chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness and swelling at site of shot 9cm x 7cm painful and itching
PT HAS ACQUIRED LARGE LOCALIZED REACTION MEASURING 3 BY 3 INCHES AT SITE OF ADMINISTRATION. PT HAS STATED THAT THE AREA FEELS VERY ITCHY, THE AREA IS TENDER. PT HAS TAKING ANTIHISTIMINE'S TO CONTROL SWELLING AT ITCHING.
medium grade flu; becoming very emotional; temperature of 103 degrees Fahrenheit; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (medium grade flu), EMOTIONAL DISORDER (becoming very emotional), PYREXIA (temperature of 103 degrees Fahrenheit), MYALGIA (body aches) and CHILLS (chills) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery. Concurrent medical conditions included HIV disease, Kidney disorder and Heart disorder. Concomitant products included LOSARTAN, CARVEDILOL, ATORVASTATIN CALCIUM (LIPITOR), VITAMIN B NOS and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced EMOTIONAL DISORDER (becoming very emotional), PYREXIA (temperature of 103 degrees Fahrenheit), MYALGIA (body aches) and CHILLS (chills). On an unknown date, the patient experienced INFLUENZA (medium grade flu). The patient was treated with PARACETAMOL (TYLENOL) for Flu, at an unspecified dose and frequency. On 14-Apr-2021, EMOTIONAL DISORDER (becoming very emotional), PYREXIA (temperature of 103 degrees Fahrenheit), MYALGIA (body aches) and CHILLS (chills) had resolved. At the time of the report, INFLUENZA (medium grade flu) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: 103 (High) Patient has temperature of 103 degrees Fahrenheit.         Patient was immuno-compromised  and received  for  booster dose as per advise from cardiologist. Patient took anti viral medication  for unknown indication. Patient reported that medium grade flu which goes away with Tylenol but came back when it wears off about 6 hours.   This case was linked to MOD-2021-308902 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Treatment medication added and event was added
Systemic: Dizziness  Lightheadness-Medium, Additional Details: Patient received vaccine. After a minute or 2 , patient got dizzy and fell foward, cut his forehead on his sunglasses that were on his forehead when he fell. Called 911, police came and so did EMT. pateint talked to police and EMT. Patient walked out of store without assistance. Patient refused EMT ride to emergency room. His girlfriend and mother were taking him to urgent care with his car.
pt recvd MMR/HIB vax on 25APR91 & immed following vax pt exp local reaction w/erythema & swelling @ both inject sites; sx lasted approx 1 hr; pt given DPH;
Palpitations; very short of breath; chest pain; sore arm; knot on the arm; redness and itching to the arm; redness and itching to the arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: E0181), via an unspecified route of administration in arm right on an unspecified date as dose 1, single for COVID-19 immunisation. The medical history of the patient included asthma, heart disease, HTN and covid-19. The patient had no known allergies. The concomitant medications of the patient were not reported. The other medications in two weeks were reported as yes. No other vaccine in four weeks. The patient was not pregnant at the time of vaccination. The covid prior vaccination was reported as yes. The patient had not been covid tested post vaccination. On 16Jul2021 at 05:45, the patient experienced palpitations, very short of breath, chest pain, sore arm, knot on the arm, redness and itching to the arm. Therapeutic measures were taken as a result of events that included breathing treatments. The outcome of all the events was reported as resolving.
Vaccine administered 10/11/10. 10/14/10 - Complain of flu symptoms that lasted until 10/17/10.
Narrative: 91 yo pt with recent hospitalization from non-agency hospital died on 9/27/21. Pt was discharged on 9/2/21 from community with the following diagnosis: acute CHF, streptococcal sepsis w/ pneumonia, hyponatremia, dementia, urinary retention, Pt had received covid vaccines on 1/14/21 & 2/12/21. Likely his death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
Patient reported difficulty swallowing and stated he felt throat closing within 10 minutes of receiving vaccine.
My skin on my hands started to peel and my pain was really severe. I had body aches and it was painful. I took Tylenol, and my hospital gave me Ibuprofen 600mg. This lasted about two weeks, the pain in my body. The headaches never went away. I have to take pain medication for it.
Patient got pail and lightheaded. May have fainted briefly. Was coherent and talking. Paramedics called. They came and did checkup. Patient vitals were normal
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Additional Details: patient stated she was feeling a little strange after injection, stated her head was hurting and felt like it had pressure in it
Patient received pediatric dose (orange cap of covid-19 Pfizer vaccine instead of the adult (purple cap) dose. The pediatric vaccine was also not diluted prior to administration. In additional 0.25mL was given instead of 0.3mL. The patient had no adverse reaction or symptoms due to the dosing error.
Left arm mild edema, erythema, local reaction probably to DTP vaccine. Sxtx: close observation.
Described by dermatologist as classic, extensive hives. He discussed with CDC MD who advised that this reaction has been documented and that biopsy is not indicated at this time.
Pt recv vax on 9/28/98; on 9/29/98 pt exp fever (103), neck stiffness x 2hr, swelling of parotid gland; dx=mumps
Headache, fever, shivering, muscle aches - lasted for the whole day. Took some TYLENOL.
caller states they know both male patients that have joint and muscle pain that got the vaccine; caller states they know both male patients that have joint and muscle pain that got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (caller states they know both male patients that have joint and muscle pain that got the vaccine) and ARTHRALGIA (caller states they know both male patients that have joint and muscle pain that got the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (caller states they know both male patients that have joint and muscle pain that got the vaccine) and ARTHRALGIA (caller states they know both male patients that have joint and muscle pain that got the vaccine). At the time of the report, MYALGIA (caller states they know both male patients that have joint and muscle pain that got the vaccine) and ARTHRALGIA (caller states they know both male patients that have joint and muscle pain that got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2021-269810 (Patient Link).
Immediately after receiving flu shot, patient complained of thickness in the throat on swallowing and tingling on roof of mouth. Patient given 25 mg benadryl with good effect. Sat for observation for 1/2 hour until feeling better.
myocarditis; Fever; swelling at injection with redness to elbow for a week; swelling at injection with redness to elbow for a week; extreme joint pain; severe headache; This is a spontaneous report from a contactable other health professional (patient). A 51-year-old non-pregnant female patient received bnt162b2 (BNT162B2), second single dose intramuscularly, administered in arm left on 06Jan2021 (Batch/Lot Number: EK9231) for covid-19 immunisation at age of 50-year-old. The patient's medical history and concomitant medications were not reported. No other vaccine received in four weeks. The patient received the first dose of bnt162b2 on 02Dec2020 at age of 50-year-old for covid-19 immunisation (lot number: EL0140) intramuscularly at arm left and experienced fever, swelling at injection with redness to elbow for a week, extreme joint pain, and severe headache. After the second dose, the events were worse than first. All adverse reactions were felt except myocarditis. Fever, swelling at injection with redness to elbow for a week, extreme joint pain, severe headache, all for 2 days before subsiding. Missed worked for both shots. The patient had Covid test post vaccination (nasal swab) was negative. Outcome of the events was recovered without treatment.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Myocarditis, Pyrexia, Vaccination site swelling, Vaccination site erythema, Arthralgia, Headache  and BNT162B2.  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.
erythema & edema @ inj site w/itching 3" x 4";no pain reported-warm to touch for about 5 days;treated w/warm compresses
felt spaced out, chills, fever, pain in legs, brain for, tired, stomach issues
Severe chills; left arm ache, severely sore/'arm is really tender'; sleepy; Muscle weakness; low grade headache; something weird: she could smell bleach but she is not using bleach; This is a spontaneous report from a contactable Nurse (patient).  A 64-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL0140), via an unspecified route of administration on 22Dec2020 15:40 at single dose (Anatomical Location: left arm) for covid-19 Vaccination. Medical history included hypothyroidism, muscle pain, legs hurt, Covid 19 infection/COVID-19 virus from Nov2020 to 10Dec2020 (recovered, duration: 39 days). Concomitant medication included levothyroxine sodium (SYNTHROID) for Hypothyroidism, ibuprofen (MOTRIN [IBUPROFEN]) for legs hurt and muscle pain.  The patient had previous diagnosis of Covid 19 infection that resolved 10Dec2020. She received 1st dose of vaccine yesterday (22Dec2020) and experiencing the following symptoms: "arm is really tender", severe chills ("i Gotta go lay under covers, like I'm freezing to death", low grade temp ("98.8F")."  "I feel like I have the virus again", "the chills are new" (when caller comparing symptoms to covid 19 infection experience). The patient stated, "I already know this is possible side effects from vaccine".  This Nurse reported she was administered her first dose of Pfizer COVID-19 Vaccine at work on 22Dec2020. She reported before she was administered that first dose of COVID-19 Vaccine she had COVID-19 virus from approximately the Saturday or Tuesday before Thanksgiving in Nov2020 and had reached point of recovered completely by date she returned to work on 10Dec2020. Starting this morning: 23Dec2020 she had onset of: left arm ache, severely sore; severe chills; she had to go back to bed she was so sleepy; muscle weakness; low grade headache; and something weird: she could smell bleach but she is not using bleach; she is definitely having COVID like symptoms.  She initially reported during call that she feels warm now; but that the chills were really bad like she could not get warm. She reported she started getting the chills again during this report. She reported seriousness criteria is not serious because she can now get warm but she cannot believe the severity of the chills Seriousness criteria as not serious because she can not use this arm because she was off of work for 2 days. COVID-19 virus causality not provided, not applicable. The patient verified yes for causality of all other reported events, with additional statement that she was feeling so well before these events started. She took her body temperature during this report (23Dec2020) with result of 98.8 degrees Fahrenheit. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was not recovered. The reporter reported all events were non-serious and related to the vaccine.
Patient misled pharmacy to deliver 2nd full dose of Moderna vaccine when patient was not eligible for full dose, having had 2 previous doses Pfizer and 1  full dose Moderna elsewhere. Patient was monitored for 10-15 minutes after vaccine delivered, and released.
My face broke out in bad pimples which is not normal fir me I have always had healthy clear skin. Now my skin is continuously getting new pimple everyday.
Red 1 cm. patch (R) lateral thigh with 3 vesicles multiple vesicles in (R) posterior back on L1 or L2.
Tingling and numbness on the left side of the face; Numbness on the left side of the face; This is a spontaneous report from a contactable reporter (pharmacist).   A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 26Nov2021 (Lot number: FJ8762) at the age of 53 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) and HYPOAESTHESIA (non-serious) both with onset 26Nov2021, outcome "not recovered", and described as "Tingling and numbness on the left side of the face". Therapeutic measures were not taken as a result of paraesthesia and hypoaesthesia.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Injection site / pain; Injection site itchiness / not resolved; Injection site warmth; Headache; Body ache; Fever; Chills; Swollen face / not resolved; Hives / not resolved; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2021, the patient received the 1st dose of Shingrix (intramuscular). On 6th February 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site itching, injection site warmth, headache, general body pain, fever, chills, facial swelling and hives. The patient was treated with benadryl (nos) (Benadryl). In February 2021, the outcome of the injection site pain, injection site warmth, headache, general body pain, fever and chills were recovered/resolved and the outcome of the injection site itching was not recovered/not resolved. On an unknown date, the outcome of the facial swelling and hives were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site itching, injection site warmth, headache, general body pain, fever, chills, facial swelling and hives to be related to Shingrix.  Additional information were provided as follows: The patient received 1st dose of shingrix and experienced headache,body ache, fever,chills, injection site warmth and pain for 2.5 days now those have resolved.  The patient also experienced swollen face ,hives and injection site itchiness,which were not resolved till the time of reporting. The patient had taken benadryl for the treatment of headache, body ache, fever, chills, injection site warmth and pain. The batch number was unknown. The reporter did not consented to follow up. This case was linked with case US2021038381 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021038381:Same reporter
3/10/2021 -  10:01 - received first Moderna vaccine 10:20 - reports difficulty swallowing and slight throat tightness, mild dyspnea HR 63, Sa02 97% RA, 158/60 10:22 - Benadryl 50 mg liquid given x 1 10:30 - 148/60, HR 58, SaO2 95% RA, patient reports that symptoms have improved. She is tolerating swallowing water without difficulty 10:40 - 140/60, HR 61, Sa02 98% RA. Patient reports that her symptoms have resolved 10:45 - patient left the office with her husband in stable condition Educated patient to go to the nearest ED if symptoms return or worsen. Patient verbalized understanding. Patient to discuss receiving second dose of Moderna with her PCP.
localized rxn 1 day p/vax 19FEB;t103, arm sore +, erythema, + warmth, blotchy, itching;medicated w/APAP & Ibuprofen;
Varicella, about 35 pox, fever of 101 for 1 day.
longer than 42 days in between first and second doses of Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (longer than 42 days in between first and second doses of Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (longer than 42 days in between first and second doses of Moderna Covid-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (longer than 42 days in between first and second doses of Moderna Covid-19 vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This report refers to a case of product dose omission issue, for mRNA-1273, lot # unknown, with no associated AEs.; Sender's Comments: This report refers to a case of product dose omission issue, for mRNA-1273, lot # unknown, with no associated AEs.
Extreme joint and muscle pain throughout body. So bad that I could only work a half day. Fatigue.
The patient has redness and swelling at the injection site.  Patient reports itching, rough skin and rash. Asked us to palpate/feel the area - feels swollen/knot-like and heat associated with the redness under the skin.  She said that it was a delayed response to the vaccine.  It did not appear until Sunday afternoon., following her shot  which was Monday.  She did report to her immunologist and from both the patient and immunologist's opinion  that she was still to receive the second shot and just to watch the area for now. She reported that she was going to take Benadryl and use hydrocortisone cream on the area.
improperly stored administered vaccine; No additional AE; This spontaneous report was received from a reporter (other types) and referred to a currently 4-year-old patient of unknown gender.  The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) (strength, dose, and route not provided; valid lot #U022727 with an expiration date: 16-JAN-2023) for prophylaxis. The vaccine was improperly stored, temperature -14 Celsius up to -10 Celsius (-11.6 Celsius) with a time frame of 30 mins (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event).
Administered vaccines at 11:40; promptly fainted; as she fainted she fell from the chair to the floor; had approx 2-3 second duration seizure with twitching of head; first aid administered; VSS with T 97.4 (O); P 82; BP 110/72; notified primary care provider; In speaking with parent who was with the student at time vaccines administered, she indicated that student has history of fainting spells and had not had breakfast.
Had a restless night as arm became very sore with soreness spreading to neck and spine areas. Woke with a headache and sensation of stuffy head. Muscles, especially in back, were very sore and achy. Over the course of the day started feeling like I had the flu. Headaches, muscles aches, nausea, dizzyness, light-headed, lack of appetite, mild fever (100.2), and general feeling of unwellness and lack of energy. Lasted 4 days. OTC ibuprofen and cold meds aleviated but did not fully clear symptoms. Thought I had a cold. Had the second shot in the series (7th Dec, early afternoon, same location) and woke up this morning with identical symptoms to last time.
Patient came next day after receiving SHINGRIX in right deltoid. Complaining of severe muscle soreness; trouble lifting her arm.
Pt recv vax in 10/97; 6 hr post vax pt exp fever (104F), body aches & chills; tx=Tylenol; pt imp 24 hr.
12/20/11 Evening - affected arm became red, swollen, hot & painful. Sat 12/31/11 the redness started above the shot mark & was 4" long. 1/1/12 pain gone, less red & less warm. TYLENOL BENADRYL & ice given by mom.
Headache; Fatigue; Hives; Bodyache; Arm soreness; Dizziness; Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 11May2021 at 17:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Concomitant medications included ethinylestradiol, norgestimate (TRI-SPRINTEC), prednisone (MANUFACTURER UNKNOWN), diphenhydramine hydrochloride (BENADRYL) and sertraline (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 20Apr2021 at 17:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 at 18:00, the patient experienced headache, fatigue, hives, body ache, arm soreness, dizziness, fever and chills. On an unknown date in 2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, fatigue, hives, body ache, arm soreness, dizziness, fever and chills were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.