chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Loss of smell; Loss of taste; Sore throat; Dry mucus lining in nose; Fever; Slight headache; Fatigue; A spontaneous report was received from a consumer concerning a 63-year-old male who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a fever, slight headache, fatigue, sore throat, dry mucus lining in nose, loss of smell, and loss of taste.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Dec 2020 at 04:30 pm, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L2O14) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Dec 2020, prior to receiving the vaccine, the patient had a negative COVID test.   On 29 Dec 2020, he developed a fever, slight headache and fatigue.   On 30 Dec 2020, he experienced a sore throat and dry mucous lining in his nose.   On 31 Dec 2020, the fever subsided but the patient lost his smell and taste. The patient wanted to know if these symptoms were common. Treatment for the event of headache included Tylenol (acetaminophen).   Action taken with mRNA-1273 in response to the event was not reported.  The event fever was considered resolved on 31 Dec 2020. The outcome of the event(s) slight headache, fatigue, sore throat, dry mucus lining in nose, loss of smell and loss of taste were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
ran a temperature for 1 day; had chills; her arm hurt; This is a spontaneous report from a contactable consumer reported for himself and his twin sister, this case is for his twin sister. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection;Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated, his twin sister in got it and she said she ran a temperature for 1 day, had chills and her arm hurt on an unspecified date and she's fine. States his niece and nephew are all fine and they all got the Pfizer shot, he doesn't understand. States, that is normal and are told that is what is going to happen and not that you are going to have heart problems. States they are told your arm might be sore and people talk about sore arm and getting chills or slight temperatures and it's no big deal. The outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
4 weeks after second dose of moderna, admitted to the hospital with chest pain, found to have acute peri/myocarditis. Troponin 17. Taken for emergent cath due to concern for ST-elevations, but cath negatative, dx ultimatly with peri-myocarditis.
This spontaneous report was received from an immunization official and refers an unknown number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23, lot # M038359 with expiry date 13-MAY-2018 and lot # M043424 with expiry date 06-JUN-2018 (exact dose and route of administration were not reported). The administered doses were exposed to the temperature between 9 and 25 degrees Celsius (11.8 degrees Celsius) for a time frame of 12.5 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse events were reported. Additional information has been requested.
Got accidentally vaccinated with Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Got accidentally vaccinated with Moderna booster) in an 8-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Got accidentally vaccinated with Moderna booster). On 15-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Got accidentally vaccinated with Moderna booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. No side effects were reported at the time of report.  Company comment- This case concerns a 8-year-old, male patient, with no known medical history, who experienced the non-serious event of product administered to a patient of inappropriate age. The event occurred  on the same day after booster dose of mRNA 1273 vaccine. The patient was supposed to get a Pfizer vaccine but was given Moderna booster by pharmacist. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 8-year-old, male patient, with no known medical history, who experienced the non-serious event of product administered to a patient of inappropriate age. The event occurred  on the same day after booster dose of mRNA 1273 vaccine. The patient was supposed to get a Pfizer vaccine but was given Moderna booster by pharmacist. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
2 pts each recvd 3 doses of Engerix-B & were determined 5MAY92 to be non-responders;
reports our agency sent her Flublok when Fluzone was ordered with no reported advere event; reports 1 year old was administered Flublok. She reports our agency sent her Flublok when Fluzone was ordered. with no reported advere event; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 1 years old male patient who experienced reports our agency sent her flublok when fluzone was ordered with no reported advere event  and reports 1 year old was administered flublok. she reports our agency sent her flublok when fluzone was ordered. with no reported advere event while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 15-Apr-2022, the patient received a  0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE  (lot QFAA2155) (strength, formulation: unknown)  via intramuscular route in the left thig for immunization.  On 15-Apr-2022 the patient developed a non-serious reports our agency sent her flublok when fluzone was ordered with no reported advere event (product dispensing error)(unknown latency) and  year old was administered flublok. she reports our agency sent her flublok when fluzone was ordered. with no reported advere event (wrong product administered) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event product dispensing error and wrong product administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I received my first Pfizer Covid injection Feb. 18, 2021.   I experienced chills, nausea, some flu symptoms starting Feb. 22 Monday evening  - Feb 25th.  I threw  up Wed. Feb. 24 morn.  I started feeling better on Friday, Feb. 26th and resumed normal activities.  My temp from Feb. 22 - 25th was 96.1.  I also experienced flu symptoms and felt as if "a truck ran over me".
Developed temperature of 104 by 11/14/2001. Red, swollen upper right arm by Urgent Care site was called by parent. Cool compresses to site and Tylenol were recommended. 11/16/2001 Called back to parent (mother) swelling and heat gone. No fever. Recommended next DTaP be given in physicians office.
pt stated recvd flu shot 17OCT95 @ 8AM on 18OCT95 about 10AM-1hr p/eating egg sandwich became lightheaded-lethargic-sweaty-disoriented;no local rxn
Pain at the injection site; Redness at the injection site; Swelling at the injection site; Expired vaccine administered; Shoulder drop; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 60-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) (batch number 3BS44,for prophylaxis.   On 23rd October 2019, the patient received the 1st dose of Fluarix Tetra 2019-2020 season .5 ml. In October 2019, less than a week after receiving Fluarix Tetra 2019-2020 season, the patient experienced acromioclavicular separation. On 23rd October 2019, the patient experienced injection site pain, injection site erythema, injection site swelling and expired vaccine used. The patient was treated with ibuprofen, benadryl (nos) (Benadryl) and non-drug therapy, non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, acromioclavicular separation and expired vaccine used were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and acromioclavicular separation to be related to Fluarix Tetra 2019-2020 season.  Additional details were provided as follows: The batch number was updated from 38S44 to 3BS44, as per sales data sheet. The patient had reaction at injection site within 24hours of vaccine administration pain redness and swelling. The redness lasted for over one week. The patient took ibuprofen and patient states that she has shoulder drop the physician that she works for looked at it initially and told her to take Benadryl and ibuprofen for pain and apply ice packs. The reporter did not consent to follow up.
low platelet count 112 collected on 14MAY97;pt recv vax 5MAY97;
I had the Moderna Vaccine and the symptom of shortness of breath and heart palpitations started 48 hrs after the vaccine and it still persists today 4 months later.
RIGHT UPPER THIGH RED AND WARM TO TOUCH. RED AREA MEASURING 4X4. MEDICATION GIVEN TODAY ON 8/14/17 KEFLEX 250MG/5CC 1TSAP PO BID X 10DAYS, HYDROXYZINE 10MG/5CC 2CC PO Q12 HOURS.
Received shot at 11am. By 12:30am that night (1/3/19) he was running 102 fever. MOTRIN would lower it by about 1 degree. Thursday was active but could tell wasnt feeling well. On 1/4/19 he still had fever that didnt drop much, but this day he wouldnt do anything but lay around and got up very minimal times, no appetite and his thigh from hip to knee where shot was given was all swelled up. Around 9:30pm, his fever finally broke but leg stayed swollen for about 2-3 more days.
Fever 100.5-101.5; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.5-101.5) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 08-Feb-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 09-Feb-2021, the patient experienced PYREXIA (Fever 100.5-101.5). At the time of the report, PYREXIA (Fever 100.5-101.5) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Body temperature: high (High) 100.5-101.5.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Breakthrough COVID-19 case with symptom onset 8/21/2021: Fever, Sore Throat, Fatigue or tiredness, Chills. Symptoms resolved 8/29/2021. Went to hospital 9/3/2021 for pre-scheduled C-section. No additional pregnancy or birth weight data available.
ARM PAIN; HEADACHE; POSSIBLE FEVER THAT FELT HOT; PAIN IN BACK OF CALF AREA OF BOTH LEGS; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-JUL-2021, the subject experienced pain in back of calf area of both legs. On 30-JUL-2021, the subject experienced arm pain. On 30-JUL-2021, the subject experienced headache. On 30-JUL-2021, the subject experienced possible fever that felt hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and possible fever that felt hot on 30-JUL-2021, and had not recovered from pain in back of calf area of both legs, and arm pain. This report was non-serious.
Flu like symptoms; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. A couple of years ago, the patient had flu like symptoms and went to emergency. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Local allergic reaction no systemic symptoms. Benadryl 1-1 1/2 tsp po q 6 hrs.
Problems breathing, sleep apnea, joint pain, headache, tingling, blood disorder, heart problem (PVC). Memory problem, skin rashes, etc.  7/5/08 Reviewed VA medical records of 8/2005-5/2008. Records reveal patient active duty 10/2003-7/2004.  Upon return patient experienced aortic & mitral valve replacement, recurrent LE DVT, atrial fibrillation, mural thrombi, cardiomyopathy, CHF, CVA, TIA, major depression, anxiety, panic attacks, adjustment reaction w/anxious mood, sleep apnea, SOB, obesity, ex-smoker, RLL pneumonia, PE, hyperlipidemia, bilateral knee pain, right knee effusion, patellofemoral pain syndrome, diverticulae, insomnia, lack of energy, anhedonia, sexual difficulties, arthralgia, abdominal pain, HA, pleuritic chest pain, dizziness, otitis media, fatty enlarged liver, axillary rash, dyspepsia, heartburn, memory loss, allergic rhinitis, elbow tendinitis, sinusitis.
I experienced symptoms of congestion, runny nose, sore throat, and body aches. I was diagnosed with a sinus infection and prescribed Amoxicillin.  My symptoms have not begun to abate yet. I have not experienced any other symptoms I attribute to the vaccine.
Patient had an indentation on his left upper arm.  This could be lipdystrophy.  Mom says that it occurred 1-2 weeks after the COVID vaccine.
Nausea, chills, fever, and aching started about 20 hours after the vaccine and lasted for about 20 hours.
Other side effects with the first and second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Nov-2021 and was forwarded to Moderna on 22-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Other side effects with the first and second 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Other side effects with the first and second dose). At the time of the report, VACCINATION COMPLICATION (Other side effects with the first and second dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-396011, MOD-2021-396028 (Patient Link).
intense pain in upper thigh.  from hip to mid thigh.  maybe muscular pain.
"NUMBNESS IN DEEP MUSCLE OF LEFT FOREARM, NUMBNESS PROGRESSED UP ARM TO LEFT NECK/ EAR AREA AND DOWN LEFT LEG.  TOOK TYLENOL FOR PAIN IN EAR AND WENT HOME.  SEEN IN THE EMPLOYEE HEALTH CLINIC ON 11/6/09 FOR THE ABOVE SYMPTOMS, STATES PAIN IN EAR SUBSIDED.  SENT TO HOSPITAL - CT SCAN NEGATIVE.  FOLLOW UP 11/10/09 FOR C/O OF INCREASED NUMBNESS IN THE SAME AREAS.  12/14/09 MR received for DOS 10/30/09. DX: paresthesias, palpitations, s/p H1N1 vaccine. Pt c/o L arm and L leg weakness, pain, palpitations, L sensory deficit. Pt steady gate.
Developed shingles soon after Shingrix vaccine on 10/6/2019. This was the second dose of the series. The first dose was given on 5/6/2019 at medical office.
This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not provided. On an unknown dates, the patients were vaccinated with an unspecified number of improperly stored doses of VARIVAX lot number N002204, expiration date 19-JAN-2019 (dose, frequency and administration route were not reported), for prophylaxis. Concomitant therapies included sterile diluent (lot number reported as "N003912" and expiration date 05-JUL-2019) used for reconstitution, which did not undergo a temperature excursion. The data logger registered a temperature of minus (-)58° Fahrenheit (F) to 5°F (-3.10) for 45 minutes, 6°F to 14°F for 2 hours 30 minutes and 15°F to 46°F for 31 hours 15 minutes. There was not previous temperature excursion. No adverse effects were reported.
No adverse event; Punctured initially at 6:15 PM last night and then was administered at 11:00 AM this morning; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Punctured initially at 6:15 PM last night and then was administered at 11:00 AM this morning) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022 at 11:00 AM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 19-Sep-2022 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Punctured initially at 6:15 PM last night and then was administered at 11:00 AM this morning). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Punctured initially at 6:15 PM last night and then was administered at 11:00 AM this morning) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Punctured initially at 6:15 PM last night and then was administered at 11:00 AM this morning).    No concomitant medications were reported. On 06-Mar-2021 (lot number 048A21A, expiration date unknown), patient received first dose intramuscularly. On 03-Apr-2021 (lot number 006B21A, expiration date unknown) patient received second dose intramuscularly.  On 23-Oct-2021 (lot number 017F21A, expiration date unknown) patient received third dose intramuscularly.  On 06-Apr-2022 (lot number 002M21A, expiration date unknown), patient received fourth dose intramuscularly. On 18-Sep-2022, a dose of vaccine was taken out at 5:00 PM, punctured initially at 6:15 PM and then was administered at 11:00 AM next morning. Vial did not undergo any temperature excursions. No treatment medications were reported.
Pt presented to the emergency department with complaints of myalgias after receiving the vaccine. She noted that she had vomiting the night prior. She denied any chest pain, shortness of breath, abdominal pain, headaches, fever at that time. Pt was left in room by herself for approximately 5 minutes and was found unresponsive. Code Blue was called. Pt was found in asystole. ACLS was initiated. Return of circulation occurred after 7 minutes of resuscitation. Pt is currently intubated and sedated.
8hours after he received shot, he started temperature, body aches, chills, weakness, brain fog. Thought it was covid, but had neg result. He is still having the same symptoms now. We are awaiting his second covid test results before patient can go to ER.
"I need to get the MMRII vaccine because my doctor said I don't have the rubella component"; This spontaneous report was received from a female patient, concerning herself. Information about her pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), injection for prophylaxis (strength, route, lot number and expiration date were not provided).   On an unspecified date, the patient reported that she did not have the rubella component (rubella antibody negative), therefore she said she needed to get a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). Additionally, it could not be determined if the consumer had negative titers to rubella or if she had ever received the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) previously, but this could not be ruled out. The patient sought medical attention and she was seen by the physician. It was not reported if other diagnostic laboratories, or studies were performed or if she received treatment for the event. At the moment of this report, the event of rubella antibody negative was not resolved.  The reporter did not provide causality assessment between the aforementioned event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).