chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Faint for 15 minutes; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint for 15 minutes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 040A21A) for COVID-19 vaccination.     No medical history information was provided by the reporter.  Concomitant products included PROPRANOLOL from 26-Mar-2021 to an unknown date for Blood pressure, ATORVASTATIN from 17-Apr-2021 to an unknown date for Cholesterol, AMITRIPTYLINE from 03-Aug-2020 to an unknown date for Depression.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced SYNCOPE (Faint for 15 minutes) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Faint for 15 minutes) outcome was recovered. Action taken  in response to the events was not applicable as she has taken 2 doses.   This case was linked to MOD-2021-056362 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report has been received from a pharmacist referring to a 69 year old female patient with hypothyroidism. Concomitant medication included FLUZONE. The patient had no drug reactions/allergies. On 12-MAR-2014 and 05-NOV-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # R018741, expiration date 06-APR-2020 for prophylaxis (strength and anatomical location were not reported) separately (inappropriate schedule of vaccine administration). On 06-NOV-2018, the patient developed redness and swelling at the site of PNEUMOVAX 23 injection. The patient called pharmacist to seek medical attention. There was no treatment given for the events. At the time of the report, the outcome of redness and swelling at the site of PNEUMOVAX 23 injection was reported as not recovered. No causality assessment was provided.
Swelling, no sleep, pain in entire body, delusional, very irritable, depressed
Information has been received from a certified medical assistant concerning a 10 year old female with no pertinent medial history or drug allergies who on 12-DEC-1998 was vaccinated with a single dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination administered on that same day included a oral dose of poliovirus vaccine live. On 01-FEB-2008, the patient developed a widespread rash. On 02-FEB-2008, the patient was examined in the physician's office and diagnosed with chickenpox characterized by 20 scattered vesicles and 6 crusted lesions. A strep culture was performed which was negative. The patient was treated with Benadryl. The patient was noted to be recovering. There was no product quality complaint. Follow-up information form the reporting certified medical assistant concerning a 10 year old male (also reported as female) who on 12-DEC-1998 was vaccinated with a single dose of varicella virus vaccine live (Oka/Merck) at another's doctor's office. At the time of vaccination the patient had a low grade temperature and a sore throat. On 01-FEB-2008 the patient developed 6 scabbed vesicles on the heck and back (amount not noted). Strep cultures at 24 hours and 48 hours were performed which showed a negative result. The physician reviewed the protocol for chickenpox. The patient was recovered. Additional information has been requested.
swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling at the injection site) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-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 an unknown date, the patient experienced INJECTION SITE SWELLING (swelling at the injection site). The patient was treated with DICLOFENAC at an unspecified dose and frequency. At the time of the report, INJECTION SITE SWELLING (swelling at the injection site) had resolved.            Treatment information included Vit B  Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-052881 (Patient Link).
No additional AE; Patient was administered Expired VAQTA; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 17-NOV-2020, the patient was vaccinated with expired hepatitis a vaccine, inactivated(VAQTA) lot # S032056 with expiration date 09-NOV-2020, for prophylaxis (strength, dose, rote of administration and anatomical location were not reported). No adverse event was reported. There was not any temperature excursion reported. combination product report: Yes; brand name: VAQTA SYRINGE (DEVICE); common device name: Hepatitis A Vaccine, Inactivated; product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp.; device lot number: S032056; expiration date: 09-NOV-2020; device age and unit: 0 ; serial number: 100424354151; malfunction: Unknown; device usage: Initial; evaluated by mfr: Not returned to manufacturer; reason for non eval: 81 Other; labeled single use device: No; mdcp reportability: No; mdcp rep rationale: Case information does not meet criteria for reportability
still get the flu with the other shot; took another 6 months to get my strength back; Initial information received on 22-Nov-2020 regarding an unsolicited valid non-serious case from a patient via social media.  This case involves an elderly (reported as over 65) patient of an unknown gender who still get the flu with the other shot (influenza) and took another 6 months to get strength back (asthenia), while the patient received influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medication was reported.  On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (with an unknown route, frequency, strength, lot number and expiry date) for prophylactic vaccination.  On an unknown date (latency unknown), after starting the suspect vaccine therapy, the patient have not gotten the flu in three years. But the patient still get the flu with the other shot (influenza) but it only lasted 3 days not 3 weeks in bed. The one year the patient did not get the shot and got the flu and the patient was in bed for 3 weeks and it took another 6 months to get strength back (asthenia).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events were unknown.  There will be no information available regarding batch number in this case.  No further relevant information was reported.
Initial misuse case was received from a healthcare professional on 18 Oct 2013. Case was received on 21 March 2014 at GPV.  A 8 month old patient whose demographic  details, medical history and concomitant medication were not reported received a 0.5 ml dose of FLUZONE vaccine on unspecified date. (Route, site, dose and batch number not reported). It was reported that on an unspecified date patient received an over dose of 0.5 ml instead of 0.25 ml of vaccine. Laboratory investigations were not reported. No adverse event was reported. List of documents held by sender: none
no additional adverse event reported; lots: U015689 and U010395 have been administered to patients since the excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 24-SEP-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number U015689 had been verified to be a valid number; expiration date 18-MAY-2023). The temperature  excursion was at -12.0 degree Celsius (C), for a time frame of 1 hour and 50 minutes. No had previous temperature excursion. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA007144:
DECAVAC TETANUS AND DIPHTHERIA WAS ADMINISTERED ON 29 OCT 08.  PT NOTED INJECTION SITE PAIN ON 30 OCT PRIOR TO CONDUCTING PHYSICAL EXERCISE, BUT NOTED THE PAIN DID NOT PREVENT PUSHUPS.  PT PRESENTED ON 31 OCT WITH INJECTION SITE PAIN.  INJECTION SITE AREA NOTED ERYTHEMA WITH TENDERNESS AND WARMTH.  PT ALSO C/O GENERALIZED MAILASE FEELING.  HE HAS SELF ADMINISTERED TYLENOL AND WARM COMPRESSES WITH LITTLE RELIEF.  TX WILL CONSIST OF IBUPROFEN AND ICE MASSAGES WITH DIRECTION TO EMERGENCY ROOM IF N/V OCCUR OR SIGNS OF CELLULITIS PRESENT.
Patient reported having increased production of phlegm in throat, resulting in the need to clear his throat "500 times per day" per patient. He states that he had/has a very hoarse voice and reports possible redness at back of throat. Saw his primary physician who then referred him to an ENT to be scoped. No diagnosis at this time. He takes Benadryl at night which seems to alleviate his symptoms. Air quality was listed as "unsafe" around that time. He may be experiencing severe allergy symptoms and states he is not sure whether or not any of this is related to the vaccine but wanted it reported.
I was really fatigued after the shot. And my heart seemed to beat faster. I wondered if I had a heart attack
Information has been received from an RN concerning a 51 year old male who on 5/25/99, was vaccinated with the 1st dose of Hep-B vaccine recombinant. On 5/25/99, the pt experienced dizziness and light-headedness. No further information is available.
I did not have an adverse reaction to the vaccine but I tested positive for COVID-19 on  07/05/2022.  I started feeling systems on 06/30/2022. I started with a sore throat and then a bad head cold.  I had a telehealth visit with my doctor on 07/05/2022.
missed a 2nd Shingrix dose by a couple of years; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose couple of years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. It was reported that the patient had missed a 2nd Shingrix dose by a couple of years, which led to incomplete course of vaccination. The reporter asked if the patient had to start over. The follow-up would not possible as no contact details were available.
The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM; dose administered past manufactures expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) and PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-May-2022 at 2:30 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-May-2022 at 2:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) and PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM).    Concomitant medications details were not reported by the reporter. There was not any other potential caused. It was unknown if patient experienced similar adverse event in the past. Dose administered after 30-day Use by Date or after manufacturer date of expiry. The vial was initially stored in the refrigerator. Was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM.  Dose were administered between 2-3 PM on 03May2022 5. The vial did not 6undergo any temperature excursions. Treatment details was not reported by the reporter.
Had very minor rash occur with itching on right side of face, neck and hands and itching of tongue that started about an hour after the vaccine was administered. Employee advised to call her Dr. and was told to take allergy medication that she carries on her. Took 2 60mg generic Allegra and symptoms dissipated within an hour. Employee also followed up with her primary care physician to discuss.
Fever, chills, body aches, headache for approximately 36 hours and also have left arm soreness; I took Tylenol.
Patient reported pain, fever, swelling, redness, "cellulitis." Patient claims to have seen physician the day after the vaccination was given.
Patient was administered a 0.3 mL dose of monovalent Pfizer vaccine instead of intended 0.3 mL bivalent Pfizer vaccine.
PT reports chest pain & being dizzy.  (More profound then 1st shot) Checked out.  High BP. Abnormal EKG. Persistent cough present. IV administered on right ac.  Transported to Hospital.
Patient presents with prolonged injection site pain that spreads to her left upper arm/shoulder/neck area. The pain comes and goes away through out the day. The pain gets worse when she lifts her arm, and /or puts on clothes. She hasn't taken any medications or seen a doctor to help treat the pain. She has only been watching-waiting the pain hoping that it goes away.
Developed an arrythmia, chest pressure, tightness/constriction, shortness of breath.  Got progressively worse over the next week. Spoke with my GI doctor on 9/14/21 about the arrythmia and pressure on the chest post vaccine.  She said follow up with PCP. Followed up with PCP when symptoms worsened and breathing was difficult and fearful of heart attack (missed work) went to urgent care 9/22/21 they did ekg.  Then sent me to ER. Another Ekg, labs, chest xray and CT scan with dye. Follow up with PCP 9/27/21.  Results of CT Scan showed enlargement of heart valves and inflammation in bronchial lining.  As of 10/9/21 chest pressure, shortness of breath have greatly decreased. Arrythmia is still present but subdued, less intense and less frequent throughout the day. Another follow up post more labs with PCP scheduled 10/13/21. Holter monitor scheduled for 10/14/21 and echocardiogram on 10/11/21
A SORE ARM FOR ABOUT 3-4 DAYS; GOT THE CHILLS IN THE  MIDDLE OF THE NIGHT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced a sore arm for about 3-4 days, and got the chills in the middle of the night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a sore arm for about 3-4 days, and the outcome of got the chills in the middle of the night was not reported. This report was non-serious.
Rash beginning 10 days after vaccination. Large patch of erythema at site of vaccination (left arm), blanchable pink maculopapular rash on face and extremities.
Diarrhea, nausea, and vomiting began on day after vaccine.  Fever and chills followed on second day after vaccine.  Symptoms were resolved by the third day after vaccine.
It progressed over a seven-day period with clear nasal drip. I went traveling and four days into I had a persist cough throughout the night from the drip. I had red and green Mucas. I knew it was infection. I went on to the doctor and nothing was noticed but sinus issues and given a steriod shot, antibiotics and an antihistamine.  I had lost my voice just about completely from coughing. Today I have minimal issues today.
Headache; Nausea; This is a spontaneous report received from a contactable consumer or other health care professional reported herself. A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL3247), via an unspecified route of administration, in left arm on 22Feb2021 at 09:30 (at the age of 62-year-old) as dose 1, single for covid-19 immunization at workplace clinic. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included HBP and Latex Known allergies latex: allergies to medications, food, or other products reported as yes. Concomitant medications included lisinopril, Pantoprazole, Vitamin D and tocopherol (VITAMIN E), patient received any other medications within two weeks of vaccination was reported as yes. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021, patient experienced the headache and nausea the day after she received the vaccine. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were reported as no. The outcome of the events was reported as recovering, since everything was good and fine on 24Feb2021.  No follow-up attempts are needed. No further information is expected.
diagnosed to have Covid (test not done yet); This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (diagnosed to have Covid (test not done yet)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (diagnosed to have Covid (test not done yet)). At the time of the report, COVID-19 (diagnosed to have Covid (test not done yet)) outcome was unknown. Not Provided      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 medications were provided  No Treatment information  were provided   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received on 23-JUL-2021 and contains No New Information.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (expired vaccine) in a 28-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 031B21A) for COVID-19 immunization. No medical history reported. On Nov 12, 2021, patient received the 3rd (booster) dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 12, 2021, patient administered expired product (expired vaccine). On Nov 12, 2021, administered expired product (expired vaccine): resolved. The reporter did not provide any causality assessments or concomitant medication. Reportedly, no treatment given to the patient.
Patient bleed more than usual when got the vaccine. Has couple of drops fall on the arm. After  that patient waited for 30 minutes to check if everything is ok. During waiting patient complained of feeling nausea and getting hot. Patient had some water to drink and after a few minutes patient said she was feeling better. Kept watching  the patient for 30 minutes and after that she left the pharmacy area without any problem.
Pain in the joint, no redness in area, patient advised warm compresses, Tylenol, and Urgent Care if needed.  Patient seen at Urgent Care, Labs Draw, Ded Rate was 9, WBC was 21,000.  Infectious Disease MD, directed urgent care physician to send patient to ER immediately.  Patient insisted on travel by private auto.
pt recv vax on 22JAN97 & had fever up to 103 & was inconsolable for 3 days;