chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 03-Nov-2021 at 2:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 2:07 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 50.38.  Concomitant product use was not provided by the reporter.  Batch number 035C21A underwent temperature excursion on 03-Nov-2021 with temperature 35 degrees Fahrenheit from 10:00 AM. This vial was moved to fridge on 05-Oct-2021, beyond use date for the vial was reported as 05-Nov-2021. Product moved to clinic on 03-Nov-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  Treatment information was not provided.   This case was linked to MOD-2022-566976 (Patient Link).
One evening in October 2022 I started getting chills and a sore throat.  The next morning, I had fever, aches and pains, and a cough.  The following day I still had fever, cough, aches and pains.  Day 4 I had no fever or aches, but I had a cough.  The cough lasted about 4 weeks.  The doctor prescribed the post COVID-19 treatment, but I did not take it due to the possible side effects.  I was lethargic for a week .
Patient passed out while sitting on medical bed and fell off causing injuries. Patient's head was jerking while she was unconscious. Nurse walked away turning her back from her not monitoring her after vaccination.
Day 1 Fever chills  body aches Day 2 Fever chills body aches Day 3 Fever chills body aches, swollen lymph nodes right armpit Day 4 Swollen lymph nodes right armpit Day 5 Swollen lymph nodes right arm pit and swollen lymph nodes in neck near right clavicle
Caller received her 1st dose of the Moderna vaccine on 03May2021 and hasn't received yet the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller received her 1st dose of the Moderna vaccine on 03May2021 and hasn't received yet the 2nd dose) 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 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller received her 1st dose of the Moderna vaccine on 03May2021 and hasn't received yet the 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller received her 1st dose of the Moderna vaccine on 03May2021 and hasn't received yet the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported. The treatment information was unknown. Patient scheduled to receive her 2nd dose on 20-AUG-2021 at 2.45 PM.
The most concerning symptom I had was a 4 hour period of continual tachycardia and palpations with a heart rate ranging from 160 to 180 while lying in bed trying to sleep (I have never had tachycardia or palpitations before). It  began  about 11  hours after the vaccination.  It self-resolved after about 4 hours.  Prior to developing the tachycardia (about 8 hours vaccination, I developed severe chills (for approx 10 hours despite being wrapped in layers of clothing and tripled blankets and having the heater on), strong headache, diffuse myalgia, SOB, and significant fatigue (i.e. I am a runner and I could not walk from my bed to the bathroom- approx 10 feet- without having to stop and sit down on the floor to breath and then muster up enough energy to make it the additional 5 steps). . All symptoms self-resolved within 24 hours and then I felt completely returned to normal and back to baseline. as if nothing had ever happened.  I had no reaction to the initial vaccine other than a mildly  sore arm at the injection site.
This is a spontaneous report received from a contactable other health care professional (HCP). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) first dose via intramuscular administered at right arm on 22Jan2021 13:30 (lot number: EL3248) (at the age of 42-year-old) and second dose via intramuscular administered at left arm on 02Feb2021 13:30 (at the age of 42-year-old) (Lot Number: EL3248) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient known allergies was unknown. Patient was not pregnant at the time of vaccination. It was unknown, if the patient receives any other vaccines within 4 weeks prior to the COVID vaccine and list of any other medications the patient received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination and patient has been tested for COVID-19 since the vaccination. The patient had symptoms of cough and nasal congestion since 22Aug2021. The patient was diagnosed with being positive with COVID on 24Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 23Aug2021 Post vaccination. Outcome of events was not recovered. Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the events covid19 and drug ineffective cannot be completely excluded.
The night of this second vaccination, I began having shortness of breath, chest pains, and chills.  The chills were gone the next morning, but the shortness of breath and labored breathing lasted for more than six weeks.  It has gotten better but comes back after light activity.  The sharp chest pains have gotten better but still occur on occasion.  The chest pressure and discomfort have lessened but still exist.
I had common side effects of cough/sneezing for 24-48 hours. I was 20 days post-op double mastectomy with DIEP reconstruction. Although we knew I?d have side effects that would out weigh me getting the virus, we didn?t think ahead of that. My adverse event is that I ended up with a hernia in my lower left stomach.  I have a bulge and some pain. My surgeon will be able to fix it after 3 months post-op.
The day after the shot, my right arm hurt, approximately 6 days later, my upper arm, around the injection site, became red and swollen, the skin was very tight.  It moved into my right shoulder area and there was swelling and pain in the shoulder by the collar bone.  It has now been 11 days and I am still having redness, slight swelling, and pain in the right collar bone area.  It tends to hurt more at night when going to bed.
Initial unsolicited report received from a consumer (patient's mother) on 29 December 2015. This case involves a 19-year-old male patient who was vaccinated with an intramuscular dose of FLUZONE (batch number UI450AD, expiration date 30 June 2016, dose and site of administration was not reported) on 18 September 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. On an unspecified date, few days following the vaccination, the patient experienced hypotension,  dehydration, elevated heart rate, pneumonia and diarrhea. The patient required emergency room or physician visit. The patient was admitted in ICU for a week. Lab data were not reported. He was treated with IV fluids steroids and antibiotics. The patient was discharged from hospital on 7 October 2015. The outcome of events was reported as unknown. List of documents held by sender: none.
This spontaneous report as received from a medical assistant for the office via company representative refers to a male patient of unknown age. On 16-MAY-2013 the patient was vaccinated intramuscular with the third dose of GARDASIL (dosage unknown, lot# not provided). Reporter explained that standard third dose of GARDASIL was given after one month from receiving second dose of GARDASIL given on approximately 16-APR-2013. Additional information has been requested.
Anterior right thigh is erythematous and edematous, edema extends into right groin and right scrotum. There is positive inguinal adenopathy on the right. Axillary temp is 97.
Throughout the evening I was feeling buzzed, like I had too much coffee. But I didn't. Then when I got into bed at 11pm (roughly 12 hours after the shot) and my heart rate picked up. I had what I'd describe as a racing heart, for about 6 hours. Breathing to calm it down did not work. I got very warm, had incredible sensitivity at the injection site that also intensified 12 hours after the shot, and I had really bad waves of joint pain throughout my body. Especially in my hands, shins and ankles/feet. The symptoms all seemed to subside around the same time, 6-7 hours after they started. I hope this is helpful.
Weakness in right arm began approximately one hour post-injection.  Sporadic twitching in right arm began approximately 4 hours post injection. I previously had an adverse reaction to the anthrax vaccine, and a VAERS report was submitted.  I was instructed not to have the anthrax vaccine again; however, the immunization technician mistakenly injected me with the wrong vaccine: she was supposed to administer a Typhoid vaccine, but she gave me anthrax instead.
Patient received 1/2 dose of Live Seasonal Flu (LAIV) and Live H1N1 on the same day (10-16-09). Pt informed to have doses repeated for immunity.
Severe stabbing heart pain.  Called 911. In hospital 2/19 thru 2/22. Chest x-ray, EKG, and ultrasound indicated no heart attack and heart looked good. Doctor stated ordeal was result of 2nd dose of vaccine. Person had previously suffered with Covid and was hospitalized from 10/26/20 thru 11/5/2020
~ 6 hrs after vaccination, headache started ~18 hrs after vaccination, still had headache and also felt malaise ~24 hrs after vaccination, still had headache and malaise, and started feeling total body aches/soreness ~36 hrs after vaccination, all other symptoms resolved but now had swollen and tender lymph node under R arm. Approaching 48 hrs from vaccination and the swollen lymph node has not resolved.  Of note - I am currently breastfeeding.  I did not have any decrease in my breastmilk supply and noted no changes in my infant either.
10hrs post vax pt exp complete numbness & lack of movement fr chin to feet - could not move or feel body. dx RSD
The following morning, pt had apnea (approx. 2 minutes). Infant became apneic and pale; no seizure or cyanosis. After tactile stimulation, pt started crying and breathing regularly. She was cranky and crying for 15 minutes. Normal examination, after 30 minutes.
positive for COVID; positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "pain I will injury my shoulder, elbow and hip" (unspecified if ongoing); "pain I will injury my shoulder, elbow and hip" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE taken for hypertension; AMLODIPINE taken for blood pressure abnormal (ongoing); PARACETAMOL taken for arthralgia, arthralgia, pain (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2023, outcome "unknown" and all described as "positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course included: Treatment included Paxlovid from 04Jan2023. The patient did not contact her doctor went to emergency number and was told to test and herself and her husband both were positive for COVID and after that all the shots and booster. Patient was told to take Paxlovid and they would call the prescription to her pharmacy. After COVID which occurred of 02Jan2023. She realized had been getting a horrible UTI (pending clarification). From Nov to End of Feb she was taking several medications not to which was marked-a lot of antibiotics. Methenamine hippurate 1g 2x/day, Cefalexin 250 mg, Cefalexin 500mg 2x/day, which primarily worked, Amoxclav 825-125 mg. "Could these antibiotics have made me more acceptable of getting covid and chill having lasting symptoms".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300135394 same reporter product event, different patient;
30 min after receiving the vaccine patient developed swollen lips and slightly swollen throat.  No difficulty swallowing or breathing.  Blood pressure was high, 02 sat 99%, no difficulty breathing or abdominal pain.   She was given 50mg IV diphenhydramine and 125mg Solumedrol.  She was monitored and symptoms improved within 10 min.  she was monitored for 30 minutes and symptoms resolved.
Sore arm to lay on; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EL3248; Expiration Date: not reported) administered in Arm Right on 19Jan2021 12:00 (at the age of 24-years-old) as a single dose for covid-19 immunisation. Medical history included ongoing hypersensitivity, ongoing, Chronic dermatitis ongoing, flu (Had flu shot unknown date, maybe 6-8 months ago). Concomitant medication(s) included dupilumab (DUPIXENT) taken for dermatitis (Injects self every 2 weeks), loratadine (LORATADINE) taken for hypersensitivity. The patient experienced sore arm to lay on (pain in extremity) on 19Jan2021 with outcome of recovered on an unspecified date 2021.
At site of shot on night of Feb 16, my arm was itchy and hurting.  By the morning of Feb 17, My arm was swollen at the site shot, red, hard and painful.  I was alarmed as this was a full week after the vaccine and my arm had not bothered me for the first week.  I reported to Health Dept & received a call from a volunteer doctor who told me I had Covid Arm and to use  cold pack, tylenol to relieve symptoms and benydryl at night to help me sleep.   I am due to get shot #2 on March 9 and am concerned.  My Covid Arm lasted 5 days and went away.
Patient was 7 years old and received DTaP when she should have received Tdap. The Mother was contacted - several attempts with no call back or answer.
Right upper arm pain; nausea; bloating, diarrhea; right breast pain; joint pain in hips, knees and ankle;  skin is sore to the touch all over body; chills; extreme fatigue
Migraines, Chest Pain, Chills, Joint pain, numbness in feet bilateral and sharp pain feet bilateral. Pain at the injection site. Symptoms lasted 5 days
Developed an itchy rash on her back and HCP diagnosed it as shingles; Warm at the injection site; 3" diameter area that is raised,firm at the injection site; Red at the injection site; Right arm was a little sore; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Developed an itchy rash on her back and HCP diagnosed it as shingles), PAIN IN EXTREMITY (Right arm was a little sore), VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE INFLAMMATION (3" diameter area that is raised,firm at the injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Shingles (The caller stated that she was having symptoms of getting shingles prior to the Moderna COVID-19 vaccine.) in January 2021. Previously administered products included for an unreported indication: ZOSTAVAX. Concurrent medical conditions included Drug allergy (Allergic to Propylthiouracil. She also has a lot of drug sensitivity but didnot list them.).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Right arm was a little sore). On 26-Jan-2021, the patient experienced HERPES ZOSTER (Developed an itchy rash on her back and HCP diagnosed it as shingles), VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE INFLAMMATION (3" diameter area that is raised,firm at the injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site). At the time of the report, HERPES ZOSTER (Developed an itchy rash on her back and HCP diagnosed it as shingles), PAIN IN EXTREMITY (Right arm was a little sore), VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE INFLAMMATION (3" diameter area that is raised,firm at the injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site) was resolving.        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 relevant concomitant medications were reported. Treatment details included ibuprofen.
Developed ringing in my ears more noticeable in left ear. Started around 2 or3 weeks after 2nd shot
SEVER DIZZINESS; NAUSEA; VOMITING; This spontaneous report received from a patient 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 not reported, batch number: 043A21A and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the patient experienced sever dizziness. On 12-APR-2021, the patient experienced nausea. On 12-APR-2021, the patient experienced vomiting. Laboratory data (dates unspecified) included: Balance test (NR: not provided) no findings, and Scan (NR: not provided) no findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, nausea, and vomiting. This report was non-serious.
On 2/2/07 noticed "welts" on left thigh came to office 2/5/07 and diagnosed with left cellulitis.
Fever started after getting vaccine, pt went to ER w/ fever 103.5, dizziness weakness, nasal congestion, abdominal pain, dry mucous membranes, tachycardia, moderate distress
Recvd vaccination on 3/16/21 woke up on 3/17 with mild flu like symptoms nausea, headache low fever began having intense nerve pain/seizure like activity 3/18 and continuing. Used to have nerve pain seizures on daily basis but has not had seizure in over 14 months prior to 2nd vaccination.
20 hours after receiving developed extreme fatigue and headache. 6 hours after that developed chills, bone pain all over and nausea. That lasted about 8 hours. When chills stopped temp was 100.2. Temp relieved by aleve.
Chest tightness and shortness of breath beginning the day after vaccination. Went to urgent care after approximately 48 hours of having those symptoms. Received a breathing treatment and was prescribed an inhaler in the event shortness of breath got worse.
This case was reported by a healthcare professional and described the occurrence of multiple sclerosis in a 11-year-old female subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine (unknown). It was reported that the subject either received two or three doses of the hepatitis B series. About two years after receiving the hepatitis B vaccine, the subject developed multiple sclerosis. The initial symptoms was blindness, and it was initially thought that the subject had mitochrondrial disease, but that was ruled out. The healthcare professional considered the events were disabling. An MRI performed on an unspecified date showed lesions indicative of multiple sclerosis. The reporter stated that the subject was "not doing well", but she stated that she did not known what that meant since she isn't working with the subject directly. At the time of reporting the events were unresolved. No additional information was reported.
Information has been received from a registered nurse referring to a 19 year old patient of unknown gender. On 11-APR-2007 the patient was vaccinated with a first 0.5 ml dose of VAQTA intramuscularly. On 07-AUG-2014, the patient was vaccinated with a second 0.5 ml dose of VAQTA intramuscularly (inappropriate schedule of vaccine administered). No adverse experience was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Information has been received from a physician concerning a 16 year old female who on 08-OCT-2007 was vaccinated with the third dose of Gardasil vaccine (lot # not reported). On 10-OCT-2007, the patient experienced nausea, drowsiness, "achiness" and sore arm after getting the third dose of Gardasil vaccine. It is unknown when the patient received the first or second dose of Gardasil vaccine. There was no adverse event involved during the first or second dose of Gardasil. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. There was no product quality complaint. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, lot # L008057 exp. 01-DEC-2016, (dose and route were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.