chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A spontaneous report was received from a nurse concerning a 57-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced positive for Covid test/ SARS-CoV-2 test positive and 2 months since 1st vaccination/ product dose omission issue. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027L20A) intramuscularly in the unknown site for prophylaxis of COVID-19 infection. On 26 Jan 2021, approximately 14 days after vaccination, the patient experienced was tested positive for Covid and 2 months since 1st vaccination. Treatment information was unknown. The second dose of mRNA-1273 was temporarily withheld in response to the event, positive for Covid test. Action taken with mRNA-1273 in response to the event, positive for Covid test, was unknown. Action taken with mRNA-1273 in response to the event, 2 months since 1st vaccination, was not applicable. The outcome of the event, positive for Covid test, was considered to be unknown. The outcome of the event, 2 months since 1st vaccination was considered to be resolved on an unknown date.
A pharmacist reported the occurrence of an injection site reaction in a 4 year old female who received Infanrix for prophylaxis. The subject had no known drug allergies or adverse experiences following previous immunizations. Concurrent conditions and medications were not specified. On 10/31/01, the subject received her fifth injection of Infanrix (517a2) into the left deltoid. On 11/1/01, the subject developed an injection site reaction characterized by soreness, redness, warmth, and inudration that extended from above the shoulder to mid arm. On an unspecified date, the injection site reaction resolved. This report has been linked to reports A0389699A, A0389700A, A0389701A, and A0365783A due to the same reporter.
Patient had blood work drawn on 2/18 which came back on 2/19 with thrombocytopenia. The platelet count has continued to drop since that date.
Headache, Myalgia, Fever, Fatigue, Injection Site Pain/Swelling Narrative:  Other Relevant History:
Within about 4-5 hours after the shot the site became very sore and continued to increase in intensity, dull intense soreness. This is unusual for me as I do not get sore arms of any note for other vaccines and also did the usual series of pushups to ward that off.   More concerning was around 10pm or later when going to bed I developed shivers without even feeling cold. No temperature that I could find with the IR thermometer. The shivers went on until I fell asleep, maybe 20-30 minutes. Covering with a blanket seemed to lessen it. Again I never felt cold, just started shivering.  Shivers were completely gone when I awoke the next morning. The arm soreness had decreased and as I used it throughout the day lessened. Soreness was gone by late the following evening.
Day after redness and swelling to injection site. Antihistamines & corticosteroids & Ibuprofen
On the 24th of January I began experiencing a full body rash, and breaking out in hives anywhere something rubbed against my skin. Affected areas include scalp, face, armpits, inner thighs, both sides of torso, feet, legs, and elbows.    It is now February 5th and the symptoms have not subsided. I have gone to urgent care, the emergency room, and have seen a dermatologist. I was  prescribed Predizone; however, the rash is still there.
The patient called the pharmacy on 10/24/19 stating that the day after the  3 vaccines she had a 3cm diameter red spot on both arms which was warm to the touch. She said this resolved by 10/23/19 and all that remained on each arm was a small nodule 4-5 fingers down from the top of the shoulder which were symptom-less.
Narrative:  Per Asdmission HPI pt"...is a 62 y/o male who presented to the ED today via caregiver from the group home where he resides for shortness of breath, defecating on himself and increase in urination that is not normal for him. Patient has had a TBI and resides in group home where there have been positive Covid 19 cases... denies any complaints of pain and reports feeling tired. He is non toxic in appearance with 2L o2 via nasal cannula and o2 sat is 100%. He was found to be hypoxic with ambulation and he tested positive for Covid 19. He will be admitted for Covid 19 pneumonia, hypoxemia and hypernatremia. Patient discharged 1/10/22
This spontaneous report as received from a registered nurse refers to patients of unknown age. On an unknown date states a provider may have vaccinated clients with improperly stored RECOMBIVAX HB. No adverse effects reported at this time. Additional information has been requested.
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported   This case was linked to MOD-2021-418891 (Patient Link).
This spontaneous report as received from a consumer, via company representative, refers to a 11 year old male patient. On approximately 2003 (reported as "at the age of two"), the patient was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Concomitant medications included a Attention Deficit Disorder (ADD) medication. Reporter stated that on 10-OCT-2013, the patient was diagnosed with chicken pox. The patient had 13 pox marks at the time of call on his back and arms. The outcome of chicken pox was reported as not recovered/not resolved. Patient sought medical attention: call the physician. The relationship between VARIVAX (Merck) and the events was not reported. Additional information is not expected.
Information regarding poliovirus vaccine live oral trivalent solution was received from an attorney regarding a male pt who experienced mesothelioma and cardiopulmonary arrest. The pt received a dose of polio vaccine in the "1980s." On or about December 1997, the decedent was diagnosed with mesothelioma. The decedent's history includes exposure to asbestos and asbestos-containing products. The legal complaint states that the "descendent's exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the descendent including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage." On 3/25/01, he died. The death certificate indicates mesothelioma and cardiopulmonary arrest as the cause of death.
Patient developed pericarditis which was diagnosed at local ER.  He was given Ibuprofen and Colchicine and recovered shortly thereafter.
About the middle of May approximately 1 month after vaccination started have intermittent right sided facial numbness and tingling.  The middle of November abruptly started experiencing constant tinnitis which has never stopped or improved yet.  I have been to see ENT who did a hearing test and recommended trying Lipo Flavanoids which I have been taking exactly as recommended with no relief yet.
Passing out, vomiting, forgot best friend, fever of 102, diarrhea, and loss control of bowels.
This is a spontaneous report received from a noncontactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The following information was reported: pain in in extremity (her brother "just had a sore arm" after getting the vaccine"), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
3/28 - swollen tongue, diarrhea, itchy 4/7 - vomit, diarrhea, hives 4/22 - diarrhea, itchy, uncomfortable 4/26 - diarrhea, vomit, hives 4/30 - diarrhea, hives, swollen feet 5/4 - hives 5/10 - diarrhea, vomit, cramps, hot 5/13 - swollen, hives 5/21 - diarrhea, swollen tongue
Vaccine was given early...first dose was on 3/19/2021.  Patient knew the vaccine was early, and had talked to a non-medical staff member and asked to receive the vaccine 3 days prior to due date.  The staff thought the member was at day 25. Error was missed and identified when documenting vaccine. prior to patient leaving site.  Informed patient vaccine was received early and agency report submitted.  Patient has no adverse reactions at present.
BODY ACHE; FEVER; INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 20 year old of unspecified sex. 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 12:20 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced injection site pain. Treatment medications included: ibuprofen, and paracetamol. On 02-APR-2021 20:00, the subject experienced body ache. On 02-APR-2021 20:00, the subject experienced fever. On 03-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102. On 04-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and the outcome of body ache and injection site pain was not reported. This report was non-serious.
This is a spontaneous report obtained from a contactable consumer. A patient of an unspecified age, gender ethnicity and race received PREVNAR 13 on an unknown date, at 0.5 ml, single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced pain and limited mobility in arm. Clinical outcome was unknown at time of this report.
pt recvd vax; c/o fever of 102; pain lt arm 6.7cm red; swollen at area of site; no adenopathy; local rxn to dpt;
reaction as a child to the pertussis part of the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) vaccine which resulted in convulsions; Initial information was received on 18-Dec-2020 regarding an unsolicited valid serious courtesy case from a consumer/non-hcp (healthcare professional) via Pfizer Inc.   This case involves a female patient (also reported as a baby) who had a reaction as a child to the pertussis part of the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) which resulted in convulsions, while she received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DTAP].  Medical treatments, vaccinations and concomitant medication were not provided.  At the time of the event, the patient had ongoing medical history of latex allergy (rubber sensitivity) which was hereditary and she was tested for this before childbirth.  She has concerns about her son receiving as well.    On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer, batch number and expiration date was not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had a reaction as a child to the pertussis part of the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) which resulted in convulsions (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant.  The reporter wanted to know about the ingredients in the PFIZER-BIOTECH Coronavirus disease (COVID-19) VACCINE.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  Information on the batch number has been requested for this case.; Sender's Comments: This case concerns a baby female patient who experienced seizure after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE from unknown manufacturer. The time to onset is unknown. The patient has the history of latex allergy. The patient's medical condition at time of vaccination, concomitant medication and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Bruising, tenderness day after injection; patient reported improvement by 10-27-07.
Start Date/Time: [Pfizer] 02May2021 01:00 PM/ Start Date/Time: [Pfizer] 18Apr2021 01:45 PM; Fever; Vomiting; Mild confusion; Extreme exhaustion; Body aches; Second dose brought back all concussion symptoms; Migraine; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular, administered in right arm on 02May2021 13:00 (Age at Time of Vaccination: 16 years) (Batch/Lot number was not reported) as dose 2, single, the patient previously took first dose of bnt162b2 via intramuscular, administered in right arm on 11Apr2021 01:00 pm for covid-19 immunization. The patient medical history included attention deficit hyperactivity disorder (ADHD) and hypersensitivity. The patient concomitant medications included methylphenidate taken for attention deficit hyperactivity disorder, cetirizine hydrochloride (ZYRTEC) taken for hypersensitivity from Jan2021 and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received first dose on 18apr2021 and second dose on 02may2021 which led to (inappropriate schedule of product administration). The patient said Second dose brought back all concussion symptoms. Migraine, mild confusion, extreme exhaustion on 02May2021, 8:30 PM, vomiting at 9:30 PM. Body aches and fever on 03May2021, 8:00 PM and lasted for 7 days. The event migraine was reported as serious (disability). The patient received treatment for fever with Motrin. The outcome of the event inappropriate schedule of product administration was unknown and other events were resolved on an unspecified date on 2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
had a problem with bleeding; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE Dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a problem with bleeding after getting her vaccine on an unspecified date. The outcome of the event was unknown. Information on lot/batch number has been requested.  Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE Question: The caller stated her husband has an aneurysm in his head and has not received the vaccine but she asked if there is any danger in him getting the vaccine? She stated he cannot take aspirin or baby aspirin because of the risk of bleeding. She wanted to know if it is safe to get the vaccine for someone with an aneurysm.  She stated she got the vaccine and had a problem with bleeding when she got it.   DSU- the caller just reported this with an agent; Reference #BWXAH3NP; e-transmitting potential duplicate AE details Response: Read from the PI section 4. Explained that there is no data or information that specifically addresses the safety of the vaccine for someone with an aneurysm. Referred to HCP for further discussion.  LAB-1457-7.0 Revised: 06 April 2021
11/7/21 presents to local ED "from an outside hospital with concern for spinal injury". PMHx "of ESRD on PD, CAD, SP CABG (1998 x3, 2006 x2), SP pacemaker".
Large edematous area to injection site. Warm to touch. Patient states it itches but is trying not to scratch it. Small red area to injection site.
Ended up in the ER.  Have been having major changes in my migraines.  They are splitting across my forehead.  Chills and hot flashes about 30 times a day and night.  My temp was so low at the hospital they were concerned.  It was 94 degrees.  Sleeping much more during the day than ever.
32 yo WM approach staff member with c/o dizziness and light headiness ten minutes after receiving 1st  dose of Pfizer vaccine. Patient stated he went to stand and felt like he was going to fall to the floor. Staff member notified EMS and NP of the complaint.  PT was evaluated by on-site by EMS and NP.  Patient stated he always experience some dizziness after receiving any shot. Initial VS were taken. BP 92/5967, 20. Patient was given a snack and a bottle of water as requested.  PMH, Anxiety D/O. NKA. After eating snack and drinking water, patient stated he was feeling better and ask to leave. Final VS were taken. BP 110/79, 71, 20, o2 98%.  Patient left facility without further incidents.
Five days after receiving his second dose of the Pfizer Vaccine, my husband  began to occasionally experience mild jabs of pain in his heart. At the time, he thought little of it. Two days later, Pt developed an irritating skin rash in the lower region of his left shoulder blade. A day later, the rash had spread to include the left side of his torso, beneath his left arm. Now, 7 days since the onset of symptoms, Pt jabs of heart pain are sharper and more frequent and the rash has intensified in its appearance and irritation. Additionally, my usually super-active, mountain-bike-riding husband has become quite fatigued.  In other words, Pt has what appears to be a classic case of SHINGLES. And, since Pt overall health has been excellent throughout his 59 years of life, we wondered if the vaccine might be responsible for having triggered his shingles outbreak. We thought it important to report this possible correlation, just in case.
After receiving your Covid-19 vaccine my taste buds and smell have change and has not gone back to normal.; After receiving your Covid-19 vaccine my taste buds and smell have change and has not gone back to normal.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAROSMIA (non-serious), TASTE DISORDER (non-serious), outcome "unknown" and all described as "After receiving your Covid-19 vaccine my taste buds and smell have change and has not gone back to normal".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
low grade fever; Shakiness; This is a spontaneous report from a non-contactable consumer (Patient's mother) received from the Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 16Jul2021, as DOSE 1, SINGLE for covid-19 immunization.The patient's medical history and concomitant medications were not reported.  The patient experienced low grade fever and shakiness on Jul2021. The reporter would like to know if it is okay for patient to take Tylenol. The outcome of the events was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt. reported pain in right arm and difficulty sleeping on her arm that night. More discomfort 11/1/15. Swelling in right arm began 11/1/15 curving downward from injection site and curves around to the front and down to the elbow. Pt. took BENADRYL 11/1/15 and looked better 11/2/15. By 11/3/15, arm was almost back to normal.
Headache, Myalgia, Arthralgia, Diarrhea & NauseaVomiting Narrative:  Other Relevant History:
Patient stated she started experiencing coughing, wheezing and shortness of breath the day after she received her 2nd Hep. B vaccine. She stated she also remembers experiencing the same symptoms after she received her 1st Hep. B vaccine, but didn't think anything of it at the time. She stated after the 2nd vaccine she was sure the coughing, wheezing and shortness of breath was due to her vaccine. Her vaccine was administered on 10/16/18. She decided to see her physician on 11/3/18 to seek care.
0825  flushed, nausea , slightly SOB,  O2 sat 96%, RR24 HR 77 BP 137/97.  Pepcid 40mg, Benadryl 50mg 0830 Dizzy, flushed, SOB 0835 Dizzy, not flushed feeling, slightly SOB. O2 sat 95% 0840 Throat  scratchy - slight difficulty to swallow O2 sat 93-94% HR 90 RR 28 0850 Epi pen injection, Throat tight and scratchy, hard to catch breath after coughing 911 called 0900 Ambulance transported to ER 0909 Ambulance arrived to ER still somewhat SOB and scratchy throat and nauseated, Dizziness improved. No stridor or wheezing, no hives or itching, no swelling of tongue or lips or facial swelling Received IV Benadryl, IV Decadron, IV Pepcid and albuterol nebulizer treatment and observed for an extended amount of time.  SOB cleared, throat issue resolved and was discharged with just a slight residual tiny scratchy throat.  He was discharged on Benadryl every 6hours until symptoms are completely resolved and Prednisone for 3 days starting on 1/26 if any residual symptoms are felt.  Also given Albuterol inhaler if develop any recurrent SOB. Released home at 1413 on 1/25. Follow up on 1/27 and he stated he had fully recovered
Narrative: Symptoms: SkinRash & RASH Treatment: HYDROXYZINE 50 MG TID