chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4482130-00. An 18-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162623) at unknown, citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1:, Route of Admin: Intramuscular, Sinus surgery), for COVID-19 vaccination, reaction(s): "Sinus surgery"; Bnt162b2 (Dose 1:, Route of Admin: Intramuscular, Sinus infection), for COVID-19 vaccination, reaction(s): "Sinus infection". The following information was reported: SINUSITIS (medically significant), outcome "recovered", described as "Sinus infection"; INFLUENZA (non-serious), outcome "recovered", described as "Flu symptoms". The action taken for adalimumab was unknown. The reporter's assessment of the causal relationship of "sinus infection" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "flu symptoms" related to BNT162b2. Clinical Course: Causality for Humira (Adalimumab). The reporter's causality for the event(s) of Sinus infection and Flu symptoms was not provided. Regulatory Authority opinion is that there is no reasonable possibility that the events of Sinus infection and Flu symptoms are related to Humira (Adalimumab). Regulatory Authority opinion is that the event of Sinus infection is not assessable. Sinus infection (Sinusitis) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): Not assessable Dechallenge: N/A 2) Flu symptoms (Influenza) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): No reasonable possibility Dechallenge: N/A Drug: Pfizer-BioNTech COVID-19 Vaccine (Tozinameran) (Tozinameran), Unknown, Unknown Daily Dose: 1) First dose (1 in 1 Once), 2) Second dose (1 in 1 Once) Route of admin: 1) Intra-muscular, 2) Intra-muscular Causality for Pfizer-BioNTech COVID-19 Vaccine (Tozinameran) (Tozinameran), Unknown:  1) Sinus infection (Sinusitis) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A 2) Flu symptoms (Influenza) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Probable Dechallenge: N/A No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information provided in the narrative, a possible contributory role of the suspect vaccine to reported event of sinusitis and influenza cannot be excluded.
On day 8 awoke with painful, warm, tender arm at injection site.  Throughout the day redness spread and pain became worse.  Patient was given ice pack in the office and medicated in the office with 1/2 tab Zyrtec and monitored for 1 hour.
I experienced mild angioedema approximately 3 hours after my second Moderna vaccination.  I took 50mg of Benadryl and the swelling and itching subsided within 30 minutes.  I have Juvaderm lip filler which in some individuals is known to cause swelling of the lips and face after the vaccine was received. I did not have this reaction after my first vaccine. I did not receive any filler 14 days before or after my first Moderna injection.  I have not received any filler injections in the past 6 months.
After vaccine became flushed across face and chest with racing pulse. Vitals taken, A&O x4; Answered questions appropriately. Pulse palpable and regular and fast. Given graham crackers and bottled water. Vital signs retaken along with blood glucose.  VS- 114/101 HR 94 138/93  HR 91 Glucose 91 Declined offered escort to ED. A&O x4; speech clear, resp evan. No signs of surface reaction at left arm site. Suggested follow up with PCP. Explained VAERS to patient.
Left foot swollen. Dr. Said was gout flair up. Dr prescribed colchicine (U/D) 0.6 MG ORAL TAB to use first and if no improvement to take  INDOMETHACIN 50 MG ORAL CAP.
Malaise, headache, fever, chills, sweats x 48-72 hours
Sweats; Sleeping for 10-12 hours; throat closing off on the right side; Headache; Extreme fatigue; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweats), SOMNOLENCE (Sleeping for 10-12 hours), THROAT TIGHTNESS (throat closing off on the right side), HEADACHE (Headache) and FATIGUE (Extreme fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Epstein Barr virus positive mucocutaneous ulcer.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweats), SOMNOLENCE (Sleeping for 10-12 hours), THROAT TIGHTNESS (throat closing off on the right side), HEADACHE (Headache), FATIGUE (Extreme fatigue) and CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Sweats), HEADACHE (Headache) and CHILLS (Chills) had resolved and SOMNOLENCE (Sleeping for 10-12 hours), THROAT TIGHTNESS (throat closing off on the right side) and FATIGUE (Extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Lymphocyte count: high (High) high. On 12-Mar-2021, Neutrophil count: low (Low) low.         Bloodwork was done which showed high lymphocytes and a low neutrophil count.  Treatment with a heating pad was reported.
1+ bilateral pitting edema in legs noted PM of 4/3/03.  Facial swelling and preorbital edema noted morning of 4/4/03.  Weight 109 pounds.  4/7/03 weight 110 pounds, temp 99.6.  4/9/03 110 pounds. 4/10/03 111 pounds.  Episodes of frequent sharp chest pain.  2 FB increased L breast nipple short durations began 4/7/03 at approx. 5PM arriving home from work.  SOB and dizziness noted 4/7/03.  Did not seek MD evaluation.
i got the watering juice before you vomit; dry heave; I feel queasy for a few minutes every three hours; This spontaneous case was reported by a consumer and describes the occurrence of   in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment information provided.
pt recvd vax 30JUL93 & 13AUG93 pt devel inguinal lymphadenopathy of the injected leg; No further details were provided;
She became ill, feeling dizzy, nauseated, has shortness of breath, fatigue, fever, chills and sweating. She fainted within a couple of minutes of the onset.
Severe rash with blisters & erythematous papules on extremities mainly. Began the night of immunizations & gradually worsened over the next several days.
developed itchy arm 1/20/21, noticing 1/21/21 that skin around injection site is red, later developed diffuse red,/itchy rash, is using Zyrtec daily for other allergies, no other sx
This spontaneous report as received from a registered pharmacist refers to a 56 years old female patient, with no pertinent medical history, drug reactions or allergies. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # not reported) on 24-AUG-2012. No other co-suspects were reported. There were no concomitant medications. On 24-AUG-2012 the patient developed a rash at the injection site of vaccine. The patient contacted the pharmacist, no treatment was given and no lab diagnostic tests were performed. The outcome of rash at the injection site was unknown. The relatedness for rash at the injection site was not provided for ZOSTAVAX. Additional information has been requested.
Approx. 26-27 hours after dose (March 11th, 2021): tingling/numbness in parts of right hand (pinky finger, tip of 3rd finger), progressing to parts of both hands (on and off, not consistent). Approx. 36 hours after dose (March 12th, 2021): numbness/tingling  in both hands and both feet, calves/parts of legs (ongoing and rotating between body parts); significant muscle fatigue - difficult to lift legs to walk up stairs, very effortful to move.  March 13th - 16th: continued muscle fatigue (lessening each day) and rotating numbness/tingling in fingers/hands, feet, and parts of leg. Some numbness in the back of throat and soft palate (mild - would only last for approx. 1 hour each time; occurred 3 times over 3 days). March 17th: symptoms gone/barely noticeable. April 15th: recurrence of symptoms - rotating numbness and tingling in parts of hands and feet (i.e., R pinky finger and tip of 3rd finger, L foot), muscles in arms and legs easily fatigued. ***These symptoms lasted for approximately 3 weeks (none of these symptoms on May 6th-May 9th). May 10th: recurrence of symptoms - rotating tingling in parts of hands and feet (i.e., mild "pins and needles" feeling; more mild and transient compared to Apr 15-May 5th symptoms; i.e., instead of lasting all day, symptoms would be only a few minutes to several hours/more intermittent). No significant muscle weakness/fatigue compared to previous symptoms.
I had body aches, severe headaches, loss of taste and smell, fever, and sinus congestion that is still persisting.
Nausea; lost a lot of muscle; cannot taste food, 80 percent of her taste buds are gone; some irregular heart beat; headache; extreme fatigue for 2.5 weeks, fatigue was terrible; chills; sick; fever of 101; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves Adult female patient who experienced nausea, lost a lot of muscle (muscle atrophy), cannot taste food, 80 percent of her taste buds are gone (ageusia), some irregular heart beat (heart rate irregular), fever of 101 (pyrexia), headache (headache), extreme fatigue for 2.5 weeks, fatigue was terrible (fatigue), chills (chills) and sick (malaise), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past vaccination(s) included influenza vaccine. The patient's past medical history, medical treatment(s) and family history were not provided.  In September 2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ212AB (Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious nausea, lost a lot of muscle (muscle atrophy), cannot taste food, 80 percent of her taste buds are gone (ageusia), some irregular heart beat (heart rate irregular), fever of 101 (pyrexia), headache, extreme fatigue for 2.5 weeks, fatigue was terrible (fatigue), chills and sick (malaise) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Relevant laboratory test results included: Body temperature - On an unknown date: 101 [101 for 2 weeks straight along with the headache and nausea]  Final diagnosis was sick, Severe chills, Severe extreme fatigue for 2.5 weeks, fatigue was terrible, headache, fever of 101, some irregular heart beat, cannot taste food, 80 percent of her taste buds are gone, lost a lot of muscle and nausea.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Recovering for headache, chills, nausea, some irregular heart beat, fever of 101, as Not Recovered for extreme fatigue for 2.5 weeks, fatigue was terrible, as Unknown for Loss of taste, sick and lost a lot of muscle.
c/o intense itching, felt like bug biting; small pink discrete rash rt arm & hand;
Expired vaccine given; pregnant patient administered expired booster shot; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant patient administered expired booster shot) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039021A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Feb-2022. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant patient administered expired booster shot). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant patient administered expired booster shot) outcome 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 reported  Nurse informed that the vial was actually already punctured since 23-Nov-2021
about 18 hours after the vaccination which she received on the 23rd the patient started getting hives on her arm each lesion would last about 1 or 2 hours but then her whole body became itchy often there are itchy areas with no visible rash but often there are hives as well sometimes the hives when scratched turned into papular lesions, which are visible on her chest and upper arms.  Symptoms may have slightly improved but are still very bothersome 3 weeks after onset, taking 2 Xyzal twice a day was also taking Pepcid not sure any of these interventions are making much difference although she does note some slight sedation.
Extreme abdominal pain, especially on right side. Shortness of breath. No energy.  Intense joint pain. Nausea.
Fatigue; severe headache; phantom pain in right deltoid at injection site.; Achy-type pain\ phantom pain in right deltoid at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (severe headache), VACCINATION SITE PAIN (phantom pain in right deltoid at injection site.) and MYALGIA (Achy-type pain\ phantom pain in right deltoid at injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 09-Apr-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (severe headache), VACCINATION SITE PAIN (phantom pain in right deltoid at injection site.) and MYALGIA (Achy-type pain\ phantom pain in right deltoid at injection site). At the time of the report, FATIGUE (Fatigue), HEADACHE (severe headache), VACCINATION SITE PAIN (phantom pain in right deltoid at injection site.) and MYALGIA (Achy-type pain\ phantom pain in right deltoid at injection site) outcome was unknown. Not Provided          Concomitant medication was not provided Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: updated event verbatim:
11 weeks gestation, previously uncomplicated history with only nausea as a symptom. Developed hyperemesis gravidarum the same day as the vaccine, (had not previously vomited). Hyperemesis lasted until 30 weeks gestation needing treatment with multiple antiemetic medications and multiple hospital visits for significant dehydration. Baby was low birth weight born at 39 weeks and <5th percentile in height, weight,  and head circumference.
Case number PHEH2014US024965, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 78 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 06 NOV 2014. The  nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 OCT 2014 and the temperature was between 46 to 49 degree F during the excursion.
Lightheadedness; Injection site has itching; Injection site a little puffy; Injection site has redness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness), VACCINATION SITE PRURITUS (Injection site has itching), VACCINATION SITE SWELLING (Injection site a little puffy) and VACCINATION SITE ERYTHEMA (Injection site has redness) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATENOLOL, ACETAMINOPHEN, ACETYLSALICYLIC ACID (BABY ASPIRIN), MELOXICAM and HYDROCORTISONE for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Lightheadedness), VACCINATION SITE PRURITUS (Injection site has itching), VACCINATION SITE SWELLING (Injection site a little puffy) and VACCINATION SITE ERYTHEMA (Injection site has redness). At the time of the report, DIZZINESS (Lightheadedness) had resolved and VACCINATION SITE PRURITUS (Injection site has itching), VACCINATION SITE SWELLING (Injection site a little puffy) and VACCINATION SITE ERYTHEMA (Injection site has redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. Hydrocortisone cream is applied at injection site  The patient reported that she got the vaccine and was doing well.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up received, contains additional event dizziness.
19 year old received an adult dose; 19 year old received an adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 19-year-old patient who received HBV (Engerix B adult) for prophylaxis.   On 5th October 2022, the patient received Engerix B adult 1 ml. On 5th October 2022, unknown after receiving Engerix B adult, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.      Additional Information: GSK receipt date: 05-OCT-2022 Reporters comment:  Pharmacist reported that a 19 year old patient received an adult 1 ml dose of Engerix. The HCP was calling on behalf of HCP that administered the dose, she did not have patient details (date of birth, gender, etc) or vaccine details (lot number/expiry details, etc). HCP said she was told that the patient would be turning 20 years in 3 months. The reporter consented to follow-up. Additional Supportive information: The patient received an adult 1 ml dose of Engerix, which led to overdose and inappropriate age at vaccine administration.
Information has been received from a Family Nurse Practitioner (FNP) and medical records regarding a 5 yr old male who was given a dose of VARIVAX (Merck), 0.5ML subcutaneous inj (not further specified) and a second dose of VARIVAX (Merck), 0.5mL subcutaneously inj (lot #0807) on 02JUN2010. On 07SEP2010, the patient "broke out in red spots on upper torso after being in the woods, itching". Varicella zoster IGG was positive (2.35). Assessment: chicken pox-primary varicella. Patient started on acyclovir 20 mg/kg QID times five days. On 29SEP2010, pt complained of rash, open areas under lt arm and itching. Assessment: left arm pit chicken pox, questionable secondary infection from scratching. Patient's nails were to be cut, no scratching, restart acyclovir 200mg/5 ml, 10ml po QID times five days, calamine lotion OTC, and BENADRYL OTC po. On 30SEP2010, the patient's mother called the office stating her child complained of pain under left arm, noticed more lesions on body. Continue acyclovir, start zithromycin 200mg/5ml first day 5 ml, 2-5 days 2.5ml and BACTROBAN ointment 2% 22 gm apply to area TID times 5 days. On 04OCT2010, patient seen for follow up of chicken pox-infection, spreading area with rash and itching. Assessment: left arm pit chicken pox with secondary infection greatly improved. All available medical records will be provided upon request. Additional information has been requested.
A report has been received from a physician via medical representative concerning children of unknown age and gender. No information regarding relevant history, concurrent disease and concomitant medications of the patients was provided. The patients received nasal FLUMIST on an unknown date. It was reported that several patients who had FLUMIST last season ending up getting flu last year. No information regarding Lot numbers, expiration dates, number of patients involved was provided. Physician also indicated that the kids who received the flu shots at school did not get the flu, but the kids who received FLUMIST tested positive for the type B strain. She thought it might have been 7 sets of kids, but she was unsure. The outcome of the event of flu was unknown. The report was considered to be non-serious by company physician.
My symptoms i had sever headache! Once April 1st Hit! Thats Was the day I Had a Heart stroke at store, i don?t remember anything and once i woke up i was at the hospital, and they told me that i had a heart stroke because i had lots of blood clots in my body.  And they told me i vomit and peed myself durong the whole situation i went in store
Pt recvd vax & 6OCT93 presented to MD w/cont sx of scattered, pruritic hives throughout body; pt was treated w/Medrol dosepak & cortisone ointment; c/o fatigue, sweating & nausea; pt vomited; 7OCT93 dx serum sickness;
A report has been received from a pharmacist concerning a 57 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The pharmd reported they accidentally gave FLUMIST to a 56 year old on 24-sep-2013. The outcome of the event of accidentally gave FLUMIST to a 56 year old is unknown. The report was considered to be non-serious.
w/in 24 hrs post vax pt had a few hives on abdo; no inject site react reported; fever reported by mom; however, no temp recorded; mom called on 14SEP93; pt had unconsolable crying & dorwsiness;
About 1-1 1/2 hours, post vax. noted to be limping. Mom then noted right thigh to be swollen and tender. Tried to apply cool compress on my advice but too tender. Tylenol was given. On exam, 10cm swelling and redness. Tender but limp is very mild.