chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Apr2021 01:00 (Batch/Lot Number: EW0164) (at the age of 48 years old) at 1st dose, single for COVID-19 immunization. Medical history included low iron, Bell's palsy in Jan2020 and patient had no known allergies. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications within 2 weeks of vaccination. On 25Apr2021 08:00 (after receiving the vaccine 2 days later), the patient had Bells Palsy symptoms started along with a head ache. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. The outcome of the events was not recovered.
Immediately hurt and felt like it hit bone. The injection site bled a lot. Severe pain the rest of evening. Swollen (bigger than golf ball), bruised and hot to touch within hours. Today is the same. I took her back to pharmicist that gave her the shot. She suggested I contact this department. I have called her family doctor and put him on notice.
Swollen/ puffy; Itchy; Red/ still pinkish; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen/ puffy), PRURITUS (Itchy) and ERYTHEMA (Red/ still pinkish) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen/ puffy), PRURITUS (Itchy) and ERYTHEMA (Red/ still pinkish). At the time of the report, PERIPHERAL SWELLING (Swollen/ puffy) outcome was unknown and PRURITUS (Itchy) and ERYTHEMA (Red/ still pinkish) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Joint Pain-Medium
p/vax pt T99, aching, non productive cough;by 48hr only dry cough persisting & has persisted;
Patient received the vaccine on 9/11/18 and was initially fine. As I was giving her mother the flu shot a few minutes later, the patient got dizzy and hit her head on the ground but was not unconscious. EMTs were called and checked all her vitals and stated she was fine. Her blood sugar may have gotten low. Patient went home with her mother.
Vertigo, unable to lay/stand/roll over without nausea and spinning. Lasted intermittently for 2 weeks. It was a solid 3 days after the vaccine and then faded off. But I have since had motion sickness when I never had before.
A non-serious spontaneous report of 62-year-old female received a dose of H1N1 LAIV was received from a registered nurse concerning a patient, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received the vaccine on 08-Dec-2009 for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
blister on top/she got sores that look like a bite with a blister on top/blisters like a bite over arms, stomach and feet; then it leaves a sore/she got sores that look like a bite with a blister on top; little bumps itch so bad/it itches like hell/itches to high heaven; it is just clear fluid that comes out/break the blister, a clear liquid comes out; This is a spontaneous from a contactable consumer(patient herself). An 87-year-od female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA, formulation: solution for injection, lot number: not reporter, expiry date: not reported) Vaccine via an unknown route of administration on 25Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced blister on top/she got sores that look like a bite with a blister on top/blisters like a bite over arms, stomach and feet, then it leaves a sore/she got sores that look like a bite with a blister on top, little bumps itch so bad/it itches like hell/itches to high heaven, it is just clear fluid that comes out/break the blister, a clear liquid comes out. Caller was wondering if was a known side effect and if there are recommendations for her about her second dose because she was supposed to have the second dose on 15Feb2021. Caller did not provide a reference number for her report from yesterday. The patient did not undergo any lab investigations. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Throwing up, headache, nausea, chills, and persistent cough I can't shake since the shot.
an improperly stored dose of VARIVAX was administered; No adverse effect; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection (lot number: R009411, expiration date: 29-MAR-2020; dose and route of administration were not reported). The diluent used to reconstitute the vaccine was properly stored. The vaccine was stored in temperatures between 15 and 46 degrees Fahrenheit (-9 and 8 degrees Celsius, -3 degree Celsius) for 2 hours. There was no previous temperature excursion. Digital data lodger was involved. No adverse effect was reported.
major flu-like symptoms; Congestions in my lungs; A slight fever; Dry cough; I had extreme fatigue; Arm tenderness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (major flu-like symptoms) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced TENDERNESS (Arm tenderness) and FATIGUE (I had extreme fatigue). On 08-Aug-2021, the patient experienced COUGH (Dry cough). On 10-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (major flu-like symptoms) (seriousness criterion medically significant), PULMONARY CONGESTION (Congestions in my lungs) and PYREXIA (A slight fever). At the time of the report, INFLUENZA LIKE ILLNESS (major flu-like symptoms), PULMONARY CONGESTION (Congestions in my lungs), TENDERNESS (Arm tenderness), COUGH (Dry cough), FATIGUE (I had extreme fatigue) and PYREXIA (A slight fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: positive (Positive) diagnosed Covid-19 positive..         Treatment medication was not reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-288218 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Itchy red Rash on neck started c. 18 days after 2nd shot (unclear if related to vaccine but highly unusual for me)
AREA INJECTED BECAME PAINFUL, HARD, RED AND HOT TO THE TOUCH.
Pt. reported feeling aches in her back, skin sensitivity, tiredness and chills starting the evening of 01-02-21 going into 01-03-21.  She took ibuprofen on Sat. and Sunday with some improvement in symptoms starting on Monday.  Today 01-05-21 she noted an approximately 4 inch in diameter oval shaped rash slightly to anterior and below to her vaccine site in the Left arm.  She is also having itchy eyes, reported as an allergy symptom
Extreme photosensitivity, swelling in ankles that would not go away for 2 weeks
Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022/Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022/Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022/Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022/Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Date the vial was initially stored in the refrigerator was reported as unknown. Number of doses/vials was reported as 173 doses.  The vial did not undergo any temperature excursions  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Followup received, additional reporter was added.
pt recv vax 15APR97 & 21MAY97 pt exp rash w/10-12 lesions, gen;
Patient experienced dilated pupils (change in vision), sweating and headache. This resolved within 1-2 minutes. No treatment given other than a drink of water once symptoms resolved.
Shortness of breath, she was gasping for air, her oxygen level was really low; Affect her lungs, her heart and esophagus; Tightness on the chest; Fatigue; Chills; Headache; Stomach pain; A spontaneous report received from a Consumer concerning, a female patient of unspecified age who received first dose of the Moderna (mRNA-1273) and experienced tightness in chest, affected lungs, heart and esophagus, shortness of breath, fatigue, chills, headache and stomach pain.  The patient's medical history included cancer survivor, heart attack, numerous surgeries, asthma and CPAP machine. Patient's concomitant included albuterol, aspirin, buspirone, covitol, B12 injections once a month, cyclobenzaprine, levoxacin, Vit D, ezetimibe, fexofenadine, Advil, levothyroxine, Nasonex, Montelukast, niacin, Xolair injection once a month, oxybutynin, prosol, potassium chloride, primidone, raloxifene, Ramipril, tiotropium bromide, tramadol, zinc and pepsin.  On 30 Dec 2020 date, the patient received their first dose of the two planned doses of mRNA-1273 in right arm (Batch #: 011J204) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   Patient stated she received her first dose of the Moderna COVID19 on 30 Dec 2020 and she experienced tightness on the chest immediately. The next day 31 Dec 2020 she felt worse, so she went to the ER and she was told that it was a reaction to the vaccine. Then, 01 Jan 2021 she went to urgent care because she was feeling worse and they gave her prednisone. Patient stated she then went to the pulmonologist and a few days later, she was admitted to the hospital. She said it affected her lungs, her heart and esophagus. She stated that the symptoms are still ongoing, she was still having issues.   Treatment received was prednisone and breathing treatment was oxygen steroids.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events tightness in chest, affected lungs, heart and esophagus, shortness of breath, fatigue, chills, headache and stomach pain was not recovered.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Pt reported muffled hearing, nausea, dizziness BP 117/59; HR 86; RR 20. Pt reported resolved sx after rehydration. Pt advised to get rest & increase fluid intake, advised to f/u w/PCP if other delayed s/sx. Pt stable & d/c'd from vaccination site
pt states had phlebitis in lt leg 2 days p/vax;pt hospitalized 9DEC96 thru 11DEC96 & 15DEC95 thru 22DEC95;had colitis & placed on TPN;tx by MD;
Pain, redness, warmth and swelling left upper arm. (Deltoid) 7x7 inch tender with some flinching and twiches noted. Cellulitis cephalexan 500mg BID x 7 days, Benadryl, Hydrocortisone oint.
This case was reported by a healthcare professional (nurse) and described the occurrence of arm pain at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In 2013 the subject received a dose of FLUARIX (unknown details). In 2013, within weeks of vaccination with FLUARIX, the subject experienced arm pain at injection site, inflammation of arm at injection site, and injection site pain radiated to rotation cuff of shoulder. This case was associated with a product complaint as the doctor's office wanted feedback on this specific lot number" regarding other "reports of people experiencing adverse events from this lot number." The subject had received flu shots in the past with no reactions. Per the nurse, the subject "had flu shots for years and never had trouble before." Per the nurse, "after 2 weeks" after receiving FLUARIX, the subject reported that they are "still experiencing inflammation and pain in the arm it was given. The pain radiates up in their shoulder." At the time of reporting the events were unresolved. Per the nurse, "after 2 weeks" the subject reported that they are "still experiencing" the events. The nurse reported 2 other cases with FLUARIX. See A1050672A and A1050681A for details on the other cases. According to product complaint investigation results reported by GSK quality assurance on 13 December 2013, the product complaint was assessed to be unsubstantiated.
1500- 1st dose Pfizer administered (lot #FH8020). Client is employee of host site 1507- patient complained of nausea and went into bathroom adjoining the clinic. NP followed client into bathroom. Diaphoretic. Attempts to vomit. Spits in toilet and takes sips of water. Chair brought into bathroom and clients sits.  1508- Ice packs applied, radial pulse 90s, BP 149/99, RR 22 Client denies allergies, hx of HTN, or medication use today. Says she has DM2. does not take insulin, but does take metformin. refuses graham crackers.  1510- Client says there is no improvement in nausea and now feels lightheaded. BP 170/98. RR 20, pulse 98, spO2 98% 1515- Client says she feels better and moves back to the room of the clinic. Drinking water and eating graham crackers.  Does not want to lay down on yoga mat at this time. NP and RN in close proximity.  1525- Client says she is feeling increasingly lightheaded. Assisted to yoga mat x2. feet raised on chair. HR 105, systolic pressure 128, RR 26, shaky, A&0x 4. Breath sounds clear.  1527- Client says she feels SOB laying down. EMS called. now sitting up on mat. Breath sounds clear. No stridor in upper airway. skin appropriate color. no urticaria/ angioedema. Radial pulse 2+ , sp02 98%  1540- fire dept arrive, take vitals BP 120/70. HR 90s, spO2 98%. They ask client if she wants to go to the hospital and she says yes.  1545- EMS arrives. Patient unsure if she wants to go to one Hospital or the other as she is leaving site via stretcher
I understand the solution has to be refrigerated. The pharmacist gave me the shot without bringing it to room temperature. Shot hurt as the solution was going into the right arm.  Within hours Pain intensified to number "10".   A little bruise showed right next to the injection site.Tylenol did not help. The next day the pain  and bruise was still in the area of shot but pain level was down to about six. If the shot was given at room temperature all that pain and discomfort would have been unnecessary !!!
On Tuesday (1/12/21) night face and neck started itching and burning.  Face was starting to swell and neck was red and had small bumps on it. Took some Benadryl and went to bed woke up this morning and eyes were swollen and face was a little worse.    No record that patient sought medical attention or visited the ED.  Patient reported swelling and itching went resolved the weekend of 1/16/21.
10 minutes after my Moderna booster of 0.25ml, I began an all over body rash that began at my face and scalp and spread downward to every area - terminating at the heels of my feet.  My face and chest became flushed.  I had mild itching to my lips but no swelling and no respiratory symptoms.  No rash.   I was given 25mg of Benadryl with no relief, and another in 30min with no relief.  I went home and took another 25mg for a total of 75 mg of Benadryl with full resolution - 2 hours after the injection was given.  Of note:  I had the same reaction 18 hours after my second dose - completely resolved in 45 min with 100mg of benadryl.
Swollen and tender right lower cervical lymphadenopathy and swollen lymph under (R) armpit, (R) upper deltoid is erythematous with increased warmth and tender to palpation, (R) arm and shoulder pain, arthralgia.
Pt received his first dose of the Pfizer COVID-19 vaccine on 2/2/20201. Pt presented to a local ED on 2/10/2021 with symptoms of dyspnea and respiratory distress and was transferred/admitted to our hospital. He tested positive per PCR testing for SARS-CoV-2 on 2/10/2021.  He is still currently admitted to our hospital receiving care.  It was noted in his H&P that he had a COVID exposure approximately 2 weeks prior to presenting to the ED (unknown if he was alerted to this before getting his vaccine).  He is currently recieveing remdesivir and dexamethazone to treat his COVID.
Erythema, edema, tenderness left thigh site. The follow up states the onset time is uncertain, approx 12-24 hrs after initial injection.
Patient states that 30 minutes after receiving covid 19 Pfizer vaccine, his eyes started watering and swelling to almost shutting on him. No trouble breathing and he did not have to use EpiPen.  On  4/5/21 he was feeling normal.
ADVERSE REACTION; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from adverse reaction. This report was non-serious.
patient reported that she had terrible "contraction", cramping, "menstrual" pain like contractions so bad she had to lay in bed for two days straight. She also reported severe lower back pain and aches. She said the contraction like pain in her uterus was 10 times greater than when she used to get periods when she was in her twenties. Patient suffered from this pain for about 5-6 days and had to miss work due to it.
Pt had varicella vaccine on 8/12/96 and developed clinical varicella on 9/11/01. This is not an adverse event but a vaccine failure.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 28-MAR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA003078:
Pt reported 3 small "shingles-like" "pustules" on the back of her neck occurring approx 5 days after receiving vaccine.
Scattered rash that consists of erythematous based papules and pustules that are located on his arms and trunk.  No fever, chills, nausea, or vomiting.
Fully vaccinated, not boosted, COVID infection breakthrough with unrelated inpatient patient stay.
Left arm - day after IMZ fever and chills for 1-2 days. Nickel sized welt appeared on the left arm in the area of the IMZ a week later. The welt went aware with no treatment. A week later after welt went away  (4/26/21) pain started. Pain from shoulder to elbow. Loss of movement (difficult to reach back). Pain at stand still. Patient has started using TEDs device in the 2nd week of June. Patient came back 5/10/21 and only suffered from normal IMZ reaction for a short term 1-2 days.
Crying that lasted over 12 hours; refusal to walk for 24 hours; erythematous rash for 12-24 hours; fever to 104 for 24 hours.
The pt experienced a rash on the face, back, abdomen, a runny nose, saw the doctor on 5/25/01.
exhaustion; stomach upset; This is a spontaneous report from a contactable consumer. A 80-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. He received his second dose also on Saturday and experienced exhaustion afterwards. He told me that he had a similar reaction and stomach upset on 11Apr2021 for about a day after the first dose. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021406911 same patient/reporter/drug in separate time