chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A bit stuffy or stuffiness; Sore arm; A spontaneous report was received from  healthcare professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who developed a sore arm and a bit stuffy or stuffiness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 on 24 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection.  On 24 Dec 2020, the patient received her first dose of the Moderna vaccine. On 25 Dec 2020, the patient notified a company representative via text message that she had a sore arm and was a bit stuffy or  stuffiness.  She had no dizziness or nausea in general. The patient does not consent to Safety follow-up.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, sore arm and a bit stuffy or stuffiness, were unknown.; Reporter's Comments: This case concerns a female patient in mid 50s, who experienced an unexpected non-serious event of Nasal congestion and an expected non-serious event of Pain in extremity. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Red at injection site, warm to touch. Red area about 2in x 3in & swollen at upper arm. Did have doctor visit. Dr. advised patient to continue with ice packs, ibuprofen, & BENADRYL. Dr. felt pt would be fine.
This spontaneous report as received from a pharmacist refers to 64-year-old female patient with codeine allergy. The patient's concomitant medication included unspecified antidepressant and unspecified medications to treat unspecified thyroid condition, high cholesterol and hypertension. On 16-SEP-2017 the patient was vaccinated with an improperly stored and expired dose of ZOSTAVAX (lot L007222, expiration date: 03-JUN-2016, dose and route of administration were not provided) reconstituted with properly stored sterile diluent (MRK) (lot #, expiration date, dose and route of administration were not provided) both for shingles prevention. Reporter stated that ZOSTAVAX was stored between 15° Fahrenheit degrees to 46° Fahrenheit degrees for "more than a year" prior to administration. The digital data logger was not used. In an approximately September 2017 the patient experienced "tingling and redness on her unspecified arm and numbness of her head. On an unknown date, in September 2017, the patient sought medical attention by seeing the physician but it was unknown, if she received any treatment for the events. The patient did not recovered from the events of tingling and redness on her unspecified arm and numbness of her head. The relatedness between the events of tingling and redness on her unspecified arm and numbness of her head and ZOSTAVAX and sterile diluent (MRK) was not reported.
Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PRURITUS (Itching). At the time of the report, PRURITUS (Itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Event outcome was updated to recovered.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE PULMONARY EMBOLISM SHOCK, UNSPECIFIED
Patient had a different taste in my mouth; This is a spontaneous report from a contactable consumer (reported for himself). A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EM9810/Batch number was not reported), via an unspecified route of administration, administered in arm left on 08Feb2021 at 09:15 (at the age of 70-years-old) as dose number unknown, single for covid-19 immunisation at Public Health Clinic/Veterans Administration facility. Medical history included cutaneous t-cell lymphoma and food allergy, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Feb2021 at 10:15, the reporter stated that after 1 hour of vaccination, patient had a different taste in his mouth that lasted 36 hours. No treatment was given for the events. The outcome of the event was resolved on an unspecified date in Feb2021.  Follow-up attempts are completed. No further information is expected.
NO ADVERSE EFFECT; the patient was administered an expired dose of MMR II; This spontaneous report was received from physician assistant regarding a patient of unknown demographics.  There was no information regarding concurrent condition, pertinent medical history and drug allergies or reactions.     On 18-APR-2019, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # N009800, expiration date: 24-MAR-2019, subcutaneous for prophylaxis (expired product administered). Concomitant therapies included sterile diluent. No adverse event was reported.
Expired product administered; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and EXPIRED PRODUCT ADMINISTERED (Expired product administered) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product administered). On 22-Apr-2021, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired product administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter.  No Treatment Information was provided by the reporter.  It was reported that once they received the shipment, the vaccines were placed at freezer temperature, at around -20 degree Celsius After that, a vial was removed from the freezer to administer vaccine. Doses that were viable up to 14-Apr-2021, the 30 days since it was thawed were administered to the patient beyond that day.   Reporter did not allow further contact
Took usual after meal BG reading, after eating usual bowl of cereal with Almond Milk (readings usually around 130-140). Today it was 275 2 hours after eating. Scared me!
Tiredness; This is a spontaneous report from a non-contactable consumer received from Pfizer sponsored program. A male patient (reporter's son) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tiredness. The consumer wanted to know how long the vaccine was good in the fridge for. The consumer was told by Pharmacy Manager that it had changed to 30 days. The patient was taking a nap. The consumer reported possible side effect of tiredness. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was inadvertently given the Pfizer COVID 19 Bivalent dose as their 2nd dose of the primary series.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 33-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 at 09:30 as dose 2, single (Lot number: GH9703, Expiration Date: 23Nov2022) at the age of 33 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. Concomitant medication(s) included: FLU [INFLUENZA VACCINE]. Vaccination history included: BNT162b2 (Pfizer Covid-19 Monovalent Vaccine , Dose1, single, Lot:  FP7133, Exp: 17Nov2022, NDC: 59267-1025-01), administration date: 22Sep2022, when the patient was 33-year-old, for COVID-19 immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (medically significant) with onset 13Oct2022 at 09:30, described as "Patient was inadvertently given the Pfizer COVID 19 Bivalent dose as their 2nd dose of the primary series.". Clinical course: It was reported that, a patient who was given the bivalent instead of their second dose of the monovalent Pfizer COVID Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the event and the suspect drug cannot be completely excluded.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 4/28/2023 Discharge Date: 5/2/2023   Clinical Narrative: This is a 75 year old gentleman who is status post a stem cell transplant for myelodysplasia and also has history of B cell lymphoma treated with Rituxan. He presented with fever of 39.5 and altered mental status with findings of sepsis and bibasilar pneumonia.   He was treated with doxycycline and Cefepime and by discharge had complete clearing of his chest x-ray. Sputum culture did not reveal the pathogen. He received a total of 4 days of IV antibiotics, and he was discharged with 3 additional days of Ceftin to complete 7 days treatment. Because of the immunocompromised state with recurrent pneumonia, he was given and additional 5 days of Ceftin to keep and start at the onset of a respiratory infection, and he was instructed in that instance to also seek medical care immediately.   Other issues included symptomatic anemia with hgb 7.5. Iron saturation was borderline low at 15% and he was started on Ferrous sulfate supplement at discharge. Also he had low potassium and magnesium levels and was started on supplementation for those as well.
Pneumonia; Fever; Head ache; body ache and muscle pain; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (Pneumonia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-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 PNEUMONIA (Pneumonia) (seriousness criterion medically significant), PYREXIA (Fever), HEADACHE (Head ache) and MYALGIA (body ache and muscle pain). At the time of the report, PNEUMONIA (Pneumonia), PYREXIA (Fever), HEADACHE (Head ache) and MYALGIA (body ache and muscle pain) outcome was unknown.            Concomitant product use was not provided. On an unspecified date, the patient had fever, headache, body ache, and muscle pain. Later, she developed with pneumonia. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 (Moderna COVID-19 Vaccine); therefore, the action taken in response to the events was not applicable.  Company Comment:  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
generalized rash, not feeling well after getting pneumonia 23 vaccine, generalized body aches (5 days), neg covid & neg flu, rapid test, Benadryl (Hx lyme disease) and medrol dose pack ordered.
Sore at injection site, full body aches, low grade fever, and persistent headache. Took 400mg Tylenol Q6h for 36 hours. After 36 hours, headache and body aches subsided, pain at injection site was minimal, and fever ceased.
Severe rash, headache, chest pain, shortness of breath, irritability, disoriented
Severe abdominal pain came back ER 01/28/2021 did CT Scan no medication, 02/10/2021 second shot throwing up every week 2-3 a couple times a week, GI doctor and EGD showed gastroenteritis labs showed that liver enzyme was elevated and doing observation. Diagnosed with COVID chronic bronchitis wheezing and cough that could not get rid of and chest congestion. March 2, 2021 - ophthalmologist  he drops steroid drops for eyes was blood red and on steroid for three months June 17, 2021. Tested positive for COVID, Quarantine or 10 days. Congestion chronic bronchitis wheezing is continuing.
Rash on torso. Started within 1 day was worst at 5-6 days. Slowly going away with BENADRYL.
I had my first dose of COVID vaccine on April 25, 2021. On May 6, 2021 evening around 8 PM I had a severe dizziness attack that lasted for 2 hours and intermittent vomiting for 4 times that night and my dizziness resolved spontaneously. The next morning I went to Urgent Care for further evaluation, they gave me Anti-Vertigo medicine. I felt well till next week. On the following week again I had a severe dizziness attack, profuse sweating, and vomiting. On next morning, I lost my hearing in the right ear, couldn't hear anything. And again i went to Urgent care, that time they gave me Antibiotics Amoxy-clavulanate for 10 days, after 2 days of loss of hearing, it recovered and felt well. After that, I took 2nd dose of COVID vaccine on May 19, 2021. Again on June 4, 2021 I had dizziness attack and profuse sweating along with i started feeling uncomfortable in my right ear and next morning my hearing loss again. Ever since my hearing is not recovered yet. I am extensively visiting my ENT/Otolaryngologist ever since and my doctors prescribe me steroid by mouth and injection in the ear. Till date i profoundly loss my hearing. I can't hear anything now.
feeling tension/pressure in same area on left side of face; feeling tension/pressure in same area on left side of face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 14Apr2021 14:45 (Lot number: ER8729) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Menstrual cycle abnormal" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: LO LOESTRIN FE taken for menstrual disorder (ongoing); FLONASE [FLUTICASONE PROPIONATE] taken for seasonal allergy (ongoing). Vaccination history included: Bnt162b2 (dose 1 at 2:45 pm, via intramuscular administered on left arm. Batch/lot number: ER8733), administration date: 24Mar2021, for COVID-19 Immunisation, reaction(s): "numbness and tingling in her face", "numbness and tingling in her face", "pressure/tightness", "face became flushed". The following information was reported: HYPERTONIA (non-serious), FACIAL PAIN (non-serious) all with onset 14Apr2021 17:00, outcome "recovering" and all described as "feeling tension/pressure in same area on left side of face". Therapeutic measures were not taken as a result of hypertonia, facial pain. Additional information: Prior patient vaccinations was reported as none.  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse practitioner concerning her daughter who on an unknown date was vaccinated with a first 0.5 mL dose of GARDASIL (lot number, injection site and route not reported). Subsequently the patient experienced fever, vomiting and muscle aches. Unspecified medical attention was sought. The outcome was unspecified. Additional information has been requested.
Severe migraine, numbness/tingling/pain in left arm, side of face and neck, dropping left eye and smile, burning/irritated left eye
Injection given, approximately 90 seconds later, while still in doctors office he fainted and began to seizure. Doctor kept him for observation for approximatley 15 minutes after episode.
Vaccine administered to the patient, was given in error beyond the recommended expiration date.  We are consulting with Moderna if it is advised to have the patient to repeat vaccine dose.
27JUL94 parent called stated rt leg was swollen quite large to knee; t100 R; parent advised to cont APAP;
No adverse event; Received First dose of Pfizer on 9th of March and on 30th of March, also received two doses of the Moderna vaccine on April 29th and May 26th; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received First dose of Pfizer on 9th of March and on 30th of March, also received two doses of the Moderna vaccine on April 29th and May 26th) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On 30-Mar-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received First dose of Pfizer on 9th of March and on 30th of March, also received two doses of the Moderna vaccine on April 29th and May 26th). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received First dose of Pfizer on 9th of March and on 30th of March, also received two doses of the Moderna vaccine on April 29th and May 26th) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received First dose of Pfizer on 9th of March and on 30th of March, also received two doses of the Moderna vaccine on April 29th and May 26th).    Concomitant medication was not reported.  On 09-Mar-2021 patient received first dose of Pfizer vaccine and on 30-Mar-2021 received second dose. Again patient received Moderna vaccine on 29-Apr-2021 and 26-May-2021. Dose details were unknown. Treatment details were unknown.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
16 hours after injection, started having chills, fever 102.2, achy all over, worst headache I ever had, symptoms continue  now as of 1/1/21 10:00 am, fever not as high, 99.4-100, aches have improved, headache remains the same, only eases after taking Norco which I had left from a knee surgery years ago.
Client, age 45, presented to clinic on 8/16/22 for second dose of Hepatitis A 19+ vaccine and HPV. Client received a pediatric dose Hepatitis A 1-18. The recommendation is to repeat the dose with the correct product of Hepatitis A 19+. VAERS will be submitted. This nurse will be contacting the client to inform them that another dose is recommended to ensure adequate protection against Hepatitis A.
For an 8 hour period, fever, chills, severe upper abdominal pain with nausea, lower back pain. Felling weak, tired, very ill .
Hospitalized 5/22/22-5/26/22 Abd pain, nausea, vomiting, chest pain, SOB, cough, tachycardia, PNA, sepsis, pruritus, bacteremia staph infection,
Area of induration, redness, warmth with small fluid-filled blisters at injection site (right arm - site of KINRIX or MMR).
Felt like something hit me in the chest; Difficulty Breathing; Swollen Face and Lips; Anxiety; Sweats; Hurting around Right side (the area of Mastectomy 2019); Eyes and Eyeballs Hurting very bad; Eyes and Eyeballs Hurting very bad; Swollen Face and Lips; Chills; Joint pain; Muscle Pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Felt like something hit me in the chest), DYSPNOEA (Difficulty Breathing), LIP SWELLING (Swollen Face and Lips), ANXIETY (Anxiety) and HYPERHIDROSIS (Sweats) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event, Glaucoma, Arthritis and Mastectomy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and CLONAZEPAM (KLONOPIN) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced CHEST PAIN (Felt like something hit me in the chest), DYSPNOEA (Difficulty Breathing), LIP SWELLING (Swollen Face and Lips), ANXIETY (Anxiety), HYPERHIDROSIS (Sweats), BREAST PAIN (Hurting around Right side (the area of Mastectomy 2019)), the first episode of EYE PAIN (Eyes and Eyeballs Hurting very bad), the second episode of EYE PAIN (Eyes and Eyeballs Hurting very bad), SWELLING FACE (Swollen Face and Lips), CHILLS (Chills), ARTHRALGIA (Joint pain) and MYALGIA (Muscle Pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Felt like something hit me in the chest), DYSPNOEA (Difficulty Breathing), LIP SWELLING (Swollen Face and Lips), ANXIETY (Anxiety), HYPERHIDROSIS (Sweats), BREAST PAIN (Hurting around Right side (the area of Mastectomy 2019)), the last episode of EYE PAIN (Eyes and Eyeballs Hurting very bad), SWELLING FACE (Swollen Face and Lips), CHILLS (Chills), ARTHRALGIA (Joint pain) and MYALGIA (Muscle Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Immunizations given 3 days ago.  Developed tenderness at injection site with erythema that increased in diameter.  Now with indurated erythematous plaque 3x3 cm at injection site with surrounding non-confluent erythema that is pruritic.