chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHHY2011US45141 is an initial spontaneous report received from a health care professional (HCP) on 24 May 2011. This report refers to a 13 years old female patient. She was given only the MenA lyophilized component of MENVEO (batch number: 1000026) reconstituted with sterile saline, intramuscularly on 24 May 2011. No other adverse reaction was reported.
pt is upset he has no immunity to hep A.  pt ran labs with his dr to find out he need to start over
OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. It was not reported whether patient had any adverse events following vaccination with first dose of covid-19 vaccine (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. It was not reported whether patient had any adverse events following vaccination with booster dose of covid-19 vaccine (dose number in series 2). The patient received second booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The product was associated with off label use (off label dosing frequency) (dose number in series 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious. This case, from the same reporter is linked to 20230138443.
Case completed primary Covid vaccine series in April 2021, then was hospitalized for Covid in February 2022. Hospitalized at Hospital. * Acute respiratory failure with hypoxia Assessment & Plan Due to covid 19 pna +/- overlying LLL bacterial pneumonia seen on initial chest imaging. He was initially needing high flow oxygen but gradually his oxygen needs have diminished down to 2 L at rest today. He is no longer dramatically hypoxic with exertion. Hopefully this will continue to improve. Home oxygen is arranged. Diuresed with IV lasix late last week, switched to oral Lasix on 3/4. Received 6 days of Rocephin completed on the 21st, 2 days of Zithromax. Completed 10 days of Decadron. Patient is no longer in isolation -See note under covid pneumonia Pulmonary embolism Assessment & Plan Small subsegmantal PE noted on admission -started on AC, will need 3 months of uninterrupted AC.  Pneumonia due to COVID-19 virus Assessment & Plan + covid with home test on 1-25-22. + test here on 2-17-22. Oxygen levels improving but still taking awhile to recover. Repeat cxr 3/2 with ongoing e/o covid pna with edema superimposed. Diuresed adequately and switch to oral Lasix. Arranging home oxygen. Out of isolation.
Patient received fourth Anthrax vaccine 2 weeks after third and patient was pregnant at the time.  Patient had pragnancy test done afternoon of shot.  Screening for was not completed.
Patient became pasty white a few minutes after the vaccination then showed SXS of Vasovagal Syncope.  Afterwards the patient was re stimulated through verbal stimuli and encouraged to rest in the Trendelenburg position for 15 min. Patient fully recovered  lastly patient stated that this has happened to him before at a previous position.
My neuropathy / burning/ pins and needles in my legs has got 10 times worse since the 2nd vaccine. I also have some numbness and tingling in my left foot I never had.
Approximately 5 days after the patient received her first dose of the Pfizer COVID vaccine, she developed shingles. She was properly treated and received her 2nd dose on 5/5/21
Injection site red, swollen, tender, some what pruritic. Macular rash on abdomen. The reaction occurred within 24 hr of injection. Macular rash on abdomen occurred approximately 48 hr after injection. Patient instructed to take BENADRYL for rash.
First muscle aches, head ache, then severe chills and fever.  After about 12 hours, the symptoms quickly resided and I began to feel better.  By the next day, I felt completely better.  I did not go to the doctor.
Monovalent vaccine administered for a booster on 9-2-22.  Bivalent booster authorized by FDA on 8-31-22. Patient contacted, will return for bivalent booster in 2 months.
Booster dose. Vaccine administered on 10/30/21. Vial expired 10/11/21. Vial was kept in freezer until 10/29/2021 and removed to fridge on 10/29/2021 for administration on 10/30/2021.
This spontaneous report as received from a medical assistant refers to one unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 24-AUG-2016, the patient received a dose of improperly stored VARIVAX (lot # L025207, expiration date: 07-JUL-2016) (dose and route of administration were not provided). There were no adverse effects reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
I was sitting down at work when out of the blue I experienced heart palpitations, lightheadedness, weakness and shortness of breath that lasted for about an hour. I went to the Emergency Room and by the time I was triaged the symptoms went away. My blood pressure was 150/90 at triage with other vitals within normal limits. I did get an EKG which was negative. I was given Valium 5mg and discharged with a diagnosis of Panic Attack.
Patient called 2 days after vaccine to say that vaccine site " reddened and raised" (erythema) starting about half dollar in size and moving "to a much larger one, going" in a band halfway around her arm". Little c/o pain. Ice decreased erythema, small in size now.
After patient received his Pfizer booster, he was sitting in observation for 15 minutes. As the team was getting ready to discharge him after the 15 minutes, the team noticed the patient was leaning to the side and asked him how he was feeling. Pt stated he was lightheaded and then lost consciousness. Team immediately called 911 and checked his vitals. Pt's pulse was palpable, blood pressure - 160/100, glucose was 77. Pt then gained consciousness as EMS arrived (approximately 2 minutes later). Pt was transported to hospital via EMS.
Inconsolable crying for 2.5 hours. Shot at 1:30pm, left office went home, changed had a bottle and went to sleep until he woke up with a blood curdling scream that he would not calm down for 2.5 hours. When he did finally calm down he was still fussing and irritable and even while eating or sleeping continued to let out high pitched screams for hours. Ran a slight fever for 24 hours. 2 days later he seems to be recovering, but still fussy.
medical assistant gave an expired vaccine to a patient, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from other health care professional and a physician via Medical Information (MI) (Reference number- 00691414) and transmitted to Sanofi on 21-Jul-2021.  This case involves a 01-year-old male patient for whom it was reported that medical assistant gave an expired vaccine to the patient (expired product administered) for HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ353AAA and expiration date: 16-Jul-2021) via intramuscular route for prophylactic vaccination on 20-Jul-2021.  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) and HEPATITIS A VACCINE INACT (HAVRIX).  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the t in the Directive requirements set ou2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
feel a bug crawling on me; This case was reported by a consumer via interactive digital media and described the occurrence of paresthesia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced paresthesia. On an unknown date, the outcome of the paresthesia was unknown.   It was unknown if the reporter considered the paresthesia to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received one of the Shingles vaccine and felt like bug crawling on him/her. The patient said there was nothing.
Pt states arm feels cold, tingling. Feels very nervous (has hx of anxiety attack). BP 151/94; HR 98; RR 20. Given water, crackers, juice. Pt was reassured w/Spanish translator BP 133/73; HR 89; RR 20. Pt stable & release w/brother from vaccination site
Patient received an undiluted dose of the Pfizer COVID-19  5-11 vaccine.
Patient accidentally received a 0.5mL Moderna dose when he came in for another shot, however he had been previously been administered Janssen. The date of his Janssen vaccine was dated 3/12/2021. When last I talked to him on the phone he had not experienced any health reactions so far with this administration.
810AM pt c/o feeeling like cotton in throat, feeling like was going to vomit & heart was racing-HR 96 Epi given;pt felt was going to pass out; 8:20HR 90 sqad called 8:25HR 102 pt c/o feeling cold-tremulous, shivering-pt taken to hosp
9/28/10 - 11:15 am. - severe swelling and soreness in arm. Much heat in affected area. - Lasted three days. Took Ibuprofen which helped some.
Fever headache body aches arm so sore I can?t lift it still have problems having a mri Thursday
felt "like I was hit by a truck"; loss of appetite; injection site became hard; injection site became hot; injection site became itchy/ severe red with constant itching; injection site became swollen; injection site red/gigantic red patch/large red patch approximately 3" tall and 5-7"wide; tired; nausea; body aches; arm pain; didn't sleep well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), INSOMNIA (didn't sleep well), FEELING ABNORMAL (felt "like I was hit by a truck"), DECREASED APPETITE (loss of appetite) and VACCINATION SITE INDURATION (injection site became hard) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tylenol), Glaucoma since November 2015, Drug allergy (Aspirin), Pollen allergy and Drug allergy. Concomitant products included DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (COSOPT PF) and LATANOPROST for Glaucoma, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and INSOMNIA (didn't sleep well). On 03-Apr-2021, the patient experienced FEELING ABNORMAL (felt "like I was hit by a truck"), DECREASED APPETITE (loss of appetite), VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE WARMTH (injection site became hot), VACCINATION SITE PRURITUS (injection site became itchy/ severe red with constant itching), VACCINATION SITE SWELLING (injection site became swollen), VACCINATION SITE ERYTHEMA (injection site red/gigantic red patch/large red patch approximately 3" tall and 5-7"wide), FATIGUE (tired), NAUSEA (nausea) and MYALGIA (body aches). On 03-Apr-2021, PAIN IN EXTREMITY (arm pain) and INSOMNIA (didn't sleep well) had resolved. On 04-Apr-2021, FEELING ABNORMAL (felt "like I was hit by a truck"), DECREASED APPETITE (loss of appetite), FATIGUE (tired), NAUSEA (nausea) and MYALGIA (body aches) had resolved. On 15-Apr-2021, VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE WARMTH (injection site became hot), VACCINATION SITE PRURITUS (injection site became itchy/ severe red with constant itching), VACCINATION SITE SWELLING (injection site became swollen) and VACCINATION SITE ERYTHEMA (injection site red/gigantic red patch/large red patch approximately 3" tall and 5-7"wide) had resolved.            As treatment the patient was prescribed a topical steroid.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Medical history updated and concomitant medications added. Event recovery date provided.
While patient was waiting her 15 minutes after receiving the Moderna vaccine (1/21/2021), she complained of a bad pain in the left side of her neck & that it was hard for her to breathe.  She was assisted by EMS (who was on site).  Her blood pressure was 249/149 per the patient.  She also experienced some lightheadedness.  It was strongly suggested by EMS & nursing staff that she be transported to the ER but she refused stating she had to work the next day.  She continued to be monitored by EMS until her blood pressure stabilized & she felt better.  She continued to refuse ER.  She was driven home by her companion.   On 1/28/2021 she sent an email to the health department showing a picture of her left arm showing redness from the injection site down to above the bend in her left arm.  She reported that on 1/26/2021 her physician  recommended that she not receive the second dose of Moderna.  She continues to complain of high blood pressure.  It is unkown if she takes medication for high blood pressure.
Painful swelling in the left inner armpit area (lymphadenopathy). Low grade fever of 100 degrees 18 hours after the administered injection, with general overall body aches.  Took 2 tablets 500mg Tylenol for fever.  At the moment, after 48hr since injection, lymphadenopathy still persists.
Pt stated that several days after her injection redness appeared in the area of the injection and spread toward elbow.   Pt states that redness is about the same when reported to pharmacy on 8/30/21.   Pt also reports soreness of arm of about 1-2 on pain scale of 1-10 with 10 being intolerable pain.
Pain in my fingers is normal, especially the pinky; my armpit is swollen; Its difficult to move my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in my fingers is normal, especially the pinky), SWELLING (my armpit is swollen) and VACCINATION SITE MOVEMENT IMPAIRMENT (Its difficult to move my arm) 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 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in my fingers is normal, especially the pinky), SWELLING (my armpit is swollen) and VACCINATION SITE MOVEMENT IMPAIRMENT (Its difficult to move my arm). At the time of the report, PAIN IN EXTREMITY (Pain in my fingers is normal, especially the pinky), SWELLING (my armpit is swollen) and VACCINATION SITE MOVEMENT IMPAIRMENT (Its difficult to move my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.
Urticaria broke out on left thigh as soon as the MMR was pushed. Patient was given BENADRYL 12/5mg and thigh was observed for 15 minutes. They seemed to improve. Baby had some dry cough (which she never had before), but lung examination was normal.
Unsure exact date and time, above date is approximate. Patient came down with shingles. It took four visits to pediatrics and ER then finally dermatologist for diagnosis. He was finally treated with acyclovir. He was in extreme pain, extremely fussy, not eating drinking or sleeping very much, severe screaming bouts.
Arrhythmia; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac) since an unknown date.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant). On 22-Apr-2021, ARRHYTHMIA (Arrhythmia) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant product use was reported.  Treatment details included Metoprolol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's history of pacemaker is a confounding factor which may play a possible contributory role.
11:07, Right after administering HPV patient had an episode of syncope that lasted approx. 5 seconds. Pt states he felt as he was dreaming. Patient oriented X3 and was given cookies, juice, and candy. 11:29 states he felt fine and no longer felt faint.
Swollen, red, warm around injection site developed within 24 hours of receiving second dose of vaccine.
The patient began to experience a red rash on her arm that is itchy, painful, and hot to the touch. As of Saturday August 26th the patient is still experiencing this.
3 days p/vax pt devel infantile spasms;Annual follow-up received on 01/16/01 provides no additional data.
Syncope reaction, loss of consciousness for approximately 5 seconds. Nausea and vomited 5 minutes after event. Patient advised to elevate feet, remain seated, drink water, and rest in the store for 15 minutes. Patient felt well and left afterwards.
Headache, Myalgia, Fever, NauseaVomiting, fatigue Narrative:
Very dizzy; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Feb2021 at 08:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to food, medications or any other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 24Feb2021 at 11:30, the patient experienced very dizzy. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very dizzy was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt received Immunization and developed hives & itching 2 hrs later. BENADRYL 50mg was given IM at the time. Symptoms resolved.
soreness around the shot area/soreness of arm more after the 1st dose then the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness around the shot area/soreness of arm more after the 1st dose then the 2nd dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LEVOTHYROXINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness around the shot area/soreness of arm more after the 1st dose then the 2nd dose). At the time of the report, VACCINATION SITE PAIN (soreness around the shot area/soreness of arm more after the 1st dose then the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has asked doctors about getting 3rd dose and patient have scheduled for 3rd dose. He was not immunocompromised and was asking for recommendation.  No treatment medications were reported.   This case was linked to MOD-2021-319641.
Patient states she had swollen gums, a headache, diarrhea and back pain. When she called this evening 6/27/18 she said symptoms subsided except for headache and back pain.
Seizures a little more than 24 hours after receiving the vaccine, Causing me to  pee and poop on myself because I had no control. Fever, vomiting headache (minor in comparison to the former).   I have also had multiple miscarriages and an ectopic pregnancy following my vaccines and am unable to have children now without IVF.  Hospitalize for the ectopic pregnancy at hospital in Aug 2021.
11/14/09- 11:30a - shot in R arm - lots of bleeding @ site, injector asked if she was on blood thinners? (No). Not pg, no regular meds, no chronic illness. Numbness, pain @ injection site that area. 11/15/09 - afternoon L hand numbness to shoulder & L side neck pain. Severe pn - Ibuprofen 600mg BID - TID x 3D. Constant pn. Strength ok, tingling gone (almost) feels warm unk fever. Never has this pn before. Unk if other flu 12 has had other vaccine. Ibuprofen helps. (4) family members got injection or flu mist = ok.
This spontaneous report as received from a registered nurse refers to a 63 years old female patient. The patient's pertinent medical history included arteriosclerotic heart disease. The patient did not have any drug reactions/allergies. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot # reported as H013014 expiration date was 03-OCT-2013) on right arm subcutaneously on 05-OCT-2012. No other co-suspects were reported. Concomitant medications included METOPROLOL, ASPIRIN and NITROGLYCERIN sublingual tablets as needed. The patient called the office on 15-OCT-2012 and reported that she had a "mild case of shingles". No treatment was given for adverse event. At the report time the outcome of event was unknown. The patient had sought medical attention via calling to office. No lab diagnosis studies performed. Additional information has been requested.