chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle aches intensified; Joint Pain intensified; Mild discomfort Intensified; Second dose after 26 days of first dose; SARS-COV-2 test: positive (Positive); This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Muscle aches intensified), ARTHRALGIA (Joint Pain intensified), DISCOMFORT (Mild discomfort Intensified), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 26 days of first dose) and COVID-19 (SARS-COV-2 test: positive (Positive)) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension, Obesity, Arthritis and Vitamin D deficiency.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2020, the patient experienced COVID-19 (SARS-COV-2 test: positive (Positive)). On 02-Feb-2021, the patient experienced MYALGIA (Muscle aches intensified), ARTHRALGIA (Joint Pain intensified), DISCOMFORT (Mild discomfort Intensified) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 26 days of first dose). At the time of the report, MYALGIA (Muscle aches intensified), ARTHRALGIA (Joint Pain intensified), DISCOMFORT (Mild discomfort Intensified), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 26 days of first dose) and COVID-19 (SARS-COV-2 test: positive (Positive)) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) He had tested positive for COVID-19 during the time frame of Moderna Vaccination.         Concomitant product use was not provided.  Treatment information was not  provided.   This case was linked to MOD-2021-264449 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Non-significant Follow up appended.; 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. Concomitant medical conditions could be potentially confounders/co-suspects for the events. This report refers also to a case of Inappropriate schedule of product administration for mRNA-1273, with no associated reported AEs. This report refers also to a case of Covid-19 test positive. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
After injection patient reported feeling dizzy and "woozy". Patient states he is very anxious and nervous about injection today. Patient was assisted to floor x 2 assist with RN and Dr. and feet put up. BP 94/51 HR 90. Patient reported feeling nauseous initially. Patient responsed well to supine position. He requested a drink of water and reports he has not eaten today. Patient remained alert during the entire episode. Repeat BP at 1225 116/72. Patient was offered water with gramham crackers to eat, okay per Dr.  Patient was assisted to a sitting position on the floor. Color improved, cheeks pink and patient appears in no distress. Patient was assisted to standing position at 12:30, reports no dizzy or light headedness and repeat BP 130/80 HR 74. Patient was assisted to the observation area with 1 assist. He will continue in observation area for 30mins.
Initial report received from reporter on 07-Oct-2013: 37 year old female patient had received TDAP vaccine (lot number E4426AA and expiration date 10-Sep-2015), on 07-Oct-2013. The patient was pregnant during vaccination. List of documents held by sender: none.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 26-JUL-2012, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (strength, route, dosage schedule, and lot number were not provided). The vaccine did not prevent shingles as intended (vaccination failure) and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 24-SEP-2015, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered (emotional distress) significant medical expenses, pain, suffering (emotional distress) and other damages (injury). The outcome of the events was unknown. Vaccination failure, emotional distress, injury, pain and herpes zoster were considered to be related to ZOSTAVAX.
PATIENT RECEIVED 5-11 BIVALENT BOOSTER INSTEAD OF 12+ BIVALENT BOOSTER
Breakthrough case admission after 2 vaccines  Moderna 2/13/21 lot# 015M20A;  Moderna 3/13/21 lot# 032M20A
Approximately 2 hours after getting the shot I began to get very dizzy. I was unable to walk, I was even dizzy laying down with my eyes closed. I was taken to my family doctor where they checked my out. While I was there I began having severe tremors or what they called rigors. When I first got there I told them that the nurse at work took my blood pressure where it was 96/60 (mine usually runs quite low) but when I got th the doctors office my heart rate went up to 140. They also took my temp right when I got there and it was 97 degrees (mine again runs low) after the rigors started they took temp again and it was 100 degrees. They took blood and my CBC was normal. They watched me for a while and by the time I left my blood pressure was normal as well as my temperature. The dizziness continued for the rest of the day but otherwise everything else stopped. The next day I was back to normal.
PATIENT WAS POSITIVE FOR COVID 19 ON 11-30-2020, NO FURTHER RE-INFECTION PATIENT DIED 2-14-2022 UNDER HOSPICE CARE, DEATH WAS EXPECTED
feeling incredibly sick; achy muscles; nausea; diarrhea; foggy memory; extreme fatigue; very bad headache; sore neck muscles; sneezing; runny nose; brief periods of rapid heart rate; no appetite; Sometimes it felt like a specific part of body was under attack, i.e. GI tract, various muscle groups, sinuses; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 26Mar2021 at 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included cervical fusion C3-C7. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (ADVIL) both for an unknown indication. The patient's history of allergies to medications, food or other products was not reported. 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 27Mar2021 at 10:00, approximately 20 hours after injection, the patient experienced feeling incredibly sick with no fever, but achy muscles, nausea, diarrhoea which still continued, foggy memory, extreme fatigue, very bad headache, sore neck muscles, sneezing, runny nose, brief periods of rapid heart rate, no appetite and sometimes it felt like a specific part of the body was under attack, i.e., GI tract, various muscle groups, sinuses. The patient reported that likely forgot some symptoms, but these ranks among the worst that patient ever felt in life without running a high fever. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events feeling incredibly sick, achy muscles, nausea, diarrhoea, foggy memory, extreme fatigue, very bad headache, sore neck muscles, sneezing, runny nose, brief periods of rapid heart rate, no appetite, felt like a specific part of my body was under attack, i.e., GI tract, various muscle groups, sinuses was resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Patient presents symptoms of hives, rash, and swelling in hands. No shortness of breath and no chest pain were reported.
tested positive; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter Treatment information was not provided
Fever of 100.4; Chills; Aching joints; Stomach upset; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 13:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to penicillin and sulfa drugs from an unknown date. Concomitant medications included paracetamol (TYLENOL) taken for unknown indication from an unknown date. The patient previously 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 13Mar2021 at 14:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. 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 06Apr2021, the patient experienced fever of 100.4, chills, aching joints and stomach upset. The patient's body temperature was found to be 100.4 (unit unspecified). 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 any treatment for the events. The clinical outcome of the events fever, chills, aching joints and stomach upset was not recovered at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
administered expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 29-Jul-2021 from a Other health care professional via Medical Information (MI) (Reference number- 00702929) and transmitted to Sanofi on 29-Jul-2021.  This case involves a patient (unknown gender) reported that patient administered expired HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  It was reported that, "The medical assistant declined to provide her e-mail address. She states that she is calling from a doctor's office because she administered Act-Hib that expired two days ago. When she was asked to provide additional AE information she declined and said not at this time. This is all the information she provided at the time of her call".  At the time of reporting, patient had no adverse event.  There will be no information available on the batch number for this case.  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.
Elevated hsCRP indicating cardiovascular inflammation, currently treating with anti-inflammatory interventions, outcome unknown.
Pt got vaccine around 4:30pm. Said he had no history of adverse reaction to vaccines. Left. Came back 30-45 minutes later with complaints of tingling and "feeling warm" in his legs. Monitored pt for 10 minutes. His condition had then spread to tingling all over. Called 911. While waiting for ambulance, pt remembers having this reaction before with vaccines just not as severe and not as soon after. EMTs took him to hospital. Unknown what happened after he left the pharmacy.
Moderna vaccine was administered outside of facility- reported by patient ? NO LOT NUMBER WERE SUPPLIED ----------------------------------------------------------------------------------------------------------------------- ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 8/22/2021 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART ACUTE DVT, UNSPECIFIED VEIN 7/13/2021 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART ACUTE DVT OF LEFT FEMORAL VEIN 8/17/2021 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 8/22/2021 ANEMIA ACUTE DVT, UNSPECIFIED VEIN 7/13/2021 ANEMIA ACUTE DVT OF LEFT FEMORAL VEIN 8/17/2021 ANEMIA ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 8/22/2021 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) ACUTE DVT, UNSPECIFIED VEIN 7/13/2021 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) ACUTE DVT OF LEFT FEMORAL VEIN 8/17/2021 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE)
2 days after receiving vaccination I experienced 18 hours of severe limiting dizziness which gradually resolved over a period of approximately 4-5 days.
pt recv vax 30JUN95 & a pregnancy test on 9JUL95 was positive;amniocentesis & ultrasound were WNL;MAY96 varicella antibody titer was negative;during labor pt was not dilating;C-section performed 2MAR96;child born w/axial polydactyly;
Initial case received from health care professional, on 06 February 2012. A 75-year-old male patient received an injection (route and site not reported) of FLUZONE HIGH-DOSE, sanofi pasteur Inc. lot number UH458AC, on 13 October 2011. The patient's medical history, any concomitant medications, and any illnesses at the time of vaccination were not reported. On 26 October 2011, the patient developed symptoms of weakness in both lower limbs. The patient was unable to put any weight on either leg and would fall down. The patient was diagnosed with Guillain-Barre Syndrome (GBS). The outcome was not reported. Documents held by sender: none.
left cheek swelling; swelling under arm pit; swelling on arm/ swelling under arm pit; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (left cheek swelling), AXILLARY PAIN (swelling under arm pit) and VACCINATION SITE SWELLING (swelling on arm/ swelling under arm pit) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included AMOXICILLIN for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced SWELLING FACE (left cheek swelling), AXILLARY PAIN (swelling under arm pit) and VACCINATION SITE SWELLING (swelling on arm/ swelling under arm pit). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, SWELLING FACE (left cheek swelling), AXILLARY PAIN (swelling under arm pit) and VACCINATION SITE SWELLING (swelling on arm/ swelling under arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
After patient received vaccine she had a mark on arm where administered and pain. The mark is still there to this day and patient still has consistent arm pain from injection site.
A wheal did not form after injecting the monkeypox Jynneos vaccine Intradermally.
sick; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 10-Nov-2020. This case involves a patient with unknown demographics who experienced sick (Illness), when received vaccine INFLUENZA VACCINE (flu shot). Relevant medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient experienced sick (Illness), unknown latency following the administration of INFLUENZA VACCINE. Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.  There will be no information available on batch number for this case.
Patient states he was hot, dizzy, lightheaded. Attending nurse states patient was diaphoretic upon his arrival to observation area. Vital signs normal. Patient had cool pack applied to back of neck, drank a juice, ate a snack and said he felt much better. Patient states all symptoms resolved prior to leaving.
Arm hurts, she has a hard time lifting it up its painful. MD sent her to physical therapy and nerve test.
Pt. arrived at ER in mother's arms.  Mom stated child was having difficulty breathing. Pt. was limp and had a blank stare.  Vital signs stable T98.6, P85, R24, O2 100% RA. Pt. responded after a few minutes to tactile stimuli. Pt. appeared post-ictal.  Pt. was monitored X 2 hrs. and was discharged home after she became more alert and talking. Ambulated on own.
WAS IN BED; ACHES AND PAINS; LOW GRADE FEVER; 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, and batch number were not reported) 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 was in bed, aches and pains, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from was in bed, aches and pains, and low grade fever. This report was non-serious.
This spontaneous report was received from a healthcare worker referring to an unspecified number of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (lot # reported as L013826, expiration date: 21-APR-2017) (dose, anatomical location, route of administration and frequency were unspecified). No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same source. Additional information has been requested.
About 2 days after receiving the vaccine I had an episode of memory fog, and was unable to remember what previously happened. My husband became concerned so I took my blood pressure and it was 140/72. This is a high read for me I usually stay at 120/70. My husband suggested that I go into the ER. The provider did a CT scan, lab work, and a urinalysis. All my lab work came back normal so I was sent home and advised to rest and monitor my symptoms.
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 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 62 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 08Apr2021 as dose 2, single (Lot number: ER2613), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: FH8030), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Feb2023) Positive, notes: Paxlovid Rebound after taking Paxlovid for positive COVID; (Feb2023) Positive, notes: Second positive text six days after absence of symptoms; (Feb2023) negative, notes: three days after negative COVID test. Therapeutic measures were taken as a result of vaccination failure, covid-19. From 07Feb2023 to 12Feb2023, the patient received Paxlovid as treatment of Covid-19. The patient had no known allergies.
Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 years old male patient who received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was received. On 14-Oct-2018, the patient received prefilled syringe of 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1818 (expiry date: 30-Jun-2019) via intramuscular route in the left deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. Patient did not have any adverse reaction. 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.
REDNESS IN PATCHES, SORE ARM, HARD SWOLLEN KNOT, BRUISE7 ON THE INSIDE OF UPPER ARM, WHOLE ARM WAS VERY SORE, SORENESS AROUND ARMPIT AREA