chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ARM STILL HURTS OFF AND ON; This spontaneous report received from a patient via social media concerned a patient of unspecified age, sex, race and ethic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an Unspecified date the patient was previously treated with covid-19 vaccine ad26. cov2.s from unspecified manufacturer (Dose Number in Series: 1) for prophylactic vaccination and did not report any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, (dose number in series was 2), 1 total administered on OCT-2021 for prophylactic vaccination as a booster. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced arm still hurts off and on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm still hurts off and on. This report was non-serious.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 03/19/21 and 4/16/21. Covid + 1/28/22. Presented to ED c/o SOB worsening x2 days. Recently admitted at medical center from 01/01/2022 to 01/05/2022 for acute on chronic resp failure with hypoxia 2/2 COPD exacerbation and CHF. Covid+ 1/18/22, treated at outside facility until 1/21. Admitted 1/27 for acute hypoxic resp failure 2/2 Covid PNA c/b  tachypnea and hypoxia. Started on non-rebreather. CXR showed bilateral pleural effusions, small on the L and trace on the R.  Tx'd with dexamethasone, torsemide. Respiratory status continued to decline throughout stay. Pt. requested comfort care/DNAR. Expired 2/15/22.
Information has been received from a registered nurse concerning a 5-year-old male with no known allergies or medical history who on 09-MAY-2001 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 12-MAR-2006 the patient developed 20 vesicular lesions and fever. Unspecified medical attention was sought and no treatment was required. At the time of the report the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
Within 5 minutes of recieving the Gardasil vaccine, my daughter had a seizure in the car leaving the parking lot of the doctors office.  She complained of a stomach ache and a headache just before the seizure began.  It lasted only a few minutes.  I took her immediately back into the office, where Dr had a nurse check her blood pressure, and gave her some water and sent us home.
One week post vaccination there was a small amount of erythema developed, centered at the vaccination site. This disappeared after several days. Then a large rash appeared on the left arm around the vaccination site 12 days post vaccination. It spread downward toward the elbow over several days, covering the majority of the bicep, but the rash resolved with repeated administration of hydrocortisone 1% cream and PO diphenhydramine.
petechial rash covering both arms on hand on inj site;did a platelet count before & rt after the shot & was down significantly;
No additional adverse effects; one patient received one dose of improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not provided.  On 08-MAY-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), lot # S002924, expiration date 28-JUL-2020, 1 dosage form, subcutaneously (exact dose was not reported) for prophylaxis. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted in a properly stored sterile diluent. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced a temperature excursion of 5.7 Fahrenheit (F), a previous temperature excursion of -13.3 degrees Celsius (C) for 18 minutes, and another excursion of 13.2 C for 18 minutes. The digital data logger was involved to capture the temperature excursion. No additional adverse effects were reported.
immediate intense dryness of the tongue. Given water. felt a little better. left and had some swelling of my tongue on my way home.  I took Benedryl , which took care of the situation. I did not contact the pharmacy or any medical provider. I took another Benedryl,  6 hours later as a safety measure, although my tongue felt ok.  I will not get another Bivalent shot. I felt a need to submit this report due to the fact the combined vaccine projected to be used,  I saw on the news will contain the Bivalent vaccine and the flu shot. I want you to know that for some of us,    the original covid vaccine is a better option.
Reporter claims pt died from pertussis vax; pt went through hell & never had a chance @ life;
HIGH BLOOD PRESSURE; HEAD AND NASAL CONGESTION; LOSS SENSE OF TASTE; SOFT STOOLS; BACK AND SIDES ARE HURTING; GOING TO THE BATHROOM 4-5 TIMES PER DAY; SOMETIMES NO STOOL; ACID BUILDUP; FELT WEAK OCCASIONALLY; PHELGM BUILDING UP IN THE LUNGS; This spontaneous report received from a patient concerned a 63 year old  female. The patient's height, and weight were not reported. The patient's concurrent conditions included hyperacidity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 23-JUN-2021) dose was not reported, 1 total administered on 09-APR-2021 on right arm for prophylactic vaccination. Concomitant medications included calcium carbonate for acid buildup. It was reported that on 09-APR-2021 evening, the patient started to feel some lightheadedness and congestion. She noted that the lightheadedness happened here and there. She had head and nasal congestion and had snot coming out the nose. She felt like her head was about to explode. There was sort of a snap, crackle, and pop in the head. Her back and sides were hurting. She was going to the bathroom 4-5 times per day, sometimes with no stool, and other times with soft stool.She noted some phlegm building up in the lungs. Coughing was noticeable. She also felt weak occasionally. She had a loss sense of taste. She also had acid buildup and took Tums occasionally but did not take on 13-APR-2021. She had noted high blood pressure and heart rate, but they had gone down due to blood pressure medicine. She had exercised in an attempt to reduce her symptoms. She did not had a healthcare professional. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high blood pressure, had not recovered from head and nasal congestion, weakness, loss sense of taste, going to the bathroom 4-5 times per day, and acid buildup, and the outcome of soft stools, back and sides are hurting, sometimes no stool and phelgm building up in the lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210423813- Covid-19 vaccine ad26.cov2.s-Phelgm building up in lungs. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Dizziness, nausea, hyperglycemia (see below) despite reduced PO solid food intake and increased PO water intake.  A1c 4 months prior 6.8%, home self monitored blood sugar readings of 322 in the AM after 12 hours of fasting, with reduction in PO solid food intake and increased PO water intake patient's blood sugar in the late afternoon reduces to 150's however her dizziness and nausea continue.
Pt. developed intense pain, swelling, redness and induration in the Rt. upper arm involving an area of 6 inches x 6 inches over next 4 days.
Tested Covid positive through at least the first two months of the rash; Tested Covid positive through at least the first two months of the rash; About 2weeks after the mild first symptoms passed I broke out in an all body red, itchy rash; About 2weeks after the mild first symptoms passed I broke out in an all body red, itchy rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Sep2022 at 13:00 as dose 1, single (Lot number: GM9694) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). There were no concomitant medications. No other vaccine in four weeks were reported. No Known allergies were reported.  The following information was reported: RASH ERYTHEMATOUS (non-serious), RASH PRURITIC (non-serious) all with onset 21Sep2022, outcome "recovered" and all described as "About 2weeks after the mild first symptoms passed I broke out in an all body red, itchy rash"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Sep2022, outcome "recovered" and all described as "Tested Covid positive through at least the first two months of the rash". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Therapeutic measures were taken as a result of rash erythematous, rash pruritic.  Clinical course: About 2weeks after the mild first symptoms passed the patient broke out in an all body red, itchy rash which lasted 3 months. She treated it with aloe and skin cream moisteners. She tested Covid positive through at least the first two months of the rash. No one else that she knew of got this rash.
Patient stated they had arm pain the day of the injection.  The pain continued to last and the patient went to the doctor's office today complaining of the pain and shoulder/joint pain.
Information had been received on 01-MAY-2017 from a pharmacist who reported that a 73 year old female received properly stored ZOSTAVAX vial 19400 PFU (lot#/expiration, dosage and frequency not reported) reconstituted with properly stored sterile diluent (lot#/expiration unknown) on 27-APR-2017. Patient sought medical attention and presented at pharmacy on 01-MAY-2017 with a blister at the injection site and complained that the injection site is "itchy". Patient's present status was not recovered. VZV packet not faxed to pharmacy as no fax number was available for the pharmacy. Pharmacist disconnected before most questions asked therefore most fields were reported as not applicable. No further information provided. Additional information has been requested.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; Poor quality vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant medicine were reported. No treatment medicine were reported. This case was for 23rd out of 100 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:MASTER  CASE
Approx 2 mos post vax, devel skin rash, swollen joints, flu-like feeling. Upon traveling to France, she was admitted to hosp and released same day.
Grade 2 injection site pain; Grade 1 injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Grade 2 injection site pain) and VACCINATION SITE SWELLING (Grade 1 injection site swelling) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (Grade 2 injection site pain) and VACCINATION SITE SWELLING (Grade 1 injection site swelling). On 09-Jan-2021, VACCINATION SITE PAIN (Grade 2 injection site pain) and VACCINATION SITE SWELLING (Grade 1 injection site swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment details was not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient was given a 3rd dose of Pfizer-COVID-19 Monovalent when should have received Bivalent. Writer was unaware of recent CDC/Clinic policy change, clinic also did not have Bivalent supplied.
ACUTE NON ST ELEVATION MI 10/16/2021  --  RECURRENCE OF SAME SYMPTOMS
Fever began 4 hrs after vaccine to 102 degrees F. Approx 10 hrs after vaccine admin. pt with fever to >103 degrees F, as well as (L) eye deviation, decreased responsiveness, decreased tone and lethargy. Pt evaluated in ER for probable febrile seizure and post-ictal state.
Vaccine received on 12/30/20, reaction reported on 01/11/2021 to left upper arm swollen, red, warm to touch area has gotten larger over the past 2 days.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 83-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Fever 102.2, chills, body aches, bone ache, headache. Fast heartbeat, pulse 110, high blood pressure 152/84 sore arm at the injection site, dizziness, loss of appetite, these symptoms lasted all day. Next day, sweating, body temp was 99.8, headache, body aches, sore arm, blood pressure was 127/80 pulse 94. Blood sugar remain constant at 194 both days.
tender, swollen left arm, feels feverish. Can't use her arm much. Patient states she is feeling better now.
EAR BLEED; BLOOD IN SEMEN; NOSE BLEED WITH CLOT; CHEST PRESSURE; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, 1 total, administered on 16-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced chest pressure. On 23-MAR-2021, the subject experienced nose bleed with clot, ear bleeding and blood in semen within first week after the vaccine, blood in semen lasted around a week that reduced gradually and resolved. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nose bleed with clot on 11-APR-2021, ear bleed on 26-MAR-2021, and blood in semen on 02-APR-2021, and had not recovered from chest pressure. This report was non-serious.
11/21/2021. I noticed my skin started itching and I had psoriasis come up out of the blue. No stress related issues. Went back to dermatologist last month, and he looked at the new psoriasis on my body. He had prescribed medication to use on my head. The treatment plan was to use medication on my body every day, if that doesn't work, we would try the injectable. Psoriasis covers 20% of my body.
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 52 years old male patient who was vaccinated with 0.5 ml FLUBLOK QIV (batch number: QFAA1815, expiration date 30-Jun-2019, and site of administration was not reported) via intramuscular route, on 06-Nov-2018, which was kept at 52 degrees for 27 hours. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. It was unknown whether the patient had any 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 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. List of documents held by sender: none.
itchy upper torso-benadryl extreme fatigue-rest GI-nausea
Rec'd #5 HepB vaccine at 11am 6/13/07 in right deltoid and at 6:15pm that night had sudden onset of neck pain/stiffness, mid upper back pain and right arm pain. No fever. Brought through Fast Track/ER and evaluated by Dr.  who concurred that this was indeed a vaccine reaction. Patient then remembered having a stiff neck after #4, not as severe, but had not connected it to the vaccine at the time.
Mom states pt started w/fever on 22NOV91 & continued to rise; Was taken to ER on 22NOV91 @ 3AM; fever was 105 @ ER; was told poss rxn from DTP also states pt has a sl cold also;
I got sick after the vaccine which was normal to my understanding and since then I?ve had constant headaches after as little as 5 minutes  after I wake up to when I go to sleep. I had asthma before I took the vaccine and I had started making huge progress in recovery and after the vaccine my cough got a lot worse. I also began feeling this stinging feeling in my nose which is quite painful. It feels like someone?s shoving something up my nose. I sometimes even feel like I can?t get out of bed.
Possible administration of Moderna COVID-19 vaccine after the 30 day beyond use date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible administration of Moderna COVID-19 vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible administration of Moderna COVID-19 vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible administration of Moderna COVID-19 vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible administration of Moderna COVID-19 vaccine after the 30 day beyond use date).    Concomitant medications details were not reported by the reporter.  Reportedly, reporter liked to know if the Moderna primary series with a use by date of 10-Feb-2023 would still be viable if the vial was stored in the refrigerator unopened and was opened on 10-Feb-2023. There was a possible administration of Moderna COVID-19 vaccine after the 30 day beyond use date.  Treatment details were not reported by the reporter.