croup at visit or reaction to FLUMIST.
Allergic reaction to pollen in the air; Cherry red rash; body rash; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGIC RESPIRATORY DISEASE (Allergic reaction to pollen in the air), RASH ERYTHEMATOUS (Cherry red rash) and RASH (body rash) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced ALLERGIC RESPIRATORY DISEASE (Allergic reaction to pollen in the air), RASH ERYTHEMATOUS (Cherry red rash) and RASH (body rash). The patient was treated with METHYLPREDNISOLONE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ALLERGIC RESPIRATORY DISEASE (Allergic reaction to pollen in the air), RASH ERYTHEMATOUS (Cherry red rash) and RASH (body rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.
Left arm pain at site & upon moving the arm, worse than last time but no headache. This pain resolved after one week. After a few days later, I found my left arm hurt when swinging it backward or trying to reach the back.  My left shoulder also tender to touch.  I took Naproxen without help.  Exercise the shoulder joint made me feel better for the arm movement, but not the pain on the shoulder when touch.
Lot # expiration had been extended and vaccine had remained in freezer until day of administration.  Vaccine was given 2 days past expiration date, Moderna consulted and they deemed the vaccine viable so revaccination was not required.  No adverse effects reported by patient.
positive COVID-19 test.; positive COVID-19 test.; This is a spontaneous report from a contactable pharmacist (patient).A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 16Dec2020 as single dose for covid-19 immunization.The patient medical history and concomitant medications were not reported.Patient tested Positive for Covid on 29Dec2020. He received bamlanivimab on 05Jan2021 and had out of quarantine 07Jan2021. Patient received 2nd vaccination 08Jan2021. Patient inquired, was he protected, with 2nd shot being so close (at time no info on how long could wait for 2n shot), should he get booster, was there blood test for active protection. the outcome of the event was Unknown.    Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine.
Initial report received from a healthcare professional on 03 JULY 2013. A 35-year-old male patient (born on 18 JUNE 1978, age not reported), had received an intramuscular dose of ADACEL (batch number: C4365AA, expiry date: 06/25/2015) in left deltoid on 21 JUNE 2013. The patient had no illness at time of vaccination and had no drug allergies. Concomitant medications were not reported. On an unspecified date 1 to 2 days after vaccination, the patient developed blisters and redness at injection site. Laboratory tests and corrective treatments were not reported.  At the time of this report, the outcome of events was unknown. Documents held by sender were none. Follow up information received from a healthcare professional on 19 AUGUST 2013. The patient outcome was recovered.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 06-JUN-2013, the patient was vaccinated with a dose of GARDASIL (lot # H021608, expiry date 13-AUG-2015), which was exposed to 31 Fahrenheit for 1 hour. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Vomiting, weakness, crossed eyes...these symptoms led me to call his doctor. It was found that he'd had an aneurysm rupture near his brain.
She got the vaccine, and got very nauseated, sick to her stomach and stayed that for the last couple of days.  She has pain and swelling in her arm, very, very painful.  She took Tylenol.  The symptoms are better, the pain is still there, not as intense, but still present.
patient presented with a maculopapular rash to trunk and extremities with a few scattered vesicles to posterior left thigh and crusting to right cheek.
Pt. stated he started having tingling sensations in both hands, both feet & (R) side of face starting 2.5-3 wks after Yellow Fever vaccination. Tingling constant initially now occurs periodically. This information was reported to clinic 02/19/13.
Pt developed whole body erythemous macular rash mild itchy. No SOB/chest tightness. Seen pt instructed to take Benadryl 25mg TID X 5 days. Go to ER sx worsen. F/U sx continue.
Started with a headache, sore throat on 1st day. Second day I developed a cough, fatigue. The cough is pretty bad and consistent. On April 27th, I experienced dizziness. One April 30th, I was still experiencing dizziness and the cough was still there as well as a minor level of fatigue. Since April 30th , everything but the cough has dissipated. With Moderna, I felt sick for a few days and headache.
High Blood Pressure: 135-91, numbness and tingling in my left hand, and itchiness in my right foot. I also experienced pain and swelling in the injection site.
WHITE ROUND AREA AROUND THE INJECTION SITE ALONG WITH SWELLING AND PAIN.
tenderness at site if injection; Hotness to the touch at the injection site; Swelling at the injection site; Redness at the injection site; Pain at the injection site; Little bit of a headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hotness to the touch at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site) and HEADACHE (Little bit of a headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hotness to the touch at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site) and HEADACHE (Little bit of a headache). On 20-Jan-2021, the patient experienced INJECTION SITE PAIN (tenderness at site if injection). On 15-Jan-2021, VACCINATION SITE WARMTH (Hotness to the touch at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site) and HEADACHE (Little bit of a headache) had resolved. At the time of the report, INJECTION SITE PAIN (tenderness at site if injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Patient is a 56 y.o. female patient of DO pmh copd, htn who presents to ED with shortness of breath and cough for the past 2 days   Acute respiratory failure with hypoxia  Influenza A and Covid-19 infection Acute COPD exacerbation Pt with symptoms for 2 days, pleuritic chest pain, cough, shortness of breath, fever, nausea Hypoxic to 85% requiring 2 to 3LNC on adm, now weaning to 2L and sats 94% CRP 100.8. procal normal Date of onset of symptoms: 12/5/22, Date of covid positive test: 12/7/22 fully vaccinated per patient (no booster) CXR no acute findings ID consulted, started remdesevir; given 1 dose of Tocilizumab 12/8 Started tamiflu, and dexamethasone Cont albuterol inhalers.  Patient weaned to room air 12/9 AM, requesting discharge home Recommend follow-up with PCP   Leukopenia Wbc 3.08, mcv 86.9, suspect viral infections contributing follow   Tobacco abuse She has smoked 2 ppd for over 30 years   Essential htn Bp controlled continue losartan, follow   OSA Does not use cpap at home currently   Anxiety and depression Home meds continued   Chronic pain Continue prn percocet   GERD Continue ppi  Morbid obesity with Prediabetes 8/3/22 hgba1c 5.7   BMI 47 Diet and exercise when able
Pt returned to clinic at 12:00 one day post vax stating he had begun experiencing numbness in face and top of head within 10-20 minutes after receiving vax. He pointed to his cheek and jaw area bilaterally. Pt also c/o dizziness. He was accompanied by wife who stated she had stayed up all night with him because they were both worried. Injection site appeared normal, neuro signs were intact, pt was alert and oriented with no deficits noted.
Client was 12 years old on the date of vaccination, and received the Pfizer formulation for ages 5-11. Both vaccine types were offered at this clinic. Multiple safeguards to prevent this type of error were in place, including color-coded wristbands, staff education prior to the clinic and just-in-time training at clinic, only one vaccine type per vaccinator station, and at least 2 points in clinic flow where age and vaccine type are verified. This error was discovered after the clinic during record review. The client's guardian (mother) was informed. She misinterpreted the posted signage and thought there was only one type of vaccine available for children <18 years old, and brought this client and their younger sibling to the same table. The vaccinator did not verify age before administering. Per CDC guidance, the client may receive another age-appropriate dose of Pfizer vaccine in 21 days; this was discussed with the client's guardian. At the time of this submission, no known adverse effects have occurred.
Patients arm got extremely sore and she was unable to even use her arm for 1 day. She went to the Dr. the morning she woke up and was unable to use arm because she was sure she would have to see a neurologist and would have long lasting problems. The Dr. just told her that it was not unusual to have that reaction and just give it a few days. She actually regained use within 12 hours and her arm was back to normal in 2 days.
Patient described the areas as red, swollen, and hard when touched. She also complain about pain in the area. She visited her primary physician who recommended Benadryl and to put ice over the injection area.
Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022.; Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022.) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 034F21A, 048B21A and 018B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension (No recent change.) since 01-Nov-2018, Glaucoma (No recent change.) since 19-Jun-2020, Osteoarthritis (No recent change.) since 05-Dec-2018, GERD (No recent change.) since 13-Jan-2021 and Chronic pain (No recent change.) since 13-Jan-2021. Concomitant products included OMEPRAZOLE from 19-Jun-2020 to an unknown date for GERD, BRIMONIDINE TARTRATE (BRIMONIDINE [BRIMONIDINE TARTRATE]) from 08-Apr-2022 to an unknown date and LATANOPROST from 14-Mar-2019 to an unknown date for Glaucoma, AMLODIPINE from 19-Jun-2020 to an unknown date for Hypertension, CELECOXIB from 13-Jan-2021 to an unknown date for Osteoarthritis and Chronic pain.   On 21-Mar-2021 at 10:08 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 20-Nov-2021 at 9:19 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 05-Jul-2022 at 1:34 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 05-Jul-2022 at 1:34 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 02-Jun-2022  The vial did not undergo any temperature excursions.  No adverse events had occurred.  Treatment information was not provided.