chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at injection iste; Swelling at injection site; Lightheadedness; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Pain at injection iste), VACCINATION SITE SWELLING (Swelling at injection site), DIZZINESS (Lightheadedness) and FATIGUE (Fatigue) 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 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection iste), VACCINATION SITE SWELLING (Swelling at injection site), DIZZINESS (Lightheadedness) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (Pain at injection iste), VACCINATION SITE SWELLING (Swelling at injection site), DIZZINESS (Lightheadedness) and FATIGUE (Fatigue) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable.  No concomitant medications were provided.  No treatment medications were provided.
12/29-- Chills, moderate arm soreness, malaise, fever 12/30-- fever 100.6 F, moderate to severe right arm soreness, nausea/vomiting, malaise 12/31- low grade fever (99.6 F), chills, mild soreness
4hr p/vax skin rash-very itchy cleared up p/1 day;lump started 3-4 days p/shot;same area as prev rash-red but not hot-lump getting bigger;now size of a quarter;all rxn in lt arm
Could not get out of bed for 4 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (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: BEDRIDDEN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Could not get out of bed for 4 days". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Information: The patient reported that she had been having ever since I had the first shot. The patient reported that she was scared to take the second shot. The patient reported that she took the first shot probably seven months ago (not clarified further) and she could not get out of bed for 4 days and she was scared to take the second shot or if she needed to go to Johnson & Johnson, may be that is what should she do, she did not know.  Follow-up (20Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Moderna, Administration Dates: 04May2021, 26May2021 / Pfizer, Administration Dates: 08Dec2021, 03May2022, 13Dec2022; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 08Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) and on 03May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04May2021 as dose number unknown, single (Batch/Lot number: unknown) and on 26May2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "small thyroid nodule" (unspecified if ongoing).  The patient had no known drug allergy. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna, Administration Dates: 04May2021, 26May2021 / Pfizer, Administration Dates: 08Dec2021, 03May2022, 13Dec2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of interchange of vaccine products, drug ineffective, covid-19 which included taking PAXLOVID from 06Oct2023 to 10Oct2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
I have developed a rash that is all over my bodyseveral months after my 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (I have developed a rash that is all over my bodyseveral months after my 2nd dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (I have developed a rash that is all over my bodyseveral months after my 2nd dose). At the time of the report, RASH (I have developed a rash that is all over my bodyseveral months after my 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.
Local erythema, edema, warmth and tenderness of left arm from deltoid down to elbow.
3 hours of sweats severe myalgias chills, relieved by acetaminphen, 12 hours after vaccination.
fever; Lips like has botox/both lips/Swollen lips; Little headache; Little pain in the arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Little pain in the arm), LIP SWELLING (Lips like has botox/both lips/Swollen lips), HEADACHE (Little headache) and PYREXIA (fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergy to tetracycline.).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Little pain in the arm) and HEADACHE (Little headache). On 13-Feb-2021, the patient experienced LIP SWELLING (Lips like has botox/both lips like Miss Pinky/Swollen lips). On 14-Feb-2021, the patient experienced PYREXIA (fever). The patient was treated with ACETAMINOPHEN for Fever, at a dose of UNK dosage form; LORATADINE (CLARITIN [LORATADINE]) ongoing since an unknown date at a dose of UNK, q12h and ACETAMINOPHEN for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Little pain in the arm), HEADACHE (Little headache) and PYREXIA (fever) outcome was unknown and LIP SWELLING (Lips like has botox/both lips like Miss Pinky/Swollen lips) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Body temperature: 102.4 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include Vitamins. Treatment information included  popsicles.
After my first dose on October 8, 2021 I started to have mild but frequent, daily, headaches. After the second dose almost instantly my headaches had intensified to moderate.  The headaches start about an hour after I wake up in the morning and last all day.  If I take ibuprofen in the morning they will go away but I have to take more ibuprofen mid day/afternoon or else the headaches come back.  If I do not take ibuprofen the headaches last the entire day.
Painful hives/Burning hives/Itching hives/Big hives that covered her whole body from head to toe; Itching hives; Patient stated it felt like she was burning out her skin; Painful hives; Feeling hot; Flushing; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Painful hives/Burning hives/Itching hives/Big hives that covered her whole body from head to toe), PRURITUS (Itching hives), SKIN BURNING SENSATION (Patient stated it felt like she was burning out her skin), PAIN (Painful hives) and FEELING HOT (Feeling hot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypersensitivity reaction, Drug allergy (Heart rate increase), Allergy (Once trouble waking up and another time woke up prematurely), Asthma and Hay fever.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Painful hives/Burning hives/Itching hives/Big hives that covered her whole body from head to toe), PRURITUS (Itching hives), SKIN BURNING SENSATION (Patient stated it felt like she was burning out her skin), PAIN (Painful hives), FEELING HOT (Feeling hot), FLUSHING (Flushing), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, URTICARIA (Painful hives/Burning hives/Itching hives/Big hives that covered her whole body from head to toe), PRURITUS (Itching hives), SKIN BURNING SENSATION (Patient stated it felt like she was burning out her skin), PAIN (Painful hives), FEELING HOT (Feeling hot), FLUSHING (Flushing), CHILLS (Chills) and PYREXIA (Fever) had resolved.     No concomitant medications were reported.  Treatment details included Benadryl and Benadryl cream which did not help at all.   This case was linked to MOD-2021-258907 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Significant follow-up received on 13-Aug-2021: Medical history and event outcome updated
Information has been received from a registered nurse reporting on an unknown number of patients of unknown ages and genders. There was no information about the patients' concurrent conditions, medical history or concomitant medication. On unspecified dates in September 2017 (reported as "on or after  07-SEP-2017 "), the patients received improperly stored doses of PROQUAD for prophylaxis lot # M021427 expiry date 29-OCT-2017 or lot # N010867 expiry date 01-OCT-2018 (anatomical location, dose and route of administration were not reported), that were reconstituted with properly stored sterile diluent. It was reported that on an unspecified date, the vaccines were exposed to a temperature between - 9 Celsius degrees and 8 Celsius degrees for 11 hours. The vaccine underwent a previous temperature excursion between - 9 Celsius degrees and 8 Celsius degrees for 2 hours. The call was placed because of a Digital Data logger report. No adverse effects were reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA012268.
This is a spontaneous report from a non-contactable physician via a Company representative. A 75-year-old female patient received PREVNAR 13, via an unspecified route of administration on 11Apr2017 at 0.5 ml, single in the upper left arm for immunisation . Vaccine Lot number and expiration date were not provided.  The patient medical history and concomitant medications were not reported. After vaccination on Apr2017 the patient experienced initially very tender large area around the injection that became swollen, hot to touch, chills, the whole upper left arm became swollen and bright to the color and resulted in cellulitis. The patient received treatment  with antibiotics for cellulitis. The outcome of the events was unknown.; Sender's Comments: Based on the compatible temporal association, the event "cellulitis/whole upper left arm become swollen and bright to the color" is assessed as related to PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Minor Swelling/itching,warm at injection site.  Low grade fever, body ache, nausea
pt recv vax & approx 30sec p/vax pt lost consciousness, started to slide out of chair & seized (jerking motions of all extremities);jerking lasted 20sec;pt wasn't incontinent;pt skin was cool & clammy, BP 80/40;pt yawned frequently;
Patient received her first dose of Pfizer vaccine on 4/1/21.  Patient has a stroke 4/6/21 and passed away on 4/10/21.
This is a spontaneous report from a contactable other health professional via a Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date in Oct2017, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site/pain on her arm and circulation problem both on an unspecified date with outcome of unknown. The patient went to the emergency room because of the events and called the doctor's office and asking for some information about Prevnar 13.
Vial stored in Refrigerator on 11-JAN-2022, Expired on 05-MAY-2022 and administered on 28-FEB-2022; patient was administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Vial stored in Refrigerator on 11-JAN-2022, Expired on 05-MAY-2022 and administered on 28-FEB-2022) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 044B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored in Refrigerator on 11-JAN-2022, Expired on 05-MAY-2022 and administered on 28-FEB-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Vial stored in Refrigerator on 11-JAN-2022, Expired on 05-MAY-2022 and administered on 28-FEB-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. On 28-Feb-2022, patient took first booster.  The vial was initially stored in the refrigerator on 11-Jan-2022 and vial did not undergo any temperature excursions, total number doses were 84 doses total administered to 82 patients total (2 of the patients received 2 doses from the same lot and their 1st and 2nd primary series dose from the same affected lot. Reportedly, the vial didn't undergo any temperature excursions. No treatment details were provided
23 hours after vaccination I just had to lie down and was what I call delirious, not knowing anything except kicking the covers freezing, then hot.  First reaction was nausea and couldn't eat anything.   It lasted from 10AM on 03/12/2021 until 10AM on 03/13/2021      I had the Corona  19 virus the last two weeks of November, 2020.   Emergency room at Hospital afte I had been sick for the 2 weeks, the doctor at the hospital thought I was practically over it so released me.
Horrible rash where the shot was given, red and elevated from the skin, three mosquito bite like dots inside the round rash. Mosquito bite like dots all over my back, neck and ears. My body feels very weak.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiration date and route was not reported). No concomitant medications were reported. On an unknown date, the patient developed injection site reactions after receiving PNEUMOVAX 23. The patient had redness and soreness at the injection site. The outcome of the reported events were unknown at the time of this report. This is one of the two reports received from the same reporter. Additional information has been requested.
Dose 1 (12/16/20 9:30 am): L arm pain, malaise, fatigue, myalgias lasting 48 hours  Dose 2 (1/06/21 9:30am): L arm pain, malaise, fatigue, myalgias, severe rigors starting at 2am and lasting 3 hours
Coughing, head/face hot and flushed, body very warm, but simultaneously with chills, aches and fatigue.  Gave Tylenol and liquids to drink.  Symptoms lasted approximately 36-48 hours.
Seven days after Moderna vaccine I got up and started feeling a warmth in my leg that started in foot and went up and it started hurting really bad, called an ambulance and went to hospital and because of blood clots, I had to have emergency surgery, it was very huge arterial clot, and developed shingles as well.
Appendicitis; This is a spontaneous report received from a non-contactable consumer (patient reported for herself). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (at the age of 51 years old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication in four weeks included influenza vaccine (FLU) taken for immunisation. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. No other medications the patient received within 2 weeks of vaccination. The patient experienced appendicitis 9 days after 1st dose (hospitalization, medically significant, life threatening) on an unspecified date. The patient was hospitalized for appendicitis for 2 days. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was recovered with lasting effects. Treatment received for the adverse event was Appendectomy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19: Covid test type post vaccination was Nasal Swab (results unknown). The outcome of the event was recovered with sequelae on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client was vaccinated with Moderna vaccine in April 2021 (client not sure of dates but knows they were in beginning and end of April, perhaps 4/2 and 4/30/2021).  Became symptomatic for Covid with sore throat and loss of taste/smell on 8/26.  Tested rapid positive for Covid 8/27.  Reported as breakthrough case of Covid in a fully vaccinated person.
No adverse effect; improperly stored vaccine administered; This spontaneous report was received from a health care professional regarding a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions, concomitant medications and drug/allergies were not reported. On 30-SEP-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R028003 and expiry date:01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). No adverse effects were reported. There was no previous temperature excursion. The vaccine was stored above 47 °F to 53.7 °F for a time frame of 6 hours 16 minutes. Data logger was present.
arm pain, aching/throbbing and warmth 6/14, followed by redness and swelling of upper arm. Pt evaluated at the ER, 6/18 VS unremarkable, well appearing and non-toxic per ER report. Treated with IM rocephin, PO Keflex, tylenol and motrin and discharged Returned to ER 6/19 for increased area of redness of arm. PEr er report confluent area of skin rednes to L upper arm, measuring an inch beyond skin marker, exam otherwise normal. Blood culture, lactic  acid, CBC, CMP, prolactin unremarkable per note. 1500ml Vancocin in dextrox 5% 500mL IVPB administered. Discharged home with prescription for bactrim, for f/u with PCP for management of cellulitis.   Pt seen for follow up appointment by this provider 6/21/22 in office, noted gradual improvement in arm pain and swelling, mild spread of redness beyond marked off area mid arm, mild tenderness at injection site, improved per pt, no abscess or drainage, normal shoulder exam, no increased warmth. Area marked, Pt instructed to continue antibiotic as ordered and call if not improving in 24hrs.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow-up included narrative updated.
Hospitalization for treatment of abdominal blood clot on 4/23/2021.  5 day inpatient stay