chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; chills; body aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea). At the time of the report, PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.
Sore Arm; Red Arm; Headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In August 2019, 1 day after receiving Shingrix, the patient experienced pain in arm, erythema of extremities and headache. On an unknown date, the outcome of the pain in arm, erythema of extremities and headache were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities and headache to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix in her left arm approximately during the first week in August and later that day developed a headache that lasted approximately one day. The next day, caller reported her arm was sore, and noticed her arm was red as she took her shower in the morning, caller mentions her arm could have been red earlier, but she did not observe it until taking her shower.  The caller reported redness and soreness were not localized to the injection site and that it occurred on her upper arm.  The caller reported soreness lasted a while, but redness lasted up to 3 weeks.  The reporter consented to follow up.
body aches; Headache; joint pain; muscle pain; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HEADACHE (Headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL SUCCINATE (TOPROL) for an unknown indication.   On 31-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 31-Mar-2021, the patient experienced PAIN (body aches), HEADACHE (Headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (body aches), HEADACHE (Headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
On July/28/2021 my daughter woke up very early to tell me,that she feels weird. He eyes looked bloodshot and strange looking, was not herself, I asked her if she was okay but she kept saying I don't know.I asked her if she was thirsty and she just kept replying I don't know. I asked her if she wanted to rest,she relied I don't know,but she also stayed very close to me,which she never does.I asked is she hungry,she said I don't know. Then she said she thought she saw my wire on the floor move,then she would ask me What is that,it seemed very weird how she acted yesterday.Ot is just about 10am and she has not woken up yet,this also strange because she always wakes up early to feed to animal(betta fish). My daughter was not herself  and I was very worried  and concerned and this is all because she had the covid shot yesterday.  I hope she is better today.
On day 9 after vaccination. Left arm where injection was given is warm to the touch, red and itching .
Nose bleed 45 minutes after administration and then 8 more subsequent nose bleeds over the last 3 weeks.
Pt parent had telephone consult and explained that pt received second pfizer vaccine yesterday (not at PCP office). This AM, pt woke up with numb tongue, and vomited 3x. Denies fever, rash, SOB. Explains symptoms resolved after episodes of vomiting. No longer feels nausea and tolerating food.
Right ear feeling like there is a pressure in my ear like it is plugged and there's some hearing loss. These symptoms are continuous.
He started acting super lethargic, screaming, wouldn't eat or drink fluids, had trouble standing, would not play or interact. He got a fever the next day and started slowing down and showing all of these symptoms the day after the shot. Gave Tylenol and Motrin for fever. Had febrile seizure 2 days after. Took by ambulance to the hospital. He was foaming out of his nose and mouth, arched back, seizing, unresponsive, turned blue for about 3-5 mins.
Initial unsolicited report received from a Pharmacist on 29 August 2016. This case involves a 68-year-old female patient who was vaccinated with a dose of YF-Vax vaccine (batch number: UI292AC, expiry date: 22 April 2018, dose not reported) subcutaneously on left arm on 17 August 2016. Patient had no known allergies. Illness at the time of vaccination was reported as none. Patient's other medical history and concomitant medications were not reported. On 18 August 2016, one day following the vaccination, the patient experienced redness and itching at the injection site on left arm and since that time, patient had intermittent redness and itching at site continued till 29 August 2016. Lab data and corrective treatment was not reported. The patient was not recovered from events (the outcome of event was also reported as unknown). List of documents held by sender: none.
Erythema, noted in left arm area with warmth approx 2 inches, itchy per grandparent. No drainage noted, pain.
Headache, Myalgia, Fever, Palpitations, CHILLLS Narrative:  Employee got the second dose vaccine 01/28/21, 920am Employee claimed at 8pm same day, he started having rapid heart beat, headache, chills, sweat, this continues to the following morning He could not come to work 01/29/2021 He stated that he stayed home to rest and felt better
DEATH Narrative: 66 yo male with PMH of HTN, HFpEF, COPD, T2DM, CKD, tobacco use disorder and bipolar disorder was found dead in his home on 2/16/2021 after police did a wellness check per request of patient's sister. Patient received the covid19 vaccine (Pfizer) on 2/9/2021, vaccine was administered without complications. No prior positive for covid19. After patient received his covid19 vaccine, he was seen at same day access for increased SOB/DOE, worsened orthopnea. Per progress notes, at this last appt, patient had expressed a number of medications which he was not willing to take, attributing his worsened health to their effects. Pt has continued spironolactone despite being advised to stop it by his medical provider. At the time of visit, provider noted that this kidney function was declining (patient does have CKD). Provider discussed the importance of medication adherence and patient was started on torsemide. Hctz was discontinued, minoxidil was increased due to patient preference. Prior to this same day access/express care visit, patient was hospitalized from 1/26 through 1/28/2021 for hypertensive urgency (211/105) and that at that time, pt already had orthopnea, SOB, and dyspnea. Patient was also admitted from 1/7 to 1/8 and left AMA. While inpatient, his MRI revealed a pontine lacunar infarct that was found to be chronic. It was recommended that patient be treated with aspirin/plavix for 21 days then aspirin alone but patient declined.
No additional adverse events reported; An expired dose of Pneumovax 23 was administered to a patient; This spontaneous report was received from a pharmacist (also reported as MNSC specialist), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On 10-SEP-2021, the patient was vaccinated with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine, 1 dose, lot # T010293 with expiration date of 30-AUG-2021 (anatomical location was not provided) for prophylaxis. The reporter stated that the vaccine dose was properly stored through time of administration. No additional adverse events were reported.
Redness to left deltoid and itching developing less then 24 hours after immunization. Symptoms waxed and waned and improved by clinic appointment. Treatment with Benadryl as needed. Fever to 102 within 48 hours of immunization treatment with Tylenol.
Information has been received for the Merck Pregnancy Registry for GARDASIL from a 25 year old white female with crohn's disease, hypothyroidism and no drug reactions/allergies and has received the complete series for GARDASIL series. ON 13-APR-2007 the patient was vaccinated with GARDASIL (lot # unknown) injection.  Concomitant therapy included SYNTHROID and ASACOL). In May 2007 the patient received a second dose of GARDASIL. In August 2007, the patient received a third dose of GARDASIL. The patient's date of the last menstrual period was on 17-SEP-2007. Medical attention was sought. The patient reported that she conceived on 29-SEP-2007. On an unspecified date the patient also had a blood test performed. To date the patient has not experienced any adverse reactions. The estimated date of delivery is 23-JUN-2008. Follow-up information was received. ON unspecified date the patient developed gestational hypertension. Concomitant therapy also included prenatal vitamins. The patient developed a normal healthy baby boy weighing 6 pounds and 15 ounces. The apgar score was 9 and 9. the patient was 39 and 4/7 weeks for LMP. Additional information is not expected.
Began developing flu-like symptoms about twelve hours after receiving first dose. I started having body aches, chills, fever, and fatigue. Ibuprofen has helped manage symptoms.
felt nauseous for only 15 seconds; she felt warm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (she felt warm) and NAUSEA (felt nauseous for only 15 seconds) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced FEELING HOT (she felt warm). On 13-Feb-2021, the patient experienced NAUSEA (felt nauseous for only 15 seconds). At the time of the report, FEELING HOT (she felt warm) and NAUSEA (felt nauseous for only 15 seconds) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment drugs were reported.
Moderna Covid-19  Vaccine EUA  Hospitalized for: COPD exacerbation, Delirium, aggression,
Pt was 17 at time of vaccination.  Moderna was not approved for under 18 at the time of vaccination.  Spoke with patient on 6/23/21 (had previously tried to contact with no answer), She did fine with the vaccine with no adverse events.
5-10 minutes after injections, mother questioned rash on upper arm with swelling, erythema, urticarial, facial swelling and redness. Given Benadryl IM at 10:15AM.
This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 10-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose and route of administration were not reported), lot # reported as K004204. No adverse reaction was reported at the time of the report. It was verified that lot # K004204 is not valid for GARDASIL 9, however it is valid for GARDASIL. This is one of several reports received from the same reporter. Additional information has been requested.
At about 7-8pm the day of vaccination I started to experience body aches, chills, low grade fever. I was so cold that my fingers turned blue and I looked very pale. In the middle of the night, when going to the bathroom, I felt nauseous and dizzy and fainted hitting my head hard on the floor . Today I have a bad headache and still feel slightly cold.
Janssen 9/2/21, Pfizer 4/7/22, 8/13/22, 12/2/22. Positive on 2/20/23
macular papular eruptions on trunk; sparse on extremities & face noted 28MAR95 per parent-noted @ eval appt on 28MAR95;
Headache, Myalgia, Arthralgia, Fever, chills Narrative:  Other Relevant History:
Pt had syncopal episode post administration. Prior to administration, we had discussions with pt. Pt disclose having a history of passing out the past vaccines he had years ago. Upon administering, pt and I was talking and he said he was fine, no symptoms. A few minutes passed and he asked for some water. I went back into the pharmacy being it was a few minutes and he looked and seem fine, upon returning to vaccination booth, pt was found on the floor. Less than 15 seconds was passed. Pt became alert and oriented and was aware he had "passed out". We gave powerade, ice pack, and did some assessments, and patient stated feeling fine. We had him sit for additional 15 mint (30 min total) and he had no episode and he stated feeling fine.
I had headaches, chills, soreness all over my body, and wanted to throw up for 48 hours after the vaccine.
Left arm injection site (Tdap) with redness / swelling approx 3 cm in diameter. Right arm injection site (MENVEO) with redness / swelling approx 5 cm in diameter.
Eight days after my first dose vaccine, I developed a big rash at the injection site. The rash was 4 inches long and 2 inches wide, it was very itchy. I also developed a lymph node under my left armpit which was was swollen and sore.
face felt very warm; also - I've had 2 liters of water today so far; minor headache (very minor); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 12:00 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 12Mar2021, outcome "recovered" (12Mar2021), described as "minor headache (very minor)"; FEELING HOT (non-serious) with onset 12Mar2021 12:30, outcome "recovered" (12Mar2021 13:30), described as "face felt very warm"; THIRST (non-serious) with onset 12Mar2021, outcome "unknown", described as "also - I've had 2 liters of water today so far". Therapeutic measures were taken as a result of headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
heart attack; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 014M20A and 032L20A) for COVID-19 prophylaxis.     The patient not had COVID test or diagnosis.  Concurrent medical conditions included Drug allergy (allergy to Demerol), Sulfonamide allergy (Sulfa allergy) and Hay fever. Concomitant products included FISH OIL for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 2 days due to MYOCARDIAL INFARCTION. The patient was treated with TICAGRELOR (BRILINTA) for Heart attack, at an unspecified dose and frequency. At the time of the report, MYOCARDIAL INFARCTION (heart attack) outcome was unknown.            Concomitant medication included blood pressure medicines (unspecified).  Company Comment : This spontaneous case concerns a 74 year old male, with a no relevant medical history reported who experienced the serious (hospitalization, medically significant) unexpected adverse event of special interest Myocardial infarction, which occurred 18 days after the third dose of mRNA-1273 vaccine administration. The outcome of the event was unknown. The patient was hospitalized for 2 days and was treated with TICAGRELOR (BRILINTA), at an unspecified dose and frequency. No other information regarding treatment or course in the hospital was provided. Patient's age and gender could be confounders for the event.  The benefit -risk relationship of mRNA -1273 is not affected by this report.   This case was linked to MOD-2022-611782 (Patient Link).; Sender's Comments: This spontaneous case concerns a 74 year old male, with a no relevant medical history reported who experienced the serious (hospitalization, medically significant) unexpected adverse event of special interest Myocardial infarction, which occurred 18 days after the third dose of mRNA-1273 vaccine administration. The outcome of the event was unknown. The patient was hospitalized for 2 days and was treated with TICAGRELOR (BRILINTA), at an unspecified dose and frequency. No other information regarding treatment or course in the hospital was provided. Patient's age and gender could be confounders for the event.  The benefit -risk relationship of mRNA -1273 is not affected by this report.
Patient received COVID-19 vaccine (1st dose) on 12-21-20. Sometime between 12-22-20 and 12-26-20 (received conflicting doses) patient noticed a rash on the torso. Rash not itchy or painful. Patient denied any tongue/lip swelling, no throat swelling, no dyspnea/dysphagia. Rash did not improve with Benadryl. Did get ok from Provider to receive COVID-19 on 1-11-21.
HEMODIELYSIS PT RECVD 1ST DOSE OF ENGERIX-B(IM) ON 03-APR-90. HBSAG ON 4-3-90 WERE WEAKLY POS. ON 4-10-90 HBSAG WAS NEGATIVE. NO TREATMENT REQUIRED.
Information has been received from a female 21 years old who on 14-DEC-2007 was vaccinated with the first doses of GARDASIL 0.5 ml. On 12-FEB-2008 the patient was vaccinated with the second dose of GARDASIL and on 26-JUN-2008 was vaccinated with the third dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently in 2008 the patient had an abnormal pap smear result after completing the three doses of GARDASIL 0.5 ml. Disability and life threatening is unknown. The patient's abnormal pap smear persisted. The patient sought unspecified medical attention. Additional information is not available.
Extremely swollen, painful arm in which received both pneumonia and Flu vaccine right vaccine. Arm red, tender to touch, unable to move. Resolving by 11/5/07 Unable to determine which site as entire affected.
received doses from vial after 30-day Use By Date.; Vaccine was placed in the fridge instead of the freezer and for the past 3 months they have administered 326 doses.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from vial after 30-day Use By Date.) and PRODUCT STORAGE ERROR (Vaccine was placed in the fridge instead of the freezer and for the past 3 months they have administered 326 doses.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from vial after 30-day Use By Date.) and PRODUCT STORAGE ERROR (Vaccine was placed in the fridge instead of the freezer and for the past 3 months they have administered 326 doses.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses from vial after 30-day Use By Date.) and PRODUCT STORAGE ERROR (Vaccine was placed in the fridge instead of the freezer and for the past 3 months they have administered 326 doses.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. No adverse events reported for the patient.  On follow-up reporter stated that,The vaccines administered September 1 - October 12, 2021 from lot number 046C21A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The vaccines administered October 13 - October 19, 2021 from lot number 046C21A likely maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration; however, some vaccine may have activity below the level studied in our clinical trials. The vaccines administered on or after October 20, 2021 from lot number 046C21A likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Information provided by reporter added in I-narrative. On 04-Nov-2021: Follow-up contains no new information.
Initial and follow-up information has been received from a health professional and a consumer who reported that her 12 year old son, whose reported weight was 100 pounds and whose reported height was 67 inches with no drug reactions or allergies and no known illness at the time of vaccination who on 14-NOV-2006, at 2:30 P.M., was vaccinated subcutaneously into the right arm with Pneumovax 23, (Lot # 655588/0883F).  Concomitant medication included influenza virus vaccine (unspecified).  The reporter stated that her son was experiencing a local injection site reaction from Pneumovax 23.  The reaction consisted of quarter-size induration of redness on the arm accompanied by chills and fever.  The patient stated that the pain in his arm was so severe that on a pain scale of 1 to 10, it was 10.  The patient did not seek medical attention.  At the time of the report, the patient had not recovered.  In follow-up it was reported that the patient on 14-NOV-2006 at 5:00 P.M. developed a large, red, warm reaction at the injection site and later had chills.  The patient was treated with MOTRIN and used an ice pack.  The patient's temperature went to 102 degrees at 24 hours.  The patient also vomited.  No swelling of throat, wheezing, shortness of breath (SOB) or hives.  The reaction was up to 6 inches in size and lasted 4-5 days before resolution.  At the time of the patient's office visit the size was about 2 inches.  It was reported that the patient recovered on an unknown date.  Additional information has been requested.