chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Asthma issues; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6208), via an unspecified route of administration on 27Mar2021 as dose 1, single for COVID-19 immunization. Medical history included allergy to chemicals from an unknown date and unknown if ongoing, patient reported that she had reactions to PEG and Anhydrase Lactase which causes generalized swelling all over her body and mostly her hands. The patient's concomitant medications were not reported. The patient also reported that her pain management doctor told her not to take Motrin or Tramadol because it made her swell. Patient reported that she received her first vaccine dose on 27Mar2021 and afterwards started having some asthma issues (2021) and wondered if the vaccine had any PEG or Anhydrase Lactase or components of those ingredients. She further reported that her second dose was due on Saturday and she wanted to make sure. The clinical outcome for the events was unknown.  No follow-up attempts are needed. No further information is expected.
Pt received 4 vaccines 3 days ago on 8-5-11 on 8-7-11 pt started having neck pain and stiffness - c/o pain on palpating around base of skull - tightness of (R) sternocleidomastoid.
Treatment of COVID-19; Treatment of COVID-19; Moderna Dose Number: 3, Date: 17Mar2022 ; Pfizer / BioNTech, Date: 23Oct2021; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 64 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Jan2021 as dose 1, single (Lot number: 039K20A), on 08Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 17Mar2022 as dose 4 (booster), single (Lot number: 026L21b) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Oct2021, outcome "unknown", described as "Moderna Dose Number: 3, Date: 17Mar2022 ; Pfizer / BioNTech, Date: 23Oct2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: had tested negative on day 9, then tested positive again after being negative for 2 days; Negative, notes: had tested negative on day 9, then tested positive again after being negative for 2 days; Positive, notes: then tested positive again after being negative for 2 days; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: No other medical history and known allergies were reported. The patient did not receive other medication in 2 weeks. The patient received treatment with Paxlovid from 29Jan2023 to 04Feb2023.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of " INTERCHANGE OF VACCINE PRODUCTS "," DRUG INEFFECTIVE ' and "COVID-19 ".
ANTIBODIES ATTACHED TO HER RED CELLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 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 antibodies attached to her red cells. Laboratory data (dates unspecified) included: Direct Coombs test (NR: not provided) Antibodies, but they have attached to red cells. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of antibodies attached to her red cells was not reported. This report was non-serious.
Mild varicella rash-zovirax 1 tsp 3 times a day for 5 days.
Menstruation started a week and  half  after vaccination and is ongoing. (Normal one already happened at the beginning of the month.)   Received several vaccinations before, never had side effects.
7 days after my vaccination my right arm started itching about an inch below the vaccination. I massaged it, it felt warm and the itching stopped withing a minute of starting. The following night about 7 pm, it started itching again, and this time it felt hot, and a 1" high, 3" wide red oval had developed along with an itchy bump on the outer edge of the oval. I quickly found an article from researchers about Covid Arm. It said most such reactions resolved in 2-3 days, so I wasn't too worried. I iced it, took a half dose of Benadryl, and the oval was barely visible the next day. The dizzyness I had been feeling all week also resolved at the same time the rash did.
Truly no adverse event.  Patient was 17 years old at time of first injection.  Moderna product is indicated for ages 18 and above.  Patient's physician was called and notified of patient receiving first dose at 17 years old.  Patient responded fine to vaccination with no ill side effects.  Her MD aware of what happened.
C/o difficulty breathing, SOB; diaphoretic. O2 via N/C at 24m, 1 dose Benadryl 50mg po. Within 20 min, sx's subsided and pt released.
Patient received a vaccine dose that was under refrigerator storage for longer than the recommended 30 days. The vial was placed in the refrigerator on 4/13/2021, and thus was given 12 days after the 30 day limit. Moderna was contacted but gave no further stability information or recommendations. There are articles available that state Moderna has found the product to be stable for 90 days at refrigerator temps. Patient was notified and no recommendation for a repeat dose was given. No adverse reactions experienced.
03/16/22 presents to ED for "syncope". PMHx of "complicated renal transplant 2016 (on tacrolimus and mycophenolate), T2DM, HTN, diastolic dysfunction EF 55%"
soaking wet; temperature of 99.9; her hands and feet swelled like balloons; felt very sick; dizzy; itchy; rash; did not feel well; nauseous; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (her hands and feet swelled like balloons), ILLNESS (felt very sick), HYPERHIDROSIS (soaking wet), DIZZINESS (dizzy) and PRURITUS (itchy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced MALAISE (did not feel well) and NAUSEA (nauseous). On 14-Apr-2021, the patient experienced PERIPHERAL SWELLING (her hands and feet swelled like balloons), ILLNESS (felt very sick), DIZZINESS (dizzy), PRURITUS (itchy) and RASH (rash). On 19-Apr-2021, the patient experienced HYPERHIDROSIS (soaking wet) and PYREXIA (temperature of 99.9). At the time of the report, PERIPHERAL SWELLING (her hands and feet swelled like balloons), ILLNESS (felt very sick), HYPERHIDROSIS (soaking wet), DIZZINESS (dizzy), PRURITUS (itchy), MALAISE (did not feel well), RASH (rash), PYREXIA (temperature of 99.9) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Body temperature: 99.9 (High) 99.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported.  Treatment drug include Benadryl, Zyrtec, Tylenol for her symptoms. The patient's rash felt better with a shower.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-081607 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-081607:
7/17/08 PEDIARIX, ROTATEQ. Mucousy diarrhea (10-15 x/day) began 7/23.  7/27-clots of blood in stool/fussy, to ER, had successful reduction of intussusception via air-contrast enema. Admitted.  Continued bloody stools/fussy, on Nutranigen, 7/24-transferred to hosp. then diagnosed as milk protein allergy, bloody stools cleared on NEOCATE. Discharged 7/31/08. 11/14/08 Reviewed hospital medical records 7/29-7/31/2008. FINAL DX: abdominal pain & bloody stools s/p intussusception enema reduction Records reveal patient experienced irritability, diarrhea, bloody stools, mucous stools, decreased activity, oral intake reduced x 4 days.  Evaluated in outlying ER/hospital.  Had been admitted overnight for observation s/p enema reduction & developed recurrent symptoms.  Barium enema done & reduced IS.  Symptoms recurred again & family requested transfer. Surgery & GI consults done. Improved & d/c to home w/outpatient GI clinic f/u.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 13-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX injection (1 dose/once, subcutaneously; lot# and expiration date were not provided), to prevent shingles. On 14-FEB-2017 (reported as "the next day"), the patient experienced a red streak on her arm. The pharmacist was not able to confirm whether the red streak was rash-like or not. However, he advised the patient to see a physician if something changes. It was reported, that Varicella Zoster Virus (VZV) was alerted as a precaution. At the time of the report, the patient did not recover from the adverse event, and she stated, that the streak did not bother her so she was not going to visit a physician. The relatedness between the adverse event and ZOSTAVAX was not reported. Additional information has been requested.
I feel off, not myself. I had chest pressure/heaviness. Hands shaking, tremors at times, internal trembling. Cold chills. Arm soreness. Insomnia. Lower body tingling. Extremely fatigued. Some issues are better some still continue.
Skin Blisters; developed a UTI; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Skin Blisters) and URINARY TRACT INFECTION (developed a UTI) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced URINARY TRACT INFECTION (developed a UTI). On 22-Mar-2021, the patient experienced BLISTER (Skin Blisters). The patient was treated with CIPROFLOXACIN HYDROCHLORIDE (CIPROFLACIN) for UTI, at an unspecified dose and frequency. At the time of the report, BLISTER (Skin Blisters) and URINARY TRACT INFECTION (developed a UTI) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No concomitant medications were reported
a 13-year-old female received Fluzone HD inadvertently/No AE; a 13-year-old female received Fluzone HD inadvertently/No AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 13 years old female patient who received 0.5 mL vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ268AA, expiry date- 10-May-2020 (Frequency = once) via intramuscular route in the left deltoid on 17-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines received.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Severe headache; increased heart rate avg. 103 bpm; very dry throat; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A 31-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot number: Unknown) via an unspecified route of administration in Right Arm on 06Feb2021 at 03:45 PM as 2nd dose single and first dose via an unspecified route of administration on 16Jan2021 at 11:00 PM as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any vaccine in 4 weeks and 2 weeks prior vaccination. The patient did not tested covid prior and post vaccination. Patient was having no allergies. On 07Feb2021 at 09:00PM, the patient experienced severe headache, increased heart rate avg. 103 bpm and very dry throat. The patient did not receive any treatment. The patient underwent lab tests and procedures which included heart rate: increased heart rate avg. 103 bpm on 07Feb2021. The clinical outcome of the events was not recovered.   Information about Lot/batch number has been requested.  Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
NAUSEA,  WOOZINESS TREATMENT- WATER, LAY ON THE COT
rt arm redness & swelling surrounding the inj site pt told to put ice pack on infected area;nurse saw rxn @ inj site when pt came for shots on 28DEC98;
vomiting; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was recovered/resolved.   It was unknown if the reporter considered the vomiting to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the Spring of 2019 in the left arm. The patient reported that, in the night after vaccination, the patient experienced vomiting for about 5 hours and then it resolved in the next morning. The patient did not consent to follow up.
lump size of duck egg at injection site; hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (lump size of duck egg at injection site) and INJECTION SITE WARMTH (hot to the touch) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 93M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE MASS (lump size of duck egg at injection site) and INJECTION SITE WARMTH (hot to the touch). At the time of the report, INJECTION SITE MASS (lump size of duck egg at injection site) and INJECTION SITE WARMTH (hot to the touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unknown medicine for blood pressure  No treatment information was reported.
DONOR HAD FEVER FOR 2 DAYS WITH BODY ACHES. CONTINUES TO HAVE HEADACHE, BITTER TASTE IN MOUTH, BODY STILL FEELS A LITTLE WARM. DONOR HAS BEEN TAKING OTC ASPRIN, DAY AND NIGHT, COUGH DROPS .
3 patients received booster doses from an expired vial (lot #001C21A & a manufacturer expiration date of 13Dec2021) of the Moderna Covid-19 Vaccine today 15Dec2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received booster doses from an expired vial (lot #001C21A & a manufacturer expiration date of 13Dec2021) of the Moderna Covid-19 Vaccine today 15Dec2021) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received booster doses from an expired vial (lot #001C21A & a manufacturer expiration date of 13Dec2021) of the Moderna Covid-19 Vaccine today 15Dec2021). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (3 patients received booster doses from an expired vial (lot #001C21A & a manufacturer expiration date of 13Dec2021) of the Moderna Covid-19 Vaccine today 15Dec2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment details were not given.   This case was linked to MOD-2021-414469 (Patient Link).
Large painful induration and fever.  Fever caused altered mental status either directly due to fever or indirectly by causing lowering of seizure threshhold and pt had complex partial seizure. 10/28/2009 hospital records from 9/26-9/29/2009. Patient with sx of chills, fever and altered mental status. Tx: IV ABX, med to decrease ammonia levels. DC DX's: AMS, PNA, vaccine reaction, Loss of consciousness, not likely due to seizure
Woke up with right side of mouth, cheek & eyelid swollen the day after receiving the shot. This resolved itself in about 2 days. Two days after the shot, the upper lip was swollen. That resolved about 5 days later.
Patient received vaccination, fainted immediately following injection at 4:20pm. Safely positioned on the floor, vital signs assessed, BP was 77/59, pulse 55, pulse ox 99 on room air at 4:21pm; alert and oriented x4, responsive and vitals reassessed within normal limits at 4:25pm. cold compress and water provided. patient ambulated to observation area, monitored by EMT at 4:30pm. patient observed for 30 minutes, advised to download vSafe for follow guidance post discharge.
Pt. recieved vaccine past 12 hours expiration. No adverse event. MD contacted pt. Pt. wants to get booster in December.
Patient is a 62 year old male and recieved the flu vaccine on 1/12/09. He reported a history of Diabetes. He was recovering from a mild upper respiratory ailment and his oral temp was 98.4   No problems initially followed the vaccine. I saw the patient the weeks following the vaccine but he voiced no complaints. The school staff notified me in early March 2009 that patient had a diabetic stroke in late February 2009 and was hospitalized. I talked to the patient by phone on 4/2/09 and he told me he has suffered a stroke on the left side of his brain that caused weakness of the right side of his body.  4/20/09 MR received for DOS 2/25-3/06/2009 with D/C DX: Acute L Subcortical Ischemic stroke, DM2, high choleterol, High BP, hx GERD and hypokalemia.  Pt presented with 1 day hx of R sided weakness and numbness as well as heaviness in the R leg.  Attmpted to walk but fell, now with slurred speech. PE (+) for mild facial droop, decreased sensation, and R arm weakness.  Some improvement by d/c to rehab.
Getting scalp on top of my head and that is like scab growing on my head; This is a spontaneous report from a contactable consumer (Patient) or other non health care professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated, I would like to speak about adverse event that I received, I had Covid Vaccine few months earlier I am getting scalp on top of my head, it is like scab that has grown. I don't know what is going on it's like "Anchil (not clarified the word) that is like scab growing on my head." Patient never had it before Covid vaccine. that is not approved and then I find a paper work, where I can do now, what am I supposed to do now. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Infant developed melena 48 hours after immunizations. Infant appeared well otherwise without any other symptoms, had 2 to 3 large black tarry stools. Referred to ED, had normal KUB and normal labs, observed for many hours, then discharged home. 2 days after ED visit (4 days s/p immunizations) infant was fussy with feeds and drinking less. Referred to ED, observed, and then discharged home. Subsequently, no further melena, GI consulted and ultimately, no specific reason identified for melena.
patient was given a PENTACEL injection, but only received the liquid component, without the power reconstituted in it with no reported adverse event; Initial information received on 27-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2-month-old female patient was given a diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] injection, but only received the liquid component, without the power reconstituted in it with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Sep-2023, the patient received a dose 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection strength, expiry date, lot number not reported via intramuscular route in the left thigh for immunization and patient was given a pentacel injection, but only received the liquid component, without the power reconstituted in it with no reported adverse event (product preparation error) on the same day.Information on the batch number was requested.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient was given a pentacel injection, but only received the liquid component, without the power reconstituted in it with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.