chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 at 11:00 as dose 1, single (Lot number: EH9899), in right arm, on 07Jan2021 at 16:00 as dose 2, single (Lot number: EH9899), in right arm and on 30Sep2021 at 17:00 as dose 3 (booster), single (Lot number: FE3592) at the age of 57 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTRADIOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Negative, notes: Tested negative on 25May; (27May2022) Positive, notes: Tested positive again on 27May. Therapeutic measures were taken as a result of vaccination failure, covid-19.  clinical course: Felt much better on 24May. Tested negative on 25May. Started feeling sick again on 26May. Tested positive again on 27May.  Information from Product Complaint Team, provided from division agency includes conclusion of Investigation for lot# EH9899 and lot# FE3592 respectively.Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot# EH9899 and lot# FE3592 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot# EH9899 and lot# FE3592 , fill lot EH9783, FF2553, and the formulated drug product lot EH9782, FA9141 respectively. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 08-OCT-2015 the patient was vaccinated with improperly stored ZOSTAVAX (lot # L003216, expiration date 30-APR-2016, strength, dose and route were unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Within 30 min. of shot I noticed my eyes were extremely sensitive to sunlight. To the point I had to cover my face and look down at the ground, to get to my car. This has never been an issue for me. Today, 48 hours later,  I am seeing zig zag, blurry lines, in my right eye anytime I go in outside, in sunlight. This happened today, while I was driving, within minutes of going outside. Happens only in right eye. I had to immediately go into a store and buy sunglasses, wear them indoors, for 15 minutes before the blurry lines will disappear.
Day after shot I had normal body aches and fatigue. The next day the symptoms continued but also added intense lower back and hip pain. I could compare them to labor pains. I needed help getting off the couch and getting out of the bed. It last about 2 1/2 days then I called my PCP to ask if I could take a larger dose of Ibuprofen. I was taking 800mg. She advised I could go to the ER if I wanted. I did not go. It took me about 2 weeks before I was at baseline without discomfort.
Headache, body aches, fever, vomit and nausea, fatigue, sinus pressure. Treatment: extra strength tylenol, sleep, fluids (water/Gatorade)
UNEVALUABLE EVENT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. 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, the patient experienced unevaluable event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unevaluable event was not reported. This report was non-serious.
(there is limited documentation in the electronic health record since seen at an outside facility)  Patient reported that she had a miscarriage after vaccination.   Vaccinated on 5.21.21 (2nd dose)  Had office visit with outside organization provider - PCP on 5.21.21 - perhaps regarding irregular menstrual cycle.  I do not see mention of positive pregnancy in this visit.  Notes:  "Here to get referral to ob due to history of c-sect and trying to get preg and wouold like trial vbac c-sect due to anencephaly.  Now on folate.  Discussed pregnancy and prev pregnancies.  Ref to ob"  There appears to be a call reporting Vaginal bleeding in pregnancy, first trimester - on 6.1.21 to MD.  No notes in chart.
Patient called on 4/10/2021 to make aware that she had her vaccine on wednesday (4/7/21) and symptoms have continued. Patient states that Thursday (day after shot) she experienced diarrhea, weakness and muscle aches. The patient states that she has not developed a fever. Thursday she was in bed all day with "flu-like symptoms" and Friday she was weak and only able to shower and go back to bed. Today (4.10.20) she was able to go to work but she is lethargic and still having GI symptoms.
arm and legs ached, felt tired and weak, sore muscles. NO rash, NO swelling, NO itching.
he is covered in hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (COMIRNATY) (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 1), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "he is covered in hives".  Additional information: The patient received vaccination probably like about 4 O'clock at his primary care office.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had pain in my pelvic area and it got worse and worse over a month and I went to see doctor (normally, I'm healthy- I exercise and I am not obese). They did tests. I had a rare thing - Epiploc Appendagitis - and it's like a tumor on the outside of colon and it's in the Appendages that hang on the outside. It's benign. They gave antibiotics for the inflammation. The whole thing lasted about 2 months - the constant pain. It is still there but not it just flares up from time to time. It has been okay since September. The doctor said to treat with ibuprofen and not Tylenol. I might need antibiotic again if it's inflaming other things.
erythema and edema of arm, pruritis of left arm, extended to elbow, urticaria and pain of arm.
I  had a sore arm within 20 minutes - red and swollen and hot. And then about 12 hours later, I had a fever - 102.7 and chills and achiness. It felt like I was hit by a dump truck. Worse achiness I have felt in my life. Terrible terrible headache - I felt like I could feel every hair on my head.  I took Tylenol for Fever and it broke and I had night sweats for the rest of night - I have never sweated like that before - wet in neck, head, back - on bed. I  had fever the next day. I had to work with the fever and the pain - (I'm a nurse). I slept for two days after that -Saturday night the  fever came back - 102.4  and had bone achiness and when the fever broke I had the bad night sweats again.  I slept all day Sunday. Monday, the swelling came back  - hands,  lower legs and on my face and the hair loss came back. The fever was gone but the night sweats lasted for about a week (with no fever.)  I am still having some of the hair loss but the worst of it was for those initial 2-3 weeks. The swelling in my hands/face etc lasted about 2 weeks. Two weeks after vaccine, I lost my sense of taste - I can taste some things but not other things. Bone aches from fibromyalgia is still bad. I am still experiencing severe fatigue and I have an issue with short-term memory now. I noticed my memory stuff around the beginning of February - Dr. prescribed Strattera but that isn't helping but it did help with my short attention span issues that I had prior to vaccine. On March 5, I had a fever again and that went up to 103 at midnight and I took Tylenol had chills and achiness and the night sweats - sopped and wet. Tired the next day and felt yucky and achy. The following Friday, March 12, the same thing happened that night around midnight. That time, I didn't get out of bed to take Tylenol but took it the next morning when I woke up - and I was really tired that Saturday and didn't feel well. Last Friday, I took Tylenol before I went to bed and I was fine. I am still a little swollen and I'm still taking the Lasix.
Arm became sore, red,  very itchy approximately 2 weeks after first dose of vaccine.  .
A non-serious spontaneous report of administration of expired vaccine has been received from a registered nurse concerning a 38-year old female. On 03-Feb-2010, the patient received FLUMIST that expired on 02-Feb-2010. The patient was instructed to call or follow-up with the reporter if she had any symptoms/adverse events after receiving FLUMIST. As of 11-May-2010, she did not report any adverse events. There were no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. On 11-May-2010, follow-up information (no adverse events were associated with this medication error), was received and incorporated into the narrative.
Redness at injection site 2 weeks after vaccination about 1 3/4"; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 25Feb2021 at 10:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The medical history included osteopenia and low thyroid. It was unknown whether the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included levothyroxine sodium (THYROXINE), omeprazole (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL); all from unknown dates for unknown indications and unknown if ongoing. On 11Mar2021, two weeks after vaccination the patient experienced redness at injection site about 1 3/4. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event redness at injection site was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Fever, almost fainted, really dizzy, my vision went black, got very weak, heart very accelerated
received the vaccine after the 6 hour vial puncture expiry; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        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.   Concomitant medications were not provided.Treatment details were nor provided.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 012M20A)  with no associated AEs.
Syncope episode. Several burns on arm where injection was given. Arm still swollen almost 2 weeks later.
9/22/08 1:15 PM call from client - says has red rash "under skin" on trunk. Began evening 9/21/08. Does not feel ill. Had fever (undocumented) on Fri, 9/19/08 few hours after vaccines. Took TYLENOL and resolved. Recommended client to see MD today for rash eval. Call back and let us know result.
After administering the vaccine, I asked the patient to have a seat in the pharmacy lobby/waiting area for 15 minutes. While seated, the patient lost consciousness for approximately one minute. After regaining consciousness, she said she had a tingling sensation in her arm and started to feel dizzy.  EMS arrived shortly after and checked her vitals then took her via ambulance to Hospital for observation.
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 22Mar2021 at 1500 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication was not reported. On 22Mar2021 1500, the patient experienced sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events. The clinical outcome for the event sore arm was resolving at the time of the report.   Information about lot/batch number cannot be obtained. No further information is expected.
Pain, fever, two syncope spells, blacking out, vomiting, extreme fatigue, 101 degree fever, muscle pain and aches.
This spontaneous report as received from a nurse practitioner refers to a identifiable patient. On 11-JAN-2018 the patient was vaccinated with improperly stored dose of RECOMBIVAX HB lot # L048848 expiry date 09-AUG-2018 for prophylaxis. Temperature and time frame was reported as 47 degrees Fahrenheit to 77 degrees Fahrenheit (47 degrees Fahrenheit) 2 Hours and 32 degrees Fahrenheit up to 35 degrees Fahrenheit for 5 Hours. There was no previous temperature excursion involved. The call was because of a data logger. No adverse effects reported. No PQC involved. No further details provided.
Information has been received from a  healthcare worker/office manager concerning a 74 year old female, with unknown medical history and unknown drug reaction/allergies, who on 1/24/06 was vaccinated intramuscularly with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 651330/1048P). About 4 hours post vaccination, on 1/24/06, the patient developed swelling and redness near the injection site. She was treated at a local ER with some form of steroids and released. The patients present status was reported as recovering. The was product quality complaint involved. The patients experiences were considered to be other important medical events (OMIC). Additional information has been requested.
Started around 9am yesterday with a sore arm and some fatigue, quickly developed a fever (100.6), headache, chills, body aches, and nausea. symptoms were improved by tylenol but came back each time it wore off. Fever broke around midnight. Today I still have severe body aches and a headache, as well as fatigue
This spontaneous reprot as received from a medical assistant and physician via company representative refers to an 84 year old male patient. Medical history and concurrent conditions were not reported. On an unknown date in 2015 at the beginning of an unspecified week, the patient was vaccinated in another medical center with a dose of ZOSTAVAX vial. Concomitant medications was unknown. On an unknown date in 2015 by the end of the same week of vaccination, the patient experienced shingles (herpes zoster). The patient's shingles were so bad that the patient had called the clinic (sought medical attention) crying in pain and asking for pain mediations (pain). The patient was treated with acyclovir. The patient had an appointment in the medical center where he was vaccinated. Action taken was not applicable. The outcome of herpes zoster and pain was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.
Day after vaccine was red, warm to touch, but not sore.  No streaking, no fever.
pt recvd vax & mom reports pt went skating then 1 hrs p/inject c/o itching on feet; devel rash & joint pain;  25OCT devel joint pain in hip-that could not even walk;
Body aches. Locations of previous injuries hurt like razorblades during my initial vaccine response. Since my "recovery" I have woken up every morning with pain and discomfort in those locations. Lower back pain is to be expected from time to time due to a chronic issue but what I am experiencing is pain in my back, left chest/shoulder joint and left groin every morning. It makes it hard to get moving in the morning. The pain reduces with movement and activity thru the day but I'm back to square one the next day when I wake up. This has been on going for months.
5 days after first vaccine my lymph node under my arm pit was swollen. It continues to be swollen a week later. 7 days later my arm was swollen, red, hot to the touch and itchy by the injection site.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 11-AUG-2014 the patient was vaccinated with an expired MMR II albumin status: HSA, (lot # H014989, expiration date: 10-AUG-2014, dose, units, route of administration, anatomical location were not reported). No adverse symptoms were reported. Additional information has been requested.
Severe Outbreak of Morbilliform Eruptions.  Extreme rash and maculopapular skin eruptions  and Papules on lower half of body. Very itchy. Treatment was Hydrocortisone and Benadryl topical.  As of Aug 19, symptoms still persist.
Rash (Chest, Injection Site); Lymph Knot (Under Armpit); Rash (Chest, Injection Site); A spontaneous report (United States) was received from a consumer concerning a 51-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash (chest, injection site)/rash, lymph knot (under armpit)/lymphadenopathy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Rash (Chest, Injection Site), Lymph Knot (Under Armpit).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash (chest, injection site), lymph knot (under armpit) was unknown.; Reporter's Comments: This case concerns a 51 Y/O F with nonserious unexpected events of vaccination site rash, rash and lymphadenopathy.  Event onset 8 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Interchange of vaccine products; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   Reporter did not allow further contact
This spontaneous case reported by an other healthcare professional, describes the occurrence of prolonged activated partial thromboplastin time (PTT is greater than 200 seconds) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# unknown) for COVID-19 immunization. Concurrent medical conditions included increased blood pressure and vitamin D deficiency. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 13, 2021, patient experienced prolonged activated partial thromboplastin time (PTT is greater than 200 seconds). At the time of the report, prolonged activated partial thromboplastin time (PTT is greater than 200 seconds) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medications or treatment medications. Reporter did not allow further contact.