chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dehydrated; slight HA; hot and cold flashes; fatigue; moderate diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 04May2021(at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, migraines, anxiety, depression. The patient was allergic to kiwi (fruit allergy) and latex allergy. Concomitant medications included topiramate (MANUFACTURER UNKNOWN), Sertraline (MANUFACTURER UNKNOWN), Rizatriptan (MANUFACTURER UNKNOWN), Paracetamol (TYLENOL), Ibuprofen (IBU) AND Spironolactone (MANUFACTURER UNKNOWN), B1 (UNKNOWN MANUFACTURER), multivitamin (MANUFACTURER UNKNOWN) and nurdec etc (MANUFACTURER UNKNOWN). The patient previously took minocycline in the past for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 (at the age of 34-years-old) for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 14:00, About 4.5 hours of after the vaccine, the patient experienced hot and cold flashes, fatigue and moderate diarrhea. It is currently the next day, On 05May2021, the patient experienced dehydrated and slight HA (headache nos) and mild diarrhea still. The clinical outcome of the event's hot flashes, cold flashes, fatigue, moderate diarrhea, dehydrated and slight HA was unknown at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow up (02Aug2021) via an agency: This follow-up report is being submitted to amend previously reported information: Past Drug Event reaction; Drug start and stop time; Event coding; Narrative updated.
This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear pain), ARTHRALGIA (joint pain), MUSCULOSKELETAL CHEST PAIN (chest wall pain) and SUSPECTED COVID-19 (COVID 19 like symptoms) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced EAR PAIN (Ear pain), ARTHRALGIA (joint pain), MUSCULOSKELETAL CHEST PAIN (chest wall pain) and SUSPECTED COVID-19 (COVID 19 like symptoms). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, EAR PAIN (Ear pain), ARTHRALGIA (joint pain), MUSCULOSKELETAL CHEST PAIN (chest wall pain) and SUSPECTED COVID-19 (COVID 19 like symptoms) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear pain), ARTHRALGIA (joint pain), MUSCULOSKELETAL CHEST PAIN (chest wall pain) and SUSPECTED COVID-19 (COVID 19 like symptoms) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced EAR PAIN (Ear pain), ARTHRALGIA (joint pain), MUSCULOSKELETAL CHEST PAIN (chest wall pain) and SUSPECTED COVID-19 (COVID 19 like symptoms). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, EAR PAIN (Ear pain), ARTHRALGIA (joint pain), MUSCULOSKELETAL CHEST PAIN (chest wall pain) and SUSPECTED COVID-19 (COVID 19 like symptoms) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. On an unknown date 5 doses of GARDASIL (dose, route of administration, LOT# and expiration date were not provided) all of which reached the temperature outside the product information, have been administered to unspecified patients. The temperature was supported. No adverse effects were reported. This is one of several reports from the same source (MARRS# 1406USA008284, 1406USA008285, 1406USA007026). Additional information has been requested.
recvd booster dose of Engerix-B 14APR92; about 2 hrs p/vax devel h/a, dizziness, fever of 100.8, flu-type sx & muscle aches; 15APR92 sx persisted;
Client complained of pressure in her head & down her face 5 minutes after  receiving the vaccine. Client provided water & crackers, admitted to not eating enough before arriving to clinic. There was no improvement of S/S P 1 hour, offered ambulance, refused. Discharged home to with father Client/Dad informed to provide Tylenol/Food/fluids & Rest If no improvement c s/s to take her to the Emergency Room. Family enrolled on site c v-safe & informed to report s/s. Pt was up & ambulatory upon discharging.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX (batch number NR4Z4, expiry date unknown) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, skin warm, stinging, skin blotches and erythema of extremities. The patient was treated with ICE PACK (NO MEDICATION). On an unknown date, the outcome of the pain in arm, skin warm, stinging, skin blotches and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the pain in arm, skin warm, stinging, skin blotches and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left deltoid. The patient experienced pain in arm and a warm, red, stinging blotch on the back of arm that took about 2 and a half weeks to go away. The symptoms did fully resolve. She applied ice to the affected area and did not seek medical attention. The health care professional was not the person who administered the vaccine. The reporter had trouble reading the lot or expiry number of what was scanned in his system. The reported SHINGRIX batch number (NR424) did not exist in the sales database and was updated to NR4Z4.
After getting the modera booster, and about 18 hours later I became extremely dizzy. I started to get tunnel vision and my vision became unfocused. I had chills so extreme that it felt like my skin was crawling and my skin was very sensitive. This was accompanied by a feeling that my heart was beating slowly.
This spontaneous report was received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with ROTATEQ (lot# L013188 and expiration date 02-NOV-2016) (dose and route were not reported) that had been improperly stored. No concomitant therapies were reported. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
On May 27, 2021 at 9:20am, I experienced drooping of the right side of my face, weakness in my right arm and leg, and right cheek, arm and leg paresthesias. I was taken to the ER  where I was diagnosed as having a transient ischemic attack (TIA).
Both arms, hands and lower legs appear with red dots in the third day I got the second COVID-19 vaccine. I didn't report before thinking that will disappear in the follow days. I didn't develop any symptoms like fiver or any of the symptoms that are in V-Safe text.  Two weeks passed and not get better  I have to seek for medical attention  and see my primary Dr. 02/25/2021. She send me to get laboratory work and now I'm waiting for the results . Hope in God  this vaccine  do not affect my health and my life.
Received MMR vaccine 10-26-06. Developed rash over entire body 11-6-06, had fever for 2 days prior.
pt broke out in hives hips to head;no difficulty breathing;no other rxn noted;ER called;MD office notified 13OCT95; states on 16OCT95 pt still c/o itching; no hives noted; c/o soreness to site
MUSCLE TIGHTNESS IN THE ARM; SWELLING OF THE LYMPH NODES; FELT TIRED; HEADACHE; 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 past medical history included neck injury, and car accident, and concurrent conditions included hashimoto's disease, overweight, sinus infection, and blood clot. The patient was previously treated with ibuprofen.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. Concomitant medications included acetylsalicylic acid for blood clot, curcuma longa rhizome for drug use for unknown indication, zingiber officinale rhizome for drug use for unknown indication, amoxicillin trihydrate/clavulanate potassium for sinus infection, ergocalciferol, magnesium, and . On 2018, Laboratory data included: Platelet aggregation test (NR: not provided) negative.  On 09-APR-2021, the subject experienced felt tired. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced muscle tightness in the arm. On 10-APR-2021, the subject experienced swelling of the lymph nodes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt tired, headache, muscle tightness in the arm, and swelling of the lymph nodes. This report was non-serious.
Headache first. Still off and on.  Then fever. 101.4 around 5pm  same day.   24 hours.  Achy neck area. About 10 hrs later    Arm redness  still ongoing Tuesday 2-23-2021  large area .
Pt recvd 2 doses of Engerix-B 2 hrs p/2nd dose exp h/a, dizziness, flu-like sx, nausea, vomiting, diarrhea, neck & back pain, somnolence, tacycardia & palpitation;
Patient presented in Health Department one day after receiving Tdap. C/O back pain in Left deltoid. Slightly red at injection site. No swelling noted.
Patient was vaccinated for HPV on 2/17/23 on the left deltoid. Injection site was sore but pain began increasing on the 19th at night. The patients mother produced photos of the area from that night that showed erythema and a raised papule like lesion that appeared elongated. Photo from this morning was similar with some slight decrease in erythema. Patient has been applying an ice pack since this morning and the erythema is no longer present. Raised lesion has decreased in size but still present. Patient describes the area as itchy and painful with some slight burning. Mom says patient is very sensitive to metals and detergents.
Moderna COVID-19 Vaccine EUA  ,,,,,eruption, pustule, area of  right  Axillary (pectoral) lymph node.   Area of redness surrounds.
states rt arm upper started to swell & became red Thursday PM;now swelling cover 3/4 of upper arm w/redness;advised to see PMD ASAP;
C/O Chest heaviness approx. 7 minutes after injection. Pulse=60 B/P 172/82
Headache, Myalgia, Arthralgia, Fatigue, sore throat, loss appetite Narrative:  The employee stated that she would go to see her doctor to  be treated for the above symptoms, if she was not directed to Employee Health Clinic to be seen.
This case was reported by a nurse and described the occurrence of drug dose administration interval too short in a 12-month-old male patient who received INFANRIX (batch number N5339, expiry date 25th March 2016). On 25th November 2014, the patient received the 4th dose of INFANRIX. On 25th November 2014, an unknown time after receiving INFANRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional information: a 12 month old child was given their 4th dose early on 25 November 2014 inadvertently when they were actually due for it on 9 December 2014.
I got my period and terrible lower back aches about 12 hours after the vaccine. I know that it arrived early because the last day of my last period was April10. This period arrived 12 says later. This is not break through bleeding. I also have horrible lower back aches and leg cramps.  28 hours after the vaccine dose I also got chills and treated those with a heating pad and some Nyquil.
Mild fever/chills for approximately 10 hours from the initial time of reaction, body aches for  approximately 18 hours from time of reaction, lymphoma in the left armpit with noticable swelling and tenderness starting at about 4 hours from initial time of reaction and continuing on to current time, approximately 54 hours from time of vaccination.
soreness; Information has been received from a lawyer and a patient on 29-OCT-2019 regarding a currently 71 years old female patient (this case was split from a legal case with case Number 1812USA002747). The patient's concurrent conditions, medical history or concomitant medications were not provided. Historical vaccines included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (unspecified) and zoster vaccine live (Oka/Merck) (ZOSTAVAX). On 09-SEP-2013, the patient was vaccinated for prophylaxis with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (route of administration, anatomical location, dosage regimen, lot number and expiration were not provided) at her physician's office. On an unspecified date, the patient experienced a side effect of soreness. The outcome of the event of soreness was not reported. Causality assessment was not provided.; Sender's Comments:  US-009507513-1812USA002747:
Couldn't eat for 3-5 days after both doses; This is a spontaneous report from a contactable consumer (patient).   A 29-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration on 11Apr2021 (Batch/Lot number was not reported) as single dose (at the age of 29) for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included famotidine, ibuprofen (DUEXIS). No covid prior vaccination. No covid tested post vaccination. The patient previously took dexamethasone and experienced drug hypersensitivity. The patient experienced couldn't eat for 3-5 days after both doses on 14Apr2021 12:00. Patient was treated with Niacinamide B6 vitamins. The outcome was not recovered. The patient underwent lab tests and procedures which included blood test: unknown, magnetic resonance imaging head: unknown.    The lot number for BNT162b2 was not provided and will be requested during follow up
18 days after receiving the vaccine I developed shingles.  I did have the shingles vaccine, both doses, September and December 2019
When he coughs she can hear his chest; When he coughs she can hear his chest; He has got real bad runny nose; I get the other allergy reaction; This is a spontaneous report from a contactable consumer or other non HCP (Reporter's grandson). A 15-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm on 27Aug2021 at 16:30 (at the age of 15-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included ongoing asthma. The patient had no family medical history relevant to AE. Concomitant medication included salbutamol sulfate (PROAIR [SALBUTAMOL SULFATE]) taken for asthma and unspecified inhaler start and stop date were not reported. It was reported the patient received this concomitant medications since born. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any events prior vaccinations. The patient got real bad runny nose and get the other allergy reaction on 28Aug2021. On 03Sep2021 in the morning, the patient can breathe, when he coughs she can hear his chest. Like how boogers escape and where they go and that why he sounds like that. The patient not visited emergency room or physician office due to the events. It was reported that the patient born in incubator and there for a month or two diagnosed with asthma. The patient received Benadryl last night for the events. Therapeutic measures were taken as a result of events. The outcome of events was unknown and for event bad runny nose was not recovered  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
There is this mild sore on the injection site noted an hour after the injection. At around 07:00pm, tiredness is noted and when I checked my temperature, it was initially 100.1F and became 100.4 F later on. I took a tablet of extra strength Tylenol relieving my symptoms. The following morning, no fever was noted( temp was 98.8F) but felt some mild right thumb joint pain. I disregarded it and at around 04:00pm, I felt tired , had body weakness with feeling of warmth all over. I took my temp and it was ranging from 100.4 and rechecked again at 100.8. I took another tablet. Of tylenol relieving the fever. April 7, I checked my temp in the morning and no fever was noted ( 98 -98.8 F) but at around 03:00pm the temp started with 99.9 f and recheck after 30 minutes ,was now 100.4 to 100.8. Tylenol was again taken. Still with pain on the injection site but is much better than the previous days.I am worried more for the afternoon fevers. No cough, sore throat, chills, stomach pain nor diarrhea noted.
Patient was given Menveo vaccine instead of Meningococcal B vaccine. Patient has no signs or symptoms.
When I woke up in the morning I felt a lump in my left underarm. My underarm was sore and the lymph node was really deep in my underarm area so I called my doctor out of concern. I called my doctor and spoke with the on call nurse. The doctor said it was a normal reaction and that it would go away in 1-2 weeks. It went away within a couple days.
Red, swollen, and warm to the touch (slightly raised) area of injection site to elbow.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19/she had a cold or sinuses or something) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (She had received three Moderna shots before). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    In January 2022, the patient received fourth dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced COVID-19 (COVID-19/she had a cold or sinuses or something). At the time of the report, COVID-19 (COVID-19/she had a cold or sinuses or something) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and Treatment medication was not provided.  The patient stated that she had a cold or sinuses or something and how long she should wait to get a bivalent booster for the COVID shot. She had received three Moderna shots before. She had her last booster in January 2022 but got COVID in August 2022. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.
runny nose; severe diarrhea; pain; Shortness of breath; cough; swollen; bodyache; fatigue; chills; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), DIARRHOEA (severe diarrhea), PAIN (pain), DYSPNOEA (Shortness of breath) and COUGH (cough) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Q40A21A and Q31L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ONDANSETRON (ZOFRAN MELT), ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), CARVEDILOL (COREG) and LOSARTAN POTASSIUM (COZAAR) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-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 RHINORRHOEA (runny nose), DIARRHOEA (severe diarrhea), PAIN (pain), DYSPNOEA (Shortness of breath), COUGH (cough), SWELLING (swollen), MYALGIA (bodyache), FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, RHINORRHOEA (runny nose), DIARRHOEA (severe diarrhea), PAIN (pain), DYSPNOEA (Shortness of breath), COUGH (cough), SWELLING (swollen), MYALGIA (bodyache), FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.            Patient was treated with Zofran. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.
Local erythema/edema Lt ant thigh (+) mild induration (+) itchy.
BODY ACHE; CHILLS; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, chills, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache, body ache and fatigue was not reported. This report was non-serious.
Heart started racing severely, tingling throughout my body, headache, sore throat, clammy with slight stomach ache. Also,the injection site was beet red, hot to the touch but had been ok just a few hours before. This event lasted for three hours and finally subsided. If I was working, I would have called 911 but we couldn't afford an ambulance drive to the hospital. I'm still dealing with headaches, feeling feverish and in general, not like my old self!!
I have a small rash around the vaccination site on my arm. About 3 inches long and 1 inch wide.
pt recv vax 21AUG95 & NOV96 pt devel asthma;in MAR97 lab eval revealed a negative test for anti-HBs;
Child exhibted fussiness and had diarrhea starting with in one hour of the vaccine through today (07/23/2014).  Parent told to take child to doctor today.