chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs or PQC reported.; Caller reported VARIVAX administered after temperature excursion.  No additional information provided.  No additional AEs or PQC reported.       ?    Names of vaccines involved (including lot/exp) VARIVAX U019906  6/24/2023        ?    Temperatur; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-APR-2022, the patient was vaccinated with improperly stored (varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter subcutaneously, lot #U019906, expiration date: 24-JUN-2023, administered for prophylaxis (strength, and site of administration were not provided) (product storage error temperature too high). The vaccine was stored in the temperature of 6.8 Fahrenheit degrees for 1 hour and 36 minutes. No previous temperature excursion reported.  No additional adverse event was reported.
Shot was on my left arm.  My left side of the face felt like i came home from a brutal dentist appointment.   The whole side of my face felt numb.  My lymph node was also giving me pain.....  It is now eight days after my shot, and I still feel a little numbness on the left side of my face.  It is not as prevalent as it was, i am not taking any Tylenol or Advil because of it, although i did on day 1-3. (Tylenol)
expired dose administered to a patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to a patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 EXPIRED PRODUCT ADMINISTERED (expired dose administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided treatment information was not provided
Low grade fever,Chills, muscle and joint pain. No treatment required. Symptoms resolved on 01/06/21
Fluzone Quadrivalent injected subcutaneously / no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves unknown demographic patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and Expiry date unknown) subcutaneous route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate route of vaccination.  It was reported that Fluzone Quadrivalent injected subcutaneously.  At a time of reporting no adverse effect reported.  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.  Information on the batch number was requested  List of documents held by sender: none.
within minutes of vaccine had palpitations and tachycardia HR 130's . Then while driving had second incidence, felt like she was going to pass out and pulling over 911 and ambulance took her to ED.  She had palpitations, diaphoresis
tested positive for COVID-19; tested positive for COVID-19;  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a program, other case identifier(s) 21K-163-4204896-00.  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Apr2021 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single, and intramuscular, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; HUMIRA, subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (medically significant) with onset 13Nov2021, outcome unknown, COVID-19 (medically significant) with onset 13Nov2021, outcome recovered (2021). The patient underwent the following laboratory tests and procedures sars-cov-2 test (13Nov2021) positive. The action taken for HUMIRA was unknown.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of COVID-19 virus test positive after vaccination with HUMIRA 40MG/0.4ML was no reasonable possibility. The reporter's causality for the event(s) of COVID-19 virus test positive after vaccination with PFIZER BIONTECH COVID-19 VACCINE was possible.  The lot number for bnt162b2 was not provided and will be requested during follow up. Based on the information in the case report, a possible causal relationship between the events Drug ineffective, Covid-19, and suspect drug BNT162B2 cannot be excluded.
covid vaccine breakthrough case  dose 1 Pfizer 3/31/21 ER8727 dose 1 Pfizer 4/22/21  EW0158
Received 2nd Covid19 Moderna vaccine on April 6  in left arm.  Very hard rock-like lump area appeared within a couple hrs.  By next day large red area around injection site.  Painful to touch, and very itchy.  Could not sleep on left side.    FYI received first Covid19 Moderna vaccine on March 9.  Arm slightly sore for couple days, but no other reaction, no  redness or itching.
event time started at 06:30pm of 04/12/2021. patient felt over at home. reported headache, increased heart rate, shortness of breath, chill, pain on head, back, leg, right leg numb. with no bleeding
Began experiencing intermittent cardiac rhythm disturbance Sunday afternoon, no chest pain, no SOB. Did not resolve, I was in the ED to care for a patient and asked a collogue to hook me up to a cardiac monitor.  ECK identified "incomplete right bundle branch block". As of  the time of reporting the symptoms have not resolved or increased in frequency.
sore arm; swelling at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Apr-2021 and was forwarded to Moderna on 08-Apr-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and INJECTION SITE SWELLING (swelling at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 PAIN IN EXTREMITY (sore arm) and INJECTION SITE SWELLING (swelling at injection site). At the time of the report, PAIN IN EXTREMITY (sore arm) and INJECTION SITE SWELLING (swelling at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28-Jun-2021 and does not contain any new information (NNI).
full blown Covid symptoms for 2 days after her 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (full blown Covid symptoms for 2 days after her 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (full blown Covid symptoms for 2 days after her 1st dose). At the time of the report, SUSPECTED COVID-19 (full blown Covid symptoms for 2 days after her 1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications was not provided by the reporter. Patient states that his wife had full blown Covid symptoms for 2 days after her 1st dose of the Moderna Covid-19 Vaccine & for 1 day after her 2nd dose. Treatment information was not provided.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected non serious event of Suspected COVID without laboratory confirmation after mRNA- 1273 Moderna vaccine. The event occurred after the first and had a duration of 2 days. The patient experienced COVID symptoms, which were not further specified. SARS-CoV-2 test was not performed. COVID symptoms were also reported after the second dose. However, since symptoms were not specified and the mRNA-1273 does not contain a virus capable of causing infection, the rechallenge was assessed as not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-395682 (Patient Link).; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected non serious event of Suspected COVID without laboratory confirmation after mRNA- 1273 Moderna vaccine. The event occurred after the first and had a duration of 2 days. The patient experienced COVID symptoms, which were not further specified. SARS-CoV-2 test was not performed. COVID symptoms were also reported after the second dose. However, since symptoms were not specified and the mRNA-1273 does not contain a virus capable of causing infection, the rechallenge was assessed as not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report
Severe fatigue, stiff neck and shoulder on side of injection.  More importantly - Severe pelvic/uterine cramping continuing through today (still present)
Minor nerve pain with first shot and second shot intense nerve pain throughout my body, still some nerve pain in hands on and off.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 23Mar2021 at 11:30 as a single dose and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 13Apr2021 at 15:30 as a single dose for COVID-19 immunisation.  Medical history was not reported. Concomitant medications included cetirizine hydrochloride (manufacturer: ZYRTEC)  and vitamin d (MANUFACTURER UNKNOWN).The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 the patient experienced minor nerve pain with first shot and after second shot intense nerve pain throughout the body, still some nerve pain in hands on and off. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcomes of the event nerve pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Rheumatoid Arthritis; This spontaneous report has been received from a female patient reporting on herself.  The patient's historical conditions included: rheumatoid arthritis. The patient's concomitant medications included: tocilizumab (ACTEMRA), evolocumab (REPATHA) and a unspecified pneumococcal vaccine.  On an unspecified date in 2009, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (dose  number, dose, route of administration, anatomical location, lot# and expiration date were not provided) as prophylaxis. On an unspecified date in 2014, the patient received another brand of pneumococcal vaccine.   On an unspecified date in 2022 (also reported as last year), the patient was diagnosed with rheumatoid arthritis. At the reporting time, the outcome for the event of rheumatoid arthritis was unknown.  Causal relationship between the rheumatoid arthritis and the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not provided. Upon internal reviewthe event of rheumatoid arthritis was considered to be medically significant.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jul2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Jan2021 at 09:00 as dose 2, single (Batch/Lot number: unknown) and on 26Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Inflammatory arthritis" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: NORVASC, start date: 01Feb2019; BUPROPION, start date: 01Nov2014; LISINOPRIL, start date: 01Jun1998; HYDROXYCHLOROQUINE, start date: 01Feb2014; FOLIC ACID, start date: 01Mar2021; MELOXICAM, start date: 01Jan2018; VITAMIN C [ASCORBIC ACID], start date: 01Jan2022; VITAMIN D [VITAMIN D NOS], start date: 01May2009; ELDERBERRY [SAMBUCUS NIGRA], start date: 01Oct2020. Past drug history included: Fluconazole, reaction(s): "known allergies:Fluconazole".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Indication: Covid-19 treatment; (Sep2022) Positive, notes: Covid positive tests following the completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt reports getting normal pain after 2019-20 Flucelvax QIV PFS then progressive worsening pain over the month. Pain radiates down arm and she is unable to lift or touch arm without experiencing extreme pain. She reports no swelling or lumps. She is seeing provider for physical therapy. Scheduled for ultrasound and had x-rays done.
10:AM nervous racing heart rate (Approx 2 hrs) on same day. 2 days later -aching left arm & neck muscles.
Pt. came in to the office with a firm mass in the left thigh after immunizations.
4 hrs p/DTP pt started screaming, unconsolable, face red & sweaty lasted 5-10 mins, very pale, weak & sleepy, hands twitched x 3mins; fell into deep sleep;
Slight tenderness at vaccine site (Right arm) x 24 hrs. Patient was given H1N1 Nasal and injection on the same day. The nurse meant to give a seasonal injection of the flu vaccine.
Per patient had fever, headache, and fatigue. But also developed  chest pain, increased heart rate and blood pressure. All side effects went away except chest pain/burning in throat. suggested patient to see doctor/ potential otc  medications.
Pt presented with open pustule - as if injection was given as subcutaneous instead of intramuscular. Pt complained of pain in the left upper arm.
Moderna was given to a patient who is younder than 18 years old.  Patient is 17  years old and will turn 18 in less than four months on April 4th of this year.    No adverse reaction occured.
Patient began to feel nauseous and dizzy about 12 midnight after 11AM vaccine.  Patient fainted in the bathroom.  Wife reported the patient became disoriented for 2-5 minutes.  Patient became re-oriented but continued to have fever/chills.  Headache persists through time of this report.
Patient is fully Pfizer vaccinated 1/28/21, 2/18/21 and booster 11/4/2021.  Admitted to Medical Center 12/6/2021  Diagnosed with COVID-19 on 12/21/22  Patient died 2/19/22 while in In-patient hospice.  no other information was provided. please contact the Medical Center for any additional information.
Pt got her Vaccine on her right arm after  a week she got her left arm swelling and pain.
Had L sided chest pain that radiated to his arm, better when sitting up and worse when laying down. Found to have large pericardial effusion.
Red skin reaction on left upper arm with mild fever. Reaction began within hours of injection. (L) bicep swollen, red and induration area about 8 inches x 5 inch area . MD to treat with acetominophen and cold compresses. Call if not improved in 72 hours.
Patient received vaccine 01/07/2021 at 1:50 pm.  Patient was sitting in waiting area for 15 minutes post vaccination.  At 2:05, patient began feeling light-headed and dizzy.  Patient was clammy and felt she might faint.  Patient was  moved out of waiting area and reclined in exam chair.  Patient felt much better after ten minutes.  Vitals were stable.  Patient had some gatorade and was carrying on normal conversation with nurses.  Patient observed x 30 additional minutes before leaving office.
Large local wheal and flare reaction at injection site (Flu vaccine). Baseball size. Tx with 0.1% Triamcinolone cream, Ibuprofen PRN and Sx RE cool compresses.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with PROQUAD (dose, anatomical route of vaccination, lot numbers and expiration dates were not provided). It was reported by the registered nurse, that PROQUAD was exposed to a defrost cycle (temperature was not provided). Nonetheless, no adverse effects were reported. No product quality issue was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Red bullet Mark on arm lasted three weeks.  Has pins and needles off and on in feet.  Losing muscle function in hands that is not going away.  Having hard time holding onto objects or writing.  Primary doctor referred to neurologist..  waiting for appointment
Soreness at injection site and right arm. Muscle aches. Unable to stand or walk the next morning at 7am due to positional vertigo and dizziness. When attempted to stand also feelings of passing out until dropping to the ground and lying still. Blood sugar was 147 and stable at the time of the incident. Positional Vertigo has continued throughout 2nd day, but it slowly improving. No vertigo or dizziness with first two COVID-19 immunizations. I am immunosuppressed and take a biologic, but did not have a biologic in my system at time of vaccine as we are in the process of changing biologics.
medium size soft bulge (about the size of a ball of ping-pong) in my right arm pit-swollen ganglion; medium size soft bulge (about the size of a ball of ping-pong) in my right arm pit-swollen ganglion; rash on my right deltoid at about 2 cm below the exact spot where the shot was applied; The area is swollen and it itches; The area is swollen and it itches; The area is swollen and it itches; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Dec2021 16:15 (Lot number: Fd7218) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Mild eczema" (unspecified if ongoing); "mild asthma" (unspecified if ongoing), notes: recovering; "sinusitis" (unspecified if ongoing), notes: recovered. Concomitant medication(s) included: CICLESONIDE; ALBUTEROL HFA; CETIRIZINE HYDROCHLORIDE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0170, Location of injection: Arm Left), administration date: 22Apr2021, when the patient was 35 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Er8737, Location of injection: Arm Left), administration date: 31Mar2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Dec2021 05:00, outcome "not recovered", described as "Booster"; AXILLARY MASS (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 13Dec2021 05:00, outcome "not recovered" and all described as "medium size soft bulge (about the size of a ball of ping-pong) in my right arm pit-swollen ganglion"; VACCINATION SITE RASH (non-serious) with onset 13Dec2021 05:00, outcome "not recovered", described as "rash on my right deltoid at about 2 cm below the exact spot where the shot was applied"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE REACTION (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 13Dec2021 05:00, outcome "not recovered" and all described as "The area is swollen and it itches". Therapeutic measures were not taken as a result of immunisation, axillary mass, peripheral swelling, vaccination site rash, vaccination site swelling, vaccination site reaction, vaccination site pruritus.  Additional information: it was reported that patient did not had covid prior vaccination nor tested covid post vaccination. Patient did not took other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Red rash covering much of upper arm starting a few days after vaccine and spreading over next several day. When shown to me was warm to touch. Told patient to see her MD.