chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chief Complaint  fever and chills, body aches x 3 days.  also complains of intemrittent chest pain since yesterday     02/20/21 10:28  History of Present Illness  This is 31 year old male with no significant past medical history. Patient is health care provider and working in surgical center. Patient ha COVID 19 second dose of vaccination on Wednesday and he was feeling sick after that including fever, chills and tiredness. He had chest pain started Thursday and which is in left side of the chest and mostly constant in nature and intensity was up and down and highest intensity was 7/10. No aggravating and relieving factor, denied any shortness of breath, leg swelling. He visited to urgent care and had 12 lead EKG and which showed ST changes in inferior lead and transfer to hospital ER. He is currently having pain about 1/10 intensity. He denied any nausea, vomiting, urinary and bowel symptoms. (sic)  Assessment/Plan  Chest pain with elevated troponin  NSTEMI vs myocarditis  post COVID 19 vaccination
Light headed and headache and that subsided about an hour later. For the next couple of weeks, I had a rash on my eyelids and bumpiness and itchiness for my upper eyelids and it eventually went away. I used antihistamine and that helped a little and then it came back.
Pt recvd 3 doses of Engerix-B & on titer check it was determined that pt did not respond to the vax series;
90 days since her first dose; COVID-19/got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19/got COVID) and PRODUCT DOSE OMISSION ISSUE (90 days since her first dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced COVID-19 (COVID-19/got COVID). In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (90 days since her first dose). The patient was treated with BAMLANIVIMAB at a dose of 1 dosage form. In 2021, COVID-19 (COVID-19/got COVID) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (90 days since her first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Added Treatment information and batch number for suspect drug On 26-Jun-2021: Follow up information received on 26-JUN-2021 contains No New Information On 07-Jul-2021: Follow up document received on 07-JUL-2021 contains No New Information On 26-Jul-2021: NNI; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. This report refers to a case of Product Dose Omission for mRNA-1273, with no associated AEs.
The patient received the Adacel vaccine on April 10, 2019.  This is April 15, 2019.  She called the pharmacy and reported she has felt a throbbing pain that got worse after each day from receiving the shot. She mention there is no swelling/redness at the injection site; however, she is unable to sleep on the injected arm site during the night, and she struggled raising her arm above her head.  She did allow one of her doctors to check her shoulder, and he also showed concern with this condition.   I have recommended her to visit her primary care physician in order to assess a therapy to relieve this condition.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, fatigue Narrative:  Pt reported symptoms lasted approximately 72 hours.  Other Relevant History:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 3:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 3:14 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 42.90.  Concomitant products were not provided.  On 07 Jan 2021, Excursion time was 09 AM and 10 AM, temperature was 34 and 34 respectively, total doses given for the day was 96, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05 Jan 2021, vial was moved to clinic on 07 Jan 2021. 6 vials were sent to clinic. Vaccine BUD date was 27 Jan 2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.   This case was linked to MOD22-013597 (Patient Link).
This spontaneous report was received from a medical assistant and refers to an infant male patient. The patient's concurrent conditions included allergy to soy and dairy. His medical history and concomitant drugs were not reported. On unknown dates, the patient was vaccinated with ROTATEQ orally (exact dose, frequency, lot # and expiration date were not reported), VAQTA (exact dose, frequency, route and site of administration, lot # and expiration date were not reported), M-M-R II (exact dose, frequency, route and site of administration, lot # and expiration date were not reported) and VARIVAX (exact dose, frequency, route and site of administration, lot # and expiration date were not reported) for prophylaxis (reported as his 2 and 4 month vaccines). On an unknown date, the patient had quite a bit of gastrointestinal discomfort. The reporter inquired if any of suspected vaccines contained soy, dairy products or derivatives. The outcome of the event was unknown. The relatedness between the event and suspected vaccines was not reported.
Pt developed rash on arms and torso two (2) days after injection; rash lasted 'couple more days'. Pt felt "flush and achy".
She started with a low fever and by 2:30 pm of 2/5/2010 the fever was 104.9. Her feet were broke out and tingling,Headache,nausea,face had a rash,lathargic,wanted to sleep all day, no appitite. Took her to the doctor at 4:00 pm and they admitted her to the hospital for observation. They had a very hard time bringing down the fever. She was not fever free until 2/7/2010. The doctor said it was a bad reaction to the shots. Needless to say I will never be getting anymore of the immunization shots for her or my other kids ever.
Vaccines given on 3/4/19. Child developed cough, vomiting, diarrhea on approx. 3/6 (suspect incidental). This illness resolved after a couple days. Developed fever on 3/17 for 2 days. Developed rash on 3/19 and evaluated in the office on 3/21. Rash was discrete erythematous papules, some vesicular, some crusted lesions. Rash consistent with varicella. Rash was all over body, not limited to site of vaccine. Rash resolved after about 1 week according to mom (child was not seen in the office again)
Chills, 103 fever, nausea, dizziness,aches, headache, fatigue.  Came and went within 24 hours.  Red face. On and off since vaccine Elevated blood pressure. Ongoing  Tinnitus. Noticed last night, getting worse.
I passed out on the plane, and they took me off. On the way to baggage claims, I passed out again in the wheelchair. I went to the emergency room, and they diagnosed me with A-fib. I was given an IV and medication was added. They did an echogram. I was there all evening until I checked myself out. I was no longer having symptoms when I left. I had an appointment to see my cardiologist and he put me on a blood thinner. I was told to wear a heart monitor for 14 days so currently I do not know if my condition has improved. I had a mini stroke about 5 years ago and so the doctor asked that I stay on blood thinners. I feel like I have recovered but it is unknown what can happen today or tomorrow.
Pt received a PREVNAR 13 shot in her left deltoid on 2/1/17. On 2/5/17, her arm became red, warm and itchy. No other symptoms. Pt. was seen 2/7/17 and her arm was red and warm from just below deltoid to elbow. Started her on Prednisone 30mg QIDx3days, then 20mgx3days, then 10mgx3days.
A non-serious spontaneous report of expired FLUMIST administered was received from a registered nurse concerning a 13-year-old female. The child was administered a FLUMIST dose that had expired 12 days earlier.  There was no adverse event associated with this inadvertent administration of expired FLUMIST; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding products from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 15-Jan-2009 includes: DOB, FLUMIST information and no late adverse events were reported. Additional information was received on 09-Apr-2009: product Complaint Investigation results.
Swollen lesion around left deltoid that looks similar to cellulitis. Pt reports feeling of warmth around the swollen areas
Received PNEUMOVAX as above afc 10/30/08. ER vs 11/1/08.Cont resolving Redness today on OV. Chief complaint UPPER EXTREMITY PAIN. This started yesterday and is still present. The quality is noted to be sharp. Severity is described as being severe. No radiation. Modifying factors (movement of shoulder makes worse.) Symptoms located in the area of left shoulder. She has had redness and swelling . No chest pain, difficulty breathing, sensory loss,motor loss or repetitive hand use at work. Patient notes an injury. Mechanism of injury (Had Pneumonia shot 2 days ago at doctors office. Patient has not had similar symptoms previously. The patient was seen recently in the office.
This case was reported by a consumer via call center representative and described the occurrence of abdominal bloating in a adult male patient who received ENGERIX B adult. On an unknown date, the patient received ENGERIX B adult at an unknown dose. On an unknown date, unknown after receiving ENGERIX B adult, the patient experienced abdominal bloating and stomach discomfort. On an unknown date, the outcome of the abdominal bloating and stomach discomfort were unknown. It was unknown if the reporter considered the abdominal bloating and stomach discomfort to be related to ENGERIX B adult. Additional information received: Patient reported the above-noted potential side effects after being administered ENGERIX-B. He refused to provide his initials or any further information related to this complaint. No further details were available at the time of this report.
Did not receive 2nd dose between day 25 and 35; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose between day 25 and 35) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 (Did not receive 2nd dose between day 25 and 35). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose between day 25 and 35) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
Dose administrated after expiration date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administrated after expiration date) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 033C21A and 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administrated after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administrated after expiration date) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Patient was an 11 year 6 month old child who received a covid-19 vaccine from the incorrect vial, was given the 12+ vaccine instead of the 5-11 vaccine. Family was made aware following discovery of this incorrect administration, advised of potential for increased side effects and to followup in our office if any occur. As of this reporting no side effects have been made aware to our office. Public health department also contacted for advise regarding this incorrect administration.
Bloody nose, treated at home, bloody nose within 24 hrs of 1st dose also!
Patient felt woozy after receiving the vaccine while sitting in the waiting area. She was lowered to the floor and her blood pressure was taken, at 104/85. She was sweaty and clammy. Patient stated that she was anxious about the vaccine and something like this had happened before. After laying on the floor she felt better and soon after sat up in her chair. Her blood pressure was taken again and rose to 133/66. She was observed in the waiting area and started feeling better after 15 minutes.
This spontaneous report Was received from a nurse refers to a 2-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 31-AUG-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045392, expiry date: 17-NOV-2018) for prophylaxis (incorrect product storage). The lot of M-M-R II was reconstituted with properly stored sterile diluent (DILUENT MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000054: Original Case : 1709USA000054.
Patient's wife reported that patient was feverish, had chills and malaise.  Also, patient complained of leg pain for 1 day.
Patient felt very ill and dizzy the day after his vaccination.  He reported tiredness, fatigue, significant body aches and was nauseated through today, a week later.  He reported being so dizzy today that he took a fall and they called EMS and EMT's checked him out, but had him rest at home.  He then called the pharmacy to report these symptoms.
Nose ears and throat burning; DECADRON im, PEPCID, CLARITIN.
This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENITIS (swelling in left armpit lymph node), MYALGIA (I had body ache), NAUSEA (Nausea) and CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A and 029L20A) for COVID-19 vaccination. No Medical History information was reported.On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-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 LYMPHADENITIS (swelling in left armpit lymph node), MYALGIA (I had body ache), NAUSEA (Nausea) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, LYMPHADENITIS (swelling in left armpit lymph node) outcome was unknown and MYALGIA (I had body ache), NAUSEA (Nausea) and CHILLS (Chills) had resolved.Concomitant medications was not provided by the reporter.
Patient received his first dose of Pfizer COVID-19 vaccine on 02/03/2021. He has significant medical history, but presented to the hospital on afternoon of 02/08/2021 with report of three days of nausea and vomiting. He thought this attributed to a new cholesterol medication. He also reported some shortness of breath, mild cough, no fever. reported some epigastrium pain the day prior but since resolved.  Significant other reported some significant swelling and that pt complained of feeling like he had a "blockage in his throat". Workup showed concerns of pneumonia so pt was started on antibiotics and Vitamin K. Shortly after meds started pt started complaining of itching arm and trouble breathing. He became bradycardic and lost consciousness. Resuscitative efforts initiated but unsuccessful. Time of death called on 02/08/2021 at 1737. Hospital notes report "cause of death is anaphylaxis", and pt would be an OME case.
Redness, swelling and very warm to touch entire upper right arm from shoulder to within 2cm of elbow encircling almost entire inner arm.
PT DEVELOPED 3 x 4 CM SWELLING DESCRIBED AS A WHEAL AT SOI 3 DAYS AFTER ADMIN OF TETANUS AND DIPHTHERIA TOXOIDS ADS, ADULT.
601 doses were given after expiration date; Expired vaccine is stored on 21-Oct-2021 and then administered on 29-Oct-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored on 21-Oct-2021 and then administered on 29-Oct-2021) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored on 21-Oct-2021 and then administered on 29-Oct-2021). On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored on 21-Oct-2021 and then administered on 29-Oct-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported. The reporter stated that initially there were 606 doses from expired lot and they found out later that some patients that were impacted had received the Janssen COVID-19 vaccine. Date the vial placed in refrigerator was on 21-Oct-2021. There was no temperature excursion. The patient had no adverse event.
Had the vaccine on Saturday and on Tuesday afternoon, felt very dizzy, became very pale, had chest pain,  pressure in  chest and couldn't take a deep breath,  vision kept moving in and out, had to sit down, felt very hot and cold at the same time and was actually sweating and feeling chills. Took it easy for the next 4-5 days and just stayed home and in bed. When it got really bad, took a dose of ibuprofen.  The symptoms slowly got better and disappeared. Took about three doses of ibuprofen total over a few days. Talked to our pediatrician a week later who said we should report this.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills, flushing, paleness Narrative:  Other Relevant History:
Immediate redness and discomfort at MMR injection site. No itching or SOB. Benadryl 12.5mg.
2-22-21 JOINTS ON RT SIDE PAINFUL - NECK, SHOULDER, ELBOW, WRIST, HIP AND KNEE. HAS BEEN TAKING TYLENOL AND USING ICE PACKS WITH TEMPORARY RELIEF - ADVISED TO CALL PCP FOR EVALUATION 2/23/21. 2-24-21 8:30AM TC - PT STATES HE FEELS BETTER TODAY. PCP GAVE HIM A STEROID SHOT AND RX FOR PREDNISONE.
I broke out in shingles after 3 days from getting the vaccination. My arm was bruised horribly and hurt. For about 2 weeks I tasted metal in my mouth. 2 months later from June 23rd - June 26th I had post menopausal bleeding. I bleed very heavy from the 2-3 day 24 That was around the time I was exposed to Covid through my Husband. The doctor gave me Valtrex for 10day round.
After about 5-7 minutes of receiving the C-19 vaccine I was sitting in the lobby and I felt hot all over my body, I felt pressure in the middle of my chest and my heart began to flutter. At the same time this was happening i felt like a tingling sensation in my chest and weak. I alerted the receptionist and she told me to come up and she would let the nurse know. As I went to get up I was concerned if I would be able to stand because I felt very weak. I have never felt any of this before. It was all new. As soon as the let me in to the back office, the temperature was cool and as walked in to the cold room, my side effects were complexity gone. Vitals signs normal. I am concerned about getting the second does and I don?t want to after I had chest pain.
This spontaneous report was received from a Nurse refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 19-SEP-2016, the patient was vaccinated with an improperly stored PROQUAD lot # M018638 (expiry date: 11-OCT-2017). No adverse reactions were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
10/8/16 Headaches, dizzy, tired. 10/09/16 Dizzy, stiff neck during the day. 10/09/16 Fever onset in evening. 10/10/16 Fever, photophobia, neck pain, frontal headache, malaise.
Chills, then it went on to vomiting, chills, 104 fever, very ill, weak, diarrhea.