chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Throat feels slightly tight; pt has a history of anaphylaxis with bee stings and carries Epi pen; pt took 50 mg Benadryl; baseline vitals were taken and pt was observed for a full 30 minutes
Started cramping and slight menstrual bleeding less than 24h after receiving the 2nd Pfizer Covid-19 vaccine (no adverse events after first shot). I'm on birth control (over a year) and have a regular period that shouldn't start for another week and a half. I'm still cramping and bleeding, not as bad as a normal period, but definitely noticeable throughout the four days since symptoms appeared.
Red area left thigh measuring 2 1/2" by 3 1/2". Motrin and warm packs given.
Swollen Lymph Node- Golf ball sized; axillary region, under left arm; Very swollen and painful; lasted for a duration of 7 days
fever; Vomiting; This is a spontaneous report from a non-contactable consumer. A 16-Years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: not reported) on an unspecified date via an unspecified route of administration as DOSE 2, single for covid-19 immunisation. Patient medical history and concomitant medication was not reported. On an unspecified date, after the second dose, the patient experienced Vomiting and fever. Treatment information not reported. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache, chills, body aches, nausea, vomiting, diarrhea.
TOOK ONE DOSE OF UNREFRIGERATED VIVOTIF; This spontaneous case report (PVX2019-2520) was received from a consumer on 08-Oct-2019. It described a female consumer who "took one dose of unrefrigerated Vivotif" (PT: Product storage error), while being on oral Vivotif (lot number: 3003297) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 08-Oct-2019, which was unrefrigerated.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.
Vaccine was filled by pharmacy 2/24/21 for administration to client. Due to COVID immunizations, all other vaccine administration appointments were delayed. Adacel sent EXPIRED 3/6/21 but was administered on 3/25/21. Pharmacist called Sanofi to determine if dose needed to be repeated. Per Sanofi (Case# 00535614) dose should be repeated ASAP and submit VAERS
On (11/15/2021): Patient complained of severe pain and stiffness around injection site area of left arm, shoulder and armpit area on the day of vaccination (11/15/2021)(during and after).  Patient did not report any issues until later in the day. She stated she was not able to move her left arm and  also felt numbness throughout her arm.  On (11/16/2021): Patient was contacted by pharmacist and pharmacy intern. Currently patient is still experiencing soreness but is able to move her arm. She is still concerned by the position of the vaccine administration and states that she has made an appointment to have it examined.
Right leg swelling and cellulitis from the knee down - days after injection of PEDIARIX given in right thigh. Treated with oral antibiotics.
Pt recvd vax & exp inconsolable crying, colic & fussy; 8 dasy later had sz; taken to ER EEG abn; hospitalized x 5 days dx infantile spasms; the myoclonus; readmitted 1 1/2 wks later w/sz; EEG: Hypsarhythmia;
9 patients received expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   No treatment information was provided by the reporter.  The vial was initially stored in the refrigerator on 11Nov2021 and was first punctured at10 AM on 18Nov2021. No temperature excursions occurred.
No adverse event; Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date).    No concomitant medication was reported.  Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 monovalent and 20 bivalent) which were beyond the 30 days beyond use date.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Significant Follow-up received; Patient information and vaccinations details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 16-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 31-JAN-2023, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Fever, chills, severe nausea, severe fatigue, muscle aches, headaches, cough.
This spontaneous report as received from a licensed practical nurse (L.N.P.) refers to a patient of unknown age and gender. On 07-JUN-2013 the patient was vaccinated with a dose of GARDASIL (lot # H021608, exp. date 13-AUG-2013) (dose, route and site of administration not reported) which on an unknown date was exposed to minus 1C for 19 hours. No adverse effects reported. This was one of several reports received from the same source. This is one of 8 reports from the same source. Other linked reports are: MARRS # 1307USA006244, 1307USA006245, 1307USA006246, 1307USA006247, 1307USA006248, 1307USA006249, 1307USA006250. Additional information has been requested.
Patient was administered Prevnar in left arm where adverse event occurred. Patient also got Fluzone HD and Boostrix in his right arm, one inch apart.
SECOND DOSE SHINGRIX. SWELLING ALL DOWN THE ARM. HAD TO BE PUT ON PREDNISONE. WENT TO URGENT CARE, PCP, AND EMERGENCY. HAD A HARD TIME GETTING OUT OF BED (1 WEEK) AND HAS A LINGERING COUGH.
Amox for OM/Conjunctivitis on 7/204/08 4y/o well check and immunizations on 7/28/08, erythema multiforme minor on 7/31/08.
got them n my cornea after having the shots/ suspected vaccination failure; got them n my cornea after having the shots; Scare tissue damaged my vision; Scare tissue damaged my vision; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), scar and visual impairment. The patient was treated with ophthalmologicals (nos) (Eye Drop (Nos)) and antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, scar and visual impairment were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, scar and visual impairment to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-June-2022 Reporter's comment:  This case was reported by a patient via interactive digital media. The patient stated that he/she also got shingles in cornea after having the shingles shots. The patient had shingles 3 times within 9 months. The patient still on drops and antiviral meds indefinitely. Scare tissue damaged patient's vision. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided.
Hives morning after shot, used benadryl and they went away. Hives a second time a couple mornings later (date unknown) benadryl again. Today Jan 21 8:20AM hives for a third time. Benadryl seems to be working less. Eating no new foods during or prior to each event.
26JUL92 ? recvd 1st dose of Engerix-B; that same day devel allergic reaction w/in half an hr p/recvd inject; rxn was characterized as little shooting stabbing pains in muscles, hot flushing skin sensation, both arms red;
NAUSEA, WEIGHT LOSS, HIVES, MYALGIA, FATIGUE Narrative:  SYMPTOMS STILL ONGOING AT THE TIME OF THIS REPORT 2/1/21  Other Relevant History:
Itching; Rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching) and RASH (Rash) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PRURITUS (Itching) and RASH (Rash). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Itching and Rash, at an unspecified dose and frequency; HYDROXYZINE for Itching and Rash, at an unspecified dose and frequency and TRIAMCINOLONE (topical) for Itching and Rash, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching) and RASH (Rash) outcome was unknown.            No relevant concomitant medications were reported.
Noticed ringing in my ears; Have lost half of my hearing ability; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2020 as dose 2, single (Lot number: ER8729), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: 2020, for COVID-19 immunization. The following information was reported: DEAFNESS (medically significant) with onset 2020, outcome "not recovered", described as "Have lost half of my hearing ability"; TINNITUS (non-serious) with onset 2022, outcome "not recovered", described as "Noticed ringing in my ears". The events "have lost half of my hearing ability" and "noticed ringing in my ears" required physician office visit. Therapeutic measures were taken as a result of deafness, tinnitus.  Clinical course: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was noticed ringing in ears. Over the course of many months-have lost half of hearing ability. Now have to use hearing aids. The adverse event resulted in doctor or other healthcare professional office/clinic visit.
chest pain; Initial information received on 04-Nov-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 75-years-old female patient who experienced chest pain, while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing chest pain and had a similar episode after last years vaccine.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious chest pain unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Patient treated in emergency room.  Laboratory details were not reported.   An unknown corrective treatment was received and had received pre treats before immunization.  On an unknown date, the patient recovered from chest pain.  There will be no information available on the batch number for this case.
At 48 h developed migraine which became continuous and hard to control w NSAIDS , baby ASA. Elevated BP to 170s/ 85 previously controlled to 135/70. At times migraine associated w scintillating Scotomas. Behind eye ache, slight ear pain. In distribution of left temporal artery. Artery tender to touch. Severe brain fog. Some word searching, memory change.Left finger joint stiffness.  Continued x 2 weeks went to urgent care. Uncertain dx.  Treated w NSAIDS, rxd prednisone 20mg but only took one dose. Aug 16 had follow up w oncologist routine. Mentioned new migraines got MRI brain contrast showed L parietooccipital meninges lighting up. Diff dx: cancer, inflammation, vascular is. Admitted to hospital same day fir work up.
Itching to face and chest around 3 hours after administration. Facial swelling noted overnight.
red at the injection site; swollen at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) 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) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.    This case was linked to MOD21-035487 (Patient Link).
Rash started the next day on her left cheek and every day it keep spreading little by little and on 5th day it had spread to her upper body and all the rash started becoming blisters. On the 5th day doctor prescribed prednisone 30 mg, but after taking prednisone for 2 days also the rash keep spreading and the rash keep becoming blisters most of her upper body. 7th day after the vaccine the symptoms got really bad and she had to get admitted to hospital to get iv steroids and antibiotics. After getting 3 doses iv steroids the rash stopped becoming blisters. Then switched over to same strength oral steroids and discharged. The rash is still present and spreading after 11 days of getting vaccine.
intense headache following administration, continues into the present, is not alleviated by pain medicine or sleep.   chest heaviness and problem taking deep breath.  site injection pain and swelling for a week following injection.
Redness, swelling, itching at site 10 cm x 10 cm.
22 out of 115 recipients of 3 doses of Engerix-B were non-responders p/completion of the series;
experienced arm discomfort, redness at the site and itching; experienced arm discomfort, redness at the site and itching; experienced arm discomfort, redness at the site and itching; rapid test IgG line came up faint pink; This is a spontaneous report from a contactable nurse reporting for herself. A female patient of unspecified age received second dose of bnt162b2 (BNT162B2, lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date in Jan2021 at a single dose on the Arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The nurse reported that she received the 2nd vaccination this week (Jan2021), which was "uneventfully after 2nd dose experienced arm discomfort, redness at the site and itching". She took a home rapid test IgG line came up faint pink. She asked if this confirm it's because she had the vaccine. She stated that she had been negative all along, so I can't see having the prior infection. Outcome of the events was unknown. The nurse assessed the events as non-serious.  Information on the Lot/Batch number has been requested.
She had high pitched screaming, completely inconsolable for couple hours, crossing of eyes, staring, and periodic jerking movements. I called doctor but they completely dismissed my concerns and doctor did not return my call or want to see her in office. I brought her for checkup at 7 months and explained again adverse reaction and the Dr completely dismissed the reaction and failed to report it.
TOOK THIRD DOSE ON DAY 6; UPPER RESPIRATORY VIRAL INFECTION; This spontaneous case report was received from a nurse (PVX2019-038) on 04-Jan-2019 and a follow-up was received on 10-Jan-2019. The report describes a 70-year-old elderly male consumer who had upper respiratory viral infection following the intake of Vivotif for an unknown indication.   The consumer's medical history included hypertension, Raynaud's disease, and BPH (Benign prostatic hyperplasia) and he had allergies from different drugs (forgetfulness from Flomax, pedal edema from nifedipine, tinnitus from azithromycin) and had a childhood history of penicillin allergy. The consumer used to take alcohol a couple of times in a week.  It was reported that the consumer took Vivotif doses on 01-Jan-2019, 03-Jan-2019, 06-Jan-2019, and 08-Jan-2019, respectively. On 03-Jan-2019, he experienced upper respiratory viral infection with the symptoms of low-grade fever (100.5-degree Fahrenheit) which was resolved on 04-Jan-2019, stuffy nose, coughing, postnasal drip, and phlegm which was resolved on 08-Jan-2019. He took a dose of ibuprofen and an hour later, he took his second dose of Vivotif.  The action taken with respect to the event upper respiratory viral infection was dosage maintained while with respect to the "took third dose on day 6" was not applicable.  The clinical outcome of the event upper respiratory viral infection was resolved with respect to the event "took third dose on day 6" was not applicable.  The reporter's causality with respect to the event upper respiratory viral infection was not related.  Company Comment: In this case a 70-year-old elderly male consumer developed upper respiratory viral infection following the intake of Vivotif. Respiratory tract infection is an infectious condition with commonly viral or bacterial etiology. Hence the causality of the event respiratory tract infection is assessed unlikely with Vivotif vaccine. The causality of the event "took third dose on day 6" was considered as not applicable.; Sender's Comments: Company Comment : In this case a 70-year-old elderly male consumer developed upper respiratory viral infection following the intake of Vivotif. Respiratory tract infection is an infectious condition with commonly viral or bacterial etiology. Hence the causality of the event respiratory tract infection is assessed unlikely with Vivotif vaccine. The causality of the event "took third dose on day 6" was considered as not applicable.
Red swelling in area of injection site. Pain and fever. The fever subsided after 24 hr but pain redness & swelling has continued. Suggested ibuprofen & BENADRYL.
This spontaneous report was received from a medical assistant, concerning a 28 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 30-MAY-2018, the patient received an expired dose of PROQUAD, subcutaneously, lot # M042500 and expiration date on 17-APR-2018, for prophylaxis (anatomical location was not reported). There were no adverse effects reported.   .
p/vax lt arm became tingly, heavy & somewhat numb from inj site (lt deltoid) to fingertips; this lasted about 60-75mins;
Patient states that she got a rash the size of a softball on her right arm below the injection site that lasted 3 weeks. She had heart palpitations and that would come and go for about 2 weeks.  She had a headache that lasted about a week and a half. She has a itchy rash on her right knee that resembles psoriasis, which she has never had. About 3 days after the vax she started having a menstrual cycle that last 20 days. She went through menopause about 15 years ago.  Pt went to her OB/GYN.  They did a transvaginal sonogram and a endometrial biopsy to rule out cancer.  Patient is waiting for test results.  Pt is waiting on a CB from her PCP.