chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Premature atrial contractions.  I am a healthy individual and have never had an abnormal heart beat.  10 days following the Covid 19 Pfizer Vaccine Dose 1, I experienced an abnormal heart beat and was diagnosed with premature atrial contractions (an abnormal heart beat).  It has lasted for 2 days and I still have them as I complete this form.
-COVID vaccine (manufacturer unknown)  -Pt  reports having some chest tightness the day after his shot and a couple of times the following week he ?felt like my heart was tearing in two and it lasted about 5 seconds?   Again this was reported to us at the time of his second shot, we declined and he is scheduled with a pcp for evaluation and recommendation as to getting second dose.
Pt recvd vax & exp nausea, dizziness & migraine h/a; went to MD who told pt was allergic to vax & advised against any further injects;
Mother to ER for episode of trembling/turning blue 1/2 hr /p immunizations, fever 40.6(R)
patient receiving a dose of YF-VAX which was inadvertently reconstituted with sterile water with no adverse event; dose was repeated on the same day reconstituting with proper diluent as patient couldn't wait for the 28-day interval of re-administration of the live vaccine with no adverse event; Initial information received on 24-Jul-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 51 years old female patient who was administered Yellow Fever vaccine - US [YF-VAX] which was inadvertently reconstituted with sterile water and dose was repeated on the same day reconstituting with proper diluent as patient couldn't wait for the 28-day interval of re-administration of the live vaccine with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Chronic back pain.  Concomitant vaccine included Hepatitis A vaccine for Prophylactic vaccination.  On 22-Jul-2023, the patient received a 0.5ml dose of suspect Yellow Fever vaccine - Solution for injection; expiry: 09-Aug-2023 (lot number: not reported) via subcutaneous route in the left arm for immunization, which was inadvertently reconstituted with sterile water with no reported adverse event (product preparation error) (Latency: Same day) and then on the same day, 0.5 ml dose of the same vaccine with an unknown batch number and expiry date via subcutaneous route in the left arm for immunization, was repeated reconstituting with proper diluent as the patient couldn't wait for the 28-day interval of re-administration of the live vaccine with no reported adverse event (off label use) (Latency: Same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event product preparation error and off label use.   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.
Patient accidently given 0.2mL of adult Pfizer 30mcg/0.3mL instead of peds Pfizer 10 mcg/0.2mL. No known adverse events reported, or treatments needed that facility is aware of.
Following the day after my 2nd dose of Moderna I lost consciousness, collapsed, hit my head on metal handle in kitchen, required 8 staples on the gash on backside of my head and two days hospital stay.
About 2 hours after immunization, patient had high fever 101+, diarrhea, chills, weak. Lasted about 2 days. Reports he lost 8 pounds.
pt stable, no SOB c/o itching arms-elbows, upper arms & under arms;tx w/DPH;
COVID symptoms -Sore throat; low grade Temperature; headache; tired.  I did two virtual visits at the start and then correspondence through my chart.
Initial report received from a healthcare professional (pharmacist) on 09 December 2013. This case is linked with cluster cases: 2013SA131895 and 2013SA131929 (Same vaccine, same reporter). A female patient, whose age, date of birth was not reported, medical history and concomitant medications were not reported, received a dose of INFLUENZA VACCINE (lot number, route manufacturer and site was not reported) on an unspecified date. The patient was pregnant at the time of vaccination. Her last menstrual period and estimated delivery date were not reported. It was reported that the patient had an aborted pregnancy due to Guillain Barre syndrome following administration of QIV flu vaccine. Laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
fever, chills, rigors, muscle weakness, joint pain, lasted for approximately 48 hours beginning approximately the morning following the dose (dose given ~5 pm)
sore throat; Feeling sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and MALAISE (Feeling sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and MALAISE (Feeling sick). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and MALAISE (Feeling sick) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact
This is not an adverse event report, but a vaccine administration error. Patient received first dose Moderna COVID vaccine 4/9 at other location, and was given Pfizer COVID vaccine as her second dose on 5/13 at Pharmacy. On the consent form, both Moderna and Pfizer were marked as first dose and the agency pharmacist couldn't recall the situation. We finally reach the patient on 5/16 and clarified her first dose was Moderna. Patient stated she felt tired after she received the vaccine, and while on the phone she stated she's feeling fine with a little sore arm. Pharmacist informed her per CDC, she doesn't need another COVID shot.
I had fever that got up to 101.  I had flu like symptoms.  I had body ache.  I lost my smell and taste for a few days.  I had a cough and was congestive.  My symptoms lasted for about 4 days.  I went got a Covid-19 test, come back positive.  I also had spikes in my blood pressure.  I did a tv vision with my doctor.
Fast heart rate; Leg numbness; Hand numbness; This is a spontaneous report from a contactable consumer (patient).  This 21-year-old male patient received the first dose of bnt162b2 (BNT162B2) (Lot # EH9899), via an unspecified route of administration at single dose in the left arm on 15Dec2020 12:00 PM at hospital for immunisation. The patient medical history and concomitant medications were not reported. On 16Dec2020 04:00 AM, the patient experienced fast heart rate, leg numbness, hand numbness. No treatment required. The outcome of the events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.
Hospitalization: 1/20/2023 - 1/24/2023 (4 days) Presentation to the ED: fevers, bilateral lower extremity edema, and weakness. admitted for sepsis. COVID + date: 1/24/2023 Treatment: none. patient was found positive on a transfer screen to hospital.  Discharge to:   EN6200 2/19/2021 EN6206 3/13/2021 32030BD 11/12/2021 010H22A 1/6/2023
FEELING CONGESTED; MILD FEVER; This spontaneous report received from a patient concerned a male 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced feeling congested, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild fever and feeling congested was not reported. This report was non-serious.
Large red, hot, firm blotch around injection site. Size and shape varied at times and lasted about a week. After 3 days of having the red blotch/rash, it started to itch severely on and off for 3-4 days. The reddness slowly went away, but I sill have itching there a few times a day.
Itchy; Hard to touch; Warm to touch; Injection site is red; Injection site is swollen; Sore arm; Lymph node swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchy), VACCINATION SITE MASS (Hard to touch), VACCINATION SITE WARMTH (Warm to touch) and LYMPHADENOPATHY (Lymph node swollen) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety, Asthma and ADHD.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and LYMPHADENOPATHY (Lymph node swollen). On 29-Mar-2021, the patient experienced PRURITUS (Itchy), VACCINATION SITE MASS (Hard to touch), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site is swollen). On 22-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 26-Mar-2021, LYMPHADENOPATHY (Lymph node swollen) had resolved. At the time of the report, PRURITUS (Itchy), VACCINATION SITE MASS (Hard to touch), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received their 1st dose of Moderna vaccine on 18-Mar-2021 and on same day the patient began to have sore arm and it went away on 22-Mar-2021. The patient also reported that their lymph node was swollen as well and went away probably on 26-Mar-2021. On 29-Mar-2021, the patient noticed that their injection site was red, swollen, hard to touch, warm to touch and itchy as well.   Concomitant medications included anxiety medication, asthma medication and ADHD medication.  No treatment information was provided.
Adult patient received Expired Monovalent COVID-19 vaccine; Monovalent vaccine was administered instead of bivalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received Expired Monovalent COVID-19 vaccine), WRONG PRODUCT ADMINISTERED (Monovalent vaccine was administered instead of bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 013B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received Expired Monovalent COVID-19 vaccine), WRONG PRODUCT ADMINISTERED (Monovalent vaccine was administered instead of bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received Expired Monovalent COVID-19 vaccine), WRONG PRODUCT ADMINISTERED (Monovalent vaccine was administered instead of bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received Expired Monovalent COVID-19 vaccine) and WRONG PRODUCT ADMINISTERED (Monovalent vaccine was administered instead of bivalent).    No concomitant medication was reported.  Expiration date was reported as 22-FEB-2023. The vial did not undergo temperature excursions. No treatment information was reported.
Last one last Dec / Got infection in my arm; Last one last Dec / Still don't feel well; This case was reported by a consumer via(Facebook) interactive digital media and described the occurrence of arm infection in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In December 2020, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 9 months after receiving Shingles vaccine, the patient experienced arm infection and feeling unwell. On an unknown date, the outcome of the arm infection and feeling unwell were unknown.   It was unknown if the reporter considered the arm infection and feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient stated that, he/she got the 2nd dose in last December and got infection in his/her arm and still did not feel well. The follow-up would not possible as no contact details were available; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR168946:Same reporter. Invalid case.
Dizziness, off balance, really bad headaches,  unable to stand without  feeling  like i will fall, one episode of vomiting, tired and low energy.
I started having mild sore throat and a few hours later I started having a fever. That night I didn't take anything and the next day I started taking Tylenol. I was still having fever on Friday. I called my doctor and was prescribed Paxlovid and I started Saturday and I had fever and felt miserable till Monday. I had headaches, fever, chills, coughing that was dry and I had a hard time sleeping. A total of 10 days later I started to improve. I keep testing and one day it will be positive and then negative the next. The medicine left a horrible taste in my mouth.
Within 5 mins of giving DTAP, pt developed redness, edema and increase in skin temperature at injection site. Ice pack applied to site
the vaccine did not prevent shingles as intended; severe herpes zoster; weakened immune symptoms; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On or about 10-JAN-2011, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 24-FEB-2015, she was treated by a physician at the a clinic for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. She was prescribed valacyclovir for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.
swollen lymph nodes; chills; cold sore on his mouth; Groin pain; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a month after receiving Shingrix, the patient experienced enlargement of lymph nodes, chills, cold sore mouth and groin pain. On an unknown date, the outcome of the enlargement of lymph nodes, chills, cold sore mouth and groin pain were not recovered/not resolved.   It was unknown if the reporter considered the enlargement of lymph nodes, chills, cold sore mouth and groin pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. Three weeks ago, from the reporting date the patient received a dose of Shingrix. The patient experienced has swollen lymph nodes in groin and chills. The reporter asked, whether it was common to get cold sore and have swollen lymph nodes after getting the shot. The reporter stated, the patient also experienced cold sore on his mouth and was having groin pain with swollen lymph nodes. The reporter further inquired whether this could be related to Shingrix. And the representative replied that the cold sore, groin pain, or swollen lymph glands are not reported in the prescribing information and recommended to the patient's wife to speak with healthcare provider (HCP) regarding the events occurred. The healthcare provider will determine the right treatment plan for the patient. The reporter stated, she would speak with the patient's HCP, however she wanted to seek the input of manufacturers too.
c/o fever, nausea, tired, arm sore red w/ 5 1/2 cm x 8 cm induration; inc in size, pt advised to ice, take DPh;
Client reported an unexplained fever (101.4) of 12 hour duration six days post vaccine. Consulted MD who advised reporting symptoms.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 33-year-old male. Neither medical history nor concomitant medication were reported. On 26-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flue season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Significant (L) shoulder pain, fever and nausea the pm after a rabies vaccine (L) upper arm - (L) shoulder pain has persisted - increased with use of (L) arm.
Pt had recvd 2 monovalent Pfizer vaccines in 7/2022. They came to clinic for bivalent booster. Moderna is the only brand in stock so it was given. States dose is invalid bc of different brand used in this age group. States it is a vaccine error but is considered valid and does not to be repeated.
RECEIVED VACCINE TWICE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 1805022, and 1808978 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUL-2021, the subject experienced received vaccine twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received vaccine twice was not reported. This report was non-serious.
Vaccine was drawn up at 9:30 AM on 06/03/2021 and was administered to patient at 04:25 PM on 06/04/2021. Reached out to patient several times, phone number out of service. Contacted manufacturer and CDC for recommendation. If able to get into contact with patient, will recommend patient to come in and to get a re-dose of the vaccine in the opposite arm to ensure proper efficacy.
Initial report was received from a consumer, who was also the patient's parent, on 24 February 2012. A 3-year-old female patient had received an injection in the thigh of TYPHIM Vi, sanofi pasteur SA (lot number, route and date of vaccination unknown) and an unspecified amount of time later developed sore less and had difficulty walking for next 1-2 days. The patient's past medical history was unknown. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
first dose/on 07/11/2019 never received the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 11th July 2019, batch Number XC972 expiry date 29th August 2021).   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.  Additional case details were provided as follows: The age at vaccination was not applicable for this report. The patient never received the 2nd dose after 1st dose till the time of reporting which led to incomplete course of vaccination. Vaccine administration Facility was reported for the 1st dose. The reporter consented to follow up.
Pfizer 5/7/21 and 5/28/21. Positive on 1/17/22
Cough started on 3/5.  Hospitalization on 3/7,  Expired 3/16.  Doctor's Death Diagnosis: acute on chronic respiratory failure.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 09-FEB-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, expiration date were unknown) for the prevention of shingles and routine health maintenance. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX); pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries; also suffered serious, progressive, permanent and incurable injuries; as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered as not recovered. The causal relationship between shingles and zoster vaccine live (ZOSTAVAX) was considered related. Upon internal review, the event was considered as disabling.