chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; chills; received a dose of bright orange -red Shingrix; This case was reported by a physician via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, chills and pharmaceutical product complaint. On an unknown date, the outcome of the fever, chills and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of bright orange,red Shingrix and complained fever and chills on the day after vaccination. The follow up consent was not granted.
pt recvd vax 30AUG90 & 4MAY93 devel parotitis on the rt side of face; area was sl tender to the touch; mumps titer @ that time was neg; seen by MD; sx persisted until 20MAY93 when recovered; lab eval on 6JUL93 showed a pos mumps titer;
Patient is 49 yo F presenting with right sided facial nerve paralysis (right eye and eyelid drooping, etc.) consistent with Bell's Palsy.  She does have a history of Bell's Palsy in the past (with Botox injections for Migraine HA). Symptoms started 1 day after vaccination (22 JAN 21) and are still present today (4 days post-vaccination). Symptoms are improving and patient will be following up in 1-2 weeks.  No treatment indicated.
couldn't sleep because felt pain in her arm (left); pain in her arm (left); a reaction; extreme fatigue; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep because felt pain in her arm (left)), PAIN IN EXTREMITY (pain in her arm (left)), FATIGUE (extreme fatigue), ARTHRALGIA (joint pain) and HEADACHE (headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Polymyalgia rheumatica. Concomitant products included VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INSOMNIA (couldn't sleep because felt pain in her arm (left)), PAIN IN EXTREMITY (pain in her arm (left)), FATIGUE (extreme fatigue), ARTHRALGIA (joint pain), HEADACHE (headache) and ADVERSE REACTION (a reaction). On 18-Jan-2021, INSOMNIA (couldn't sleep because felt pain in her arm (left)), PAIN IN EXTREMITY (pain in her arm (left)), FATIGUE (extreme fatigue), ARTHRALGIA (joint pain), HEADACHE (headache) and ADVERSE REACTION (a reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication included unspecified supplements. The patient had severe symptoms about two days. After 2 days the symptoms ended. The patient reported that she did not have any breathing problems and never thought her life was at risk.; Sender'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.
no adverse effects; The patient received Vaqta following a temperature excursion; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 28-OCT-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA), one dose for prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported) (product storage error).  The administered dose of the vaccine experienced a temperature excursion below 36°F/2°C (35F) for 430 minutes. No adverse effects reported.
This spontaneous report as received from a registered nurse refers to a 79 year old male patient with allergy to all mycins and peripheral neuropathy. The patient's medical history included spinal stenosis s/p cervical laminectomy in 2000. On an unspecified date in 2007 the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported). Concomitant therapies included metoprolol, FLOMAX, simvastatin (manufacturer unknown) and aspirin (manufacturer unknown). On 20-NOV-2013 the patient was diagnosed with shingles. The patient sought for medical attention and was seen in office visit, patient was found to have lesions on the left side of his back radiating to the left abdomen. No lab diagnostic studies were performed. VALTREX was the treatment given for the event. The outcome of the event was not recovered. Additional information has been requested.
Shortness of Breath; Chest Pressure; Chills; Headache; muscle pain; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath), CHEST DISCOMFORT (Chest Pressure), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (muscle pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DYSPNOEA (Shortness of Breath), CHEST DISCOMFORT (Chest Pressure), CHILLS (Chills), HEADACHE (Headache), MYALGIA (muscle pain) and PYREXIA (slight fever). At the time of the report, DYSPNOEA (Shortness of Breath), CHEST DISCOMFORT (Chest Pressure), CHILLS (Chills), HEADACHE (Headache), MYALGIA (muscle pain) and PYREXIA (slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Received the second shot as of 2/21/21.  In June of that summer woke up with back pain between the shoulder blades.  Could not relieve the back pain.  Suffered Cardiac Arrest on drive to hospital.  Revived by wife and EMT using CPR compressions and an AED device.  Received a stent at hospital.  Have recovered with no side effects other than soreness from compressions.
Vaccinator poked her very hard (she felt like it hit the bone); Arm  was very sore; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced product administration error and pain in extremity.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 06 Jan 2021 intramuscularly for prophylaxis of COVID-19 infection.   The health care provided called to report she had received the Moderna vaccine on 06 Jan 2021 and the vaccinator poked her very hard (she felt like it hit bone). She feels that the injection was improperly administered. Her arm was very sore after.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, product administration error, was considered resolved on 06 Jan 2021. The out come of the event, pain in arm, is considered unknown.; Reporter's Comments: This case concerns a female patient, who, experienced a non-serious unexpected events of product administration error and a non-serious expected event of pain in extremity. There was no AEs associated with product administration error. However, the event of pain in extremity occurred the same day after mRNA-1273 (Lot# unknown) administration. 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.
muscle spasms in legs, moved to ribs, hands, feet, forehead, back, and arms.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 15.45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included alprazolam (XANAX) and sulfasalazine (MANUFACTURER UNKNOWN); both from unknown date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 03Mar2021 , the day after the received the first shot, the patient experienced muscle spasms on his legs which had moved to his ribs, hands, feet, forehead, back, and arms and it was reported that there had not been a day since the initial shot that the patient had not experienced the event. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the event muscle spasms was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
75 y.o male came back to the health department c/o twenty min. after taking the flu and pneumonia shot his right jaw began to swell. On assessment public health nurse, noted the right jaw is edematos. Patient tell nurse he gets the flu shot every year, but this is the first time he has ever gotten the pneumonia shot. He got the pneumonia shot in the RT Deltoin and is RT jaw is swelling. I contacted patient's PMD. I contacted Our Dist. health Officer. Dr.  told me to get the patient to ER. PHN transports pt. to ER. By now his lip was swelling and it had become more difficult for the pt. to speak. He remain alert and oriented. I called one of his friends to come to the ER while pt. went in to see ER doctor. He was given two inj. and prescriptions x 3 to get filled.
During vaccination, some vaccine leaked out; Nurse said she drew up more than the recommended dose, to allow for leak; Pain in injection site and tenderness; A spontaneous report was received from a physician who was a 55 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced during vaccination, some vaccine leaked out; nurse said she drew up more than the recommended dose, to allow for leak; and pain in injection site and tenderness.    The patient's medical history was not provided. Concomitant product use was not provided.   On 26 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Dec 2020, during the vaccination, some vaccine leaked out, but the administering nurse said she drew up more than the recommended dose, to allow for the leak. The patient believed she received 0.45 - 0.48 ml of the dose. She also experienced pain in the injection site and tenderness and the symptoms went away the same day. No treatment was reported.   Action taken with mRNA-1273 in response to the events was not reported.   The events, during vaccination, some vaccine leaked out; nurse said she drew up more than the recommended dose, to allow for leak; and pain in injection site and tenderness, were considered resolved on 26 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect dose administered and product selection error for mRNA-1273 (Lot number: 039K20A) and concerns a 55 year-old, female patient, who experienced the event of injection site pain. The event occurred the same day after the first dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.
Pfizer vaccine was administered outside of Facility - reported by patient- ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------------------- J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/24/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA    LEFT BUNDLE BRANCH BLOCK J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/30/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA    LEFT BUNDLE BRANCH BLOCK J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/24/2021 SEIZURE, UNSPECIFIED J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/30/2021 SEIZURE, UNSPECIFIED
Initial report was received from a health care professional on 16 September 2011. A 76 year-old female patient with a history of allergy to polysporins, esophageal reflux, COPD, hyperlipidemia, anxiety and hyperthyroid had received on 14 September 2011 a dose of FLUZONE HIGH-DOSE No Preservative 2011-2012, lot number UH458AA and an unspecified amount of time after vaccination the same date, experienced shivers, chills, temperature 110 F, pain at injection site, shortness of breath and cyanosis around mouth, lips and fingertips. The patient did a "breathing treatment" and the shortness of breath and cyanosis improved. Additional treatment included TYLENOL with temperature returning to within normal limits but the patient continued to feel "very tired". Concomitant medications included SYNTHROID, XANAX, ZOCOR, ADVAIR DISKUS AND PROAIR HFA INHALER. Illness at the time of vaccination and other vaccines given within four weeks prior to the suspect vaccine were not reported. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Severe weakness, a week later, diarrhea, chills, and fever, collapsed in hospital parking lot, flown to hospital where they did two spinal taps to confirm I had GBS. EMG showed I have a severe case and spent several weeks in different hospitals and rehabs.
A report was received from a health care professional in the USA on 7/5/04 concerning a 1 year old male vaccinee who inadvertently received Fluvirin on 11/3/03. This report was received as follow up and involves a group of 10 children under the age of 4 years who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.
Vaccinated with Pfizer x 2. Tested positive for CoVID on 02/04/2022. Admitted to Medical Center on 02/04/2022. Expired on 02/22/2022 while still hospitalized
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022.; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022.; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.  On 11-Mar-2022 at 1:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Mar-2022 at 1:11 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022.) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Vaccine administration time was given as 11-MAR-2022 at 13:11:07   No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869.
Tested positive for COVID after Moderna booster; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID after Moderna booster) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, the patient experienced COVID-19 (Tested positive for COVID after Moderna booster). At the time of the report, COVID-19 (Tested positive for COVID after Moderna booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was reported. No treatment medication was reported. Company comment: This spontaneous case concerns a 68-year-old, male patient with no reported medical history, who experienced the unexpected, non-serious of COVID-19. The event occurred after administration of third dose of mRNA-1273, the exact date of administration of third dose of mRNA-1273 was not provided, the initial two doses of mRNA-1273 were given unknown dates. On May 24, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old, male patient with no reported medical history, who experienced the unexpected, non-serious of COVID-19. The event occurred after administration of third dose of mRNA-1273, the exact date of administration of third dose of mRNA-1273 was not provided, the initial two doses of mRNA-1273 were given unknown dates. On May 24, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
pt recvd vax;had been crying & fussy for approx 2 1/2 hrs;mom gave apap;pt cont to cry & could not be comforted;was not taking fluids;RN advised mom to contact MD;saw MD 11mar95; no residual effects reported;
I had a headache and sudden lethargy.  I ended up sleeping for 3 hours.  Throughout that time, I woke up several times with 'cotton mouth' and a strange feeling that the back of my mouth, roof of my mouth and maybe a bit of my throat had a numb and tingly feeling.  I drank quite a bit of water, but kept falling back to sleep.  I can only compare it to when you receive novacane at the dentist but the sensation starts to goes beyond your mouth and  a bit into your throat.  This feeling stayed about the same for 3 hours and then over the next 3 hours started to dissipate.   After that I just hand a mild lingering headache and general feeling of tiredness.  By the next morning I just had a slight headache and physical feeling of tiredness.
After vaccines patient had syncopal episode on examination table and a momentary seizure with right arm and leg shaking. This lasted seconds and she came to immediately afterward. Never happened before.
Delayed onset of redness and itching at injection site discovered in morning (0/20/2021) prior to shower.  Better in afternoon but still visible
This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. A 32 year-old female patient (pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single, for Covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", SUPRAVENTRICULAR TACHYCARDIA (non-serious), PALPITATIONS (non-serious) all with onset 25Feb2021, outcome "recovered" (May2021) and all described as "SVT and palpitations 1 week before delivery lasting until 2 months after delivery". Therapeutic measures were not taken as a result of supraventricular tachycardia, palpitations. Additional Information: Facility type vaccine: Workplace clinic. Other medications in two weeks: Prenatal. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up.
Received a call from patient stating she had a metallic taste in her mouth, tongue felt numb and felt tired. Physician administered IM-steroid & BENADRYL PO - 2 tabs with relief.
On 05/04/2022 I went to bed at around 09:30 and fell asleep. I woke up at around 10:15 with rapid heartbeat and trouble breathing. My husband called an ambulance that took me to a local emergency room. My blood pressure extremely elevated and I was having chest pains. They performed an EKG that revealed that my heart was doing some strange things. They told me I was in A-fib but it corrected itself. I followed up with a cardiologist who basically said that things were ok and I just needed to wait and see if it happened again.