chrisvoncsefalvay/vaers-outcomes huggingface dataset:
low grade fever; experienced pounding tachycardia; Shortness of breath; inappropriate age at the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (experienced pounding tachycardia), DYSPNOEA (Shortness of breath), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at the vaccination) and PYREXIA (low grade fever) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0077727399/012M20A and 0077727399/031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (sulfa(rash)), Allergy (many Airborne allergy), Food allergy (some food) and Autism spectrum disorder since 23-Nov-2003. Concomitant products included MELATONIN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 03-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at the vaccination). On 13-Mar-2021, the patient experienced TACHYCARDIA (experienced pounding tachycardia) and DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced PYREXIA (low grade fever). On 13-Mar-2021, TACHYCARDIA (experienced pounding tachycardia) and DYSPNOEA (Shortness of breath) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at the vaccination) had resolved and PYREXIA (low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Oxygen saturation: 92 percent (Inconclusive) 92 percent oxygen saturation per pulse oximeter. On an unknown date, Body temperature: inconclusive (Inconclusive) low grade fever.         No treatment medications were reported.   This case was linked to MOD-2021-035571 (Patient Link).
Received vaccine 10/27/08. Seen in ER with hives 11/01/08. Given Benadryl 25 mg PO. Epinephrine 1: 1000 0.3 mg SQ. Note - was around Cousin who was also seen with hives - no vaccine.
The patient was accidentally given a 0.5 ml dose of Moderna vaccine for his first booster dose. His last second dose of Moderna was over one year prior.  Error was not recognized until the dose was charted. The patient has been notified of what happened and was told of the chance of increased side effects. He states he feels fine now and will monitor. He was told to contact us with any further questions and to see a health care provider for any concerning issues. The signs and symptoms of potential myocarditis was emphasized--he stated he had no issues with his first two vaccines last year. Procedures have been reviewed and training reemphasized to make sure this doesn't happen again.
Father stated patient passed out on the way to the truck while walking, put in wheelchair and brought to clinic, Patient presented to clinic, clammy, no muscle tone, unable to bear weight on legs, trembling, shaking and stating she could barely breathe. Elevated heart rate, elevated BP. Dr, administered an Epi-Pen, patient placed on 2L O2 and sent to Emergency room
He has been experiencing pain when moving his arm out to the side since the injection date, but it has been slowly improving. He has been taking Tylenol as needed but has not sought medical treatment because the pain does not affect his daily functions.
No additional AE reported; Temperature excursion that was intermittent begining 7/28/2020, involving PROQUAD; This spontaneous report was received from a nurse referring to patient, age and gender were not reported. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter for prophylaxis (lot #T009929 has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 16-SEP-2021) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were from -14° Celsius (C) to -10°  C and 38 hours and 30 minutes respectively.  A digital data logger was involved but there was no previous temperature excursion.   No adverse effect was reported.
On 4/13/2021, strong chills and mind racing followed by fatigue.  Then on or about 5/3/21, onset of severe  anxiety, panic attacks, raised blood pressure, buzzing in left thigh muscle, loss of appetite, frequent urination, strong urge to urinate, not able to sleep, feel on edge at all times, cannot focus, brain fog, fatigue.  On 5/7 GP increased desvenlafaxine to 100 mg and prescribed lorazepam .5 to 1 mg to sleep.  On 5/14, no improvement of symptoms, added buspirone 3 times a day.  As of 5/24, no improvement in symptoms, muscle buzzing is worse, and hands are unsteady.  Still no real appetite, constant cold sweats and headache.
pt recv vax;7 days later, while MD was examining noted 3x3 inch hyper pigmented area on lt deltoid under a band aid of H-dtp immun;area was hard to touch but pt denied pain; tx:observe
pt recv vax 28SEP98 & 29SEP98 exp migraine h/a;pt was lightheaded;9OCT arthralgias, tender occipital  & cervical adenopathy, hypersensitivity of skin;11OCT macular rash on trunk to neck & face x 2 days;diff concentrating, diff w/memory;
06/28/2005 - Called and said left leg has a red 2x3 area below middle injection site, warm to touch.  No hives, no fever, no difficulty walking.  06/29/2005 called again increased redness.  seen in office to re-evaluate 11cm x 7 1/2cm area of redness and swelling, received Augmentin for possible Cellulitis.
Chronically ill patient with a PMH of systolic HF, afib, COPD was admitted to  Medical Center on 12/17/2021 with Covid-19 PNA and acute CHF exacerbation and renal failure.  Patient was encephalopathic on admission.  Patient received Remdesivir x 5 days, Baricitinib, and Decadron.  Patient was discharged to Home Hospice on 12/30/2021- Hospice name unknown.  Patient expired on 01/21/2022 at home.
227pm pt c/o itchiness and redness to both forearms and hands.  pt also c/o of tingling around lips.  pt has red raised rash on forearms.. RN's with pt to assist BP- 132/80 P- 82 SA O2 98% called for Dr  1428 pm Benadryl 25mg IM admintered to R deltoid. ...................................................................RN  March 26, 2021 5:08 PM confirmed Benadryl with Dr up on his arrival.  per Dr pts lungs were clear with good air exchange. continue to observe pt for another 15 m inutes.  1447pm pt c/o continued itchiness on bilat forearms and hands with hands now feeling heavy with tingling.  pt continues with tingling around lips.  per Dr pts lungs continue to be clear with good air exchange, Bp- 136/88 P-80 SAO2 98% V.O DR  25mg Benadryl now IM  1449 Administered 25mg Benadryl IM now. ..................................................................RN  March 26, 2021 5:23 PM instructed pt to call for ride home.  pt called for sister to give ride home.  1515 pt now stating that itchiness to forearms and hands has resolved.  hands no longer tingle.  no more tingling around her lips.  pt states that she is feeling much better.  pt is waiting for her sister to recieve her covid vaccine prior to leavig the clinic.  1555 BP- 130/80 P- 82 R- 18 SAO2- 98% Pt continues to feel much better.  denies tingling of mouth or lips or hands.  itchiness of hands and forearms has resolved.  denies any sob or difficulty breathing.  lungs remain clear with good air exhange.  pt given ER and benadrul precautions and instructed to go to ER for any severe reaction, sob, difficulty breathing, rash, itchines, lip/tongue/throat swelling.  pt and sister verbalized understanding ...................................................................RN  March 26, 2021 5:30 PM
The first shot made me really sick like had the flu or pneumonia or something; The first shot made me really sick like had the flu or pneumonia or something; The first shot made me really sick like had the flu or pneumonia or something; Body was aching and hurting so bad; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 25Feb2021 as single dose for COVID-19 immunization. Medical history included high blood pressure and asthma from an unknown date. Concomitant medications included amlodipine taken for high blood pressure; hydrochlorothiazide taken for high blood pressure; and salbutamol sulfate (VENTOLIN) taken for asthma. It was reported that the first shot made the patient really sick like she had the flu or pneumonia or something. She also took some over the counter extra strength Tylenol as her body was aching and hurting so bad. The patient had lab test in the past 2 weeks in 2021, she had her blood drawn. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Acute pancreatitis; A spontaneous report  was received from a healthcare professional concerning a male patient  of unknown age,who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  acute pancreatitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the events, the patient received  mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced acute pancreatitis.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, acute pancreatitis, was considered unknown .; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Left eye burning & itchy. Lower left lid and area below the left eye started to swell. Cold compress applied to left eye & two regular strength Tylenol tablets were also given.
Complaining of headache since receiving last vaccine.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 13:00 (Lot number: FD7218) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin; "Ache" (unspecified if ongoing). Concomitant medication(s) included: MINOCYCLINE taken for acne, start date: Sep2021 (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0181), administration date: 15Jun2021, when the patient was 15 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW1080), administration date: 21May2021, when the patient was 15 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 27Dec2021, outcome "not recovered", described as "Complaining of headache since receiving last vaccine.". Therapeutic measures were taken as a result of headache.  Additional information:The patient received treatment with Tylenol and Advil.The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
PT STARTING HAVING WHAT HE DESCRIBED AS A POSSIBLE ANXIETY ATTACK. HE WAS SWEATING. INCREASED HEART RATE. NAUSEA AND VOMITING. EMS WAS CALLED AND HE WALKED OUT TO THE AMBULANCE TO BE CHECKED OUT BUT DIDN'T GO TO THER ER. PATIENT CAME BACK INTO THE PHARMACY TO INFORM US THAT HE WAS FEELING OK.
Case number PHEH2015US025341 is an initial spontaneous report received from a nurse on 02 Dec 2015. This report refers to a 52 year old female patient. Past medical history and concomitant medications were unknown. She was vaccinated with FLUVIRIN (batch number: 1516401) via intradermal route at a dose of 0.5 ml on 30 Nov 2015. She experienced redness, swelling and itching at the vaccination site on an unknown date. She was given lidocaine/hydrocortisone cream. The events outcome was unknown. The events were reported as non-serious. The causality of the events was not reported.
Strong headache; Chills; Diarrhea; Vomiting; Muscle aches; Extremely tired; Some mild difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 14Mar2021 at 09:30 (at the age of 63-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease) and COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies. Concomitant medications included phenylephrine (MANUFACTURER UNKNOWN), for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 14Mar2021 at 19:30, 10 hours after receiving injection, the patient experienced strong headache, chills, diarrhea, vomiting, muscle aches, extremely tired and some mild difficulty breathing. Lasted about 30 hours then all symptoms went away. The patient had same symptoms after his second shot but only lasted about 10 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events of headache, chills, diarrhea, vomiting, muscle aches, extremely tired and some mild difficulty breathing was recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Baby became fussy and lethargic.  Under arm temperature was 101 degrees.  Gave baby Tylenol every 8 hours.  Baby's temperature lowered to 100 degress the following day and was not as fussy as the day before.  He played in the am and afternoon so I did not give him Tylenol during the next 9 hours as I checked several more times during the day and baby maintained under arm temp of 100-101 degrees.  Then at 4:00 pm, baby once again became fussy and lethargic.  Under arm temperature was at 103.5.  I gave him a lukewarm bath to cool his body and took another underarm temp which was 102.5.  Baby then began twitching with his right arm and was crying alot so we took him to the ER at 5:00 pm. The ER nurse took a rectal temp of 102 degrees when we arrived.  The baby was given a Tylenol suppository and then 30 minutes later, he once again began to twitch and suffered a fever seizure.  ER attendants rushed to administer oxygen as the baby looked like he was going to pass out with eyes rolling up and head bobbing.   The seizure lasted about a minute.
Extreme fatigue; Stuffy nose; Runny nose; Coughing; Sore throat at night; Slight headache; Temperature up only one degree; Chills; Unable to sleep; Body ache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9263), via an unspecified route of administration in left arm, on 22Jan2021 at 12:30 PM, at a single dose, for COVID-19 immunization. The patient's medical history included slightly high blood pressure and depression. The patient was taking unspecified concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 at 12:15 PM, the patient experienced extreme fatigue, stuffy nose followed by runny nose, coughing and sore throat at night, slight headache, temperature up only one degree but chills, and unable to sleep due to body ache.  These events ended quite abruptly on 29Jan2021. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 29Jan2021.
This spontaneous report as received from a registered nurse refers to a 9 weeks old infant. The patient's concurrent conditions, medical history and drug allergies were not reported. On 11-NOV-2016, the patient was vaccinated with a dose of ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017; and a dose of PEDVAXHIB from lot # M025194 (route and expiry date unknown), both for prophylaxis; which were improperly stored. Concomitant medications were not reported. The vaccines were exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 was changed from Company Number to Linked Report. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
lightheaded without syncope, burning/itching to right arm then tingling/itchy lips and roof of mouth, tachy sent to ED after Benadryl 25mg po and watched for 45min wasn't improving.  In ed given Solumedrol 125mg, Pepcid 20mg, Zofran without improvement and then began dry heaves, Phenergan given and epi 0.3mg IM with improvement of symptoms,   No hives but red rash to right arm/neck.
HSP diagnosed after noting purpuric rash, fever, joint pain, appetite decrease, abnormal complaints, elevated platelet count, low hemoglobin.
I went to emergency and was hospitalized for 4 days due to rhabdomyolysis; Urine darkened; Chills; Slight fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of RHABDOMYOLYSIS (I went to emergency and was hospitalized for 4 days due to rhabdomyolysis) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pancreatic cancer. Previously administered products included for an unreported indication: Keytruda. Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for Pancreatic cancer.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced CHROMATURIA (Urine darkened), CHILLS (Chills), PYREXIA (Slight fever) and FATIGUE (Tired). On 22-Apr-2021, the patient experienced RHABDOMYOLYSIS (I went to emergency and was hospitalized for 4 days due to rhabdomyolysis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 22-Apr-2021 to 26-Apr-2021 due to RHABDOMYOLYSIS. At the time of the report, RHABDOMYOLYSIS (I went to emergency and was hospitalized for 4 days due to rhabdomyolysis), CHROMATURIA (Urine darkened), CHILLS (Chills), PYREXIA (Slight fever) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood creatine (70-90): high (High) Patient reported a blood creatinine level should have been 70-90 but was 38,000, which then dropped over 2 days.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  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; 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
encephalopathy, unk etiology; sz, encephalopathic behavior & coma, w/fluctuating neurologic signs; no definite etiology was found; pt had aseptic meningitis @ time of vax, MMR vax given inadvertently, order was for mumps skin test;
Swelling, redness, lump ("slightly bigger than a quarter"), warmth to injection site, fever 101.2 degrees F the next day of injection.
12/18 vaccination  12/21 I felt a tingling hypersensitivity to L vaginal area. Went on for about a week, thru the holidays.  12/28 blisters started to appear on L vaginal side.  12/31 Gyno appt. Sent to lab; came back as Shingles. Lesions started to heal on its own without medication.
Pt reports that arm is still warm to touch, inflamed and hurts. It has been 12 days post injection
HBP reported AE for improperly stored administered vaccine.; This spontaneous report was received from an office manager (also reported as HBP) and refers to 8-month-old patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 17-MAY-2022, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # 1742431 confirmed to be valid with expiration date 31-JAN-2023 (exact dose was not reported) for prophylaxis. The vaccine underwent a temperature excursion of 28 degrees Fahrenheit (F) for 96 hours on an unknown date before administration (product storage error). There was no previous temperature excursion.  This is one of six reports from the same reporter.; Sender's Comments:  US-009507513-2205USA005815: US-009507513-2205USA005673: US-009507513-2205USA005882: US-009507513-2205USA005914: US-009507513-2205USA005906:
This spontaneous report as received from a female consumer of unknown age reporting on herself. On 26-MAR-2014, "last Wednesday", the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). The consumer reported that in 2014, "reported as now", she had red rectangular welt at the injection site. The outcome of red rectangular welt at the injection site was unknown. Additional information is not expected.
Information has been received concerning a female who on an unspecified date, was vaccinated IM with the third dose of GARDASIL (lot # not reported). Subsequently the patient went through a neurological event and was hospitalized ("days unspecified"). At the time of reporting, the outcome of the event was unknown. Additional information has been requested.