chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash,raised, warm.-- oblong -2 inch in width, 6-7 inches length.  below injection site. enlarging over past 48 hours. slight pain.
Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016389690) on 23-Aug-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Fluzone (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient developed asthma (allergy to Fluzone). Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
pt states her left arm  was itchy on 1/29 but when she woke up on 1/30 her arm was itchy, red and blotchy.  She took antihistamine pill and  put hydrocortisone  cream on her arm.  Pt has tried to reach her PCP but not able to get in touch with them.  She will try to call them again.
Patient received a dose of vaccine that may be less than completely effective because of storage conditions.   No adverse effect noted.
At 1132, Pfizer was administered. RRT called at 1138 in the post-vaccine Recovery area for a 66 y/o female that complains of upper chest tightness and temporal tightness, pain 3/10, non-radiating. 4 RNs responded to the scene. Head-to-toe assessment completed. She reports allergies to sulfa. She took multiple morning medications today, all regularly taken. Hx of stents, HTN, HLD, DM, WPW, irregular HR. Initial vitals: HR: 125, BP: 126/80, RR: 19, O2 98% on RA. Denies nausea and SOB. At 1148, she reported that her pain was subsiding. Given medical hx, RRT activated 911 response, called by Site Manager. At this point, client calm, AA0x4, skin WNL, resp WNL. 1201 EMS arrived and report was given to them. Client taken into ambulance for EKG. ALS response provided. Nitro and ASA given. EKG revealed A-fib, HR 120, O2 96%. Client to be taken to Hospital via ambulance, truck number 490. EMS assumed care at 1214. Husband that was with client was told of plan.
Patient started experiencing shoulder pain 12 hours after getting vaccine. She think the vaccine may have been administered too high. She also has a lump on her shoulder
2-3cm erythematous area, warm to touch, given Bbactroban ointment.
Left arm local erythema, subjective low grade fever.  Treatment Ibuprofen, fluid watch 1-2 more days. Ok otherwise.
Pfizer Covid-19 vaccine administered on 04/06/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and a repeat dose is recommended.
DVT and pulmonary Embolus. Other risk factors exist (recent surgery, OCP, immobilization (driving and work).  Second Vaccine in series given on 05/18/2021
2.5 inch diameter redness, swelling, little pain appeared 1-2 days after receiving Anthrax vaccine.
39 y/o female with past medical history of Anxiety, HTN, Anemia, Asthma, Hypercholesteremia who presents with dizziness and palpitations post vaccination. Patient states that this is her second vaccination in the two-dose series. Patient denies previous vaccination reaction. Patient discloses now that she had an anaphylactic reaction to anesthesia in the past but did not disclose to registration and/or nursing staff prior to any of her vaccination. Patient placed  and monitored by the NP and paramedics. Patient initial vitals showed that patient hypertensive, 206/112 BP, 89 HR, 99% RA and 16 Resp. EKG was obtained and showed NSR. Glucose 108. Patient states that she did not take her blood pressure medication today and that she only takes it if she feels that it is elevated. Patient is prescribed Losartan and Ferritin. Patient denies sore throat, difficulty swallowing, chest pain, nausea, itch or rash. Patient describes her symptoms as a ?Panic Attack? which she suffers from. Patient requested emesis bag to breath but became dizzy post. Patient placed on NRB at 15L O2 due to nasal cannula not available at this time. Patient monitored for over 30 mins with resolution of symptoms. BP normalized at 137/76. Patient was weaned off O2 and sats remained normal, 99% RA. Patient HR 78 prior to discharge. Patient again denies chest pain and/or palpitations prior to discharge home. Patient aware that if symptoms return or worse to please seek medical attention at an Urgent Care or ER. Patient cleared home in stable condition.
Chronic spontaneous urticaria; pruritic eruption papules; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC SPONTANEOUS URTICARIA (Chronic spontaneous urticaria) and RASH PAPULAR (pruritic eruption papules) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHRONIC SPONTANEOUS URTICARIA (Chronic spontaneous urticaria) and RASH PAPULAR (pruritic eruption papules). The patient was treated with OMALIZUMAB at an unspecified dose and frequency. At the time of the report, CHRONIC SPONTANEOUS URTICARIA (Chronic spontaneous urticaria) and RASH PAPULAR (pruritic eruption papules) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Rash around eyes (side of eyes, on eye lids and under the eyes), stiffness on left arm with the injection site and achiness  started on the left side  the next day and traveled down the leg and on the right side by the second day after the shot.  Achiness went away by the evening but headache started on the left temple and moved over to the right by the 3rd day.    All but the rash were also experienced with the second Pfeizer shot.  The first shot had the mildest reactions and included the stiffness and achiness but possibly not the headaches.    Still have the rash as of today, Oct 30, 2021.
Strong cramping, continuously from the ankle to the top of the legs, back sides only.  This went on for more than four days and nights, when it became less severe.  During this time, sleep was difficult and the legs felt weak at times.  Tingling and numbness in both feet, particularly toes.  The tingling and numbness in the feet is still ongoing, though less severe.  Tingling and numbness in fingers on both hands, appearing and disappearing sporadically.  The right hand has become purplish in color at times.  It is still manifesting sporidically.
After the second Pfizer vaccine, my tinnitus increased dramatically within a couple weeks. It has made hearing challenging. It doesn't seem to go away and hasn't decreased in intensity since onset in mid April 2021.
Chills, fever (101), swollen arm, nausea, blurred vision, ringing in ears; seen at urgent care evening of 10/15 diagnosed as adverse reaction to Bexsero, treated with antinausea medication.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Pfizer product on 03/05/2021 and 03/26/2021. They tested positive for COVID-19 on 11/23/2021.  A surviving family member reported this individual had a symptom onset of approx 11/24/2021. They were admitted to hospital on 11/23/2021 with cough, shortness of breath, fever, nausea, diarrhea, and respiratory failure. The decision was made to put the individual on palliative care, and transition to comfort care only. They remained hospitalized until their death on 12/02/2021.   This individual had significant medical history of COPD, lung cancer, and a past pulmonary embolism. The individual's last infusion of Keytruda was approx 11/04/2021. The individual had made the decision to discontinue chemotherapy for the lung cancer on 11/23/2021, which is the same day they were admitted to hospital for shortness of breath.
Vaccine leaked from hub during administration and ran down patient's arm.  A second dose was drawn and given.  Patient said she felt the vaccine and needle the second time.  The first time she felt the jab, but nothing else.  Patient waited the appropriate time after injection without incident and went home.
no other adverse events; vaccine that was expired and administered to a patient; Proquad had 1 prior temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 08-OCT-2020, the patient was vaccinated with an improperly stored and expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin(rHa)) (PROQUAD) 0.5 ml, lot # S009760 was confirmed to be valid, expiration date 27-SEP-2020 (route of administration and anatomical location were not reported) for prophylaxis. On 13-APR-2020, administered dose of vaccine experienced temperature excursion. The product reached temperature 39.9 degrees Fahrenheit for 9 hours.  The reporter confirmed there was no other adverse events.
1 1/2hr p/vax pt vomited & had fever of 101.2, cried & screamed for an hr, was seen in ER given med per ER MD;resp 40;
Patient developed hives the day after the vaccine then took a zytec and they went away. Patient states its not abnormal for him to get hives Narrative:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 15-OCT-2006, the patient was inoculated with ZOSTAVAX, administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-JAN-2016, the patient was treated by a physician for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as shingles. She was prescribed VALTREX, TYLENOL 3, and methylprednisolone (reported as MEDROL PAC) for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
The same day I received the vaccine beginning at 3:45 pm I felt a dull ache at the site of injection. At 4 pm I took two Tylenol and continued with my evening. By 5:30 pm I had an entire body ache and stiffness. By 9  pm I was running a mild fever and had body mild body aches. The following morning (03/13/21) at 7 am I was experiencing extreme fatigue, body aches and a temperature. I again took two Tylenol and continued with my day. My activities that day were limited due to my symptoms. It continued throughout the day and by 6:30 pm I was running a high temperature, chills, all over body ache, and a intense headache. I continued with two Tylenol every 4-6 hours. Sunday morning (03/14/21) my fever was gone but I am still experiencing body ache and headache. Two Tylenol as needed throughout the day.
Tinnitus in the right ear; First dose Janssen covid-19 vaccine/second dose bnt162b2; First dose Janssen covid-19 vaccine/second dose bnt162b2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jan2022 12:45 (Lot number: FJ1614) at the age of 21 years as dose 2 (initial pfizer dose), single for covid-19 immunisation. Relevant medical history included: "suspected shell fish allergy" (unspecified if ongoing); "suspected gluten allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Janssen covid-19 vaccine (DOSE 1,SINGLE, Lot number: 1805031, Administration time: 10:00 AM , Administration location: Left arm), administration date: 22May2021, when the patient was 21 years old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 31Jan2022 12:45, outcome "unknown" and all described as "First dose Janssen covid-19 vaccine/second dose bnt162b2"; TINNITUS (non-serious) with onset 01Feb2022 10:00, outcome "unknown", described as "Tinnitus in the right ear". It was unknown if therapeutic measures were taken as a result of tinnitus.  Additional information:  The facility type vaccine was pharmacy or drug store. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. There were no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergy, had suspected shellfish and gluten allergy.  No follow-up attempts are needed. No further information is expected.
about 30 after vaccine, patient starts to feel  weakness on his legs, dizzy and when turn had side to side, pt noticed delayed reaction (delayed fuison)
Painless left eye optic nueritis on 3/11/21 noticed, went to optometrist, referred to Opthamologist saw at 11 am 3/12/21, visual fields, eye exam, verified swelling in left optic nerve. sent to ED for stroke workup. MRI Brain, CTA Head, stroke protocol and various lab tests. No findings to indicate stroke, assigned to Nuerologist admit for further acute retinal artery ischemia workup. IV Steroids (methylprednisolone) for 2 days, discharged and recieved 1 day OP IV steroids, followed by 14 days oral predisone, followup with Dr. (and primary Dr.); no known diagnosis by hospital nuerologist or Dr., Refered to a Nuero/Opthamologist  Dr. in state on 4/30/2021. Full optical workup, visual fields, photographs and lab script for MOG antibody test. MOG antibody test 5/7/21 Negative.  Swelling of Optic Nerve is gone, additional Visual Field loss in left eye. Only have bottom outside quadrant of vision after this episode, .
This spontaneous report as received from a certified medical assistant refers to an unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patients were vaccinated with improperly stored COMVAX, (strength, lot #, dose and frequency were not reported). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. There was no additional information to report. This is one of several reports received from the same reporter. Additional information has been requested.
Fever 100 degrees F, body aches, chills starting ~10 hours after injection, ending ~36 hours after injection.
pt verbally attest to needing pfizer booster and showed on phone vaccine history and dates to technician.  dose 1 :3/10/21, dose 2 : 4/7/21.  Pharmacist verified with patient that pfizer was being administered and asked pt to bring physical card next day to fill out for pt since they only had a digital image available. Later in day when billing insurance and get rejection, saying different manufacturer.  After checking state registery discovered pt had moderna dose 1 and 2 and was not due for a booster.  Pharmacist attempt to call pt to discuss and had to leave a voicemail
Sharp stabbing pains in right rib then left.; Shortness of breathe; cough; eyes swelled shut; This is a spontaneous report from a contactable nurse. This 55-year-old female nurse reported for herself and received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL 3246; Expiration date was not reported) on 30Dec2020 08:45 (at the age of 55-years) as single dose, Intramuscular in left arm for COVID-19 immunisation. Medical history included allergy to hydroxychloroquine sulfate (PLAQUENIL), patient experienced sleep disorder, migraine, and lupus. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19.  Concomitant medications include pregabalin (PREGABALIN), amitriptyline (AMITRIPTYLINE) for sleep, solifenacin succinate (SOLIFENACIN SUCCINATE), leflunomide (LEFLUNOMIDE), omeprazole (PROTONIX), ondansetron (ZOFRAN), mirabegron (MYRBETRIQ), azathioprine (AZATHIOPRINE), and sumatriptan succinate (SUMATRIPTAN SUCCINATE) for migraine. Since the vaccination, the patient has not tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 31Dec2020 at 17:15, the patient experienced sharp stabbing pains in right rib then left. Shortness of breathe, cough, and eyes swelled shut.  The patient did received treatment as a result of the event with benadryl, aderol inhaler.  The outcome of event eyes swelled shut was recovering, Shortness of breathe was recovering, cough was recovering, and sharp stabbing pains in right rib then left was recovering.
Cerebral venous sinus thrombosis; This is a spontaneous report from a contactable consumer, the patient. This 69-year-old male patient the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318; Expiration Date: 31May2021), via an unspecified route of administration in the left arm on an unspecified date as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On 08Mar2021, the patient experienced cerebral venous sinus thrombosis and treated with PRADAXA. The patient underwent multiple "over 100" unspecified lab tests in the hospital with unknown results. The patient was hospitalized for cerebral venous sinus thrombosis from 26Mar2021 to 28Mar2021. The clinical outcome of cerebral venous sinus thrombosis was improved/resolving.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe
J18.9 - Pneumonia, unspecified organism D69.6 - Thrombocytopenia, unspecified R56.9 - Unspecified convulsions
Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer for herslf.  A 57-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EL1284) vaccine , intramuscular in the right arm  on 30Dec2020 10:30 at single dose for Covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.   Since 03Jan2021, the patient has been sick.  Her fever started out at 99.7 degrees Fahrenheit with a terrible cough and then it just kept getting worse. This weekend it was 102.7 degrees Fahrenheit all weekend. Her cough improved. She took some Delsyn one day. The cough improved but is not gone away.  Headaches started on day 4 or 5. Lot of pressure in forehead and eyes. Fever kept going up day after day been up to 101.2°F and then up 102.7°F all weekend. Then she just felt weak all weekend. Just walking to bathroom is short of . Yesterday fever was 101.5°F and she went to doctor and they did a rapid COVID test and it came back positive. Slept a lot more this weekend. Done nothing but slept. She did not think it would make her this sick. only vomited once. she is supposed to get second dose on Saturday. She is  afraid to get second. The patient also reported the following information: Fever 08:30 Terrible Cough 08:30 Headache 10:00 Weakness 12:00 Shortness of breath when walking 12:00 Increased sleepiness 12:00 Positive for Covid 09:21 Diarrhea 08:00 Vomiting 14:00  The patient underwent lab tests and procedures which included body temperature: 99.7 Fahrenheit; 102.7 Fahrenheit;  101.2 Fahrenheit  then up 102.7 Fahrenheit ; 101.5 Fahrenheit.  Sars-cov-2 test: positive   on 11Jan2021  .  Further information has been requested
soreness and pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness and pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (soreness and pain). At the time of the report, PAIN (soreness and pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was reported.
Period was supposed to come that next day and it has been postponed and still has not come; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0169 and expiration date: 31Oct2021), dose 1 via an unspecified route of administration on 27Apr2021 (age at vaccination: 44-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the first dose of vaccine about 3 weeks and was supposed to get the second dose of the Pfizer COVID 19 vaccine tomorrow. The patient stated the problem was when she got the first dose her period was supposed to come that next day and it had been postponed and still had not come. The patient thought it was related to the vaccine and wonders, for this situation if she should still get the second vaccine. The patient wants to know if this was normal for women after getting the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sick after 1st dose; Did not get the 2nd dose within day 25-35; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (Sick after 1st dose) and PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose within day 25-35) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick after 1st dose) and PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose within day 25-35). At the time of the report, ILLNESS (Sick after 1st dose) and PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose within day 25-35) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No treatment information was reported.
Starting Wednesday January 13th I had severe lower leg cramps continued to upper leg lower back shoulders and arms through Thursday the 14. Then beginning Friday January 15th I had nasal congestion and all over body aches. Now as of Monday January 18th I have developed a circular rash with an outer diameter redness ring. I sent a photo to health clinic  of my arm and they have sent me this vaers report to fill out. I still have a bruise from my shot and I have tested positive now for covid19 as of Saturday January 16th 2021. Thank you I am in contact with my MD and my work has been notified as well.
Rash on legs, knees & forearms.  Used BENADRYL gel.