chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/12/2016 3.5X5cm reddened area of induration. Advised Tylenol &/or Ibuprofen. Alternate heat and cold compresses.
Swollen lymph nodes under left arm; Painful and noticeably swollen compared to area under right arm; This is a spontaneous report from a contactable consumer. This 40-year-old female consumer (patient) reported for herself that:   Serious: (NO)     Seriousness criteria-Results in death: (NO)     Seriousness criteria-Life threatening: (NO)     Seriousness criteria-Caused/prolonged hospitalization: (NO)     Seriousness criteria-Disabling/Incapacitating: (NO)     Seriousness criteria-Congenital anomaly/birth defect: (NO)      Race ethnicity information available. patient occupation: None of the above  Start Date/Time: [Pfizer] 28Oct2021 12:30 PM  Location of injection for vaccine received same date: Flu Shot (Afluria Quad PF) - Right Arm  Dose received: 3 most_recent_dose_details: Product=COVID 19, brand=Pfizer, Brand unknown=False, lot number=320308D, lot unknown=False, Administration date=28Oct2021, Administration time=12:30 PM, dose_number=3, vaccine location=Left arm  Previous dose details: Prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EW0167, prev dose lot unknown=False, prev dose administration_date=29Apr2021,  prev dose dose number=2, prev dose vaccine location=Left  arm}, {prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=ER8732, prev dose lot unknown=False, prev dose administration date=01Apr2021,  prev dose dose number=1, prev dose vaccine location=Left arm  Other vaccine same date details: Other vaccine same date product= Flu Shot (Afluria Quad PF), other vaccine same date vaccine date=28Oct2021, other vaccine same date dose number=1, other vaccine same date vaccine location=Right Arm  facility type vaccine: Pharmacy or Drug Store facility name and address: Withheld  other medications in two weeks: D-Amphetamine, Escitalopram, Tri-Sprintec, Vit D  adverse event: Swollen lymph nodes under left arm. Painful and noticeably swollen compared to area under right arm. adverse event start date: 30Oct2021 adverse event country: US AE resulted in: None of the above if patient recovered: Recovered if treatment ae: No  Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No  Prior to vaccination, was the patient diagnosed with COVID-19?:No Since the vaccination, has the patient been tested for COVID-19?:No Device Date : 02Nov2021 known allergies: no other medical history: no  No follow-up attempts are possible. No further information is expected.
Chills (oral temp taken @ 98.6), aches, especially right deltoid, headache, mild nausea
Patient completed Tdap & Shingles IZ 2 days ago, noticed last night small erythema/warmth to L arm below injection site of first Shingles IZ. Site has not changed from last night. Denies pain, just some mild itching.   Vaccine from pharmacy
Client given High Dose instead of Regular flu vaccine. Regular flu and High Dose vaccine container bins had been moved/switched.
Patient with skin redness, itching, and large wheal (urticaria) to left upper arm surrounding site of Gardasil injection. First dose of HPV vaccine administered in clinic with parent consent on 7/1/19. Mother of child brought child to clinic with siblings who had appoitnments on 7/3/19 and asked for arm to be looked at by PCP. Patient was scheduled for appointment and seen. Benadryl was administered in clinic and advised continued use every 6-8 hours as needed for 1-2 days or until symptoms resolve. At time of vaccine administration no known allergies to any drugs, foods, or vaccines. Of note, mother of child reports the skin reaction began same day as administration later in the evening after leaving clinic, but was smaller. No medications were given at home and MOC sis not call to reprot because she wasn't sure if it was serious and planned to ask PCP at siblings appoitment 7/3/19. No other associated symptoms.
Extreme fatigue, extreme pain in ankle, hip & shoulder joints.  Extreme pain in neck.
(1st day around 930pm)  tired, stomach issue and chills, (2nd day, started around 12 pm) Fever - 101.6, chills, body aches, tired (Noticed second day thru current) large red welt at injection site, itchy; husband had similar reactions minus red welt and no stomach issues. His shot was two hours after mine.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This report was received via a Pfizer sales representative.  A female patient of an unspecified age and ethnicity received PREVNAR 13 and influenza vaccine; both via unspecified routes of administration on an unspecified date at single doses in the same arm for immunisation.  The patient's medical history and concomitant medications were not reported.  On an unknown date, after the vaccination, the patient experienced very red painful swollen arm with erythema, and mild fever. The patient was seen at the Emergency Room. Therapeutic measures were taken included treatment with antibiotics. The clinical outcome of the events, was unknown. Follow-up (14Sep2016): New information from a contactable pharmacist via Pfizer sales representative includes: new events and description.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 23-SEP-2016, the patient received improperly stored doses of PROQUAD (lot # M010478 with expiration date 01-SEP-2017, therapy type HSA; dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; They reported significant body aches.; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (BNT162B2 Formulation: solution for injection) via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced 15 persons received pfizer vaccine from vials that has been reconstituted with 1.3 ml instead of 1.8 and they reported significant body aches on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient
ADE: Major- Speech impairment, Coordination and balance difficulties, blurry vision, fatigue, muscle twitches,  confusion,  vomitting and severe migraine pains. (Minor: Inflammation of left arm, rash and swelling) Duration: (Continuing symptoms: fatigue, confusion and muscle twitches) (lasted 1-2months: speech impairment, coordination, severe migraine pains and balance difficulties) (Lasted a 2 to 3 days: vomiting and blurry vision) Treatment: Zofran and rest (failure to diagnose and treat) Time course: One hour of administration- difficulty of breathing and rashes; within few hours to days of administration- build up of ADE listed above.
Patient was given a COVID-19 vaccine not authorized for their age group. Patient was monitored for 15 minutes after the injection and no side effects were observed at that time. To this date, patient and/or guardian have not reported any side effects or symptoms since being vaccinated. Patient has since completed the vaccination series as recommended by the CDC which can be found on the Administration Errors and Deviations document. A discussion has occurred about how the error took place and strategies have been implemented to ensure that the error does not happen again.
This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients received improperly stored doses VAQTA (dosage, route of administration and indication were not provided), which were exposed  8.5C for 15 minutes. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Nausea, aches, flu-like symptoms, fatigue for 3 days.
During temperature excursion evaluation customer reported that a patient had been given a vaccine after it was improperly stored. No PQC. No additional information.          ?    Names of vaccines involved (including lot/exp) MMR II W035041 5/24/20; This spontaneous report was received from a medical assistant and refer to a 5-year-old male patient. There was no information about patient's concurrent conditions or pertinent medical history.  Concomitant therapies included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid(QUADRACEL) and varicella virus vaccine live (oka/merck)(VARIVAX).     On 20-JUL-2023, the patient was vaccinated with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) in the right deltoid, lot # W035041 with expiration date 24-MAY-2024 (dose was not reported) for prophylaxis (product storage error). The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was exposed to 1.4 degrees Fahrenheit for 8 hours and 2 minutes.
Vaccination on 1/6/2021.  Pt noticed pain behind her R ear on 1/11/2021. Pt then noticed right-sided facial weakness and asymmetry on 1/12/2021.  Pt went to  ED for evaluation.  Pt diagnosed with Bell's Palsy and given Valacyclovir and prednisone to be taken orally for 7 days and referred to  Neurology for ongoing care.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 23-AUG-2017, the patient was vaccinated with VARIVAX (lot # N002204, expiration date 19-JAN-2019) (route, dosage and frequency were not reported) which was improperly stored. The sterile diluent used to reconstitute the VARIVAX was properly stored. No symptoms reported. The vaccine was stored at -1.6 degree centigrade for 15 hours. The vaccine had previous temperature excursion which was stored at a temperature from -9 degree centigrade to 8 degree centigrade for 30 hours and 15 minutes. Data logger was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010758: US-009507513-1708USA010756: US-009507513-1708USA010757: US-009507513-1708USA010762: US-009507513-1708USA010754: US-009507513-1708USA010760: US-009507513-1708USA010761.
10/27/02 sx began with numbness, tingling, pain. Dx-transverse myelitis of spinal cord. Pt under treatment-improving.
Left arm right after given Pneumonia shot arm become very red, face, hands" 10-23-07 - Redness increased q day - put ice pack and Tylenol - Doctor gave Flu shot 10-16-07 in left arm - no reaction to that > recommend cold-compress, Tylenol inform MD
a rash started top of my head (forehead, scalp) and gradually worked its way down to my hips. After noticing that the rash was getting worse everyday, I consulted a dermatologist. He diagnosed me with pityriasis rosea. Prescribed Prednisone. The rash started to go away as I took the prescription. But once I finished it, the rash started to come back.
She has had a low-grade fever and been very irritable for a week now, having been in good spirits and fine before her shots.  Daily Tylenol and Ibuprofen.
"Left shoulder/arm pain started after flu shot 2 weeks ago.  I have been icing it and taking ibuprofen."  C/O weakness in left arm.  Then, as of 11/19/08, 14 days after vaccination, her pain had continued.  She then disclosed that she had left shoulder pain 2-3 days prior to the vaccine.  She was referred to her PCP for f/u evaluation and treatment
Patient received 2nd dose of Pfizer today. He did not disclose his Janssen COVID vaccine administration from earlier this year until after receiving his 2nd dose of Pfizer. Patient should not have received his 1st or 2nd dose of Pfizer with this clinic due to his previous COVID vaccination status.
Fatigue, weakness, Acute kidney injury, shock liver, thrombocytopenia, pneumonia, syncope, wide complex tachycardia over last 2 weeks
Primary series was Moderna 3/21 and 4/21 no issues, 1st booster Pfizer 1/17/22 no known reaction except that I has suddenly become sensitive to adhesive did not assume a correlation, after 2nd booster on 6/16/22 now noting adhesive sensitivity increased. I have used adhesives for years as an RN without issues, now even with Transparent Dressing Tegaderm / Bioclusive  I have Dermatitis and Pruritus .
Rash onset: 10 min after vaccines. Temp 100, body aches, wheezing onset: over 12 hrs after vaccines.
Dizziness. nausea, and vomiting, one time on 06/08/2005. " Sx resolved over 24 hour period".
This case was reported by a other health professional and described the occurrence of wrong vaccine administered in a patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccination. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccination were unknown. It was unknown if the reporter considered the wrong vaccine administered and inappropriate age at vaccination to be related to BOOSTRIX. Additional information received: A patient was given BOOSTRIX instead of PEDIARIX. No other information was given.
Pt received MENACTRA injection subcutaneously, developed some redness of the skin and warmth in area of injection later in the evening after receiving shot earlier in AM. Vaccine should have been given IM. Pt seen 1/14/13 and symptoms were resolving.
Local symptoms: Pain-discomfort. General Symptoms: Chills, fever, headaches, joint pains, fatigue. Narrative:
Over a period of 24 hours, I experienced: Severe headache, severe chills, severe joint and muscle pain, fogginess/confusion (I couldn?t comprehend anything), immobility and a 102 fever. I experienced those symptoms over the entire duration of the 24 hours.
PULMONARY EMBOLISM Patient reported to OSH 24 days after second Pfizer COVID-19 Vaccine with SOB--diagnosed with bilateral PE/DVT and remained inpatient for approximately 3 days. Patient also diagnosed with Afib and new onset CHF during admission. Discharged home with anticoagulation.
I was rushed to hospital and diagnosed the next day with Afib and put on Xarelto and metoprolol. Had a pharmacological stress test and an echocardiogram - all normal.
Patient presented with 4-inch circular swollen red, hot area at injection site. Started within 24 hours of injection, subsiding within 48 hours of injection.
Pt. reported feeling dizzy, faint, sweating, seeing spots. Her lips turned white. She stayed this way for approx. 10 mins. Recovered and walked out on her own volition. (Mom was present).
Reaction after Shingrix vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2019, the patient received Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The pharmacist asked any information on any cross ingredients between Boostrix and Shingrix. The health care professional stated that the patient would like Boostrix but had a previous reaction to the Shingrix. The reporter consented to follow up.
This spontaneous report was received from a Registered Nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date, the patient was vaccinated with improperly stored VARIVAX, lot # R002054 and expiration date on 22-JAN-2018, for prophylaxis (route of administration and anatomical location were not reported). It was reported that the vaccine was reconstituted with properly stored sterile diluent. The administered dose of the vaccine experienced a temperature excursion of -9 to 8 degrees Celsius for 2 hours and 47 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA012082: US-009507513-1810USA012270: US-009507513-1810USA012269.
Extrema fatigue, shortness of breath, headache, chills, for 24 hours wheezing and cough and headache for 3-4 days
This is a positive one, and I can hardly believe it. My irregular pupil dilation independent of each other, occuring for 12 years corrected itself! I swear this is not a joke. I'm flabbergasted.   The longer explanation:  Something I never talk about, partially because I am scared, is an issue with my eyes that started when I was 19. I am now 36.  My right pupil will dilate quite irregularly from my left. A bright light will correct it, but then it will start again after. I've mentioned it to eye doctors, and they brushed it off. Research only has scary answers, with no help, so I have learned to live with it.  It used to make me dizzy, nauseous, and I'd lay down. But over the years I've adjusted, and it doesn't bother me.  I received the first dose of the Pfizer vaccine on 3/11. Last night, 3/14, I became dizzy and faint.   Today, I still felt that way. I was splashing cold water on my face, when I realized, looking in the mirror, my pupils were exactly the same size! And maintained that same diameter.  I keep checking, but, so far, it's consistent.   I assume the dizziness, lack of balance, and slight faintness today is my body getting used to this, as it's been compensating for the difference for 12 years.  So, is this a positive side effect? A coincidence? The vaccine is the only recent change, and nothing else has effected this issue over the years.
Tingling entire face; Right side chest pain; Mid lateral left thigh pain; Body ache; Fever; The patient received third/ booster dose of BNT162B2; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Nov2021 at 18:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included fatty liver. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. The patient previously first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 02Nov2021 at 18:15, the patient experienced tingling entire face, right side chest pain, mid lateral left thigh pain, body ache and fever. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling entire face, right side chest pain, mid lateral left thigh pain, body ache and fever was resolved on an unknown date in Nov2021.    The lot number for BNT162b2 was not provided and will be requested during follow up.
2nd dose outside of dosing interval; Pain in arm; Diarrhea; Headache; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose outside of dosing interval), PAIN IN EXTREMITY (Pain in arm), DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose outside of dosing interval), PAIN IN EXTREMITY (Pain in arm), DIARRHOEA (Diarrhea), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose outside of dosing interval), PAIN IN EXTREMITY (Pain in arm), DIARRHOEA (Diarrhea), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.            On 08-Jan-2021, the patient received their 1st dose of Moderna vaccine and late on 24-Mar-2021 the patient received their 2nd dose which was outside of dosing interval. The patient reported side effects experienced only post receiving the 2nd dose which included nausea, fever, pain in arm, headache, and diarrhea.   Reportedly these symptoms resolved in 12 hours. The patient also stated that their Health care professional planned to administer the 3rd dose of Moderna vaccine since their 2nd dose was given outside the 42 day window and informed that their HCP doesn't believe that the patient was protected.  No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
slight hallucination; headache; lethargy; This is a spontaneous report received from a contactable consumer. A adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient was not pregnant. The patient medical history and concomitant medications were not reported. 48 hours the patient experienced slight hallucination, headache, lethargy on an unspecified date with outcome of recovered on an unknown date. Treatment for adverse event was No. The events were reported as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv 1st dose of vax;devel v,flu like sx, concentrated urine, rt upper quadrant pain & swelling under her rt breast & rt side of back;gallbladder ultrasound was neg;pt felt that sx related to vax & discontinued the series;recovered;