chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Malaise; Body ache; significant painful swollen lymph node under left armpit; fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), MYALGIA (Body ache), LYMPHADENOPATHY (significant painful swollen lymph node under left armpit), PYREXIA (fever) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event (Medical history not provided).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced MALAISE (Malaise), MYALGIA (Body ache), LYMPHADENOPATHY (significant painful swollen lymph node under left armpit), PYREXIA (fever) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise), MYALGIA (Body ache), LYMPHADENOPATHY (significant painful swollen lymph node under left armpit), PYREXIA (fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: positve positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Client received covid vaccine @ 2:15pm in left arm, complained of tingling in same arm down to elbow @ 2:20 pm.  Client denies any shortness of breath, tightening of throat, chest pain.  Denies itching, no swelling or redness noted at site.  Client denies any medical conditions, not taking medication, denies allergies.  Vital signs assessed, all within normal limits.  Client advised to continue with observation.  At 2:42 pm, client reports tingling has resovled, states she needs to leave at this time.  Client advised to complete observation, also educated to follow up with primary care and ER precautions given.  Vital signs stable, client leaves with steady gait @ 2:45 pm.
mom brought pt in for immun informed pt had gotten sick p/both set of immuniations; having nausea, vomiting & t101; no bowel movements; 13MAY93 to PMD for conjunctivitis;
Diarrhea; Stomach ache; Second dose given on day 37; Fever, 39°C; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach ache), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 37) and PYREXIA (Fever, 39°C) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 37) and PYREXIA (Fever, 39°C). On 07-May-2021, the patient experienced DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach ache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 05-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 37) had resolved. On 07-May-2021, PYREXIA (Fever, 39°C) had resolved. At the time of the report, DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Body temperature: 39 (abnormal) fever of 39°C.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.   This case was linked to MOD-2021-114377 (Patient Link).
First dose: headaches; This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, ( Batch/Lot Number: EW0150), via an unspecified route of administration in Arm Left on 06Apr2021 15:00 as 1st dose, single dose and received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection,( lot# EW0172, NDC/Expiry not known) via unspecified route of administration in the left arm on 27Apr2021 as 2nd dose, single dose for COVID-19 immunisation. Medical history included ongoing migraine verbatim: migraines. Concomitant medications included tylenol, excedrin, sumatriptan, reyvow taken for an unspecified indication, start and stop date were not reported. The patient experienced after first dose headaches on unspecified date Apr2021. The event was assessed as non-serious. Therapeutic measures were taken as a result of first dose: headaches.The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room visit. On 19May2021 the patient underwent lab tests and procedures which included blood count: unknown and computerized tomogram: negative. The patient received the second Covid 19 vaccine on 27Apr2021 and she started getting headaches probably the next day on 28Apr2021 and the headaches just keep going on. They are pretty much staying the same. They are pretty much staying the same. The headaches do get better with medication. She's fine in the morning but by lunchtime she has a full blown headache. She says it's positional. When asked to clarify she reports it gets better when she's laying down but she's also taking medication so she doesn't know if the laying down is helping or the medication is helping. Her headaches are very cyclical. She does report a history of migraines. She was diagnosed around this time last year in 2020. She had had migraines undiagnosed prior. She reports her migraines are well controlled. She was in contact with her neurologist on 05May2021 or 06May2021. She was seen by her neurologist on 10May2021, 11May2021, and 17May2021. Her neurologist instructed her to go to the emergency room yesterday, on 19May2021. She had a CT scan of her head done yesterday and blood work. At her neurologists office she had an injection in her skull. She doesn't know the name of the medication used. She was given a cocktail of generic Toradol, Benadryl, and Zofran. The outcome of the event was recovered.  Follow up (20May2021): This is a follow up spontaneous report from a contactable consumer. This 59 year-old female consumer (patient) reported that: Pfizer Suspect Vaccine and Vaccination Details ( Dates for first and second dose), Medical history and Concomitant medication, Clinical information added.
PATIENT HAD NAUSEA, FEVER, VOMITING WAS TAKEN TO URGENT CARE 2 TIMES
Blood pressure spiked up above 200/117 for several weeks; More than 35 days from 1st vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure spiked up above 200/117 for several weeks) and PRODUCT DOSE OMISSION ISSUE (More than 35 days from 1st vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure spiked up above 200/117 for several weeks) and PRODUCT DOSE OMISSION ISSUE (More than 35 days from 1st vaccination). The patient was treated with LISINOPRIL for Blood pressure, at an unspecified dose and frequency and METOPROLOL for Blood pressure, at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure spiked up above 200/117 for several weeks) was resolving and PRODUCT DOSE OMISSION ISSUE (More than 35 days from 1st vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 200/117 (High) 200/117 High Blood Pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug information was provided by reporter.   Reporter did not allow further contact
blood sugar has dropped; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 84-year-old male patient received BNT162b2 (COMIRNATY), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "blood sugar has dropped". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Reporter's 84 year old Diabetic brother in law also got the Pfizer Covid19 2nd booster vaccine on Monday and said that his blood sugar has dropped since getting it. Reporter is asking if this is a side effect of the booster vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Started with unproductive coughing, was awake for about 2 hours that night from coughing, the same the following night but worse. Friday morning, I still went to work although I felt misserable. I also had diarrhea. By 9:15, I had to ask my superior to get me a substitute because I had to leave. I was chilly and I did not have any energy. I went home and slet all day. I woke up to a terrible headache and fever. All Friday night, I kept waking up because of headache and coughing. Today is Saturday and I still have fever, coughing and headache. Had I known that this is what I will get after a flu shot, I would never have gotten it in the first place.
He received Engerix-B today. The product expired 8-NOV-2022/Expired Drug Used; This case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a adult male patient who received HBV (Engerix B adult) (batch number unknown, expiry date 8th November 2022) for prophylaxis.   On 11th November 2022, the patient received Engerix B adult. On 11th November 2022, unknown after receiving Engerix B adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional Information: GSK receipt date: 11-NOV-2022 Reporter's comment: The reporter was the adult patient. He had received Engerix-B on the day of reporting.  The product was expired 8 November 2022. Nothing else was reported. The reporter wished to remain anonymous and had declined to provide demographics or lot number. The reporter had denied to provide further contact details. Additional supportive information: The patient had received an expired dose of Engerix-B, which had led to expired vaccine used.
Patient has not come on menstrual cycle which was due 1Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Patient has not come on menstrual cycle which was due 1Apr2021) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 01-Apr-2021, the patient experienced MENSTRUATION DELAYED (Patient has not come on menstrual cycle which was due 1Apr2021). At the time of the report, MENSTRUATION DELAYED (Patient has not come on menstrual cycle which was due 1Apr2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She had three negative pregnancy test .
Fainted after receiving injections. Per mom this is normal response after receiving injections occurs 10-15 min after that pt faints. Vital signs were stable.
Vasovagal syncope:  suddenly felt extremely sick the next morning.    Went to bathroom, thought I might vomit.  Passed out, hit face on floor, needed stitches in brow and chin, split lip, broke tooth.    The sick feeling lasted maybe 10 minutes before passing out.  Did not notice it again after regaining consciousness.
First dose to a patient who is under 18 years of age by a couple months; A spontaneous report was received from a pharmacist concerning a patient under 18-year-old, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown), unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient who is under 18 years of age by a couple months received Moderna's COVID-19 vaccine (mRNA-1273).  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, patient who is under 18 years of age by a couple months received Moderna's COVID-19 vaccine (mRNA-1273) was considered resolved.; Reporter's Comments: This report refers to a case of Inappropriate age at vaccine administration for mRNA-1273, batch number - unknown, with associated AEs.
Pt presented to the ED on 1/14/22 for weakness, dark tarry stools and vomiting x2 days.  Denied chest pain, chills, headache, SOB.  XR Chest 1V [Auth (Verified)] (01/14 2018): FINAL IMPRESSION: Cardiomegaly with an atherosclerotic tortuous aorta.Right perihilar atelectasis versus fibrotic change.  Pt admitted for GI bleed.  Remained asymptotic for COVID through hospitalization.  Was discharged 1/27/2022.  Previously vaccinated Pfizer 2/1/21 & 2/23/21.
Pt received vaccines at HMV on 7/16/19- Tdap, Menactra and HPV.  That evening on left arm where Tdap and Menactra were given pt noticed small location reaction at injection site.  Everyday since then has worsened.  on 7/18 it was painful and pruritic.  7/19 less painful but very pruritic.  Larger area on 19th than 18th.  No fevers. No other hives or rashes noted.  No v or d.   left upper arm with 4in erythematous edematous warm to touch area with pruritus and mild tenderness on palpation.  37.5 mg benadryl given in office waited 25 mins no change in area.  Area unchanged with benadryl so 7 days of Cephalexin treatment done, arm felt/looked better after antibiotics
Lethargy; swollen and painful arm and armpit; swollen and painful arm and armpit; swollen and painful arm and armpit; chills; nausea; headache; muscle aches all over body; restlessness in muscles (feel like she had to flex everything); This is a spontaneous report received from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via unspecified route of administration in left arm on 12Feb2021 12:30 PM (at the age of 25-year-old) as 2nd dose, single for COVID-19 immunisation. Vaccine facility type was reported as hospital. The patient's medical history included depression and anxiety, both from unspecified date. No known allergies and no COVID prior vaccination were reported. The patient's concomitant medications reported as within two weeks from vaccination included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (reported as generic ADDERRAL), duloxetine hydrochloride (reported as generic CYMBALTA), both from unspecified date. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in left arm on unspecified date as 1st dose, single for COVID-19 immunisation. The patient did not receive other vaccines within 4 weeks from vaccination. On 13Feb2021 12:00 AM the patient experienced lethargy, swollen and painful arm and armpit, chills, nausea, headache, muscle aches all over body, restlessness in muscles (feel like she had to flex everything). Treatment for the events were received and reported as patient took lots of extra strength paracetamol (TYLENOL). Patient had not been tested post vaccination. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information is expected.
Sore arm immediately, flulike symptoms beginning the next morning including: headache, body aches, shivering, inability to get warm, lightheadedness, and fatigue.
Ongoing symptoms :  shortness of breathe, nausea, no appetite, no taste or smell, joint Pain, exhaustion, mental confusion
THROAT NUMB; UVULA NUMB; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) .5 ml, administered on 06-MAR-2021 11:45 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021 12:30, the patient experienced throat numb. On 06-MAR-2021 12:30, the patient experienced uvula numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throat numb, and uvula numb. This report was non-serious.
PREVNAR 13 vaccine was given then noted to be expired. Patient's physician notified, will notify parent and revaccinate.
He has parkins She said it will be a least another 3 weeks before he is out of the hospital; Caller stated that her husband was in the hospital; This is a spontaneous report from a contactable consumer (patient's wife). This is a spontaneous report from a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that her husband was in the hospital when it was time for his second dose. He has parkins. She said it would be at least another 3 weeks before he was out of the hospital. She wanted to know if he should start over with the vaccines or just get a second dose even though it was way over the 21 days. The outcome of event was unknown.  Information about the lot/batch number has been requested.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Within hours of vaccine admin, patient experienced left arm pain from neck to forearm, paresthesia of entire left side of body, and headache.  Paresthesia resolved with 24 hours.  Radiating pain and headache persisted through evaluation in office 09/01/22.  Evaluated in office.  Treated with supportive care and muscle relaxer (baclofen)
Pt developed raised red, mottled area at injection site: surrounded by erythema to 3 1/2-4" in diameter and warm to touch.
Information has been received from a nurse practitioner, concerning a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 01-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II, lot number M016233 with expiration date in 31-MAR-2018 (strength, dose, dose number, route of administration and anatomical location were not provided), for prophylaxis. The M-M-R II dose was stored at a temperature range of 47 degrees Fahrenheit (degrees F) to 77 degrees F for the time frame of 15 minutes and 45 seconds. There was no previous temperature excursion and the call was because of a data logger. No adverse effects reported. Product Brand: M-M-R II; Lot number: M016233; Expiration Date: 31-MAR-2018; Date of administration of Vaccine:  01-FEB-2018.  Date of Excursion, Temperature of Excursion, Duration of Excursion: 06-FEB-18, 32.90 F degrees, 34 secs; 05-FEB-18, 48.5, 33.8 F degrees, 4 mins 30 secs; 01-FEB-18, 48.20 F degrees, 5 mins 13 secs; 31-JAN-18, 48.30 F degrees, 6 mins 2 secs; 30-JAN-18, 32.50 F degrees, 2 mins 3 secs; 29-JAN-18, 33.40 F degrees, 3 mins 10 secs; 28-JAN-18, 33.80 F degrees, 3 mins 22 secs; 27-JAN-18, 33.00 F degrees, 3 mins 3 secs; 26-JAN-18, 33.20 F degrees, 3 mins 37 secs; 25-JAN-18, 32.50 F degrees, 4 mins 55 secs; 24-JAN-18, 33.40 F degrees, 3 mins 36 secs; 23-JAN-18, 33.80 F degrees, 3 mins 30 secs; 22-JAN-18, 33.40 F degrees, 2 mins 56 secs; 21-JAN-18, 33.60 F degrees, 2 mins 55 secs; 20-JAN-18, 33.90 F degrees, 3 mins 23 secs; 19-JAN-18, 34.50 F degrees, 42 secs.
Fever that started Monday 06/20/22 and lasted until Tuesday 06/21/22 Rash that started Tuesday 06/21/22 and is current
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). A female patient received BNT162b2 (BNT162B2), in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "Since then Ive developed a few hard/ swollen lymph nodes in my neck.". The event "since then ive developed a few hard/ swollen lymph nodes in my neck." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: : In Feb2022, patient received 3rd dose of the Pfizer covid-19 vaccine. Since then, she developed a few hard/ swollen lymph nodes in my neck. She had been to a handful of doctors and had an MRI in July to confirm.  All the articles she read said these should go away but they're still large and hard in Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Arm could not move (frozen shoulder) due to the placement of the vaccine. Went to Primary Care, been sent to PT, did not work, going to see ortho, and get cortisone shot, but did not give full relief, still issues with mobility, can not put behind the chest. Can raise overhead more now.
Seen in ER for complaints of pain in right upper arm and a fever that started 6/12/12.  She received Pneumovax vaccine in right deltoid and since then it has become red, painful.
Experiencing what seems to be covid arm. Noticed on Saturday the area around my shot location on my arm is swollen and red,. At times is itchy. It seems to be less red today but the area is still visible. It is about the size of a baseball.