chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feel achy; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd March 2020, the patient received the 2nd dose of Shingrix. On 3rd March 2020, 1 days after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 64 or 65 years old. The patient received Shingrix and experienced feeling achy. The patient was enquiring that if it was okay to take Naproxen or Ibuprofen. The reporter consented to follow up.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 14-MAR-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot#L025210, expiry date: 07-JUL-2017 (dosing details, route and strength were reported). It was reported that the vaccine was exposed to the temperature of 6F for a time frame of 15 hours. Previous temperature excursion was reported as 7F for 24 hours on 16-MAr-2016 and 10F for 24 hours on 11-MAR-2016. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
p/vax pt exp local swelling & redness @ the inj site, fever, chills, muscle soreness & h/a;
When the vaccine was removed from the freezer it was labeled with a beyond use date. The beyond use date was dated after the manufacture expiration date. The vaccine was then administered after the manufacture expiration date.
Sudden memory loss for approx 2 hours required 4 days hospitalization. No treatment.
Sickness; Cough; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) and COUGH (Cough) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sickness) and COUGH (Cough). The patient was treated with AMOXICILLIN for Cough, at an unspecified dose and frequency. At the time of the report, ILLNESS (Sickness) outcome was unknown and COUGH (Cough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment also includes the cough syrup. Patient is due for second shot. concomitant medications were not provided.
18FEB81 ER MD saw pt w/sx of fever, Lt upper arm that bruise, edematous & painful. BC neg; Given Rx Duracef; 16FEB91 fever, vomiting; 18FEB fever; 20FEB diarrhea; MD saw pt & dx "injection reaction"
Fever, chills, extreme body aches, muscle and joint pain, severe headache. Dizziness started at 4:30 and by 5:30 all of the other side effects were present.
Soreness and swelling started at the injection site after 5 hours.  Fever started after 10 hours.  Fever peaked at 101.9 degF at 15 hours.  Fever down to 99.7 after 24 hours.  No drugs were taken to lower fever.  First dose only produced some injection site swelling. and was taken 3 months before this 2nd dose.  Didn't expect a high fever on second dose.
Patient was hospitalized due to breakthrough COVID-19 infection. Patient received Pfizer vaccine (2nd dose in series) on 03/29/21. Patient was hospitalized from 01/11/21 - 01/13/21. Patient was 30 weeks pregnant upon admission. Below is copied from discharge summary:   Hospital Course:   Patient is a 42 y/o F with Hx of HTN currently not on meds who presents with c/o HA/cough x 1 day, found meeting sepsis criteria with evidence of COVID 19 PNA.   Sepsis 2/2 COVID 19 PNA/Sinus tachycardia: -Better, tolerating RA -o2 stable -Case discussed with ED PA who spoke with OB/GYN on call-> since no fetal complaint, no OB admit->plan for NST inpatient -EKG with Sinus tach HR 133 bpm now 120s s/p 2L LR, personally reviewed -chest Xray showed atypical PNA -No benefit of remdesevir or decadron at this time -Supportive care  - Continue OP follow up w PCP   Pregnant 30W: -OB/GYN consulted -Resume prenatal meds   HTN: -Controlled -No ACE or ARB   Patient is discharged in stable condition with stable vital signs. All questions rearding hospital course and plan of care after discharge have been answered to satisfaction. Prescriptions for medications needed to be taken after discharge have been given to patient. Patient has been instructed to follow up with PCP, DO within the next 7 days after discharge. Patient verbalizes understanding all given instructions and has no further doubts regarding discharge.
I developed a slight ringing in my left ear. It's similar to what you hear in absolute silence but I can hear it in loud environments and only in my left ear.  I was also wearing foam ear plugs the day prior. It could be related to that as well. What made me report is my wife felt like her ears were draining just hours after her booster shot of moderna. I wanted to put this out there incase others also report issues.
redness, swelling, and itching at the injection site; redness, swelling, and itching at the injection site; redness, swelling, and itching at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2020, the patient received the 2nd dose of Shingrix. On 3rd December 2020, 2 days after receiving Shingrix, the patient experienced injection site itching, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site itching, injection site swelling and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. About 2 days after dose of Shingrix, she experienced redness, swelling, and itching at the injection site. The reporter did not consent to follow up. This case is linked to the case US2020240883, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020240883:same reporter
pt fainted after receiving his 1st dose of Pfizer.   He fell out of his chair and hit head on the ground.  He fainted 1-2 more times after initial collapse. EMS came and he reported being fine after about 10 minutes after the incident. Patient admitted to not eating anything before his shot.  He was fine and when follow up call occurred, indicated he wanted to get his 2nd dose in three weeks and we will take precautions and eat food and sit on a carpeted floor against a wall in case he faints again.
Prolonged crying for six hours.  Not his normal cry.  He didnt eat and when he tried he would start crying again.  His stomach made loud growling noises.
Pt c/o "feeling flushed and like I was going to pass out." c/o chest pain at level 1 verbally. States "it could be nerves"as was notified at 0500 of father in law's sudden passing this morning and upset from news.  Pt verbal and oriented x 3. S&S began as pt was going to sitting position immediately after receiving vaccine injection.  Pt obvserved for 50 minutes then left as states" I think I'm fine. I don't have any chest pain, sob, or other c/o, other than grief over loss of father in law". No rash noted. Vitals unchanged. see chart for v/s. Pt states did receive one dose of Pfizer vaccine on Jan 11, 2021 but didn't receive 2nd dose because of feeling "guilty" that there were other people needing it more than she was.  Pt states has new dx (after 1-11-21) of cardiomyopathy unknown cause. Pending vascular consult.
p/vax pt felt faint, nauseous & felt hot flashed throughout the body x 2-3hr;pt had nodule for 3mo & could not lift arm;also felt cramping & numbness on lt arm & neck;constant tingling from elbow to neck;systemic rxn;
Right arm red warm to touch at site of injection and surrounding area approx 2" diam. No fever.
Patient received Pfizer dose 1 in March and made an appointment for Moderna 2nd dose for our clinic.  Patient asked at the counter and was informed it was Moderna clinic, however failed to inform us about her first dose being Pfizer. After vaccinating while we were updating her clinic details on  the vaccinator noticed that patient was supposed to get Pfizer and not Moderna. Informed the patient that it is not recommended to get 2 different types of mRna vaccine. The patient ended up getting 2 different mRna Vaccine.
Convulsion like shaking but no chills, sweating, throat constriction, no tongue swelling
The supplies for the covid shot were prepped by the pharmacist at the start of the day. the mixing, drawing up, and administration was left to be completed. The graduate intern thought the pharmacist already mixed and drew up the vaccines. An injection of 0.3 ml air was administered to the patient.   The patient was contacted and no adverse reactions have been reported.
Patient woke up on 11/11/15 with a swollen and painful injection site. Patient said it was swollen to the size of an egg and tender and painful. Patient said the site was not red. She thinks it has gotten bigger during the day (only called the pharmacy around 6pm).
1 day after receiving 2 month vaccines, patient developed mucousy stools, frequent. Persisted for almost 2 weeks. No fever, appetite appeared diminished but not dehydrated. Then 10 days after symptoms started, developed blood in stools.  Mother had been avoiding dairy already due to concern for milk protein intolerance. Strong family history of food allergies
Extreme muscular pain, headache, tiredness, chills/ cold sweats, swelling of upper arm at injection site, no energy at all, almost passed out early in the morning.  These symptoms lasted about 24 hours. The second day, I was still tired, the injection site had more swelling as well as a rash. I was, however, able to get out of bed and function.
Initial report received on 11 February 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 4 doses of PENTACEL on 04 February 2011, 04 April 2011, 02 June 2011, and 15 March 2012 (lot numbers, routes, and sites of administration not reported). The subject developed a cough on 03 January 2013, approximately 9 months after the last dose, and a paroxysmal cough without a whoop on 04 January 2013. The subject also developed cold like symptoms on 31 December 2012 and posttussive vomiting and sleep disturbance (start date not reported). Laboratory testing included positive PCR on 09 January 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 January 2013 for 5 day. The subject was not hospitalized. At the time of final contact on 25 January 2013, the subject's cough was not persisting. The duration of the cough was reported at that time as 20 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Information has been received concerning a 2 month old female patient who on 1/11/02 was vaccinated with the first dose of Haemophilus B conjugate vaccine, hepatitis B vaccine recombinant (yeast) IM in the left leg (lot #639444/0776L. Concomitant therapy that same day included the first dose of diphtheria toxoid/pertussis vaccine/tetanus toxoid (INFANXRIX) IM in the right leg (lot #S16A2), the first dose of poiovirus vaccine (IPOL) SC in the right leg (lot #T1390), and the first dose of Streptococcus pneumoniae vaccine (PREVNAR) IM in the left leg (lot #484132). It was noted that sometime later, the patient became cranky and developed a fever of 104F and was admitted into the hospital. On 1/11/02, a lumbar puncture was positive for viral meningitis. Additional correspondence received on 9/4/02 from manufacturer reported that no further medically significant information was provided. No further information is available. This case is closed.
Around 4/26/21 patient developed difficulty breathing. This was progressive. On 5/2/21, the shortness of breath became severe and she had pre-syncope and chest pressure. She came to the ER at Hospital, where she was initially hypotensive and tachycardic. D-dimer was unreadably high (over 20) and CT pulmonary angiogram disclosed bilateral pulmonary emboli with right heart strain. She was initiated on heparin drip and admitted to ICU. She has stabilized but remains hospitalized at time of this report (5/4/21).
slight rash; Headache on and off; Throwing up; Chills; Fever; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (slight rash), HEADACHE (Headache on and off), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body Aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history is provided and concomitant drugs are provided.  Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE, CLOPIDOGREL, METFORMIN, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), LISINOPRIL, PANTOPRAZOLE, ACETYLSALICYLIC ACID (BABY ASPIRIN), ASCORBIC ACID, MAGNESIUM, PYRIDOXINE HYDROCHLORIDE (MAGNESIUM COMPLEX [ASCORBIC ACID;MAGNESIUM;PYRIDOXINE HYDROCHLORIDE]) and BIOTIN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body Aches). On 08-Feb-2021, the patient experienced VOMITING (Throwing up). On 17-Feb-2021, the patient experienced VACCINATION SITE RASH (slight rash) and HEADACHE (Headache on and off). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (slight rash), HEADACHE (Headache on and off), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body Aches) and VOMITING (Throwing up) outcome was unknown.        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.
lump at injection site; Lump is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump at injection site) and VACCINATION SITE ERYTHEMA (Lump is red) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE MASS (lump at injection site) and VACCINATION SITE ERYTHEMA (Lump is red). On 06-Feb-2021, VACCINATION SITE MASS (lump at injection site) and VACCINATION SITE ERYTHEMA (Lump is red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication and treatment provided
Pt started to complain of dizziness and feeling flushed. Pt states she has a history of SVT. Pt states the incident feels like her SVT symptoms. Pt's symptoms went away after 5 minutes. EMS was called and pt refused transport to the hospital.
This case was reported by a nurse via sales rep and described the occurrence of discomfort in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was recovered/resolved.  It was unknown if the reporter considered the discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had received first dose of SHINGRIX with minimal discomfort. This case has been linked with case US2018GSK147353, reported by same reporter for same patient for the tolerance of 2nd dose.
Had moderate hives, starting about 1 hour post-vaccination. No respir. symptoms. IM Antihistamine & SubQ epi give once.
Within 10 minutes after getting vaccine I was nausea and had major headaches.. After I got home I took drink some water and it was burning my throat . The next day it was  hard  to close my hands because the inflammation. I went to the Dr.  and She prescribed me a steroid and it helped but I'm still having trouble with my left hand.
Vertigo. Unable to balance or walk or stand without holding on to something, dizziness.
Vaccine seems to have affected my A-Fib in that I now have constant A-Fib flutter leading to shortness of breath even while sitting or routine life activities. This was a big change since the administration of the vaccine. Also, my TSH levels were elevated -from 6.4 to 10.4-in less than two months.
Heart Rate increased greater than 100, Blood pressure decreased, patient became clammy and light headed.  Continued to monitor patient for 30 minutes, gave water, monitored vital signs.  Patient reported restlessness that night.  No other complaints or adverse effects noted or reported
Pt given 2nd dose of Menactra. 1st dose given 6-9-05. 2nd dose given 7-26-07
Rapid onset of hives/redness on arms following injection-hives bilaterally down arms, (-) torso or lower extrem. No lip, tongue or face swelling.
pt recv vax 10APR98 & 14APR98 pt devel severe hives for which med assistance was sought on 2 occasions;tx w/med;
I had a very runny nose so I decided to test for COVID-19, I used one of my home COVID-19 test that came back positive. I called my doctor and had a telehealth visit described how I was feeling. He prescribed the PAXLOVID that I started taking that evening. I started feeling better within the week and I feel more like myself now.
Patient under 16 years old received the vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 16 years old received the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 16 years old received the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 16 years old received the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.
on 2JAN98 nurse inadvertently splashed in the eyes w/MMR;the reporter stated that the nurse flushed eyes thoroughly w/water;2JAN98 pt exp a burning sensation in eyes;5JAN98 pt exp febrile illness w/a few red papules on cheeks;
I did receive my shingles vaccine in between my first and second dose of the covid vaccine on 19Feb2021; I did receive my shingles vaccine in between my first and second dose of the covid vaccine on 19Feb2021; Yesterday I started aching all the way to my bones; chills; felt a little puny last week; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Feb2021 (Lot number: EN6198) at the age of 85 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: DIOVAN taken for blood pressure measurement; COREG CR taken for blood pressure measurement; OMEPRAZOLE; EZETIMIBE taken for blood cholesterol; TYLENOL. Vaccination history included: Bnt162b2 (1st dose, Lot number: EL8982, Anatomical Location: left arm), administration date: 24Jan2021, when the patient was 85 years old, for Covid-19 immunisation; Shingrix (She got her shingles vaccine on the 19Feb2021, Prior Vaccinations (within 4 weeks)), administration date: 19Feb2021, when the patient was 85 years old. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "I did receive my shingles vaccine in between my first and second dose of the covid vaccine on 19Feb2021"; PAIN (non-serious) with onset 09Mar2021, outcome "unknown", described as "Yesterday I started aching all the way to my bones"; CHILLS (non-serious) with onset 09Mar2021, outcome "unknown", described as "chills"; MALAISE (non-serious) with onset Mar2021, outcome "recovering", described as "felt a little puny last week". Therapeutic measures were taken as a result of pain, chills. No follow-up attempts are possible. No further information is expected.
headache, nausea, vomiting, numbness in hands feet, vomiting lasted a day (I called doctor and he called in zofran), nausea 6 days, headache 9 days, I don't know when hypertension started but it is ongoing.  My blood pressure before the vaccine was low (which is normal for me) 98/65 approx. At its highest at any dr appt it has gone up to 120 systolic. My BP at last appt was 147/88 (11/23/2021) and has consistently been around 135 to 140 over 85 since (I've been taking it every day). I have a weird sensation in my hands, calves, and feet which feels like swelling but does not look like it. At times I feel a "pins and needles" sensation in hands, calves, and feet.  Still feel fatigue and unable to do normal exercise and activities.   Unknown as to whether the hypertension and fatigue and issues with extremities constitute permanent damage.
Waited 15 min as required.  On drive home around 3:15 p.m. developed tingling in lips and tongue no swelling,  It eventually subsided. At around 8 p.m. back began to itch no rash nor hives and subsided within 15 min. guess.  Soreness in arm  next morning with slight headache.   Soreness at vaccine site all day and night unable to raise arm over head.  Wednesday morning Feb. 3 less soreness at site and able to raise arm above head.