chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FATIGUE; This spontaneous report received from a patient concerned an adult male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210436136.
I traveled abroad and was flying back and one hour into my flight I went to sleep for seven hours and woke up with a fever. I took ibuprofen. When I landed, 15 hours later, on February 9th, I started having diarrhea on the 10th. On the 11th, I went to urgent care and thought I may have malaria. They took blood work. By the evening of February 13th, I went to the emergency department, and I was positive for Campylobacter, and I was admitted to the hospital. I was given IV fluids. We believe that it came from the chicken on the plane.
I recall having chest pain whenever I sneezed or coughed. On the day I went to the ER, I had a headache, cough, sore throat, chest pains and some chills. At first, I had to go to my base clinic to get the referral from my provider. Then once the referral process was complete, I was referred to St. Luke's ER in Mount Home Idaho. They did the screening and tests on me. They hooked up stickers to analyze my body rhythm and breathing capabilities. They found out that I have Strep throat.    RECALL HAVING CHEST PAIN WHENEVER I SNEEZED OR COUGHED. ON THE DAY I WENT TO THE ER I HAD A HEADACHE, COUGH, SORE THROAT, CHEST PAIN AND SOME CHILLS. AT FIRST I HAD TO GO TO THE CLINIC TO GET THE REFERRAL FROM MY PROVIDER AND THEN ONCE THE REFERRAL PROCESS WAS COMPLETE I WAS REFERRED TO THE ER. THEY DID THE SCREENING AND TESTS ON ME - THEY HOOKED UP STICKERS TO ANALYZE MY BODY RHYTHM AND BREATHING CAPABILITIES. THEY FOUND I HAVE STREP THROAT.
Mom called 12-6-10 and stated that 2 days after pt got flu vaccine, he started having a "tic" - "twitching" or flapping of his hands - seems oblivious to it - does note an increase with stress or fatigue - pt has had "tics" in the past per mom, but not this one - wonders if other ones now may have been related to when he got flu vaccine in past? No previous tics documented in chart.
Received FLUZONE High Dose on 11/24/20126. The day after a medium sized bump occurred at injection site and significant bruising also. Patient came in on 12/5/16 and the bump and bruising has not improved much. She was concerned. It did not cause much pain but I referred her to her Doctor.
pt recvd vax & w/in 7 days p/vax exp arthralgia & fever;sx resolved;
Had problems breathing.  Couldn't get a good breath and felt like someone was sitting on my chest.  Because of that I kept coughing and had a high fever. Took a Benadryl which helped a little and then later took a second which helped a lot more.
dizziness starting the day after 2nd dose and continuing every day. There have been times that I had to sit down and other times I had someone else drive.
This is a spontaneous report received from a contactable reporter. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization; Bnt162b2 (DOSE:2), for Covid-19 Immunization. The following information was reported: immunization, malaise, fatigue and headache.  Additional information: The expiry date, NDC and UPC number of BNT162B2 was unknown. The patient was unwilling to complete the report when asked for no lot number. The patient got booster dose Wednesday afternoon and by Thursday evening was really wasn't feeling good, and started having chills really bad, and was just really tired, so went to bed. On Friday, the patient did not go to work but worked from home and was feeling quite a bit better although still got a headache every once in a while, and was just kind of a little more tired than normal and needed to go to work next week 'quite' every day. So just wanted to make sure that it's safe to go to work. The patient was informed about the role of the Pfizer Drug Safety and also informed that Pfizer Medical Information is the concerned department to answer the question that patient had regarding the vaccine and offered the number. The patient was provided with the number of Pfizer Medical Information number and was requested to select option 3, timings as and 8 am to 8 pm Monday to Fridays as per (EST). When requested to probe to file a safety report, patient was getting text on cell phone after the first and second vaccine and told that it was okay and don't think it's safety report and thought the events were more of a reaction and they were very mild and wanted to make sure that it was okay to be around people. Further probing could not be done as the patient was unwilling to share any further information. Hence limited information available over the call. QR Comment: Reporter type could not be probed as the consumer was unwilling to share any further information, hence limited information available over the call. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE PRURITUS (COVID arm Rash/Itching) and INJECTION SITE RASH (COVID arm Rash/Itching) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (COVID arm Rash/Itching) and INJECTION SITE RASH (COVID arm Rash/Itching). At the time of the report, INJECTION SITE PRURITUS (COVID arm Rash/Itching) and INJECTION SITE RASH (COVID arm Rash/Itching) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product used was not provided by the reporter. Treatment information was not provided.
pt recv flu vax 8OCT96 w/in a few day pt felt weak was adm to hosp on 18OCT96 & dx w/GBS by neurologist;
The arm reaction I believe was less after the second vaccination.; sleep for the day or afternoon; I typically have when I get sick with a flu or virus; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (The arm reaction I believe was less after the second vaccination.), SOMNOLENCE (sleep for the day or afternoon) and MALAISE ( I typically have when I get sick with a flu or virus) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to molds (mild to moderate) and Pollen allergy (mild to moderate). Concomitant products included HYDROCHLOROTHIAZIDE, FAMOTIDINE, FLUVOXAMINE MALEATE, GABAPENTIN, MIRABEGRON (MYRBETRIQ), LEVOTHYROXINE SODIUM (SYNTHROID), LORATADINE (CLARITIN [LORATADINE]) and SPIRONOLACTONE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (The arm reaction I believe was less after the second vaccination.), SOMNOLENCE (sleep for the day or afternoon) and MALAISE ( I typically have when I get sick with a flu or virus). At the time of the report, VACCINATION SITE REACTION (The arm reaction I believe was less after the second vaccination.), SOMNOLENCE (sleep for the day or afternoon) and MALAISE ( I typically have when I get sick with a flu or virus) outcome was unknown. Not Provided          Other concomitant medications such as pataday eye drops and patanase nasal spray. No treatment  medications were provided by the reporter.    This case was linked to MOD-2021-017719 (Patient Link).
Patient tested COVID-19 positive via PCR on 3/17/21; she had her 2nd COVID-19 vaccination on 1/19/21 (1st on 12/28/20). Patient currently not hospitalized. Has no signs/symptoms of illness. COVID-19 test was done due to requirements by Nursing Home facility where she was to visit her father. Patient was COVID-19 positive in October of 2020. Patient was not hospitalized due to illness.
Like he was going to pass out; Weakness; Cold sweat; The vaccinator pulled out the needle, blood came out and ran down his arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Like he was going to pass out) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Passed out (Patient has history of passing out when blood drawn from right arm as it usually hits a nerve).   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Like he was going to pass out) (seriousness criterion medically significant), ASTHENIA (Weakness), COLD SWEAT (Cold sweat) and VACCINATION SITE HAEMORRHAGE (The vaccinator pulled out the needle, blood came out and ran down his arm). At the time of the report, LOSS OF CONSCIOUSNESS (Like he was going to pass out), ASTHENIA (Weakness), COLD SWEAT (Cold sweat) and VACCINATION SITE HAEMORRHAGE (The vaccinator pulled out the needle, blood came out and ran down his arm) outcome was unknown.            Patient has drank water & ate M&M to relieve the  symptoms.   No relevant concomitant medications were reported.      Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Of note, the patient's history of 'passing out when he gets blood drawn on his right arm because they usually hit a nerve' is a confounding factor that may play a possible contributory role.
patient  had a reaction to the vaccine, she had a reaction started on Friday (12/10/2021) afternoon, feeling itchy, then after on the following day on Saturday (12/11/2021) Patient had a redness and bumps(very small/tiny) started from arm to chest and hips and legs. patient took Benadryl 25 mg of 2 doses and did not relieve her.
This spontaneous report as received from a licensed practical nurse refers to an 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2015, the patient was vaccinated with the dose of GARDASIL (lot # K014191; expiration date, dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine on 06-Apr-2022) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine on 06-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by the reporter. The patient had never been diagnosed with or tested positive for COVID-19. The vial did not undergo any temperature excursions. There were no adverse events from the vaccine. The vaccine had an expiry date of 18-Mar-2022 but the Moderna stability study showed the vaccine was active against COVID-19. No treatment information was provided.
Rash entered as ADR. Per occupational nurse note- Received on 10/21/09 Lot # UP005AA Exp- 03/15/11. Manufacturer - Sanofi Pasteur. Also c/o chest tightness and feeling flushed.
Had MMR, Varicella vaccines 2/17/04. Developed fever 2/24/04 (7 days later). Seizure activity onset 2/27/04 with fever and questionable acute otitis media (not examined by doctor; was away on vacation).
Generalized rash of vesicles on both arms and legs; This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix in left deltoid at a local pharmacy sometime within the last month, and 3-4 days post-vaccination the patient developed a generalized rash of vesicles on both arms and legs.  Currently, the rash was only localized to lower left extremity. The reporter consented to follow up.
sore throat; runny nose; hacking cough; fever; diarrhea; injection site pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), COUGH (hacking cough) and FATIGUE (fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (amoxicillin), Drug allergy (penicillin) and Drug allergy (Bactrim).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced FATIGUE (fatigue). On 24-Feb-2021, the patient experienced DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (injection site pain). On 25-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), COUGH (hacking cough) and PYREXIA (fever). On 23-Feb-2021, FATIGUE (fatigue) had resolved. On 28-Feb-2021, DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (injection site pain) had resolved. On 01-Mar-2021, OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose) and COUGH (hacking cough) had resolved. At the time of the report, PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Body temperature: 99 (High) Fever of 99 degrees Fahrenheit.     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.   Concomitant medications were not provided.
The patient received the Influenza vaccine on 12/12/00. The patient stated it was very painful when given. The patient returned on 12/20/00 and stated his arm had been painful and achy since injection was given. No edema or erythema was noted a the site, the patient stated it hurts badly to move her arm. Upon inspection the arm appeared normal, but the patient stated she had trouble using the arm but could do ROM, no numbness noted.
insufficient dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (insufficient dose) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (insufficient dose). At the time of the report, ACCIDENTAL UNDERDOSE (insufficient dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment medication provided.
12/31/20, 1:30 PM: I RECEIVED THE SHOT.  12/31/2020, 4:00PM: I HAD SEVERE FATIGUE AND FELL ASLEEP. I DID NOT WAKE BACK UP FOR 17 HOURS.  1/1/2021, 9:00AM: WHEN I WOKE UP I HAD A LARGE RED RASH OVER MY FACE AND DOWN MY NECK- NO WHERE ELSE ON MY BODY BESIDES MY FACE. MY FACE HAD A BURNING SENSATION AS IF IT WERE ON FIRE.  1/2/2021: BY 48 HOURS MY ENTIRE FACE  (INCLUDING MY EYELIDS) HAD THE RED RASH. I TOOK BENADRYL AND THE BURNING SENSATION WENT AWAY BY THE MORNING.  1/3/2021: ON DAY #3 I USED A POISON IVY TYPE CREAM BEFORE BED, AS WELL AS BENADRYL. 1/4/2021, 05:00:  THE MORNING OF DAY#4 THE REDNESS AND RASH HAD SUBSIDED TREMENDOUSLY, HOWEVER STILL PRESENT. 1/4/2021, 1:30PM: VISITED HEALTH CARE PROVIDER. I HAD A STEROID SHOT ADMINISTERED, AND WAS SENT A PRESCRIPTION FOR AN EPI PEN AND A "PACK" TO MY PHARMACY.  THE PHYSICIAN REACHED OUT TO OTHER COLLEGUES, ALL STATING THAT THEY HAD HEARD OF CASES ARISING WITH RED RASHES ON PEOPLES FACES, BUT NONE OF THEM HAD PERSONALLY SEEN IT YET. MY PHYSICIAN SAID I WAS THE FIRST PERSON TO COME IN. I ASKED ABOUT MY DERMA- FILLERS, AND IF THEY HAD ANYTHING TO DO WITH THE RASH BUT NOTHING COULD BE CONFIRMED. MY TEMPERATURE WAS EXACTLY 98.5, HOWEVER THE DR STATED MY SKIN WAS HOT TO THE TOUCH.
Rash the night of vaccination. Responded to diphenhydramine. Started limping the day after vaccination. Fevers noted the day after vaccination. Lip swelling and hip pain noted 2 days after vaccination
Fever of 100 F; Horrible headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100 F) and HEADACHE (Horrible headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, High cholesterol, Blood pressure high and Myasthenia gravis. Concomitant products included OLMESARTAN for Blood pressure high, METFORMIN and GLYBURIDE for Diabetes, ATORVASTATIN for High cholesterol, PYRIDOSTIGMINE for Myasthenia gravis.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 31-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 01-Feb-2021, the patient experienced PYREXIA (Fever of 100 F) and HEADACHE (Horrible headache). At the time of the report, PYREXIA (Fever of 100 F) and HEADACHE (Horrible headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    The daughter reported the events on behalf of her mother. Treatment medication recommended by her HCP was Advil (ibuprofen). No known medication allergies reported.
After 2 weeks, I developed severe rash and it was all over my body below my neck. The rash is super itchy and I cannot scratch otherwise it got more severe. The itching prevented me to sleep for 2 consecutive nights all ready.  2 days later after first rash, I have a sever fever (up to 104.3 F).   There were blisters in a few limited rash spots  I got OTC Claritin hoping to reduce the allergy but so far it has small impact or none. I also used Benadryl itch stopping gel to sooth super ithing spots. But the effect lasted in very short time.
Four days after given her first dosage of the MMR vaccine she had a twenty minute seizure that had to be stopped by paramedics giving her a shot. We were taken to the hospital and admitted.
8/6/03 queasy stomach, dizzy, continued through 8/10/03. No fever, no vomiting, no diarrhea, little headache. Off work for one week. To Dr on 8/7/03.
12/12/20 @ approx 1800. Mom found pt "limp and unresponsive, eyes unfocused but not deviated". Pt had tonic-clonic seizure for approx 1.5min in presence of EMS. Given 2mg VERSED IM x 1 with no further seizure activity noted. Temp 101.4 at the time; pt had not been sick or running any fevers prior to this event. No cough or diarrhea. ED report mentions "nasal congestion for a couple of weeks" but no report of nasal congestion or illness reported during well visit on 12/4/20. Pt vomited x 1 s/p seizure activity.
This spontaneous report as received from a registered nurse refers to a 17 year old patient (unspecified gender). On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
My reactions to the second shot started with a sore arm, night sweating for the first day of injection (5/9). In the morning of the two days after the shot, there are also some minor nose bleedings. The primary reason I'm reporting is because of the symptoms below:  On 5/10, I suffered from fatigue that I had to sleep every other couple of hours. In the night the adverse event that resembled myocarditis occurred when I went to bed (around 10 PM). The symptoms included respiratory difficulties/shortness of breath and severe chest pain especially when lying on my back, and pains in the upper body mostly in both arms. As a result, I wasn't able to sleep until 4 AM when these symptoms started to reduce. However the fatigue and periodic shortness of breath persisted for a couple of more days.   I recognized these symptoms are much like the ones I experienced once in 2018, although I was able to get a diagnosis of myocarditis after being tested with ECG and blood tests. During that event the trajectory of serverless and recovery was similar.