chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US001607 is an initial spontaneous report from the pharmacist received on 16 Jan 2014. This report refers to a male patient of an unknown age. He was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on an unknown date. On an unknown date in Dec 2013, after vaccination his prostate specific antigen changed. The outcome of the event was unknown. The seriousness and causality of the event were not reported.
Patient received J&J COVID 19 vaccine and proceeded to waiting area for required 15 minutes with his family.  After a couple minutes, he starting getting dizzy, pale, nauseated and lost consciousness briefly. 911 was called and patient was transported to a hospital due to low blood pressure.
on 12JUL93 approx 30 mins p/taking vax pt started c/o h/a, fever & crying; a few hrs later, temp went up to 105; pt was seen by MD felt this was a reaction to vax;
my symptoms included: migraine, nausea, diarrhea, swollen lymph nodes on same side where injection site is,  induced period. I am at home experiencing these currently and am asking if i should see a health professional?
Redness and mild swelling first noted in upper arm around injection site. The patients physician was notified and did come in to see pt. No new orders. By the second day it was noted that the redness extended down the arm from the injection site to the wrist. Site was warm to touch. Physician notified again and did come in to see patient. Physician felt patient was experiencing a delayed hypersensitivity-type reaction. Reaction gradually faded.
presented to the local hospital with shortness of breath, associated with mild coughing and stuffy nose and chilly feeling
Arm was a little sore; Something similar to little pimples; Red; A little bit of rash right around the injection area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore), ACNE (Something similar to little pimples), ERYTHEMA (Red) and VACCINATION SITE RASH (A little bit of rash right around the injection area) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little sore), ACNE (Something similar to little pimples), ERYTHEMA (Red) and VACCINATION SITE RASH (A little bit of rash right around the injection area). On 30-Jan-2021, ACNE (Something similar to little pimples) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was a little sore), ERYTHEMA (Red) and VACCINATION SITE RASH (A little bit of rash right around the injection area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event , included methimazole, metoprolol , folic acid and vitamin B12. Treatment information includes cortisone cream.
immediate swelling and hives followed by continued hives, itching, erythematous rash, periorbital edema x 2 weeks at time of presentation to Urgent Care
Started off as a bright red spot on my left arm, a few inches down from the injection site. Over the next few days it began to spread across my arm and it was hot to the touch. No itching but it was raised and painful when pressed on. After putting OTC hydrocortisone cream on it and taking Benadryl the rash went away and my arm feels fine now. It lasted probably 3 days.
I just want to report a minor side effect for 2 weeks now; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I just want to report a minor side effect for 2 weeks now) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I just want to report a minor side effect for 2 weeks now). At the time of the report, VACCINATION COMPLICATION (I just want to report a minor side effect for 2 weeks now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Itching, redness, swelling, (3" circumfrence), pain lasted x 5 days.
Information has been received from a registered nurse concerning a 70 year old female gastroesophageal reflux, hypertension and osteoporosis and no known allergies who on 21-AUG-2007 was vaccinated SC in the left upper arm with a single dose of Zostavax (Oka/Merck) (Lot#658086/0761U). Concomitant therapy included alendronate sodium (MSD), lansoprazole (PREVACID) and aspirin (ECOTRIN). On 21-AUG-2007 the patient developed a red, raised, itchy area at the injection site of the left upper arm several hours after vaccination. The patient self treated with diphenhydramine topical cream (BENADRYL). The patient was examined in the office on 28-AUG-2007 and found to have a 9x7 cm erythematous, warm wheal at the injection site. The patient was prescribed diphenhydramine HCl (BENADRYL) and a methylprednisolone (MEDROL) dose pack and was advised to apply ice packs to the affected area. No lab studies were performed. A follow up appointment was scheduled for 31-AUG-2007. At the time of this report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Pt only gets one vaccine at a time. Per mom - localized redness/swelling. Failure to thrive x 8 hours.
Symptoms of polymyalgia rheumatic with exception of normal inflammatory markers, however symptoms have been responsive to treatment for PMR
Pfizer Vaccine 0.2mL (2nd dose)  2nd dose of pfizer vaccine was given today 12/4/21 which was 4 days early previous dose was given 11/17/21.   Patient is having no symptoms of reaction.
Woke up 8/29 with 104 fever, chills, and could not move. Woke up and went to school 8/30 with severe headaches. Woke up and went to school 8/31 and had severe chest pains starting at 8am and lasted till about 3pm. Woke up that night at 10:30 and the chest pains came back. Went to the ER at 10:45. ER took EKG and said everything was fine. Got Tylenol and went home at 2am. The next day 9/1 I woke up and had chest pains worst than the night before. Went to ER at 1:45pm. Got a room at 10pm. Took another EKG and blood tests. EKG came back abnormal and my troponin levels came back as 38. Was admitted into PICU at midnight. Had heart damage and was diagnosed with myocarditis. Also a valve in my heart was leaking blood backwards. I have more cardiologist appointments set and will need another echo 9/7 and an MRI of my heart at an unknown date.
Office Visit  10/18/2021  Urgent Care -    CRNP  Family Medicine COVID-19 +2 more  Dx Cough  ? Sore Throat  ? Runny nose ? watery eyes ? Fatigue ? Poor Appetite ? Headache   Reason for Visit  History Chief Complaint Patient presents with ? Cough     eating cough drops like candy ? Sore Throat     sx started wed.  ? Runny nose ? watery eyes ? Fatigue ? Poor Appetite ? Headache     for weeks seeing neuro appts keep being canceled     HPI Patient is a 75 y.o. male presents to UC without family accompanied with complaint of cough sore throat congestion fatigue and decreased appetite.   Symptoms started on Wednesday.  He is a farmer and has been dealing with corn dust, relates that this is his typical allergies this time of year.  Typically he gets steroids and an antibiotic.  No shortness of breath.  No fever.  He is vaccinated.  Relates that he has also been dealing with some headaches and intermittent vertigo for months.   Has been seen by ENT previously and has a pending appointment with neurology.  Chief Complaint Patient presents with ? Cough     eating cough drops like candy ? Sore Throat     sx started wed.  ? Runny nose ? watery eyes ? Fatigue ? Poor Appetite ? Headache     for weeks seeing neuro appts keep being canceled
103.0 temperature x 12 hours, chills, fatigue, muscle aches, chest pain, nausea, vomiting, arm tenderness at vaccination site
Multiple sclerosis; This is a literature report.  A 43 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (FIRST DOSE, SINGLE). The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "recovering", described as "Multiple sclerosis". The patient underwent the following laboratory tests and procedures: csf test: presence of 8 oligoclonal bands, otherwise not, notes: present in the serum, but normal cell counts (1 leukocyte/uL); investigation (normal high range 5): 4, notes: per scale; investigation: negative; 4, notes: per scale; magnetic resonance imaging: did not show any signal abnormalities; magnetic resonance imaging head: enhancing and non-enhancing temporal and callosal, notes: periventricular ovoid lesions, as well as enhancement of the proximal right trigeminal nerve. Therapeutic measures were taken as a result of multiple sclerosis.; Sender's Comments: Linked Report(s) : PFIZER INC-202200012186 Same article/drug and different patient/events
Approximately 5 days after my first COVID 19 vaccination shot I became severely nauseous and began experiencing severe upper abdominal pain.  These symptoms remained MORE OR LESS CONSTANT FOR AT LEAST 90 DAYS, and were much worse than the somewhat similar intermittent symptoms normally caused by my chronic condition.  I do not know whether or not the COVID 19 vaccination caused these symptoms but feel compelled to report them nonetheless since I suspect it might have caused them.   Once I began experiencing the above-described symptoms I sought out help from my PCP and one of my gastroenterologists.  Lab work (on multiple occasions) and an EGD surgical procedure were performed but nothing unusual for me was found.
A non-serious report of expired FluMist administered has been received from a nurse concerning a teenage female. No medical history nor concomitant medications were provided.  The patient, her mother, and her two teenage siblings received FluMist on 27-Dec-2007. The expiration date on the FluMist was 25-Dec-2007. No adverse event was reported at the time that the report was received, nor on 21-Feb-2008 when the reporter was contacted for follow-up. The event was resolved on 27-Dec-2007. The reporter was provided information regarding additional dosing of the product when a patient is inadvertently administered product after the expiration date. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to the case for the patient's mother and two teenage siblings who also received expired. FluMist: MEDI-0006351; MEDI-0006353; MEDI-0006352. Additional information received on 21-Feb-2008 and incorporated into the narrative; No adverse event occurred.
Developed increased fever and headache on Saturday 08/14.  Stiff neck, discomfort occurred Sunday 08/15.  To say PMD 08/16.  08/18: Fully recovered and off to school.
dystonic rxn both upper extremities rxn w/IM DPH & resolution in minutes;
Information has been received from a woman working in a physician's office concerning a child who was vaccinated with a dose of Varivax. "Very recently", in 2006, the patient experienced breakthrough chickenpox. It was reported that he child was being boostered. It was also noted that the child was in an unspecified stage of breaking out with lesions. It was reported that the patient's experience was currently ongoing. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a physician indicated that he was aware of the breakthrough of chickenpox at the local school, but had "no idea" about any additional information. Additional information is not expected.
Low grade fever, sore throat, swollen neck lymph nodes, runny nose, muscle aches and fatigue.  Taking ibuprofen.
Fever of 101.9 in morning, chills, loss of apetite, weakness, feeling lousy!  Nite sweats, for almost 30 hours, feeling better this morning, getting strength back and eating.
The patient received the vaccine and reported shortness of breath, pallor and feeling that her throat was closing. Patient was given 25mg PO Benadryl and brought to the ED. On arrival patient continued to report feeling tightness in throat but states that she is breathing well.
Expired Menactra vaccine was accidentally given with no reported adverse event; Initial information received on 11-Aug-2021 regarding an unsolicited valid non-serious case from a other health care professional via Global Medical Information (Reference number- 00719410).  This case involves a patient (unknown demographics) who was vaccinated with the expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 10-Aug-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6576AA and expiry date: 04-Apr-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported that "Caller with provider office stated that an expired Menactra vaccine was accidentally given yesterday. Caller asked if there are any concerns or what should be done next. She would like to know if they should wait a week before administering a second vaccine. She would like to know if there might be any side effects expected by giving two vaccines".   At time of reporting, no adverse event was reported.   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 requirements set out in the Directive 2001/83/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.
pt exp myalgias & arthralgias 10 days following dose 2 of Engerix-B;
Cellulitis infection. Side effects: 102 fever, Shivering, Red Swelling Traveling Down Arm, Warm to Touch, and Diarrhea. Treatment: Levofloxacin 10 Day Caplets.
Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2015 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles at a pharmacy. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2017 the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to an 88 year old male patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 15-NOV-2013, the patient was vaccinated with the first dose of ZOSTAVAX (dose and route of administration were not provided) lot # J006827, expiration date 14-SEP-2014 (reported as 01-FEB-2014). On 28-APR-2015, the patient was vaccinated with the extra dose of ZOSTAVAX (dose and route of administration were not provided) lot # K015308, expiration date 17-DEC-2015. The patient had not reported any adverse effects. Additional information has been requested.
Case received from a healthcare professional on 14 October 2010 under the local reference number 10-0735. A 37-year-old female patient, with no illness at time of vaccination, no known allergies, no known medical conditions and no adverse event following prior vaccination, had received her dose of ADACEL, batch number C3491AA, in the left deltoid concomitantly with her dose of FLUVIRIN (other manufacturer, batch number 111784P1) in the left deltoid, on 08 October 2010. On an unspecified date post-vaccination, the patient experienced pain at the injection site. The patient also reported for past 1 week, had continued to experience pain at site and in shoulder, lethargy and "waking up at night". The outcome was not reported. Follow-up information was received on 01 November 2010 from a health care professional. The patient's had received an intramuscular right deltoid injection of ADACEL (previously reported as left deltoid) on 08 October 2010 at 13:00 and ten minutes later, experienced general lethargy and an inability to sleep regularly. She also reported "moderate-severe" pain at the injection site and surrounding shoulder area. The patient sought no medical assistance. No treatments were reported. No further information was provided at the time of the report. The patient's outcome was recovered on 13 October 2010. Documents held by sender: none.
PATIENT HAD PFIZER VACCINE  Dose 1 date: 01/06/2021,  Dose 2 date: 01/27/2021, AND TESTED POSITIVE TO COVID.
it got worse; site has fever (warm to touch); looks like a circle (small circle, half dollar); it is hard; red ring on left arm (where she received the vaccine); little bit of headache; sore arm/a little sore; breastfeeding; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (site has fever (warm to touch)), ERYTHEMA (looks like a circle (small circle, half dollar)), EXPOSURE VIA BREAST MILK (breastfeeding), VACCINATION SITE INDURATION (it is hard) and VACCINATION SITE ERYTHEMA (red ring on left arm (where she received the vaccine)) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Hydrocodone and Bactrim). Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced EXPOSURE VIA BREAST MILK (breastfeeding), HEADACHE (little bit of headache) and MYALGIA (sore arm/a little sore). On 20-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (red ring on left arm (where she received the vaccine)). On 21-May-2021, the patient experienced VACCINATION SITE WARMTH (site has fever (warm to touch)), ERYTHEMA (looks like a circle (small circle, half dollar)) and VACCINATION SITE INDURATION (it is hard). On an unknown date, the patient experienced VACCINATION SITE PAIN (it got worse). At the time of the report, VACCINATION SITE WARMTH (site has fever (warm to touch)), ERYTHEMA (looks like a circle (small circle, half dollar)), EXPOSURE VIA BREAST MILK (breastfeeding), VACCINATION SITE INDURATION (it is hard), VACCINATION SITE ERYTHEMA (red ring on left arm (where she received the vaccine)), HEADACHE (little bit of headache), MYALGIA (sore arm/a little sore) and VACCINATION SITE PAIN (it got worse) 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.   Concomitant medications include Cymbalta   Reporter did not allow further contact
1st dose vaccine, I had very typical reactions- redness and soreness at the injection site, muscle aches and low grade fever. It went away a couple of days and I am fully recovered.    The 2nd dose vaccine  (IM RA)-I had the same reactions as the 1st dose.  About 8-10 days after, I started having SOB, coughing and chest congestion. I went to urgent care and got a covid test (negative) and got a Chest x-ray which came back positive for viral pneumonia. I was prescribe amoxicillin, albuterol inhaler, Codeine base cough medicine,  and prednisone.   I am fully recovered from my viral pneumonia.
This patient received a Pfizer first dose, and a Moderna 2nd dose. He alerted us to the fact the next day. We saw him again on and 1/23 and was not having any physical issues.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. The patients pertinent medical history was not reported. On an unknown date the patients were vaccinated with a supported dose of (Oka/Merck) VARIVAX (Dose, route and lot number was unknown). No adverse effect was reported. No product quality complaint (PQC) was reported. This is one of the several reports linked with same reporter link. Additional information has been requested.
Patient said she experienced a tingling feeling in her arm post immunization an hour afterwards and is still occurring. Additionally, patient reports a knot came up on arm that has not went away with massaging it over the past week. Welts appeared around the knot with redness, skin pealing, and bruising occurring as well.