chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bad headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache) in a patient of an unknown age and gender 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 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Bad headache) (seriousness criterion hospitalization) and CHILLS (Chills). At the time of the report, HEADACHE (Bad headache) and CHILLS (Chills) outcome was unknown.            No concomitant medication reported. No treatment information was provided.  Company Comment: Very limited information regarding this event (headache) has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event (chills), a causal relationship cannot be excluded.   This case was linked to MOD-2021-218728 (Patient Link).; Sender's Comments: Very limited information regarding this event (headache) has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event (chills), a causal relationship cannot be excluded.
On 3-15-21 Mouth ulcers - Multiple - 6 - 8 On 3-18-21 Notified Dept of Health -  On 3-21-21 was doing warm salt water gargles started Valtrex (had some at house) 3-29-21 To Dr. - Rx for mouthwash with lidocaine, benadryl, Carafate, nystatin + cortisone stopped Valtrex - on 3-29-21 Nothing was helping -  4-12-21 To Dr. office again - Blood drawn for B12 level and Arthritis profile  Rx for Medrol dose pack 4-15-21 ALL Lab Work was Normal -  ulcers are getting better but not WELL yet!
Entire left upper arm became extremely swollen, red, hot to touch, chills, joint pain, transient diarrhea,  brain fog with occasional light headedness.
After both the first and second vaccine shots, I had the same reaction.  15 to 20 minutes after the shot, I felt a numbness in my mouth.  I also had a slight throat constriction sensation that I know well given my history with severe allergic reactions to tree nuts.  However, to be clear, the reaction to the vaccine shots was far more mild than my reaction to tree nuts.  If I eat any tree nuts, I have a severe reaction that involves throat closure, hives, vomiting and related symptoms for 6-8 hours.  While the Epipen shot helps with keeping my throat open, it does not reduce all of the other symptoms.  Here, the throat constriction was only approx. 1/100th of the reaction I have when I eat tree nuts.  Further, the slight throat constriction and mouth numbness only lasted 10-15 minutes, as compared to 6-8 hours if I eat tree nuts. I did not need to use an Epipen.
Recieved shot Thursday, FRiday night severe chills so bad your shaking. Then Since Saturday, chest pain and palpitations. Heart is fine as i had cardio look at it .
woke up 31JAN96 red, itchy spot on lt upper arm dime size;pt states spot cont to inc in size w/dec ROM in lt arm & inc pain;area on visit 4 1/2 x 5 1/2 & dec ROM;bright red & warm to touch;dx cellulitis; elevated temp;swelling noted lt ax
After 2nd dose of Pfizer vac, severe short memory loss, confusion, difficult concentration and understanding simple instructions. Unable to preform daily tasks at work correctly. Dr advised I report this possible side effect.
Immediately, felt a pinch that encompassed entire arm; it felt like bucket of ice water was going down armit took 5 minutes to dissipate. Site of vaccination was not at right location--it went on top of bicep near shoulder joint. Mentioned to the nurse but did not think it was anything out of norm. Within a couple of hours the pain continued; it was finite burning pain not muscle achesit felt like fingernails torn off with pliers. Called the doctor but no appointment available so decided to go to the ER on 11/6. Patient followed up with an orthopedic doctor 11/13 who then sent her to neurologist 12/1. Second apt with neurologist a week later for nerve conductivity test; test found that there was a minor pinch on wrist but it had nothing to do with shoulder. Has 3rd appointment with neurologist because no pain relief on 1/19. Pain getting worse and doesn't have full rotation in shoulder--hard to even lift a glass of water. Patient is a massage therapist. Pain is at 5 or 6 even before taking Bayer (Back & Body).
Severe Headache started within 4 hours and lasted about 28 hours. I started with Aleve, also tried Tylenol, and eventually  took Sumatriptan. Chills and low grade fever and muscle aches (100.2 - after taking Aleve 3 hrs prior) started about 10 hours after injection.  Fever lasted 24 hours.
I have chills and 102.4 fever.  I was tested for antibodies 1/8/2021 and it was determined I had antibodies.  Not surprising as my wife was hospitalized for 2 weeks starting on 11/16/2020.  I was exposed to her for 3 days prior and I didn't get symptoms like her's.  I had two negative Covid test, one on the week before her symptoms and another on 12/18/2020.
Weakness; nauseous; asthma attack; This is a spontaneous report from a contactable consumer (patient). A 76-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 14Feb2021 09:30 am (Lot Number: EN5318) as single dose for covid-19 immunisation. Medical history included high blood pressure and patient took two blood pressure medicines, take that one in the morning and one in the night, asthma and pre-diabetic. Concomitant medication(s) included amlodipine taken for hypertension; candesartan taken for hypertension; cetirizine hydrochloride (ZYRTEC) taken for asthma; calcium carbonate, colecalciferol (VITAMIN D); cyanocobalamin, folic acid (VITAMIN B12); vitamin b complex (B COMPLEX). Patient previously took BNT162B2 first dose on 23Jan2021 for covid-19 immunisation. Patient stated first one didn't give Asthma. The first shot patient was sick for about 5 days, very nauseated, very unstable with balance and very tired. Patient stated had pneumonia, shingle shot (unspecified shot) and Flu shot. The second shot patient had on 14Feb2021 the Valentine's day and patient had about 9:30 am and by 11:30 pm it caused an asthma attack on patient and when went to get up patient was very weak and very nauseous in the morning but the asthma attack it going all night patient did have asthma but wasn't had any attacks for a couple months, so it was that patient tried to pull himself (or herself) and had very hard time to pulling himself (or herself) up to sit on the bed and when patient sat on near to bed to stabilize and when went to step down on patient's legs which gave up and couldn't get back up, and finally hours after when patient could not back up, patient live alone and called and the paramedic team to pick patient up and the asthma continues and the weakness continues that whole week and then went to the doctor, patient was given antibiotic and prednisone, patient took steroid for two weeks to get recover from it. Patient stated about 147 pounds. Patient stated have a lab test done, a blood test done on February may be done on. Patient didn't have the results yet, it was basically for "A1C" (not clarified) and sodium because patient go "low" (not clarified) on sodium, it was a CBC or something 4-5 and patient didn't know what all test. Patient was pre diabetic. Patient was not taking because kept exercise up and it kept weight down. Patient stated took asthma medicine including "Claritin" and "Singulair" (further not clarified name). Patient took Zyrtec and had asthma but patient had not having any asthma symptoms, patient's nebulizer used was not even charged and patient was clear of asthma and upon having the Pfizer shot that morning that was second one and took over the counter like Vitamin D and take B12 and patient took B Complex. The event outcome for events was recovered on unspecified date.
Miscarriage. I found out on 11/29 at the hospital that my baby died a week and half earlier which is days after I received the swine flu vaccine shot.
Client experienced a seizure reaction shortly after vaccine injection (2 mins.) for few seconds (5).  Mother verbalized she always has that reaction after she shot.  VS BP 95/66, P 90, O2Sat 100%. VS 114/73, P 90, O2Sat 100%. After 30 mins. of observation resident stated, "I am feeling great."  Mom declined the need to go to the hospital.  In stable condition, resident was send home.
Local reaction to right upper arm.  Redness to area and felt hot to touch with swelling.  Induration about 5 inch x 5 inch erythema.  No treatment.  Necessary only observation and apply or take Benadryl.
Aching, fever, headache, nausea, chills  All started at around 2 AM, almost 13 hours after my injection
Fever began 4 hours after PENTACEL, PREVNAR 13, ROTATEQ, Flu. Tm = 104 degrees 3d after shots, resolved 4d after shots. No other sx, no ill contacts.
She was admitted requiring mechanical ventilation and tracheostomy support.  She was unable to wean from mechanical ventilator.  She had progressive decompensation with hemodynamic insufficiency, renal failure and progressive respiratory failure despite all efforts of support.  She was seen by the nephrology service for consultation.  Family was understanding of the complexity of her comorbidities and did not want advancement of care. She eventually continued to decompensate.  She died on September 4th and was pronounced at 1:53 p.m..
numbness, swelling and pain in his right foot and lower leg; numbness, swelling and pain in his right foot and lower leg; numbness, swelling and pain in his right foot and lower leg; numbness and pain in lower right leg and foot was reported as worsened; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A 25-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0179), via an unspecified route of administration, administered in Arm Left on 05-MAY-2021 09:00 am (at the age of 25-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Note: since he was 8 years old. The patient's concomitant medications were not reported. The patient previously took fluticasone (Dose-250mcg), salmeterol (Dose-25mcg). On 05May2021 the patient experienced numbness, swelling and pain in his right foot and lower leg, numbness and pain in lower right leg and foot was reported as worsened. Patient stated that he got the Pfizer COVID 19 vaccine at 9 am. Then, 3 hours later, he started experiencing numbness and pain in his right lower leg and foot. Is that normal? Caller doesn't have a prescribing doctor. It has become more numb since he first realized it. He does have Asthma since he was 8 years old. The outcome of the event was unknown for numbness and pain in lower right leg and foot was reported as worsened while Not recovered for numbness, swelling and pain in his right foot and lower leg.   No follow-up attempts are needed. No further information is expected.
stressed; wanted to sleep; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (stressed) and SLEEP DISORDER (wanted to sleep) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Prediabetes and Blood clot in urine. Concomitant products included METFORMIN and RIVAROXABAN (XARELTO) for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced STRESS (stressed) and SLEEP DISORDER (wanted to sleep). At the time of the report, STRESS (stressed) and SLEEP DISORDER (wanted to sleep) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. Treatment medication information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received. Suspect product start month and first dose events, events outcome as resolved were added.
Info has been rec'd from 2 physicians concerning a pt with diabetes mellitus and histories listed below, was vaccinated with a 1st dose of pneumococcal 23 (lot#637487/1071K). On 2/25/02, the pt rec'd a booster dose of pneumococcal 23. Within 2 hrs post vaccine, the pt went to the ER because of shivering. In the ER he had a fever of 105F, severe hypotension, and large local reaction at injection site. The physician reported that there was concern with sepsis. The pt was admitted to the hospital on 2/26/02 and treated with broad-spectrum antibiotics and fluids. The pt recovered within 24-48 hrs, and was discharged on an unspecified date. The pt's physician reported that he thought that the reaction was a systemic inflammatory response. The allergist thought the local reaction resulted in a severe hypotensive reaction due to cytokines being released causing vasodilatation. He did not think the pt had anaphylaxis or a serum sickness reaction. There was no hiving or urticaria. Additional info has been received from the patient's physician. The patient's physician reported that 2 to 3 hours post vaccination, the patient developed rigor-like chills, fatigue, tachycardia and HTN. The patient subsequently developed a fever of 105. Laboratory  evaluations revealed blood and urine cultures were negative,and an echocardiogram was negative. The patient was hospitalized for 3 days. The patient subsequently recovered on 03/06/02. No additional information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 03-DEC-2013 the patient was vaccinated with an improperly stored dose of ZOSTAVAX, lot# and expiry date not reported, 0.65 ml, subcutaneous. No symptoms reported. It was not reported if the patient had sought medical attention. Additional information is not expected.
Has a low rubella titer and unknown MMR II vaccination status; This spontaneous report has been received from a nurse, and refers to a 41 year old female patient. The information about patient's concurrent condition, medical history, drug history and concomitant medications was unknown.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) as prophylaxis (exact dose, strength,frequency, route of administration and anatomical site of vaccination, lot number and expiration date were not reported). On an unknown date, the patient had a low rubella titer (Rubella antibody negative) and unknown measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) vaccination status (Rubella antibody negative). It was reported that, the patients measles and mumps titer was within normal limits. The patient did not receive a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) at the current time. No treatment was given for the adverse event.  At the time of reporting, the outcome of the rubella antibody negative was unknown. The reporter did not provide the causality assessment between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).
Patient described oral tingling, numbness, and burning for 2 weeks since receiving 2nd dose of Moderna vaccine. Became acutely worse on the evening before presenting to ER. Was prescribed antihistamines and oral steroids.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID 19) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 030N20A and 029L20A) for COVID-19 vaccination. The patient's past medical history included Rib injury (history of rib injury with surgery) since an unknown date. Concurrent medical conditions included Asthma, Eczema, Pre-eclampsia (severe) since 2011, HELLP syndrome since 2011 and Latex allergy. Concomitant products included NAPROXEN SODIUM (ALEVE) from 01-Mar-2022 to an unknown date, MULTIVITAMINS [VITAMINS NOS] from 01-Sep-2021 to an unknown date and PARACETAMOL (TYLENOL) from 01-May-2022 to an unknown date for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 16-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID 19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2022, SARS-CoV-2 test: negative (Negative) Negative (tested at home). On 22-May-2022, SARS-CoV-2 test: positive (Positive) Positive. No treatment medications were reported. Company comment: This spontaneous case concerns a 41-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID-19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID-19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for 6 days as treatment for COVID-19 from 11-May to 16-May. Patient tested negative for COVID-19 on 16-May. 5 days later the symptoms returned, and patient again tested positive for COVID-19 on 22-May. Patient received 2 doses of mRNA-1273 vaccine as per recommended schedule approximately 8 and 9 months prior to the last dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 41-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID-19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID-19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for 6 days as treatment for COVID-19 from 11-May to 16-May. Patient tested negative for COVID-19 on 16-May. 5 days later the symptoms returned, and patient again tested positive for COVID-19 on 22-May. Patient received 2 doses of mRNA-1273 vaccine as per recommended schedule approximately 8 and 9 months prior to the last dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
severe peripheral neuropathy;" lost of nerves in lower body & hands" -extreme pain in legs & feet-  no treatment;Annual follow-up dated 09/28/00 states pt has progressive nerve loss, uses a walker and has sudden fluctuations in blood pressure. The pt has loss fine motor and large motor skills.
UPPER LEFT ARM PAIN/SORE/ACHES; CAN NOT SLEEP; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic kidney disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced can not sleep. Treatment medications included: paracetamol. On 12-APR-2021, the subject experienced upper left arm pain/sore/aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from upper left arm pain/sore/aches, and the outcome of can not sleep was not reported. This report was non-serious.
redness; swelling; itching; red bull's eye appearance and hot to touch; spot removed of head; constipation; gas; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 24th June 2019, less than a day after receiving Shingrix, the patient experienced constipation, gas and skin discoloration. On 25th June 2019, the patient experienced injection site erythema, swelling, injection site itching and injection site warmth. The patient was treated with ibuprofen (Advil) and non-drug therapy, non-drug therapy (Ice Pack (No Medication)). On 28th June 2019, the outcome of the injection site erythema and swelling were recovered/resolved. On an unknown date, the outcome of the injection site itching, constipation, gas, injection site warmth and skin discoloration were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, swelling, injection site itching, constipation, gas, injection site warmth and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on left arm. The patient received Shingrix and after 1 day had a red bull's eye appearance at the site with hot to touch. The patient saw her doctor for those and itching at the site that she described as itching on the inside of her skin. The redness had resolved along with the swelling today. The patient had the itching. The patient used ice packs and Advil as advised by her physician. It was just a bad day all together on day of vaccination. The patient saw her Dermatologist that day, had a spot removed on her head. The patient had a couple of stitches placed and noted she had overdone it on fiber, and had to go to her local Emergency room with constipation and gas. She noted all of that has resolved also. The reporter give consent to follow up. Emergency room visit required. The reporter reported Advil taken and itching had stopped.
While I waiting the 15 mins after the shot  I thought my feet felt hot.   I was home a couple hours and took off my tennis shoes and the bottom of both feet were bright red. They stayed red for about 5 hours. Also,  I had some chills during night and woke up in a cold sweat about 5 am. I was ok after that. Took Tylenol.
left arm very sore; wheezy; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (wheezy), DIARRHEA (diarrhea) and VACCINATION SITE PAIN (left arm very sore) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced WHEEZING (wheezy) and DIARRHEA (diarrhea). On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (left arm very sore). On 01-Apr-2021, WHEEZING (wheezy) and DIARRHEA (diarrhea) had resolved. At the time of the report, VACCINATION SITE PAIN (left arm very sore) outcome was unknown.            No treatment details were provided.