chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Notified by general clinic staff that client's mom reported child vomited after getting into her car. Evaluate client-color pink, skin slightly clammy, pulse slow and regular. Client stated she was feeling ok. Per mom, client was in for 1st Hep B, was afraid and crying before the shot and she feels this is reason child vomited. Mom gives history of reaction to 1st DTP of prolonged crying. Did not share this info when 2nd DTP given. Following 2nd DtP became limp after receiving. Talked with client and mom for awhile and child seemed ok. Advised to notify health department if further problems. Call from mom approximately 1 1/2 hours after leaving health dept. States child vomited x 2 after getting home. Advised to have PMD evaluate and notify health dept of recommendation. Discussed above with RN who advised completing VAERS form and send to her. Call from client's mother states she talked with PMD by phone. PMD does not feel vomiting is related to Hep B immunization and ok to give 2nd dose. 06/17/02 3pm, call to pt's home-mom at work but pt states she has had no more vomiting or effects from shot.
This spontaneous prospective pregnancy report was received from a physician assistant refers to a female patient of unknown age. The medical history, concurrent conditions and concomitant medications were none. On 08-FEB-2016, the patient was vaccinated with VARIVAX (Merck) lot # L016127, expiry date 06-MAY-2017, 0.5 ml, subcutaneous. The patient's LMP was 29-NOV-2015 and EDD of 04-SEP-2016. The patient had an unspecified pregnancy test performed on 15-FEB-2016 which came back positive. The patient sought medical attention. Additional information has been requested.
TDAP VACCINE ADMINISTERED THIS 0800 AM.  Pruritis and hives on limbs @0830. PT TAKEN TO TX ROOM. GIVEN 25 MG BENADRYL IM NOW IN TREATMENT ROOM.
Medical consult text was sent to medical lead since client reported with the first Pfizer COVID vaccine, he had diarrhea in the middle of the night then six to seven episodes of diarrhea on the first day. For an additional 5 days, he had two to three diarrhea episodes a day. He stated had occasional diarrhea with milk consumption but denied milk consumption prior to those episodes. He treated the diarrhea with Pepto Bismol. He denied other signs or symptoms of anaphylaxis or dizziness. He stated he didn't have a follow-up with PCP.  He reported he has history of hypertension but discontinued medications on his own. He reported no known allergies.
Very hot to the touch; At the injection site there is really hard section of her upper arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Very hot to the touch) and VACCINATION SITE INDURATION (At the injection site there is really hard section of her upper arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced VACCINATION SITE WARMTH (Very hot to the touch) and VACCINATION SITE INDURATION (At the injection site there is really hard section of her upper arm). At the time of the report, VACCINATION SITE WARMTH (Very hot to the touch) and VACCINATION SITE INDURATION (At the injection site there is really hard section of her upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.  Events had gotten worse rather than better was noted.
Information has been received from a certified medical assistant referring to 11 children patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications were not reported. On 19-MAR-2015 improperly stored PROQUAD (Merck) (dose, route of administration were not reported) was administered to these 11 children. Lot# and expiration date of PROQUAD (Merck) was reported as Lot# K02248 Exp 13-MAY-2016; Lot# K022445, Exp 13-MAY-2016, Lot# K022447, Exp 13-MAY-2016. The reporter did not specify which lot numbers of PROQUAD (Merck) were administered. No adverse events were reported. This is one of several cases reported by the same source. Additional information has been requested.
Pt developed a typical case of chickenpox following exposure to a household contact who was vaccinated in 10/1999 with one dose of varicella virus vaccine live.
Patient got vaccine on a Wednesday and still had swelling and fever in her arm at the site of injection on Monday. She went to see her primary physician for treatment on Monday.
Rash on his left arm, both legs; Dry mouth; Dehydration; Two days after / vaccine / started to have Diarrhea which is ongoing; This case was reported by a consumer via patient support programs and described the occurrence of diarrhea in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included post-traumatic stress disorder.   On 16th June 2021, the patient received Shingrix. On 18th June 2021, 2 days after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the patient experienced rash, dry mouth and dehydration. On an unknown date, the outcome of the diarrhea, rash, dry mouth and dehydration were not recovered/not resolved.   The reporter considered the diarrhea to be unrelated to Shingrix. It was unknown if the reporter considered the rash, dry mouth and dehydration to be related to Shingrix.  Additional details were provided as follows: This report was submitted via the online direct entry reporting system.  The patient received Shingrix and 2 days after receiving vaccine, patient started to have diarrhea which was ongoing.  The patient started to get a rash on his left arm and both legs after receiving the Shingrix Vaccine.  Also the patient had dry mouth and dehydration after taking the Shingrix Vaccine. The Health Care professional (HCP) not consented to contact.
20-25 post vaccination, pt reports swelling in tongue & difficult breathing. Administered epipen. Pt immediately said she felt much better. Counseled her to seek medical attention even though she was feeling better. Called & checked on pt about 2 hours later. She said she's doing just fine.
I think this is still a little early to tell if the length of my period was truly impacted by the vaccine or not but it has shortened by a couple days (average) the past 3 cycles - which would have been all of the cycles since being fully vaccinated. I changed BC to a non-hormonal IUD on June 1st. The first cycle after getting the IUD was 30 days; then they were all pretty consistent at 27-28 days with the exception of 2 months which were 31 and 32 days. The start dates of the 2 longer cycles were Feb 5, 2020 (100% pre-vaccination) and March 8, 2020 (first shot received March 23). Considering I already had one long cycle prior to any vaccination I do not think the following cycle being longer had to due with the fact that received my first vaccine at Day 16 of my cycle. I had two normal cycles following that: April 9th was the start of a 28 day cycle - I received my second dose of COVID vaccine on April 20th which was day 12 of my cycle. The following cycle also seemed normal at 27 days starting on May 7th. However, that was my last normal cycle. I have since had 3 cycles all at 25 days. Given that my cycle history only goes back 14 months I am a little hesitant to say this is definitely a result of the vaccine but I do feel like I was pretty regular at the 27/28 day mark with it never being less than that until the past 3 months. Also, this is still considered a regular cycle length so I am not concerned but figured I should give the information for study purposes.
She feels sick; A1C was 7.1; This is a spontaneous report from a Pfizer sponsored program  support. A contactable 62-year-old female consumer (patient) reported for herself.   A 62-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 18May2021 (at the age of 62-years-old) (Lot Number: EW0177) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (at the age of 62-years-old) (lot number: EW0161, vaccine location: Right arm) on 25Apr2021 for covid-19 immunisation. The patient experienced she feels sick and A1C was 7.1 on an unspecified date in 2021. It was reported that the patient doesn't know why she didn't had immunity. She felt sick and according to the doctors, she did't had a serious disease. The only problem that she had was her blood sugar. She states she did't had severe diabetes, her A1C is below. She clarifies her A1C is 6.9, the callers states she did't had severe diabetes, or high blood pressure or high cholesterol. She did't had an autoimmune disease, so she did't understood why her results were what they were. The caller clarifies she received her A1C after the vaccine. Her A1C was not bad either when she had the COVID-19 vaccines. Her doctor is very careful with her. When probed to clarify if she was diagnosed with diabetes, the caller responds not really. She states her doctor gave her Metformin because he doesn't want her glucose to go higher. She clarifies around the time she had the COVID-19 vaccine, her A1C was 7.1.  The patient underwent lab tests and procedures which included antibody test: no immunity/no antibodies on 27Aug2021, glycosylated haemoglobin: 7.1 on 2021, glycosylated haemoglobin: 6.9 on 27Aug2021. The patient received treatment for the events. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
15hrs after injection. Developed a rash/hives. Started under arms, spread to breasts, chest, neck, and chin. Then down armpits and eventually top on thighs. Extremely tender and itchy. Treated with calamine lotion and Benadryl.
Patient received HPV #1 (GARDASIL) and MCV4#1 (MENACTRA). No c/o instructed to wait about 20 minutes to monitor for any adverse reactions. Mother stated "My daughter wanted to drink some water, so she walked over to the drinking fountain then I heard to commotion and realized my daughter was on the floor. Patient stated I felt dizzy and I know I was on the floor." Mother staff assisted patient complained of bumping left knee only. No other physical injury reported. Advised mother to follow up at nearest emergency room if symptoms worsen or any problems or concerns.
Patient is a 73 y.o. female patient of, MD with history of severe COPD steroid-dependent, hypertension,  presented to Hospital with worsening shortness of breath admitted for acute hypoxic respiratory failure secondary to COPD exacerbation and COVID.   Discharge Diagnoses:   Acute respiratory failure hypoxic and hypercapnic Severe COPD exacerbation Symptom onset x3 days (9/6/2023) positive COVID test at home and in the hospital O2 sats 84% on room air with exertion, VBG pH of 7.31 with a PCO2 of 70.8 On BiPAP at bedtime; 2 L during the day Chest x-ray: severe emphysema Started on IV Solu-Medrol 80 every 6 hours, DuoNebs, Dulera, oral Zithromax Will complete steroid taper as outpatient   Troponin above reference range Troponins increased from 140-201 with a positive delta Denies chest pain, no new EKG changes Echo: EF~60%, grade I diastolic dysfunction, no significant valvular heart disease Cardiology consulted, demand ischemia favored etiology for elevated troponin No further ischemic testing indicated at this time   Covid-19 Virus Infection ? Sepsis due to covid-19, POA Date of onset of symptoms: 9/6/2023 Symptoms present on admission: Cough, worsening shortness of breath Date of covid positive test: Home COVID test positive on 9/6 Vaccination status: vaccinated Imaging: Chest x-ray Oxygen requirements on admission: BiPAP/heated high flow Current oxygen requirements: BiPAP/2 L Medical therapy: steroids Prescribed Paxlovid but patient developed diarrhea, stopped taking after 1 day and does not want to continue Consultants following: Pulmonary Anticipated special isolation end date: Until symptom improved/10 days of symptom onset Empiric Lasix given to maintain dry lung strategy   Hypertension Continued lisinopril   Severe malnutrition with cachexia POA BMI of 14.7, dietary consult Nutritional supplements provided
Per documentation, this person received the Moderna vaccine 2/5/2021 and 3/13/21. This person has been admitted twice with COVID-19. 7/20/21 - 7/25/21 and 8/15/21 and 8/19/21
Right side partial facial numbness; Right arm pins and needles (whole arm); Severe dry mouth; Metallic taste; Nausea; Diarrhea; Headache; Chest pain; Difficulty breathing; ear pressure in right ear; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER 8763), via an unspecified route of administration in left arm on 22Apr2021 at 13:15 (at the age of 29-year-old) at single dose for COVID-19 immunisation. Medical history included endometriosis and prior to the vaccination, the patient was diagnosed with COVID-19. Patient had no known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC), acetylsalicylic acid (BABY ASPIRIN) and pseudoephedrine hydrochloride (SUDAFED). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 13:45, the patient experienced right side partial facial numbness, right arm pins and needles (whole arm), severe dry mouth, metallic taste, nausea, diarrhea, headache, chest pain, difficulty breathing, ear pressure in right ear. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events included prednisone 40 mg for five days. The clinical outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: lab data was removed as no relevant information reported.
"Tightness in chest after having flu shot and TB test" ; shortness of breath, dizziness/nausea received ZOFRAN, BENADRYL, and TORADOL in ED.
Tingling in fingers on 10/18. 10/19 Numbness beginning in toes; not feeling well resulting in ER visit. 10/20 Weakness in legs progressing to inability to walk.  Called primary care physician and went in - saw physician's assistant.  Unable to walk in - had to use a wheelchair.  Unable to grasp a pen or sign my own name.  PA was unable to pin down the issue and indicated return to ER if symptoms continued to progress.  Referral given to neurologist. 10/21/16 Symptoms continued to progress up the body - moved upward to thighs. Returned to ER - no reflexes present in lower extremities.  Suspected Guillain Barre Syndrome and admitted to ICU.
1 patient received a dose from expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient received a dose from expired vial) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient received a dose from expired vial). On 16-Oct-2021, EXPIRED PRODUCT ADMINISTERED (1 patient received a dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had reported that on 15Oct2021, the vaccine vial was moved to refrigeration.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Significant FU appended. Include updated patient demographics, dose details, Batch number. On 21-Oct-2021: Include no new information.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient with cerebral amyloid angiopathy, parenchymal microhemorrhages, and seizure disorder with recurrent seizures presents to emergency department with alertered mental status and left-sided weakness immediately following a seizure and two days after vaccination. Admitted to hospital, anti-epileptic medications adjusted, and patient discharged home in good condition.
Immediately after vaccination patient had soreness and stiffness at the site of injection.  Five hours later, patient described extreme headache, muscle soreness, and stiffness.  Patient stated that she felt hot but no fever suspected based on touch.  Also, no visible sweating, but some flushing in cheeks.  Majority of pain was bilateral at base of skull.    Patient's mother massaged the neck and base of the skull, some relief experienced.  At midnight, appx. 10 hours after vaccination Patient experienced a seizure that lasted 30-40 seconds in length with a thrashing of arms and legs and loss of consciousness.  Patient reported feeling faint and a metallic taste in her mouth just prior to the seizure.    Mother of patient monitored her all night, call and spoke with RN on Sunday, Feb 2.  Reported symptoms and scheduled a phone call appointment with Dr. for Tuesday (first available).  Spoke with Dr., patient's family concerned that there has been an adverse reaction with the vaccination and Citalopram.  Dr. took copious notes that will be kept in the patient file.  In addition, Dr. stated that she will follow-up with the clinical pharmacist and contact a Neurologist to inquire about any follow-up tests that may need to be completed.  Dr. will get back to the patient's mother via phone call.   Family is to watch for any other side effects and if any other seizure activity occurs, they were told to go to the nearest ER.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concomitant therapies, medical history and drug reactions or allergies provided. On 12-APR-2017, the patient was vaccinated with improperly stored dose of VARIVAX 0.5 ml, once, subcutaneously, lot# M038857, expiration date: 14-SEP-2018 (site of administration was not reported). Sterile diluent, lot#: M033585, expiration date: 21-APR-2019, was used to reconstitute the dose of improperly stored VARIVAX received by the patient. No temperature excursion was identified for the sterile diluent. No adverse effects were reported. Administered dose of vaccine was stored in temperature between 15 degrees Fahrenheit to 46 degrees Fahrenheit (the range was 35.5 degrees Fahrenheit) for 3 hours. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007776: US-009507513-1705USA015680: US-009507513-1705USA015681: US-009507513-1705USA015682: US-009507513-1705USA015683:
Headache; Chills; fatigue; Body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Feb2021 09:45 (Lot number: EL3247) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (brand=Pfizer, Lot number=EL3247, Lot unknown=False, Administration date=20Jan2021, Administration time=12:00 AM, Vaccine location=Left arm, Dose number=1, Route of administration: Intramuscular), administration date: 20Jan2021, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 10Feb2021 01:00, outcome "recovering", described as "Headache"; CHILLS (non-serious) with onset 10Feb2021 01:00, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 10Feb2021 01:00, outcome "recovering", described as "fatigue"; PAIN (non-serious) with onset 10Feb2021 01:00, outcome "unknown", described as "Body ache". Therapeutic measures were not taken as a result of headache, chills, fatigue, pain.  Additional Information: Patient did not receive any other vaccines within 4 weeks. Patient has not COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. Vaccination facility type: Workplace clinic.  No follow-up attempts are possible. No further information is expected.  Follow-up (16Apr2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included that: Route of administration was captured. Vaccine facility information was updated. New event body ache was coded to ache.  Follow-up (07May2021): Follow-up attempts completed. No further information expected
Pt was immunized and ambulated to inside waiting area. Ten minutes later c/o feeling sick. Vital signs were monitored every five minutes until stable and she felt well after 30 minutes.
Gums swelling; Tingling in tongue; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 14Mar2021 12:30 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "Allergies to sulfa" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1; 12:30 PM; left arm), administration date: 16Feb2021, when the patient was 69 years old, for COVID-19 immunization, reaction(s): "Swollen gums". The following information was reported: GINGIVAL SWELLING (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Gums swelling"; PARAESTHESIA ORAL (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Tingling in tongue". Therapeutic measures were not taken as a result of gingival swelling, paraesthesia oral.  Additional Information: The patient's concomitant medications included unspecified thyroid, blood pressure, and statin medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Next day following vaccine - site injection pain (right arm). Arm pain has continued and progressed limiting mobility.  In the past 7 days patient has progressively declined in from independent to requiring assistance with walking. Pain and limited mobility in legs
Information has been received from a registered nurse concerning a 10 year old female patient who in approximately August 1998, when she was 12-15 months of age, was vaccinated with VARIVAX (Merck). The nurse reported that on approximately 06-JUN-2008, 5 weeks ago, the patient developed shingles. The patient received an unknown treatment. At the time of the report, the patient had recovered. The patient sought unspecified medical attention. No further information is available.