chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-OCT-2013, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-DEC-2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed VALTREX to manage her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term 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, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Pain in upper right arm & shoulder - NO REDNESS/SWELLING/RASH - advised to follow CDC treatment protocol.
Patient states the day after the vaccine, she started having pain in the opposite arm.  Not sure if it is related.  She called today
tongue swell and throat close.; tongue swell and throat close.; still have lingering side effects with breathing; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eng206), via an unspecified route of administration, administered in arm left on 08Mar2021 15:45 as a single dose (at the age of 37-years-old) for covid-19 immunisation. The patient had no known allergies or other medical history. The patient was not pregnant at the time of vaccination. There were no concomitant medications. On 08Mar2021 17:00 (as reported) about an hour after receiving the first does, she felt her tongue swell and throat close. Resulted in multiple epi shots, hospitalization and still have lingering side effects with breathing. The reported events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized for 2 days. The patient received epi shot in urgent care, another at hospital. The outcome of still lingering side effects with breathing was not recovered, while recovered on an unspecified date for the other events.
Headache and severe shaking and chills approximately 3 hours after receiving his vaccines. Fever at 1540 - 103.1(O), 1430 - 98.1 (O), BENADRYL 50 mg. Temp. at 1630 - 99.6 (O) ibuprofen 400 mg. 12-8-16 at 1430 no fever or chills overnight but tired today, will stay home from school.
On 3-17-22, the patient came in to get his booster shot.  He mentioned that his arm was sore the next day after the second shot, but then the pain level increased.  He said he had pain from his wrist to the top of his shoulder for about 2 months and then that pain changed from the entire arm to just the top of the shoulder and rotator cuff area.  He was concerned that maybe the shot had been given incorrectly, but he also mentioned that the pain may be related to his job.
Pfizer Vaccine administered after being stored at regular freezer temps longer than recommended. Dose determined invalid, client contacted, and recommended dose repeated.
no further information provided/no further AEs reported; inadvertently administered an expired dose; This spontaneous report has been received from a physician referring to a 4-month-old patient of unknown gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 04-MAY-2021, the patient was inadvertently vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 1 injection orally for prophylaxis (strength was not reported; lot # 1660999, expiration date was reported and validated as 03-MAY-2021) (expired product administered). No further information or adverse event was reported.
pt recvd vax 9AUG94 & pt exp fever, nausea, vomiting, & body aches; 21AUG94 devel a rash on torso & face; No further details were provided;
flu-like symptoms a couple of days; redness at injection site; pain after injection and still a little painful today; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number P9733, expiry date 8th February 2021) for prophylaxis.   On 8th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, injection site erythema and injection site pain. In February 2020, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the injection site erythema and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu-like symptoms for a couple of days, redness at injection site, pain after injection and still a little painful today. The reporter did not consent to follow-up.
Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
right sided weakness with numbness from her face down her entire body; right sided weakness with numbness from her face down her entire body; right sided weakness with numbness from her face down her entire body; bad headache; pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 41 unknown unit) received the first dose of bnt162b2 (BNT162B2) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know how long side effects last after receiving the first dose of the Covid vaccine. The patient received first dose of Covid vaccine on Thursday (unspecified date) and reported side effects. She reported side effects of right sided weakness with numbness from her face down her entire body. She describes the feeling as if she's been "shot up with novocaine on the right side of her body." She was also experiencing a really bad headache and pain at the injection site. She reported that the side effects do not seem to be wearing off. She wanted to know if this has been reported as a common side effect. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a medical assistant via a company representative refers to a 50 year old male patient. The reporter stated that the patient was vaccinated with a dose of GARDASIL, 0.5 ml (route and lot number not reported) at age 50. No adverse effects reported. Additional information has been requested.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/3/2021  HYPOXIA 7/15/2021  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/3/2021  HYPOXIA 7/15/2021
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated IM with a dose of PNEUMOVAX 23 in 2010 (Lot # and dose not reported). No other co-suspects were reported. No concomitant medications were reported. On 13-SEP-2012, the patient received IM a dose of PNEUMOVAX 23 (Lot # and dose not reported). There were no known adverse effects. Additional information has been requested.
Looks like shingles, body rash especially forearms and upper thighs. Began about 2-3weeks after 2nd shot and began to spread gradually. Treatment has been applying ointment.
flu-like symptoms; headache; aches; chills; night sweats; more fatigue than normal; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration in the left arm on 17Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included Seizure disorder, depression, anxiety, mild hyperthyroidism and Penicillin allergy. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included carbamazepine, citalopram, buspirone hydrochloride (BUSPAR), and omeprazole. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced flu-like symptoms, headache, aches, chills, night sweats, and more fatigue than normal on 17Dec2020 19:00. Treatment was not provided in response to the events. The outcome of the events was recovered on an unspecified date. The reporter assessed the events as non-serious. The patient has not been tested for COVID-19 since the vaccination.   Information on the lot/batch number has been requested.
COVID-19; 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 33-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details included COVID 19 Treatment Paxlovid from 11Sep2022 to 15Sep2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
When she woke up this morning her arm where the injection was given, was red, hot, and swollen to the size of a baseball, per her call in to the pharmacy.
feeling very tired; having chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling very tired) and CHILLS (having chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Bone cancer.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 FATIGUE (feeling very tired) and CHILLS (having chills). At the time of the report, FATIGUE (feeling very tired) and CHILLS (having chills) outcome was unknown.            Concomitant Product included blood pressure medication   treatment product included Bone cancer medication.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.
Seen at urgent care on 5/11/21. c/o of symptoms of HA headache,ear ache,sore throat and ulcer in mouth x5 days  starting 5/7/21 following dose 2 of vaccination. Pt given chlorhexidine mouth rinse by urgent care MD
Extreme pain and swelling at injection site, chest pain and hard time breathing , extremely bad headacheit'sdizzy, body aches,  I  thought I was going to die.
headaches,  shooting pains in head, canker sore. Don't know if problem is connected to vaccine
No Adverse event; 14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) 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. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, 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 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      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 (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.).    No relevant concomitant medications were reported.  Dose was administered on 01-Dec-2022 from lot number 021H22A, best use by date of 26-Nov-2022. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-685141 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2022: Upon internal review on 24-Jan-2023, significant correction was performed to update the Worldwide unique case identification number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-685141:Samer Reporter
.5 ml administered instead of .25 ml;  Patient had only minor reaction, including pain and swelling of site and some temporary swelling of lymph nodes
Lack of taste; Muscle soreness; joint pains; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lack of taste), MYALGIA (Muscle soreness) and ARTHRALGIA (joint pains) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced AGEUSIA (Lack of taste), MYALGIA (Muscle soreness) and ARTHRALGIA (joint pains). At the time of the report, AGEUSIA (Lack of taste), MYALGIA (Muscle soreness) and ARTHRALGIA (joint pains) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-067223 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067223:2nd dose
On 8/10/17, I rec'd a vaccine mentioned above. My arm was a bit sore and sl. red but I figured that's what to expect. On 8-11/17 (morning of) my arm seemed much more sore and unable to raise arm w/o pain. I looked in the mirror prior to my shower and my arm had red streaks going down The arm, under arm pit and a little streak on my left breast. I was very alarmed and called office to "ask a nurse," and notified my M.D. Told to put cold compresses on it and take OTC pain meds. Better the following Monday.
The area around the injection is warm to the touch and feels swollen with mild rash. This started a week after the injection and as of today the symptoms are still present. Took 1 dose of Benadryl one time and will take as needed.
No complications until day 7 when a 4" x 2" red, hot and itchy area appeared where I received the vaccination
Headache Developed headache, which is atypical for him, the same day as vaccination. The headache was intermittently present for the subsequent 2-3 days and was a/w fatigue and "brain fog" the day after vaccination. He took ibuprofen. No other adverse effects noted.
Warmth; Dizziness; Redness; Pain; Swelling; Headache; Fatigue; Chills; Fever (Temperature 102 to 104F); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warmth), DIZZINESS (Dizziness), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Pain) and VACCINATION SITE SWELLING (Swelling) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included ASCORBIC ACID (VIT C), LISINOPRIL, CHLORTHALIDONE, CLOPIDOGREL, ASPIRIN [ACETYLSALICYLIC ACID], CETIRIZINE, METOPROLOL, ATORVASTATIN and MONTELUKAST for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warmth), DIZZINESS (Dizziness), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Pain), VACCINATION SITE SWELLING (Swelling), HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever (Temperature 102 to 104F)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 04-Mar-2021, HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever (Temperature 102 to 104F)) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warmth), DIZZINESS (Dizziness), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Pain) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 102 - 104f (High) Temperature 102 to 104F.     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.
Got really bad flu symptoms, diarrhea, chills vomiting.  As long as I was sitting or laying down I could keep from vomiting.  Spent remainder of day in bed. Next day just felt tired and weak Spent Friday in bed, ate some toast and eggs. Went to work not feeling too good, but did o.k.   Got my appetite back Saturday evening.
Information has been received from a registered nurse concerning a 37 month old female who on 1/10/03 was vaccinated with a dose of varicella virus vaccine live (lot # 637975/1897K). Subsequently, on 10/25/04, the patient developed a vesicular rash with about 20 lesions. No other symptoms were noted. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Patient call to say she is having difficulty breath, wheezing, weakness and fast heart beat. The patient is on her way here to there hospital.
I have had major swelling above my collarbone between my shoulder and neck on the left side, the same side as I received my shot.  It is tender to the touch.  After four days, I can feel harder masses inside.
Patient given Pediarix instead of Pentacel. Patient was due for DTap, Hib, Polio(pentacel), Hep B, Rota and PCV13.  She was given DTap, Hep B, Polio(pediarix), hep b, rota and PCV13.
Myocarditis; This spontaneous case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis) in a 30-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in February 2021 due to MYOCARDITIS. At the time of the report, MYOCARDITIS (Myocarditis) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.   Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
This spontaneous report as received from a nurse practitioner via a company representative refers to a 57 year old male patient. On an unknown date the patient was vaccinated with ZOSTAVAX (0.65 ml/single dose, subcutaneous in the arm, lot number was not reported). On an unknown date, 24 hours after vaccination, the patient experienced hard, indurated, warm area around the vaccination site in an unspecified arm while using ZOSTAVAX. The patient was treated with doxycycline. The patient sought medical attention via visiting physician. The outcome of events was reported recovering (reported as the adverse reactions had improved). The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
When shot given, extreme pain down center of upper arm. Continued for 10 days then onset of excruciating pain in shoulder and arm --worse when lying on either side. Limited ability to lift, push, pull etc. Arm/shoulder does not have full range of motion as of 10/31/2016.
After administration of DTaP 1, IVP 1, Prevnar 1, Comvax ! on 6/28/06 at 2 months the child developed uncontrollable shaking of whole body about 1 min, rash lower extremities lasted 2 days, no fever, uncontrollable crying for about 5 hours.
A report has been received from a Health Professional concerning a patient of 2 years 39 weeks 4 days, Female subject, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal). FLUMIST Quadrivalent (Intranasal) started on 11-Mar-2016. Nurse reports that expired FLUMIST was administered today to 3 patients. FLUMIST expired on March 9, 2016. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between expired FLUMIST and FLUMIST Quadrivalent. Based on the information in this report and awaiting the reporter's assessment, the company physician considered the event expired FLUMIST and drug FLUMIST Quadrivalent to be unrelated.