chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 11Jan2021 as dose 2, single (Lot number: ELO142), in left arm and on 19Sep2021 as dose 3 (booster), single (Lot number: 301358a) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Sep2022 as dose 4 (booster), single (Lot number: AS7163B), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTRADIOL, start date: 01Apr2021; VIT D3, start date: 01Apr2021. Past drug history included: Bactrim, reaction(s): "Known Allergy: Bactrim". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19, which includes: Mucinex and Paxlovid.  Clinical course: The reporter was the patient herself.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. 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.
This spontaneous report as received from a consumer refers to her 12 year old daughter with psoriasis and sulfa medications allergy. On 13-AUG-2009, the patient was vaccinated with her first dose of GARDASIL, on 16-OCT-2009 with the second dose and on 19-AUG-2010 with the third dose (doses, lot# and routes of administration were not reported). On 12-AUG-2014, the patient received 4th dose of GARDASIL inadvertently (dose, lot# and route of administration was not reported). Concomitant therapies included triamcinolone ointment. In approximately August 2014, reported as "soon after receiving 4th dose" the patient experienced soreness at the injection site. The patient sought medical attention by calling the office. No treatment was given. No lab diagnostics studies were performed. The patient present status was reported as recovering. The reporter states also, that the patient might have experienced soreness at the injection site on an unknown date with the other doses, as well. The outcome of soreness at the injection site on an unknown date with the other doses was not reported. Relatedness between soreness at the injection site and therapy with GARDASIL was not provided. Additional information has been requested.
Sore at injection site. Low grade fever; back pain started 6/4 in pm; lethargic; aches; cough; weakness in limbs, decreased PO all lasted 2 days. No long term sequelae.
On third day after 2nd vaccine was given, urticaria  appeared throughout my body, along with tongue swelling, wheezing, flushing, and eye irritation. Because my daughter suffers from allergic reactions, I knew to immediately administer Benadryl. I also took an additional dose of Zyrtec and Pepcid, which helped temporarily and symptoms subsided when I called my primary care doctor. I had a virtual visit,  and she then prescribed Medrol.
One day after receiving vaccine in right upper arm patient presented with fever, pain, redness right upper arm from shoulder to elbow. Admitted to hospital, treated with IV Cefactin but symptoms increased. Switched to IV Clindamycin, symptoms improved. Blood cultures NEG, Sed rate normal, WBC 145. Discharged on oral Didoxacillin.1/24/08-records received for DOS 9/19-9/22/07- DC DX: Right arm cellulitis. Day prior to admission C/O pain in right arm, constant throbbing, increased redness, swelling and warmth from shoulder to elbow. Malaise, weakness, epigastric pain, vomiting, nausea and dizziness. Felt feverish and chills. Right elbow pain.
Weakness,  Loss of weight bearing capacity,  spasticity,  loss of proprioception,  progressive numbness of hands and feet, brief  period expressive aphasia
On 10-14-2007 states she started feeling like she had the flu, achy all over, dizziness, diarrhea, felt clamy then hot, fatigue, stated she felt like her hips did not want to work. Stated that to her knowledge, her temperature was not over 98.8.  These symptoms still continue to present day.  Saw nurse practitioner, on 10-17-2007, 11-13-2007, 11-21-2007 and 11-28-2007.  On 11-21-2007 Labs were ordered and on 11-28-2007 was prescribed Zyrtec 10 mg. and Septra DS.
Received vaccine on Tues. June 10, 2008; arm was sore on June 11th; sore with swelling, warmth and redness on June 12th - swelling was golf size; soreness, swelling warmth and redness on June 13 and 14 - racquetball sized; Back to golf ball size June 15 and 16 with less soreness, but still warm and pink
Left upper arm became sore, very hot, red spot the size of a an orange, slightly swelled. Stayed that way for 5-6 days before it gradually went away. Also some itchy feeling.
The client received the Moderna Bivalent booster dose preparation instead of the Moderna Vaccine authorized for the primary vaccination series.   The patient was called and advised of the CDC recommendation to repeat the dose immediately.  The patient agreed and returned to the clinic for revaccination.  0.5mL Moderna Primary series  (LOT # 017822A preparation administered without incident
I recieved the shot on 2/5/2021 on 2/8/2021 I was off balance all day.  I would run into walls and doors. As I went down the steps of my home I couldn't stop at the bottom.  I ran into the door and it stopped me.  I was this way all day.  When I got up the next morning on 2/9/2021  I was o'k until around 9:00 then my tongue got sore and my mouth got all coated. My whole mouth was coated.  Around  10:00 my tongue swelled. This lasted all day.  The next morning I was fine.
Minor soreness at injection site. Lasted about 48 hours; Minor sweats day of vaccination. Lasted 5 hours; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 19Jan2021 09:00 at SINGLE DOSE on Arm Left for covid-19 immunisation. The patient medical history was not reported. No covid prior vaccination. No other vaccine in four weeks. Known allergies: No. Had other medications in two weeks. The patient experienced minor soreness at injection site. lasted about 48 hours since on 19Jan2021 with outcome of recovered on 21Jan2021, minor sweats day of vaccination. lasted 5 hours on 19Jan2021 with outcome of recovered in Jan2021. No treatment received. No covid tested post vaccination.
Information has been received from a male consumer who on approximately 26-JUL-2007 was vaccinated with a dose of ZOSTAVAX. On approximately 26-JUL-2007 4 days after vaccination the patient developed puffiness on both of his eyes which has "remained the same 3 days now" and it has not improved. Patient does not want to provide any further information. There was non product quality complaint involved. No further information is available.
Flulaval Quadrivalent (Influenza Vaccine) Product Malfunction in a one-week period beginning on October 4, 2020, our facility received approximately five reports of Flulaval Quadrivalent leaking drug at the at the hub of the syringe. Most cases were noted to have been caught prior to reaching patients. However, in one specific occurrence, the needle was inserted into the patient's deltoid and the syringe plunger was depressed. However, the entire dose escaped from the hub resulting in an insufficient administration. Upon further investigation, it was determined that the needle was indeed appropriately secured to the syringe. Note that the lot # provided only pertains to one associated incident. The products in the other incidents were not isolated. Further, the drug manufacturer representative has been contacted and scheduled to meet with pharmacy leadership in the coming weak.
After injection went home felt tired and slept for 5 hours; Woke up with middle of back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administration date 13Sep2021 10:00 (Lot number: Fc3182) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 13Sep2021 17:00, outcome "recovering", described as "After injection went home felt tired and slept for 5 hours"; BACK PAIN (non-serious) with onset 13Sep2021 17:00, outcome "recovering", described as "Woke up with middle of back pain". It was unknown if therapeutic measures were taken as a result of fatigue, back pain.  Additional information: No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Adverse event resulted in None of the above. Unknown if treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
16-year-old female was admitted for chronic recurrent abdominal pain which was on the right subcostal and posterior infrascapular area.  She described the pain as constant and stabbing in nature and was not relieved with Tylenol or NSAIDs that she has use so far nor was relieved with Prilosec.  Her CBC with diff, CMP CRP procalcitonin were all negative.  Her stool occult blood was positive.  She was found to be COVID-19 positive and therefore we could not get the upper and lower GI endoscopy done during this admission as she was COVID-19 positive.
She was exposed to a germicidal chemical at work which has caused dermatitis.; This is a spontaneous report from a contactable consume, the patient.   A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) dose 1 via an unspecified route of administration on 28Mar2021 as dose 1, single for covid-19 immunisation. The patient stated she was prescribed steroids to help resolve the dermatitis. The patient's concomitant medications were not reported. On an unknown date on 2021 the patient was exposed to a germicidal chemical at work which has caused dermatitis. She states this exact type of reaction happened last year and she was prescribed steroids to help resolved the dermatitis. She would like to know if she could take steroids or use steroid cream to help the dermatitis prior to receiving her second dose of the vaccine. The patient wanted to know if she should proceed with the second dose of the Pfizer COVID-19 vaccine on 19Apr2021. The patient states that this incident had nothing to do with the Pfizer COVID-19 vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever (101 degrees) 20-28 hours post injection. Local pain and redness 6-36 hrs post.
PATIENT PRESENTED WITH INJECTION SITE REACTION. PATIENT COMPLAINED OF SORENESS, SWELLING, SENTISITVITY, AND HEAT IN THE AREA. SHE MENTIONED PAIN IN THE AREA ASWELL.   PATIENT CAME BACK TO THE PHARMACY 2 DAYS POST INJECTION AND THE INVOLVED AREA WAS STILL SWELLED  AND RED AND A LOT OF HEAT FROM THE SITE. PATIENT HAS HAD THE FLU VACCINE IN THE PAST WITHOUT ANY PROBLEMS.
Swelling of lips, tongue and throat. Additional symptoms: headache, low grade fever, body aches, swollen glands. Self-treated with Benadryl. Symptoms are still present but improving.
Patient became immobile on 1/25/21 (4 days after receiving Moderna COVID-19 vaccine). He died on 1/27/21
skin rash; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID:   A 73-year-old male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer: Unknown, Lot Number: Not Provided), for Covid-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "skin rash"  Additional information: States she has a 73-year-old patient on the line and he is calling to report when he got the 2nd dose and the booster dose of the Pfizer Covid booster vaccine and got a skin rash after the 2nd dose and after the booster dose, he got night time skin rashes. States he had the 1st dosage more than two months ago and the 2nd dose maybe long ago and so he received the skin rash and wanted to know if anybody reported that they got a skin rash after the vaccine. States his question is if anybody had complained of a rash or get a skin rash after the vaccine and states he is driving at this time.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Cough, body aches, headache began 11/19/22. Positive Covid test on 11/22/22.  Treated with Paxlovid. Negative Covid test 11/29/22.
Fever of 100.6 at night which occurred 36 hours after the vaccine shot and it lasted for about 6-8 hours.
Initial reaction 10/28/21  Severe joint pain, elevated heart rate, elevated blood pressure, severe swelling of hands and knuckles.  Second Reaction 12/1 Severe joint pain, elevated heart rate, elevated blood pressure, severe swelling of hands and knuckles. Subsequent steroid treatment did not improve blood inflammatory levels (3, 3 week steroid treatment cycles) Heart rate increased further after second dose, saw Cardiologist 1/11/22, cardio echo-sound performed 1/27, heart rate 150+, Atrial Flutter discovered on echo-sound/EKG, did not exist previously. Severe ongoing joint pain ? travelling throughout body with different location every few days (hands , wrist, elbows, knees, feet, chest) Repeated blood tests during steroid treatment cycles reflect elevated blood inflammatory levels continuing (as of 2/26/22). Doctor has recommended Cardiac Catheter Ablation procedure (to be scheduled on 2/28/22). Reaction has required 15+ office/ blood test visits and cardiac catheter procedure is pending. Joint pain, elevated heart rate and atrial flutter remain unresolved. Severe ongoing daily joint pain. Inflammatory Blood test levels remain high after 2 full 3-week steroid treatment cycles. (CRP Non-Cardiac 2.12mg/dl on 2/22 after 6 weeks total of Prednisone, currently on third 3-week cycle). Note I had a full physical in September 2022, No Atrial Flutter at that time, full blood panel, all blood test results were normal except slightly high cholesterol levels.  Reaction condition remains unresolved, high blood inflammatory levels, elevated heart rate and constant joint pain in new locations every day (Left hand, knuckles, wrist, left elbow is primary, with other joints variable). Rapidly losing hand strength in left hand and ability to grasp / twist objects (i.e., doorknob twist is not possible every day)
Next day the rash came back; Covid arm; that went to my upper arm; After several days, I got a bad rash on lower arm; chills; Super tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Super tired), CHILLS (chills), RASH (Next day the rash came back), RASH (Covid arm) and RASH (that went to my upper arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot# 025J20A and Lot# 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, 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 FATIGUE (Super tired), CHILLS (chills), RASH (Next day the rash came back), RASH (Covid arm), RASH (that went to my upper arm) and RASH (After several days, I got a bad rash on lower arm). At the time of the report, FATIGUE (Super tired), CHILLS (chills), RASH (Next day the rash came back), RASH (Covid arm), RASH (that went to my upper arm) and RASH (After several days, I got a bad rash on lower arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment drugs taken for rash : Tylenol, Benadryl, "AND" ointment.
20 Jan 2009- received vaccination. 21 Jan 2009 had chills and weakness. 23 Jan 2009 had chest pains. Went to Aid Station was told he had gas. Continued to have chest pains for 3 days. 26 Jan 2009- returned to Sick call. Was admitted to Emergency Room. Diagnosis- Pluerisy. Received medicine. 29 Jan 2009 still has chest pain and weakness- but not as badly as before.  2/9/09 Received ER medical records of 1/26/2009. FINAL DX: pleuritic chest pain, UTI Records reveal patient experienced chest pain, DOE, chills, nonproductive cough x 3 days.  Tx w/meds & d/c to home.
A little bit of bleeding, pt complained of itchiness the night of immunization; then complained of throbbing pain.
On 5/3/2022, began experiencing symptoms: Post-Nasal Drip, Sore Throat, Cough, Headache, Weakness, Low Energy, No Stamina.
An 88-year-old patient was sitting in the observation area when she started scratching and told her daughter that she felt itchy. Provider is immediately notified and the patient is moved to the evaluation site. She begins scratching her left arm and head. Provider, who is called by Dr., who orders 25mg of Benadryl PO and puts Benadryl cream on his arm. Vital at the time of evaluation BP: 110/70mmhg RR" 16 Temperature: 36.8 HR: 64 Dextro: 83 After half an hour of observation she reports that she does not feel itching and is discharged at 4:12pm Vital at the moment of the high BP:110/70mmh HR;67 Temp 36.8 dextro:82 RR:16.
pt recv vax; 2-3 min later, sudden pallor & limpness following vax;
I started getting a headache six days after receiving the vaccine. The headache worsened, and I began having joint pain and full body muscle aches.  On the sixth night and seventh day I had a temperature of 100.9. I took a covid test on the seventh day which had a negative result. On the eighth day I began having sinus pressure. Today is the tenth day and I continue to have all symptoms, although the joint and muscle pain has diminished some.
I started getting symptoms of a headache, nasal congestion, and fatigue. My husband had tested positive so I took a PCR COVID-19 that was positive. My symptoms did progress to heaviness on my lungs but not a bad cough. I was prescribed Paxlovid. The Paxlovid did help some. I still have lingering symptoms of shortness of breath and headaches.
Tachycardia at rest.  Heart rate 130-150?s with frequent palpitations lasting approx 8 hours.  Symptoms started approx 15 hours after administration of second dose of Pfizer COVID vaccine.
Fluid in the ears - creating a ?clicking? noise. Doctor described as Eustachian Tube Dysfunction.
Pt. reported pain in vaccinated arm beginning almost immediately after receiving Tdap, pain increased over time and by day 7 it extended from elbow to neck with limited ROM in shoulder. Pain interferred with sleep and ADLs. Temporary relief with heat, acetaminophen. No visible swelling, erythema. Started ibuprofen 600 mg tid with improved ROM. Pain still present but improving day 23.
3-4 hrs postvaccination, he had febrile seizure with Tempt of 106 and cervical lymphadenopathy. Next morning refused to bear weight on his right leg nor straighten his leg. Fever never went away.
Patient received Janssen COVID-19 vaccine on 3/10/2021, and Moderna vaccine on 12/8/2021. Patient hospitalized several days with COVID-19 pneumonia on 1/24/2022.
Diagnosed with Guillan-Barre.  Improved after IVIG therapy. Discharge summary states pain in legs, abnormal gait. msv
One hour after vax hives developed on face and arms, swelling under both eye lids (lower), no swelling in throat, nasal congestion slight.
Received Adult Hepatitis B at approximately 8:05 am. Returned to health department at 9:00 am with complaint of arm swelling, rash, and itching. Red rash noted on lower arm with slight edema. No rash noted at site of injection although area was itching.  No signs or symptoms of respiratory distress. Was advised to take Benadryl and to go to the Emergency Room if symptoms worsen.
This case was reported by a other health professional via sales rep and described the occurrence of generalized urticaria in a adult female patient who received Seasonal Influenza vaccine. Previously administered products included Seasonal Influenza vaccine with an associated reaction of erythema (1st dose received on an unknown date, see case US2016GSK098540). On an unknown date, the patient received the 2nd dose of Seasonal Influenza vaccine. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced generalized urticaria. On an unknown date, the outcome of the generalized urticaria was recovered/resolved. It was unknown if the reporter considered the generalized urticaria to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient (receptionist in nurse practitioner office) told to sales representative that, she had reaction to flu vaccine (unknown if this was a GlaxoSmithKline vaccine)  for 2 consecutive years. On an unknown date, in the next year after receiving 1st dose, the patient received the 2nd dose and experienced hives all over her body. The patient said that, it was fine if GlaxoSmithKline wants to contact her directly. It was unknown if the event caused the patient to be hospitalized overnight or prolong an existing hospitalization. It was unknown if the reporting healthcare professional considered the event to be life threatening, to result in persistent or significant disability and incapacity as well as congenital anomaly or birth defect. The patient did not die due to the event. It was unknown if the event required surgical or medical intervention.
p/vax pt c/o coughing, runny nose & mucus in throat; also became hoarse; BP 102/58, P80, R20; lungs auscultated-clear;advised to see pvt md; symptoms improved over time but pt continued to c/o mucus in throat
Fever X 2 days after Varivax given on 7/22/02. After 10 days, post vax, started to get red, papular-vesicular lesions on legs, trunk, arms, face and scalp. Pruritic.
The day after the injection the patient reported that his left arm is numb and tingly and also his right thumb is numb. He says that it comes and goes.
Pt recv vax on 11/10/98; 1 hr post vax pt exp headache, rapid heart beat, wheezing, coughing, dry/burning eyes, achiness, dizzy, difficulty breathing
Vaccine given in August 2021, Septemper 2021- started noticing tightness in chest upon cardio exercise.   Blood pressure started going up.   Symptoms didn't go away.  In fact it was getting worse, upon only 5 min of cardio I would feel the tightness and "angina."   Positive for Covid 19 January 14th recovered after a few days. Reported to my Dr. - ordered stress test.  Nothing noted.   MRI perform MYOCARDITIS discovered.   Angiogram conducted -  No blockage and no issues found within Coronary Arteries.