chrisvoncsefalvay/vaers-outcomes huggingface dataset:
29NOV93 pt recvd vax & 15DEC93 pt noticed RA SQ arm enlarged area-size of a pea; referred to MD; 15DEC93 to ER MD felt caused from MMR vax;
DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; FLU LIKE SYMPTOMS; OFF LABEL USE; This spontaneous report received from a physician concerned a 16 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and  expiry: 21/JUN/2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced drug administered to subject of inappropriate age. On 03-APR-2021, the subject experienced flu like symptoms. On 03-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 04-APR-2021, and the outcome of drug administered to patient of inappropriate age and off label use was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.
have root cannel (surgery on a tooth); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ENDODONTIC PROCEDURE (have root cannel (surgery on a tooth)) 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 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced ENDODONTIC PROCEDURE (have root cannel (surgery on a tooth)). On 25-Feb-2021, ENDODONTIC PROCEDURE (have root cannel (surgery on a tooth)) outcome was unknown.            The patient take antibiotics previously and after the procedure .
15 minutes after injection, developed lip tingling, itching tongue and back of throat.  No swelling noted on exam.  Persists 1 hour after injection.  G
Vaccine shot at 10:20 am Sunday. Severe swelling of lips, face and around eyes starting at 6:00 pm on Monday. Several days for swelling to go down. Not anaphylaxis. No swelling of tongue or throat. No trouble breathing. Exactly the same reaction and time line after second shot, 3/7/2021.
pt recv vax 14NOV94 & 15NOV94 pt devel a temp of 100 & local rxn @ the inj site; pt exp chills, a sore arm & stomach cramps; pt's fever was treated w/APAP; local rxn @ the inj site & arm soreness lasted for 2 days;
patient developed persistent vertigo, developed on the same day as the vaccination. made patient too dizzy to be able to drive. tried chiropractic treatment to correct possible otoliths without resolution. eventually resolved around 2 months following onset with meclizine
This is a spontaneous report from a contactable consumer or other non-hcp (Patient). Report 1 of 2 is for the reporter as the patient. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced nausea and dizziness. Adverse events lead to Emergency Room Visit. Caller stated that she and her husband are scheduled to get the second dose of the COVID-19 vaccine on day of reporting, but caller was not feeling well so they were unable to get the second dose. Caller stated she went to the ER with nausea and dizziness and the ER told her these symptoms were related to medication changes. Caller confirmed that she went the ER and was admitted into the hospital. The clinical outcome of the events was unknown. Follow-up attempts completed. No further information expected.
PATIENT EXPERIENCED SWELLING, PAIN AND RASH THAT LASTED 5 TO 7 DAYS. ADVERSE REACTION CONTINUED TO GET WORSE AS DAYS PASTED.
fainted; Nausea; lips white; Really pale; 12 year old daughter; This is a spontaneous report from a contactable consumer (patient's mother). A 12-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 got it closer to 12:00 (Batch/Lot number was reported: First letter was R, W or B, followed by A6256) at the age of 12-years-old as SINGLE DOSE for covid-19 immunization. The COVID-19 vaccine was administered at Pharmacy/Drug Store. Medical history reported as none. No family medical history relevant to adverse event, reporter who was the patients mother, is a fainter, who fainted a lot when she saw blood. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. As they were driving away, her daughter started feeling really nauseous, then fainted, was super pale, lips were white and she was really pale. It all occurred at the same time all started 10 minutes after vaccine on 14May2021. Then the ambulance came. Her daughter looked really bad and it freaked reporter out. Her daughter sat for a little while and was feeling better now. Her daughter was no longer pale, it went away. They checked her and everything was normal. No Emergency Room and no Physician Office visit required. Ambulance was called, they checked her and she was fine. Told her to keep any eye on her at home. The outcome of the events pale, lips were white was recovered on 14May2021, the outcome of the events nauseous, and fainted was recovering.  Information about Lot/Batch number has been requested.
Skin rash and local skin redness, soreness, soft tissue edema. Hydrocortisone 125 mg once, diphenhydramine 25 mg once.
ambulated then fall with 3-5 second loss of consciousness and hit head on ground surface, 911 activated.
Feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick) 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 07-Apr-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 MALAISE (Feeling sick). At the time of the report, MALAISE (Feeling sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment Not Provided - Call Disconnected
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Approximately on an unknown date in December 2013 (reproted as sometime in the last week) the patient was vaccinated with ZOSTAVAX dose unknown. No concomitant medication was reported. Approximately on an unknown date in December 2013 the patient experienced red area that has developed around the injection site. The patient also had reported as well a round the injection site. The outcome of the events was reported as not recovered/not resolved. The patient sought medical attention and called pharmacy. Additional information has been requested.
Narrative:  Fully COVID vaccinated, positive on admission, passed away due to hypoxic respiratory failure secondary to COVID
pinpoint macular lesions appeared on10/25, fever;pt placed in negative air pressure room & contact & airborne isolation;
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age. On an unknown date, the unspecified patients were vaccinated with 6 doses of improperly stored ZOSTAVAX (lot # L000448 and expiry date: 08-MAR-2016, lot# L002422 and expiry date: 23-APR-2016). 0.65 ml subcutaneously. No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
Information has been received from a physician concerning a 67 year old female with a penicillin allergy, allergic reaction to tetracycline and an allergic reaction to barbiturates who on 18-JUN-2007 (also reported as 31-MAY-2007) was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included SUDAFED, BENADRYL, cyclobenzaprine HCl (MSD), PROTONIX, folic acid, LIPITOR, aspirin, PLAVIX and corticosteroids vaginal cream (unspecified).  On 19-JUN-2007 the patient was seen by the physician who identified varicella-like rashes on both sides of the patient's face and neck with some watery blisters.  Each lesion was about 2 mm.  The patient reported the rashes as being itchy and burning.  At the time of the consultation some of the rashes had crusted.  No lab studies were performed.  At the time of this report the patient's status was unknown.  There was no further information provided.  There was no product quality complaint involved.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Initial and follow up information has been received from a physician and a health care worker, concerning a 67 year old female with a penicillin allergy, allergic reaction to tetracycline and an allergic reaction to barbiturates, a history of coronary artery disease, hypercholesterolemia, restless leg syndrome, dyspepsia, and iron deficiency who on 31-MAY-2007 (previously reported as 18-JUN-2007) was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included SUDAFED, BENADRYL, cyclobenzaprine HCl (MSD), PROTONIX, folic acid, LIPITOR, aspirin, PLAVIX and corticosteroids vaginal cream (unspecified). On 01-JUN-2007 (previously reported as 19-JUN-2007) the patient was seen by the physician who identified varicella-like rashes on both sides of the patient's face and neck with some watery blisters. Each lesion was about 2 mm. The patient reported the rashes as being itchy and burning. At the time of the consultation some of the rashes had crusted. No lab studies were performed. At the time of this report the patient's status was unknown. In follow up information it was noted that within 24 hours of vaccination the patient's skin "felt weird". The patient's varicella like rash lasted 2 weeks and eventually spread to her neck, fingers and left hand. The patient had another breakout with the same symptoms 2 months after the injection. There was no further information provided. There was no product quality complaint involved. Additional information has been requested.
Altered taste in mouth. Milky taste in mouth. Tightening of throat after consuming food.
Patient received vaccine and moved to waiting area as counselled during the administration of vaccine.  Shortly after sitting down patient alerted pharmacist that they felt dizzy.  Patient was pale and said they felt hot and nauseous, He was provided water and a trash can. His companion said the patient hadn't eaten all day and went to get him something to eat.  After the patient rested, drank some more water and ate part of a sandwich they felt better and were ready to go home.
Can feel increased heart rate at times and harder beating. Started day of vaccine and has continued to today, nearly 2 months later.  My watch has data on heart rate variability and has seen a statistically significant  increase  variability since the date of the shot.  The feeling can come and go. It can persist for hours at a time in a noticeable  At its worst it can stop me from an activity for up to a minute of intense heart rate and chest pounding feeling. Does not totally seem to be related to physical exertion.
On 7:30 PM 10/21 after flu shot, noticed fine rash on stomach. By 10/22, rash was all over with hive like areas on left wrist. Not talked with MD over the phone. Started child on Benadryl. Rash better on Saturday and gone on Sunday 10/24. MD didn't feel related to flu shot.
(L) thigh swollen, red w/diffuse rash after receiving DTaP on 7-10-07 (AM). No fever. 19x19cm
Expired Drug Used; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 36-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA703A, expiry date 30-APR-2023) and (batch number AMXA703A, expiry date 30-APR-2023) for prophylaxis.   On 01-JUN-2023, the patient received Menveo. On 01-JUN-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired Drug Used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 02-JUN-2023 A pharmacist reported about a patient who received expired Menveo vaccine. The reporter consented to follow up. The patient received an expired dose of Menveo vaccine, which led to expired vaccine used.
30 minutes after injection - neck and chest felt hot and itchy, resolved after several hours. The next day felt increased fatigue. 2 days later fever 100.2, headache, nausea, chills. Day 3-4 twitching left side of face.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 27-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter link). Additional information has been requested.
Cytokines Storm; Thickening of the blood; Polycythemia; Extremely Short Of Breath; Elevated Heart Rate; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CYTOKINE STORM (Cytokines Storm), HYPERCOAGULATION (Thickening of the blood), POLYCYTHAEMIA (Polycythemia), DYSPNOEA (Extremely Short Of Breath) and HEART RATE INCREASED (Elevated Heart Rate) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical reported history provided by the reporter.     On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced CYTOKINE STORM (Cytokines Storm) (seriousness criteria hospitalization and medically significant), HYPERCOAGULATION (Thickening of the blood) (seriousness criterion hospitalization), POLYCYTHAEMIA (Polycythemia) (seriousness criterion hospitalization), DYSPNOEA (Extremely Short Of Breath) (seriousness criteria hospitalization and intervention required) and HEART RATE INCREASED (Elevated Heart Rate) (seriousness criterion hospitalization). At the time of the report, CYTOKINE STORM (Cytokines Storm), HYPERCOAGULATION (Thickening of the blood), POLYCYTHAEMIA (Polycythemia), DYSPNOEA (Extremely Short Of Breath) and HEART RATE INCREASED (Elevated Heart Rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Heart rate: elevated (High) Elevated.         No treatment related information has been reported.  Since receiving the second vaccine patient visited the ER a total of 4 times. Patient had no medical history of heart disease or Short Breath.  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.; 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.
less than 24h the upper lip swelled; This is a spontaneous report received from a non-contactable other healthcare professional reporting for a patient.. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization and also injected with hyaluronic acid, lidocaine (JUVEDERM ULTRA SMILE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) as 0.55ml for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced immediately after the vaccine, less than 24h had upper lip swelled. HCP believes it is an allergic reaction to the vaccine rather than a reaction to the Juvederm filler. The patient recovered in 24h without treatment. Outcome of the event was recovered.  Complaint - Dermal No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A physician reported that an unidentified patient received Flu Shield (2001-2002 Formula) (influenza virus vaccine, trivalent, types a & b/2001-2002 formula) on 6 Nov 2001. One hour post immunization, the patient experienced itching around the mouth and "feeling funny". The patient was treated with fexofenadine hydrochloride (Allegra) and the symptoms resolved. No additional information was available as of the date of this report.
Patient described the adverse event as her arm being swollen. It hasn't been itchy and she was prescribed an antibiotic for the reaction.  She isn't sure how long it took for the reaction to arise, but once she notice it she said her arm was swollen and red. She has been prescribed cephalexin and will see her physician for further follow-up.
Hot red rash with jagged edges on upper arm below injection spot. Occurred about 1 week after getting first shot of Moderna Covid-19 vaccine.
No additional AE reported; Caller reports that an improperly stored dose of PROAQUAD was administered to the patient on 19 MAY 2022.; This spontaneous report was received from a physician and refer to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 19-MAY-2022, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, 0.5 ml, lot # U029148, expiration date 16-MAR-2023 (dose number and route of administration were not provided) for prophylaxis (product storage error). The administered dose of the vaccine underwent temperature excursion of 74.01 Fahrenheit degrees for 15 hours. There were no previous temperature excursion. No additional adverse event was reported (no adverse event).
t103 10MAY94 PM; t102 11MAY94 & lethargic;
This spontaneous report as received from a nurse refers to an 18  month old patient of unknown gender. Medical history and drug reactions or allergies were not specified. On 11-SEP-2014, the patient inadvertently received one dose of GARDASIL injection (route and lot number were not reported). No adverse effects were noted. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Baby had fever T100 deg F and decreased appetite on 8/21/07. He broke out with rash on 8/22-bright red confluent papular rash on chest spreading to arms. Rash resolved on 8/28/07
This spontaneous report was received from a registered nurse refers to a 14 year old female patient. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown dates, the patient was vaccinated with three doses of GARDASIL (unspecified lot number/expiry date and dosage). On an unspecified date, patient was inadvertently vaccinated with GARDASIL 9 injection as a fourth dose, of GARDASIL vaccination series (unspecified lot number/expiry date and dosage). Additional information is not expected, as there is no consent to contact the reporter.
Rash developed around shot site after 2 days increased after 3-4 days to red lesion with small bump. Pt now has small spots on torso/arms & legs - started on 9/30/12.
Moderna COVID-10 Vaccine EUA: Woke up on Jan 10 with injection site red, swollen (hard) and itchy.   Less red on Jan 11, but still swollen and itchy.  No obvious detrimental effect, but want to report the condition.
Red, hot, bumpy, itchy red spot appeared 6.5 days post vaccine in area where vaccine was injected. Itchy spot on bottom of left foot started at same time with no remarkable redness or warm feeling. Red spot on arm expanded and appears to be spreading now at 9.5 days post vaccine. Using topical 1% cortisone cream and oral diphenhydramine for relief.
COVID-19 Disease 5-7 days after first vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19 Disease 5-7 days after first vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 Disease 5-7 days after first vaccine). At the time of the report, COVID-19 (COVID-19 Disease 5-7 days after first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to ED one day after second dose of vaccine reporting polydipsia, polyuria, nausea, vomiting, and myalgias but no abdominal pain. Vitals within normal ranges except blood pressure 127/100 mmHg and pulse 110 beats per minute. Administered antiemetics, analgesics, intravenous fluids, antidiabetic medications and discharged to home in late afternoon. When additional triglyceride results became available patient contacted to go to ED for nausea and other symptoms in setting of elevated triglycerides. Shortly after midnight the next day patient presented to ED nauseated and fatigued. Vitals within normal ranges except for blood pressure 162/96 and pulse 107 beats per minute. Patient admitted with diagnoses of mild DKA and mild pancreatitis. Administered antidiabetic medications, intravenous fluids, antiemetics and discharged the next day with improvement in symptoms and laboratory values.
Headache, Myalgia, Arthralgia, chills, fatigue, fatigue Narrative:  Other Relevant History:
Patient received 1st dose of Moderna vaccine on 2.6.2021 at approximately 1030. By 1500 that day the patient describes the following symptoms: intolerable pain (9 out of 10), chest pressure, extreme weakness and fatigue, itching all over with a rash, shaking, dizziness, vomiting, and diarrhea. Patient says she saw some improvement after 24 hours, but still is having some diarrhea today (2.9.21). Recommended patient to contact PCP with symptoms.
Erythema, induration and warmth of (L) thigh. Augmentin and cold compresses.