chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistance, concerning a patient of an unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 14-FEB-2017, the patient was vaccinated with an expired dose of MMRII (dose, frequency and route were not reported), for prophylaxis. Lot # L004658 with expiration date of 02-FEB-2017. The vaccine did not have any previous temperature excursions. No adverse symptoms were reported. No product quality complaint was involved (PQC). Additional information has been requested.
Child developed diarrhea evening of 3/6/09. Fever Sat-Mon & Tues. which mo. kept controlled with Tylenol & Advil. Caught runny nose developed over weekend. Visit to PMD 3/9/09 with Dx undecided. Rx of Zithromax given. Mo presented with child at health dept 3/10 with report of matting eyes & possible posturing/ description by mo. Recommend PM Dr visit. Seen again by PMD 3/10/09 afternoon. Dx of possible reaction to MMR (cough, runny nose, conjunctivitis) Rx for eye cream steroids (?) & told to continue Zithromax. 3/11/09 Mo. states child showing improvement in eyes since therapy begun.
Patient had two seizures today, one at 4:30 AM and another at 11:30 AM. They did not require medications to stop them, but he is being admitted to the hospital for a neurologic workup.
Patient received 3 doses pf Pfizer COVID vaccine on 9/27/21, 3/25/21, and 3/4/21, and was hospitalized on 1/26/22 for resp. failure and COVID infection
Information has been received from a 75 year old female consumer with high blood pressure who on 17-FEB-2010 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included TYLENOL extra strength. On 19-FEB-2010 the patient experienced a headache. It was reported that she needed to use ice packs constantly and that her symptoms were very similar to a sinus headache. The patient did not seek medical attention. At the time of the report, the patient's headache was still not gone. The headache was considered to be disabling by the consumer. Additional information has been requested.
Left upper arm swelling and slight rash x 3 days, fever x 1 day, swelling in (L) axilla area x 3 days.
Initial unsolicited report received from a consumer on 19-Dec-2016. This case involves a patient (gender and age not reported), who was vaccinated with INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose and site of administration not reported) on an unknown date (reported as one month ago). Patient's medical history and concomitant medications were not reported. On an unknown date (reported as one month ago), after the vaccination, patient was sick and missed school for next two weeks. Lab test and corrective treatment was not reported. Outcome of the event was not reported. Documents held by sender: none.
sore arm; body ache; weakness; fever; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (body ache), ASTHENIA (weakness), PYREXIA (fever) and HEADACHE (headache) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (body ache), ASTHENIA (weakness), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (body ache), ASTHENIA (weakness), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) outcome was unknown.            No concomitant medication use was provided by the reporter. Treatment of events was not reported.    Reporter did not allow further contact
Nausea; pain in injection site; fever; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 02Mar2021 (at the age of 56-years-old) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included MS (multiple sclerosis), hypo thyroid, chronic migraines, and COVID-19. The patient has known allergies to amoxicillin, sulfa, dozicillian (doxycycline), and pretizone (prednisone). The patient was not pregnant at the time of the events. The patient did not receive other vaccine in four weeks. Mavenclad was received in two weeks. The patient had COVID-19 prior to vaccination. The patient had not been tested for COVID post-vaccination. Concomitant medication included cladribine (MAVENCLAD) taken for multiple sclerosis, start and stop date were not reported.  On 02Mar2021 at 13:30, the patient experienced nausea, pain in injection site, and fever. No treatment was received for the events. The outcome of the events was not recovered/not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Onset of many apthous ulcer in bilateral buccal mucosa and inside of top and bottom lip, and 1 lesion on base of right tonsil
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 43-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
Localized reaction at site of injection:  inflamed (red, hot the the touch, swollen), very itchy.  Area of inflammation measured about 2 inches in diameter. Started around 26 hours after vaccine administered, continued to worsen for an additional 24 hours.  3 days post vaccine itching is starting to improve.  Treated with hydrocortisone cream OTC 1%, and Benadryl.
Retinal Detachment; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. On or about 25-AUG-2011, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered from retinal detachment. As a direct and proximate result of the vaccination, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her 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. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the vaccination, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was reported as not recovered. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was related.  Upon internal review, the event of retinal detachment was determined to be medically significant. The reporter considered the event to be disabling.
Having a cough and some stuffiness; Having a cough and some stuffiness; This is a spontaneous report from a non-contactable consumer (patient). This 33-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Aug2021, at the age of 33 years, as the first single dose, in right arm, for COVID-19 immunisation. No other vaccine was administered in 4 weeks. Medical history included sulfa drugs and strawberries allergy. The patient did not have COVID prior vaccination. Concomitant medications were not reported. On 15Aug2021 the patient experienced having a cough and some stuffiness. COVID was not tested after vaccination. The events were resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (an horrible allergy), SWELLING FACE (Swelling in the face , ears and nose), GASTRITIS (gastritis), HEADACHE (headache) and NAUSEA (nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (an horrible allergy), SWELLING FACE (Swelling in the face , ears and nose), GASTRITIS (gastritis), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HYPERSENSITIVITY (an horrible allergy), SWELLING FACE (Swelling in the face , ears and nose), GASTRITIS (gastritis), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Pt received a TD and Flu shot on 10/25/06. According to pt, he did not plan on getting the flu shot, but was encouraged to get it. About 4 days later his throat was itching and he could "feel phlegm coming on".  He states he could hear it on forced expiration. In a week the phlegm was yellow for 2 weeks to a month.  After a round of antibiotics he would feel the symptoms leaving, but they would return immediately "that evening". He states he is still taking antibiotics, is on Levaquin 500mg to "dry up the chest" and has taken 3-7 day courses of this. States he can not get a good breath and becomes short of breath with very little activity. He loses his voice quickly and needs his voice on his job.  States he "sweats or freezes", but really does not feel sick the way he thinks he should with the flu. He has a history of Hep C diagnosed 5 years ago and has not had problems with this recently.
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided.  It was reported that total 19 patients received expired vaccine out of which 3 were males and 16 were females.  It was reported that 10 vials out of 15 doses each were stored in a freezer whose temperature range was at all times from  24.3 degree Fahrenheit to 24.7 degree Fahrenheit.  The healthcare provider mentioned that they always had the freezer between this temperature range. Two vials were used to administer to healthcare provider's office employees. All doses were injected intramuscularly in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  The reporter informed that, the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt.  The patient did not experienced any adverse events after receiving the vaccine and the healthcare provider was informed that the vaccine could be used until the date of expiration.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Updated narrative.
felt like an anxiety attack that lasted almost 3 hours; pressure on my chest; pain on the side of my ribs; It got worst on the 3rd hour and was localized then right under my left breast; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0187), via an unspecified route of administration, administered in Arm Left on 17May2021 at 13:15 (at the age of 37-years) as single dose for covid-19 immunization. The patient medical history included: known allergies Zytromax. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included cetirizine hydrochloride (Zyrtec Allergy), Bloom Protein powder, bloom collagen. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 19May2021 at 21:00, the patient felt like an anxiety attack that lasted almost 3 hours. Patient had pressure on her chest and pain on the side of her ribs. It got worst on the 3rd hour and was localized then right under her left breast. The patient did not receive any treatment for events. Since the vaccination patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in May2021.
positive for covid19; had vaccine.; positive for covid19; had vaccine.; I have been sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 58-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 58 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant), outcome "unknown" and all described as "positive for covid19; had vaccine."; ILLNESS (non-serious), outcome "unknown", described as "I have been sick". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive: had vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mild fever onset at 4am on 2/21, mild fatigue throughout the day. Not debilitating.
The patient had mild local erythema, followed by onset of probable local cellulitis after 5-7 days. Treated with Keflex.
Severe muscle pain in shoulder where vaccine administered.  Very painful to even move arm for 2 days and continued moderate-severe pain for 4 more days.
itching on hands, feet, arms, legs and red patches 12 hours after injection and still occurring at 8:30 am (the time of this report); consistent to prevent sleep
No adverse effect; A 28 week pregnant female patient received GARDASIL 9 on 11-SEP-2019; This spontaneous prospective pregnancy report was received from a medical assistant via a company representative referring to a female patient of unknown age who were 28 weeks pregnant. There was no information about patient's concomitant medications, past drug reactions, allergies or pertinent medical history. Her last menstrual period was in 28-FEB-2019.   On 11-SEP-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose number, dose route, anatomical site of vaccination, lot number and expiration date were not reported) (exposure during pregnancy). In addition, no adverse effect was reported.    At the moment of the report, the pregnancy was on going.
burst blood vessels in the left eye / "red spot in the left eye."; felt a loud noise in the head, last night while sleeping; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (burst blood vessels in the left eye / "red spot in the left eye.") and HEAD DISCOMFORT (felt a loud noise in the head, last night while sleeping) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEAD DISCOMFORT (felt a loud noise in the head, last night while sleeping). On 09-Jun-2021, the patient experienced EYE HAEMORRHAGE (burst blood vessels in the left eye / "red spot in the left eye."). At the time of the report, EYE HAEMORRHAGE (burst blood vessels in the left eye / "red spot in the left eye.") and HEAD DISCOMFORT (felt a loud noise in the head, last night while sleeping) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Patient did not receive any treatment.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-214739, MOD-2021-214735 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Soreness of arm; Sick; Sore throat was worst; Super fatigue; Dizziness; Diarrhea; Cough; Severe muscle pain; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm), ILLNESS (Sick), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and COUGH (Cough) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety and Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), SERTRALINE for Anxiety.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), COUGH (Cough), MYALGIA (Severe muscle pain) and ASTHENIA (Weakness). On 04-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat was worst) and FATIGUE (Super fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness of arm) and ILLNESS (Sick). At the time of the report, PAIN IN EXTREMITY (Soreness of arm), ILLNESS (Sick), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), COUGH (Cough), ASTHENIA (Weakness), OROPHARYNGEAL PAIN (Sore throat was worst) and FATIGUE (Super fatigue) had not resolved and MYALGIA (Severe muscle pain) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-067712 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067712:
??18-24 hours post-vaccination: fever/chills 101.3°F ??45-70 hours: Severe nausea/vomiting & muscle pain (back, legs, arms)  ??71-96 hours: Mild fatigue/nausea
Patient experienced carpal tunnel-like pain numbness, tingling, difficulty sleeping about a week after vaccination. 1 week later, itcing, which have since resolved.
pt recv vax 25SEP95 & 19JAN97 pt devel chickenpox;
14 days after vaccination given, patient unexpectedly died. Collapsed and in immediate cardiac arrest. No prior complaints.  No pre existing health conditions. Otherwise healthy. Autopsy results pending.
Patient received smallpox vaccine LUE (Good to go no issues) last week. yesterday 16 Mar 04 after received Anthrax vaccine RVP. Awoke this morning 17 Mar 04 with erythematous macules non-pruritic on anterior chest and upper back. Possibly small satellite lesion (2) on upper back (LUE). No dyspnea. No edema. Patient was...: he had protein shake and asparagus last night. Treated with motrin and pseudoephedrine.