chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Atopic dermatitis on face started with eyes and has progressed to entire face with periodic outbreaks over last 4 months; Atopic dermatitis on face started with eyes and has progressed to entire face with periodic outbreaks over last 4 months; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 28Feb2021 15:00 (Lot number: EN6200) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma 3 yrs ago; "Breast cancer" (unspecified if ongoing), notes: breast cancer 21 years ago. There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". Vaccination history included: Bnt162b2 (Dose 1, single; Batch/Lot No: EL9265; via Intramuscular route in right upper arm; at 03:00 PM), administration date: 01Jan2021, when the patient was 76 years old, for Covid-19 immunization. The following information was reported: DERMATITIS ATOPIC (non-serious), BLEPHARITIS (non-serious) all with onset 03Jul2021 03:00, outcome "not recovered" and all described as "Atopic dermatitis on face started with eyes and has progressed to entire face with periodic outbreaks over last 4 months"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Feb2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The event "atopic dermatitis on face started with eyes and has progressed to entire face with periodic outbreaks over last 4 months" and "atopic dermatitis on face started with eyes and has progressed to entire face with periodic outbreaks over last 4 months" was evaluated at the physician office visit. Therapeutic measures were taken as a result of dermatitis atopic, blepharitis. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not receive any other medications within two weeks of vaccination. Relevant tests reported as none. Specific relevant tests for thromboembolic events with thrombocytopenia reported as none. Atopic Dermatitis starting 4 months after 2nd dose of vaccine- started with eyes and has moved to all over face with varying lengths of duration. Have seen a dermatologist who has only given creams to use to diminish length of outbreak, lot no. long term effects- one cream had a steroid bot not recommended for long term use. Eye ointment with a steroid and antibiotic. She previously never had any skin rashes. No follow-up attempts are possible. No further information is expected.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild
Neuropathy in legs, back, hands and feet. Guillain Barre diagnosis. Spent several weeks I. The hospital and I?m in patient therapy.
Initially slept then awoke with temperature to 102. Inconsolable crying often for 20 hours per mom. No Rx as only on subsequent PE was informed.
Numbness along the entire left side of my body:  face, arm, hand, chest, leg, foot Also felt slight tightness in my throat and slight short of breath.  My body still feels weak and slight numbing sensation along the left side of my body I took 25mg of benadryl immediately and also 600 mg of motrin.
1 of 2 adult pts who devel dollar-sized area of erythema, edema, warmth & pain @ inject site; tx w/DPH & warm compresses; resolved w/in 48 hrs;
Pharmacist reported on behalf of  patient after receiving second dose of Moderna 5/20/2021, 24 hours later on 5/21/2021, two red blotches on vaccinated arm near where shot was given. Patient reported tired, no fever but red blotches were warm to the touch, not raised but painful. Patient reported taking Tylenol for 1 day only. Patient reported less red from initially and  still visible,lighter in color and still warm to the touch.Pharmacist referred patient to her GP for evaluation.
Pt reported symptoms of pain,tenderness and swelling in left upper arm at injection site.  Pt rated pain at 8/10.  She complained of feeling ill-after resting felt better.  During follow up visit with doctor, her temperature was 97.1 F.  Doctor's impression was that she was having a severe local reaction.  Doctor wrote a prescription for Lortab for pain if needed.
Information has been received from a physician concerning a 79 year old male with unspecified chronic heart disorder and reportedly had well tolerated previous vaccinations who on 27 Oct 2006 was vaccinated intramuscularly in the right upper arm with Pneumococcal 23v polysaccharide vaccine (lot 654243/0049F and Batch ND58630) and was concomitantly vaccinated with secondary suspect therapy Influsplit (lot not reported), intramuscularly in the left arm. three to four days post vaccination the patient experienced enlarged lymph nodes in the right axilla and an enlarged spleen that was enlarged (14 centimeters) in length. At the time of the report it was not reported if the patient recovered. Follow up information has been received. Further investigations revealed that the patient has chronic lymphatic leukaemia. leukocyte count was 63100, among them 77% lymphocytes. The reporter considered that there was no causal link between the event and Pneumococcal 23v polysaccharide vaccine. Upon internal review, chronic lymphatic leukaemia was considered to be an other important medical event (OMIC). No additional information is available. The case was closed. Other business partner numbers included E200605692. Annual followup 01/4/2010 Pt diagnosed with chronic lymphatic leukemia. The reporter considered that there was no causal link between the eent and the pneumovax.
Patient complained of pain in right arm approximately 2 hours after she received the vaccination.  On the 2nd day, 11/18/2021 she had a hard time using her right are and it was noted to be swollen, and the area was warm, and hard to touch.  Care giver applied a cool wet compress to the area and she started feeling better.  Referred to her doctor or urgent care for an evaluation.  Care giver took her to  Health Care, but patient was unable to be seen because it was so crowded.  Son will take patient in the morning to be seen , 11/19/2021.  Called son on Monday, 11/20/21, patient doing okay did not want to go to urgent care.  Patient did well and area improved.  Seen by primary doctor on 12/9/2021 and was told she was doing well.  no further issues.  swelling had went away / cleared.
Patient is a 50 year old female in the observation area presenting with "funny feeling on her throat" post vaccination. Denies SOB, CP, swelling of tongue or lips. Physical exam unremarkable. Initial BP with HTN, but endorsed that she haven't taken her BP med today. Otherwise, pt is nervous and anxious because of the possible allergic reaction she might have. Given Cetirizine and felt better. Symptoms resolved. Referred to Allergy clinic given unverified if allergic reaction.  Sent home stable and in no distress.
p/ pt recv vax 9 days later pt devel fever & cough, then following day devel suspicious chickenpox like rash, approx 50 lesions, some w/fluid. meds given for itching by m.d.
Patient reported of itching in the left arm approximately 30 minutes after receiving COVID vaccine. No shortness of breath, hives or redness was noted. Vitals were taken with normal results; client waited for 15 minutes reporting itching subsiding. Vitals reported at 1219: pulse 91 bpm, temp 98.1 degrees Fahrenheit, blood pressure 162/84 (reported normal for client), and oxygen 100% on room air.
The day after vaccine, April 8, 2021, soreness under left armpit starting at 12:00 p.m.  At 8:00 p.m. felt like a mass of liquid, not hard.  Did not feel anything under right armpit.  April 9, 2021, at 1:00 p.m. is a red circle two inches wide at injection site and slightly swollen.   At 9:00 p.m. feels the same, a mass of liquid the size of a regular female hand.
Started with temperature of 100.4 degrees Fahrenheit at around 0200 on 02Aug21 accompanied by chills, excessive sweating, nausea, lightheadedness, and a headache. Extreme exhaustion set in as well around the same time with my temperature increasing to 101.2 after an hour (0300). The same symptoms continued until 1000 on 02Aug21 when my temperature reached 101.8 degrees. Around 1600 on 02Aug21, I was having a very hard time breathing while sitting down. I also felt very dizzy when not in motion, more chills and excessive sweating, a very intense headache, and a temperature of 102.7 degrees. I slept through the night and my fever had gone down to 100.2 degrees by 0700 on 03Aug21. I developed a dry cough that would often leave me out of breath (similar to bronchitis in asthmatic people). I also had a lingering headache until roughly 1400 on 03Aug21 and no longer had a fever. Lingering cough remains on 06Aug21 with no other symptoms. Throughout the few days of having symptoms, I only took over the counter ibuprofen to help with my headache and my Albuteral inhaler to help with breathing.
Around 8 hours after the shot I started to experience fatigue, body aches, uncontrollable body shakes, blueish lips and sweating (which to me indicated I had a fever). After taking some Advil my lips returned to normal and the body shakes stopped although it was hard to regulate my body temperature. I was sweating but felt cold. The worst of the symptoms seemed to last around 13 hours after they had started (so about 7pm on 3/25 to about 8am on 3/26). It's now been around 30 hours and I'm feeling better but still fatigued and have soreness in my left arm where I received the injection.
I had extreme feelings of weakness and lethargy after the second dose of the vaccine which dragged out for weeks. I did not feel shortness of breath, but I just felt very weak. I could not walk or exercise during that time. I had swelling in my lymph nodes. My Lymph nodes under my arm on the right were very swollen for quite a while. I fell down the stairs because my knees while I was so weak during that time. I felt that extreme fatigue for six weeks. It was two months before I felt normal, and I could walk and exercise.
expired dose of Menveo administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA517A, expiry date 30th April 2022) for prophylaxis.   On 16th June 2022, the patient received Menveo. On 16th June 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 01-JUL-2022. Reporter's Comments: The patient was vaccinated with Menveo which was already expired. The Vaccine Administration Facility was the same as Primary Reporter. It was reported that they were forgot to asked about follow up. Additional supportive information: The patient administered expired dose of Menveo, which led to expired vaccine used.
pt recvd vax; same day exp severe pain at inject site, arm stiffness & a low grade fever of 99; no tx; sxs resolved p/ 4 days;
It was reported by the patient's parents that DTAP(lot# U0537AB) was administered about one year ago to their 4-year-old daughter. Immediately after vaccination, the patient developed a large red and swollen area at the injection site. The patient was seen and treated in the emergency room. the events were fully resolved.
This patient was administered the pediatric dose instead of the adult dosage of Hepatitis B vaccine.
- chest pain  and teeth pain started 04/14/21. Normal physical assessment , vital signs within normal limit. Mom not sure if chest pain/teeth pain is real, child acting normal. Supportive care encouraged for pain. ER warnings given  -redness and swelling at vaccination site - advised mom this is common side effect. Encouraged ice pack to area as tolerated twice a day and ibuprofen. Return to clinic of no improvement in 2 days or fever >100.4F
This spontaneous report was received from a nurse and refers to a 14 year old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 14-NOV-2016, the patient was subcutaneously vaccinated with a dose of GARDASIL 9 injection (site of administrations, dose, lot number and expiration date were not reported). On the same day, after being vaccinated, the patient felt dizzy. Product quality complain was not involved. The outcome of feeling dizzy and the relatedness between this event and the vaccination with GARDASIL 9 were not reported. No further information was provided. Additional information has been requested.
Sore arm (after the first and second dose); Woke up in the middle of the night (after the 2nd dose); Body achess (after the 2nd dose); Nausea (after the 2nd dose); Chills (after the first and second dose); Fatigue(after the first and second dose); 101°F fever (after the 2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm (after the first and second dose)), SLEEP DISORDER (Woke up in the middle of the night (after the 2nd dose)), PAIN (Body achess (after the 2nd dose)), NAUSEA (Nausea (after the 2nd dose)) and CHILLS (Chills (after the first and second dose)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 013L20A) 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 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm (after the first and second dose)), SLEEP DISORDER (Woke up in the middle of the night (after the 2nd dose)), PAIN (Body achess (after the 2nd dose)), NAUSEA (Nausea (after the 2nd dose)), CHILLS (Chills (after the first and second dose)), FATIGUE (Fatigue(after the first and second dose)) and PYREXIA (101°F fever (after the 2nd dose)). At the time of the report, PAIN IN EXTREMITY (Sore arm (after the first and second dose)), SLEEP DISORDER (Woke up in the middle of the night (after the 2nd dose)), PAIN (Body achess (after the 2nd dose)), NAUSEA (Nausea (after the 2nd dose)), CHILLS (Chills (after the first and second dose)), FATIGUE (Fatigue(after the first and second dose)) and PYREXIA (101°F fever (after the 2nd dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
DIZZINESS AND BRAIN IS FOGGY , PT. IS SEEING A DOCTOR TODAY 4/19/21
Patient had trouble breathing, blurred vision within 15 minutes after injection. 911 paramedics came and believed she was having a panic attack. After breathing exercises she started feeling better but was taken to the hospital for further assesment.
Redness at injection side and maculopapular rash on neck and chest. Tongue swelling/thrusting, mother reported unusual affect/behavior.
mild tightness around sternum, pain/discomfort. NP addressed patient and cleared him with no future eval neccessary unless pt feels discomfort later. Pt stated he feels fine
Rec. 4th Anthrax IZ 1/01-approx./pneumonia and anemia. Now found to have low IgA, IgM with small monoclonal gammopathy, bone marrow slightly increased plasma cell.
The pt died of crib death at daycare on 9/18/01. One day post vax. The cause of death was diagnosed as SIDS. Autopsy report confirms cause of death to be SIDS. Death certificate lists cause of death as SIDS also.
Body gets hot then cold, with constant urination, and I am not a Diabetic, no energy.
The patient woke up early in the morning a day after the vaccination with severe itching and rash. She came to my office today as rash is persistent and itchy. She denies breathing difficulty. On examination, she has fine urticarial rash on face, trunk and arms but not on legs. She is advised to take Claritin 10 mg once a day for itching and to take Benadryl 50 mg every 4-6 hours as needed.
tennis ball size hives on injection site with pain, redness and warmth after 12 hours of vaccination. Low grade fever with chill and body ache, dizziness and fainting after 18 hours. Took Tylenol for fever and Motrin for pain, bedrest and lots of fluids for hydration. Fever goes away after 24 hours but still have pain/lump on injection site.
Blood pressure had been well managed for decades was very high for months after vaccine, new tremors and full body shaking, also waiting on biopsy but believed to have new small fiber neuropathy
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 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 had no relevant medical history. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Patient received other medication in 2 weeks. Patient had no known allergies. Vaccine lot unknown reason: Misplaced/ discarded. The patient received Paxlovid from 09Sep2022 till 13Sep2022 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Bleeding Gums Sore Throat Onset Friday two days after vaccination ongoing as of Sunday
Shot received on sept 29, 9:30 am.  On oct 1, 2:00 am noticed to have very stuffy ears bilaterally with no URI symptoms.  No current  or recent cold symptoms.  Ears constantly feel clogged, even after clearing.  Slight dizziness.   Also , left axillary pain, possibly from lymph nodes.
Received positive COVD-19 PCR test result on 3/15/21 after exposure to someone with COVID-19. Symptoms included fatigue, headache, tightness in chest, and eye discomfort sporadically for 4 days.
This is a spontaneous report from Pfizer-sponsored program via Regulatory Authority. A contactable consumer (patients wife) reported for a male patient (reporters husband) for a Pfizer sponsored program. A male patient received bnt162b2 (BNT162B2), administration date 28May2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), EAR PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "He back of his ears had a rash and it hurts". Additional information: Patient took 1st dose Pfizer Covid-19 Vaccine on 28May2021. Verbatim and Event Description including that Caller (withheld) (Patient wife) wants to know what is the recommended vaccine for her. She had varicose veins but they are not noticeable. She doesn't have a schedule yet but if it's recommendable she would like to get a schedule. While reading the ISI she mentioned that her husband (withheld) had a reaction when he got the first dose, the back of his ears had a rash and it hurts. He took the first dose 28May, until now he didn't take the second because it might get worse. Caller wants to know if her husband experienced a reaction from the vaccine. She wants to know if her husband will take the second dose or need to start all over again. Provided FAQ When do I receive my second dose. Provided PM number and HOO. Cold transferred. Created AE form. Whereas medical Information unaddressed medical questions referred or forwarded to Medical Information. Reporter a Healthcare Professional was unknown, Reporter's contact information available to you or a sub-contracted party was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient is a resident at a skilled nursing facility.  The facility filled out the paper work with consent from the patient & family that makes medical decisions.  We were under the impression this would be the first shot the patient would receive, but upon entering it into GRITS, found out it is the third shot.  She got two doses prior; on 1/11/21 & 2/2/21.  The patient has had no adverse effects from this third dose.
I received an incoming call from one of our specialty pharmacy patients. Upon speaking with the patient she has admitted that she fainted the following day after receiving the first dose of CV19 from Pfizer. She did not mention this prior. After fainting, she did appear ok per patient report. She received the second dose in the series with no report of fainting. Patient reported lying in bed the entire day after the second dose to prevent any syncope.
Information has been received from a nurse concerning a 9 year old female who approximately 11-MAR-2007 was vaccinated with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck), and forty eight hours later on 13-MAR-2007, the patient had a red location reaction on the injection site. Unspecified medical attention was sought. There was no treatment given to the patient, but she has already recovered. No further information was provided. Additional information has been requested.
pt reported had fever of 102 for 3 days, couldn't move arm for 3 days & arm looked like a balloon;arm recv vax in was sore & swollen;pt did not come in for f/u
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2023) Positive, notes: Rebound of COVID symptoms and test positive 48 hours. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received vaccine. Patient took no any Other medication in 2weeks. Lot no was unknown due to not available provided to reporter at the time of report completion vaccine. Paxlovid Product: COVID 19 Treatment start: date: 19Jan2023, Treatment: stop: date: 24Jan2023 Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.