chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bad rash; Fever; Chills; Did not get her second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Bad rash), PYREXIA (Fever), CHILLS (Chills) and PRODUCT DOSE OMISSION ISSUE (Did not get her second dose 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 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Bad rash), PYREXIA (Fever), CHILLS (Chills) and PRODUCT DOSE OMISSION ISSUE (Did not get her second dose yet). At the time of the report, RASH (Bad rash), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not get her second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported. No treatment information was provided.   Reporter did not allow further contact
pt was here for office visit. Moderna 2nd dose was requested by patient and Dr. Chart does not have any prior documentation of covid vaccine. pt was asked and confirmed that this was her second full dose and she confirms. Asked pt if she had Vaccine card with her today and she denies. Asked pt if she has any issues with 1st moderna dose and she denies any problems. pt signed consent and a full dose of Moderna 0.5ml was admistered. pt later returned to front desk and asked if she received booster, after further discussion and clarification it seems that pt did receive full series of Moderna vaccine prior. pt reports 2nd  dose of full series was  received in March of 2021. Advised pt she was given full 3rd dose and to report any adverse reactions or s/e to us if any. Notified pt we will report full 3rd dose to the health dept and will follow up with her if there is any further action needed. pt was agreeable.
I have had raging in both ears since the second dose of the Moderna vaccine. I have not seen a doctor yet. I thought it would be temporary but it's continuing and it's extremely distracting and makes listening very difficult.
get terribly sick; Initial information received on 06-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).  This case involves a patient of an unknown demographic who got terribly sick (Illness) after receiving INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (unknown latency) every time get a flu shot get terribly sick. The first time was sick with the flu for 4 months. The second time was sick for 9 months. Won't / can't take them.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown, at the time of reporting.  There will be no information available on the batch number for this case.
PATIENT CAME TO PHARMACY 9/21/19 TO REPORT SHE HAD EXPERIENCED A LARGE AREA OF REDNESS ON HER UPPER RIGHT ARM, SURROUNDING THE AREA WHERE SHE RECEIVED PNEUMOVAX 23.  THE AREA OF REDNESS WAS HOT AND SLIGHTLY RAISED, WITH AN IRREGULAR OVAL SHAPE, APPROXIMATELY 3 OR 4 INCHES IN DIAMETER.  I DREW A BORDER AROUND THE AREA OF REDNESS. WHEN I CALLED TO CHECK IN WITH THE PATIENT ALMOST 24 HOURS LATER, SHE REPORTED THE TOP OF THE AREA OF REDNESS HAD RECEDED AN INCH OR TWO, BUT AT THE BOTTOM THE REDNESS HAD MOVED BEYOND THE LINE BY AN INCH OR TWO.  PATIENT REPORTED THE SPOT APPEARED TO BE "MOVING DOWN HER ARM."  PATIENT WILL BE SEEING HER DOCTOR TUESDAY 9/24/19 FOR AN UNRELATED ISSUE, AND WILL CONSULT WITH HIM THEN.   SHE WILL SEEK URGENT MEDICAL CARE IF HER SYMPTOMS WORSEN SIGNIFICANTLY PRIOR TO THAT PLANNED APPOINTMENT.
1 week after MMR had a generalized convulsion per mom 1 - 2 mo. Seen in ER
STORAGE IN REFRIGERATOR (2C- 8C) UP TO 30 DAYS (VACCINE USED AFTER 10/16/2021
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 (Lot number: EWO169) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE. LOT# for first shot: ER87Z7. administration of vaccine: Left arm.), administration date: 02Apr2021, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Patient head is hurting extremely"; FATIGUE (non-serious), outcome "unknown", described as "I am overall now the super tired like I just keep sitting my bed"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "my stomach hurts a lot, I threw up few times"; PAIN (non-serious), outcome "unknown", described as "overall my whole body is super week and sore"; INSOMNIA (non-serious), outcome "unknown", described as "I can't sleep". No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose number unknown, single (Lot number: El3246) at the age of 51 years, in left arm for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "hbp" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Zyrtec, reaction(s): "Known allergies"; Vicodin, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received treatment brand=paxlovid, treatment start date: 27jun2022, treatment stop date: 02jul2022, Ae treatment: Paxlovid round 2. The patient Known allergies: Zyrtec and Vicodin and Other medical history: Anxiety and depression, Gerd, hbp.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: The company cannot completely exclude the possible causality between the reported COVID-19, which is considered as failure of vaccine BNT162B2, and the administration of BNT162B2, as the efficacy of a vaccine varies individually and may be affected by different factors including drug potency.
Fast heart rate of 137 during activity and rest 118. Large 6x6 in rash at injection site on left arm.  Extremely warm and itchy
Used Moderna vaccine as diluent for Pfizer COV 5-11 yr vaccine (lot # FL8094)
About an hour after receiving the vaccine I began to feel a little dizzy, tired, and started to develop a headache.  By the next day my headache became overwhelming and the the dizziness became so pronounced that I could not stand for more than 5 minutes at a time.  I a had an intolerable headache on the entire bottom of my head that made my neck start to hurt.   I felt nausea that did not improve until four days later. My joints were hurting sharply  two days after the immunization and lasted two days.    Most of my symptoms improved on the 13th of January, but were still lingering.  About 5 days after the shot my symptoms resolved completely.
Patient experienced nausea and dizziness seconds after administration of the influenza vaccine.  She became very pale. Pulse was at 70 BPM and pulse ox was at 92%. Pt also experienced sharp pain in her back that lasted a few minutes. No medications were given. An ambulance was called because pt was very upset and we (pharmacy staff) did not feel safe having her drive herself home.  After 30 minutes of examination, pt felt much better and left home with her husband. Pt was advised to call her PCP.
pt recv vax 1SEP95 & 1JUL97 lab values indicated that the pt failed to seroconvert;
Pain in arm/sore arm; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from another company (MFR. Control No.: 20K-163-3447228-00). A 35-year-old male patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: e10142, expiry date: Mar2021), intramuscular on 11Jan2021 at single dose for covid-19 immunisation, adalimumab (HUMIRA), subcutaneous from Sep2019 to an unspecified date, 10Jun2020 to Jun2020 and 24Jun2020 and ongoing at 40 mg (40 mg, 1 in 1 wk) for Moderate to Severe Hidradenitis Suppurativa. Medical history included hyperlipidaemia, high cholesterol, depression, hypothyroidism, sleep apnea from an unknown date and unknown if ongoing, Down syndrome from 31Jan1985 to an unknown date, pneumonia from 1986 to 1986, open heart surgery in May1988, May1994 and Jul2012, acute respiratory distress syndrome from 08Dec2002 to 04Apr2003, aspiration pneumonia from 08Apr2003 to 15Apr2003 and clinical trial participant in 11Jan2021. Concomitant medication included atorvastatin at 20 mg for high cholesterol and hyperlipidemia, fluoxetine at 40 mg for depression, levothyroxine at 0.75 mg, 1 in 2 D for hypothyroidism and sleep apnea, colecalciferol (VITAMIN D3 1000) for supplement. The patient previously took Reglan and experienced vomiting, confusion and disorientation, Percocet and experienced vomiting and disorientation, Toradol and Zofran and experienced vomiting, confusion and disorientation; Humira for moderate to severe hidradenitis suppurativa in Sep2019 and experienced abdominal hernia on Nov2019 which resolved in 19Jun2020 and hidradenitis suppurativa breakout underarm and in groin area/hidradenitis suppurativa flare in Sep2019 which resolved on an unspecified date. The patient experienced pain in arm/sore arm on 12Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on an unspecified date, ultrasound abdomen: unknown results (Abdominal Hernia that needed surgical repair) on 11Jan2020.  The action taken in response to the event for adalimumab was dose not changed. The patient recovered from the event on 13Jan2021. The reporter assessed the event as probable to the drug and vaccine.; Sender's Comments: There is a reasonable possibility that the event pain in arm/sore arm was related to BNT162b2 based on known drug safety profile and close temporal relationship.
Patient complained of pain, redness, swelling, and that the area was warm to the touch.
My arm started feeling itchy and I felt it and it feels hard and it's a red circle.
Breakthrough COVID case. 67 year old male. Presented to ED 8/21/2021. Immunocompromised Patient with Leukemia. Patient was brought to the emergency room for fever, nausea, vomiting, diarrhea, HA that have been ongoing for approximately 10 days. Patient states on 8/14/2021 was diagnosed with COVID-19. Patient received Moderna COVID-19 vaccine, last admin Feb 2021. Diagnosed with: COVID-19 pneumonia. 8/31/2021: Patient discharged home
Pt woke morning after vaccine feeling fatigue, rapid heart beat, body aches and pains for the next 24 hours.
54y.o. male presenting with COVID-19. Fortunately, he did not have hypoxia or viral pneumonia. He did have approximately 4-day history of fever, diarrhea, myalgia, fatigue. Notably, he is a renal transplant patient on immunosuppression. He was seen by, transplant nephrology. He was begun on Paxlovid. Mycophenolate was decreased as was Procardia to avoid interaction with Paxlovid. Tacrolimus was held. His creatinine improved with IV hydration, was actually the best creatinine he has had all year. The following day, he was feeling much improved, GI symptoms had resolved and he was able to maintain hydration by mouth. He wished to go home. He was then discharged to complete course of Paxlovid. He will follow-up expediently with nephrology for medication check as well as resumption of tacrolimu
05/01/2022 I started having body aches, headache, sore throat, nasal congestion, foot pain, low garade  fever , oral pain, nauseousness. and lingering joint pain. I tested positive for COVID-19. I was also tested for Strep throat and Influenza, and they were negative. I am a high-risk patient and was given Antiviral intravenously. I also was prescribed Zovirax antibiotics.
They have not received a second dose at this time; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They have not received a second dose at this time) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They have not received a second dose at this time). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They have not received a second dose at this time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not  provided.
After injection upper arm extremely sore, 4-5 hrs later unable to raise arm without intense pain in shoulder and upper arm area. After several days with no improvement contacted PCP. RX Oral Prednisone. Still no improvement, PCP made referral to Orthopedic Surgeon who administered an injection to the site. Within 48 hrs the pain was gone. Approx. 5 months later the pain returned.
6/3 to 6/4/00 legs and knees swollen, 6/4 runny nose and low grade temp, 6/11 fever of 100.4 (ear), 6/12 went to MD, 6/13 rash on face and spread to trunk, 6/14 cheeks and neck swollen, 6/16 to MD, told mom he could not differentiate the rash from roseola or from the MMR vaccine.
Patient remained in immunization room for observation after shots given. When pharmacist returned pt. was slumped in chair. Pt was awake but non-responsive for approx 2 mins. EMS arrived approximately 5 mins later. Pt was responsive and cognitive by that time.
Patient was with father while waiting in the store after the vaccination - Father stated that he "blacked out" and "slid down his chair" - The father let me know and we grabbed some water for the patient - After having some water the patient felt better - Father stated he has had this with previous vaccines as well - No other issues after having the vaccine
A child was given an expired vaccine.  The vaccine expired on 4/23/23, which was on a weekend.  The cold chain nurse inadvertently prepared the vaccine for administration and did not note the beyond use date "BUD" of 4/23/23 which was marked in several places on the box.
Patient developed blurry vision Left eye and Left sided temporal headache with vomiting x 2 days. Also developed numbness of the L ankle and weakness that has progressed to dragging left leg on walking. Seen at a community clinic and was diagnosed as asthma, tachycardia and neuropathies. Blood tests ordered but not done. Patient denies resppiratory difficulties, bladder or urinary sypmtoms.
This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, 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 PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant) and MALAISE (wasn't feeling good). At the time of the report, PNEUMONIA (pneumonia) and MALAISE (wasn't feeling good) outcome was unknown.            Concomitant product use was not provided by reporter. Treatment information was not provided. It was reported that the patient was not feeling good for Christmas and was hospitalized for pneumonia. She was expected to be released around Saturday. The patient got the two Moderna shots more than 6 months ago.  Reporter didn't want to answer questions to report to Safety.  Company comment: This is a spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced unexpected event of pneumonia (seriousness criteria hospitalization and medically significant). The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Patient received two Moderna vaccines more than 6 months ago, she  wasn't feeling good for Christmas and was hospitalized for pneumonia. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Follow-up information included no new information. On 29-Dec-2021: Follow-up information included no new information. Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced unexpected event of pneumonia (seriousness criteria hospitalization and medically significant). The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Patient received two Moderna vaccines more than 6 months ago, she wasn't feeling good for Christmas and was hospitalized for pneumonia. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Constant ringing in the ears (tinnitus) with feeling of my inner ear being "swollen" since receiving the injection.  Major headache , fatigue and weakness has continued since receiving the injection.  Sought care via telehealth twice, was told to go to urgent care.  Urgent care was full.
Information has been received from a physician concerning a 12 year old female patient with asthma who about two weeks ago was vaccinated with PNEUMOVAX 23, lot # not reported. Concomitant therapy included FLUMIST, manufacturer unspecified. It was reported that the patient had an allergic reaction to the pneumonia vaccine, the patient's arm swelled up and had the appearance of an abscess at the injection site. The physician stated that the patient was treated with antibiotics. The patient was hospitalized for two days and was discharged, dates were not specified. Additional information has been requested.
Patient is fully vaccinated.  COVID + on 11/21/2021. ED visit on 11/20/2021.  76y.o. male presenting to the emergency department for chills. Patient has a history of diabetes and has a chronic right foot ulcer that he has had for one year. Patient states the chills recurrently and he requires admission to the hospital and antibiotics. Patient denies cough, shortness of breath, chest pain, abdominal pain, vomiting, dysuria.Patient has hypomagnesemia, magnesium replaced. Patient has warmth and erythema of left lower leg. Patient also has an ulcer on the dorsal aspect of right foot.Patient was informed of their diagnosis and instructed to follow up with PCP and podiatry in 2 days.Patient remains stable and discharged to home.  Patient to be discharged with follow-up for monoclonal antibody for COVID-19.
soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site) 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 31-Mar-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 VACCINATION SITE PAIN (soreness at injection site). At the time of the report, VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable  No relevant concomitant medications were reported  No treatment information was provided.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown), in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: INSULIN taken for type 1 diabetes mellitus; HUMALOG taken for type 1 diabetes mellitus. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient received "COVID-19 Treatment" Paxlovid from 01Jul2022 to 03Jul2022, after vaccination with Pfizer/BioNTech COVID vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Phantom smell. Smell is similar to old flowers or smoke. This smell gives me a slight headache/nausea.
Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected. This is one of several reports from the same source.
Five minutes after receiving his second dose of COVID-19 vaccine, patient reported experiencing palpitations. His blood pressure taken at 2:38pm was 176/111 mmHg with 97 BPM. He stated that he had not exercised, smoked, or had caffeine products prior to vaccination, and his most recent meal was at 12:30pm. He also stated his usual blood pressure is around 120/90 mmHg. Patient was told to remain seated in the lobby as his palpitations were beginning to resolve with no new symptoms. The second blood pressure reading at 2:57pm was 157/114 mmHg with 81 BPM. By then he reported no palpitations and "felt fine". Patient was told to monitor for at least another 20 minutes. The last blood pressure reading at 3:24pm was 167/96 mmHg with 80 BPM. Patient had no further complaints and was released. Pharmacist called him around 5:00pm and he stated everything remained fine.
Vaccine given to patient was expired. Patient's provider was notified. Per vaccine manufacturer guideline patient was to be revaccinated, which was later done on 9/26/2022
Red oval (about 2-in in diameter) at injection site, slightly tender and warm to the touch. Swollen lymph nodes in armpit and neck on the same side as the vaccine.