chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Non itching rash on chest and upper abdomen; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included erenumab (AIMOVIG MONTHLY INJECTION), topiramate (TROKENDI XR 50MG) and "vitam"; all taken for unknown indications from unspecified dates and unknown if ongoing. The patient previously received nortriptyline (MANUFACTURER UNKNOWN) and experienced a drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 31Mar2021 at 15:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 23Apr2021 at 06:00, 2 days after the second dose, the patient experienced a non-itching rash on chest and upper abdomen. She noticed it first thing in the morning. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event non-itching rash on chest and upper abdomen was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Narrative:  Patient presented to ER with chief complaint of SOB, work up in the ER revealed GI bleed (hemoglobin ~5 mg/dL), hypovolemic shock, ARF and hyperkalemia. PMH significant for COPD, Prediabetes, CKD stage 3, osteoporosis, remote history of duodenal ulcer and anemia (HGB 12.9 at PCP visit on 4/21/21) Patient was stabilized and heading to ICU when his HR dropped to 30's and became unresponsive. Pt. was given atropine, D50, calcium, IV fluids. Pt. did not respond, became apneic. Per patient's wishes to be DNR, no shock/cpr/intubation was initiated and patient passed away. Of note patient was not on anticoagulants or other blood thinners at the time of presentation, patient had received dose one of the Moderna COVID vaccine on 4/21/2021
Narrative:  74 year old male with a PMH of COPD, HLD, Stage IIIa NSCLC and HTN presented to the ED from facility with chief complaints of chest pain. In the ED, his blood sugar was around the 300s, BP 220/110, d-dimer 668 (0-500). Chest CT was then done which showed multiple bilateral segmental and subsegmental PEs. He was given hydralazine IV push for his hypertension. Patient did not have known active cancer at this time and reported he has not been treated for cancer and roughly 10 years, but did have a pleural-based nodule on his CT today as well which would need further work-up. Patient was extremely well-appearing without shortness of breath and pain-free on my evaluation, and has appropriate vital signs. The provider discussed admission with the patient for further work-up of this pleural-based nodule in addition to management of his small bilateral PEs, but the patient was adamant that he wanted to be discharged as opposed to admitted. Due to the patient living in facility, the provider thought it was reasonable to discharge him on rivaroxaban and have him follow-up as an outpatient for further work-up and management of his new PEs and this pleural nodule. His provider in the community reported this adverse event because the patient received second booster dose of COVID 19 vaccine 4 days prior to the event. The provider was unsure if COVID 19 vaccine caused this but would like to report just in case.
Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Additional Details: pt passed out immediately after vaccination briefly, when she regained consciousness she convulsed for about 2 seconds, heart rate at 58, with weak pulse, called 911, pt taken to er as a precaution
Had upper respiratory infection with sore throat and ear ache. Took over the counter cough syrup and doctor prescribed azithromycin.
Herpes infection; Sore arm; General joint pain; The day after he received his first dose of the covid vaccine, he got a herpes re infection; herpes infection flared up again big; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of bt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that whenever he received the first dose of the COVID vaccine, he had a herpes infection at the time. The herpes infection was healing up. The day after he received his first dose of the COVID vaccine, he got a herpes re infection. The patient had other COVID vaccine symptoms. He had a sore arm and general joint pain. His herpes infection flared up again big. He asked if that was a documented side effect and if he could take his herpes medication. He also asked if his herpes medication was contraindicated with the COVID vaccine. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient complained of redness and swelling as well as pain at injection site which began and got worse.
body aches; fever; fatigue; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body aches"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FATIGUE (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to patients of unknown age. The patients medical history was not reported. On an unknown date the patients were vaccinated with PROQUAD which were improperly stored. No adverse effect was reported. The outcome of improperly stored PROQUD administered was unknown. This case is linked to case # 1406USA013610 (same reporter link). Additional information has been requested.
heart racing event up to 130 bpm; Inappropriate schedule of vaccination as dose 1 took on 21may2021 and dose 2 took on 30May2021 outside the  window period; This is a spontaneous report from a contactable healthcare professional, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 30May2021 at 11:45 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease(GERD), irritable bowel syndrome(lbs). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), ranitidine hydrochloride (ZANTAC), mefenamic acid (ADVIL), probiotic and womens vitamins; all from an unknown date and for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 21May2021 at 11:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. On 18Jun2021, 3 weeks after her second vaccine she had a heart racing event up to 130 bpm. She went to general provider and had ekg. At that time she was at 120bpm. Since this time she had the same symptoms off and on and cannot exercise or exert herself without inducing more heart racing. She was  scheduled to see a cardiologist in the near future. It took her a long time to convince herself to get this vaccine and now she was regretting it. The event resulted in doctor or other healthcare professional office/clinic visit. On an unknown date, the patient underwent EKG and the result was 120 bpm. On 18Jun2021, the patient checked heart rate and the result was 130 bpm. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heart racing event up to 130 bpm, she went to general provider and had ekg, at that time she was at 120bpm, since this time she had the same symptoms off and on and cannot exercise or exert herself without inducing more heart racing was not resolved at the time of this report.
Skin rash including hives, itching, and what appears to be histamine sensitive skin.
This spontaneous report as received from a healthcare worker via field representative refers to a male patient of unknown age. Patient's concurrent conditions and relevant medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. On an unknown date the patient experienced shingles post vaccination. The reporter stated that the patient was not vaccinated at the physician's office where the healthcare worker works. The outcome of shingles was unknown. The causality of the event with zoster vaccine live was not reported. Product quality issue was not involved. This case is linked to # 1502USA012238 via same reporter link. Additional information has been requested.
Patient received expired Dtap, no treatment was needed, patient did not experience any adverse signs or symptoms.
ADMINISTERING MORE THAN PRESCRIBED/DRUG OVERDOSE; NOSE DRIPPAGE OUT OF NOSTRIL THAT RECEIVED FULL DOSE; FULL DOSE ADMINISTERED IN ONE NOSTRIL; NOT FOLLOWING IFU; ADMINISTERED ANOTHER HALF DOSE INTO THE OTHER NOSTRIL; A spontaneous report has been received from a pharmacist. The report concerns a male patient (age 18 years).    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) (batch number MH2024) 0.2 ml once/single administration, via nasal route, for vaccine for influenza on 03-OCT-2020.     The report described a medication error for Flumist Quadrivalent. The reported term was "full dose administered in one nostril" (Preferred term: Product administration error). The reported term was "not following ifu" (Preferred term: Wrong technique in product usage process). The report described an overdose for Flumist Quadrivalent. The reported term was "administering more than prescribed/drug overdose" (Preferred term: Overdose) and administered another half dose into the other nostril (Preferred term: Intentional product misuse).    On 03-OCT-2020, the patient experienced nose drippage out of nostril that received full dose (preferred term: Rhinorrhoea).     The outcome of the event(s) of administering more than prescribed/drug overdose, nose drippage out of nostril that received full dose, full dose administered in one nostril, not following ifu and administered another half dose into the other nostril was unknown.     The events were considered non-serious.     The reporter considered the following event(s) related to treatment with Flumist Quadrivalent (influenza virus vaccine live, intranasal): not following ifu.    Summary of follow-up information received by AstraZeneca/MedImmune 13-Oct-2020 received from Pharmacist via spontaneous: Reporter causality added for event not following IFU. Lot number updated for suspect FluMist. Start date of vaccine FluMist updated to 03-Oct-2020 from 04-Oct-2020. Event onset date updated to 03-Oct-2020 for event not following IFU and event onset date 03-Oct-2020 updated for rest of events. Reporter case ID added. Reporter middle name and address updated for Pharmacist. The patient demographic details added. Form completed date updated as follow up. Narrative updated. Corrected report on 16-Oct-2020: Reporter type corrected to patient from patient assistance program for second reporter Valid null flavors added to Reporter 6 (Reference). Overdose ticked on product add info. Order of events and association corrected. Form completed by, Have you reported this adverse event previously (Vaccines only) and Relation to patient ticked for Pharmacist on reporter tab.    Minor corrrection on 19-Oct-2020: Null flavour added in reporter tab.
Stiff/sore neck, shoulder/upper arm aches (both left and right...right more than left, even though shot was in left).  Pain STILL exists today , 23 days later.  Tylenol  and Ibuprofin help some.
This spontaneous report was received from the patient's mother concerning to her 7 months female daughter. The patient had not concomitant medication, medical history or drug allergies. On an unknown date (reported as "a couple of days ago"), the patient was vaccinated for mistake with GARDASIL 9 intramuscularly (dose, lot number and expiration date were not reported) for prevention of HPV. At the time of the report, the patient seemed alright and there were no known occurring side effects. The patient did not received any treatment and an unspecified physician said "keep an eye on the patient" The patient did not see medical attention. A product quality complaint was not involved. Additional information has been requested.
10 days after the vaccine I got a 2 inch red circle on my left arm. There was a hard center and it was itchy. The lump seems to have subsided however the area still remains with a 2 inch red circle and sometimes itchy
Customer was to get the vaccine in the left arm. There was a malfunction with the needle/syringe when giving the patient the vaccine. The pharmacist prepared another syringe and administered the vaccine in the right arm. The patient said that her left arm was still painful. She said that the tissue felt "hard".
Local - hot red, swollen 3 times area mid upper arm to mid lower arm, painful times 1 week. Systemic - headache, other aches times 4 days.
Erythematic and warm rash to injection site measuring 10cm x 14cm. Mild tenderness on palpation
Initial information received on 23-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional (physician assistant/ patients mother) via other company (Pfizer) (Manufacturer Report Number: 2018314537) by phone. This case involves a 16 years old male patient who was vaccinated with a dose of TRUMENBA and BEXSERO instead of MENACTRA (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date (same visit). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unspecified date of Jul-2018, the patient developed a non-serious sinus infection (sinusitis) and double ear infection (ear infection) a couple of days following the vaccination. It was also a case of actual medication error due to wrong vaccine administered because patient was about to receive MENACTRA but was given TRUMENBA instead because they pulled the wrong one. It was reported that the reporter wants to known when should the patient get the second dose of BEXSERO, and should he wait until he gets his MENACTRA. No Lab data was reported. Final diagnosis was double ear infection, sinus infection, a TRUMENBA and a BEXSERO were both given at the same time, same visit and supposed to get MENACTRA but was given TRUMENBA instead because they pulled the wrong one. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for sinus infection and double ear infection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
I had a runny nose, low-grade fever for a couple days, sore throat and felt really bad for a couple days. I took a home COVID-19 test that came back positive, I took another 12 hours later waited another 12 hours when that one also came back positive, I called my doctor and had a telehealth visit. She discussed my symptoms; she prescribed the antiviral that I started to take immediately. I started to feel better within  fives after taking the medication. On day seven I slept all day, by day 10 I had some fatigue but I was feeling much better. I did test positive until the 16th day.
Within 6 hours of the shot my arm was still and sore,  by about 9:30 pm nausea started and from my shoulder to elbow hurt and I couldn't lift my arm at all without significant pain. Between 9:30 and 10:00pm I very quickly became severely nauseous, slightly dizzy, shivering and not able to get warm but having a sudden fever of 103°, and my heart rate sitting down wouldn't go below 135. All events except for the nausea came on very suddenly, from starting to feel it to full effects hitting it was 20 minutes max. I am just now able to move my arm normally, 2 days later, and the other symptoms subsided by 9:30 pm yesterday (day after the shot).
Left deltoid-edema+erythema from entire deltoid region: pt complained of arm pain. Afebrile, no systemic symptoms.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective with Paxlovid from 29Aug2022 to 03Sep2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2:30pm - complained about stomach pain, tightness in chest. 3:30-4pm - hives. 4:30pm - passed out, called 911, went to hospital. EPIPEN given at hospital.
Redness and excessive swelling in injected arm from shoulder to elbow, hot and painful to touch, last 3-4 days before resolution.
5-10 minutes after the vaccination, I experienced tingling and numbness in my tongue. Very similar to the feeling when you go to the dentist and he uses the numbing agent before procedures. Comparing to the dentist, my adverse reaction is not as severe, 10 being a whole injection of numbing agent to prevent sensation in the mouth, this is likely a 4/10 tingling/numbness feeling. It has persisted for 3 hours now, the intensity of the feeling has slowly decreased overtime, but I still notice it after 3 hrs.   My right arm where I get the injection is also a little sore, but that is expected and very similar to all the other vaccines I get.
nurse just administered the green vial with the Hib power that was reconstituted with a sterile water diluent from another vaccine and not the blue vial with no reported adverse event; Initial information received on 04-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old male patient whose nurse just administered the green vial with the hib power that was reconstituted with a sterile water diluent from another vaccine and not the blue vial with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination.  On 02-Feb-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot-UJ572AAA,11-Sep-2022) via intramuscular route in the right vastus lateralis for immunization.  On an unknown date the patient developed a non-serious event "nurse just administered the green vial with the hib power that was reconstituted with a sterile water diluent from another vaccine and not the blue vial with no reported adverse event" (product preparation error) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was reported "nurse just administered the green vial with the Hib power that was reconstituted with a sterile water diluent from another vaccine and not the blue vial. She would like to know how to proceed with the patient and if what they did receive would be considered a valid Hib dose".  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event nurse just administered the green vial with the hib power that was reconstituted with a sterile water diluent from another vaccine and not the blue vial with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Swelling and pain at the base of my neck at the shoulder on the left hand side. Same side the injection was on.
Body aches, very tired, which I think is very common effect for what hear  from others BUT I am experiencing  a tingling sensation in my head and face, and I could not sleep most of the night very uncomfortable feeling , I had to miss work because of this problem the only time I had experience that sensation is when I had  the Shingles  about 10 years ago
Mild symptoms of fatigue, sore throat and low grade fever of 99F started the evening of 8/22/2021.  Tested positive for COVID-19 on 8/23/2021.  Symptoms included Severe arthralgia, fever 102F, cough, congestion.  Treated with Regeneron antibodies on 8/24.  CXR on 8/24  showed early pneumonia and also treated with  steroids and inhaler.