chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Welts appeared to childs r/upper leg and r/outer forearm.  No other areas noted. Mother was advised to have the Child seen by a MD. The MD prescribed medication for rash.  Mother states child is better.  Rash lasted for 2 days.
Test positive for Covid; Test positive for Covid; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4397011-00.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), on 30Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "recovering" and all described as "Test positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Positive. The action taken for risankizumab was dosage permanently withdrawn. The reporter considered "test positive for covid" related to BNT162b2.  Clinical course: Causality for SKYRIZI (RISANKIZUMAB): The reporter's causality for the event(s) of COVID with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. Causality: COVID-19 (COVID-19); Action(s) taken with drug : Drug discontinued; Causality as per reporter (Drug/Vaccine): Not Related; Dechallenge: Yes.  PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) Causality: COVID-19 (COVID-19); Action(s) taken with drug : Unknown; Causality as per reporter (Drug/Vaccine) : Possible; Dechallenge : N/A.  Did event abate after stopping drug was reported as yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
Chills, fever, headache.  Started approximately 36 hours after 2nd vaccination.  Symptoms resolved 48 hours later.
Received Tdap vaccine. Approx. 18 hours later, felt a combination of chills, fever, body aches which lasted approximately 2 full days.
Chills, Bad headache, Entire body was in pain, uncontrollable shaking of both hand,  fatigue, Temp was 100
Woke up Sunday morning around 0700 1-24-2021 after had receiving my 2nd dose of the vaccine the day prior and was feeling all the normal muscle aches, pain and fatigue. At that time I was also experiencing a severe headache at the base of the back of neck, my neck was very stiff and one of my lymph nodes at the base of the front of my neck had swelled to the approximant size of a half dollar and raised up about 1 to 1 and 1/2. inches. The site where the swelling was located was very sensitive to the slightest touch, also on the same arm I received the injection. About 2 hours after waking, I started experiencing dizziness and nausea very suddenly to the point where I had to sit myself down in the hall way for a few minutes. I thought at one point I needed to call an ambulance as I made my way to lay down on my couch because I felt so sick. With in about 15 minutes after laying still on the couch the overwhelming need to vomit came over me. Which I did do for a good 5 minutes. There was quite a bit of relief from the nausea and dizziness shortly after but remained present the entire day. However the severe head ache continued until the morning of 1-27 and the lymph node still is slightly swollen with sensitivity to the touch.
fainted; pain; tingling; numbness; difficulty breathing; felt very weak/bad reaction; This case was reported by a other health professional via call center representative and described the occurrence of fainting in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA94AA, expiry date 28th February 2022) for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 23rd July 2020, the patient received the 2nd dose of Bexsero. On 23rd July 2020, 1 hr after receiving Bexsero, the patient experienced fainting (serious criteria GSK medically significant), pain, tingling, numbness, difficulty breathing and feelings of weakness. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the fainting, pain, tingling, numbness and difficulty breathing were unknown and the outcome of the feelings of weakness was not recovered/not resolved.   It was unknown if the reporter considered the fainting, pain, tingling, numbness, difficulty breathing and feelings of weakness to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero in right upper deltoid.  The patient was okay for about 30 minutes in the doctor's office and also, she was okay for about 30 minutes after reaching home.  Around 1 hour after receiving the vaccine, the patient started to feel pain, tingling and numbness in her whole body and she fainted.  The patient was having breathing difficulty and felt very weak. The patient was taken to the emergency room and was given fluids and pain medications overnight and at the time of reporting she was at home. But the patient was still feeling very weak.  Doctor's office stating, the patient had a very bad reaction to the Bexsero. The reporter was consented to follow up.
sudden onset severe mid abdominal pain x hours, one episode of vomiting, then persistent pain which then also radiated to back. Whole episode lasted about 12 hours.
Patient had first dose of J&J vaccine (More than 6 months ago). Was here for Moderna booster. After administering booster patient sat out in out waiting area (15 minutes recommended) with her daughter.... after about 2-3 minutes the daughter yelled that her mom passed out....she was leaned over on her daughters shoulder, eyes rolled back in head, red from neck up, non responsive when yelling and slapping her face.....i did feel a pulse at her neck....we moved her to the floor.....after about 2 minutes she came around. Parametics came and she was taken to Hospital.
Tested positive for COVID after the first Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID after the first Moderna COVID-19 vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID after the first Moderna COVID-19 vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID after the first Moderna COVID-19 vaccine) 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.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of tested positive for COVID-19 and mRNA-1273 is assessed as not applicable.
Felt Sick; Got very ill; Fever of 104 degrees Fahrenheit for 3 days; arm was big and round; arm was so swollen it would not fit in her sleeve; Patient has not received second dose of Moderna COVID-19 vaccine, with first dose being given 21JAN2021 /  Patient claiming they will decide to not get the second dose of the Moderna COVID-19 vaccine.; body ached so bad; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt Sick), ILLNESS (Got very ill), PYREXIA (Fever of 104 degrees Fahrenheit for 3 days), PERIPHERAL SWELLING (arm was big and round) and PERIPHERAL SWELLING (arm was so swollen it would not fit in her sleeve) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 08-Oct-2020. Concomitant products included DILTIAZEM HYDROCHLORIDE (CARTIA XT), POTASSIUM, LEVOTHYROXINE, ISOSORBIDE MONONITRATE (IMDUR), ARGININE, VITAMIN C [ASCORBIC ACID] (VITAMIN C), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), VITAMIN E NOS (VITAMIN E) and BIOTIN for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced MALAISE (Felt Sick), ILLNESS (Got very ill), PYREXIA (Fever of 104 degrees Fahrenheit for 3 days), PERIPHERAL SWELLING (arm was big and round), PERIPHERAL SWELLING (arm was so swollen it would not fit in her sleeve), PRODUCT DOSE OMISSION ISSUE (Patient has not received second dose of Moderna COVID-19 vaccine, with first dose being given 21JAN2021 /  Patient claiming they will decide to not get the second dose of the Moderna COVID-19 vaccine.) and MYALGIA (body ached so bad). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Jan-2021, MALAISE (Felt Sick), ILLNESS (Got very ill), PYREXIA (Fever of 104 degrees Fahrenheit for 3 days), PERIPHERAL SWELLING (arm was big and round), PERIPHERAL SWELLING (arm was so swollen it would not fit in her sleeve), PRODUCT DOSE OMISSION ISSUE (Patient has not received second dose of Moderna COVID-19 vaccine, with first dose being given 21JAN2021 /  Patient claiming they will decide to not get the second dose of the Moderna COVID-19 vaccine.) and MYALGIA (body ached so bad) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 104 (High) ..     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 medication include cranberry pill once a day.
Invalid dose administered from a vial that had been punctured and administered for a period greater than 6 hours; 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 (Invalid dose administered from a vial that had been punctured and administered for a period greater than six hours) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Invalid dose administered from a vial that had been punctured and administered for a period greater than six hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Invalid dose administered from a vial that had been punctured and administered for a period greater) had resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Expired Vaccine Used for mRNA-1273 (Lot #: Unknown)  with no associated AEs.
reoccurrence of positive covid test; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (reoccurrence of positive covid test) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Sjogren's and Drug allergy. Concomitant products included PREDNISONE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 19-May-2022, the patient experienced COVID-19 (reoccurrence of positive covid test). At the time of the report, COVID-19 (reoccurrence of positive covid test) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.Concomitant product included Hydroxcflorine.  Company comment: This spontaneous case concerns a 86-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving first dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 7-May-2022 to 12-may-2022.She was tested positive 7 days after the treatment with Paxlovid. SARS-CoV-2 test positive on 19-may-2022. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 86-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving first dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 7-May-2022 to 12-may-2022.She was tested positive 7 days after the treatment with Paxlovid. SARS-CoV-2 test positive on 19-may-2022. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Morbiliform rash face, ears, neck; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206), via an unspecified route of administration on 15Mar2021 in left arm as single dose for COVID-19 immunisation in Doctor's office/urgent care. The patient's medical history included arthritis, blood pressure and cholesterol. no known allergies. Patient was not pregnant at the time of vaccination. Concomitant medications included secukinumab (COSENTYX), leflunomide, duloxetine, atorvastatin and Traza. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198) on 19Feb2021 in right arm at the age of 64-years for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced Morbiliform rash face, ears, neck on 25Mar2021 at 02:00 PM. Events resulted in Doctor or other healthcare professional office/clinic visit. The patient received steroid as treatment for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sinus congestion; minor cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP),   A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SINUS CONGESTION (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown", described as "minor cough".  Additional information: After a trip, my wife and I tested positive for Covid. Thanks to our Pfizer vaccinations and booster shots, we breezed through recovery. Except for a little sinus congestion, and a minor cough, we had no other symptoms. No fever, no loss of taste, no tiredness, nothing. We have had colds that were worse. Considering over a million died from this virus, we feel very fortunate. The vaccine works.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a 60 year old female with no known drug allergies, and had pericarditis and a history of back problems who "about one month ago" (in approximately August 2010), was vaccinated with a dose of ZOSTAVAX (Merck) (LOT# not reported). "About one week ago" (on approximately 21-SEP-2010) the patient experienced a zoster like rash located all over her body after administration of ZOSTAVAX (Merck). Patient was examined by another physician and diagnosed with zoster. She was prescribed acyclovir four times a day for 5 days. This physician would examine the patient later on the reported day. The patient was complaining of severe pruritis. There was no lab diagnostics studies performed. At this time of reporting, the patient was not recovered. Follow-up information was received from the physician who reported that the patient's condition turned due to poison ivy, and was not related to vaccination. The patient was seen by dermatologist. On 10-OCT-2010, the patient was recovered. Physician did not administer the vaccine to the patient. No further information is available.
Pt describes that MD say pt has mild chicken pox symptoms including blister and rash due to vaccine.
Developed food allergies: whole wheat, walnuts, almonds & peanuts a few weeks after second injection. . At doctors directions took multiple doses of Benadryl until systems subsided.
Pain in affected vaccinated arm followed by blistering over several days tiredness and nausea and vmiting
Prev dose brand= Johnson and Johnson, Prev dose administration date= 07Apr2021 / Prev dose brand= Pfizer Booster FH8027, Prev dose administration date=20Nov2021; Really bad night sweats; Other vaccine same date product=Flaurix; Other vaccine same date product=Flaurix; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Oct2022 at 13:00 as dose 3 (booster), single (Lot number: GH9702) at the age of 82 years, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 29Oct2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: TRAZONE [TRAMADOL HYDROCHLORIDE]; VIT C; CALCIUM + MAGNESIUM; ARNICA EXTRACT. Vaccination history included: BNT162b2 (Dose 2 (Booster), Single; Administration site: Left arm; Batch/Lot No. FH8077), administration date: 20Nov2021, when the patient was 81-year-old, for COVID-19 immunization; johnson and johnson (Dose 1, Single; Administration site: Left arm; Batch/Lot No. 042A21A), administration date: 07Apr2021, when the patient was 80-year-old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 29Oct2022, outcome "unknown" and all described as "Other vaccine same date product=Flaurix"; NIGHT SWEATS (non-serious) with onset 30Oct2022 at 15:15, outcome "unknown", described as "Really bad night sweats"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Prev dose brand= Johnson and Johnson, Prev dose administration date= 07Apr2021 / Prev dose brand= Pfizer Booster FH8027, Prev dose administration date=20Nov2021". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of night sweats.  Additional information: Other medications in two weeks was reported as Trazone Vit C Calc-Mag 1 a day Homeopathic Arnica. Known allergies were reported as none.  The information on the batch/lot number for (BNT162B2, BNT162B2 OMI BA.4-5), has been requested and will be submitted if and when received.
Prominent left axillary lymph nodes in area of left arm and breast. Had to get mammogram and ultrasounds done. Extensive lymph swelling and pain in left axillary area.
itch, then rash/hives & cough; remedied w/Adrenaline, DPH, Prelone
This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018) (dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (°F) to 77 degrees Fahrenheit (°F) (60.33 °F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Approximately 48 hours after vaccination, I began to experience a substantial reduction in my ability to smell. In particular, my ability to smell retronasally (i.e. to detect aromas while eating and drinking) is diminished. 12 days later, I'm still experiencing this form of hyposmia.