chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm redness, slight swelling, heat from injection site. Denied any other symptoms. Pt was advised to administer Benadryl, apply cold compress, and observe and report any changes or to call 911 if experience shortness of breath or chest pain.
Sore at the injection site, low grade fever, chills, light headedness and painful body aches.  Started at 4am and pain progresses until 2pm.  Took 800MG of Ibuprofen and aches and pains started to subside arounbd 3pm.
(L) arm pain with movement began 4 days after injection above injection site around rotator cuff; no redness, no inflammation at site, no swelling, no fever; referred to neurologist.
Narrative: ALL SYMTPOMS ARE NOW RESOLVED Symptoms: Headache, Diarrhea & SORENESS AT INJECTION SITE Treatment: ACETAMINOPHEN 160 MG ONCE
Tested covid positive 25 days after first dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Tested covid positive 25 days after first dose.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested covid positive 25 days after first dose.). At the time of the report, COVID-19 (Tested covid positive 25 days after first dose.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant was provided. Patient treatment information was not provided.
No adverse event; 5 doses administered after expiration date. Doses administered today. Bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Dosage text was reported as unknown. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information of 3rd patient out of 5.   This case was linked to US-MODERNATX, INC.-MOD-2023-729599 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729599:Master case
Pain redness itching lump and heat at and 1/4" around injection site. Each day since the lump redness and itching area has expanded. Currently encompasses a 3-4 inch area at and around site. Itching currently not as severe but involves a larger area and is not constant.
First symptom was moderate tiredness and dizziness that lasted all day and night. Excessive thirst,  arm was very sore. Later that evening I experienced some difficulty breathing, severe muscle pain in my legs, arms and shoulders, and moderate to severe headache. Burning but no rash around my hips and back that felt like severe razor burn.  Today, I am still experiencing leg pain, burning sensation and headache.
July 23, 2022 Severe 8/10 abdominal right sided pain  Two ER visits (August 1, 2022 & August 5, 2022) Diagnosed with abdominal abscess. August 10, 2022 70ml of purulent substance drained                  organism - MORGANELLI - moganii
Patient called on 7/29/19 complaining of inject site pain and inflammation "swollen and egg size lump". I asked if patient tried used tylenol or advil, she had not. Asked patient to try tylenol or advil and ice if needed. If site continues to get worse then call doctor.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 20-NOV-2015 at time- 00:22, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which was stored were 3.4 and 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
On 03/29/2021 I felt a hotness in the abdomen and felt flushed and went to sit down in my couch. I went to the ER at night, was taken by my daughter and all vitals were taken and signals were taken. Two to three days later I felt worse, I went to bed and the hotness went to my head and my ears hurt and I felt out of it. On 03-30-2021, I still felt out of it and was at home. On 03-31-2021, I was at home, and I told my husband I was going to take a nap. I felt like death near me and I felt weird from my head and felt a numbness, tingling sensation in my vagina. I started to feel my head weird and had no sex drive. I went to the ER again and again they took my signals and had a pain in my abdomen. The doctor they said I had hemorrhoids in my rectum and gave me Xanax as well and was discharged home. I then went to see my PCP who told me I had an allergic reaction to the vaccine. I was placed on Naproxen medication but this medication gave me chills and shakiness and also had a pain in my rectum, terrible pain. I had a gastroenterology appointment, had an endoscopy showed I had a bacteria, H. Pylori caused a terrible stomach pain. I was placed on H. Pylori medication and this was in April and May 2021. I went to the ER due to panic attacks also. They told me to take Xanax medication. My head is still foggy, my sex drive is lost. I was placed on Provera but my sexual drive is still not there. I have lost sense in my things, the emotions, the sensations in my sexual drive I cannot feel and my sensations in my vagina and it does not go to my head. My sexual drive is not the same as before. My sex drive is lost since receiving the second dose vaccine. Prior to the second dose vaccine, I weighed 153 pounds and now I weigh 110 pounds. My appetite was also lost and I feel completely deteriorated. I have gone to a neurologist as well and an EEG was done. I continue with these symptoms and was told to see a psychiatrist and the medication they gave me put me to sleep and I still have no sex drive and feel irritable and the sensations in my head are numb, feel horrible. The neurologist told me that all my sensations are normal. I still have my menstrual cycle but this month I have not received it yet. I feel that there is no solution to what I have and feel and the doctors say this is new and there is no answer for how you are feeling. They gastroenterologist told me the H.Pylori is fine only have GERD. Recently I had Covid and on 09-11-2021, I am a teacher, and I went to get tested but it was negative. On 09-12-2021; I started with a cough. On 09-13-2021, felt no taste in my mouth and I went to the school office to let them know. I was then tested on 09-13-2021 with a PCR test and NAAT test and tested positive for Covid. I had lost of sense of taste, pain in my elbows and body but no SOB. I took medication for my cough and after the ten days I still felt fatigued. I also had an x-ray of the chest and I went today for results and it was normal, no pneumonia seen.
Patient came to the pharmacy on 11/5/2020  at 2pm to report that her left arm was still sore from her vaccination on 10/04/2020
Inappropriate age; This non-serious case was reported by a consumer via sales rep and described the occurrence of inappropriate age at vaccine administration in a 3-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:05-JUN-2023 and 06-JUN-2023 The reporter stated that he/she spoke to one of his/her targets who gave Boostrix to a 3 year old patient.  The reporter stated that he/she know that it is indicated for 10 years old. The reporter wanted to contact medical information to put you in contact with the office. Attempted to call GSK vaccine sales representative back but the number provided was a general GSK phone number and unable to reach sales representative to obtain additional details regarding adverse event and healthcare professional reporting adverse event. The patient received a dose of Boostrix at an inappropriate age, which led to inappropriate age at vaccine administration
Soreness at injection site, three inch diameter rash, very warm skin temperature, pain upon movement of right arm for four days after initial injection.
Drug ineffective; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment of Paxlovid started on 04Mar2023, stopped on 8Mar2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300108730 same patient, different drug and event.;
Pt developed dizziness, lightheadedness and fast heart rate.  Was flushed and nauseated.  Vomited and was ill with GI complaints and fatigue for 24 hours.
This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEVICE CONNECTION ISSUE (Syringe leaked upon administration), EXTRA DOSE ADMINISTERED (Administered an additional dose of the Bivalent moderna covid-19 vaccine from the same lot number and expiration date/ This was her 5th dose of the vaccine) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7143C and AS7143C) for COVID-19 prophylaxis. No Medical History information was reported. On 13-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Sep-2022, received sixth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 13-Sep-2022, the patient experienced DEVICE CONNECTION ISSUE (Syringe leaked upon administration) and EXTRA DOSE ADMINISTERED (Administered an additional dose of the Bivalent moderna covid-19 vaccine from the same lot number and expiration date/ This was her 5th dose of the vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (Syringe leaked upon administration), EXTRA DOSE ADMINISTERED (Administered an additional dose of the Bivalent moderna covid-19 vaccine from the same lot number and expiration date/ This was her 5th dose of the vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.  No concomitant medications were provided. Patient received her dose of the Moderna COVID-19 bivalent vaccine by intramuscular injection as the syringe leaked upon administration. This was give on 13-SEP-2022. This was her 5th dose of the vaccine. During the call the pharmacist administered an additional dose of the Bivalent moderna covid-19 vaccine from the same lot number and expiration date. Patient has not experienced any symptoms. No treatment medications were reported.
tested positive 28Dec2020; Post Covid Syndrome Headaches.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on 21Dec2020 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 21Dec2020 patient was given the first dose of Pfizer covid vaccine, unfortunately unknown to everyone patient was already positive, became symptomatic on 22Dec2020 and tested positive on 28Dec2020. Since that time patient has been experiencing post Covid Syndrome Headaches from an unknown date in Dec2020. Patient would like to know whether should take the second vaccine and when. Outcome of events was unknown.
headachy, tired (same as prev 3 doses); headachy, tired (same as prev 3 doses); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: 331308A) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes; "Known allergies: penicillin", start date: 2003 (unspecified if ongoing), notes: Known allergies: penicillin- one time skin reaction in 2003. There were no concomitant medications. Vaccination history included: BNT162b2 (lot_number=EW0172, dose number=1, Left arm.), administration date: 03Apr2021, when the patient was 41-year-old, for Covid-19 immunization, reaction(s): "tired"; BNT162b2 (lot_number=EW0172, dose number=1, Left arm.), administration date: 03Apr2021, when the patient was 41-year-old, for COVID-19 Immunization, reaction(s): "headachy"; BNT162b2 (lot_number=EW0172,dose_number=2, Left arm.), administration date: 26Apr2021, when the patient was 41-year-old, for Covid-19 immunization, reaction(s): "tired"; BNT162b2 (lot_number=EW0172,dose_number=2, Left arm.), administration date: 26Apr2021, when the patient was 41-year-old, for COVID-19 Immunization, reaction(s): "headachy". The following information was reported: HEADACHE (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "headachy, tired (same as prev 3 doses)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Facility type vaccine was Pharmacy or Drug Store. Patient did not take other vaccine in four weeks and no other medications in two weeks.
Left shoulder pain, stiffness, decreased range of motion.  Persistent/worsening since vaccine administered on 4/16/08.
About 7 minutes post 1st dose vaccination, patient began to feel lightheaded, clammy, tingling, nauseas, and diaphoretic. He was brought to lay down and vitals were taken. His vitals were stable and upon laying down he began to feel better. He stated he felt tingling in his left arm but it was just for a few minutes. He denies any numbness, rash, CP, SOB, HA, or palpitations. Patient reports he usually has a vaso vagal reaction when he gets his blood drawn. He felt better about ten minutes of laying down and water was provided. He declined transportation to the hospital but agreed to follow up with his PCP or the ER if he has worsening symptoms. Patient was stable upon leaving the vaccination POD.
Redness of the arm 8/22/2019-8/25/2019.  Client's mother reports that area felt warm. Tenseness 8/22/2019-Present.  Client's mother reports that client complains arm feels tense when she moves it.  Client still able to use arm effectively.  Describes more as being tense rather than painful.    Patient's mother called doctor and they suggested they call Health Department.  Mother may schedule a visit with patient's PCP.
HX SYNCOPE, UNPRESCRIBED MARIJUANA INTAKE. AFTER PFIZER VACCINE, PT IS SWEATING/DIZZINESS, HEADACHE BUT EASILY AROUSABLE. PROVIDED WATER, SX RESOLVED. REFUSED TRANSPORT.
PT COMPLAINED OF SORE ARM AND A RASH THAT WAS FORMING - HE ALSO STATED HIVES ON LEGS - HE STATED IT STARTED AFTER GIVEN THE VACCINATION - NOT SURE WHICH WAS CAUSING THE ADVERSE EVENT - HE SAID HE WAS FEELING HOT AS WELL
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dosing details were not reported). Concomitant medications were unknown. On an unknown date, the patient experienced Guillain-Barre Syndrome. The outcome of the event Guillain-Barre Syndrome was not reported. The reporter did not provide the causality assessment between the event and the suspect therapy. There were no product quality complaints involved. Upon internal review, Guillain-Barre Syndrome was determined to be medically significant. Additional information has been requested.
Patient received Tdap (ADACEL) 0.5ml IM for + pertussis. Patient should have received pediatric dose since ADACEL is for persons between the ages of 11-64 years.
Hives on neck, both arms and abdomen; This is a spontaneous report from a contactable healthcare professional, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included seasonal allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included allergy pills from an unknown start date, for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 11:00, the patient experienced hives on neck, both arms and abdomen and they did not itch. The patient experienced hives after the first dose, but did not report because thought that would go away then the patient got more hives after the second dose. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event hives on neck, both arms and abdomen were not recovered.   No follow-up attempts are needed. No further information is expected.
My husband had caught COVID first and then he gave it to me. I had shortness of breath. My O2 levels was dropping down to 90. I had a 103.6 degree fever. The fever lasted for about 3 days. I had a little bit of delirium. I had flu like symptoms and all over body pain. I had malaise, and I was exhausted. I was still doing breathing treatments 2 months after catching COVID. I did have asthma as a kid that I grew out of but now I am on nebulizers for breathing now. After getting over COVID the first time I had brain fog. I am very articulate but I am losing words now. I was prescribed a Z-Pak, Benzonatate, and breathing nebulizer treatments. I also have issues with joint swelling. I had weight gain because of my swollen joints.
Red, raised, itching area measuring 3x3in at injection site. Full body itching. Lasted for 12 hours. Used hydrocortisone cream and Zyrtec.
Tested positive for Covid; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for Covid) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (With rheumatoid factor of multiple site). Concomitant products included TOCILIZUMAB (ACTEMRA) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The patient reported that the Covid was getting into the lower part of her lungs.  No concomitant medications were provided by the reporter.  Treatment information was not provided.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
Convulsions; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient experienced convulsions on an unspecified date with outcome of unknown.  Follow-up attempts are completed. No further information is expected.