chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; chills; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21May2023 at 12:00 as dose 7 (booster), single (Lot number: GJ3270) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin Allergy" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, SINGLE, Lot Number: EL982, Anatomical site: Right Arm), administration date: 23Jan2021, when the patient was 65-year-old, for COVID-19 Immunization; comirnaty (DOSE 2, SINGLE, Lot Number: EN624, Anatomical site: Left Arm), administration date: 13Feb2021, when the patient was 65-year-old, for COVID-19 Immunization; comirnaty (DOSE 3 (BOOSTER), SINGLE, Lot Number: FF2590, Manufacturer: Unknown), administration date: 15Oct2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "Myalgia", "Headache", "Myalgia"; comirnaty (DOSE 3 (BOOSTER), SINGLE, Lot Number: FF2590, Manufacturer: Unknown), administration date: 15Oct2021, when the patient was 66-year-old, for COVID-19 immunization, reaction(s): "Nausea"; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Lot Number: Unknown, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Lot Number: Unknown, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, Lot Number: Unknown, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 22May2023 at 03:30, outcome "recovering"; CHILLS (non-serious) with onset 22May2023 at 03:30, outcome "recovering"; NAUSEA (non-serious) with onset 22May2023 at 03:30, outcome "recovering". Therapeutic measures were taken as a result of headache, chills, nausea.  Additional Information: It was reported that the patient was not diagnosed with COVID prior to vaccination and has not been tested COVID post vaccination. It was also reported that Tylenol 2 tablets was taken as treatment for the events.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101383789 Same reporter, patient, product, different dose and events;
On day 5 after the vaccine, I experienced blurred vision and a crushing headache.  It came on extremely quickly.  I took pain medication and laid in a dark room and slept.  By the next day, it was gone.
pt recvd 1st dose of Engerix-B & on the noc of the inject exp stomach upset & vomiting that lead to dehydration; treated w/Carafate for poss ulcer;
BILATERAL DEEP VEIN THROMBOSIS TO LOWER EXTREMITIES; PULMONARY EMBOLISM IN BOTH LUNGS; BODY ACHE; CHILLS; This spontaneous report received from a consumer concerned a 54 year old female. The patient's weight was 190 pounds, and height was 66 inches. The patient's past medical history included cancer, and concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient had no known allergies and drug abuse/illicit drug usage.  The patient received JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) (suspension for injection, route of admin intramuscular, batch number: 1805031, and expiry:not reported) dose was not reported, 1 total, administered in left arm on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAR-2021, the patient experienced chills. On 06-MAR-2021, the patient experienced body ache. Since 09-APR-2021, patient started experiencing leg pain and was admitted to a hospital on 10-APR-2021. The patient was diagnosed with 2 deep vein thrombosis (DVTs) to the lower extremities with pulmonary embolism. The patient was on therapeutic Lovonox (enoxaparin sodium) and was prescribed Lovonox injection twice a day for 6 months. The patient had visited emergency room and hospitalized for 5 days. The patient was discharged from hospital on 13-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and chills on 10-MAR-2021, and was recovering from bilateral deep vein thrombosis to lower extremities, and pulmonary embolism in both lungs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This 54-year-old obese female with BMI of 30.7 was hospitalized due to bilateral deep vein thrombosis (DVT) to lower extremities and pulmonary embolism (PE) in both lungs 35 days after receiving JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) in left arm for prophylactic vaccination.  The patient's past medical history included cancer. The subject had chills 2 days prior to the vaccination and body ache 1 day post vaccination.  The symptoms resolved 5 days post vaccination. She started experiencing bilateral leg pain 33 days post vaccination and chest pain 34 days post vaccination. The patient visited emergency room and was hospitalized. She was diagnosed with bilateral DVTs to the lower extremities and PE in both lungs. Details of the hospitalization were not reported. She was discharged after 5 days of hospitalization with prescription of enoxaparin injection twice a day for 6 months. The patient was recovering from bilateral DVT to lower extremities and PE in both lungs.  Based on the available information, with risk factors of obesity and cancer, DVT and PE are assessed as indeterminate with causal association to immunization, per WHO causality classification for adverse events following immunization.  Company causality is considered not related to JANSSEN COVID-19 VACCINE. Additional information has been requested for further assessment.
Pain at right arm biceps and shoulder starting 2 days after the vaccination. Treated with RICE and Naproxen Sodium 550 mg one tab orally every 12 hours as needed.
Arm still sore and red spots about the size of a silver dollar  Been this way since the morning after the shot.
Localized erythema at injection site approximately 4cm diameter. No fever. No chills. No paresthesias.
Right upper arm cellulitis - given KELFELX 500mg QID x 7 days.
From the day before, very sharp arm pain and not able to lift arm above shoulder, despite heavy garden  work the day before (day of vaccine) which is usual for this subject; woke up 050521 with lethargy, low  fever and stiffness. However the strangest was what I found that evening - a large red area NEXT to the  vaccination site all the way to underarm. This area felt bruised, including the underarm, and hurt to  touch, as well as being warm.
04/18/21, 02:00 awoke uncontrollable shaking (could not get warm). By 0600 had thrown up everything I could. By noon I had thrown up my toenails (Dry Heaves)-- This continued till 04/19 around noon.  04/18/20-04/19/20, Diahrea in addition to the Dry Heaves. Extreme Headache and Thirst (couldn't keep liquids down or take Tylenol). Very Weak at that time.  Body Aches began 04/19 and still continue.  injection site pain, Arm Red on that side and still continues.  By 04/20 I was up and around and able to eat. 04/21 eating well.  Still don't have full strength.
Severe fatigue, weakness, nearly fainted, low grade fever, inability to concentrate, muscle aches, chills, ringing in ears, headache, extreme soreness at injection site
large local rxn @ inj site 24hr p/vax; redness, mild swelling, clear vesicles @inj site;sx & supportive measures, rest, fluids, PAPA or Ibuprofen, cool compresses, DPH;monitor;
Patient with prior Covid infection Nov 2020, fully recovered, received first dose Moderna vaccine on 3/13/21 and next day developed body aches, fevers, chills, shortness of breath. Admitted 3/17/21 due to hypoxia, had ground glass opacities on CT. SARS-CoV-2 PCR negative x 2.  Vigorous immune response could have caused lung inflammation and hypoxia, similar to a covid infection, but from the vaccine. 60YM with a history of a chronic inflammatory arthritis on methotrexate, hospitalization in November 2020 with Covid pneumonia, he was discharged on 1 to 2 L of home oxygen, and reports that he was told by his PCP about a month after discharge that he was able to come off the oxygen as his oxygen saturations had normalized.  He returned to his usual state of health and activity with no issues until he received the first dose of his Moderna covid-19 vaccine through his primary care office on 3/13.  The next day he developed arm pain and then progressive body aches, headaches, fevers, chills, and shortness of breath.  He presented to the ER and was found to be febrile with hypoxia and admitted for treatment and evaluation.   Acute hypoxemic respiratory failure with ground glass opacities on CT : oxygen 87% on RA in ER, 84% on room air 3/19, resolves with oxygen support of 2lpm.  CTA was negative for pulmonary embolism. SARS-CoV-2 PCR negative x2 as well as respiratory virus panel, CT shows ground glass opacities, patient was started on ceftriaxone and doxycycline for empiric treatment for possible community-acquired pneumonia, although procalcitonin was negative.  BNP was elevated at 458, so an echocardiogram was performed which showed a normal EF, and grade 1 diastolic dysfunction.  Patient was given 2 doses of furosemide during the hospitalization and BNP normalized. Patient was started on prednisone to calm down a possible inflammatory response triggered by the COVID-19 vaccine in a person who likely already has antibodies, causing hypoxia.  With this patient significantly improved and at discharge is on room air at rest, but still requires 2 L/min with exertion.  CRP was markedly elevated, supporting an inflammatory process.  Autoimmune lung disease panel was sent and is in process at time of discharge.  Patient requested discharge home, Discharged on a slow prednisone taper to avoid rebound with abrupt discontinuation of steroids.  Patient will complete 2 additional days of Augmentin and doxycycline at discharge.
A Vaccine dose was administered to a patient while an excursion occurred; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (A Vaccine dose was administered to a patient while an excursion occurred) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced PRODUCT STORAGE ERROR (A Vaccine dose was administered to a patient while an excursion occurred). On 28-May-2021, PRODUCT STORAGE ERROR (A Vaccine dose was administered to a patient while an excursion occurred) had resolved.        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.   No concomitant medications were reported.  No treatment medications were reported.
Patient stated that she was fainted from last year travel vaccine.  Immunizer and patient both aware it might happen. immunizer told patient will monitor closely then gave the shot. Right after shot, patient stated that she is feeling dizzy and is going to faint. she fainted. gained conscious right after ( about 2- 5 seconds ) and offered to call 911 and she said it is ok. She was sitting that same chair for 10 minutes, then she wanted to sit on the ground ( not lying down) . after she was sitting on the ground, she felt better, so we moved to outside of immunization area chair for monitor. She felt fainting is coming again so she sit on the ground. but she did not faint again. She wanted to lying down. she lied on the ground for about 20 minutes , then sit up for another 15 minutes. she felt find and went home . checked back 3:30 pm on same day, she was ok .
Rash, hives, vomiting - onset 15 minutes after vaccines administered - given Epinephrine and BENADRYL - admitted to ICU x 1 day.
The adverse event was a small stroke which occurred after/during a severe headache . There was numbing/tingling and muscle contractions in my left hand followed my face drooping and slurred speech. It was never said that the stroke was caused by the vaccine. It may have been a factor though.
Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Medium
Neck pain; This case was reported by a pharmacist via call center representative and described the occurrence of neck pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced neck pain. The patient was treated with cortisone (non-proprietary). On an unknown date, the outcome of the neck pain was unknown.   It was unknown if the reporter considered the neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 53 or 54 years. The reporter did not know the history of the patient and could not confirm if if patient was receiving cortisone shot for neck pain prior to 1st dose of Shingrix. The lot number/expiry date of Shingrix was unknown. In April 2019, the patient received a dose of Shingrix and in July 2019, the patient had cortisone shot in the neck for neck pain. The contact was a floater and did not work full time at this pharmacy. The reporter consented to follow up. This case had been linked to the case US2019180868, reported by the same reporter.
joint pain; headache; tiredness; uncomfortable; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 62-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced joint pain, headache, tiredness. She mentioned that she was confined to her room and how her family was making her feel uncomfortable. For this she had not slept for 2 days. Outcome of all the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No adverse event was reported. However, patient was given 3rd booster dose of Pfizer at age 16.
Felt something on the arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt something on the arm) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020.    On 03-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 FEELING ABNORMAL (Felt something on the arm). At the time of the report, FEELING ABNORMAL (Felt something on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments    This case was linked to MOD-2021-213283 (Patient Link).
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medications and medical history was not provided. Since 14-NOV-2014 (on unspecified dates of November 2014), the patients were vaccinated with doses of ROTATEQ (oral, lot#, dose and frequency were not provided), which were exposed to unknown temperatures since 14-NOV-2014 (due to the MinMax feature of the thermometer not being cleared with each temperature reading). Because the temperatures to which the vaccines had been exposed were not known, it was not known whether or not the vaccines were supported. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax 19APR93 & 1 min p/yellow fever vax pt became dizzy &lightheaded; pt was sitting down, placed head between knees & fainted; color was pale & was diaphoretic; BP dropped to 80/40 & was lightheaded;
This spontaneous report as received from a nurse refers to a male patient of unknown age (a child). On 18-JUL-2014 the patient was vaccinated with the first dose of ROTATEQ (dose and lot number were not reported) oral. The ROTATEQ was improperly stored. Concomitant medications were not reported. No adverse effects reported. Additional information is not expected, as the nurse stated she did not want to provide any other information.
pt recvd vax & initailly cried hard but settled down; pt became mottled & exp shock-like sx; 02 was administered & pt was taken to med ctr 215PM; WBC were 28,600; pt HR was upt to 220 beats/min;
The first day about 4 hours after shot my arm started hurting and steadily got so i could not lift it more than 1/3 up. My neck hurt. by Tuesday my neck and back hurt so bad I had a hard time talking and raising my head all the way. I had to take more of my prescribed pain med and prednisone to control the pain. The pain/burning is now all the way down my neck/spine around my right rib and into my arms and mostly right leg. I called my doctors and she called in a medrol dose pack which i will pick up today.  I also started having a bad headache Thursday. I may have to go to urgent care if I can't control the pain.
Patient called stating he received a flu vaccine yesterday in the morning and in the evening he developed rib and back pain. The next morning he developed pain in his tonsils and nasal drainage. He also reports a little difficulty breathing which he has not previously experienced.
A pharmacist reported that a 29 year old female received an injection of TD Adsorbed, Purogenated on 6/7/00. The pt received vaccine either from lot 462364 or 464259. She subsequently, developed an injection site reaction characterized by redness, swelling and pain. On 6/12/00, the pt was seen by the physician and the reaction had resolved by that date.
4wk p/vax sneezing, hives, lt eye swelled shut got DPH over the noc & sx resolved;brought to medical unit of residential treatment;
10 minutes after patient received vaccine she reported feeling flush, hot and sweaty. She denied having any issues breathing, throat swelling. We administered Benadryl and gave patient a bottle of water.
Same day of vaccine became sick with a fever, lightheaded and unsteady motor coordination that required assistance to prevent fall. Excessive daytime sleepiness unrelated to other health conditions with thyroid levels being within normal limits at the time. Excessive daytime sleepiness persisted for 2 years before sleep study referral. Completed sleep study, including the PSG and MSLT. Results from those tests indicated an appropriate diagnosis of Narcolepsy without Cataplexy; Follow up with specialist sleep doctor every 6 months. Prescribed Armodafinil and Xyrem to treat the symptoms of Narcolepsy and to continue daily functioning and responsibilities.
The day of the vaccine I had horrible body aches and horrible nausea as well that lasted approximately 36 hours. But starting on the 24th so about 11 days post vaccine, my injection site got very red and itchy. The redness then spread down my arm and I developed hives around my elbow. I treated it with a topical Benadryl spray to get rid of the itchiness, and the hives lasted about 36 hours and have already almost faded.
Pt felt dizzy after vaccination & was assessed by EMS. Pt is a type I diabetic. Sugar was elevated. Pt.'s other vitals were within normal limits. Pt was wheeled in a wheelchair to a vehicle driver by pt's driver by pt's assistant back to her work site to take insulin & have snack.
Information has been received from a physician concerning an unspecified number of patients who were vaccinated with a dose of GARDASIL. The patients experienced pain when they received the injection. It was unknown whether medical attention was sought. Patient outcome was not reported. No further information is available.
Patient received HPV vaccine by accident. Was in the office for Hep A vaccine, brother was meant to get HPV vaccine. Medical assistant accidently gave HPV vaccine to 2- year old patient which is below the recommended age. Patient was observed for 20 minutes after the event and was experiencing no side effects.
BODY WAS REALLY REALLY WARM BUT NOT A FEVER; FELT YUKKY LIKE WAS GETTING A COLD; ARM HURT LIKE CRAP; CHILLS; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included heart condition, chronic obstructive pulmonary disease (copd), pleurisy, osteoporosis, cat dander allergy, and pollen / seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: 1-JULY-2021) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced body was really really warm but not a fever. On 05-MAY-2021, the subject experienced felt yukky like was getting a cold. On 05-MAY-2021, the subject experienced arm hurt like crap. On 05-MAY-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body was really really warm but not a fever, felt yukky like was getting a cold, and chills on 06-MAY-2021, and arm hurt like crap on 05-MAY-2021. This report was non-serious.
Patient received the Jansen vaccine on 9/1/2021 and returned to get another vaccine on 9/29/2021.  The patient requested and was administered the Pfizer vaccination.
Patient received H1N1 vaccine on 12/2/09. Next morning at 7:30 when she woke up noticed arm discomfort in right area that received the vaccine. Arm discomfort became worse as the days progressed. Also had arm weakness and loss of range in motion. Saw family doctor to prescribed Neurontin which has made improvement.
Developed pruritic erythematous papular rash over lower extremities within 24 hr of administration. Rash progressed to involve most of body, including face, over the next week.  Ongoing at the time of this report despite diphenhydramine.  Popliteal fossae lesions weeped after several days then cleared.
Tiredness - 22 hours after injection - lasted 36 hours Muscle pain - 22 hours after injection - lasted 10 hours Shivering - 22 hours after injection - lasted 6 hours Fever - 22 hours after injection - lasted 6 hours Headache - 48 hours after injection = lasted 2 hours Stomach pain - intermittent 36 hours             nausea - intermittent 36 hours Inflammation at injection sight - more than 36 hours
Per patient "excruciating" pain in arm 3 hours post administration.  + Edema at injections site.   + fever.  Reported 100.0 F fever despite taking acetaminophen.   Reported fever broke on 8/11/19.   She reported sore throat on left side on Sunday. 8/12/19:  she reports edema resolved.  Fever is resolved.   She reports 3 red, raised areas on her legs that are itchy.