chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose several years ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Aditional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter declined to provide any additional information. The reporter did not consent to follow up.
p/vax pt exp a 6-7 inch painful, red, hot & swollen area @ inj site;no tx given;the most recent info recv on 6/3/99 reports their sx resolved;
Prolonged muscle soreness, pain Pt. went to MD - MD prescribed Pt. x 3 wks. Continues to complain muscle ache doing certain activities.
Resting tachycardia; Heart pressure continued; 5-10 min after; shortness of breath; 5-10 min after; pressure on right side of chest; Usual sore arm; This is a spontaneous report from a contactable physician, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Sep2021 at 16:45 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. It was unknown if patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14Sep2021 at 16:55, 5-10 min after, the patient experienced shortness of breath and pressure on right side of chest. It lessened a few hours after but still felt short of breath. She also experienced usual sore arm that evening and next morning. On 15Sep2021, short breath and heart pressure continued intermittently. On 16Sep2021, third day after vaccine, the patient had put her apple watch on to track her heart that day and specifically during the phases of pressure. The patient had resting tachycardia about 130 beats per minute lasting one to two hours and slowly dropped to about 90 beats per minute average throughout the work day. The patient's usually resting heart rate was about 60 beats per minute. This continued for another few days. The patient had not tracked her heart rate in the last few days to say if the tachycardia had continued or not. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On the 16Sep2021, the patient underwent heart rate test and the result was about 130 beats per minute and 90 beats per minute. On an unknown date, the patient underwent heart rate test and the result was about 60 beats per minute. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 5-10 min after, the patient experienced shortness of breath and pressure on right side of chest, usual sore arm, heart pressure and resting tachycardia were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Felt like I was losing consciousness; Mouth watering; fought to breathe; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Felt like I was losing consciousness), SALIVARY HYPERSECRETION (Mouth watering) and DYSPNOEA (fought to breathe) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX in 2020, TETANUS VACCINE in 2020, PNEUMOCOCCAL VACCINE (pneumonia vaccine) in 2020 and INFLUENZA VACCINE in 2020. Concurrent medical conditions included Drug allergy ("allergic to caines"). Concomitant products included SIMVASTATIN, LISINOPRIL, METFORMIN and ACETYLSALICYLIC ACID, ASCORBIC ACID (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) for an unknown indication.    On 29-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PRESYNCOPE (Felt like I was losing consciousness), SALIVARY HYPERSECRETION (Mouth watering) and DYSPNOEA (fought to breathe). On 29-Jan-2021, PRESYNCOPE (Felt like I was losing consciousness), SALIVARY HYPERSECRETION (Mouth watering) and DYSPNOEA (fought to breathe) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Heart rate: increased (High) heart beating fast. On 29-Jan-2021, Respiratory rate: increased (High) rapid breathing.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of these events were not reported.  Per report, within 25 minutes following vaccination, the patient experienced two episodes of presyncope, dyspnea, and increased salivation. About one hour after vaccination the patient reported feeling normal again.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Additional information received on 22APR2021 included updates on end date, outcome and events.
Patient developed a sensation of feeling "warm" and reported to the checkout station.  I was at the patient's side and a pulse ox was placed immediately.  She appeared otherwise well w/o signs of distress, SOB, or AMS.  Patient was given cold water and monitored.  SPO2: 99%  HR: 73.  Within 15 minutes her symptoms improved and patient required not additional monitoring or treatment.  She was released from the facility with strict follow up precautions.
Anthrax vaccine given in May, 2000, before she went overseas. Developed muscle ache, fatigue, diarrhea, severe RUQ abdominal pain, anorexia, joint pains, headache and folliculitis. Also fever, nausea & vomiting. Medical records indicate additional diagnoses of GERD and depression.
This spontaneous report as received from a pharmacist refers to a 67 year old male patient with migraines and reaction/allergy to unspecified Nonsteroidal anti-inflammatory (NSAIDS) drugs. The patient's medical history was not reported. On 17-DEC-2010, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-Forming Units (PFU), 1 shot, subcutaneous (lot number and expiration date were unknown). Concomitant therapies included unspecified medications. On approximately 17-JUN-2016, reported as "about a week ago" the patient developed an unspecified rash on his chest. Then, the patient was seen by his unspecified physician on an unspecified date and he prescribed VALTREX for the adverse event. The outcome of rash was unknown. The causality between ZOSTAVAX and the rash was not provided. Additional information had been requested.
During our covid site visit on 12.15.22, it was discovered that we had a pfizer batch in the frig past BUD date. During the investigation they went back through all the covid injections that were given and saw this patients lot number was given past BUD date. patient has been contacted and revaccination was offered. manufacture was notified and reports were filed pending outcome.
no high fever;no limpness;persistent high pitch crying x 3hr that evening w/o recv vax 11JUN96
This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M004883, expiration date: 02-OCT-2017 and lot# M019690, expiration date: 02-NOV-2017) (orally, dose was not provided). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion above 46 degrees Fahrenheit and less than 77 degrees Fahrenheit (the highest temperature: 46.81 degrees Fahrenheit) for 90 minutes. Data logger was involved. There were no previous excursions reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA010895: US-009507513-1702USA002226: US-009507513-1702USA002227:
01/15/22 presents to EC ED for "toe pain, nausea/vomiting, and decreased urination". PMHx of "CKD stage 3, lupus, insulin dependent diabetes (Basaglar 62 units Q12hours and Novolog 15 units TIDAC), HTN"
Pt was vaccinated with 2 doses of MMRII. Post vax pt experienced a negative antibody test for rubella. No further info is available.
B/L rash - thighs around shot, larger than 50 cent piece for one week. Has not seen MD, now has runny nose, green mucous Sat AM, off and on temp. Mom will call if she takes child to the MD.
About 2 hours after the 2nd shot, my arm was extremely painful all the way down to my wrist. About 10:30 pm last night, I woke up and realized that I was shaking uncontrollably, even violent at times, for the next 1 1/2 hours and then it suddenly stopped. But then 20 minutes later I started shaking uncontrollably again for several hours.  It is currently 8:30 am the next morning and I am still noticing some shaking,  just not as violent as before.
administered expired ACTHIB with no reported AE; Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19 months old male patient who got administration of expired HIB (PRP/T) vaccine [ACT-HIB] with no reported ae.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination.  On 22-Nov-2022, the patient who got administration of expired HIB (PRP/T) vaccine [ACT-HIB] with no reported ae (expired product administered) and received a dose 4 of 0.5 ml once Powder and solvent for solution for injection of standard strength (lot: UJ594AAA, expiry date: 26-Oct-2022) via intramuscular route in the right deltoid.  Action taken: not applicable.  Outcome: Unknown.   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 guidelines. 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.
Information has been received from a pharmacist concerning a 53 year old female patient with a drug allergic to morphine. Information regarding pertinent medical history was reported as unknown. Concomitant therapies included metoprolol succinate, tamoxifen, hydrochlorothiazide (manufacturer unknown), PROTONIX, PRAVACHOL and indomethacin (manufacturer unknown). On 26-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # M018593, subcutaneous, expiration date 28-JUN-2017, dose not reported). On 31-JUL-2016, the patient stated that she "felt drained and tired" which started on an unspecified date after being administered ZOSTAVAX. The pharmacist reported "the patient's physician submitted a prescription for the patient on 02-AUG-2016 for a methylprednisolone dose pack and a Z-PACK." The outcome of event was unknown. Additional information has been requested.
pt recv vax JAN96 & on 7JUL96 pt devel pruritic bumps on forehead, both arms & legs,, chest & back;the bumps were described as lighter in color @ the top of the bumps than surrounding skin;tests showed no breakthrough chickenpox;
Following varicella/MMR vaccine given on thighs B/L hives noted about 1/4 inch welts resolved in 3-4 mins. Responded to Benadryl. patient watched for 20 min for no other reaction.
The patient received the pfizer vaccine to the patient for the first dose. About 5 minutes after the vaccine the patient experienced adverse effects and could not breathe.  Due to this we administered a epipen to the patient and the patient was able to breath afterwards. We also called the EMT who examined the patient. The EMT said the patient was okay and did not have to take the patient to the ER.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.     On 06-Feb-2022 at 10:25 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022 at 10:25 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. It was unknown if other vaccines were given on the same day or within one month prior to any dose of as Moderna COVID-19 Vaccine to the patient.  Patient received booster dose. Patient ethnicity reported as white. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.   No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
pt states she experienced pain an numbness down her arm the of vaccination, but only had a sore shoulder the following day. she states that 8 days later she experienced a 'frozen shoulder' where she experienced pain with movement and difficulty moving her arm.
First shot was in left arm. Within 2 days of first shot, I had what felt like bee stings/sharp, shooting pain in left axilla. I received second shot in the right arm. Within 2-3 days after second shot, I had severe left arm symptoms. These included severe pain in axilla, burning in upper arm, aching/weakness of whole arm, involuntary muscle contractions, and electrical, sharp, shooting pain. Symptoms were the worse in the first couple months. Over time, the symptoms lessoned. Over 4-6 months, I was much better. Currently, I am typically symptom free with rare 1-2 day mild flares of pain in left axilla and left arm weakness.
7 month old received kinrix inadvertently; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2LK4K, expiry date 09-NOV-2023) for prophylaxis.   On 16-JAN-2023, the patient received Kinrix. On 16-JAN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 7 month old received kinrix inadvertently). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAR-2023 The nurse reported that a patient received the kinrix vaccine inadvertently. The patient received Kinrix at the age of 6 months, which led to an inappropriate age at vaccine administration. The reporter consented to follow up.
103.1 temp, Nauseous, next day after the booster,  swollen lymph node, headache    now sinus issue, gone into upper teeth on left side and jaw pain  continue to not feel well, 5 days later
1.5? diameter area of redness, itching, painful to touch, firm to touch (hard lump), warm to touch
Nausea; Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 (Lot number: ER8730) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Lot number =EN62085,, administration date =03/03/2021,, administration time =03:45 PM,, vaccine location =Right arm,), administration date: 03Mar2021, when the patient was 51 years old, for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 17Apr2021 08:00, outcome "not recovered", described as "Nausea "; DIZZINESS (non-serious) with onset 17Apr2021 08:00, outcome "not recovered", described as "Dizziness". The events "nausea " and "dizziness" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of nausea, dizziness.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021452255 same drug/event, different patient
Daughter instantly complained about her eyesight.  Within 6 weeks of hearing same complaint I took her to Eyecare.  Dr indicated he "rarely sees such abrupt changes in eyesight.  20/20 to 20/70 and it is possible she will not be able to drive as she gets older".   He emphasized the severity of the condition and referred us to Opthalmologist.
active case of Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2022, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt date: 25-Jan-2023. Reporter's Comment: The patient self-reported this case. The patient received Shingrix on left arm. The patient stated that she had an active case of Shingles (lack of effect). The reporter consented to follow-up.
blood sugar 300-500 low blood pressure 70/54 headache pain in right leg llimited mobility right arm painful ;limited memory clamy feeling  sweaty
Patient had a reaction to a vaccine where the injection site became red and swelled up. Patient stated that the redness became worse when she came in on 09/03/2018. Pharmacist on duty informed patient that if it spreads further to contact her primary care doctor. However, if the redness subside that she will be fine. Patient was taking hydroxyzine prescribed from her doctor which seem to help.
Pt received injection of H1N1 vaccine through the Health Department, they came to his workplace on 12/22/2009. On 12/26/2009 he developed a red rash with hives more on inside of his both arms than on the outside of his arms, he also had some on his chest and back, but not as many raised areas as on his arms.  He saw a physician on 12/28 and was diagnosed with a rash, as per conversation with mom , he was placed on a "cream" and oral Benadryl".  His symptoms are gone now but according to patient's mom they lasted "well after the New Year" He has received seasonal flu vaccines in the past and had no reaction.  Mom and dad are reluctant to give information over the phone.  Mom stated they do not want to receive "anything in the mail" The patient does not have a private doctor but sees various doctors when necessary.
I was sore and extremely tired, also headache but now I have a bad sore throat that has not resolved. I am concerned because I took Tylenol before my second shot and have now heard that I shouldn?t have.
Dizzinesss, nausea, off balance, wobbly. (R) arm (Flu shot) hot red spot 30x20 mm. (L) arm (Tdap) hot to touch, sore arm. Rx Loratadine 10 mg tabs.
Swollen arm, red, rashy, hot and itchy arm all reported to manufacturer on 2/10.  Went to visit doctor 2 days later and Dr said to take antihistamines and that this happens to about 1 in 3 patients. Patient now reporting (2/17/2015) that it looks like she has chicken pox in certain areas under he breasts and arm.
On 1/16-17, he started to have left arm/shoulder pain that slowly migrated and became chest pain 2/21: chest pain, nausea, vomiting, fevers
red and swollen; red and swollen; experienced tenderness in her armpits; began experiencing itchiness; experiencing headaches; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (began experiencing itchiness), VACCINATION SITE ERYTHEMA (red and swollen), VACCINATION SITE SWELLING (red and swollen), TENDERNESS (experienced tenderness in her armpits) and HEADACHE (experiencing headaches) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included DIETHYLPROPION HCL for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (experiencing headaches). On 18-Mar-2021, the patient experienced PRURITUS (began experiencing itchiness). On 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red and swollen), VACCINATION SITE SWELLING (red and swollen) and TENDERNESS (experienced tenderness in her armpits). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, PRURITUS (began experiencing itchiness), VACCINATION SITE ERYTHEMA (red and swollen), VACCINATION SITE SWELLING (red and swollen), TENDERNESS (experienced tenderness in her armpits) and HEADACHE (experiencing headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Tylenol.