chrisvoncsefalvay/vaers-outcomes huggingface dataset:
started feeling quite itchy at and around the area of the injection site in the upper left arm/It is a distinct tingly itchy sensation; .  It has been pretty much continuous since yesterday and continues today. It is a distinct tingly itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 65-year old female non-pregnant patient received first dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: unknown) via unspecified route of administration, on left arm at 11:45, on 23Jan2021, at single dose for COVID-19 immunisation. The patient medical history included heart attack, high blood pressure, high cholesterol. The concomitant medication included carvedilol, rosuvastatin, glycine, glucosamine, colecalciferol (D3) and msm. The patient previously took tylenol and experienced allergies. It was reported that about a week after the injection on 30Jan2021, I started feeling quite itchy at and around the area of the injection site in the upper left arm (as reported). It has been pretty much continuous since yesterday and continues today (as reported). It is a distinct tingly itchy sensation. It was reported that patient didn't see anything unusual in this around the area of the injection site. The patient used cortisone which helped slightly. The patient was not sure if it was safe to take second dose. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she was not overweight at all. The outcome of the events was recovering  Information on the lot/batch number has been requested
Over 35 days since 1st dose; 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 PRODUCT DOSE OMISSION ISSUE (Over 35 days since 1st dose) 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.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Over 35 days since 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Over 35 days since 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment information was provided.  Patient was not comfortable giving any additional AE information nor with follow up from Safety.   Reporter did not allow further contact
Bottom lip on left side corner started swelling the size of small bubble/swollen into a big bubble; Lip was hard; Bubble on part of right side of face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIP SWELLING (Bottom lip on left side corner started swelling the size of small bubble/swollen into a big bubble), SKIN INDURATION (Lip was hard) and ACNE (Bubble on part of right side of face) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Diabetes and Environmental allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN), LISINOPRIL, HYDROCHLOROTHIAZIDE, METFORMIN HCL, CETIRIZINE HYDROCHLORIDE (CETRIZINE) and COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) for an unknown indication.    On 17-Feb-2021 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced SKIN INDURATION (Lip was hard) and ACNE (Bubble on part of right side of face). On 17-Feb-2021 at 3:45 PM, the patient experienced LIP SWELLING (Bottom lip on left side corner started swelling the size of small bubble/swollen into a big bubble). On 18-Feb-2021, SKIN INDURATION (Lip was hard) had resolved. On 18-Feb-2021 at 9:00 AM, LIP SWELLING (Bottom lip on left side corner started swelling the size of small bubble/swollen into a big bubble) had resolved. At the time of the report, ACNE (Bubble on part of right side of face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: age, race, weight, height of patient, current conditions and allergy added, additional events added
Extensive rash, moving, started on legs, now on arms and belly and back, moved from back of legs to front - red, coalescing papules, pruritic, no other ysmptoms
On and off symptoms include: light headedness,  light weakness/tingle on the underside of my left arm, on and off achey weakness in right hand too. It started on day 12, 13, 15 (up to two weeks after vaccination).  Symptoms went away and returned at night on April 27 and throughout the day on April 28, 2021.  I was borne with mitral valve prolapse (no work/life restrictions) and wondered if the vaccine has any connection to the mitral valve prolapse.
Lack of appetite, weakness, dizziness, headache, Nausea, Vomiting, Diarrhea for 48 hours causing dehydration. Advised to go the ER for IV fluids. Did not fully recover until 11/14/2009.  11/17/09:  ED Records received for date of service 11/9/09 and Prenatal records received for date of service 10/6/09.  Dx:  Gastroenteritis, Dehydration, Pregnancy.  Assessment:  Gravida 5, Para 1,  11 wks. EGA, EDC 5/29/10 presents to ED with c/o nausea, vomiting and diarrhea for 48 hrs.  SPO2 99%.  Rehydrated with 2 L normal saline IV.  Given Zofran for nausea.  D/C'd home to f/u with OB/GYN.    12/08/09 Duplicate ED rec received for DOS 11/09/09 and prenatal records received for DOS 08/22/09-11/09/09.  Clinic note 11/02/09 noted patient received H1N1 vaccine. Clinic note of 11/09/09 noted patient called and reported nausea, vomiting, diarrhea since yesterday and reported feeling weak, lightheaded, having cold sweats, temp 99.0. Advised to go to ER./rem
Mom noticed rash to legs on 2/20/01, Tuesday evening. By Wednesday, noticed the rash was worse with intermittent hives. Took child to ER and was treated with Benadryl. ER doctor told mom not to get Prevnar again.
Headache; Muscle ache; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6201), via an unspecified route of administration, administered in the left arm on 15Feb2021 12:43 (at the age of 72-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. On 15Feb2021 (after the vaccination), the patient experienced sore arm. On 22Feb2021, the patient experienced headache and muscle ache. The outcome of events headache and muscle ache was recovered on 23Feb2021 while the outcome of event sore arm was unknown.  No follow-up attempts are needed. No further information is expected.
COVID 19 Treatment/ Rebounded and test positive 2 weeks after testing negative; COVID 19 Treatment/ Rebounded and test positive 2 weeks after testing negative; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: ER8731), in left arm and on 06May2021 as dose 2, single (Lot number: ER8736) at the age of 49 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered", COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment/ Rebounded and test positive 2 weeks after testing negative". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 Treatment; Negative, notes: after testing negative; Positive, notes: Rebounded and test positive 2 weeks. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Onset of paresthesias of hands approximately one month after vaccination.  Slow progression of symptoms to include paresthesias of lower extremities followed by weakness. Diagnosis of Guillian Barre Syndrome made on Jan. 14, 2004.  1/10/06 Received hospital medical records of 1/14-1/15/2005. FINAL DX: Guillain Barre syndrome Records reveal patient experienced numbness & tingling in her extremities, decreased endurance, myalgias for several mo.  Saw PCP 12/08.  Continued to worsen & again saw PCP on 1/13 who did LP.  Admitted for IVIG.  Exam revealed decreased reflexes, sensation decrease in stocking-glove pattern, gait disturbance.   Per 60 day follow up report-Still with paresthesias of feet. Not yet working full time due to fatigue. Still with pareythemus of feet; weakness; fatigue but I continue to see improvement monthly.
-Vaccine at 6:30 PM -Intense tingling though arm vaccine was administered in -Soreness in arm 10:30 PM -Extreme fatigue but restless through night -Temperature of 102.5 with chills -Extreme nausea and headache -Could not get out of bed for 36 hours due to fever, chills, extreme headache and nausea. -Lesser headache and nausea and low grade fever of 99-101 2/26 from 9:30 am throughout day -Rash and lump around vaccine sight appeared.
pain at injection site (left deltoid) radiating to left breast and then an eruption of erythema multiforme on chest, bilateral arms
ANAPHYLACTIC REACTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included family history of anaphylaxis. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination .The batch number was not reported and has been requested . No concomitant medications were reported.  On an unspecified date, the patient experienced anaphylactic reaction. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210354170-COVID-19 VACCINE AD26.COV2.S -Anaphylactic reaction. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 26Jan2021 (09:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included anemia and allergies. Concomitant medications included an unspecified allergy shot. The patient was not pregnant at the time of vaccination. On 26Jan2021 (12:15), the patient had felt pains; lymph nodes had swelled; had pain on tongue; extreme dehydration; fatigue; and difficulty swallowing. The patient had received diphenhydramine (BENADRYL) as treatment for the events, and drank lots of water. The outcome of the events, 'felt pains', 'lymph nodes swelled', 'pain on tongue', 'extreme dehydration', 'fatigue' and 'difficulty swallowing', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.  Information on the lot/batch number has been requested.
had some weird feelings during the night/ was a very strange feeling"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "had some weird feelings during the night/ was a very strange feeling  Additional information: Patient had the 2nd shot from the Pfizer vaccine and reported an adverse event regarding the Pfizer-BioNTech Covid-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient with varicella rash that developed about 3 weeks after getting varicella vaccine. Has approximately 25 lesions total on trunk, extremities, head. Recommended supportive Tx with antihistamine.
Moderna booster 1/5-Within about 20 mins left thigh started to itch 2 hours later about 6 episodes of diarrhea flushed skin, mild arm pain. 1/6- arm pain and heaviness. Stomach very upset, itchy hands, legs and arms 1/7 whole body itchy, stomach upset, arm pain heaviness. Bottom 1/2 of face, chest unvaccinated right armVery hot and itchy. Feels like bad sunburn. 1/8- work up to bright red bottom half of face, chest and right arm. Felt palpitations on and off all day. 1/9 continued burning, palpitations  1/10 burning, itching, palpitations better 1/11 continued feeling better 1/12- general feeling of unwell not sure how to explain. Went to ER with constant palpitations, mg, k, CA, hemoglobin low. Recieved 2gm magnesium iv, 40 meq K.  1/13 feeling unwell seen Dr heart patch ordered 1/14 unwell off and on palpitations heart patch placed.
A report has been received from a health professional concerning a female patient. The patient's relevant medical history or concomitant medications were not reported. In the 2011-2012 season the patient received FLUMIST and was hospitalized for wheezing after taking the product. The action taken with FLUMIST and the outcome of the events was unknown. Assessment of the serious criteria by reporter for the report was as follows: hospitalised. Follow-up of insignificant information received by AstraZeneca/MedImmune on 20-Feb-2013 from health professional: new reporters added.
The Saturday morning following my vaccine the previous Sunday, my eyelids swelled. I was staying at a hotel when this happened. My eye doctor said it was contact dermatitis possibly caused by the laundry detergent the hotel used and prescribed a steroid ointment. A few weeks later, I was out of town again and my eyelids started to swell. Luckily I brought the ointment with me and things calmed down quickly. In December, my neck and décolletage became red, inflamed, and very itchy. I didn't see a doctor for about 3 weeks (because of Christmas + holiday travel) and treated at home with Benadryl at night and Zyrtec during the day.  Once I received the steroid ointment, everything calmed down in about 48 hours. I do not typically have skin reactions like this ever.
Pt recvd 3 doses of Engerix-B vax & titers were checked 6 months p/last dose & titer result was 2.8, indicating a low pos response;
This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a male patient who received SHINGRIX. On 21st April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced adverse drug reaction and unexpected therapeutic effect. On an unknown date, the outcome of the adverse drug reaction and unexpected therapeutic effect were unknown. It was unknown if the reporter considered the adverse drug reaction and unexpected therapeutic effect to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX at the local pharmacy. For the next few days, the patient experienced the expected side effects (not specified) of the immunization to varied degrees. On Monday (not specified), after receiving SHINGRIX, while commuting on public transportation, the patient noticed that the left knee pain which he always had on walking up a flight of stairs was gone. The patient figured he had a good day. Almost two weeks had past and the patient was completely pain free in the knee that had been problem for at least five years. The patient reported that, the pain initially was extreme on walking but that was solved with isometric exercise and avoiding the direct air conditioning vent airflow while sleeping. The slight pain while climbing stairs was controlled by holding on to the banisters and walking up a little more carefully and slowly. Now after receiving SHINGRIX, that was all unnecessary and the patient had no pain, which led to unexpected therapeutic effect. The patient stated it made no sense why a shingles vaccine would have this effect, but it had and the patient would like to talk to someone about this very positive side effect.
Patient developed significant worsening of fatigue exhaustion patient was nearly completely bed rest for approximately 4 months; barely get able to take care of himself; complete body pains fevers; developed tachycardia orthostatic hypotension heart racing palpitations; patient had never been this sick before all symptoms started within 5 hours of getting his second maternal vaccine.  Patient's never been this exhausted tired or sick before; patient has not made a complete recovery he's still having significant problems .
flu-like symptoms; he is disoriented; feels dizzy; taste buds really tasted funny; fever; body aches; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), DISORIENTATION (he is disoriented), DIZZINESS (feels dizzy), DYSGEUSIA (taste buds really tasted funny) and PYREXIA (fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immune system disorder (pre-existing compromised immune system).    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), DISORIENTATION (he is disoriented), DIZZINESS (feels dizzy), DYSGEUSIA (taste buds really tasted funny), PYREXIA (fever), MYALGIA (body aches) and FATIGUE (Tired). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), DISORIENTATION (he is disoriented), DIZZINESS (feels dizzy), DYSGEUSIA (taste buds really tasted funny), PYREXIA (fever), MYALGIA (body aches) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-086105 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086105:crosslinked
Bivalent vaccines have undergone several temperature excursions and may have been administered to patients; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2022 at 11:58 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 25-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    Patient received vaccine in deltoid. No concomitant product reported by the reporter.  Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. No adverse reactions experienced by the patient. It was unknown if patient had ever been diagnosed or tested positive for COVID-19.  No treatment medication reported by the reporter.
Patient was hospitalized post urethral stent insertion due to complication. She was found to be COVID positive without evidence of pulmonary process. She was subsequently placed in isolation for the length of her stay.
4/1 first shot:    Broke out in a red rash upper body arms face 24 Hrs later after shower (hot Water). Went to skin Dr April 14. Have Triancinolone 0. 025% cream x 2weeks 2 x day plus Allegra AM & Zyrtec PM (Dr. said Dermatitis ). I am told reporting this??
pt recv vax devel myositis;No further info was available @ the date of this report;f/u info was recv 13JUN97;
Patient presented on 10/24/2019 displaying injection site. Upper arm was warm to touch and inflamed to elbow. No other complaints. Patient advised to seek further medical attention from her physician. Doctor was unsure if reaction was allergy or cellulitis, so he marked the inflamed area and called in KEFLEX for patient. Patient was instructed to check area on 10/25 and if redness and inflammation had spread further then she should pick up the prescription, but if same or reduced, she should continue to monitor. RPH spoke to patient in the morning of 10/25 and area hade reduced, so patient is monitoring as instructed.