chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Arm pain; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Feb2021 (Lot number: EL9267) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ovarian cysts" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYZINE; ESTRACE. Past drug history included: Codeine, reaction(s): "Drug allergy", notes: known allergies: codeine. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "Fatigue"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Arm pain"; HEADACHE (non-serious), outcome "recovered", described as "Headache". Therapeutic measures were not taken as a result of fatigue, pain in extremity, headache.  Additional information: Patient was not pregnant at the time of vaccination. 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 COVID-19 vaccine. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Can not move arm; Have so bad fever 100.8 degree Fahrenheit; Body ache; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (Can not move arm), PYREXIA (Have so bad fever 100.8 degree Fahrenheit) and MYALGIA (Body ache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included DULOXETINE and FLUOXETINE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced LIMB DISCOMFORT (Can not move arm), PYREXIA (Have so bad fever 100.8 degree Fahrenheit) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Feb-2021, LIMB DISCOMFORT (Can not move arm), PYREXIA (Have so bad fever 100.8 degree Fahrenheit) and MYALGIA (Body ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Body temperature: 100.8 °F (High) 100.8 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included,  unspecified cholesterol medications for unknown indication and unspecified high blood pressure medications for blood pressure   This case was linked to MOD-2021-218636 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up information was received on 14-May-2021 from the initial reporter and contains no new information.
Pt recvd 2nd dose of vax 7JAN93 & a few days later knees were painful & unable to sleep; severe pain; also devel severe allergic react w/urticaria & angioedema w/large brown blotches; also devel visual problems; pt shaky;
The pt experienced hot, cold, weakness, dizziness, blacked out on floor and nausea.
Initial unsolicited report received from physician assistant on 26-Sep-2017. This case involves 21 year old female patient who was vaccinated with a 0.5 ml once dose of ADACEL (Batch number- U5770AA, expiry date - 15-Sep-2019, dose in series not reported) intramuscularly in right deltoid on 26-Sep-2017. Patient had a medical history allergy to milk, peas and eggs. Concomitant medications were not reported. On an unknown date, 15 minutes following vaccination patient had cough, shortness of breath (SOB), nasal congestion, flushing, mild nausea and itching to mouth and lips. Laboratory investigations were not reported. Corrective treatment included 50mg BENADRYL that was administered to patient. On an unknown date, patient got recovered from all the event as patient was asymptomatic upon discharge. List of documents held by sender: none.
Right side of her face was swollen; Having an allergic reaction to the Pfizer-BioNTech COVID-19 Vaccine; This is a spontaneous report from a contactable consumer (patient). This is report 1 of 2. A 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EP7534; Expiration Date: Jul2021), via an unspecified route of administration, in Right Arm on 16Mar2021 15:30 (at the age of 39-years-old) as dose 1, single for covid-19 immunization at pharmacy. Vaccine was not administered at military facility. The patient medical history was not reported. No Family Medical History Relevant to adverse event. There were no concomitant medications. No other products. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There were no additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks) If applicable and no list of any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. No Adverse events following prior vaccinations. This consumer was the patient who was administered her first dose of Pfizer-BioNTech COVID-19 Vaccine on 16Mar2021 around 15:30. Approximately 2-3 hours later, around 17:30-18:30 she noticed the right side of her face was swollen. She was not sure if it was swollen a little or a lot. Patient sister was a nurse, so patient called her sister last night and sister said she was probably having an allergic reaction to the Pfizer-BioNTech COVID-19 Vaccine, so the patient took some Benadryl last night and the Benadryl seemed to help, the event has improved, was less today. She reported initially she thought maybe she was just having an allergic reaction to the Pfizer-BioNTech COVID-19 Vaccine, but then patient girlfriend came to her house yesterday after she was also administered the Pfizer-BioNTech COVID-19 Vaccine at the same administering facility as reporter and her girlfriend also had right side of her face was swollen. Girlfriend information documented in clone report 2 of 2. Reporter requested contact information. The adverse event did not require a visit to emergency room and physician office. The patient was not hospitalized. The patient underwent lab tests and procedures which included mammogram and ultrasound scan: nothing found, no notable results on 08Mar2021. No more information available. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Joint pain, back pain, knee pain, hip pain, numbness in hands and feet-ongoing. Treatment: Orthopedic surgeon. No relief.
Body aches; Fever reached 102.9 F, then decreased of 101 F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) and PYREXIA (Fever reached 102.9 F, then decreased of 101 F) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID-19 on July 2020). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (Body aches) and PYREXIA (Fever reached 102.9 F, then decreased of 101 F). On 07-Mar-2021, PAIN (Body aches) and PYREXIA (Fever reached 102.9 F, then decreased of 101 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 102.9 (High) High and 101 (abnormal) Decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
I had itching and redness on my left arm where I received the shot on day 2. I also had some small bumps and itching on the back of my hands. As the days went on, I had more red bumps on my feet, ankles, forearms, and other areas of my body. It was really bad on 03/08/2021. I could not stop itching one my feet and ankles. The also in other places.
The symptoms of COVID-19 included headache, body aches, sore throat, and a cough. The symptoms lasted about two days. I contacted my doctor. She prescribed Paxlovid.  I also took Mucinex, Tylenol, and Airborne. After the first two days, I just felt very fatigued.
Itchiness, jaw, cheek area - swelling & welts on (L) side. Same side as vaccine.
Took my Humira shot a couple of hours before getting the Moderna vaccine. Felt okay until later that evening. Started feeling out of sorts; did not want to eat or drink anything. Started getting chills around 7:30/8 pm. Went to bed. Woke up around 10 pm to take temp. Had low fever101 F. Went back to bed. Got up a few times to use restroom. Each time I felt weaker and more nauseous. At 3:30 am I went to the bathroom but was extremely weak, then overwhelmingly nauseous. I was trying to get back to bed but passed o out. Luckily, my husband caught me and put me on the bed. I started coming to after that. I was too weak to move. Ambulance came. BP was about 198/98. I was soaked with sweat. Taken to hospital.
pt recv vax 8AM that evening 8PM felt induration 33mm @ site, joint pain (especially in hands, no dexterity at all) throughout body;also had extreme fatigue, malaise & nausea w/lower abd pain;had UTI but urine cult negative when saw MD;
booster dose; get COVID after booster dose; get COVID after booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster dose"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "get COVID after booster dose".  The lot number for bnt162b2 was not provided and will be requested during follow up.
taking RITUXAN during his dose 2 series rendered the vaccine ineffective; This is a spontaneous report from a contactable consumer (patient), via medical information team). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date, as Dose 2, single for COVID-19 immunization; and received rituximab (RITUXAN), via an unspecified route of administration on an unspecified date (taking during his Pfizer dose 2 series), for an unknown indication. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date, as Dose 1, single for COVID-19 immunization. The patient asked if there was any information in taking a second 2 dose series of the Pfizer COVID vaccine and he was taking RITUXAN during his dose 2 series, which rendered the vaccine ineffective (encoded as potentiating drug interaction). He was wondering if the medication was out of his system now if he would take the 2 dose vaccine series a second time. The outcome of the event of drug interaction was unknown.  Information on the lot/batch number has been requested.  Follow-up (28Jun2021): New follow up spontaneous report received from a contactable consumer included: Reporter contact details updated.  Amendment: This follow-up report is being submitted to amend previously reported information: updated RITUXAN as suspect product, and re-coded event as drug interaction for VT "taking RITUXAN during his dose 2 series rendered the vaccine ineffective".
Patient had soreness in the neck and elbow after getting the 1st dose; Patient had soreness in the neck and elbow after getting the 1st dose; soreness as his whole muscle area.; soreness on his arm from his elbow up to his neck; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EN6202), dose 1 via an unspecified route of administration, administered in Arm Right (stuck it in his arm, he was not sure if it was in a muscle) on 01Mar2021 between 1:00 to 2:00 pm (age at vaccination 66-Years-old) as dose 1 single for covid-19 immunisation. The patient did not had any medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. On an unknown date in Mar2021, patient had soreness on his arm from his elbow up to his neck. His second dose is due in three days. Later patient clarified soreness as his whole muscle area. Soreness on his elbow up to his neck started about two weeks ago (Mar2021). Patient stated that it was painful bit was not excruciating. It was about the same from when it started. Patient received ibuprofen as a treatment drug which was not working. It was reported that patient will have the 2nd dose of the PFIZER-BIONTECH COVID-19 VACCINE on 22Mar2021. No Prior Vaccinations within 4 weeks and did not have any adverse event following prior vaccinations. No family medical history relevant to adverse event. the reporter assessed as non serious. The outcome of the event soreness as his whole muscle area was unknown and for rest all it was not recovered.   No follow-up attempts are possible. No further information is expected.
pt recv vax & 5 hr later awoke from a nap-was gasping acting as if couldn't breath, glassy eyed; paramedics called-transported by amb to hosp; pt has reflux;
It tastes like I'm sucking on a penny. My face is swollen, throat is sore, and feel alittle foggy.
Pt developed an urticarial rash on bilateral arms, armpits, posterior legs, back, chest and neck. Pt denies respiratory symptoms. Pt treated with Benadryl, Kenalog, and Atarax.
Vomiting; Diarrhea; Sweating; Aches; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:EN6204) via an unspecified route of administration in the left arm on 23Mar2021 at 11:30 (at the age of 38-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 13Apr2021 at 11:30 (at the age of 38-year-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and the gallbladder was removed last summer. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included loratadine (CLARITIN) from an unknown date for an unspecified indication and unknown if ongoing. On 15Apr2021 at 07:30, 48 hours after, the patient experienced vomiting and diarrhea, sweating, and aches. The patient experienced the same side effects on 26Mar2021, 3 days after the first vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting, diarrhea, sweating and aches that occurred after first dose was resolved on an unknown date in 2021 and the outcome of the same events vomiting, diarrhea, sweating and aches that occurred after second dose was resolved on 15Apr2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated medical history data and vaccine facility data.
I started off with a sore throat, muscle aches. The 2nd night I had fever and chills like a bad flu. It lasted about 4 days before my fever broke and my body aches went away. I called my doctor and she had me to keep an eye on my pulse oximeter. I was taking nyquil and Benadryl. I did have some stomach issues and tachycardia , that lasted a couple of weeks with some fatigue.
40min p/vax exp a gradual onset of "severe" headache, flushing & dysphagia. Tx unspecified prescription medication. Later recovered. Additional info requested. F/U 1MAR91:  BP = 160/90, ALSO HAD THROAT TIGHTNESS, DYSPHAGIA, AUDIBLE BR SOUND
Mom states no energy, feels tired a lot of the time, is sensitive/emotional - cries a lot.
Immediately after receiving the injection, the patient passed out. She was already in the proper sitting position, and I ( immunizer) saw that she was passing out. I had just placed the syringe in the sharps container and was about to place her bandage on, when her head went slack and I saw her eyes roll. I immediately leaned one arm over her to keep her from falling out of the chair, while using my other hand to steady her neck and head. The patients mother was in the room with us, and was talking to her daughter, trying to revive her. I informed the patients mother that I would be unable to leave her daughter, and gave her the name of my pharmacist on duty and asked her to step out and go to the consult window and have him come back to the immunization room. Pharmacist and the patients mother returned in short order and pharmacist verified what I had already checked that she was showing signs of breathing, chest was rising and falling. He helped support her head and asked the mother to gently rub her face to try to wake the patient back up. He stepped out briefly while I was continuing to support the patient and came back with some wet paper towels to place on the back of the patients neck and forehead. After approx. 10 minutes the patient came to and was able to stand and walk under her own power. She sat in the waiting room for an additional 15 minutes before leaving.
leg weakness; arm soreness; headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (leg weakness), PAIN IN EXTREMITY (arm soreness) and HEADACHE (headache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN and ENALAPRIL for an unknown indication.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and HEADACHE (headache). On 17-Feb-2021, the patient experienced MUSCULAR WEAKNESS (leg weakness). On 17-Feb-2021, PAIN IN EXTREMITY (arm soreness) and HEADACHE (headache) had resolved. At the time of the report, MUSCULAR WEAKNESS (leg weakness) outcome was unknown.            No treatment information provided.
large local rxn red, hot, swollen & low grade fever 99-100 x 48hr;
1/2 dose of vaccine was given in R arm and the other 1/2 given in the L arm.
I became extremely dizzy, passed out in bathroom and fell onto tub. Severe head and shoulder damage
Mother called stating son had gone into bathroom at approximately 3:00 p.m. and that she heard a loud noise. Upon investigating she found child was passed out in stiff position with hands curled on chest. Patient was like this for 5 - 10 minutes and then it resolved. Representative spoke with patient via speaker phone with Supervisor present to confirm that patient was alert and oriented by requesting age and location of school. Patient responded in the affirmative by stating he was 18 years old and attended High School. The patient stated he was "feeling ok", but still felt "sleepy" and that his "head hurt". Mother stated she could not palpate or see any bumps, bruising, or bleeding. Representative recommended to have patient go to E.R. of their choice and the mother and the father of the client agreed.
I've got some reactions through the day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I've got some reactions through the day) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (I've got some reactions through the day). At the time of the report, VACCINATION COMPLICATION (I've got some reactions through the day) outcome was unknown.       Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Information has been received from a nurse practitioner concerning a 16 year old female who was vaccinated with a dose of GARDASIL.  The nurse practitioner reported that "a month or two after receiving a dose of GARDASIL" the patient had developed warts on her face, which were predominately on her lips.  No lab diagnostics were performed.  The nurse practitioner did not know if the patient is going to receive any more doses of GARDASIL because she had not heard back from the patient as of yet.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2008.  Follow up information has been received from a physician assistant who reported that the patient presented at the walk in clinic for an unrelated complaint.  Mentioned that she had received GARDASIL injection from another clinic approximately 1 month ago and now had a large wart on face on upper lip (0.5 cm flat wart was seen on right upper lip).  No prior history of warts of any kind.  Adverse event following prior vaccination was reported as:  patient wart on upper lip, onset age 16 with GARDASIL, dose in series, 3.  Additional information is not expected.