chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with guillain Barre based on CSF and EMG findings.; signs/symptoms of acute ascending neuropathy in stocking glove distribution that began on 29Aug2021; This is a spontaneous report from a contactable physician. A non-pregnant 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jul2021 (Batch/Lot number was not reported) as dose number unknown, single at the age of 54 years old for COVID-19 immunisation.  Medical history included hypertension (HTN). No known allergies. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient experienced signs/symptoms of acute ascending neuropathy in stocking glove distribution that began on 29Aug2021. The patient was diagnosed with Guillain Barre based on CSF and EMG findings. The events resulted in emergency room/department or urgent care visit. The patient received IVIG as treatment for the events. No history of COVID prior to vaccination and has been tested for COVID post vaccination via nasal swab/rapid PCR on 02Sep2021 and via nasal swab/rapid dry swab on 06Sep2021 with negative results. The patient is recovering from the events. The events were assessed as serious (hospitalization).   Information on the lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to events Guillain Barre and signs/symptoms of acute ascending neuropathy in stocking glove cannot be excluded based on temporal association and available information. 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.
H1N1 Medimmune FLUMIST given to clients at public health. I read the directions on dispensing, had a hard time reading them, reviewed the photo instruction on the insert, then gave the doses. I missed the section about removing the clip to dispense the second half on the dose, so 13 clients were underdosed. I made some calls, talked w/Medimmune, received guidance.  I contacted 13 clients and am giving them the second half in the opposite nostril within the guidelines given to me by Medimmune.  I contracted 13 clients and am giving them the second half in the opposite nostril within the guidelines given to me by Medimmune.
This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient's concurrent condition included allergy to neomycin. No information regarding the patient's pertinent medical history and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) to prevent shingles. On an unknown date, approximately one week after vaccination, the patient experienced dizziness and "feeling of being off balance". The reporter stated that the patient saw a physician who prescribed an unknown medication to treat dizziness. The outcome of the events was reported as not recovered. The causality assessment was not provided. Additional information has been requested.
Shingles.  Rash.  Nerve pain. Headache.  About 6 weeks after vaccination.   No other causes present.   I have a great immune system.
Fever, head ache, body ache, fatigue between hours 24 and 48, some phlegm in throat started at at 48 hour mark
11:15PM-Heart rate 79,sats 60%-stimulate 1:30AM- Heart rate 64-sats 50%-stimulate 6:30AM- Heart rate 72-sats 54%-stimulate and increase fio2 to 28% 1/4lpm via nc 7:15AM-Heart rate-61-sats 60%-stimulate
Case number PHEH2015US017214 is a spontaneous report initially received from a nurse on 02 Sep 2015. This report refers to a 41 year old female patient. Past medical history was not reported. Her vaccination history include administration of seasonal influenza vaccine (manufacturer and batch number: not reported) for the past 4 years. Her concomitant medications were not reported. She was vaccinated with 0.5 ml FLUVIRIN (batch number: 157103, expiry date: May 2016) pre-filled syringe intramuscularly in the left deltoid on 01 Sep 2015 at 9:40 am. It was reported that the before administration to the patient, the vaccine was out of temperature range at 0.4 degree Celsius for 6 hours, but it was not frozen. The reporter stated that the physician in their office gave his clearance to administer the affected FLUVIRIN vaccines which were not frozen, but was only exposed to low temperature. The reported stated that patient tolerated the injection well and did not have an adverse reaction after maladministration. The caregivers for patient also did not report adverse reaction either. No further information was provided. Follow up information received from the nurse on 02 Oct 2015: Reporter's comments updated. Follow up information received from the nurse on 02 Oct 2015: Updated vaccination history, dose, site, expiry date and time of administration of suspect vaccine and reporter's comment.
Got really cold than nauseous. Over the next hour I started feeling dizzy and my heart was pounding. It continued to get worse. My heart rate was at 126. I felt like I was going to pass out. My head felt really fuzzy. I went home from work and laid down over the next 7 hours they subsided, except for a headache and stomachache.
Developed severe vesicles on her face 1 week after varicella vaccine, covering on area of approximately 3 vesicles from her mouth up to paranasal area and (L) cheek. Reoccurred once. Has a previous history of occasional dev. 1-2 vesicles
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 72-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 at 13:00 as dose 4 (booster), single (Lot number: fj4991) at the age of 71 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: "Asthma" (unspecified if ongoing); "known allergies: dairy" (unspecified if ongoing). The patient's concomitant medications were not reported. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) negative; (Oct2022) Positive, notes: Next day,  turned positive in 20 seconds; (Oct2022) Positive, notes: positive until day 14,. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Patient developed severe headache about 10 minutes post vaccination.  Patient took Ibuprofen 800mg.  Headache resolved approximately 1 hour later
1st dose Dec2020, asking about getting the 2nd; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report.  The patient did not receive the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter inquired the order in which she should take the 2nd Shingrix dose, Flu vaccine and COVID-19 BOOSTER and the side effects associated with the Shingrix vaccine.  The consent to follow up was declined. Unwilling to give any further demographic information and unable to collect HCP contact information
Patient had apneic event, was intubated, and transferred to hospital. Per note from RT on 2/18 at 1913. - "1230 this afternoon transport team arrived to transport patient to hospital for PDA ligation. Patient was stable at this time on 5cm 21% bubble CPAP. When transport team removed Patient from CPAP and placed on transport CPAP with Ram canula Sats dropped and baby did not tolerate change. NIPPV mode was also attempted on transport ventilator with no success. Baby was bagged with Neo tee by transport team with no improvement of sats in the teens. MRSOPA was utilized and then switched to self inflating Ambu bag with peep valve with PIP35 and Peep 7 and SpO2 maintaining in 20-30s. Two attempts were then made by NNP with successful intubation on 2nd try with 3.0 ETT at 7.5 cm at gums, Lg leak observed. Lg amt of Blood visualized in airway before any attempts were made at intubation. CXR obtained and showed complete white out. Baby was then placed on APV CMV mode on transport ventilator with no improvement in sats and little to no volumes. PC CMV was then tried and no Vt observed with Sats in the teens. Baby then placed on Flow Interupter by transport team. CBG obtained with PH 6.7 PCO2 >130. 1 unit of PRBC and 1 unit FFP started due to suspected pulmonary hemorrhage. On Flow Interupter pressures gradually increased with final settings MAWP 22, 10 HZ. Life flight was called and asked to switch plans from ground transport to flight. SpO2 finally reached high 80s and 90s briefly. Life flight arrived and while preparing for transition to transport isolette a repeat CXR was obtained and still showing complete whiteout. ABG obtained Ph 7.44 PCO2 34. SpO2s began to decline again and decision made to keep baby here on Oscillator and try to stabilize. SpO2s in low 30s again. Baby placed on 3100 A oscillator and MAWP gradually increased from 16-22 over period of time with Delta P eventually topping out at 44 with 10 HZ. Sats still in 20s and 30s and very poor chest wiggle. Nitric ordered by Dr. and 2nd RT began preparing Nitric to be placed on baby. Dr. decided to reintubate with larger tube due to large leak, poor chest wiggle and poor saturations. Dr. had sucessful intubation at 1620 with one attempt. 3.5 ETT taped at 8cm at gums. Very small leak heard. Repeat CXR shows good placement. Placed back on 3100 A with MAWP 22 Delta P 40 and 8 HZ with 100% FiO2 and sats began to climb to 60s and 70s. Nitric Oxide started at 1635 at 20 ppm and sats steadily improving to 80s and low 90s."
Patient presented to ED on 6/13/21 with left sided chest pain for 3 days with radiation to left arm and left neck, improved with nitroglycerin sublingual. EKG unremarkable, troponin 0.23. D-dimer 0.66, CT angiogram chest negative for PE. Patient admitted and cardiac workup done, CT coronary score 0, new onset atrial fibrillation started on Multaq and Eliquis, Pt converted to NSR, chest pain improved. Final diagnosis = chest pain due to myopericarditis, elevated troponin due to acute myopericarditis unlikely NSTEMI, new onset paroxysmal atrial fibrillation.
Patient received moderna bivalent booster around 02:30 PM on 02-01-23. Patient felt fine and had no signs of allergic reaction while in 10-15 minute observation period at the pharmacy. Patient then left and went over to the next shopping center to have lunch. While in the restaurant Just before receiving meal (around 03:15 PM), patient felt dizzy and lightheaded. He then proceeded to pass out. An ambulance was called and the patient was taken away to a hospital. He stayed at the hospital for a day and a half. All kinds of tests and scans were performed (according to wife), and everything came back negative. The only abnormalities noted were high blood sugar and low blood pressure.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 at 13:00 as dose 1, single (Lot number: EN6204), in left arm, on 31Mar2021 as dose 2, single (Lot number: ER8737), in left arm, on 07Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 05Aug2022 as dose 4 (booster), single (Lot number: FP7139) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: May2017; MALARONE, start date: 30Sep2022, stop date: 13Oct2022. The following information was reported: VACCINATION FAILURE (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, notes: COVID 19 Treatment; (19Oct2022) Positive, notes: tested positive on the 6th day after completing the full course of Paxlovid with a faint T line; (24Oct2022) Positive, notes: I am now on day 5 of positive testing; (18Oct2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient took Paxlovid for the full 5 day course. I then tested negative for COVID using an at home antigen test. Patient tested positive on the 6th day after completing the full course of Paxlovid with a faint T line. Patient now on day 5 of positive testing with no fever but having nasal congestion and an occasional dry cough and some fatigue.
urticaria over a 48hr period encompassing 70% of body;also had fever arthralgias of neck & feet;12MAy96 devel angioedema of lips;tx w/oral pred & as of 15MAy96 sx resolved;
elevated temp x 2 days treated w/Pediaprofen & APAP; temp was 105 @ 7PM 20MAY93;
Information has been received from a physician concerning a female who was vaccinated IM with a dose of Gardasil. Subsequently the patient experienced dizziness and nausea for approximately 15 minutes after the vaccination. (The patient did not have anything to eat or drink prior to the office visit). Medical attention was sought. The patient recovered from dizziness and nausea. No product quality omplaint was involved.
Patient  on left jaw felt dull discomfort from ear to center of jaw   Lower lumber/ Spine felt numbness for 20 minutes.  Area still remain tight
No additional AE reported; HBP responsible for vaccines reported a dose of PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 24-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #W017570, expiration date: 29-NOV-2023, administered for prophylaxis (dose, strength, site, and route of administration were not provided) after a temperature excursion (product use issue). The temperature: 5.7F, time frame: 0 Hours 30 Minutes and 0 Seconds. The previous temperature excursion: 6 degrees Fahrenheit (F) up to 14 degrees F (9.1F) for 1 Hour 6 Minutes and 0 Seconds. No additional adverse events details or product quality complaints were reported (no adverse event).
Pt had allergic reaction like bad rash on back of the hand, foot, leg, stomach, head.
ST elevation on ECG Elevated troponin level chest pain Normal LV systolic function, absence of global or regional systolic myocardial dysfunction
it has made a couple of people really sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (it has made a couple of people really sick) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (it has made a couple of people really sick). At the time of the report, ILLNESS (it has made a couple of people really sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-276849 (Patient Link).
Swelling, redness, knotted, warm to touch, painful in area where shot was given.  Pain in underarm, swollen lymph node. Pain in shoulder to side of neck. Lymph node in side of neck tender.
very cold feet; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL COLDNESS (very cold feet) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL COLDNESS (very cold feet). At the time of the report, PERIPHERAL COLDNESS (very cold feet) outcome was unknown.            Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Vaccine 1100 on 01-10-2012; began to flare with swelling & inflammation at 1600. 9 cm x 7.5 cm (RT) thigh anterior temp 98.4 degrees temporal. Local reaction.
Injection site turned red later, the same day after injection. Next morning, injection site was swollen and sore under arm. Pt couldn't lift arm without feeling pain. On appt 10/10/08, pt was still swollen a little, but could lift arm.
Fever 100.1 48 hours so far Sore arm Diarrhea  Nausea  Headache
Intense colorful dream at night towards morning, very restless night otherwise, A short time after getting out of bed I got nauseated and became more and more dizzy, I had a blackout and woke up on the floor.  I don?t know how I got there nor how long I was laying there. My guess is 1/2 minute to 5 minutes, My injection site is hurting since the night and I have a Golfball seize swelling in that armpit, All together also have I light headache day of and day after
29JUL 3AM awoke w/pain, redness & heat @ inject site of lt arm; w/in 12 hrs, redness swelling & heat extended down the arm; ?questionable area of abscess developing;
Immediately following administration of PENTACEL in (L) leg annular red patch and localized edema noted. Heat pack administered, reduction seen after 10 minutes.
This spontaneous report was received from a physician refers to a 81 years old female patient with allergy to penicillin and sulfa who on 11-OCT-2012, was vaccinated subcutaneously on her left arm with a 0.65 ml dose of ZOSTAVAX (lot number H01436). No other co-suspects were reported. Concomitant medications included several medications but physician would not specify which ones. The physician reported that on 12-OCT-2012, the patient developed itching on the right side of her chest which then developed into red bumps and a rash. No treatment information was reported. At the time of the report, the patient had not recovered. The physician thought the expiration date of the vaccine was November 6th but she did not know the year because she could not get her computer to bring up the information. The relatedness for patient developed itching on the right side of her chest, red bumps and a rash was unknown for ZOSTAVAX. Additional information has been requested.
pt recvd vax; fever, muscle aches, lymphadenopathy, v, redness, swelling, pain, itching, warmth at site p/ dose 1 & 2;
Developed clustered pox lesions at injection site L anterior thigh-symptom therapy only recommended (PO Benadryl, topical Calamine, tepid soaks) with appropriate isolation measures.
Gave a second Moderna booster to this individual who is age 45 years old, does not list being immunocompromised. First Moderna Booster dose was given on 11.29.2021. No immediate adverse effects. Observed 15 minutes after injection.
arm got red; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (patient reported for herself). An 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 13Mar2021, the patient experienced arm got red. Caller reported getting the 1st dose of PFIZER-BIONTECH COVID-19 VACCINE on 06Mar2021, and reported had no side effects everything was fine, on 13Mar2021 (a week later) all of the sudden her arm got red, and it was still red, 5 days and it was still red. Patient was due for the next vaccine on 27Mar2021, was this normal. Was there here something can do to make a redness go away then. Caller stated when she got the injection on the 06Mar2021, it was red when she gave it to her, next day it was all  gone she had no side effects, she had no pain, no headaches, nothing, so she thought she was fine then the following week, exactly a week to a day that she got a vaccination, her arm got red and it has been 5 days and her arm was still red, it was less but it was still red. Should she take a second shot. Second dose refer to healthcare professional. No product quality complaint was reported. The outcome of the event was reported as not resolved.  No Follow-up attempts are Possible: information about lot/batch number cannot be obtained.
Systemic: numbing on the tip of the tongue than spread to both sides-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: pt reported tingling at the tip of the tongue and then spread to both sides. Monitored the pt for an hour and one side of the tingling on the tongue has subsides. Advise pt to seek medical care if experience throat swelling, rash, diffult breathing.
I started with a cough and a stuffy nose on 11/19/2022, in the evening I has a low-grade fever. I took two home COVID-19 test and they came back negative. I was still felling back so I called my doctor's office and made an appointment and was able to get in on 11/22/22. I did not have a fever when I went in for the appointment, I had a rapid COVID-19 in the doctor's office that came back positive. I was prescribed Paxlovid and cough medication. I decided not to take the Paxlovid. The cough is still lingering but I do feel better. I do consider my case very mild.
Information has been received from a physician, via a company representative, concerning a 23 year old female patient, who on approximately 20-Oct-2007 ("a month ago") was vaccinated IM with the first dose, 0.5 ml, of Gardasil (lot # not provided).  After an unknown duration of time, the patient experienced stomach pain and vomiting.  Subsequently, the patient recovered from stomach pain and vomiting (duration not specified).  The patient sought unspecified medical attention.  The patient's 17 year old sister also experienced the events as described above, when vaccinated with Gardasil (WAES #0711USA04358).  Further information is not available.
01/21/21 achy joints, chills, 01/22/21 fever 101.5, achy joints, fatigue, pain and tingling in both feet and toes 01/23/21 fatigue, pain and tingling in both feet and toes,, both lower leg achy 01/24/21 and 01/25/21 pain and tingling in both feet and toes