chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient completed COVID-19 Moderna vaccine series on 2/19/21. Lot number is not available to writer. Patient was admitted to the reporting hospital on 8/27/21 with an admitting diagnosis of Fever. Patient was reported in ER to have fatigue, fever and general recent decline. Patient comes from an assisted living facility with his wife. Admission test for COVID was positive on PCR NP Swab 8/26/21. Pt was discharged 8/27/21.
A little arm soreness; more tired than normal the day after receiving the 2nd dose of the vaccine.; achiness; This is a spontaneous report from a contactable consumer (patient).  A 42 -year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number unknown, route of administration unknown in left arm on 15Feb2021 at 09:15 (at the age of 42 years) as single dose for COVID-19 immunisation.  Past vaccination included dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for immunization on 25Jan2021 at 2:30pm (14:30) in left arm. The patient medical history includes hypothyroid, and the patient has a drug allergy to Bactrim.  The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccine and since the vaccine the patient has not been tested for COVID-19. Concomitant medication included levothyroxine sodium (LEVOXYL).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced achiness and was more tired than normal the day after receiving the 2nd dose of the vaccine as well as a little arm soreness on 16Feb2021.  The patient did not receive any treatment for the events.  The outcome of a little arm soreness was not recovered, more tired than normal the day after receiving the second dose of the vaccine was not recovered and achiness was not recovered.   Information on the lot/batch number has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: Rebound COVID. After testing negative on Day 6; Positive, notes: tested positive on Day 10 of COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that, the patient received antiviral COVID 19 treatment with Paxlovid orally from 20Jul2022 to 24Jul2022. It was reported that the patient has rebound COVID. After testing negative on Day 6 and sx had improved the patient began to have sx again and tested positive on Day 10 of COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
left arm "swelled" and "hurt"; Left arm hurt; Face swollen; Eyes swollen; A spontaneous report was received from a Consumer concerning a 69-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, left arm swelled and hurt, face swollen, and eye swollen.  The patient's medical history was not provided. Concomitant medications reported were Wellbutrin, Zoloft, Ativan, Synthroid for drug use for unknown indication.  On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, left arm swelled and hurt, face swollen and eye swollen.  Treatment details included ketotifen fumarate antihistamine eye drops.  Action taken with mRNA-1273 in response to the events, left arm swelled and hurt, face swollen, eye swollen was not reported.   On an unknown date the outcome of events include, left arm swelled and hurt, face swollen, eye swollen was not reported.; Reporter'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.
This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 16-month-old male patient who received BOOSTRIX (batch number N2K27, expiry date 1st October 2015). On 24th September 2014, the patient received BOOSTRIX. On 24th September 2014, an unknown time after receiving BOOSTRIX, the patient experienced inappropriate age at vaccine administration, under dosed wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, under dose and wrong vaccine administered were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration, under dose and wrong vaccine administered to be related to BOOSTRIX. Additional information: A BOOSTRIX vaccine was accidentally administered to two 16 month old twins. BOOSTRIX was recommended in a patient 10 years of age and older. No adverse event reported.
appox. 10 minutes after receiving vaccine, I began to experience SOB, tightness in chest, mild tachycardia, blurring of vision, and nasal congestion.  I also, experienced  some heavens in my head.    My throat felt tight, and I was not able to sallow easily. i was all slightly shaky.    The entire adverse effect lasted approx. 20-25 minutes.   After I was able to sallow I took small sips of ice cold water, used my recuse inhaler ( Provental) .
MILD BRAIN FOG; SORE ARM; MILD TIREDNESS; This spontaneous report received from a consumer concerned a 68 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced mild brain fog. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced mild tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild brain fog, mild tiredness and sore arm was not reported. This report was non-serious. This case, involving the same patient is linked to 20210450010.
some diarrhea; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (some diarrhea), PYREXIA (fever) and NAUSEA (nausea) in a 30-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 OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced DIARRHOEA (some diarrhea), PYREXIA (fever) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (some diarrhea), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
fever; headache; everything; miserable; flu-like symptoms; dry cough; chills; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (everything), DEPRESSED MOOD (miserable), INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (dry cough) and CHILLS (chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ADVERSE EVENT (everything), DEPRESSED MOOD (miserable), INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (dry cough), CHILLS (chills) and HEADACHE (headache). On an unknown date, the patient experienced PYREXIA (fever). The patient was treated with ACETYLSALICYLIC ACID (ASPRIN) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT (everything), DEPRESSED MOOD (miserable), INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (dry cough), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication reported
All PCR covid tests ( 3 DIFFERENT TIMES) after vaccination turned positive. Rapid antigen tests are all neg. ALL RECOMMENDEd quarantine, mask, social distance, disinfection was followed individual live alone in the jouse
Pt recv vax on 10/7/98; on same day pt exp local rxn & oral ulcers
Tender & sensitive at site, chest pain, cough, fever, severe decreased ROM of LUE, location of injection.
Left arm redness and pain. Muscle aches. Fatigue. Fever to 101.3.  Treated with Tylenol, fluids and rest.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 4-year-old male patient who received KINRIX (batch number 7574T, expiry date 19th May 2019). Concomitant products included PROQUAD. On 1st August 2017, the patient received KINRIX (intramuscular) .5 ml. On 1st August 2017, several hours after receiving KINRIX, the patient experienced injection site erythema and injection site swelling. In August 2017, the patient experienced fever. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the fever was unknown. The reporter considered the injection site erythema and injection site swelling to be probably related to KINRIX. It was unknown if the reporter considered the fever to be related to KINRIX. Additional details were provided as follows: The patient received KINRIX on the right thigh. On the same day, the patient concomitantly received PROQUAD (batch number M049122, expiry date 13th June 2018) intramuscularly on the left thigh. In August 2017, less than a week after vaccination, the patient experienced fever. The patient had a scheduled visit on the reporting date for follow up and further evaluation of the injection site. KINRIX was administered to two patients on different days by two different healthcare professionals at different sites (refer case US2017121960).
This spontaneous report was received from a certified medical assistant and refers to a male patient of unknown in his 70's-80's with genital warts. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with GARDASIL 9 injection (lot#, expiration date, dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I woke up feeling a little flu-ish and achy. I had been testing every morning on board the ship because I had been traveling with a group. Some of the travelers had some fragile health conditions. I was in a room by myself and was not sharing quarters with anyone. I took a self test and tested positive. I called the medical personal on the ship and they sent someone up to test me. I tested positive again and they isolated me on the ship. My temperature was 99.5 and I did have a cough with chest congestion. I also had a bit of a sore throat but I think that was because of the coughing. I did nap a lot because I was very tired. Thursday when I was diagnosed we reached port and my husband picked me up to bring me home. I had started Paxlovid on the 06/18/2022  the same day when symptoms began. I did start to feel better within a couple of days. By Monday I felt much better but still had a lingering cough and fatigue. Wednesday morning I tested negative on a home test and have been testing negative every since. The only lingering symptom I have currently is fatigue. I'm usually not someone who takes a nap but every two or three days I have to take a nap for an hour. Other than that I feel fine.
Approximately 5 hours after injection began having chills which turned into tremors.  Within the hour had a fever of 100.  Nausea and trembling with severe chills continued into the night.  Headache began around 1 am.  Heavy sweats at 5 am and diminished chills.  Weak and fatigued next day with no fever. In bed for 2 days.  Headache, intermittent cough, and sore throat for the 3 days.  Two episodes of fast heart rate.  (I have AFIB that I neglected to list in the chronic illnesses.)  I did not see the doctor because by Monday, I was feeling okay.  Have taken flu shot for past 30+ years with no reaction.  First year of 65+ dose.  Scary.
DAPTACEL ordered incorrectly, patient needed PENTACEL RN caught order error and spoke with physician. Correct vaccine given.
This study case was received from the investigator on 27 September 2012. A 32 year-old female subject with a history of blood clots and numbness or paralysis was found to have an other acute myocarditis 13 days after she had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 05 April 2012. Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 02.90 on 18 April 2012. An was not available ECG. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (date mining, non-interventional) study. Documents held by sender: none.
shoulder pain started on the way home so around 11:30 am. For 5 days I could hardly move my arm and could not complete daily tasks. 14 days out I still have shoulder pain and weakness. I am able to complete most daily activities, however I do have pain. I still cannot sleep on the same side as the injection. 6pm that night I developed chills, fever, muscle aches-these lasted through Sunday evening
Tingling, numbness, pain, limited ROM and inability to perform many normal activities of daily living. Diagnosed with axillary nerve dysfunction... put on medrol dose pack... after 1 week symptoms were not improved ... placed on another medrol dose pack ... two weeks later symptoms still not improved. MRI done and then began cortisone injections related to bursitis secondary to nerve and muscle inflammation.
Sore arm the night of the vaccination, Hives developed 2 days after vaccinated. Hives spread all over body. Very itchy. Hives stays more than 1 week after the vaccine.
Initial unsolicited report received from a physician on 12-Oct-2017. This case is linked with: 2017SA199339, 2017SA199365, 2017SA199373, 2017SA199379, 2017SA199386 (same reporter). This case involves a male patient (age not reported), who was vaccinated FLUZONE HIGH-DOSE (batch number: UI845AB, expiry date, dose, route and dose in series and site of administration not reported) on an unknown date. Patient's medical history included early mild Parkinson's (ongoing). Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had significant increased tremors on underlying early mild Parkinson's. Lab test and corrective treatment was not reported. Outcome of the events were not reported. Documents held by sender: none.
Patient is still having pain 1 month later on the front of the arm and on back of arm in a horseshoe pattern but not pain at injection site. Advised patient to call MD.
This medically confirmed spontaneous report (initial receipt 28-Oct-2014) concerns a 64 year old male patient. On 26-Oct-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-Oct-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-Oct-2014, the patient received temperature excursions AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
delayed itching rash around site of arm injectiion; delayed itching rash around site of arm injectiion; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (delayed itching rash around site of arm injectiion) and VACCINATION SITE RASH (delayed itching rash around site of arm injectiion) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (delayed itching rash around site of arm injectiion) and VACCINATION SITE RASH (delayed itching rash around site of arm injectiion). At the time of the report, VACCINATION SITE PRURITUS (delayed itching rash around site of arm injectiion) and VACCINATION SITE RASH (delayed itching rash around site of arm injectiion) had resolved.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 28-JUL-2016, the patient was vaccinated with a dose of improperly stored inactivated VAQTA (dose and route were unknown, lot # M011839, expiration date 13-SEP-2017, which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt is pregnant, mild symptoms beginning 7/4, symptoms increased severity over two weeks and on 7/21 the Pt was hospitalized in maternity care section at Hospital for multiple COVID symptoms
Patient complained of nerve pain of arms and legs. Had reaction later in the night of date of administration on 9/27/16 and had to seek medical attention by going to ER. Patient has discussed to primary care physician of adverse reaction and was referred to neurologist for further evaluation.
c/o soreness/tenderness, like a bruise;mom discovered lump 2 quarter sized, egg shape lump;
The report was first received from 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 18-JAN-2018, the patient was vaccinated with ROTATEQ (strength were unknown, lot# N003984 and expiration date 19-NOV-2018) 1 dose form orally for prophylaxis (product storage error). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 was 47 degree Celsius for max 15 hours. And on 07-DEC-2017 was 50 degree Celsius for max 8.75 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-009507513-1810USA001958.
hypersomnia; Fever; Bodyaches; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (hypersomnia), PYREXIA (Fever), MYALGIA (Bodyaches) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 11-Feb-2021, the patient experienced HYPERSOMNIA (hypersomnia), PYREXIA (Fever), MYALGIA (Bodyaches) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) on 11-Mar-2021 for Fever, at an unspecified dose and frequency. On 11-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, HYPERSOMNIA (hypersomnia), MYALGIA (Bodyaches) and FATIGUE (Tiredness) outcome was unknown.            The patient associated  symptoms with immunocompromised state of Lupus. Concomitant medications were not provided.
Approximately 5 minutes after receiving vaccine, patient said she wasn't feeling well and sat down and then had a seizure lasting a minute or two.  EMS was called and patient was transported to hospital.
Dr. ordered the following vaccinations for patient: DTap-IPV-Hib, Hep B, Prevnar 13, and Rotarix.  Patient was given the Hep A (Havrix) vaccination instead of the Hep B (Recombivax) vaccination. The medical assistant discovered her mistake immediately when documenting the vaccination in the EMR. The medical assistant immediately informed the Dr. of her medication administration error. The medical assistant then explained to mom what had occurred. The Dr. also then spoke to the mom. Dr. explained that the Hepatitis A vaccination is usually given to children 12 months of age and up. She explained the vaccine should not harm the baby in any way, but patient would still need to receive the Hepatitis A vaccine at age 12 months and up and she still needs her second Hepatitis B vaccine. The mother was understandably very upset. She began to speak very loudly, screaming , and became agitated. This alerted security. Security advised the mother she could talk to the clinic manager. The mother left the building. Shortly afterward, the mother retuned to the building with the baby's father and other family members. The family spoke with our Chief Operating Officer. This RN attempted to call mother on Wednesday to follow-up. Mother hung up on RN x 3. RN spoke with the father Wednesday. He stated, "Patient is more sleepy than usual, but otherwise fine." This RN attempted again to call the mother and father on Thursday to follow-up. RN was unable to reach either parent. The medical assistant has been counseled. Medication rights and responsibilities have been reviewed with the MA. Vaccination safety has been reviewed with the MA.