chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received 2nd shot 3 months after the first shot,They did not have the vaccine available so received the second dose as soon as it became available; Received 2nd shot 3 months after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Received 2nd shot 3 months after the first shot) and PRODUCT AVAILABILITY ISSUE (Received 2nd shot 3 months after the first shot,They did not have the vaccine available so received the second dose as soon as it became available) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Received 2nd shot 3 months after the first shot). On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (Received 2nd shot 3 months after the first shot,They did not have the vaccine available so received the second dose as soon as it became available). In June 2021, PRODUCT ADMINISTRATION INTERRUPTED (Received 2nd shot 3 months after the first shot) and PRODUCT AVAILABILITY ISSUE (Received 2nd shot 3 months after the first shot,They did not have the vaccine available so received the second dose as soon as it became available) had resolved.            No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-339758 (Patient Link).
Fatigue - 4 PM - 02/26/2021-Present Nausea - 5 PM - 02/26/2021-Present Headache - 5 PM - 02/26/2021-Present Inject Site Soreness - 5 PM - 02/26/2021 Increase in Abdominal pain - 5 PM - 02/26/2021-present 101.2 Fever - 5 PM - 02/26/2021-02/27/2021. Lowered to 100.1 2/28/2021-present. Muscle aches - 6 PM - 02/26/2021 - lasted through the night only Dizziness - 10 PM - 02/26/2021-present Dry throat and mouth/unquenchable thirst - 10 PM - 02/26/2021-present Loss of voice (no sore throat) - 11 PM - 02/26/2021 Heart racing - 02/27/2021 since waking up - lasted about 30 hours Rash on left shoulder and arms. Itchy. 2/28/2021 - 9 AM to present
booster dose; I have COVID; I have COVID; I'm sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3, (booster) single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster dose"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 25Dec2021, outcome "unknown" and all described as "I have COVID"; ILLNESS (non-serious) with onset 25Dec2021, outcome "unknown", described as "I'm sick". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19, illness.  Additional information: Do you have any information of the availability of PAXLOVID?"  Response: Responded as per attached SRD. Informed caller: "Paxlovid has not been approved, but has been authorized for emergency use by FDA , for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalization or death. Under the Emergency Use Authorization, Department of Health and Human Services is overseeing the fair and equitable distribution of nirmatrelvir tablets; ritonavir tablets. Individuals should visit their healthcare provider to determine eligibility for treatment. Pfizer Medical Information does not have additional information on product availability".  The lot number for bnt162b2 was not provided and will be requested during follow up.
2nd dose 1 month after the 1st; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received HAV (Havrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comments: The patient received Havrix 2nd dose 1 month after the first dose instead of waiting for six months. No further information provided via form.  The reporter consented to follow up. Additional Supportive Information: The patient received the 2nd dose of Havrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Passed out on driveway; Arm Pain; Tremors in hand; Could not get up; Headache; Nausea; Vomiting; A spontaneous report was received from a consumer concerning an 81-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm pain/ pain in extremity, headache, nausea, vomiting, passing out on the driveway/ loss of consciousness, could not get up/ hypokinesia and tremors in hand/ tremor.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included xylometazoline hydrochloride, simvastatin, cyanocobalamin, folic acid, metformin, lisinopril, propanol, hydrochlorothiazide and levothyroxine.  On 01 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly on right upper arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly on left upper arm for prophylaxis of COVID-19 infection.   On 02 Mar 2021, the patient experienced arm pain, headache, nausea, vomiting, medically significant event of passing out on the driveway, could not get up and tremors in hand.  Treatment for the event included nausea medication.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, arm pain, headache, nausea, vomiting, passing out on the driveway, could not get up and tremors in hand was resolved on 06 Mar 2021.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events, a causal relationship with the events cannot be excluded.  Fever, nausea and vomiting are consistent with the product safety profile.
felt dizzy, pale-inc sweating & collapsed on the floor while standing;recovered p/few min;
Patient reported brief chest pain events starting day after Moderna COVID vaccine.  They decreased over time.  I saw him in clinic 11 days later - but were mildly present.  I obtained a D-Dimer which was positive.  He was referred to the ER.
passed out; seizure; fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) and SEIZURE (seizure) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history provided.).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), SEIZURE (seizure) (seriousness criterion medically significant) and PYREXIA (fever). On 10-Mar-2021, LOSS OF CONSCIOUSNESS (passed out) and SEIZURE (seizure) had resolved. At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  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. Further information has been requested   This case was linked to US-MODERNATX, INC.-MOD-2021-072687 (E2B Linked Report).; 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. Further information has been requested US-MODERNATX, INC.-MOD-2021-072687:1st dose vaccine
Patient said 4 hours after injection she was driving home and got dizzy so needed to pull off the highway and wait to pass.  She said it only lasted a few minutes.  Patient explained that she also has a history of headaches, dizziness, and sinus issues.  She said she was not too sure of what caused the sudden dizzines but wanted to tell me the reaction she experienced.
Left arm was swollen around injection site; there are bruises after 2 days. Patient took some pain medication OTC for pain. Patient cannot remember which pain medication she took.
I had tingling down my injection arm, up my neck, up the side of my face, and into my scalp all on the right side. In addition to the burning tingling; Burning tingling sensation,; Throat tightness.; Chest pain; Allergic reaction; This is a spontaneous report from a contactable consumer (patient herself). A 34-year-old non pregnant female received of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration date was not reported), via unspecified route in right arm on 18Mar2021 09:15 (at the age of 34-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not prior vaccination and COVID tested post vaccination. The patient medical history included 2 c-sections and wisdom teeth surgery. The patient concomitant medications include omeprazole, Ibuprofen and levonorgestrel (MIRENA) taken for an unspecified indication, start and stop date were not reported. The patient previously received promethazine (PHENGRAN) and experienced allergies. On 18Mar2021 10:00 patient experienced tingling down her injection arm, up neck, up the side of her face, and into scalp all on the right side and to the burning tingling sensation, she had chest pain, and throat tightness also diagnosed with an allergic reaction. Patient went to the emergency room and he was given an iv, fluids, solu-Medrol, Benadryl, and sent home with a prescription for a steroid dose pack to take for the next 8 days, Benadryl, and epi pens. The outcome of all events was resolved with sequel.  Information on the lot/batch number has been requested.
redness and a rash on the left arm; redness and a rash on the left arm; This is a spontaneous report from a contactable consumer (patient).  A 34-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EN6206), dose1, single at Arm Left on 10Mar2021 08:00 and 2nd dose (BNT162B2, Solution for injection, lot number ER8730) on 31Mar2021 08:00 in left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included famotidine and ethinylestradiol, norethisterone acetate (LOESTRIN). Prior to vaccination, the patient was not diagnosed with COVID-19. After 1st dose, patient developed redness and a rash on the left arm that was injected 10 days after vaccine (onset date 18Mar2021 08:00 PM) and it lasted 1 day. After 2nd vaccine, patient developed redness and a rash on the left arm that was injected 1 day after vaccine and it lasted 4 days. The adverse event result in Emergency room/department or urgent care. No treatment received for the adverse event Since the vaccination, the patient had not been tested for COVID-19. At the time of report, outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash at the injection site (Covid arm); Butterfly rash in face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site (Covid arm)) and BUTTERFLY RASH (Butterfly rash in face) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol and Blood pressure high.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash at the injection site (Covid arm)) and BUTTERFLY RASH (Butterfly rash in face). At the time of the report, VACCINATION SITE RASH (Rash at the injection site (Covid arm)) and BUTTERFLY RASH (Butterfly rash in face) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included high blood pressure and high cholesterol medications.  No treatment information was provided.; 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.
Fever 102 on 07/11/2010. Rash on 07/14/2010.
Pt recv vax on 10/15/97; 1 hr post vax pt exp dizziness, nausea, vomiting, sore throat &swollen neck glands
Seven days after injection, I developed a large, red area about 3 inches below injection site. The area itched and felt warm to the touch.
Fever; Soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and PAIN IN EXTREMITY (Soreness in the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm). On 27-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) and PAIN IN EXTREMITY (Soreness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient wanted to know if it is okay she took Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: TCR received- Caller disconnected
No additional adverse event; the patient was inadvertently administered a dose of VAQTAthat had been improperly stored; This spontaneous report as received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.      On 20-APR-2020, the patient was inadvertently vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe (strength, dosage regimen, route of administration, and anatomical location were not reported; lot number S032056 has been verified to be valid, expiration date reported and validated as 09-NOV-2020) as prophylaxis (product storage error). No additional adverse event.  The temperature reported was of 47.7 degrees Fahrenheit (F) for 12 minutes, with a previous temperature excursion of 58.3 F for 14 hours. A data logger was used. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress:  manufacturercity: ; manufacturerstate: ; manufacturercountry:; devicelotnumber: S032056; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Arm soreness occurred about 15 hours after injection. At about 20 hours, I experienced fatigue, dizziness, and body aches. I got stung by a bee in my upper chin near my lower lip about 3 hours after injection so I don't know what symptoms are caused by what but I also experienced a lump in my right lymphnode.
Presented with weakness, fever, SOB, productive cough; + Covid ED; Admitted  to medical with Covid PNA; tx with maxipime, steroids, remdesivir, zithromax, rocephin, singulair, zinc, minimal O2 supplement;  DC home on O2.
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to an unspecified number of unspecified patients of unknown age and gender. Medical history and drug allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (lot#, reported as L010596, expiration date 06-APR-2017, route of administration, dose and frequency were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Swollen lymph nodes in his right armpit; swelling in the lymph node in the armpit, the lymph nodes in the site of injection; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in right arm, first dose on 22Dec2020, and second dose on 12Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was reporting the side effect after taking the two doses and wanted to know if this is normal. The patient received both doses of the COVID-19 vaccine (22Dec2020 and 12Jan2021) and had swollen lymph nodes in his right armpit on an unspecified date, the same arm he received both doses of vaccine in. The patient's lymph nodes were swelling where he got injected with the vaccine, specifically his right arm. The patient had swelling in the lymph node, his lymph node in the armpit in the same side (in the right arm) is swelling, the lymph nodes in the site of injection. The patient's concern is that is that something he may expect from the vaccine. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
This case was reported by a physician via call center representative and described the occurrence of pain in a adult male patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020) for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain and fatigue. On an unknown date, the outcome of the pain and fatigue were recovered/resolved. It was unknown if the reporter considered the pain and fatigue to be related to SHINGRIX. Additional information was reported as follows: This case was reported by the patient who was a physician. The age at vaccination was not reported. The patient experienced aches and fatigue which started the day after the vaccination and persisted for approximately 24 hours.
Injection site is raised, red, and warm (generally inflamed). Site is described as tender, although not more than is ordinary after a flu vaccine. Patient states that it burned when the vaccine was given, moreso than other flu vaccines. Otherwise the patient feels fine and has no other symptoms.
Starting 06/10/2022, I developed pain in my upper right inner thigh. It continued to get worse and became tender to touch and started spreading down my leg. I went to the ER on 06/24/2022 because I thought I might have a DVT. They did an ultrasound and discovered a blood clot in my right Great Saphenous Vein near my Femoral Vein. They put me on ELIQUIS (blood thinner). I followed up with my cardiologist the following week and I was told I needed to be on the blood thinner permanently.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history of the patients was not provided. On unknown date(s), the patients were vaccinated with improperly stored GARDASIL 9 (lot # L037554, expired date 25-DEC-2017, dose and route was not provided) for prophylaxis. No adverse effects reported. The vaccine was stored between 9 Celsius degree to 25 Celsius degree (20C) for 9 hours and 30 minutes. Previous temperature excursion was between 9 Celsius degree to 25 Celsius degree (20C) for 11 hours.
After we left pharmacy and was in the car at a stoplight, my daughter starting feeling very uncomfortable.  She complained that she did not feel well, she could not see and that her ears were "foggy".  When I looked over at her, her face was pale as can be and her lips had bluish tinge to them and she looked limp laying in the passenger seat of the car.    It came on very quickly and lasted about a minute or so and was extremely scary.  It took close to 30 minutes for her to regain her color.  We sat in a parking lot for thirty minutes to make sure she was stable and gave her water.  Went home and gave her benadryl.  She slept through the night fine and this morning so far is ok.
Arm pain; Swollen eyes; Red ring around injection site; Fatigue; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), EYE SWELLING (Swollen eyes), VACCINATION SITE ERYTHEMA (Red ring around injection site), FATIGUE (Fatigue) and MYALGIA (Muscle pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 006B21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), EYE SWELLING (Swollen eyes), VACCINATION SITE ERYTHEMA (Red ring around injection site), FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, PAIN IN EXTREMITY (Arm pain), EYE SWELLING (Swollen eyes), VACCINATION SITE ERYTHEMA (Red ring around injection site), FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.            No relevant concomitant medication was reported.  Treatment information was not provided.