chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 25 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high functioning autism" (unspecified if ongoing); "22q deletion syndrome" (unspecified if ongoing); "asthma" (unspecified if ongoing); "generalized anxiety disorder" (unspecified if ongoing); "milk" (unspecified if ongoing); "tree pollen" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE; GABAPENTIN; CLONAZEPAM. Past drug history included: Trazadone, reaction(s): "Known allergies: trazadone".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient treated with Paxlovid. Treatment start date= 01Dec2022. Treatment stop date= 05Dec2022. This covid medication has helped patient signifyingly recover from his covid infection especially since he have asthma.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
sickness; unable to walk/Couldn't walk and has had to crawl ever since; pain in her lower back; groin pain; Hip pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sickness), GAIT INABILITY (unable to walk/Couldn't walk and has had to crawl ever since), BACK PAIN (pain in her lower back), GROIN PAIN (groin pain) and ARTHRALGIA (Hip pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Osteoporosis.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced GAIT INABILITY (unable to walk/Couldn't walk and has had to crawl ever since), BACK PAIN (pain in her lower back), GROIN PAIN (groin pain) and ARTHRALGIA (Hip pain). On an unknown date, the patient experienced ILLNESS (sickness). At the time of the report, ILLNESS (sickness), GAIT INABILITY (unable to walk/Couldn't walk and has had to crawl ever since), BACK PAIN (pain in her lower back), GROIN PAIN (groin pain) and ARTHRALGIA (Hip pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. Treatment : Patient is taking pain pills and got a shot in her hip.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Events added and dosage text added On 20-Apr-2021: No specific follow-up information recorded.
Around 6:00 am on April 18th, 2021, "my" body developed hives, on "my" arms, legs.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0151) via an unspecified route of administration in the left arm on 14Apr2021 at 14:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included may be allergy to penicillin and cephalosporin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the vaccination included first dose of influenza vaccine, Lot number: unknown via an unspecified route of administration in the left arm on 09Mar2021 as a single dose for immunization. Concomitant medications included multivitamins (VITAPRIME) by labs for an unknown indication on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 23Mar2021 at 14:45 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 06:00, 88 hours after receiving the second shot of vaccination, the patient body developed hives, on his arms and legs. On 19Apr2021, as writing this, he did not see hives anymore. The event did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. Therapeutic measures were taken as a result of the reported event and included treatment with fexofenadine hydrochloride (ALLEGRA) from an unspecified date in Apr2021 and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body developed hives, on arms and legs was resolved on 19Apr2021.  No follow-up attempts are needed. No further information is expected.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no previous temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 6-month-old patient of unknown gender. On 18-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N012920 (expiration date 07-FEB-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
I was dizzy and I thought I was going to faint; Temperature was 100 degrees; Headache; Muscle pain; Joint pain; Nausea; She was so cold; Pain at the injection site; chills; Arm was swollen and puffy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen and puffy), DIZZINESS (I was dizzy and I thought I was going to faint), FEELING COLD (She was so cold), VACCINATION SITE PAIN (Pain at the injection site) and CHILLS (chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0011A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen and puffy), FEELING COLD (She was so cold), VACCINATION SITE PAIN (Pain at the injection site) and CHILLS (chills). On 26-Mar-2021, the patient experienced DIZZINESS (I was dizzy and I thought I was going to faint), PYREXIA (Temperature was 100 degrees), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and NAUSEA (Nausea). At the time of the report, PERIPHERAL SWELLING (Arm was swollen and puffy), DIZZINESS (I was dizzy and I thought I was going to faint), FEELING COLD (She was so cold), VACCINATION SITE PAIN (Pain at the injection site), CHILLS (chills), PYREXIA (Temperature was 100 degrees), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and NAUSEA (Nausea) outcome was unknown.            Concomitant medications were not reported. Treatment information were not provided.
Atrial Fibrillation. Waiting for Booster, before going to Emergency Room. Omicron variant has me concerned about waiting in ER waiting room.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administration date 14Apr2021 08:45 (Lot number: ER8729) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: er8732), administration date: 28Mar2021, for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset Nov2021, outcome "not recovered", described as "Atrial Fibrillation. Waiting for Booster, before going to Emergency Room. Omicron variant has me concerned about waiting in ER waiting room.". The event "atrial fibrillation. waiting for booster, before going to emergency room. omicron variant has me concerned about waiting in er waiting room." was evaluated at the physician office visit.  Clinical information: Patient did not receive any other vaccines within 4 weeks. Prior to the COVID vaccine, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
sore arm; fever up to 101.3 (fever dropped to 99 with tylenol, was still at 100 30 hours after injection); full body chills and aches; full body chills and aches; nausea; loss of appetite; 1 instance of vomiting after eating a banana; This is a spontaneous report from a non-contactable healthcare professional.  A 29-year-old female patient received second dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318), via an unspecified route of administration on the right arm on 04Feb2021 08:00 at single dose for COVID-19 immunisation.  Medical history included chronic lung illness and sulfa allergy.  Patient has unspecified concomitant medication. The patient previously took BNT162B2 on 13Jan2021 first dose (lot number=EL3249) on the right arm; Allergies: CEFZIL, amoxycillin and NEOSPORIN.  The patient experienced sore arm, fever up to 101.3 (fever dropped to 99 with TYLENOL, was still at 100, 30 hours after injection), full body chills and aches, nausea, loss of appetite, 1 instance of vomiting after eating a banana on 04Feb2021 04:00. Other events does not received treatment.  The outcome of the events were recovered on Feb2021.  No follow-up attempts are possible. No further information is expected.
Heart attack. Emergency Surgery.  Only one artery totally clogged. No other signs of heart disease. All other arteries clear. Regular exercise, Low cholesterol,  blood pressure 125/72 , no family history, not overweight. 6'1" 221Lb  No apparent reason
Whole left arm felt tingly all the way down to fingertips and was sore, no bruising or swelling.  Later as day progressed both wrists hurt serverely to the touch, like bones were brittle to break! Called Dr. later that afternoon and he left as was referred to call CDC, they had no reports of such side effects and to call VAERS, by the time I called (3:23pm Calif time) offices were closed on the East Coast.
Rebound COVID after two negative tests; Rebound COVID after two negative tests; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CYTOMEL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound COVID after two negative tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid (oral) from 23Nov2022 to 27Nov2022, for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded.
Patient passed out in parking lot approx. 20 minutes after injection, checked BP and was found to be 146/104 with pulse of 88. Pt said this was high for her, patient also stated a tingling in left arm.
I experienced dizziness, headaches, SOB, chest pains, diarrhea, nausea, occurred when I am under physical stress.   Walking 10ft or up the stairs triggered my symptoms. Once I stopped moving, my symptoms would dissipate.   I called my PCP along with a cardiologist up until today.   I was tested for blood clots, had complete blood panel, stress test and nuclear stress test. My symptoms are getting better but still have mildly present.  My last meeting with the cardiologist, what he saw after the nuclear stress test, that there was a lack of blood flow where to the lower right heart chamber. He said it probably due to a blood blockage or plague and at this time he is trying to figure it out.
Side effects  began 17 days after 2nd vaccine shot.  The side effects : dizziness, slight nausea
Sweating,  lightheadedness, dizziness within 5 minutes of administration.  Patient  requested medical attention and to lay down. Paramedics were requested and ,  upon arrival took care of patient.  Once stable and feeling better, patient went home by himself ( 40 min aprox after symptoms started)
Initial unsolicited report received from a Nurse on 30-MAR-2017. This case involves a 27-year-old female patient who was vaccinated with dose of TENIVAC (batch number: U5251AA, expiry date, dose and dose in series were not reported) intramuscularly in the left deltoid on 28-MAR-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at the time of vaccination was reported as none. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also reported as none. On 29-MAR-2017, one day of following the vaccination, the patient had developed sore throat, body ache and mild headache. The patient's emergency room (ER) or doctor visit was not reported. Laboratory investigations were not reported. Patient received salt water gargle, OTC Chloroseptic, hot liquids, Ibuprofen PM, Emergen "c" drink as Corrective treatment. The outcome of event was not reported. List of documents held by sender: none.
sore arms; low-grade fever; feels achy all over; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from a sales representative. A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 20Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), administration date: 2021, for Covid-19 immunization, reaction(s): "headaches"; Bnt162b2, for Covid-19 immunization, reaction(s): "sore arms where the injection".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "sore arms"; PYREXIA (non-serious) with onset Aug2021, outcome "unknown", described as "low-grade fever"; PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "feels achy all over". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: I was reporting the events, especially since their healthcare provider had warned them of the exact experiences they encountered. Event took place after use of product. She told me that she received her second shot yesterday (20Aug) and that her arm is very sore and that she is running a low-grade fever and just feels achy all over  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Seizure (staring, unresponsive to verbal stimuli) started approx. 5 min post vaccination.
death R56.9 - Unspecified convulsions E87.1 - Hypo-osmolality and hyponatremia D69.6 - Thrombocytopenia, unspecified R56.9 - Seizure  J18.9 - Pneumonia
Presented with SOB, cough, congestion; + covid 1/26/22; dx resp failure d/t covid bilat PNA; required transfer to PCU as requiring more O2; eventually weaned to 4 LPM NC; Tx: Decadron, Remdesivir, maxipime, zinc, Vit C, Vit D3, lovenox, Singulair; home on O2
Chest discomfort/pain continues,  severe fatigue for four weeks, swelling and redness of the arm.  Seizure 4 weeks after vaccine.  CARDIOLOGIST visit with ct of heart, echo, going for stress test, going for eeg, mri of brain, and concussion clinic from head injury from seizure.
I?ve been experiencing a metallic taste in my mouth since vaccination. I noticed it a few hours afterwards. It seems more pronounced today. I?m hoping it goes away.
WITHIN 24 HOURS AFTER RECEIVING THE ABOVE IMMUNIZATIONS PATIENT REPORTED FLU LIKE SIGNS AND SYMPTOMS, SORE TONGUE, SORE THROAT, BURNING LIPS, BURNING THROAT, JOINT PAIN, CHILLS, FATIGUE, FEVER, AND HEADACHE.
The pt reports waking up with numbness in both legs on 12/30/00 which had resolved and then reoccurred on 1/9/01. No weakness. Symptoms subsided and then reoccurred again on 1/19/01. FU received states final diagnosis is myelopathy.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient), for a Pfizer sponsored program (115193). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for immunization. The patient experienced pain ("she hurt all over"), with outcome of unknown. Additional information: Patient posted online she was "up all that day after the second Pfizer shot and she hurt all over." No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
States on morning of 10/14/2023 he didn't feel well. Left Upper arm tender, pain, mild redness and firm. 10/15/23 - 10/16/23 He felt horrible like he had the flu with sleepiness/fatigue as he slept for two days, headache, irritable, loss of appetite, fever/chills, joint pain, muscle pain. States today (5 days after vaccination) he still feels off, but functioning enough to work.   States he didn't receive any other injections that day.
5 minutes after the injection she started to get tingling lips and tingling in the top of her tongue. It lasted several hours and resolves spontaneously. 2 hours after the vaccine she also started to get some severe heart palpitations episodes, each one lasting no more than 15 minutes, and total of several episodes, the whole of which went on for no more than 2 hours. no abdominal pain or diarrhea. no rashes, no SOB, no cough, didnt feels like her throat closed up.
Rapid onset of vision loss, first blurry then a sheet came over her vision. She went to the ER and was referred immediately for retinal surgery
3 days after vaccine I developed shingles on the back of my left thigh; This is a spontaneous report from a contactable consumer (patient) via COVAES. This 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8734) via an unspecified route of administration in the left arm on 09Apr2021 at 11:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included ankylosing spondylitis, Sjogren's syndrome, fibromyalgia and interstitial cystitis, all from unknown dates and unknown if ongoing. The patient reported no allergies to medications, food or other products. Concomitant medications included ixekizumab (TALTZ), baclofen, and docusate sodium "plus," all from unspecified dates for unspecified indications. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. The patient reported that on 13Apr2021, 3 days after vaccination she developed shingles on the back of her left thigh. The event resulted in a doctor or other healthcare professional office/clinic visit. Treatment was received for the event and the treatment was reported as ongoing. The clinical outcome of 3 days after vaccine I developed shingles on the back of my left thigh was recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
VASOVAGAL SYMPTOMS AFTER VACCINE ADMINISTRATION. PATIENT PASSED OUT WHILE SITTING DOWN A COUPLE OF MINUTES AFTER VACCINE ABOUT 30 SECONDS LATER HE CAME TO. BLOOD PRESSURE WAS 90/50 mmHG. PATIENT LAID DOWN FOR ABOUT THIRTY MINUTES AND SYMPTOMS RESOLVED.
Customer was vaccinated with both vaccines in upper right arm per request on 9/26/21. Returned to pharmacy on 9/27/21 reporting swelling, redness, and discomfort to right arm. Rash, warmth to touch, and mild swelling was noted on upper arm by pharmacist. Instructed customer to contact PCP to discuss possible reaction to vaccinations. Instructed to apply cool compress to area and medicate as needed with OTC medications for comfort and to monitor site closely , taking pictures each day to monitor progress and report any changes to PCP.
Approximately 10 minutes after receiving the injection, patient became short of breath and developed numbness on the injection arm. Patient's care was transferred to EMS.