chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 24 hours after receiving HBV dose #3 he had congestion, weakness, chills, cough - flu like symptoms which continued and then began to lessen 7/26 when he called Employee Health. Today 7/27 he has continued to improve. His physician recommended MUCINEX which he said was helpful.
Right eye periorbital edema developed February 2021. My right eye swells up every morning and slowly decreases throughout the day. It has not been normal for more than 8 months now.  Multiple autoimmune abnormalities on lab work including positive ANA with high titer, homogeneous fluroescence, positive AMA which has lead to an increase in bilirubin and has a strong correlation to development of primary biliary cholangitis (cirrhosis) of the liver. I have been evaluated by my primary care physician, ophthalmologist, neuro-opthalmologist, urologist, cardiologist, rheumatologist, allergist/immunologist and a hematologist for various abnormalities since receiving this vaccine. I was previously completely healthy.
9:30am - hives, itching, 10:00 - swelling tongue,face, 11:00 ER - received Prednisone IV and orally for 1 week, Benadryl, pepcid. Hives came and went for 3 days.
Swollen underarm and right side chest area. Swollen, pain and sensations travel down arms almost to wrist, stabbing pain in eye area.   (NOTE: Those were some of the newer adverse reactions that occurred after dose 1 February 12, 2021 . Adverse reactions from first dose February 12, 2021 which included chest pain, irregular heart beat, pain and twitching movements travelling down arms and legs. . .)  Report submitted via VAERS Adverse Event Reporting via text also on timely basis.   TO DATE SOME NEW CONDITIONS INCLUDES: PAD/Venous Insufficiency multiple sites. Current treatment includes compression stocking and pneumatic compression device. Decrease mobility treatment is physical therapy . . .
Covid 10 positive 8/22/21 with 8/21/21 onset
Subcutaneous injection formulation administered by other route; no adverse event; Information has been received from a nurse Practitioner, referring to a patient of unknown age and gender. The patients medical history, concurrent conditions and concomitant therapies were not reported.   On unspecified date, the patient was vaccinated with a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (0.5 ml, Intramuscularly, lot number: T037028 with expiration date on 03-NOV-2022) (Incorrect route of product administration (10081202) with sterile diluent MRK ( lot number: T027314 with expiration date on 19-MAR-2023) for prophylaxis. No adverse event was reported.
sore arm; arm is stiff if I try to reach; swelling injection; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), MUSCULOSKELETAL STIFFNESS (arm is stiff if I try to reach) and VACCINATION SITE SWELLING (swelling injection) in an 86-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu. Past adverse reactions to the above products included No adverse event with Flu.    On 09-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced PAIN IN EXTREMITY (sore arm), MUSCULOSKELETAL STIFFNESS (arm is stiff if I try to reach) and VACCINATION SITE SWELLING (swelling injection). At the time of the report, PAIN IN EXTREMITY (sore arm) and VACCINATION SITE SWELLING (swelling injection) had not resolved and MUSCULOSKELETAL STIFFNESS (arm is stiff if I try to reach) outcome was unknown.            No relevant concomitant medications were reported. Patient had received Moderna doses Dose 1 on 2-Feb-2021 batch 004MA0A, Dose 2 on 02-Mar-2021 batch 014M20A, Dose 3 on 05-Nov-2021 batch Q77C21B, Dose 4 on 06-May-2022 batch Q49L21A, Dose 5 on 07-Oct-2022 batch 06VF22A. Patient was not taking any treatment medications.   This case was linked to MOD-2023-745753, MOD-2023-745729 (Patient Link).
Erythemic blotchy hives first noted on arms then legs - daily - 2 days after receiving TDAP and MENACTRA. Responds to ZYRTEC - must take daily or hives will reoccur. This reaction has persisted - last seen in office 8/11/14.
1st dose in 2020, 2nd dose in 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number fa277, expiry date 24-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (received first dose in October 2020).   On 25-MAR-2023, the patient received the 2nd dose of Shingrix. On 25-MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose in 2020, 2nd dose in 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 4-Apr-2023 The pharmacist asked that should restart the vaccine series. The reporter was in a hurry and just mentioned that lot number and was unable to confirm. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Seriousness criteria other medically significant (OMIC). Initial report received on 11/3/06 from a health care professional. A 17 year old male pt had received an injection of Fluzone  SV 2006-2007, lot number U2275AA, at some time during the week of 10/23/06. Within a few minutes post vaccination, the pt experienced chest tightness, and swelling of the nose and throat. He was transported by ambulance to an ER where he was treated and released. At the time of this report, the pt had recovered.
Had influenza vaccine 10/25/04 2 days later red patch at site. Few days later malaise, maculopapular rash with MU at site.
Chills, body aches, exhaustion on days 3-5 after the flu shot. Red rash with burning sensation on chest and back on days 6-7 after shot. Tired with rash gradually disappearing days 8-15.
atrial fibrillation; This is a spontaneous report from a contactable other hcp(patient). A female patient of 62-Year-old received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date (at the age of 61 year old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  Historical vaccine included BNT162B2 as 1st dose for covid-19 immunization. The patient experienced atrial fibrillation on an unspecified date. The reporter filed a safety report with Pfizer and is reporting having an episode of atrial fibrillation after receiving her second dose of the Pfizer Covid-19 vaccine. She Asked if there have been any reports of this being associated with the Pfizer Covid-19 vaccine.  She had done a little research, and found some ventricular things but nothing atrial. Outcome of the event was unknown.   Information on lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event" Atrial fibrillation " and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Swelling of the glands under the armpit; On side of the body resulting in tenderness; Inability to relax arm fully because pressure on the area causes pain; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Jul2021 at 15:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic migraines and COVID-19 infection. The patient had known allergies to bee stings and calamari. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Jul2021 the patient experienced swelling of the glands under the armpit, on side of the body resulting in tenderness and inability to relax arm fully because pressure on the area causes pain. No therapeutic measures were taken as a result of reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the swelling of the glands under the armpit, on side of the body resulting in tenderness and inability to relax arm fully because pressure on the area causes pain was not recovered at the time of this report.  The lot number for BNT162b2, was not provided and will be requested during follow up.
Flurry of unusual toothaches approx 2 weeks after 1st moderna shot, and also ~24 hrs after 2nd moderna shot.  No treatment other than OTC pain meds/NSAIDs, seems to have passed at this point.  Uncertain if related to the vaccine or not; I do have tooth issues but I have not had pain of that sort before. I have been advised to report it regardless so I am.
patient received a potentially partial dose and felt a drop on her skin after the injection/ no AE; Initial information regarding an unsolicited valid non-serious case was received from Nurse via Medical Information  (Reference number- 00822914) and transmitted to Sanofi on 21-Oct-2021 in a specific country.  This case involves a 61-year-old female patient who received a potentially partial 0.5 mL (once) dose of INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE] (lot UJ767AA and expiry date 30-Jun-2022) via intramuscular route in the left arm on 19-Oct-2021 for prophylactic vaccination and felt a drop on her skin after the injection (underdose).  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to vaccine underdose (latency was on same day).  It was reported "Nurse asks when can re-administer after a potential partial dose was administered. The patient said she felt a drop on her arm and felt it was an incomplete dose. The MA administered the dose said it was a tiny drop and it was wiped from the skin."  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
2 hrs after shot--pain at injection site, mild headache 12 hrs after shot--chills, muscle pain, fatigue 3rd day--chills and muscle pain fade, fatigue remains 4th day--less fatigue, but dizziness starts 5th day (today)--dizziness increases
16:06, patient went into syncope x3. 911 was called. Blood sugar: 116, RR-14, O2SAT-98%, heart was 45 bpm. When patient awoke heart rate would stay above 80 bpm but would drop back down to mid 40's, then she would become unconscious. Patient's speech was sluggish. Skin was pale and warm to the touch. Constant communication was given to try to keep patient awake. Airway remained. Patient showed no signs of inflammation. 16:10, patient was awake. Alert and oriented to person, place and time. O2SAT-98%, heart rate 82, RR-20. 16:22, patient was taken by ambulance.
caller reported an improperly stored and adminitered MMR II; This spontaneous report was received from a physician referring to a patient of unknown age and unknown gender. Information about concomitant medication, pertinent medical history, drug reactions or allergies was not provided.     On 13-AUG-2020, the patient received 1 dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S020963, expiration date: 07-JUL-2021; route was not reported) for prophylaxis (Product storage error). The vaccine was exposed to temperature 2 degree Celsius to 8 degree Celsius (8.4 degree Celsius) for 34 hours and 41 minutes; and above 9 degree Celsius (10.5 degree Celsius) for 6 hours. There was no previous temperature excursion. Data logger was involved.
Today while at recess- student says he was playing soccer though only walking at the time and his lower back cramped up; he did not fall, did not lose consciousness but walked hunched over and teacher called school nurse (the reporter); school nurse arrived student sitting able to move his legs and back- student was able to talk. Transported via golf cart to the nurse's office. Afebrile, 84/62, pulse 72. Was given a heating pad (low). Began feeling a little better says his back loosened up- felt best laying down or with knees up; student also said he was dizzy; mother arrive to see student; student able to sit up- take ADVIL. Had student drink water- dizzy feeling subsided and he returned to class accompanied by his mother (also a teacher at the school); mother called physician's office (put on a long hold) but since student was feeling better will call back later as needed.
Bilateral puffy eyes, itchy throat headache, rash on chest 2 hrs post vaccine - no localized adverse reaction at injection site.
Background note: I am a very fit and healthy, now 34 yr old, who never drinks nor does drugs, is plant based, and never gets sick.  Got 2 doses of the pfizer vaccine end of April 2021. In May - starting noticing very dry skin and hair. In June, Started experiencing, hair loss, dizziness especially when getting up, increased body heat and sweating (i used to run cold and rarely sweat), and sudden weight gain (not other variables changed.) .... major hair loss continued. chunks every 4 days for the last 8 months.  Occasional Headaches (and occasional weird thunderbolt feeling in head..not too painful, but uncomfortable bolts in certain areas of my head. Never had this before)  Major Insomnia for months. Not emotional. definitely biological.  Much Weaker and out of breath  when working out  10-15lb weight gain without any diet change   skin changes - acne and rashes  Brain fog and poor memory  Very painful periods
local reaction pain, swelling, inc warmth, induration/lump w/o abscess; screaming epiosde (high pitched abn cry or screaming lasting >3hrs); mom unable to comfort pt-cont crying;
Aches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills) 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 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD-2021-364470 (Patient Link).
swelling in lymph node on left side of neck; Fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in left arm on 16Jan2021 13:45 at single dose for COVID-19 immunization. Medical history included ulcerative colitis and sulfa drug allergy from an unknown date and unknown if ongoing.  Concomitant medication included mesalazine (APRISO), multivitamin and ergocalciferol (VIT D). The patient was not pregnant at time of vaccination. The patient experienced fatigue and headache on 17Jan2021 for two days. Eight days after vaccination on 24Jan2021, the patient experienced swelling in lymph node on left side of neck. The outcome of the events was not recovered. No treatment given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in the Public Health Department. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Red, stiff circular rash with swing developed at injection site with some itchiness noted (approx. 2 inches in diameter); warm to touch. Significant soreness in left axilla. Rash increased in size over the course of 36 hours to approximately 4 inches in diameter. Redness, swelling, and stiffness have decreased as diameter of rash has increased. Soreness in axilla has decreased significantly. No other symptoms.
Information has been received from a physician referring to a female patient of unknown age. The patient's concurrent conditions, medical history were not reported. Concomitant therapy included sterile diluent (manufacturer unknown) (lot#, and expiration date were unknown). On an unspecified date in 2011, the patient was vaccinated with M-M-R II (lot#, expiration date, dose and route were unknown) for prophylaxis. Exactly 7 days later, on an unspecified date in 2011, the patient was vaccinated with VARIVAX (lot#, expiration date, dose and route were unknown) for prophylaxis. No adverse effects were reported.
pt recvd vax; vesicular rash on trunk,like chicken pox;no fever,non pruritic;
swelling and red at injection site on 1/14/10 after shot on 1/13/10 Back to normal appearance, but still sure when contacted patient at home 1/18/10
I developed a red oval shaped welt about 4?  by 3? that was raised(like a hive) hot to touch and itchy, At the injection site. It was concerning because it was two weeks after the injection. Today it seems to be fading.
felt flushed; warm inside but no fever (T-98 something F); chills; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (felt flushed), FEELING HOT (warm inside but no fever (T-98 something F)), CHILLS (chills) and FATIGUE (tiredness) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced FLUSHING (felt flushed), FEELING HOT (warm inside but no fever (T-98 something F)), CHILLS (chills) and FATIGUE (tiredness). On 30-Apr-2021, FLUSHING (felt flushed), FEELING HOT (warm inside but no fever (T-98 something F)) and CHILLS (chills) had resolved. At the time of the report, FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-109489 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109489:
pt recv vax 20APR99  2PM & pt devel fever to 105 on 21APR99 @ 2300;mom gave APAP fever persisted 103 on 22APR99;
None- vaccine given 6days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6days post expiry) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter. No Concomitant medicines were reported.   This case was linked to MOD-2021-395985 (Patient Link).
Vaccine Administered at 3:27 PM. After 15 minute obersation patient stated she was feeling tingling sensation on Left Arm. FNP assessed patient and per provider observe patient for additional questions. After (15) minute observation took vitals 3:59 PM Spo2: 89 % Pulse : 71 BP: 94/62 mmg. Per patient symptons were relieved after observation, Notified provider and was release home. Advised is symptoms persist she may contact Per PCP or our office. Or she may go to nearestest emergency room if symptons worsen or other symptoms develop. patient verbalized understanding and agreed
Pt does not handle getting shots very well.  Pt "worked herself up", and caused her to feel dizzy and light-headed, which lead to her "passing out".
Red, hard hot area at injection site by day two. By day three redness was resolving.
Vaccine was given after manufacture expiration date of 9/30/22.   No symptoms reported regarding vaccine administration
This spontaneous report was received from a registered nurse concerning a patient of unknown age gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # M005733, expiration date: 01-OCT-2017, (dose number was unknown). The temperature excursions reported were: 51.3 F for 40 minutes, and 50.2 F for 1 hour and 10 minutes. The temperature excursions were detected by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.