chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021 at 3:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 02-Nov-2021 at 3:40 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vial was stored in frozen storage which was in super cold freezer. On 19-Nov-2021 vial was went from super cold freezer to the refrigerator. 70 vials were still in the ultra cold freezer, 8 vials were in the refrigerator, so a total of 78 vials were affected.  Vaccine vial state changes were noticed and vial was never refrozen. None of the vials were punctured before the event. Temperature excursion remained for 1 month.  No treatment medications were reported.   This case was linked to MOD-2021-402935 (Patient Link).
Hives; Itchy rash; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 at 09:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) for an unknown indication from an unknown date and unknown if ongoing. On 09Apr2021 at 17:00, the patient experienced hives and itchy rash. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with antihistamines and steroid cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives and itchy rash were unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
3-4 hours after vaccines (and after dinner + dessert), developed hives, lip/tongue swelling, throat and chest discomfort and dyspnea;  then syncope.  Resolved after EPINEPHRINE, SOLUMEDROL, BENADRYL. 4/6/09 Received hospital medical records of 2/26-2/27/2009. FINAL DX: anaphylaxis Records reveal patient experienced facial swelling, bilateral pinna edema, rash, nausea, pallor, difficulty speaking, shortness of breath, chest discomfort & lightheadedness approx 2.5 hr s/p vaccinations.  Had eaten ice cream w/peanut butter.  Had syncopal episode & became obtunded while in ER.  Eats nuts/PB regularly.  Tx w/epi, IV steroids.  Rash resolved, swelling decreased.  Admitted overnight for observation.  No rebound & d/c to home w/epipen.  Already had allergist appt for coming mo.
At 1023 patient was into post vaccine approximately 10 minutes when complaining of feeling light headed.  He did not eat prior to vaccine.  Pt vital 136/118 Pulse 62, Pulse Ox 98%.  Patient given juice and crackers.  After 4 more minutes, patient stated he feels if he stood up, he would pass out.  Emergency Response called for further eval.  Patient refused further eval via ER.  Left facility at 1036, still feeling "something wasn't right".
Chills, body aches, headache, bones hurt all over, joint pain, severe back pain, kidney pain, fever, several fever blisters
Ear starting to feel "stopped up" or clogged; Mild ringing in left ear; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0217) via an unspecified route of administration in the left arm on 26Jun2021 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. 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 four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination.  On 26Jun2021  at 18:00, after her first vaccination, the patient experienced a very mild ringing in her left ear. The ringing had continued but was still mild at the time of this report. On 28Jun2021, the patient ear started to feel "stopped up" or clogged. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. The clinical outcome of the event mild ringing in left ear and ear started to feel "stopped up" or clogged was not recovered at the time of this report.
Fatigue; Joint pain; muscle aches; swelling at the injection site; scar tissue; anemia; Erosion of energy; itchiness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SCAR (scar tissue), ANAEMIA (anemia), ASTHENIA (Erosion of energy), VACCINATION SITE PRURITUS (itchiness at the injection site) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (few years ago). Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 07-Apr-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 SCAR (scar tissue), ANAEMIA (anemia), ASTHENIA (Erosion of energy), VACCINATION SITE PRURITUS (itchiness at the injection site), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), MYALGIA (muscle aches) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, SCAR (scar tissue), ANAEMIA (anemia) and ASTHENIA (Erosion of energy) outcome was unknown and VACCINATION SITE PRURITUS (itchiness at the injection site), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), MYALGIA (muscle aches) and VACCINATION SITE SWELLING (swelling at the injection site) had not resolved.        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.   Patient have been in the hospital for a blood transfusion.She was 3 units low.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received and added the events scar tissue,erosion of energy and anemia.
All the side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (All the side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    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 VACCINATION COMPLICATION (All the side effects). At the time of the report, VACCINATION COMPLICATION (All the side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history or concomitant medications provided.
This case was reported by a consumer via interactive digital media twitter and described the occurrence of influenza like illness in a female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu shot (received on an unknown date without any reaction). On 25th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced influenza like illness and feeling abnormal. On 25th February 2019, the patient experienced insomnia. On an unknown date, the outcome of the influenza like illness, insomnia and feeling abnormal were unknown. It was unknown if the reporter considered the influenza like illness, insomnia and feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient got the SHINGRIX last night of reporting and thought symptoms were at the extreme. The patient was not breaking out in hives and did not have an allergic reaction to it. It stopped the patient from working on the day of reporting in addition, the patient could not sleep until 4 AM last night. This was not very common and the patient felts like had been hit by a mack truck. The patient had the flu shot before and never had any reaction. The patient felt like had the flu or something worse. The patient asked that, how long was this supposed to last.
I started feeling a sore arm that evolved into a fever 101.3. My body and joints ached.  Felt generally yucky. Injection site started getting red and puffy and expanded down my arm.  Looked like cellulitis. I work where my doctor is so I went in and the doctor put me on antibiotics.
Four days after first Moderna vaccination (2/13/2021) I experienced severe hair and color loss. It persists to this day (3/14/2021) My hair continues to fall out and is white in color.
Inappropriate schedule of vaccine administered; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) 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 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
This spontaneous report as received from a nurse refers to a female patient of unknown age (currently an adult). Nurse stated that the patient who had unknown vaccination history, may have received M-M-R II in childhood, was exposed to measles. Upon learning of exposure on 30-MAY-2016, the patient was tested serologically at an unknown hospital lab (no hospital stay) where patient was found to be seronegative to measles. The patient was then vaccinated with M-M-R II on 06-JUN-2016 (lot number L039612, expiry date: 07-OCT-2017). Nurse stated that the patient was doing fine but the outcome of the event was unknown. No product quality complaint was involved. Additional information has been requested.
Ramsay Hunt Syndrome sx per patient fever, nausea, loss appetite. She experienced these symptoms 1 month ago when she had active case of shingles.
Please see immunization administration sheet for lot numbers and site of administration. Pt here for MCV4 given in L deltoid.  As soon as bandaid was placed on arm pt eyes rolled up and he started to twitch and then started to slide out of the chair. As I got him to the floor I was calling for assistance to help lay him down. Staff came around the corner and finished helping to lay him down. He was an assisted fall and did not hit head. He started to punch me in the arm several times. He took approx 5 seconds to start coming around. Staff started to assess him while on the floor checking his vision and motor skills. Breathing and heart rate were regular.  We checked his bp which was at 111/68. He was then allowed to sit up which he tolerated well and stated he was no longer having dizziness or any other symptoms.  He then started to tell us that at the time that he went out he started having a dream about his brother hitting him.  He was able to answer all questions at that time and drink a cup of water.  After a few minutes we got him up into a chair where we kept talking to him and get more water down him.  After a few more minutes he was allowed to walk down the hall with no issues. Patient again reported feeling no dizziness or other symptoms and reported feeling "normal". Mom stated that he has been becoming dizzy with his blood draws for accutane as well but has never passed out before. Staff then released him to mom to go home.
"gastro-type effects"; Diarrhea; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT ("gastro-type effects"), DIARRHOEA (Diarrhea) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT ("gastro-type effects"), DIARRHOEA (Diarrhea) and NAUSEA (nausea). At the time of the report, ABDOMINAL DISCOMFORT ("gastro-type effects"), DIARRHOEA (Diarrhea) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.
Colorless, itchy hives under the injection site, which I noticed 53 hours after injection.; Colorless, itchy hives under the injection site, which I noticed 53 hours after injection.; This is a spontaneous report from a contactable other hcp. A 32-years-old male patient received first dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 12Mar2021 15:30 single dose for COVID-19 immunization. Medical history included Known allergies to Penicillin. Concomitant medications (other medications in two weeks) included escitalopram (ESCITALOPRAM) and trazodone (TRAZODONE) from an unspecified date and unknown if ongoing. The patient had no COVID prior vaccination not tested for COVID post vaccination.  On 14Mar2021 at 09:30 PM the patient experienced colorless, itchy hives under the injection site, which he noticed 53 hours after injection. No treatment received for the event. The outcome of event was recovering.   No follow-up attempts are possible. No further information is expected.
Narrative:  82 yo male patient with comorbidities including CKD 3A, chronic pain, HTN, BPH, and unspecified HLD who presents with dyspnea and coughing. Really came to the hospital just for a swab but was noted to be hypoxic and was admitted. COVID positive test on 8/23/21 with symptom onset on 8/16/21. Patient was fully vaccinated with COVID vaccine (Pfizer in 2/11/21 and 3/4/21). Patient was initiated on Remdesivir and Dexamethasone but required transfer to ICU due to worsening hypoxia.
Patient received 2nd covid vaccine - a few minutes later he became lightheaded and blurred vision. Neg nausea. Had Pt lie down. Vitals stable. Patient ate crackers and water and after about 15mins he felt better. Pt declined EMS. Discharged Pt with Wife and I accompanied Pt to car.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 29-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot # N013863 and expiration date 31-OCT-2018) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PRURITUS (itching), VACCINATION SITE RASH (rash at injection site grew to 2 inches), VACCINATION SITE ERYTHEMA (redness at injection site) and PYREXIA (fever of 100.7 F) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE RASH (rash at injection site grew to 2 inches), VACCINATION SITE ERYTHEMA (redness at injection site), PYREXIA (fever of 100.7 F) and CHILLS (chills). On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching) and AXILLARY PAIN (armpit pain). At the time of the report, VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PRURITUS (itching), VACCINATION SITE RASH (rash at injection site grew to 2 inches), VACCINATION SITE ERYTHEMA (redness at injection site), PYREXIA (fever of 100.7 F), CHILLS (chills) and AXILLARY PAIN (armpit pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 100.7 (Inconclusive) 100.7F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  On 04-FEB-2021, the patient had experienced Rash at the injection site that was red and warm to the touch, Patient had a fever of 100.7 F. and chills. The next day the rash grew to 2". Then the rash disappeared on 12-Feb-2021. Rash had returned that was red and warm again, it itches and there was armpit pain.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up received on 23APR2021, No new information received denied the call
in hot and sweaty; thought a truck hit him and he must've over done it. He said that as the day went one he felt worse.; headaches; he felt so bad; He has not moved around much at all; watery eyes; sneezing; abdominal pain; gas; tender if you touched directly at the injection site; in hot and sweaty; weight loss; Mucousy Mouth; Hoarse voice; low oxygen; weird dreams; can't sleep; blood pressure down; no appetite; breathing is shallow; muscle aches; imbalanced; Weakness; Fever; minimal injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 77-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9209, Expiration date was not reported), via an unspecified route of administration on 06Mar2021 17:15 as single dose for covid-19 immunisation. Medical history included ongoing high cholesterol. Concomitant medication included levothyroxine, tablet via oral from unknown date 2018 at 100 uCi, once a day for chemical thyroid condition, atorvastatin calcium (LIPITOR, tablet) via oral 10 mg once a day for blood cholesterol increased. Historical vaccine included first dose of BNT162B2 on 13Feb2021 for covid-19 immunisation. The patient experienced mucousy mouth, hoarse voice, weight loss on 27Mar2021, low oxygen, weird dreams, can't sleep, blood pressure down, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, Fever 26Mar2021, patient hot and sweaty, in hot and sweaty, thought a truck hit him and he must've over done it. He said that as the day went one, he felt worse, headaches, he felt so bad, He has not moved around much at all, watery eyes, sneezing, abdominal pain, gas and tender if you touched directly at the injection site on an unspecified date, minimal injection site pain on 14Feb2021. As per the reporter seriousness criteria reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021 and 132/76 on 28Mar2021, temperature: 100.8 on an unspecified date and 98.3 on 26Mar2021 and 98.3 on 28Mar2021, Pulse oximetry: 89 % on 26Mar2021, 95-96 % and 96 % on 29Mar2021. The outcome of the event mucousy mouth, hoarse voice, weird dreams, can't sleep, weight loss, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, fever was not recovered, minimal injection site pain was recovered on 15Feb2021, blood pressure down recovering and unknown for other events.
This spontaneous report as received from a nurse and a healthcare worker refers to a 5 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-NOV-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vomiting and diarrhea, then over a week progressed ot fever (101) bodyaches, migraine, tremors, increased anxiety, visual changes, "zoning out".