chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A LITTLE SORE ARM A COUPLE OF DAYS; Initial information was received on 11-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves a 85-year-old and unknown gender patient who experienced a little sore arm a couple of days (pain in extremity) after receiving INFLUENZA VACCINE and COVID-19 VACCINE.  It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine.  The patient had no medical history, concomitant disease or risk factor.  Medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date: not reported) via unknown route in the right arm for prophylactic vaccination.  On an unknown date, the patient received a booster dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (batch number and expiry date: not reported) via unknown route in the left arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious a little sore arm a couple of days (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE and COVID-19 VACCINE.  It was reported "NO REPERCUSSIONS WHATSOEVER OTHER THAN A LITTLE SORE ARM A COUPLE OF DAYS. NO BIG DEAL!!! THAT IS WHAT I DO. I AM 85 YEARS OLD AND COUNTING!! I DARE all of you to do the same.!!!"  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown from the event.  There will be no information available on the batch number for this case.
Information has been received from a consumer concerning his 2 month old son who on 21-OCT-2009 was vaccinated intramuscularly with "single dose" of ROTATEQ.  Concomitant medication include "other vaccines for that age: unspecified which ones".  The baby had been fussy "after getting the vaccine" and experiencing diarrhea.  The baby was taken for some gastrointestinal test on 15-DEC-2009.  The baby was not hospitalized.  The patient's fussy and diarrhea persisted at the time of this report.  No further information is available.
The patient experienced a cardiac arrest 2 days after receiving the second dose of the Covid-19 vaccine. He later died on 2-17-2021 with complications including respiratory arrest and acute kidney failure.
Widespread rash on my upper body which lasted for approximately two weeks as well as extreme menstrual cramps which I've never had before.
Md believes the shot was given too high in the patient's arm causing a tendonitis. Patient will require a MRI
Feel like crap; This case was reported by a pharmacist via call center representative and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. The pharmacist reported that about 30 percent of patients feel like crap for two days after a dose of Shingrix. The reporter did not provide patient demographics, event specifics, lot numbers or expiration dates. The reporter did not consent to follow-up.
Mild headache; sore arm; tired; he got light headed and dizzy that lasted for 30 minutes; This is a spontaneous report from a contactable consumer. This consumer (Patients wife) reported for a patient (Reporters husband). A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FA7484), dose 1 via an unspecified route of administration, administered in left arm on 26Jul2021 14:00 (at the age of 49-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included high cholesterol. Concomitant medications were not reported. On unspecified date in Jul2021, the patient experienced mild headache, sore arm, tired and he got light headed and dizzy that lasted for 30 minutes. It was stated all these side effects are from the first dose and her husband right when he got injected he could feel the medication going through his blood stream, he got light headed and dizzy that lasted for 30 minutes, then he had a headache from that day, and he felt tired, and had a sore arm that still hurts today. The headache was the day of the vaccine and was relieved with motrin. Adds all his side effects were gone after about 30 minutes that day. The only thing he still has is a sore arm. The vaccination sites will monitor patients for at least 15min in case there is an allergic reaction, may refer to the vaccination site for more specific information. No specific statistical data is available but it's possible that severe reactions occurred, they may be reactions that were not in the clinical studies. Patient will get second dose on 16Aug2021. Treatment included motrin. Outcome of the event sore arm was recovering. Outcome of the other events was recovered on unspecified date in Jul2021.
9/18/16 MD Notes: Left upper arm - erythematous, warm and slightly swollen on inner surface of entire upper arm. Doesn't pass elbow or armpit. Injection site of vaccine clear. Symptoms consistent with allergy.
This spontaneous report as received from a nurse refers to a 7 months 29 days old female patient. No concurrent condition, medical history of allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant mediations were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
This reaction was not reported by patient until 3/21/19 at follow up visit. Swelling of arm
Had menstrual bleeding after both vaccinations - I have not had a period in 13 years (have IUD's) and after first vaccine had extremely large unprovoked bruising to left posterior leg
Positive COVID test. Fever , shortness of breath, headache congestion, fatigue , cough, Nausea
About a week later developed MRSA; A spontaneous report was received from a pharmacist concerning a 36-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and about a week later developed MRSA (Methicillin-resistant Staphylococcus aureus).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unknown date, about a week after vaccine administration, the patient developed MRSA. No further information was provided regarding the patient.   No treatment information was provided.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the event, about a week later developed MRSA, was unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Information has been received from an investigator regarding a 2 month old female who received her 1st dose of Prevnar, as well as, DTAP, HbOC, Hep-B and IPV as part of the study, "Post-Marketing Evaluation Of Prevnar Pneumococcal 7-Valent Conjugate Vaccine (CRM197 Protein Conjugate): Safety Of Prevnar Administered Concurrently With Routine Infant Vaccinations At 2, 4, 6, and 12 to 15 Months Of Age" on 4/21/00. That evening, the pt was seen in the ER at 21:30 and a dx of "possible" febrile seizure was made. She recovered. Information has been forwarded to the manufacturers of IPV. Febrile seizure is considered to be an "Other Important Medical Event". The investigator considered this event (febrile seizure expected per USPI) "possibly" related to study vaccine administration. The medical monitor's assessment was unknown.
Information has been received from a consumer concerning a 7-year son who was vaccinated on 7/21/95, at 30 months of age, with one dose of MMR. He also received Tetanus toxoid adsorbed, Purogenated in 1994 at approximately 18 months of age. Subsequently the pt developed a fever of approximately 105 degrees F, autism and lost his speech abilities. The pt also developed gastrointestinal problems. The pt was reported to be doing much better now. The pt did not receive additional boosters of the MMR vaccine. The pt's autism was determined to be an "other medical event: Additional information has been requested.
Drug ineffective; COVID-19 virus test positive; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4214623-00.  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 75 years as dose 2, single and intramuscular, administration date 01Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 20Dec2021, outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant) with onset 20Dec2021, outcome "not recovered", described as "COVID-19 virus test positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) positive. The action taken for adalimumab was dosage permanently withdrawn.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality: COVID-19 virus test positive (SARS-CoV-2 test positive) Causality as per reporter (Drug/Vaccine): Possible  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious events and the suspect BNT162B2 cannot be excluded.
swollen upper lip rash on neck  * No treatment yet. I am going to call the doctor.
ADVERSE EVENT NOS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced adverse event nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos was not reported. This report was non-serious. This case, from the same reporter is linked to 20210438321.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
On evening of dose #2 of twinrix, client experienced symptoms of headache, cough, congestion, aches, chills, pain in chest, fever of 99.5 deg F. Client was recently exposed to a child on commercial flight that had flu-like symptoms. Client encouraged to seek medical attention for possible flu diagnosis.
This is a spontaneous report from a contactable other hcp. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose1, single and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took the second vaccine and then had breakthrough COVID-19 case and tested positive with a PCR 8 months after the second vaccine on an unspecified date. The adverse event was considered as serious with seriousness criteria of medically significant. The patient underwent lab tests and procedures which included sars-cov-2 antibody test, positive on an unspecified date. Reporter also wants to know if patient had a heart condition and considered immunocompromised. The outcome of the events was reported as unknown.  Information about lot/batch number has been requested. Sender's Comments: As there is limited information in the case provided, the causal association between the event Covid-19 and the suspected vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Left leg DVT.    I am a nephrologist practicing in my area.  10 days or so  after receiving Pfizer vaccine I started noticing left leg swelling and some redness. I didn't pay attention to it because I thought this could be a muscle or tendon issues because of my exercise. But the swelling did not go away, however, it decreased overtime with leg elevation, etc but when I checked my leg I found out that I have a DVT.   I am a healthy 39 ( when I received the vaccine but I am 40  now). I don't smoke. No family history.  I am on a blood thinner now.   I need to report this as I think that it is important to be reported.   I read in the news that a 40 year-old man was diagnosed with DVT after Pfizer vaccine  Please call or email if you need further info
p/vax pt wrists aching & burned, hands aching, flu sx, fever, felt terrible, cold, shaky & chills;
On September 29, 2007 at about 10:00 p.m. Patient, started having difficulty in breathing, a rapid heart beat, a dry cough and a lot of wheezing especially at night (wheezing). This continued until October 13, 2007 about 2 weeks. Since then and up to today October 22, 2007, I still feel a little wheezing and difficulty in breathing is now less than before.
Fever and body aches started at 11pm the night of the 2nd vaccine does. No treatment other than Tylenol, symptoms still present the next day.
Nose started bleeding; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose started bleeding) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced EPISTAXIS (Nose started bleeding). At the time of the report, EPISTAXIS (Nose started bleeding) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient wanted to know if she needs to go to the hospital or not.
SIDE EFFECT OF THE VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced side effect of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effect of the vaccine was not reported. This report was non-serious.
Patient received her second dose with us, having gotten her first dose elsewhere. First dose was 4/23/21.  Received second dose with us 5/28/21.  Patient states she had no reaction with the first dose.  For the second dose, she reports having rash and welts appearing a couple days after the vaccine on the arm the vaccine was administered.  Patient started taking antihistamines and reports that the welts have disappeared, but little red bumps are spreading out that cover now her stomach and neck.  Received the vaccine 5/28/21 and reports this ongoing issue today, 6/14/2021.  We have suggested contacting her doctor to determine the cause/course she should take since OTC antihistamine therapy has not been working.  Patient stated she would do that.
pain in his left shoulder; pain in his left shoulder/ not in the injection site but muscles around it; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date Jan2021 (Lot number: EL9265) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious) with onset 01Feb2021, outcome "not recovered", described as "pain in his left shoulder"; VACCINATION SITE PAIN (non-serious) with onset 01Feb2021, outcome "not recovered", described as "pain in his left shoulder/ not in the injection site but muscles around it". Therapeutic measures were not taken as a result of arthralgia, vaccination site pain.  Additional information: The patient has no known allergies. He did not receive any other vaccines within four weeks prior to the COVID vaccine and other medications within two weeks of vaccination. He also received the second dose of BNT162B2, administered in the left arm, administration date 20Feb2021 13:00 (Lot number: EN6201) for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination, and he has not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Within 5 hours of receiving the shot my entire right arm was numb and tingly and my pinky finger felt like it wasn?t there.  I also has the worst headache of my life, ibuprofen didn?t help it.  The next morning (Friday) I felt somewhat better but by noon, I felt just as bad as the night before and the horrible headache was back.  Saturday and Sunday were exactly like Friday.  Monday morning, my arm was back to normal and the horrible headache was gone.  Since them I?ve had headaches on and off, but not as horrible as Thursday thru Sunday. This afternoon marks 1 week since my first of 2 doses.  I?m not sure at this point if I want to get the 2nd dose or not when it?s due.
Patient initially had fatigue & nausea on day one. Over the next 5 days patient has dizziness especially in the morning after waking up. Condition continues all day but not as severe as morning. Will be contacting PCP to set appointment.
After receiving the vaccine I had pain in my arm that had worsened. I had a fever of 101 degrees so I took Tylenol at that time. I had chills, muscle aches, joint aches, and headaches. I had a slight swelling on my left foot. I started having anxiety for 4 days including today. I also had pink discharge from my eyes, and they were really red and even more red on the left side. On 12/2/2021 I went to the ER at  Hospital. The doctor said I had an eye infection. I was given some antibiotics to take for it called Gentamycin and Olopatadine. My eyes had started feeling itchy after 3 days, but it has a gone down a lot. I still have anxiety and itchy eyes.
Narrative: This 38 year old FEMALE h/o asthma, c/o bilat hands tingling starting about an hour after her 2nd Moderna coronavirus vaccine. She denies dyspnea/wheezing/throat tightness/lip swelling, denies dizziness/syncope. PT to be followed up by PCP
fever to 104 w/complicated febrile seizure; hospital records available w/signed release;
rash in the top of right hand/rash on the left hand; looks like dryness; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN9899), via an unspecified route of administration on 15Jan2021 at 13:30 on the left arm at a single dose for COVID-19 immunization.  Medical history included partial seizures complex, asthma, beginning of heart disease and high cholesterol all from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had no prior vaccination within four weeks. The patient stated she has a rash on the top of her hand right hand and rash on the left hand; it is real dry, it looks like dryness, on 18Jan2021. The patient stated that she doesn't know if it is allergic reaction. She needs help to figure it out. She is asking if she needs to see her doctor. The patient stated that otherwise, the vaccine was healing her and helping her. She stated that she knows you can have a rash all over your body and she wants to know if that is going to happen. She clarified she noticed the rash on the top of her right hand - not the palm. She isn't sure if it came from taking out the trash or cleaning stuff or some other reason. She stated that it is now trying to get on the other left hand too. She said you can't really tell it on her left hand but she noticed it on the night of 18Jan2021. She is unsure if when she washes her hands it is getting from the right hand onto the left hand. She just needs to know if it is from the vaccine or if she needs to stop taking out the trash or maybe wearing gloves. She is scheduled to receive the next dose on 5Feb2021. She lives in a senior facility building. One of the staff members got COVID so they had to get the vaccine. The adverse event did not require a visit to the physician or emergency department (ER). The outcome of the events was not recovered.
Muscle weakness in arms and legs, falling down, numbness, tingling, muscle twitching, constipation, tiredness, finger stiffness EMG, 2x Lumbar Puncture, Muscle and Nerve Biopsy.
It has been 12 days since I received the shot and my arm still feels bruised and it's a little swollen. No other symptoms or reactions.
I had a sore arm at the site of the injection for less than 24 hours. I used Tylenol and ice packs and that resolved those issues. Five and half months later after receiving my 2nd dose of the vaccine I contracted COVID-19. I went to medical facility on that Thursday 9/16/21 thinking I just had a bad sinus infection. I was tested for COVID-19 and was prescribed antibiotics, steroids, and received a steroid shot to treat the sinus infection.  The clinic called me that Saturday and advised to me that my COVID-19 Test came back positive and to continue taking the medication I was prescribed. I had the antibody infusion done on 9/20/21 at hospital. After I received the infusion, I still took the Tylenol twice a day to help with any aches or pains. I never ran a fever while having COVID-19.
Rash at injection site covering upper arm. The first reaction started about 7 days after  first dose and resolved approximately a week after.
PATIENT DID NOT INDICATE (VERBALLY OR IN THE VAR FORM FILLED OUT) THAT HE HAS HAD  ANY REACTIONS TO VACCINATIONS IN THE PAST. HE RECEIVED HIS VACCINE, SAT DOWN AS INSTRUCTED AND WITHING FEW MINS, PASSED OUT AND FELL FACE DOWN ON THE GROUND UNCONSCIOUS FOR A FEW SECS. HE WAS ATTENDED TO IMMEDIATELY BY THE RPH ON DUTY. PATIENT GAINED CONSCIOUSNESS WITHIN A FEW SECS AND WAS TAKEN TO THE HOSPITAL BY PARAMEDICS AS HE ENDED UP GETTING A GASH ON HIS FOREHEAD FROM THE FALL.