chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to herself, a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX. Dosing information was not provided. On an unknown date in April 2013 the patient experienced redness at injection site, size of silver dollar, warm, burning, itch, has small circle after 1 week. The outcome of burning, itch, redness at injection site, size of silver dollar, warm, and has small circle after 1 week, is unknown. The relatedness of the events to ZOSTAVAX was not reported. Additional information has been requested.
Vomiting and diarrhea began approx 3 days after Rotateq given, lasted about 10 days.
1 affected vaccine vial was used for 1 dose given to a patient/ their freezer went out of  temperature range on 03MAR2022 for 24 minutes.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (1 affected vaccine vial was used for 1 dose given to a patient/ their freezer went out of  temperature range on 03MAR2022 for 24 minutes.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (1 affected vaccine vial was used for 1 dose given to a patient/ their freezer went out of  temperature range on 03MAR2022 for 24 minutes.). At the time of the report, PRODUCT STORAGE ERROR (1 affected vaccine vial was used for 1 dose given to a patient/ their freezer went out of  temperature range on 03MAR2022 for 24 minutes.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided. Maximum temp exposure was 11.8 degrees F Total time of excursion duration was 24 minutes Vaccine is remained in the freezer now. There was no Visual inspection noting any vaccine state changes Number of vials/doses impacted was 10 vials in which 1 was used, 9 vials remaining unused.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Live follow-up/Non-significant follow-up appended.
Significant histimine reaction; minor tightness of airways; nasal flow; sneezing; itchy/watery eyes; itchy/watery eyes; dose 3 (Booster); This is a spontaneous report from a contactable consumer (patient).  A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: FE3590), dose 3 via an unspecified route of administration, administered in left arm on 20Oct2021 at 13:00 (at the age of 63-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization at Pharmacy or Drug Store. Medical history included allergic reaction to cats, some pollens (not applicable since Booster vaccine). There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration, administered in left arm on 27Mar2021 (Lot Number: FE3590) at 13:00 as DOSE 1, SIGLE and second dose via an unspecified route of administration, administered in left arm on 19Apr2021 (Lot Number: ER8731) at 13:00 as DOSE 2, SIGLE both for covid-19 immunization. The patient received dose 3 (Booster) on 20Oct2021 at 13:00 and experienced significant histamine reaction, minor tightness of airways, nasal flow, sneezing, and itchy/watery eyes 21Oct2021 at 14:00. The patient did not receive any treatment as a result of events significant histamine reaction, minor tightness of airways, nasal flow, sneezing, and itchy/watery eyes. The outcome of the event significant histamine reaction, minor tightness of airways, nasal flow, sneezing, and itchy/watery eyes was not resolved.  Follow-up attempts are completed. No further information is expected.
pt recvd vax & 7-10 days p/vax exp lower back pain, neck pain (cervical spine discomfort), arthritis (stiffness of hands, fingers, feet), arthralgia & a high sed rate; tx Ibuprofen, relafen; fibrositis in OCT93 w/anti-inflammatory med; pain
Developed shoulder joint pain in left arm and right arm. Have pain when doing everyday tasks and also when sleeping at night. Hurts to lay on left or right arm. Occasionally have pain shooting down left arm.
Administer expired vaccine to 450 patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients, after the manufacture date of expiration.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that dose administered after 30-day Use By Date or after manufacturer date of expiry. 168 doses were administered. On unknown date the vial was stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received contain non significant information.
ITCHING ON THE FEET, ANKLES, ON THE BACK, HAND AND ARMS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAY-2021, the subject experienced itching on the feet, ankles, on the back, hand and arms. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from itching on the feet, ankles, on the back, hand and arms. This report was non-serious.
Patient returned to the pharmacy about 3 weeks after receiving vaccine and informed the immunizer and pharmacist of numbness and lack of strength in patients left arm. Vaccine was given in the RIGHT ARM. Patient was advised to contact their PCP. Patient returned again to pharmacy on 6/21 to receive second dose of Moderna covid vaccine. After discussing that he did not seek medical attention the pharmacist on duty refused to give the 2nd dose and strongly urged the patient to seek medical attention, including going to the nearest ER.
Constant ringing in both ears.  Started a week or so after second COVID19 shot on April 17, 2021.
After administration of the Influenza vaccine. Stood and walked to the checkout station then passed out standing. Another nurse grabbed the patient and laid the patient down on the gurney. Patient was temporary passed out then came to shortly after by laid down with feet up.
After receiving flu vaccine, noticed increased weakness in hands bilaterally. Inability to open IV bags, twist tops. Weakness has not improved.
Erythema multiforme; Hives over parts of the body growing and changing shapes; itchy; painful to touch; high fever 104.5; intense night sweats; chills; cough; wheezing; fatigue; body weakness; muscle pain; headache; cannot sleep; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 66 years old, administered in arm left on 19Mar2021 19:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Diabetes type 2, CAD (coronary artery disease), BPH (benign prostatic hyperplasia), osteoarthritis, gall stones. Concomitant medications included metformin; eicosapentaenoic acid ethyl ester (VASCEPA); ezetimibe (ZETIA); fenofibrate; ursodiol. The patient previously took morphine and known allergies to morphine, the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 66 years old, administered in arm left on 26Feb2021 18:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Covid-like symptoms (high fever 104.5, intense night sweats, chills, cough, wheezing, fatigue, body weakness, muscle pain, headache, cannot sleep) from 18Apr2021 and had a covid test (Nasal Swab) on 22Apr2021: negative. The patient also experienced hives over parts of the body growing and changing shapes, itchy, painful to touch - erythema multiforme on 29Apr2021. All events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of all events and included amoxicillin sodium, clavulanate potassium (AUGMENTIN), azithromycin (Z-PACK), ibuprofen (ADVIL), paracetamol (TYLENOL), diphenhydramine hydrochloride (BENADRYL), cetirizine hydrochloride (ZYRTEC). The outcome of the events high fever 104.5, intense night sweats, chills, cough, wheezing, fatigue, body weakness, muscle pain, headache, cannot sleep was recovered on 27Apr2021, of the other events was not recovered.  Information about lot/batch number has been requested.
pt recv vax 28OCT96 & 28OCT96 pt exp rash, wets, & was very sore;
When I received my first dose of the Moderna COVID vaccine (Lot # 010M20A) my arm was extremely sore and limited range of motion. I contributed it to just being sore like the literature had sad. When I received my second dose within 20 minutes my arm was extremely sore. It got to the point where I could not lift my arm at all and had no ROM in it at all. It was like my arm just was not working and I would have to move my arm around with my right arm. I was taking 600-800 mg of Motrin every 6 hours and alternating Tylenol 1000 mg and it was not easing the pain. It got to the point where the pain was so unbearable that I went to the Emergency Room on 4/3 where I was diagnosed with Shoulder Injury Related to Vaccine Administration (SIRVA). The gave me some Toradol and Decadron IM and sent me home with Naproxen and Prednisone with orders to follow up with my PCP
Tingling sensation in her arm, on her left arm that is where it was given and then right; Tingling sensation in her arm, on her left arm that is where it was given and then right; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 21 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jul2021 (Lot number: FA7485) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), VACCINATION SITE PARAESTHESIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "Tingling sensation in her arm, on her left arm that is where it was given and then right".  Additional information: Tingling sensation in her arm, on her left arm that's where it was given; feel tingling sensation at the tip of her right hand.  No follow-up attempts are possible. No further information is expected.
chills; small fever for about 8 hours; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (small fever for about 8 hours) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   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 an unknown date, the patient experienced CHILLS (chills) and PYREXIA (small fever for about 8 hours). At the time of the report, CHILLS (chills) and PYREXIA (small fever for about 8 hours) outcome was unknown.            Patient had Chemo and an Operation.   Reporter did not allow further contact
This spontaneous report has been received from a nurse and refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-MAY-2017, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU), subcutaneously, lot # M042851, expiration date 18-JAN-2018 (dose was not reported) and also with VARIVAX injection, lot # M044347, expiration date 04-NOV-2018 (dose and route of administration were not reported) due to human error. The reporter stated that she was going too quickly with the checking" prior to administration of the doses. The vaccines were reconstituted with sterile diluent (DILUENT MRK) lot # N07932, expiration date 06-MAY-2018 (dose and route of administration were not reported). The patient had not experienced an adverse effect. No product quality complaint was involved. Additional information has been requested.
VERY DIFFICULT BREATHING/RAPID HEARTBEAT/ CHILLS/AND RESULTING ANXIETY INTENSE FOR APPROX 2-3 HOURS BARELY AVOIDING THE EMERGENCY ROOM. STILL EXHIBITING LATENT EFFECT BUT, SEEMINGLY DEMINISHING. HOME TREATED WITH EXTRA DOSE(S)OF ADVAIR,MUCINEX,AND MENTHOL DROPS.
Admitted with RUL cavitary lesion and found to also have COVID Pna. From group home where other residents were "sick". Completed vaccine 2/2021. Not hypoxic or requiring O2. Treated with cefepime, doxy, merrem, zinc. Patient is being discharged back to her group home she is doing well from the COVID-19 standpoint.
Shortness of breath Myocarditis  Fever Chills  Dizziness Muscle spasm Torticollis  Weakness
At 1:00 am on 9/7/19, pt stated that her left arm was swollen, painful, red, itchy, and hot from where the shot was given to her elbow.  I asked the pt what pain relievers she had at home and she said that she was taking diclofenac, which I told her to continue taking to help with the pain, inflammation, and swelling.  I also asked her if she had an antihistamine on board and she said no.  After ensuring that she had no contraindications to Benadryl, I suggested that she take that every 4-6 hours.  Also, I asked that she put ice or ice pack on her arm, but not directly, to have  cloth or towel in between the ice and her arm and to keep it on for 15-20 minutes at the time and to use several times throughout the day.  I instructed her that if her arm didn't get any better, to go straight to the doctor.  Follow-up:  I checked on the patient today (9/8/19) and she says that she went to an Urgent Care clinic yesterday (9/7/19) in the afternoon, and says that the Physician Assistant questioned whether it was a severe allergic reaction or if there was cellulitis involved.  So, she says that he/she is treating her for possible cellulitis with doxycycline and asked her to continue taking an antihistamine.  She is to return to the PA tomorrow for a follow-up.
Severe and constant joint pain. Knees, Hips, Arms, Shoulders, and hands. I can't bend down. I can barely lift things. My body feels 80.....I am only 48. My life has drastically changed. Before my shot, I was doing 2 pilates classes a day....Now I have to use my hands to lift my legs up to get out of the bed.
The patient said that she experienced hot/cold symptoms. She also stated that she had an upset stomach( said it felt like a burning feeling). She said that she experienced it on 4-8-21, she said that she will give it another day and follow up with her physician if not feeling better.
Patient was only 17 years old and had received Moderna vaccine. Recommended age for Moderna is 18 years or older. Spoke to patient and had no reported health concern or doctor visit after receiving the vaccine. Advised patient to contact his PCP to find out if he needs to repeat the vaccination.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The physician reported that on 26-AUG-2014 the patient was mistakenly administered 2 doses of PROQUAD (Merck) inj during the same office visit (dose, route and lot number not provided). No adverse effects reported. Additional information has been requested.
fever, chills, body aches, weakness, very frequent urination for 1 day, headache for 2 days
I became pregnant in November of 2021, 2 months after receiving the Moderna vaccine. I began experiencing placental hemorrhaging in January 2022 at the end of my first trimester. I experienced a missed miscarriage on January 25, 2022 when the baby?s heart stopped beating. Due to this miscarriage I had to get a D&C. Although miscarriages can be related to other things, I think it?s extremely important that this data is added to the Moderna COVID vaccine data as well considering it hasn?t even been 6 months.
Approximately 10 minutes after patient received vaccine, she became shaky and lightheaded. BP 125/80, pulse 100, pulse ox 95%. Respirations unlabored at 18/min. Patient was talkative and oriented. She did request further evaluation at the ER. She requested transport to the ER and EMS was called. Patient ambulated to the squad per medic.
shingles; Information has been received from lawyers referring to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported.  On or about 28-APR-2011, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for the prevention of shingles (herpes zoster).  On an unknown date, the patient experienced a bad case of shingles. The patient did not recover from the event. As per the reporter, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The event of post herpetic neuralgia was determined to be disabling.  The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
Severe, multi-joint pain  from day of injection. Initially only occurred on right side of body and is now bilateral (ankles, knees, elbows, shoulders, wrists, fingers) and worsening
-Local swelling of injection site with warmth/erythema, -fever (100 deg), -Myalgias
PATIENT LEFT PHARMACY AFTER SHOT AND WENT OUTSIDE TO HER CAR.  SHE CAME BACK TO PHARMACY APPROXIMATELY TEN MINUTES AFTER INJECTION AND MENTIONED FEELING FAINT. PATIENT TOOK A SEAT INTHE LOBBY AND THEN GOT DIZZIER AND SLID/FELL OUT OF CHAIR AT 2:12 PM.  WE CALLED 911 AT THIS TIME.  PATIENT SAID SHE FELT "HOT " AND WAS GIVEN WATER TO DRINK AND A COOL WATER BOTTLE TO APPLY TO HER NECK.  PATIENT SAID SHE WAS FEELING BETTER JUST BEFORE EMTs ARRIVED.  PATIENT DOES NOT HAVE ANYONE LOCAL TO CONTACT AND CHOSE TO LEAVE WITH EMTs AT APPROXIMATELY 2:35PM.
Covid rebound after taking paxlovid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid rebound after taking paxlovid) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Concurrent medical conditions included Asthma and Allergy (Drug name not reported (Patient do not think so)).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, 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 experienced COVID-19 (Covid rebound after taking paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 21-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (Covid rebound after taking paxlovid) outcome was unknown.            No concomitant medication was provided.  Device Date : 28-May-2022.  Company comment: This is a spontaneous case concerning a 74-year-old, female patient with no relevant medical history and with vaccine history of receiving first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 28 days. The patient experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 5 to 6 months after the third dose of mRNA-1273 vaccine administration. Allegedly the event was described as, approximately 179 days after the third dose of mRNA-1273 vaccine administration, patient took Nirmatrelvir + Ritonavir (Paxlovid) as treatment for Covid-19. Approximately 7 days after the last dose of Paxlovid, patient experienced rebound Covid. No other information surrounding the event was reported. The outcome of the event was reported as unknown from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 74-year-old, female patient with no relevant medical history and with vaccine history of receiving first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 28 days. The patient experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 5 to 6 months after the third dose of mRNA-1273 vaccine administration. Allegedly the event was described as, approximately 179 days after the third dose of mRNA-1273 vaccine administration, patient took Nirmatrelvir + Ritonavir (Paxlovid) as treatment for Covid-19. Approximately 7 days after the last dose of Paxlovid, patient experienced rebound Covid. No other information surrounding the event was reported. The outcome of the event was reported as unknown from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
I became itchy, but not a regular itch. It traveled around. For example, both wrists would itch. Then it would stop and both ankles would itch. Then it would stop and the palms of both my hands itched, then the back of my neck, then my back, then my stomach. It was not the same route every time, but every time BOTH my wrists, ankles, palms itched at the same time. This has NEVER happened to me before.
Chills. Fever 103+, body aches. Headaches. Sweating. Light sensitivity. Rash on the location of shot