chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a patient with unknown demographics received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number: UJ029AB, expiry date: 02-May-2019, via unknown route in unknown administration site. The patient's past medical history, medical treatments, vaccinations and family history were not provided. It was case of actual medication error due to underdose. It was also a case of syringe leak. The syringe was in the sharp container and not available for return. It was unknown whether the patient had any adverse event. Complaint reference number: CO2018-00303. 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.
Pityriasis Rubra Pilaris rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GJ5342) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Lot EH9899), administration date: 09Jan2021, for Covid-19 immunization; BNT162b2 (Dose 2, Single Lot EL1284), administration date: 30Jan2021, for Covid-19 immunization; BNT162b2 (Dose 3 (Booster), Single, Lot FF8839), administration date: 04Oct2021, for Covid-19 immunization; BNT162b2 (Dose 4 (Booster), Single, Lot FM9992), administration date: 18Apr2022, for Covid-19 immunization. The following information was reported: PITYRIASIS RUBRA PILARIS (non-serious) with onset Sep2022, outcome "unknown", described as "Pityriasis Rubra Pilaris rash". The event "pityriasis rubra pilaris rash" required physician office visit. Additional Information: She was seeking any information on the adverse effect of Pityriasis Rubra Pilaris rash being reported from the Pfizer Covid booster. States she was originally seen by the doctor on 09Sep and diagnosed sometime in Oct (as reported). It is a life changing rash that has been going on for months. She is calling now because she was diagnosed with Pityriasis Rubra Pilaris in the middle of Aug2022, 2 weeks after the last booster approximately. At the time, no one she knew had this, don't know why this happened, she wondered to herself why everything could be. It's a rare rash, a very rare, an autoimmune issue, she doesn't know anyone with it, nothings changed, she's just dealt with it, this has been life changing for her. She read as much she could find but since its rare she is not finding much, she thought she will go back online to find new information, and this time all kinds of articles were tied to the covid booster. She is wondering she should get another booster or did she mess up her autoimmune system, when she asked the doctor they don't know anything. After providing her vaccine dates she clarified that she was wrong about being diagnosed with Pityriasis Rubra Pilaris in Aug2022, she does not know the specific date but it certain it was after the 3rd booster. The patient was diagnosed with pityriasis rubra pilaris last Sep (as reported) and would like information about how her Covid boosters may be involved in this. Should she get the next booster or she has already strained her immune system too far.
Injection site redness, swelling, itching, and a "hot" sensation developed the day after the patient received the injection.
Approximately 4-5 days after receiving the Hepatitis B booster scattered red patches develop on her anterior and posterior chest, abdomen and back. The patches are very slightly elevated and vary in size and aren't uniform. Rash has remained consistent since the time it has developed. Ice pack helps with itching and hot water irritates the rash and makes it more red and itchy. No rash patches are noted anywhere else on her body.
Progressive bilateral panuveitis and retinal vascular is that started 2 days after vaccine administration. Started with dry eye and light sensitivity and progressed to decreased visual acuity and near blindness. Associated with tinnitus.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 75 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported.  The patient's concurrent conditions included: severe rheumatoid arthritis, hypercholesterolaemia, hypertension, immunocompromised, sulfa allergy, non-alcohol user, and non-smoker. The patient was not a drug abuser or illicit drug user. The patient was previously treated with methotrexate and was instructed not to take sulfa drugs while on methotrexate. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-APR-2021 to left arm for prophylactic vaccination.  Concomitant medications included atorvastatin calcium for hypercholesterolaemia, losartan for hypertension, rituximab for rheumatoid arthritis given on an unspecified date in JUL-2021, acetylsalicylic acid, ascorbic acid/sodium ascorbate, denosumab, ergocalciferol, fish oil, levothyroxine, loratadine, losartan potassium, omeprazole, potassium citrate and prednisone.  The consumer (patient's wife) reported that on 08-OCT-2021, the patient received lab result of SARS Covid-19 spike antibody as not detected (Confirmed immunological vaccine failure). Laboratory data included: COVID-19 antibody test (NR: not provided) Not detected. The consumer was very much concerned about the possibility of lack of immunity because the patient had underlying immunocompromised health status. The reporter wanted to know if medicine rituximab would interact with the efficacy of the vaccine as rituximab was administered on an unspecified date in JUL-2021. The action taken with covid-19 vaccine was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0- 20211020586-covid-19 vaccine-Confirmed immunological failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Adverse symptoms were mild.  Within a few minutes of getting the shot  I felt a mild cold sweat which lasted maybe 15 minutes.   Around 30 minutes after getting the shot left side of face began to feel  a little prickly numbness which eased off so at 120 minutes after getting the shot left side of face felt mildly like it feels after dental visit numbness wears off.  That's about it.  This is recorded at around 120 minutes after getting the shot.  I am home and feel fine wasn't sure to report this or not but since experimental it may be of use.
Severe arm/shoulder pain (from onset to 1 month later), immobility in arm movement limited (2 months), dull, aching pain (to present).
Develop a cough with wheezing hours after receiving vaccine. 3/18 Rx's antibiotics and steroids.
102 degree fever, headache, achiness, night sweats overnight on 8/18.  Fever came back today (100.1)
2 weeks after receiving the Moderna Covid-19 vaccine on 11-29-2021, I developed shingles (I was already vaccinated with Shingrex and also immediately started treatment with Valtrex). As a result the case was mild. However, simultaneously I developed moderate to severe tinnitus (in both ears) that has not resolved and has intensified with time. I am a physician by training and understand that these are unexpected adverse events. I am unsure of causality, however, it is odd that these AEs occurred after 2 weeks of the 3rd vaccine (booster). Vaccinations are very important and I recommend vaccinating to all patients, family and friends regardless of these potentially related AEs.
Sudden onset of dizziness, nausea, vomit & syncope sensation approx 20-30 min. after vaccination of HPV, MCV, DTP, VARIVAX.
6 abscesses; This spontaneous case was reported by a consumer and describes the occurrence of SUBCUTANEOUS ABSCESS (6 abscesses) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease. Concomitant products included COBICISTAT, DARUNAVIR ETHANOLATE, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (SYMTUZA) for HIV infection.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, 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 SUBCUTANEOUS ABSCESS (6 abscesses). The patient was treated with Surgery for Subcutaneous abscess. At the time of the report, SUBCUTANEOUS ABSCESS (6 abscesses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was prescribed Septra initially and later the drug was replaced with Enaumentin. Patient also reported to be on 40 days antibiotic drug (unspecified).   This case was linked to MOD-2021-203334 (Patient Link).
Reconstituted with sterile diluent; Reconstituted with sterile diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 3FE44, expiry date 17-JUN-2024) for prophylaxis.   Previously administered products included Shingrix (Received first dose on an unknown date).   On 13-MAR-2023, the patient received the 2nd dose of Shingrix. On 13-MAR-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted with sterile diluent) and inappropriate dose of vaccine administered (Verbatim: Reconstituted with sterile diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-MAR-2023 The reporter reported that they inadvertently administered a patient with Shingrix lyophilized powder reconstituted with a sterile diluent.  The reporter confirmed that this was an attempt at the second dose of Shingrix series for the patient. The reporter did not consent to follow-up. At the time of reporting, the patient was inadvertently administered with Shingrix lyophilized powder reconstituted with a sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was linked with US2023042730 reported by the same reporter.; Sender's Comments:  US-GSK-US2023042730:Same reporter
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from an other health care professional. This case is linked to cases 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298593, 2018SA298573, 2018SA298622, 2018SA298644, 2018SA298649, 2018SA298631, 2018SA298611, 2018SA297575, 2018SA298603, 2018SA298695 and 2018SA298701. This case involves a patient (age and gender not reported) who was vaccinated with 5 ml dose of FLUZONE HIGH DOSE which was previously frozen, (lot U1995AB and Exp. Date 20 Jun 2018) via intramuscular route in the arm (either right or left) during the period lasting 01Oct2018 to 08Oct2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. No any information about adverse event reported. 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. List of documents held by sender: none.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "One lady hasn't had a flare up in 30 years but after her injection did have flare up". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My neck broke out into a rash all around. Itchy rash. I took the Levocetirizine medication and rubbed the triamcinolone cream on it. It was the same rash event that happened after my dose 1st, and it's happened 3-4 times since then. When I take the pill and put the cream on it it goes away. And then I didn't have it for a little while, and then I took the Booster and a week later my neck broke out again. It was itchy with a rash.
Information has been received from a physician concerning an 8 year old female pt who in approximately 1995, when she was an infant, was vaccinated with Haemophilus B conjugte vaccine (+) hep B vaccine recombinant "or" Haemophilus B conjugate vaccine. On approximately 1/20/03, the pt developed h. influenza. Additional info is not available.
Patient experienced right flank pain upon waking at 5:00 AM. At 6:00 also began to have chills with diaphoresis which was immediately followed by a flash of "orange" with subsequent tonic/clonic witnessed "seizures' x2 of 6 minutes duration. She was transported to the ER by ambulance for evaluation.
Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves a 59 years old female patient who experienced tingling in hands and feet, while she received vaccine INFLUENZA VACCINE. The patient's past vaccination(s) included flu vaccine received 6 years ago and resolved in a week. The patient's past medical history and concomitant medication were not provided. At the time of the event, the patient had ongoing Chronic fatigue syndrome. On 15-Nov-2018, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, The patient experienced tingling in hands and feet (paraesthesia) following the administration of INFLUENZA VACCINE. Event had persisted. (Other relevant tests included no lab test.) Final diagnosis was tingling in hands and feet. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for tingling in hands and feet.
My arm was sore right after the administration which is common so I didn't think anything about it.  The soreness never seem to go away.  My daughter and I got our shots at the same time by the same doctor so I asked her if her arm was still sore and she said no.  I had a lump in my arm the size of a pea.  I thought maybe the doctor hit something and it would just be sore for a bit longer and didn't think much of it until the pain didn't subside and actually felt as though it was getting worse and limiting function and mobility.  I started looking up "is it normal to still feel pain weeks after flu shot" and read sometimes it can take a while longer to heal so I gave it some more time.  I generally have a high tolerance to pain so just dealt with it and babied that arm.   It started to interfere with my daily routine making simple tasks more difficult such as holding a blow dryer, lifting anything, manipulating my arm in certain directions so I researched it further and learned shoulder injuries are an actual thing from vaccine administration and was shocked and worried to discover this.  I have an appt at an orthopaedic set to do an MRI and evaluate the injury.,
Patient stated she was having a stiff arm but since then has reported it has gotten better. Thinks it could be arthritis.
cold sxs 20DEC95 & earache;cervical gland enlarged as of 28DEC95;dx acute parotitis;10-15lbs weight loss;exp congestion;swelling in the lt side of neck which was much worse-painful & larger;
very low BP; This is a spontaneous report received from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had very low bp (blood pressure). The patient underwent lab tests and procedures which included blood pressure measurement: low. The outcome of the event was unknown.   Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Running a 101 plus fever.; Chills; Body aches; Influenza like illness; She started feeling bad yesterday.; She had really bad tremors; This is spontaneous report received from contactable other consumer (Patient mother) report for her daughter reported. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in arm right on 11Mar2021 at 11:30 as dose 1 single, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2 single for COVID-19 immunization. Medical history included anxiety, depression, attention deficit hyperactivity disorder from an unknown date and unknown if ongoing Verbatim: ADHD, cardiac operation from an unknown date and unknown if ongoing (had open heart surgery when she was child, a baby, abdominal pain lower from an unknown date and unknown if ongoing monitoring her heart all time but her lower abdomen hurt too). Concomitant medications included valproate semisodium (DEPAKOTE), fluoxetine hydrochloride (PROZAC), zolpidem (ZOLPIDEM), ibuprofen (ADVIL 12 HOUR) and ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported; hydroxyzine (HYDROXYZINE) taken for anxiety, start and stop date were not reported; diazepam (DIAZEM [DIAZEPAM]) taken for attention deficit hyperactivity disorder, start and stop date were not reported. On an unspecified date, the reporter reported about the events "My Daughter and I both got the shot yesterday. She got the flu like symptoms, was running a 101 plus fever and chills and body ache." Post the second shot it was reported that the patient had body ache and it felt like flu like symptoms. The patient also experienced "She started feeling bad yesterday yes and then that morning probably last this got kind of little worse and she had really bad tremors". The patient underwent lab tests and procedures which included bacterial test: with results unknown on an unspecified date, body temperature: 101 on an unspecified date, electroencephalogram: unknown on 24Feb2021 (She had a what's the brain's scan EEG where they put the 'lobes' on your head"). Outcome of the events was reported as unknown.   No follow-up attempts are possible. No further information is expected.
BRIGHT REDNESS AND FIRM SKIN WITH SURROUNDING DULL ERYTHEMA. HOT TO THE TOUCH.
She started vomiting at about 11 PM after receiving the shot. She also had headache and on 10/25/12 starting having body ache. She received treatment at ER (anti emetic) and injection for pain at urgent care.
On the morning of 03/25/2021 (five days after receiving the COVID shot), I began to develop mild hives (itchy rashes with red spots) on my legs. The gives began to intensify later that evening. The next day (03/26/2021), the hives grew and appeared all over my body. The itching intensified. Severe hives lasted  for five dayse until 03/29/2021
headache, Myalgia, Arthralgia & Fever Narrative:  Other Relevant History:
Swelling; PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT; On 20 Apr 2021, patient received 1st dose, On 01 May 2021, patient received 2nd dose; TIRED; PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT; HAD MODERNA VACCINATION AND HAD IRRITATION AT INJECTION SITE; Fever; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE IRRITATION (HAD MODERNA VACCINATION AND HAD IRRITATION AT INJECTION SITE), SWELLING (Swelling), PAIN (PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 20 Apr 2021, patient received 1st dose, On 01 May 2021, patient received 2nd dose) and FATIGUE (TIRED) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Rheumatoid arthritis.    No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE IRRITATION (HAD MODERNA VACCINATION AND HAD IRRITATION AT INJECTION SITE) and PYREXIA (Fever). On an unknown date, the patient experienced SWELLING (Swelling), PAIN (PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 20 Apr 2021, patient received 1st dose, On 01 May 2021, patient received 2nd dose), FATIGUE (TIRED) and RASH (PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT). In 2021, VACCINATION SITE IRRITATION (HAD MODERNA VACCINATION AND HAD IRRITATION AT INJECTION SITE) and PYREXIA (Fever) had resolved. At the time of the report, SWELLING (Swelling), PAIN (PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 20 Apr 2021, patient received 1st dose, On 01 May 2021, patient received 2nd dose) and RASH (PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT) outcome was unknown and FATIGUE (TIRED) had not resolved.            Concomitant Drugs Not Reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.