chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; sleepiness; arm soreness; occasional nosebleeds; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable consumer (patient) reported for herself. A 57-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient previously took ibrance 125 mg orally on 27Jan2021, for breast cancer for 21 days on and off for 7 days with ongoing and previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an un-specified date as dose 1, single for Covid-19 immunisation. Concomitant medication(s) included letrozole (LETROZOLE). The patient reported that she had some sleepiness, a little headache and arm soreness yesterday on an unspecified date. The patient states she had her Covid 2 vaccination on Tuesday and believes these were side effects from that and had already resolved today. Patient also reports her oncologist had her hold her adjunct therapy of letrozole the past 2 days due to vaccination and was resuming today and she was currently on her 7 days break for her ibrance. previously mentioned, occasional nosebleeds had resolved. no other side effects reported. She reported repeat blood work on Monday. MD unaware of side effects. The outcome of events recovered on unspecified date.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Feeling achy; exhausted; Headache; fever/fever of 101.3 degrees Farenheight; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Feeling achy), FATIGUE (exhausted), HEADACHE (Headache) and PYREXIA (fever/fever of 101.3 degrees Farenheight) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced MYALGIA (Feeling achy), FATIGUE (exhausted), HEADACHE (Headache) and PYREXIA (fever/fever of 101.3 degrees Farenheight). At the time of the report, MYALGIA (Feeling achy), FATIGUE (exhausted), HEADACHE (Headache) and PYREXIA (fever/fever of 101.3 degrees Farenheight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 (High) 101.3 degrees Farenheight.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment  medications were reported. Patient received her booster dose of the Moderna COVID-19 vaccine on 14-Dec-2021, theexpiration date was 02-Jan-2022. The patient received the booster dose in the right arm. The patient had no side effects or adverse events to the booster dose Patient with the family was at a wedding on 26-Dec-2021 and exposed to COVID-19 infected individuals. None of them caught COVID-19.   This case was linked to MOD-2022-567683 (Patient Link).
Left upper deltoid/shoulder pain aggravated by raising left arm above shoulder level and behind head x 1 month.
Itch. redness. induration pain. Since he got the vaccine. 0 fever . given Cephalexin - Benadryl - cold compresses.
PT CLAIMS NEXT DAY REDNESS AT INJECTION SITE WHICH TRAVELED DOWN ARM IN RECTANGULAR FORM(NOT HEAT RADATING OFF AND NO FEVER)
Nausea, severe rashes (hives) red and burning and itchy throughout  the body, second high fever that went up to 102.1 followed by chills and body ache, light headed ness and headache. Rashes occurred 10-12hrs after vaccine and got worse till was treated at a medical clinic and er. Had heavy heart rate of 120+  IV administered with diphenhydramine which is continued even now as slight rashes still exists and prednisone was given on Sunday April 19 2021 at 11:50am  Later since rashes still persisted was advised by the urgent clinic to go to ER where hydroxyzine was given
Patient developed flu vaccine reaction. Was given BENADRYL 25 mg IM injection and began to improve within 5 minutes. Was also given prednisone 30 mg PO. Provider noted: Chest is CTA without noted rales/wheezing. There is no noted shortness of breath.
Tiredness; Some achiness; Muscle aches more tenseand uncomfortable; Queasiness; This is a spontaneous report received from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 11Mar2021 at 09:45 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Relevant medical history included prediabetes and rheumatoid arthritis. Concomitant medication included omeprazole (MANUFACTURER UNKNOWN) taken for an unknown indication from an unspecified date. The patient previously received penicillin and sulphonamide and experienced an allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 11Mar2021, the patient experienced tiredness, some achiness and muscle aches. On 12Mar2021, the patient reported that the muscle aches were more tense and uncomfortable. On an unspecified date in Mar2021, the patient experienced queasiness. Therapeutic measures included intake of VICKS flu syrup for the adverse events experienced. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events tiredness, aches, muscle aches and queasiness were resolved on 13Mar2021.    No follow-up attempts are needed. No further information is expected.
Dx w/ COVID 5 days PTA. Was admitted for one night after initial dx, then sent home. RTER for N/V and hypoxia, dx w/ COVID pna. Fully vaccinated 3/2021. O2, azithro/rocephin, steroids. Did not require remdesivir or plasma. Weaned to RA. Discharged home.
Urticaria occurring 5 hours after vaccine. No other symptoms. Urticaria resolved with an appropriate weight based dose of oral Benadryl. Suspect this is not an allergic reaction but rather a delayed urticarial reaction.
A large local reaction to Flucelvax; This spontaneous case was received on 12-Nov-2020 from physician via Med Communications (reference number: SEQW20-05057) and concerned an adult, female patient. The patient's age at the time of reporting was 24 years.   The patient's medical history and concomitant medications were not reported.  On unspecified date in 2019, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, indication, dose, anatomical location and route of administration: not reported). The batch number was not reported.  On unspecified date in 2019, an unknown amount of time after receiving Flucelvax QIV, the patient was having a large local reaction to Flucelvax.  The outcome of the event was not reported.  The reporter assessed the event to be related to Flucelvax QIV.  This case is linked to 202006474 (the same patient).  Company comment: The patient developed local reaction an unknown amount of time after receiving Flucelvax QIV. Although onset date for the event was not provided, narrative suggested plausible temporal relationship. The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed local reaction an unknown amount of time after receiving Flucelvax QIV. Although onset date for the event was not provided, narrative suggested plausible temporal relationship. The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Fluzone Quadrivalent 0.25 mL was administered to a 14 year old boy instead of the Fluzone Quadrivalent 0.5 ml/No AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA281534 same reporter.  This case involves a 14 years old male patient who received 0.25 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot U6653BD, Expiration Date: 30-Jun-2020 via unknown route in the left deltoid on 04-Oct-2019, instead of 0.5 mL dose.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive other vaccines on that day.   It was a case of actual medication error due to vaccine underdose.  No side effects noted.  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.  Documents held by sender: none.
Noted about 1 week after vaccinated. Swelling of hands which comes and goes put on tapering doses of Prednisone which was not effective. Another doctor said he didn't think it was due to vaccine.
This spontaneous report was received from a 78 year old female patient, referring to herself. The patient was taking unspecified over-the-counter medications as concomitant therapies. There was no pertinent medical history, drug reactions or allergies. On 21-MAY-2018, the patient was vaccinated with a dose of ZOSTAVAX Injection, subcutaneously, for prophylaxis (reported as "prevention of shingles") (strength, lot number and expiration date were not reported). The patient reported that one day after being vaccinated with ZOSTAVAX, on 22-MAY-2018, she experienced an unspecified rash, headache, redness and soreness around the injection site. The patient did not seek medical attention and no treatment was given for the events. The outcome of the events was reported as not recovered. The patient did not provide a causal relationship between the events and vaccination with ZOSTAVAX.
MODERNA COVID VACCINE #3 GIVEN 11/11/2021, LOT #939904; 2/22/22 pt had a positive COVID test at Hospital in and was admitted with COVID pneumonia; stayed in hospital x 4 days, then dc'd to home with prednisone Dosepak and doxycycline; since he's been home his sx have worsened; nausea, vomiting, dyspnea, fatigue, dizziness, fever, cough; 3/10/22 admitted to Hospital; CXR shows bilateral pneumonia; CT of abdomen shows cirrhosis, splenomegaly; given ABX; worsening respiratory status requiring ICU and intubation; 3/27/22 extubated; respiratory status worsened; pt on maximum Vapotherm; status changed to DNR and comfort care since he wasn't improving; pt passed away in the hospital
Nausea, lightheadedness, and fatigue noticed the morning after vaccinations.  Needed to stay in bed all day due to lightheadedness.  Nausea improved with zofran.  Symptoms gradually improving.
Tinnitus in her right ear; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus in her right ear) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 032L20A) for COVID-19 vaccination.     No medical history reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced TINNITUS (Tinnitus in her right ear). At the time of the report, TINNITUS (Tinnitus in her right ear) outcome was unknown. Not Provided          Concomitant medications were not reported.  No treatment information was reported.  Per reporter, the patient's was being getting an ENT referral from her primary care doctor.    Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Reporter has no further information about the event.
Left arm pain for 48 hours immediately following vaccination; redness/swelling/itchiness around injection site onset 8 days after vaccination
Sore throat. Fever 102 degrees. Chills, shaking, mucus secretions. Coughing voice still irritated, hoarse.
Painful left neck-TYLENOL or MOTRIN, ice, heat, ROM (range of motion).  Began am after vaccines given resolved in few days.
Right thigh swollen, red area around injection site. Hives followed 3-5 days later.
Severe nausea; This is a spontaneous report from a contactable physician (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a 1st dose, single for covid-19 immunisation. Medical history included skin condition (skin disorder). Concomitant medications included methotrexate and infliximab (REMICADE) taken for skin disorder. She reported that she was on remicade which was a monoclonal antibody drug and there was a specific question before the vaccine they ask are you on a monoclonal antibody drug and she says that answer would always be yes for her. After her first COVID vaccine she had severe nausea and that went away. She stated that she would have to try and figure out when her first dose was, she did not remember the date, but her nausea was 2 days later after the first dose and it lasted for about 12 hours. She confirms the nausea was recovered completely at this time.  Information on lot/batch number is not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.
Malaise, chills, flushed, temperature of 99.1 with concurrent antipyretics (acetaminophen 1000mg PO Q6H) starting approximately 20 hours post-vaccination
Received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037k20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-370033, MOD-2021-370217, MOD-2021-370033 (Patient Link).
This spontaneous report was received from a nurse practitioner via company representative and refers to a several unspecified patients of unknown ages and genders. Historical condition for all the unspecified patients included shingles before vaccination. On an unknown date, the several unspecified patients were vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot # and expiration date were not informed). After they were vaccinated, then they developed shingles on unspecified dates. No product quality complaint was involved. At the time of the report, the outcome of shingles was unknown. The relatedness of the adverse event and suspect therapy was not provided. Additional information is not expected because the physician cannot be contacted.
Information has been received from an office manager referring to an unspecified number of patients of unknown age and gender. There was no information regarding concomitant medication, pertinent medical history or drug reactions/allergies. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M025192 with expiration date 21-MAR-2019; dose unknown, route was not reported). The vaccine was exposed at 35 Fahrenheit for 24 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
did a test for COVID which was positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (COMIRNATY), administration date 09Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Nov2021, outcome "unknown", described as "did a test for COVID which was positive". The event "did a test for covid which was positive" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: patient got COVID a week after first dose. The caller got his first COVID 19 vaccine (Pfizer covid 19 vaccine confirmed), and got sick a week later. He is calling to report that. He didn't get sick after the vaccine. He got the vaccine, and the following week he started getting a head cold that moved into his chest. He was away from home when he was sick so when he got back, he went to the doctor. The doctor check him out and did a test for COVID which was positive. He has went through his quarantine. As of tomorrow , he is okay to go to work. Caller received his first dose of the vaccine on 09Nov2021 and is due to receive his second dose on 30Nov2021. He is calling to ask a question. Now that he has had COVID how long does he need to wait to get his Pfizer COVID second dose? It turned out someone at his job had COVID, and he didn't find out until a couple of days after ward.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 28-MAR-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and lot # not reported) intramuscularly. The nurse reported that a patient was inadvertently given a dose of PNEUMOVAX 23 from an expired vial. No adverse effect was reported. PQC filed to document that the lot number from the carton did not match the lot number from the vial of PNEUMOVAX 23. Additional information has been requested.
Intestinal issues, bleeding, diarrhea, pain now after visiting ER and getting medications
No adverse reaction. Patient given Moderna Monovalet booster instead of Moderna bivalent booster. Patient notified.
whole arm started to ache as if she was writing too much (shoulder to her hand); there is still mild itchy; red, raised rash at the injection site that was warm or hot to the touch; rash continued to grow and extending from 4cm above the elbow to above the shoulder on the injection side of the arm and started to wrap around the other side of the arm but never engulfing the entire arm; This spontaneous case was reported by a health care professional and describes the occurrence of RASH ERYTHEMATOUS (red, raised rash at the injection site that was warm or hot to the touch), RASH (rash continued to grow and extending from 4cm above the elbow to above the shoulder on the injection side of the arm and started to wrap around the other side of the arm but never engulfing the entire arm), PAIN IN EXTREMITY (whole arm started to ache as if she was writing too much (shoulder to her hand)) and PRURITUS (there is still mild itchy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included CICLOSPORIN (RESTASIS), DOXYCYCLINE, VITAMIN D3, CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID), ZINC and IBUPROFEN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced RASH ERYTHEMATOUS (red, raised rash at the injection site that was warm or hot to the touch), RASH (rash continued to grow and extending from 4cm above the elbow to above the shoulder on the injection side of the arm and started to wrap around the other side of the arm but never engulfing the entire arm) and PRURITUS (there is still mild itchy). On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (whole arm started to ache as if she was writing too much (shoulder to her hand)). On 06-Apr-2021, RASH ERYTHEMATOUS (red, raised rash at the injection site that was warm or hot to the touch), RASH (rash continued to grow and extending from 4cm above the elbow to above the shoulder on the injection side of the arm and started to wrap around the other side of the arm but never engulfing the entire arm) and PAIN IN EXTREMITY (whole arm started to ache as if she was writing too much (shoulder to her hand)) had resolved. At the time of the report, PRURITUS (there is still mild itchy) outcome was unknown.        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.   Treatment included Ice gel pack and Ibuprofen 200mg (2 tablets) for a total of 3 times
she got Covid; she got Covid; This is a spontaneous report from a contactable physician. A female patient (Patient Age: 18; Unit: Unspecified) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date t a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse that her first Pfizer Covid 19 vaccine and a couple of days later developed symptoms of Covid and tested positive. Stated that she recovered and had no symptoms.   Information on Lot/Batch number has been requested.; Sender's Comments: The reported symptoms of Covid with tested positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Patient experienced chest tightness and anxiety 5 minutes after vaccination. Onsite EMS was called vitals are HR 89  BP 160/79  99% O2 room air. Patient went home.
SIDS 25SEP93 family homeless & living in van; on 02 until wk a/death;