chrisvoncsefalvay/vaers-outcomes huggingface dataset:
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210950001 and 20210949993.
Client described itching ad hives lasting less than 24 hours.  He took Benadryl, went to bed and the itching and "hives" were gone when he woke up.  He reports that his B/P was elevated and he was sent home from work due to that, but his place of employment reported no record of that happening.
pt recv vax 1DEC92 & 1JAN93 pt exp night terrors & had several episodes of screaming fits;
pain in knee and elbow joints - arthritis - pills and injections. memory loss/confusion in detailed situations-took less complicated job. tried to simplify my life
First dose during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (First dose during pregnancy) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 immunisation.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (First dose during pregnancy). On 22-Mar-2021, EXPOSURE DURING PREGNANCY (First dose during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided. Patient did not want to provide information about pregnancy but said patient would contact if wants to register via email.
Pt. informed nurse of anaphylaxis to flu vaccine approximately ten years ago. Her personal MD, advised her to have COVID-19 vaccine and to have Benadryl and EPI-Pen in purse. Pt. monitored for 30 minutes instead of usual 15 minutes. Twenty-five minutes post-vaccination, pt. developed rash on wrists and shortness of breath. Five minutes later O2 Sat. 97% on RA and rash spread up arms and around lips. Reported feeling clammy. Pt. took 25 mg of personal Benadryl by mouth and declined further Benadryl as it would "make me too sleepy to drive". Six minutes later O2 Sat. 85% on RA and rash on trunk, lips and face. EMS was dispatched, and pt. transferred to ER via EMS.
Patient presented to emergency department on 11/4/2021 with progressive dyspnea and shortness of breath. He was found to be COVID-19 positive and was admitted for further management. His oxygen requirements progressively increased and was transferred to the intensive care unit on 11/17/2021. He was treated with supplemental oxygen, dexamethasone, baricitinib. Patient become unresponsive on 11/20/2021 and was DNAR. He was placed on comfort measures and expired on 11/20/2021.
Pt recv vax & devel inj site rxn w/swelling,redness,warmth & pain. This is 1of 5 pts to devel inj site rxn w/this same lot #.
Arm swelling , Soreness, pain. the following day(s) nausea, labored breathing, funny feeling  like a heavy chest. dizziness ( still happens occasionally seven days after vaccination) fatigue still happening to date.
USING WHEELCHAIR; FEEL LIKE COMPLETELY FULL BLADDER; URINATES 5 OR 6 TIMES IN THE LAST HOUR; SLUGGISH; MULTIPLE SCLEROSIS; PROBLEMS STANDING UP; This spontaneous report received from a consumer concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, and no alcohol user, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. patient had no any side effect from a previous vaccine in the past. he had cold as a cucumber and temperature is in normal range. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 expiry: 04-AUG-2021) dose was not reported, administered on 24-JUN-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced multiple sclerosis, experienced problems standing up and sluggish. On 26-JUN-2021, the subject experienced feel like completely full bladder, urinates 5 or 6 times in the last hour, using wheelchair. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Normal. Treatment medications (dates unspecified) included: fampridine, and teriflunomide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sluggish, had not recovered from problems standing up, feel like completely full bladder, and urinates 5 or 6 times in the last hour, and the outcome of using wheelchair and multiple sclerosis was unknown. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210660422-COVID-19 VACCINE AD26.COV2.S-Multiple sclerosis. 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)
Severe headache that has continued. Has been to doctors. has had CT scan. No source of HA has been found. Headache began about two days after Td
After receiving influenza vaccine, patient was waiting in the waiting area and started hyperventilating. Patient started complaining of nausea, went pale and had a 5-10 second vasovagal syncopal event. After awakening, patient was brought to a patient room and glucose was taken-found to be within normal range.
HCP calling to report 12 patients received expired doses of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP calling to report 12 patients received expired doses of the Moderna COVID-19 vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 043L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP calling to report 12 patients received expired doses of the Moderna COVID-19 vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (HCP calling to report 12 patients received expired doses of the Moderna COVID-19 vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: FollowUp received include No new information
Pt recv vax on 3/19/99; on 4/2/99 pt exp chicken pox
injection site pain; Muscle Pain; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 at 11:45 as dose 1, single (Lot number: HF9275) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 20Oct2023 at 05:00, outcome "not recovered"; MYALGIA (non-serious) with onset 20Oct2023 at 05:00, outcome "not recovered", described as "Muscle Pain"; VACCINATION SITE PAIN (non-serious) with onset 20Oct2023 at 05:00, outcome "not recovered", described as "injection site pain". Therapeutic measures were taken as a result of vaccination site pain, myalgia, headache with Advil.  Additional information: Patient got vaccine at Workplace clinic. Patient did not have other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not tested COVID post vaccination. Patient had no known allergies.
This spontaneous report as received from a medical assistant referring to an approximately 16 year old female patient. The patient had no concurrent conditions, pertinent medical history or known allergies. Additionally, she was not taking any concomitant therapies. On 16-MAR-2018, the patient received a dose of GARDASIL 9 intramuscular, Lot# N021732, expiration date on 01-FEB-2020 (strength, frequency were not provided) for prophylaxis. Then on 04-JUN-2018,  the patient was vaccinated with another dose of GARDASIL 9 intramuscular, lot # N028567, expiration date 17-MAY-2020 (strength and frequency were not provided) for prophylaxis. On 13-JUN-2018, the patient experienced headache. On 14-JUN-2018, the patient experienced muscle pain (myalgia) and paralysis of the fingers (paralysis). On 18-JUN-2018, the patient developed hives on her whole body (urticaria).  It was reported that, on an unknown date, the patient sought medical attention and went to see the nurse practitioner. Therefore, treatment was given to the patient due the events and ibuprofen (MOTRIN) (manufacturer unknown) was started. It was reported that unspecified "blood tests" were performed, however the results were not provided. At the reporting time, the outcome of paralysis, urticaria, myalgia and headache was reported as not recovered. The causality between the events and the GARDASIL 9 was not provided. Upon internal review, the even paralysis was considered to be medically significant.
FEVER; HEADACHE; PAIN AT THE SITE; MUSCLE ACHES; STIFFNESS RIGHT AWAY, LEFT SIDE OF THE NECK AND BACK DOWN TO THE ELBOW; This spontaneous report received from a patient concerned a 55 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 in left arm (Deltoid) for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced stiffness right away, left side of the neck and back down to the elbow. On 31-MAR-2021, the subject experienced muscle aches. On 31-MAR-2021, the subject experienced pain at the site. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, muscle aches, and headache, and the outcome of pain at the site and stiffness right away, left side of the neck and back down to the elbow was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Complains of muscle weakness of legs bilaterally, onset 6-8 hours after vaccination, symptoms continued. E.R. visits on 8/25 and 9/2/16.
Dizziness, Sedation & NauseaVomiting Narrative:  Other Relevant History:
DTaP in right deltoid 1/13/03. On 1/15/03 grandmother called me re area red, swollen, itching. Brought child in. Area red, hot, puffy. No loss of ROM. No acute distress. Referred to PCP, PCP Dx'd as local reaction. Grandmother stated she is allergic to tetanus.
Child awoke with swollen, red left upper arm. The area was warm, redness extended to about 2 1/2 inches above elbow. Afebrile, Mother tried Motrin about every 6 hours yesterday and today. Redness area approximately 2 inches x 9 1/2 inches.
mom states pt had t104.8R temp in ER: pt had 2 sz @ home @ was taken to ER;
Fever, all over heaviness, unable to get out of bed. Nausea. Starting after about 12 hours and lasting for a day
This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (sore arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered first shot to a 16-year-old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Aug-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 27-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered first shot to a 16-year-old). On 27-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered first shot to a 16-year-old) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications was reported. No treatment drug details was reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up received on 08-sep-2021 and contains no new information.
Beginning on 11/21/12 our son began throwing up all solids and liquids given for about 48 hours.  Towards the end of the 48 hours he could keep down some solids and breast milk.  He was seen at the emergency room on 11/22/12, where they gave him an anti-nausea medication and recommended the continued feeding of breast milk.  By 36 hours after the onset of vomiting, he was keeping all foods down, but not eating as much as usual.  By 11/24/12 we noticed that he was having diarrhea which was leaving a bright red rash on his bottom as well as a rash with sores on the inside of his right thigh near his scrotum.  Within a few days the sores began to bubble up to about a half dollar size, with a string of sores continuing from his inner thigh to his right butt cheek.  He was seen again at Emergency on 12/2/12 and diagnosed with Herpes Zoster: shingles.  The doctor also took a look at a string of itchy "bug bites" that I had running from my left abdomen to my left mid-back and believed I had shingles as well.  I do not know which of us first displayed symptoms as I believed that I had bug bites.  Within a week both of us had progressed to dried and scabbed up wounds where the lesions had been with minor itching and burning at the lesion locations.  Neither of us took any medications to get the lesions to clear up or go away.  I had never been vaccinated with the Varicella vaccine, but had the chicken pox around the age of five.  According to my records, my son had the first varicella vaccine on 4/27/2012 and he never received the second dose.  He received the flu vaccine on 10/25/2012.
pt recv vax; fever & rash at inject site; rash gen next day;MD impression was viral exanthem but rxn to immun could not be ruled out;
Very little after Dose #1.  The day after Dose#2: achiness (back, chest, head and of course the injected arm). These are NOT severe enough to seek help immediately. However, patients ought to be aware of the potential.
Within 10 hrs of vaccination of Feb 5, developed erythematous papular rash that became urticarial over next 3 days as well as generalized with intense pruritus.
12/20 Pt to the ED with complaint of right side pain, cough, fever, x 3 days, found to have renal abcesses 12/22 COVID resulted Positive  12/30 Removed from Iso Precautions 1/6 Patient discharged to facility
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Mar2021 as dose 2, single (Batch/Lot number: unknown), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left leg and on 14May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Known allergies: Sulpha" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Painful, swollen glands at back of neck, shivering, fever, pounding headache, general body aches for 48 hours
DIZZINESS; BLURRED VISION; BODY SHAKES; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 261 pounds, and height was 67 inches. The patient's past medical history included ablations of heart, atl knee surgery, foot surgery, jaw surgery, 2 cesarean section, and cholecystectomy, and concurrent conditions included brain tumor right temporal lobe, thyroid tumor 4 cm benign, non alcohol user, and cigarette smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient experienced rash (drug allergy) when treated with erythromycin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 14:00 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, the subject experienced dizziness. On 26-MAY-2021, the subject experienced blurred vision. On 26-MAY-2021, the subject experienced body shakes. On 26-MAY-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from abdominal pain, and had not recovered from dizziness, blurred vision, and body shakes. This report was non-serious.; Sender's Comments: V0:  Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
ringing in her ears; it's burning in her skin.; flushing face; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 (Lot number: EW0153) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "blood pressure" (unspecified if ongoing), notes: The patient was only taking a blood pressure pill and vitamins when she got her vaccines and stopped them to see if it was and it wasn't. , The patient stopped taking her blood pressure pill about 2 weeks ago. The patient took concomitant medications. The following information was reported: FLUSHING (non-serious) with onset 08Apr2021, outcome "recovering", described as "flushing face"; TINNITUS (non-serious), outcome "recovering", described as "ringing in her ears"; BURNING SENSATION (non-serious), outcome "unknown", described as "it's burning in her skin.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, she has received 3 doses of the vaccine and she has been experiencing a flushing face, ringing in her ears and rashes all over her body; stating also to have hives and blotches in her back and torso. She mentioned that every time she puts her clothes on it feels like it's burning in her skin. She went to the dermatologist and she had a biopsy and they told her that this side effects might be due to a medication. She's taking Benadryl and a medication for her blood pressure but they verified if the manufacturer changed the formulation for this medicines and at the end they see most probable that the side effects are due to the vaccine. The caller got the first dose on 08Apr2021 and she immediately had flushing in her face. The patient stayed there for 15 -20 minutes until it subsided. Then the patient had ringing in her ears, mostly in her left ear but it went down until 29Apr2021 when she got the second dose, then it increased and she had more ringing. No follow-up attempts are possible. No further information is expected.
Headaches Chills Fever of 102.8 for more than 6 hours Vomiting  Diarrhea  Aches  Soreness
Red, swollen, hot.  Size of baseball and increasing although the sides are not as dark red as the injection site.
Swollen clavicle and lymph nodes; Swollen clavicle and lymph nodes; booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 14:15 (Lot number: 33025BP) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOVASTATIN taken for blood cholesterol (ongoing); AMLODIPINE taken for blood pressure measurement (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Lot: EL3248, Exp: Unknown, Administered left upper arm), administration date: 03Feb2021, when the patient was 55 years old, for Covid-19 Immunization; Bnt162b2 (Second Dose, Lot: EL9264 , Exp: unknown, Administered left upper arm), administration date: 24Feb2021, when the patient was 55 years old, for Covid-19 Immunization, reaction(s): "Swollen clavicle and lymph nodes", "Swollen clavicle and lymph nodes". The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021 14:15, outcome "unknown", described as "booster dose"; BONE SWELLING (non-serious), LYMPHADENOPATHY (non-serious) all with onset 28Dec2021, outcome "not recovered" and all described as "Swollen clavicle and lymph nodes".  Additional information: After getting booster shot to Pfizer covid vaccine, patient had a swollen clavicle and lymph nodes which was worsened, and she could not sleep last night due to this. She could not put a bra on that day because it irritated that area. She said same thing happened with second Pfizer covid vaccine also but that was not as severe as this and not this painful. She was on concomitant medication vitamins. No additional vaccines were administered on the same date of the Pfizer suspect. No prior vaccination in last four weeks. Last vaccine was in Feb2021. It was reported that the AE(s) did not require a visit to Emergency Room or physician Office. She only called the doctor's office. She was recommended to go to ER the events got worse.  Follow up attempts are completed. No further information is expected.