chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm in vacinity of injection was warm; arm in vacinity of injection was slightly swollen; Right arm "Larger" than left; arm in vacinity of injection was Itchy; arm in vacinity of injection was red; Rash; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), INFLAMMATION (Right arm "Larger" than left), VACCINATION SITE WARMTH (arm in vacinity of injection was warm), VACCINATION SITE PRURITUS (arm in vacinity of injection was Itchy) and VACCINATION SITE ERYTHEMA (arm in vacinity of injection was red) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATENOLOL, TERAZOSIN, ATORVASTATIN, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 14-Mar-2021, the patient experienced INFLAMMATION (Right arm "Larger" than left), VACCINATION SITE PRURITUS (arm in vacinity of injection was Itchy), VACCINATION SITE ERYTHEMA (arm in vacinity of injection was red) and VACCINATION SITE RASH (Rash). On an unknown date, the patient experienced VACCINATION SITE WARMTH (arm in vacinity of injection was warm) and VACCINATION SITE SWELLING (arm in vacinity of injection was slightly swollen). At the time of the report, PAIN IN EXTREMITY (Sore Arm), INFLAMMATION (Right arm "Larger" than left), VACCINATION SITE WARMTH (arm in vacinity of injection was warm), VACCINATION SITE PRURITUS (arm in vacinity of injection was Itchy), VACCINATION SITE ERYTHEMA (arm in vacinity of injection was red), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (arm in vacinity of injection was slightly swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    This case was linked to MOD-2021-164375 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow-up was received on 25-MAY-2021 and contain  medical history, conc meds, AE details and outcome, Dose 2 vaccination date was updated On 25-May-2021: follow-up was received on 25-MAY-2021and contain no significant information
Joints are swollen; This is a spontaneous report from a contactable consumer.   A 71 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included allergy to monosodium glutamate. Concomitant medications were not reported. The patient experienced Joints are swollen on an unspecified date with outcome unknown.   No follow-up attempts are possible, information about batch number cannot be obtained
Almost immediately after the vaccine I started feeling numbness and tingling in my bilateral hand and face. I had to lay down and was dry heaving and immediately I had to go to the restroom 3 different times in a row with severe diarrhea. That night my face was numb and loss of appetite. No appetite the next morning but went to work. Started not feeling well so I left work and around 2pm I lost my voice and couldn't talk, began vomiting and loss all energy. I was so out of it I could not talk for about 24hrs. I was vomiting for about 8hrs straight with diarrhea close to every 30 minutes. I had a bad headache feeling like my head was going to explode and severe body pain. I was extremely nauseated. The next day my stomach felt as if it was burning, and I couldn't keep any food down. I have had diarrhea, been fatigued and extremely nauseated with acid burning from my stomach to my throat, can't sleep and gastritis since the day of the vaccine. On 8/18 I went to the ER because the symptoms were just so bad.  I was administered Zofran and was sent home.  On 8/31 I went back to the ER at and was given IV fluids and various meds to try to calm my stomach to bring down the acid. I have been referred to a GI specialist. I have a disability appointment scheduled. 9/10 appointment scheduled for an Endoscopy and have since been prescribed: Famotidine, Zofran, Pepcid, Ativan and Phenergan if the Zofran doesn't work. And I continue to have the diarrhea, nausea, upset stomachs and I still can't sleep without the Ativan. One provider feels I am allergic to the poly ethanol in the vaccine.
Note: Dose 1 and 2 patient had Moderna. Reaction occurred to Pfizer booster (3rd shot). Redness on arms/chest, tightness in the chest and felt hot. Reaction only lasted 30 seconds to a minute. Patient could speak the entire time. EpiPen not needed as reaction subsided. Patient felt fine when EMS arrived but went to the hospital as a precaution to be checked-out.
This spontaneous report received from a healthcare worker refers to a patient of unknown demographics. No medical history was reported. On an unknown date the patient was vaccinated with an improperly stored  GARDASIL 9 (lot # L011846, expiry date: 16-JUN-2017, dose and route: unknown). No other concomitant therapy was reported. The outcome was unknown. This case is linked to cases: # 1509USA011272 and # 1509USA007856. (Same reporter link). Additional information has been requested.
Left deltoid area swollen, itchy and warm to touch. Cellulitis of left arm patient placed on KEFLEX x 7 days and hydrocortisone 2.5 % cream.
Immediate headache, elevated blood pressure for 6 days after each dose. Normal for me is 110/65- after each dose went to 140+/90-100. Right lower leg went numb for 6 months. Blood pressure is still elevated, average is 120/90. Terrible headaches, heart flutters, HR around 115 average.
Intense, continuous nerve pain by left shoulder blade, intense pain down left arm & into left hand. Intense continuous pain in left armpit & into left breast.  Bloodwork & Xrays taken. Received little to no relief from Tramadol HCL 50.  Currently taking Gabapentin 100mg with some relief, but symptoms persist.
Redness, swelling, soreness of upper Rt arm (elbow) to shoulder, warm to the touch, irregular heart beat and went to ER w/diagnosis of PAC's, gave steroid pack and better after taking.
Within 2 minutes of vaccination, patient was light headed. Patient was asked to sit - water and orange juice give to patient EMS called, however patient declined
no additional adverse event reported; pnuemovax 23 following a temerature excursion; This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 20-JUN-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S034299, expiration date 01-JUL-2021 for prophylaxis (dose #, exact dose, route and anatomical location were not reported). The temperature excursion was above 48 degrees Fahrenheit for 24 hours and 27.9 F degrees Fahrenheit for 24 hours. There were no previous excursions reported. The digital data logger was not involved. No adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: S034299; expirationdate: 01-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
temperature excursion ROTATEQ/one dose of ROTATEQ being administered to a patient; This spontaneous report was received from a medical assistant referring to a 6-month-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.     On 04-JAN-2021, the patient was vaccinated with  an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1691141, expiration date 01-NOV-2021, at a dose of 2 milliliter, orally for prophylaxis.       The vaccine was stored in a temperature of  8.6 degree Celsius (C) for 11 hours, 15 minutes and 8.7 C for 59 minutes, as recorded by a data logger. There was no previous temperature excursion reported.
Patient arm is swollen, and red at the site of injection, and pt complains of severe pain in right arm and fevers.
Fever, headache, nausea,  muscle aches, joint aches, chills, hematuria. I started peeing blood Wednesday the 18th and had to go see a doctor. He took a urine sample, put me on 5 day antibiotic until the culture came back, it still showed no growth. Bloody urine cleared up by Saturday.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid was given from 31Dec2022 to 04Jan2023. It was unknown if patient received any other medications within 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per the available information the causality of the events drug ineffective and covid-19 with the suspect can not be ruled out completely.
Fully vaccinated, not boosted, asymptomatic COVID-19 infection with inpatient hospital stay for non-COVID-19 reason.
This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. Initially reported as PNEUMOVAX23, (sealed vials) (lot # K007824, expiration: 05-NOV-2015) and GARDASIL vial wet SD 120 Y (lot # K005083; expiration 04-NOV-2016) were improperly exposed to 31 Fahrenheit (F) for 48  hours on an unspecified date, and to several other unspecified temperature excursions on unspecified dates. An unspecified number of patients received at least one of these vaccines on unspecified dates. Further it was reported that PNEUMOVAX23, (sealed vials) (lot # K007824, expiration: 05-NOV-2015) were exposed to 31 F for 600 hours and GARDASIL (lot # K005083; expiration: 04-NOV-2016) were exposed to 31F for 15 days (360 hours). However later it was confirmed that GARDASIL was not administered to anyone. On 29-SEP-2014, the patients were vaccinated with improperly exposed PNEUMOVAX23 intramuscularly (lot # K007824, expiration: 05-NOV-2015).  Later it was confirmed with the reporter that PNEUMOVAX23 were improperly exposed to 33F for 96  hours from 04-SEP-2014 to 08-SEP-2014, and to 34F for 48 hours from 09-SEP-2014 to 11-SEP-2014, and to 34F for 72 hours from 12-SEP-2014 to 15-SEP-2014, and to 33F for 168 hours from 15-SEP-2014 to 22-SEP-2014, and to 31F for 240 hours from 26-SEP-2014 to 06-OCT-2014. No adverse effects reports. Outcome of events was unknown. No product quality complaint (PQC) was involved. No further information reported. This is one of several reports received from the same reporter. Additional information has been requested.
Approximately 3 days after the injection I had a bad breakout of acne on my scalp and on my temples.  I went to the dermatologist and this was treated with Doxycycline Hyclate.  The bad breakout of acne cleared up in about 1-1.5 weeks.  At the two week mark I started to have a burning sensation near my left eye that felt like a sunburn or some nerve tingling.  I interpreted this to potentially be the early signals of shingles so I started taking Valtrex.  I will take a 1,000 mg dosage of Valtrex twice a day for 7 days to treat this.  I had the Shingrex vaccine on 12/19/19 and 4/29/20.  I feel like both of these issues were potential side effects from the Covid vaccine.
Anaphylaxis (rash on chest), sensation of throat closing, tachycardia and hypotension.
CHIEF COMPLAINT:   dx w/covid 12/24  Poor appetite, poor intake having increased sinus presure. Increased anxiety. No chest pain No sob Headache , fatigue   HISTORY OF PRESENT ILLNESS:     Patient is a 61-year-old male who presents the emergency department with chest discomfort, shortness of breath, poor appetite.  Patient states that he has been experiencing symptoms of illness for several weeks.  He states that he was diagnosed with a lung infection at the end of November.  He was on antibiotics and steroids.  He does not recall being diagnosed with Covid.  He states that he started experiencing feeling of panic and anxiety today he states that he was feeling like he was unable to get a deep breath.  He states that he had Christmas with his family this morning but was unable to participate due to not feeling well.  He states that he is feeling very anxious, down and depressed.  He denies any history of depression or anxiety.  He states that he is becoming very frustrated with feeling ill.  He is tearful.
PT PRESENTED WITH A SWOLLEN, RED, AND PAINFUL ARM TWO DAYS AFTER RECEIVING HER PNEUMOVAX 23 VACCINE AND FLUCELVAX QUAD IN HER RIGHT ARM.  SHE SAID IT SWELLED UP THE FIRST NIGHT, BUT HAD NOT IMPROVED MUCH AFTER 48 HOURS. I RECOMMENDED SHE USE SOME ICE ON IT AS WELL AS TYLENOL TO HELP WITH THE PAIN AND TO KEEP AN EYE ON IT.  I ADVISED HER TO LET US KNOW IF HER SYMPTOMS WORSENED.
localized swelling and pruritus at site of injection 10 minutes after injection . She had no difficulty breathing but did experience mild lip tingling several hours later. All symptoms were relieved with Benadryl
All day and night body aches, head ache, nausea, and chills. "Covid arm," with redness/rash, hardness, heat and itching at the injection site.
pt had sx of epileptic sz activity; eyes rolled back, lt arm posturing; pt became unconscious for approx 2 min; BP 100/60; pulse 60 reg rhythm, r-20; immediately brought to lying position-observed 15 minutes then went home;
Lump that was after shot. Was swollen for about 3 weeks. Swelling has gone down, but lump remains. Recommended seeing a doctor for lump. Denied any other symptoms.
10/11/2001 the patient was seen at the Dr's office for tenderness and pain at the injection site with associated redness and swelling. The symptoms were noted within 2 hours after receiving the injection. The patient was treated with Levaquin for 5 days.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2nd via an unspecified route of administration, on 15Feb2021 (Lot Number: GN6201) as single dose, dose 1st via an unspecified route of administration on 21Jan2021 14:00 (Lot Number: EL3302) as single dose for covid-19 immunization. The anatomical location for both was left arm. Medical history included chronic obstructive pulmonary disease. Concomitant medications included: heart pill within 2 weeks of vaccination. On 11Mar2021, the patient had lab nasal swab test and the result was positive. The patient did not receive any treatment for the events. Patient was not diagnosed with COVID-19 Prior to vaccination. The outcome of events was reported as unknown.  Follow up needed, further information requested.
"covid arm" rash - itchy , hot to the touch; "covid arm" rash - itchy , hot to the touch; "covid arm" rash - itchy , hot to the touch; Extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 41-year, on 19May2021 19:45 at single dose in right arm for COVID-19 immunisation. Medical history included Seasonal allergies and COVID-19. The patient was not Pregnant at time of Vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20May2021, the patient experienced "covid arm" rash - itchy , hot to the touch. Extreme fatigue. Treatment received for the events included benadryl and cortisone creme. The outcome of all events was not resolved.   Information on the lot/batch number has been requested.
Previously received two shots of Moderna on 3/17/21 and 4/14/21 respectively. Mild headache and fever felt the night of 11/30, headache worsened on 12/1. Headache subsided on 12/2 but mid day on 12/2 floaters appeared in both eyes. A couple floaters were present previously but became markedly worse and more numerous on 12/2.
pt recv vax AUG95 & 3MAY96 lab eval revealed varicella antibody less than 0.86, pt failed to seroconvert;
Information has been received from a physician concerning a 72 year old female patient who on 10-JUN-2009 was vaccinated with ZOSTAVAX (Merck). On 24-JUN-2009 the patient was seen in the office with a diagnosis of BELLs palsy and herpetic lesions of mouth. The physician did not prescribe treatment and stated that the condition was expected to be self-limited. The patient had not recovered. Upon internal review, BELLs palsy was determined to be an other important medical event. Additional information has been requested.
I had spontaneous onset of Atrial fibrillation. I called the doctor and had a EKG, and some a lab work. A complete metabolic panel. I have long standing history of blockage. That was seen of course, To control rate he started metoprolol. That did really cover it I start a few doses of apixaban. The AFIB only lasted three in half days and weaned off the medications yesterday. I feel fine. The AFIB has not recurred.
1/30/14 - Received vaccine. 1/31/14 - Started KEPPRA because of history of seizure. First time seizure occurred was in week preceding vaccine, head CT was normal, patient was scheduled for brain MRI on 2/3/14. 2/4/14 Mom brought child into office - stating he had been behaving abnormally since night of 2/3/14 and deteriorating till time of visit. He was lethargic, falling asleep constantly, his speech was abnormal, no fever at the time, and was assessed as having altered mental status and transferred to hospital ER.
Patient received moderna vaccine on 3/8/21, 4/5/21 and 12/20/21. Found to be COVID positive on 1/20/22. Presented to ER on 1/26/22 and started to have some shortness of breath, sore  throat and cough about a week prior, was tested positive for COVID-19 on  01/20/2022.  Came back to emergency room because of on-and-off chest pain and  cough productive of occasionally yellow sputum.  No fever, chills.  No nausea,  vomiting, diarrhea.  No bleeds or melena.  His first troponin was slightly  elevated at 92 and second one is slightly more elevated at 95.7, however, his  EKG does not show any acute ST-T changes, but there are some nonspecific  abnormalities.  I doubt this is acute coronary syndrome per se.  Patient does  have an element of reproducible chest wall as well.  However, we will put him  in as an observation for now with a consult to Cardiology and check a 2D echo  this morning. Since I am not ordering any stress test so I am not keeping the  patient any n.p.o.  Please note ABG is pending as we speak.  Patient has no  fever or chills.  No abdominal pain. Was on doxycycline due to cellulitis. DIscharged 16 hours later. No COVID19 treatments.
Onset of severe daytime sleepiness.  Saw sleep doctor who diagnosed pt with narcolepsy and informed parents that it may have been due to the flu/H1N1 vaccine.
Body aches, fatigue, sore throat, pain at injection site, low fever ~100f, sinus congestion, cough
Information has been received from a physician's assistant concerning a 10 month old male with no past medical history who was vaccinated with hepatitis b vaccine recombinant (yeast) and varicella virus vaccine live (MSD) on the same day. There was no other concomitant therapy. Subsequently, the patient developed a rash post vaccination. It was noted that the patient was being tested for vaccination. It was noted that the patient was being tested for allergies. The patient had received medical attention for his experience. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to multiple patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored (temperature excursion: 34.3F, time frame: 10 hours) doses of RECOMBIVAX HB with lot/batch # K023310, expiry date 15-APR-2017 and lot/batch # L026037, expiry date 17-JAN-2018 (dose, dose number, vaccination site and route of administration not provided). Concomitant therapies were not reported. The previous temperature excursion was reported  as 48.4F for 7 hours. Product quality complaint (PQC) was not involved. This is one of three reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 07-NOV-2012 at 00:40, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.