chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness/lightheaded, felt hot,hard to breath right after injection. Had lip/tongue tingling, dry mouth, and chest tightness within a few minutes. They had me wait for 30 mins before allowing me to leave. I woke up at 3:30 in the morning with a severe headache, and had stiffness in my neck and trap muscles. I still am having a severe headache, neck/trap muscle pain, dizziness/lightheaded, diarrhea, sweats and I feel like Im having panic attack sypmtoms throughout the day.
Chest pain, SOB, left arm pain, nausea, body aches , sweating, inability to lie down. Started 4/26 10 pm. To Medical Center ER at approx 5:30 am. 4/27/21. Admitted to cardiac unit. Myocarditis
pt recvd vax 28NOV94 states arm is now swollen-went to MD dx w/tissue infection & poss cellulitis; presently taking oral ATB; moist hot packs to area-to return to MD on 1DEC94 if not noticedably improved;
First shot gave Severe Edema in the feet and ankles. Went to ER to check it.  Second one occurred the same night of the vaccine which is also reported at this but that was on 5/21/21. That gave similar effects to the first one. Following after which legs started to hurt and gave pitting edema. This is not related to high sugars as it happened instantly verses long period of time. Then arms and hands began to get neuropathy as well, continuing to the present.
Woke up with soreness in right arm in area of injection site.  Did not take anything for soreness.  In afternoon approximately 1:00 pm noticed itching and redness in right arm area of injection site and to the side of it.  Slight raise to reddened area.  Employee Health was made aware.
Passed out; Right arm became norm down to her fingers; No longer move right arm from elbow down to fingers / lost functioning completely in the entire right arm; Terrible pain in the entire right arm; Heart rate dropped; Vomited; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPOAESTHESIA (Right arm became norm down to her fingers), HYPOKINESIA (No longer move right arm from elbow down to fingers / lost functioning completely in the entire right arm), PAIN IN EXTREMITY (Terrible pain in the entire right arm), HEART RATE DECREASED (Heart rate dropped) and VOMITING (Vomited). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), HYPOAESTHESIA (Right arm became norm down to her fingers), HYPOKINESIA (No longer move right arm from elbow down to fingers / lost functioning completely in the entire right arm), PAIN IN EXTREMITY (Terrible pain in the entire right arm), HEART RATE DECREASED (Heart rate dropped) and VOMITING (Vomited) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electromyogram: unknown (Inconclusive) result unknown. On an unknown date, Heart rate: low (Low) Drop in heart rate was reported. On an unknown date, Spinal X-ray: normal (normal) Reported to be normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included the use of ibuprofen and oral steroid prednisone.   A week later the patient's arm was still very painful and some functioning had returned but not up to 50%. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD21-083933 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-083933:2nd dose
Breaking out in hives. The first time was on Sept. 2nd in the afternoon, the hives were around the injection site. Second time was later that evening - hives in various areas all over body. Third time, Sept 3rd late afternoon on face and neck. Fourth time on Sept 16th in evening on back of leg. Each time hives have broken out after eating chicken, except for the first time.
pt became pale & diaphoretic, c/o ears ringing, SOB, stomach cramping, pain in both hands, pulse 90, resp 28, lips very pale, lungs clear;911 was called, 02 started @ 21/2 liters per min;pt taken to hosp by amb for observation;
After second shot I had high fever, chills, nausea, dizziness,fatigue, and loss of appetite.  Also had swollen knot on arm and tenderness for almost 1 month after the second shot.  Did not have this with the first shot.
On 02/19/2016, patient presents to the clinic's triage with redness and swelling (measuring about 5 inches in diameter) to the upper left arm after receiving Adacel (Tdap) seven days ago (02/12/2016).  Patient denies knowing of any allergies prior to agreeing to receive Adacel (Tdap).  Patient also denies fever, chills, SOB, or itching in any other area.  All vital signs are within normal limits.  PA-C notified and advised to apply warm compresses, take OTC Benadryl as directed, and go to the nearest Emergency Room if no improvement.
Menstrual Cycle came early and was extremely heavy. A lot of blood clots. Have been extremely fatigue for going on two weeks now.
diagnosis is idiopathic sensory neurology; impacting his quality of life; I developed a persistent pins & needles sensation in both hands & both feet; This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW1071) via an unspecified route, administered in Left Arm on 07May2021 (43-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The patient's medical history included peanuts and almonds allergy. Overall healthy person. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8730) via an unspecified route, administered in Left Arm on 16Apr2021 (43-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. Facility type vaccine was reported as Other. The patient neither receive any other vaccine in four weeks of Covid-19 vaccination nor received any other medications in two weeks. Prior vaccination the patient was not diagnosed with Covid. On 02Jun2021 (approximately 3.5 weeks after the 2nd dose), he developed a persistent pins and needles sensation in both hands and both feet. The symptoms developed over the course of 24 hours on both sides. He visited his regular physician as well as a neurologist and went through a number of prescribed tests (contrast MRI of the brain and spine, as well as specific neuropathy-related bloodwork). All tests appeared negative or within range. Yet, the symptoms have continued for over a month now, impacting his quality of life. At this point his diagnosis was idiopathic sensory neurology. These adverse events resulted the patient to visit doctor or other healthcare professional office/clinic visit. No treatment had been prescribed. Post vaccination the patient was not tested for Covid. The patient had not received any treatment medication for resulted events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information was expected.
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-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 VACCINATION SITE PAIN (Sore Arm). The patient was treated with IBUPROFEN for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
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 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:15 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 24.02. Concomitant products were not provided. On 15-Apr-2021, Excursion time was 09. Temperature was 34. Total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021. On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Unknown, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42. 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.
C/O FACIAL FLUSHING IMMEDIATELY AFTER RECEIVING H1N1 FLUMIST.  C/OLIGHTHEADEDNESS AND DIZZINESS FOR A FEW HOURS.  ALSO C/O TINGLING BEHIND EARS AND NECK AREA.
Information has been received from a nurse practitioner concerning a 28-year-old female who was vaccinated with a single dose of ZOSTAVAX (lot # "0426U") and was supposed to be given VARIVAX.  The patient did not have any adverse side effects.  A product quality complaint was not involved.  Additional information is not expected.
Severe generalized itching; painful skin on back, trunk, arms; Rash on back; This is a spontaneous report from a contactable nurse (patient). An elderly non-pregnant female patient of an unspecified age (Age: 74; Units: Unknown, as reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6200, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 24Feb2021 at 09:45 as dose 1, single for COVID-19 immunisation. Medical history included psoriasis, cancer survivor, antibiotics allergy, and shellfish allergy. The patient previously took codeine and experienced allergy. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 28Feb2021, the patient experienced severe generalized itching, painful skin on back, trunk, arms, and rash on back. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included antihistamine and anti-inflammatory. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
He got his vaccine, the shot itself was OK, he has to travel by bus for local transportation.  He got the shot and needed to do some shopping, started to shop and then about 15 minutes later he started to feel pressure in his chest similar to his prior heart attack.  He then got pain 5-6/10 building up.  He decided to check out as the bus was coming to get home.  He waited for the bus, and then he started to feel sick.  He checked the symptoms which were flu-like.  He started to have different unusual feelings while he was on the bus, woozy, nauseous.  He got home, laid down around 11:00 AM.  By evening he started to feel palpitations, had a fever which was to about 100.2, he had all the classic flu signs, sore throat, cough.  He is still having the symptoms of flu today, it's been 9 days.  The pain in his chest is still present, he gets the same type of pressure and also gets sharp pains, which he had the first day as well to 7-8/10 level.  He has had 3 heart attacks and knows that type of feeling, which is what he has been having since the vaccine.  He talked to his doctor yesterday and spoke with his pharmacist as what needed to be done and any recommendations.  He saw his PCP yesterday and he was more interested in some of his other issues (was born with a heart defect), was worrying about blood clots that he had had in the past.  His PCP told him to take Eliquis.    He did get the flu vaccine, over 65 6 days prior to this vaccine.  He had no AE from that.  He asked his pharmacist if it was possible that the shingles vaccine activated the flu vaccine.  He is having trouble breathing, and productive cough, and wonders if he's going into more serious problems from the vaccine.    He had a lot of problems with his lungs in 2017, and feels like he is running in that direction and wants to know if he has the flu, which damaged his lungs and ended up with 3 bugs.
Per Grandma- patient got a "pimple like" mark on arm where Tdap was given.  Patient was swimming in a pool and at the beach.  Bump gone 2 days later.
No adverse effects were reported; administered improperly stored PROQUAD; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 04-JUN-2019, the patient was administered with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number S002503 with expiration date in 23-JUL-2020 (strength, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot number, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (C) to 8 C (-3 C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA008643: US-009507513-1906USA010325: US-009507513-1906USA010323: US-009507513-1906USA008695: US-009507513-1907USA011955: US-009507513-1907USA011954:
severe muscle pain; numbness in both my arms and both my legs; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 12May2021 as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced severe muscle pain and numbness in both arms and legs on 13May2021 (within 24 hours of the shot). The patient stated that, I am still experiencing pain and set to begin physical therapy this week with hopes that it helps restore my strength in my arms and legs as I am slowly losing strength to carry out daily activities. This is a first time occurrence for me, no history of any muscle pain in the past. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sudden onset Extreme dizziness with racing heart/palpitations. ER visit. IV fluids administered. Duration of extreme symptoms a few hours. Less extreme a few more days .
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 15-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J001700 and expiry date: 08-MAY-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
initial red swelling around injection site, about 2" diameter . Went away in about 5 days return about a week later. Warm to the touch but no longer raised
Tiredness/fatigue started a few hours post injection. Middle of the night, fever/flu like symptoms. Morning, fatigue, achy joints, tiredness all day. Stuffy nose. Thirsty constantly drinking water - could be in relation of my immune system fighting the injection and wanting to flush it out. Took an afternoon nap and felt better around 5:30 pm.
INFLAMMATION AT INJECTION SITE SPREAD TO BELOW ELBOW.  REDNESS/RASH SURROUNDING INJECTION SITE (WHITE CLEAR CIRCLE AT DIRECT SPOT OF INJECTION), PATIENT ALSO REPORTS BODY ACHES.
This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (scanned the vaccine box to pull up the expiration date it states 20-May-2022 but portal has the expiration date listed as 31-Dec-2069) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (scanned the vaccine box to pull up the expiration date it states 20-May-2022 but portal has the expiration date listed as 31-Dec-2069). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (scanned the vaccine box to pull up the expiration date it states 20-May-2022 but portal has the expiration date listed as 31-Dec-2069) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
extra dose of menactra with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 years old and unknown gender patient who was administered extra dose of menactra with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (formulation, strength, dose, route, administration site and lot number not reported) for prophylactic vaccination.  On an unknown date, (unknown latency) the patient was administered an extra dose of menactra with no reported adverse event (extra dose administered).  It was reported, "Patient was administered a 3rd dose 1 year after the patient's 2nd dose by mistake".  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. It was reported that. on 15-MAY-2013, the patient was vaccinated with a first dose of GARDASIL (lot number, dose, route and anatomical site of injection were not reported). The second dose was received on 28-AUG-2013 and the third dose was received on 11-AUG-2015. Later, on 18-MAY-2016, the patient received a dose of GARDASIL 9 (lot number, dose, route and anatomical site of injection were not reported). Concomitant therapies were not provided. No adverse effects were reported. No product quality complain (PQC) was involved. Additional information is not expected, since the reporter did not allow further contact for follow-up.
Patient received Janssen covid19 vaccine, she was sitting in post-vaccination waiting area, when she became little headed. Patient closed her eyes and slumped over in chair and fainted. We brought patient to the floor and she came to. Patient stated this commonly happens after vaccines or giving blood as she has anxiety of both. She also stated she did not eat anything all day. Patient was given ice pack and remained in post vaccination waiting area for 30 minutes. Patient stated she felt fine shortly after laying down on the floor.
red swollen sore arm to elbow, right arm and shoulder sore on 10/20 rash 10/25 on wrist of right arm.  Went to Chiropractor for treatment for aches in arm and shoulder .  Rash get worse is on right arm and hand Dr diagnoses it as allergic reaction to a cream. Get worse, 2nd Dr. diagnoses shingles. I was vaccinated for shingles in 2015. Still being treated for shingles by Dermatologist.