chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Lot number: gh9694) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: Oct2018; LISINOPRIL, start date: Dec2018; CETIRIZINE HYDROCHLORIDE, start date: Mar2017. Past drug history included: Aspirin, reaction(s): "allergies"; Erythromycin, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID-19"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Within five minutes of receiving vaccine I noticed that I was extremely lightheaded while waiting the 15 minutes in the doctors office. I was very dizzy and seeing darkness around my peripherals. I waited the 15 minutes after the shot and noticed that I still felt this way and alerted the person at the desk. The nurse took me back to the doctors office where they monitored me for another two hours. The lightheadedness would come and go but didn?t get better until after they gave me a Benadryl. I also noticed that my hands, shins and feet got extremely cold and I had a slightly metallic taste come in my throat and nose a couple of times. They said my blood pressure and heart rate remained normal the two times they checked it.  20 min after taking a the Benadryl my hand started warming back up. After the Benadryl wore off around 9 PM that night I became lightheaded again. Then at 5 AM the next day I was extremely nauseous and lightheaded again so much so that it woke me up. Around 8am next day and I have normal post vaccine reactions, extreme soreness and aches and chills. Still slightly dizzy as well.
Patient was given the incorrect formulation for the COVID Bivalent Booster. No Reaction noted in clinic. Health authority was notified for further guidance.  Revaccination is not necessary.
Approximately 1 week post vax, the pt woke with severe pain in the shoulder area, face and neck. This worsened and the pt was taken to the ER and given IV antibiotics and morphine. The pt was sent home on Cephalexin, Vicoden and Advil. The pt continues to have pain in area.
Patient received vaccine at ~3:10pm  was instructed to wait 15 minutes based on the answers she gave on vaccination questionnaire form. Patient indicated on form no allergies and that she she had no prescription for  an Epipen. Patient and her husband approached pharmacy counter at ~3:50pm after having received their vaccines , they  had been shopping in the store beyond  15 minute wait time, asking  to speak with pharmacist. Upon speaking with patient, patient stated " I do not know if this is all in my head but I am starting to fill itchy all over and I have a burning feeling all over my body." Patient stated I am not swelling anywhere and I am not red or blotchy anywhere. I asked patient if her tongue felt funny or like it was swelling or if she was having difficulty breathing or light headed. She stated no. Patient did not appear to have any swelling and  was have no difficulty breathing. I asked patient about allergies even though consent form said no allergies . Patient stated that she did have allergies to bees and had an anaphylaxis reaction before to bees and that she also carries Epipen. She stated she also had allergies to other medications. I recommended that patient have seat in pharmacy vaccine area for me to closely monitor her for 30 minutes. Patient agreed. I monitored patient very closely for 30 minutes and  checked on patient every 5 minutes and took  patients vitals at ~4pm and again at ~4:10pm . Vitals were fine and within normal limits of patient stated usual vitals. Patient stated she took blood pressure medications. Informed patient that we did have Benadryl or hydroxyzine on had if she would like me to adminster a dose per our vaccine protocol. Patient stated no as symptoms were beginning to improve. Asked patient if she would like for me to call EMS to have her checked out. Patient stated no. As the time past patient stated she was not as itchy and the burning feeling wasn't as bad. At 4:25pm, after 30+ minute monitoring period,  informed patient it had now been 30 minutes, patient stated she felt like she was ok and was feeling better. She stated itching had improved and burning feeling improved. Patient asked about taking a benadryl at home and stated that would be fine. Informed patient that if symptoms changed or got  worse at all to be sure to follow up with ER  or PCP depending on severity. Patient husband was with her at the appointment and he was the person driving her home and would be with her once she got home. Patient left pharmacy after symptom improvement and symptoms never got worse than initially presentation.
Patient states that she received her first dose of Moderna covid-19 vaccine on 04/01/2021. She reports feeling itchiness of left arm one day ago in which that is where she received the vaccine at. She reports seeing redness around the injection spot. Use of ice compress. No fever or other symptoms other than the appearance and size of the localized redness. She reports she has hypersensitive
Fever with vomiting lasting at least until my evaluation on day 3.   Mild diarrhea.
c/o pain in both knees & ankles, difficulty walking 2nd to pain; stayed out school 20FEB now swelling noted on 25FEB; Improved 27FEB less pain in knees & ankles;
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours 20 min. On 13-NOV-2012, the patient was vaccinated with an out of temperature range of ZOSTAVAX (dose and route administration were not provided) (lot # H012576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Rash noted 9 days after vaccine. Multiple discrete erythematous macular, slight raised lesions post neck, post auricular, torso, and back. Fading lesions upper arms, thigh.
Pt awoke with severe headache, nausea, chills (hot/cold spikes) and exceptional neck stiffness. More mild (but significant) sx were injection site pain and distributed body pain. Pt had only mild sx for injections 1 and 2, which were also Pfizer from this clinic. It is worth noting 2 other Pts in the family went to the same clinic at the same time and received doses from the same lot without any significant sx.
This spontaneous report was received from an administrator, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of VARIVAX lot # M027347 and expiration date on 01-JUN-2018 (strength, dose, route of administration or anatomical location were not reported), for prophylaxis. The storage temperature was 6 to 14 degrees Fahrenheit (°F) (-14 to -10 degrees Celsius (°C)) for a time frame of 24 hours with multiple temperature excursions for a total cumulative time frame of 432 hours (dates between 12-JAN-2017 and 01-JUN-2017). This lot # was also exposed to storage temperature as 15 to 46 degrees Fahrenheit (°F) (-9 to 8 degrees Celsius (°C)) for a time frame of 24 hours with multiple temperature excursions for a total cumulative time frame of 1080 hours (dates between 15-FEB-2017 and 01-JUN-2017); and temperatures from 47 to 77 degrees Fahrenheit (°F) (9 to 25 degrees Celsius (°C)) for a time frame of 24 hours with multiple temperature excursions for a total cumulative time frame of 144 hours (dates between 27-MAR-2017 and 01-JUN-2017). Data logger was involved but no adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA011485: US-009507513-1706USA011490: US-009507513-1706USA011487: US-009507513-1706USA011488: US-009507513-1706USA002362: US-009507513-1706USA011484: US-009507513-1706USA011486:
My lips and right side of face were swelling/ swollen. I was given prednisone at the ER and a prescription for 5 days of prednisone. I took the prednisone and benadryl for 5 days. When I stopped taking the meds, the right side of my face felt stiff for 2 days. At 11 days after the shot, I think the right side of my face still feels somewhat swollen and slightly stiff at times. I have an appt with my Dr tomorrow and will follow up.
Patient reported feeling sick with flu-like symptoms (shivering, nausea, headache, dizziness), increased blood pressure and heart rate, severe swollen and warm to the site of the injection after a few hours of getting the SHINGRIX vaccine. Patient got nervous so she went to the hospital. She said she stayed at the ER for half a day until her blood pressure got normal.
Premature ventricular contractions; This spontaneous case was reported by a physician and describes the occurrence of VENTRICULAR EXTRASYSTOLES (Premature ventricular contractions) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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, 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 experienced VENTRICULAR EXTRASYSTOLES (Premature ventricular contractions). At the time of the report, VENTRICULAR EXTRASYSTOLES (Premature ventricular contractions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant details were provided No treatment details were provided; Sender's Comments: There is limited information provide to assess the causal association between the reported event and the administration of mRNA-1273 as the date of treatment  and onset dates of the event were not specified.  Additional information has been requested
A big lump under my armpit on the same side as the shot.  It is sore to the touch.
patient received influenza vaccine with a pediatric sized needle. patient was advised to seek another dose of influenza vaccine for this season
Pt came to the ED with worsening shortness of breath and wheezing over the last 2 days.  Pt is currently 10 weeks pregnant.  Admitted due to ground glass opacities and pulmonary edema on CT.
Fever, vomiting, chills, joint pain, muscle aches, soreness at site of injection
No additional AE details or PQC.; administration of PROQUAD instead of VARIVAX to a patient; This spontaneous report was received from a nurse and refers to a patient of an unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-MAR-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #W032152, expiration date: 07-APR-2024, administered for prophylaxis (strength, and route of administration were not provided) with sterile diluent (manufacturer unknown),  (strength, formulation, dose description, lot #, expiry date, route of administration, and indication were not provided); instead of  varicella virus vaccine live (oka/merck) (VARIVAX) as prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) (Wrong vaccine administered). No additional adverse event administered.
Service member presented to point of distribution to receive 2nd Pfizer Covax one week after receiving first dose. Member was educated on waiting period between vaccinations. Early presentation was not caught by ordering team, nor vaccinator before being erroneously administrated. No adverse reactions noted at time of distribution or time of reporting
Information has been received from a physician concerning a female patient who was vaccinated with her first dose of Gardasil and one day later developed hives and itchiness through out her body. Unspecified medical attention was sought. Her outcome was unknown. Additional information has been requested.
Received vaccine past its 30-days Exp date vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2022 at 10:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022 at 10:50 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.  Patient received booster vaccine past its 30 day expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. Reporter no longer possess this lot number.
Pt recv vax on 10/29/98; on same day pt exp fever&chills, tired, nausea, headache, LA swollen; tx=Tylenol
Woke up from chills and nausea 10 hours after shot was administered. In the next two hours, a headache stemming from the neck area began. A combination of Tylenol and Ibuprofen lessened symptoms for a short time, and then when they returned, I also noticed an elevated resting heart rate. 90-111 BPM (my normal rate is 73).  I have felt feverish, but my temperature has never gone above normal.
Extreme pain in joints (knees, ankles, wrists, shoulders, lower back), fever, confusion, Headaches (almost migraine like) with sensitivity to light, sound and touch, irregular heartbeat, insomnia, lack of appetite.
Developed cellulitis in right arm. Large knot, red with streaks. Temp 100 F. ER physician gave client IM ROCEPHIN x2. Client now OK. Skin peeling around injection site.
Injection site is hard, marble size lump under skin, large rash about the size of a half dollar coin, tiny bumps, child is uncomfortable and not walking well.
Left Arm red, hot to touch, itching, pain and swelling.  5.5 inches x 6.0 inches Ibuprofen given at lunch time05/05/2021, given Benadryl at bedtime on 05/05/2021, decreased swelling
Presented with SOB/AMS; + covid 2 days PTA; received monoclonal antibodies PTA; DX: DKA, CVA, resp failure d/t Covid; CXR- patchy mid and lower lung bilat infiltrates; Labs: D-dimer 1.43; CRP 24.61, Ferritin 941; Meds: Zithromax, Maxipime, Decadron, Remdesivir, Vit C, Rocephin, Lovenox, zinc,  patient required high-flow oxygen. patient is being gradually weaning off from oxygen.   patient will be prescribed with nasal cannula oxygen for 3 months at d/c
Tongue felt thick, tingling in extremities, shortness of breath.  Given 50mg Benadryl, 20 mg famotidine
Completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:02/15/21pfizer,Lot#EL9266 2nd dose: 03/08/21Pfizer,Lot# EN6206 Diagnosed covid positive:04/21/21 Symptoms:
Severe discomfort in hands and feet, tense muscles, fast heartbeat followed by slow heard beat, perfuse sweating, shortness of breath, increased tiredness. This lasted for over 4 weeks from the day after the first injection.
Pt seen in doctor's office on 2/12/02 at 09:30 for symptoms of runny nose, coughing until vomiting, history of fever. Temperature 97.8F at visit. MD prescribed Amoxicillin, Neb treatments tid and Albuterol and Intal, Phenergan with Codeine tid. Mom gave pt Motrin for fever and at 18:25, the pt had probable febrile seizure; tonic/clonic of body, lasting 2 1/2 minutes as timed per Mom (an RN). Taken to ER. Mom stated the pt was "post-ictal" and sleepy. Temperature in ER was 101F. Admitted to hospital for evaluation and treatment. Remained on same PO meds and nebs in hospital that had been prescribed earlier in the MD's office. Pt's temperature dropped to and remained below 101F while in the hospital; she ate and drank without vomiting. No further seizure behaviors. Pt discharged home less than 24 hours, post admission, remains afebrile and continues to recover from illness. Probable dx remains seizure.
24 hours after receiving 3rd shot the typical symptoms of muscle aches and minor fever started.  however, extreme lower back pain was noted unlike other times.  by day 3 symptoms started to alleviate.  by day 5 lower back pain increased exponentially.  by day 7-10 pain is so severe i cannot put my socks on, get out of a car, or sometimes walking is difficult.  an appointment with my primary is scheduled today shortly after this report.  fear of GBS.
Immediate weakness, lethargic, muscule pain in all extremities.  Continued to remain ill for months with dizziness, stomach pains, diahrea, numbness in arms, hands and fingers, jaw pain, unable to eat for prolonged periods (going from 103 lbs to 89 lbs) Experienced mental fuzziness and continues to feel numb on left side of body.  Bad headaches. Is still being treated by Kinesiologist for high levels of metal in body.  Had full blood work-up on 3/21/09. Continues to experience illness due to vaccine.  Was perfectly healthy prior to second vaccine .
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 24-JUL-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 31-AUG-2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. He was prescribed acyclovir and tramadol to manage his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
He has had a ulcer in his stomach,and he had bleeding inside; and his stomach liner opened up; Black stools; Black stools was reported as worsened.; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0169; Expiration Date: 31Aug2021) via an unspecified route of administration at arm left on 17Aug2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included gastric ulcer from an unknown date and unknown if ongoing Verbatim: Stomach ulcer. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. He got the Pfizer COVID shot on Tuesday 17Aug2021. Then, he noticed the next day his stool was black. He had this before, and he had bleeding inside. His stool is really black. It is really bad now. The dark stools started 18Aug2021. It had worsened. He hasn't seen a doctor or went to the Emergency room. He hasn't had treatment yet. He just went to the bathroom and noticed it was really bad. He just came from the bathroom. He will probably tell his boss today he will need to go get checked out. He has had a ulcer in his stomach, and his stomach liner opened up (gastric disorder). They asked if he had ever had an issue with bleeding before. on 18Aug2021 condition aggravated. Outcome of the events faeces discoloured and condition aggravated was not recovered, gastric ulcer and gastric disorder was unknown.
pt says his right arm became very heavy the day he got his vax.  He says it was so heavy he had to take his other arm to move it.  He has had some shortness of breath and very fatigued. He has fever, dizziness, body aches and pains, chills, and joint pain.  He says these symptoms come and go but has them almost ever day.  He had a seizure one night while sleeping but was better next day.  He will get cold and have to go to bed to sleep before warming up.  He had an episode where his feet became very heavy and he couldn't walk.  He has become extremely weak and has trouble doing daily task.  He has cramping in his back muscles that moves up and down his back. He has never had any other these symptoms before getting vaccinated and has only had a couple of days where he felt normal.
Itchy bumps (small) formed at injection site for both vaccines given: left upper deltoid and right back of upper arm.
Client received her second dose of the Moderna COVID-19 vaccine, and during the 15 minute post-vaccination wait period, she developed a tingling on her left arm, from above the elbow to her fingers. She denied any itching, rash, pain, difficulty breathing or history of allergies. Her vital signs were as follows: BP=184/117, Pulse=83, Resp=16. She stated that she had been previously told her blood pressure was high, but was not on any medication for it. Client stated that she did not want ?911? to be called, and said she was already feeling better. She was asked to see a physician for her elevated blood pressure and also told to call 911 if she developed any additional symptoms and she verbalized understanding.
PATIENT PRESENTED TO E.R. WITH ONE DAY HX/O LETHARGY, ALTERED MENTAL STATUS, LOW-GRADE FEVER, POST NASAL DRIP, CONGESTION, COUGH, POOR PO INTAKE. LOW O2 SATURATION CONTINUED, COVID-19 TEST POSITIVE. PROGRESSED TO HYPOXIC RESPIRATORY FAILURE. FAMILY DECIDED  ON COMFORT MEASURES AND PATIENT EXPIRED ON 01/16/2022
Pt. began feeling ill about 7 pm. Started with a "deep cough", itchy eyes and watery eyes, sore throat and muscle aches. My "skin hurt". Took cold and sinus medication - went to bed - symptoms resolved 2-3 pm 10/13/10.
Vomiting four times 8-10 hours after vaccine with blurring of left eye with numbness and tingling of the left arm. Symptoms have resolved.