chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-Sep-2020 and the estimated date of delivery was 26-Jun-2021. On 18-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  On 18-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Information has been received from a certified medical assistant referring to a patient of unknown age and gender. No relevant medical conditions were reported. In August 2014, a year ago, the patient was vaccinated with an initial dose of GARDASIL (strength, dose, route, lot# and expiration date not reported). There was no concomitant medication reported. On 03-AUG-2015, the patient was at the provider's office to receive a dose of GARDASIL 9 (inappropriate schedule of vaccine administration). The patient had not yet been administered the dose of GARDASIL 9 at time of call. No adverse effect was reported. Additional information is not expected since the reporter declined to participate in adverse event collection process.
Four cm elevated area surrounded by white line, 9x9 cm. Prescribed Benadryl and Cortisone.
Fever, headache, body aches, arm pain for two days at site of injection. Approaching 72 hours with fever.
patient having chill and fatigue at 6:30am this morning. Patient states that she is weak and feels like she could pass out
Child with niece - began "seizuring" and quit breathing. Was at fair and close to ambulance - EMT's gave treatment and took to ER where diagnosed as febrile seizure and bacterial infection. Was put on Zithromax and given shot according to mom - child had temperature for 2 days prior to injections and teething.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose and route were not reported), lot # N001528, expiration date: 13-JAN-2019  that was reconstituted with sterile water diluent (MERCK) (lot number and expiration date were not provided) or PROQUAD (dose and route were not reported), lot # N000336, expiration date: 03-JUL-2018 that was reconstituted with sterile water diluent (MERCK) (lot number and expiration date were not provided) both for prophylaxis. The vaccines were exposed to temperature between 6 to 14 degrees Fahrenheit for a time frame of 965 hours and 7 minutes. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. Additional information has been requested.
Chills; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 132 and height was 64 inches. The patient's concurrent conditions included penicillin allergy, sulfa drug allergy, alcohol use(3-4 glasses of wine), non smoker, and rash, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no history of drug abuse.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1085022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 14:13 on right (site unspecified) for prophylactic vaccination. Concomitant medications included atorvastatin calcium.  On 10-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 11-MAR-2021. This report was non-serious.  Additional information was received from physician on 30-MAR-2021 following information was updated and incorporated into case narrative: Patient demographic details (height, weight), concurrent conditions (penicillin allergy, sulfa drug allergy, alcohol use, non smoker, and rash), covid-19 vaccine therapy details (batch number, therapy start date and vaccination site), concomitant medication (lipitor), reporter details was added.
This spontaneous report as received from a pharmacist refers to an unknown number of patients of under the age of 50. The pharmacist reported that an unknown number of patients under the age of 50 were administered ZOSTAVAX (lot# unspecified) (dose, route and locations unspecified) (administration of ZOSTAVAX to the patients occurred at another unspecified site). No adverse event reported. Additional information is not expected.
Information has been received from a certified medical assistant via medical records concerning a 4 year old female who on 28-SEP-1995 was vaccinated with the first dose of MMR II. In approximately 1998 the patient developed chicken pox. The outcome was unknown. On 06-AUG-2007 the patient was vaccinated with the second dose of MMR II. Subsequently, the patient had inappropriate schedule of vaccination of GARDASIL (MSD) (WAES# 0905USA00732). Additional information has been requested.
Complete hearing loss; A spontaneous report  was received from a physician concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced complete hearing loss.  The patient's medical history was not provided by reporter. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced complete hearing loss after receiving COVID-19 vaccine. Laboratory details were not provided. Treatment information was not reported.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, complete hearing loss, was unknown.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of Deafness, after receiving 1st dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.
She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energy; Tired; Feeling sick; She was shaky, cold; She was shaky, cold; She had the flu; This is a spontaneous report from a contactable consumer reporting for herself.   A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1284), via an unspecified route of administration left arm single dose on 18Jan2021 17:30 for covid-19 immunisation. Medical history was none. There were no concomitant medications. No other vaccine was received in four weeks.  The patient experienced passed out on 20Jan2021 14:00, tired on 18Jan2021 21:00, feeling sick on 18Jan2021 21:00, chills on 19Jan2021 09:00, aches on 19Jan2021 09:00, headache 19Jan2021 09:00, had no energy on 19Jan2021 09:00, lack of appetite on 22Jan2021 09:00, she was shaky in Jan2021, cold in Jan2021, she had the flu on Jan2021, she felt same the way but worst on an unspecified date. The outcome of the events was recovered on 22Jan2021
pt presented to emergency department on 3/6/21 with change in mental status first noted at 10am; per reports, his employees noticed he was not acting himself, and he went home to rest; ED notes indicate he reported a right sided headache and was confused and had difficulty with word finding, but did say, "I can't remember anything." Pt also had elevated BP in ED; he was able to follow some commands but continued to have difficulty forming words and hand squeeze noted to be weaker on the right side and he could not keep his right leg elevated; pt fell asleep during exams; patient's neice, who is an ED physician, reported that pt had become encephalopathic with severe DKA and AKI in the past; he was started on IVF and insulin drip and transferred from ED to ICU; he went into rapid atrial fibrillation and was then started on diltiazem drip; cardiology was consulted, adjusted medications, and anticoagulation was not recommended as the episode was transient; he started spiking fever with Tmax of 101; blood cultures were drawn and he was started empirically on ceftriaxone, vancomycin, and acyclovir; IR was consulted for LP with results showing WBC 123, RBC 41, 90% neutrophils, glucose 186, protein 100; he was seen by ID and noted that CSF profile was consistent with most likely an early viral infection
Passed out for around one minute and did not remember anything for that one minute; Her arm was very itchy; Passed out for around one minute and did not remember anything for that one minute; Feeling tired after vaccination; A spontaneous report was received from a consumer on 22 Feb 2021, with additional information received on 15 Mar 2021, concerning about a female patient of an unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an adverse reaction including passed out for around one minute and did not remember anything for that one minute, Her arm was very itchy, and Feeling tired after vaccination.  The patient's medical history was reported as the patient have allergy towards nuts, cats, dogs, dust and trees. Concomitant medications were not reported.  On an unknown date in Feb 2021, prior to the onset of the events, the patient received their planned doses of mRNA-1273 (Batch number: unknown) via unknown route for the prophylaxis of COVID-19 infection.  The patient experienced an adverse reaction including passed out for around one minute and did not remember anything for that one minute, Her arm was very itchy, and Feeling tired after vaccination. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not provided.  The outcomes of the reported events remain unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Started with left hip pain that was limiting my ability to get up/down from chairs and in/out of my vehicle. By that evening I also had severe pain in my left shoulder. The following morning, 10/18/2014 I was unable to dress myself as I had pain in both shoulders which limited my mobility. Pain continued. On Sunday the pain in my hip had subsided, but by Sunday evening I had pain still in both shoulders but also in my right wrist/hand. I was unable to work for 3 days. On Wednesday 10/22, I went to the on-call physician and received scripts for prednisone and toradol. With medication the pain was managable. I still have periodic episodes of pain, primarily in right shoulder and right wrist.
mild to moderate flu-like symptoms; joint pain; fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (mild to moderate flu-like symptoms), ARTHRALGIA (joint pain), FATIGUE (fatigue) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-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 INFLUENZA LIKE ILLNESS (mild to moderate flu-like symptoms), ARTHRALGIA (joint pain), FATIGUE (fatigue) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (mild to moderate flu-like symptoms), ARTHRALGIA (joint pain), FATIGUE (fatigue) and CHILLS (Chills) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-268098 (Patient Link).   Reporter did not allow further contact
a couple of years ago they had a patient having a procedure, and so they delayed the vaccine; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of an unknown demographics who received vaccine of delayed schedule. The vaccine involved was IPV (VERO) [IPOL] (batch number, expiry date, route and site of administration were unknown).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate schedule of vaccine administered.  It was unknown whether the patient had any adverse event.  A patient started their Ipol schedule later than they should have but he is not at work to provide any template information. Also mentions a couple of years ago they had a patient having a procedure, and so they delayed the vaccine.  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 and Module VI of the 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.  Information on the batch number was requested.  Documents held by sender: none.
2nd dose pfizer vaccine was given to patient on 07/08/2021. We found out on 07/09/2021 vaccine was stored outside the recommended 31 day expiration window.
COVID; COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4490359-00 (AbbVie).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 24Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID". It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken for adalimumab was dosage not changed.  The reporter considered "covid" related to BNT162b2. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product bnt162b2 cannot be ruled out.
Developed red discoloration of skin about 10 minutes after HPV 9 vaccine. Redness of upper clavicle, upper back, upper arms. Observed 30 min. Lungs - clear, vital signs stable throughout. Sent home. Dad called 2 hr later "fine".
This is a spontaneous report from a contactable consumer (patient's wife) via Medical information team. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 13Aug2021 (Lot Number: FC3180) as DOSE 1, SINGLE for COVID-19 immunization at the age of 42 years old in the Pharmacy/drug store; tilactase (LACTAID), oral from an unspecified date (Batch/Lot number was not reported) and ongoing, at UNK [take 1 tablet by mouth with meals as consuming dairy. taking it with anything having dairy] for lactose intolerance; and metformin hydrochloride (METFORMIN), oral from an unspecified date (Batch/Lot number was not reported) and ongoing, at 500 mg, 2x/day [(once in the morning and once at night)] for diabetes. Medical history diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes), obesity, diabetes and pre-diabetic all from an unknown date and ongoing lactose intolerance from an unknown date. There were no concomitant medications. The patient's wife stated, "my husband is having some side effects from his Pfizer Covid-19 vaccine, I wasn't sure if they are common or if you any remedies for them. After the first vaccine, he is lactose in-tolerant very very mild, generally doesn't have to take Lactate, he usually just drinks lactaid milk and is fine. He usually does not have to take Lactaid tablets unless he chugs a whole gallon of milk. His lactose intolerance has increased in severity and he has to take Lactate tablets now. He did have to call in sick to work one morning because the night before he had a dollop of sour cream and some cheese on a taco which used to be okay." The patient also experienced severe reaction to dairy in Aug2021. The patient's wife further stated, "Now he is taking Lactaid tablets at every meal, but he still has dairy issues and they are now worse after getting the vaccine". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The action taken in response to the events for tilactase and metformin hydrochloride was dose not changed. The outcome of severe reaction to dairy was not recovered and unknown outcome for the rest of events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Breathing difficulty, fluid retention, upper respiratory congestion and flu like symptoms. No fever or chills.
At 3am, I awoke to use the restroom. Before opening my eyes, I turned my head and developed a severe case of vertigo. This has continued until the time of me filling out this form. I have menieres, so I had a dietetic (Dyazide) and antivert at hone, which I began taking immediately. On Saturday evening, I evened a prescription for a Medrol dose pack and that was started immediately. I have vertigo, difficulty walking due to it. I vomited once on date I day due to the vertigo. I have continued vertigo and nausea.
Per mom, rash on forehead and face; no swelling around lips or eyes began one day after vaccination. Diffuse rash across abdomen, chest, and upper/lower extremities began two days after vaccination.   Upon examination, diffuse rash across the body, scattered maculopapular bumps mainly across face and forehead, some rash along the abdomen appears more urticarial. Pt has had no signs of anaphylaxis, breathing normal, no swelling around face or mouth, no changes to PO intake. Benadryl 5 mL every 8 hours needed for symptoms and Tylenol 5.5 mL every 8 hour as needed for pain. Pt to follow-up as needed.
Dizziness; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 05-SEP-2023, the patient received Arexvy. On 05-SEP-2023, 1 hr after receiving Arexvy, the patient experienced dizziness (Verbatim: Dizziness).  The outcome of the dizziness was not resolved.   It was unknown if the reporter considered the dizziness to be related to Arexvy.     It was unknown if the company considered the dizziness to be related to Arexvy.   Additional Information: GSK receipt date: 11-Sept-2023 and 12-Sept-2023 The patient stated that she received Arexvy vaccine around 2 pm and 1 hour later she started feeling dizzy.  According to reporter, she still had the dizziness and she tried contacting her physician last week on Friday without success.  The patient was very good unfortunately all they were doing was filing a report and she was hoping that she could have more information on having dizziness from this RSV shot and did not know she had called the physician and have not gotten anything back so she will check again. Reporter would like to be contacted by the safety team regarding this concern.  The reporter consented to follow-up.
Dermatographic urticaria. Was taking OTC zyrtec without relief. Is now being treated with 20mg zyrtec BID.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patent's concurrent conditions, concomitant therapies or medical history provided. On 16-MAR-2018, the patient was inadvertently vaccinated with both dose of PROQUAD and dose of VARIVAX (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis reconstituted with sterile diluent (manufacturer unknown) (lot# and expiry date were not reported) which did not undergo a temperature excursion. No adverse effects were reported.
High blood pressure, dizziness, lost of memory, skin rash (black spots in my skin) and other strange symptoms not easily identified.
Patient was given in left arm toward bottom left side of deltoid muscle.  Several days after the vaccination, the patient reported having a large red spot, knot, and itching.  The pharmacist instructed her to use Benadryl or hydrocortisone topical to relieve the signs and symptoms she was having, and to take a Benadryl by mouth to help with the itching.  The patient reported that she had already tried these options.  She stated that she would continue this and see her doctor if it progressed.  I told the patient to let us know what she found out.  I contacted the patient back on March 11, and she told me that she visited the doctor since our last discussion, and they told her to continue the hydrocortisone and Benadryl along with a cold compress on the area.  The patient reported that the redness and itching had subsided but a knot was still present.
SHORTNESS OF BREATH; HEADACHE; This spontaneous report received from a consumer concerned a 24 year old male. The patient's weight, height, and medical history were not 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 07-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and shortness of breath was not reported. This report was non-serious.; Sender's Comments: V0: As per standard protocol, non-serious cases does not require comment
I had pain and some swelling for 3 days at the site which then subsided.  On day 10, I went in to get allergy shots at my doctor's office and they saw that my arm was red and swollen so they did not give me an allergy shot in that arm.  I should tell you that I did receive an allergy shot in the same left arm on 3/15 and again on 3/18 which did not seem to cause any issues.  My left arm has been itching in the injection site location for about the past 24 hours.   The red swollen area is about 3" long and 2" wide and is warmer than the surrounding area.
pt recv vax;approx 5 days later devel maculopapular rash on trunk & extremities;was given solumedrol & is currently on pred;