chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by another manufacturer (Schering Plough) and described the occurrence of self-destructive behavior in a 37-year-old male subject who was vaccinated with TWINRIX, GlaxoSmithKline. On 13 November 2009 and 29 January 2010 the subject received unspecified dose of TWINRIX (unknown). On 13 November 2009, less than one day after vaccination with TWINRIX, the subject experienced self-destructive behavior, localized muscle pain, swelling, erythema, hotness, low grade fever, sleeps all day, and flipped out. On 29 January 2010, at the time of vaccination with TWINRIX, the subject experienced inappropriate schedule of vaccine administered. This case was assessed as medically serious by GSK. At the time of reporting the localized muscle pain, swelling, erythema, hotness, low grade fever and sleeps all day were resolved; self-destructive behavior and flipped out were unresolved.
C/O arm pain 1-2 days after vaccines given. C/O generalized muscle soreness, fevers on and off and exhaustion. Unable to pursue activities (walking and swimming) due to fatigue. Arm pain resolved. Other sxs persist.
Lymph nodes under the left armpit grew enormously large, there is clearly an inflammation and it hurts a lot; Migraine; Temperature over 100; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 20Apr2021 at 12:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included an allergy to cats. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 30Mar2021 at 12:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 06:00, the patient experienced migraine, temperature over 100 and lymph nodes under the left armpit grew enormously large, there was clearly an inflammation and it hurt a lot. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. On 21Apr2021 at 06:00, the patient underwent test for body temperature and the result was fever with temperature over 100. On an unknown date in Apr2021, the patient underwent lab tests and procedures, which included ultrasounds exam and the result was several large nodes up to 3 cm. Therapeutic measures were taken as a result of events and included treatment with ibuprofen (MANUFACTURER UNKNOWN). The clinical outcome for the events migraine, fever and swollen lymph nodes were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
at injection site - hotness; Skin hardness at injection site; Extreme pain at injection site; Redness at injection site that has spread; This is a spontaneous case from, initially received from other health professional via agency (case ID: SEQ19-04875) on 16-Oct-2019, concerning a female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100112490, expiration date: 11-Jun-2020, route of administration and anatomical location: not reported] for an influenza prophylaxis.  On an unknown date, after vaccination, the patient experienced hotness, extreme pain, skin hardness at injection site and redness at injection site that had spread.   On 24-Sep-2019, the reporter stated that the patient was doing well.  The outcome of all the events was recovered, on an unspecified date.  The reporter did not provide seriousness and causality assessment.  The case is linked to 201905307, 201905317, 201905318, 201905320, 201950321, 201905322, 201905323, 201905324 and 201905325 due to same reporter.  Follow up received from other health professional via agency (SEQ19-05499) on 24-Oct-2019: The reporter stated that all vaccine recipients were doing well. The outcome of all events updated to 'Recovered/resolved'. Narrative amended accordingly.  Company comment: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Employee reports redness and welt like appearance that started shortly after getting flu vaccine, is getting worse, denies fever, denies SOB, denies trouble moving L arm
Chills Headache  Difficulty breathing Swelling of throat  Weak In bed for 2 days
No adverse event; HCP stated they accidentally administered dose to children after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered dose to children after the expiration date  ) and NO ADVERSE EVENT (No adverse event) in an infant male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 03-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered dose to children after the expiration date  ). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered dose to children after the expiration date  ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered dose to children after the expiration date  ).    No concomitant information was reported. It was reported that patient number 3 did not experienced any adverse event and was 6 months and 2 weeks old . No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-716545, US-MODERNATX, INC.-MOD-2023-716441 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716545:same reporter US-MODERNATX, INC.-MOD-2023-716441:same reporter
I developed extreme pain in right side of neck. I have a high pain tolerance. I experienced extreme pain. It was a lot more than an ache or soreness. I went to sleep around 11:30. Due to the intensity of the pain, I got up and took two tylenol tablets, each 650 mg, with a scant amount of water and no food, at 12:30 am. I got some sleep, not a full night. It was better in the morning. I took one tylenol tablet 650 mg. with breakfast. it is now 1:16 pm and aches a bit. I may take another tylenol with lunch. Dr. faxed a letter to Pharmacy on 08/31/2021 requesting that I be given the Covid-19 Booster since I started taking Losartan Potassium 50 mg. for high blood pressure on 08/27/2021. Item #21 - I had With regard to Item #21 - I had an appointment this morning with, M.D. I was asked whether I had any pain. I provided Dr. with the information included on this form with regard to my reaction to the vaccine. Dr gave me the CDC phone number. The CDC directed me to VAERS. I also reported this information to Dr.
3 days after receiving the 2nd vaccine I began experiencing muscle weakness and joint popping, the joint popping happens with every movement I do. It has not subsided and has become worse since my booster. Now the joint popping and cracking are louder and have gone to my fingers and toes. After numerous supplementations and trial and errors with exercises, the popping of the joints and muscle weakness have not stopped. I am not vitamin deficient and have had blood work and am not anemic. I have no pain or swelling of the joints, but the joint popping has reached my spine and chest, I can now pop my chest as if a person can crack their knuckles. I was told by my doctor to continue with calcium and vitamin D supplementation. I work in healthcare and absolutely none of my older patients have any popping or cracking in their joints like I do. Nothing seems to alleviate this symptom, I stretch, I do cardio, I am physically fit for my age, I weigh 125 lbs. with muscle. I have even checked if I had rheumatoid arthritis, ANA was negative. Please, I urge whoever handles these messages is able to provide me with some resolution. It is so bad that my bones sound they are about to pop out of the socket or their placement in the joint, again, no pain or swelling, but very loud and with every movement I make they pop.
Started noticing soreness in my left arm late on 2/25/2021, similar to what I had the next day after my shot. It got worse during the night, couldn't lay on that arm all night, and on awakening my arm was very painful, red, hot with a large lump.
Heart attack; Greater than 35 days between Moderna Covid-19 vaccines/Did not get second shot, first on Apr 2021; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, LISINOPRIL, METFORMIN and ATORVASTATIN for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19 vaccines/Did not get second shot, first on Apr 2021). The patient was treated with TICAGRELOR (BRILINTA) for Heart attack, at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] for Heart attack, at a dose of 81 mg and Surgery (Cardiac stents placed in JUL 2021) for Myocardial infarction. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19 vaccines/Did not get second shot, first on Apr 2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company Comment: This case refers to a 68-year-old female patient with no known medical history but taking concomitantly Metoprolol, Lisinopril, Metformin and Atovarvastatin which are suggestive of an underlying medical condition. She experienced the unexpected event of Myocardial Infarction on an unspecified date after the first dose of Moderna COVID-19 Vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow up received included reporter information, patient demographics, vaccination details, concomitant medications and treatment details.; Sender's Comments: This case refers to a 68-year-old female patient with no known medical history but taking concomitantly Metoprolol, Lisinopril, Metformin and Atovarvastatin which are suggestive of an underlying medical condition. She experienced the unexpected event of Myocardial Infarction on an unspecified date after the first dose of Moderna COVID-19 Vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Fever; fatigue; body aches; sore arm; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Jan2022 15:00 (Lot number: FJ5682) at the age of 16 years as dose 3 (booster) , single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0187, Route of Administration: Intramuscular), administration date: 13Jun2021, when the patient was 15 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0178, Route of Administration: Intramuscular), administration date: 23May2021, when the patient was 15 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 13Jan2022, outcome "not recovered", described as "Fever"; FATIGUE (non-serious) with onset 13Jan2022, outcome "not recovered", described as "fatigue"; PAIN (non-serious) with onset 13Jan2022, outcome "not recovered", described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 13Jan2022, outcome "not recovered", described as "sore arm"; HEADACHE (non-serious) with onset 13Jan2022, outcome "not recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, fatigue, pain, pain in extremity, headache.  Additional information: The patient did not received any other vaccine with 4 weeks prior to vaccine. The patient did not received any other vaccine with 2 weeks prior to vaccine. The patient did not had COVID prior to vaccine. No known allergies.  No follow-up attempts are possible. No further information is expected.
Fever; Chills; Cough; Lung irritation; Nasal congestion; Aches; This is a spontaneous report from a contactable other health care professional, the patient. A 32-year-old non-pregnant female patient received unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Unknown) via unspecified route of administration in the right arm on 30Mar2021, at 13:15 as a single dose for COVID-19 immunisation (at the age of 32-years-old). Medical history included neck injury and allergy to sulfa antibiotics. Concomitant medications included sertraline hydrochloride (ZOLOFT), tramadol (MANUFACTURER UNKNOWN), carisoprodol (SOMA), paracetamol (TYLENOL), ibuprofen (MOTRIN), and magnesium (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was diagnosed with COVID-19 in Dec2020, on unknown date. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 31Mar2021, at 16:00 the patient experienced fever, aches, chills, cough, lung irritation, and nasal congestion. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient had not received treatment for events. The clinical outcome of events fever, aches, chills, cough, lung irritation, and nasal congestion was not resolved at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pfizer vaccine was reconstituted with Moderna vaccine that was sitting right next to it, instead of the sodium chloride
Pt reports having repeat post injection site reactions again after 1st shot: arm soreness at the injection site a week ago, about 65 days after injection at the injection site, and then about 3 days ago, area at and around injection site became red and pt has been fatigued. The symptoms that appeared were like getting the shot again without getting the shot. Pt reports that the fatigue has improved but still sore and red at injection site.
A PFIZER COVID VACCINE WAS ADMINISTERED TO A PT WHO IS A 15 YEAR OLD PATIENT. IT WAS GIVEN IN THE LEFT DELTOID MUSCLE. THERE WERE NO IMMEDIATE ADVERSE REACTIONS.
pt recv vax 8JAN96;parents are concerned because they feel that since then has devel fibromyalgia;chart review indicated many sx prior to vax;
I was administering a Pfizer Covid 19 vaccine into the left deltoid of the pt when the syringe failed. Vaccine was sprayed out from the base of the needle onto the pts arm and the floor. Pt did not receive much if any of the dose. event was reported to onsite doctor who instructed to administer another dose in the pts right deltoid.
This case was reported by a nurse and described the occurrence of incorrect storage od drug in a patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016 and (batch number HM4FY, expiry date 6th December 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Nurse at this time did not have any other information. 10 patients received BOOSTRIX that was exposed to temperature of 30.4F Two Lot Numbers 3P9CL exp 4/15/2016 HM4FY exp 12/6/2016. This case is one of the 10 cases reported by the same reporter for the same vaccine.
pt recvd 1 dose of Engerix-B vax aobut 2 1/2 wks follwoing dose exp joint swelling, joint pain & fever; hospitalized; tx unk; sx persist;
Unknown if related, but had injection in right arm, burning rash/redness in left armpit.  Probably unrelated but then 4 days later, go sinus infection.
Covid19 breakthrough.  1st vaccine received on 08/03/2021.  73y/o PMH of DM, HTN, BPH, HLD, Parkinson's admitted to ED 1/4/22 with c/o generalized weakness, mild back pain and urinary incontinence x1 week as to weak to get out of bed.  CXR-no acute, afebrile, room air sat 99%.  Pt being considered for rehab placement so COVID PCR ordered and came back + on 1/7/2022.  Treated with IV ABX.
Chest pain, some sharp pains; difficulty catching my breath; extremely sore arm; chills; tiredness; feeling unwell. Started around 6 pm day of injection. Next morning, woke at 6 am with tender arm. Chest pain continued throughout the day periodically, and so did difficulty catching my breath. A general feeling of illness. Still occurring as of current hour, 7:44 pm, on 7/24/2021. These affects were from vaccine #1.
Fever; Chills; total body aches; joint pain and then the joint pain localized into both hands; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number N7NP4, expiry date 9th April 2023) for prophylaxis.   On 22nd December 2021, the patient received the 2nd dose of Shingrix .5 ml. On 23rd December 2021, 1 days after receiving Shingrix, the patient experienced fever, chills, general body pain and joint pain. On an unknown date, the outcome of the fever, chills and general body pain were recovered/resolved and the outcome of the joint pain was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, general body pain and joint pain to be related to Shingrix.  Additional details were provided as follows: The reporter that the patient experienced fever, total body aches/joint pain and chills the day after receiving her second dose of Shingrix. The reporter further stated that these symptoms subsequently resolved, however, after approximately 1 week after receiving the vaccine, the joint pain localized into both hands. The reporter stated that the joint pain in the hands was described as a pain level 5 and had not resolved.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 06-OCT-2017, the patient was vaccinated with a dose of GARDASIL 9 intramuscularly, lot number L014198 with expiration date 05-SEP-2017 (anatomical location was not reported) for prophylaxis. No adverse effects were reported in the patient.
Couldn't lift left arm, could barely walk, no strength, no energy and felt weak for about 3 weeks.
Swelling and redness in left arm, just below the vaccination site.  After one week the swelling and redness seem to be somewhat reduced
Pt took oral dose of Typhoid vaccine, 1st dose 9/2/06, diarrhea began 9/3/06 temp 100, syncopal episode and nausea 9/7/06 with ER visit. Requiring IV fluids.
body felt heavy; felt cold; she had trouble moving her arm close to her body(she felt like she had an inflamed ball inside); bruising at the injection site; injection site redness 2-3 inches oval shaped; a lot of body aches; feeling tired; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (body felt heavy), FEELING COLD (felt cold), MOBILITY DECREASED (she had trouble moving her arm close to her body(she felt like she had an inflamed ball inside)), VACCINATION SITE BRUISING (bruising at the injection site) and VACCINATION SITE ERYTHEMA (injection site redness 2-3 inches oval shaped) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (body felt heavy), FEELING COLD (felt cold), MOBILITY DECREASED (she had trouble moving her arm close to her body(she felt like she had an inflamed ball inside)), VACCINATION SITE BRUISING (bruising at the injection site), VACCINATION SITE ERYTHEMA (injection site redness 2-3 inches oval shaped), MYALGIA (a lot of body aches), FATIGUE (feeling tired) and CHILLS (chills). At the time of the report, FEELING ABNORMAL (body felt heavy), FEELING COLD (felt cold), MOBILITY DECREASED (she had trouble moving her arm close to her body(she felt like she had an inflamed ball inside)), VACCINATION SITE BRUISING (bruising at the injection site), VACCINATION SITE ERYTHEMA (injection site redness 2-3 inches oval shaped), MYALGIA (a lot of body aches), FATIGUE (feeling tired) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been reported.
Arrived w/ SOB; tested + for COVID day prior. 2 shots, no booster. Admitted for COVID pna.  Given O2, singulair, zinc, zithromax, rocephin, remdesivir, zosyn, merrem, vit-d. Progressed to BiPAP and eventual intubation/vent support. Continued to deteriorate and transferred to a HCF for higher level of care.
EMPLOYEE HAS ITCHING AND REDNESS  TO THE ENTIRE BODY. SHE ALSO HAS SWELLING, WARMTH, AND REDNESS AT THE INJECTION SITE. SHE ALSO COMPLAINS OF PAIN TO THE RIGHT ARM AND SHOULDER. EMPLOYEE WAS GIVEN ICE PACKS TO APPLY TO AREAS OF REDNESS AND ITCHING AREAS. SHE STATED ICEPACK CAUSE SOME RELIEF AFTER A FEW MINUTES OF APPLICATION.