chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Someone right now that is in the hospital with heart conditions with the shot; This is a spontaneous report from a non-contactable consumer via Medical Information Team. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as a dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she was concerned about the safety of the vaccine when there had not be a 5-6 year review/study and that it was approved so quickly by the FDA. She was just wondering. She heard yesterday that the Pfizer shot was not FDA approved yet just which was an emergency basis, based on the fact that it hasn't done enough reviews, for a long enough time. She knew a lot of people who have serious side effects to this shot. People are having terrible side effects to it. These are people's lives they are messing with. These are people who want to live, they don't want to have serious consequences. For something to be FDA approved in such a short time was very scary to parents and comprehension. That's not long enough to said something was going into her body that had been reviewed to 6 months. That just doesn't seem logical. She know someone right now that was in the hospital with heart conditions with the shot, so she questioned it. She remain anonymous and declined to share any information about herself. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Experiencing chronic ringing in the ears, mainly left ear.  Range from low pitch to high pitch. It is now March, and the ringing has become more chronic.
Patient received Moderna Vaccine and was waiting per protocol in view of pharmacy staff after vaccination. Patient was sitting in the waiting area for approximately 10 minutes before she came up to the counselling window and stated that she did not feel well and might faint. I told patient to sit down and that I will get some water for her. Patient fainted right after that, when I reached her she was on the floor but conscious. She was able to sit up after approximately 5 minutes and stated that she did not need the paramedics. Patient started complaining about tingling in her fingers, at that time the paramedics were called. Ambulance arrived after 10 minutes and the medics monitored patient for another 10 minutes before she was taken away by the ambulance. Patients stated that she has fainted in the past after blood work or vaccine administration, was noted on consent form. Called patient next day, patient complained that after she left the pharmacy she had cramps in the vaccinated arm and was vomiting as well.
Information was received on 21-MAR-2017 from an attorney in the form of an initial legal complaint. On or about 09-SEP-2013 a female patient (age not provided) received a ZOSTAVAX injection for the prevention of shingles. On or about 07-JUL-2015 the patient went to her primary care physician with complaints of sharp and throbbing pain. The patient was diagnosed with shingles and postherpetic neuralgia which was considered severe. The patient was prescribed ondansetron for nausea, ELAVIL, and LORTAB to treat the severe and ongoing pain associated with shingles and neuralgia. As a direct result of ZOSTAVAX, the patient suffered, is suffering and /or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her condition. Additional information has been requested.
Vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022; Patient received a vaccine past the 30 day storage on the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     The patient had no known allergies.  Patient did not have COVID-19 preceding the month of vaccination.  Concurrent medical conditions included Diabetes, Anemia, Hyperlipidemia and Thrombocytopenia. Concomitant products included GLIPIZIDE for an unknown indication.    On 06-Apr-2022 at 3:14 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 3:14 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 25-Feb-2022 the vial was initially stored in the refrigerator, its 30 day used by date was 25-Mar-2022. The vial did not undergo any temperature excursions.  Treatment details were not given.
vaccination site had a rebound reaction/the site she said she looked like a lobster; anaphylaxis; arm got swollen; feeling like crap; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaxis) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 028620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung operation NOS (she was holding her right side since she could not inflate right lung due to surgery.). Concurrent medical conditions included Hernia. Concomitant products included PREDNISONE and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Hernia NOS.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criterion medically significant), PERIPHERAL SWELLING (arm got swollen) and FEELING ABNORMAL (feeling like crap). On an unknown date, the patient experienced VACCINATION SITE REACTION (vaccination site had a rebound reaction/the site she said she looked like a lobster). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 50 mg every six hours. At the time of the report, ANAPHYLACTIC REACTION (anaphylaxis), PERIPHERAL SWELLING (arm got swollen), FEELING ABNORMAL (feeling like crap) and VACCINATION SITE REACTION (vaccination site had a rebound reaction/the site she said she looked like a lobster) had not resolved.            Event includes:while at the site she said she looked like a lobster  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.   This case was linked to MOD-2021-291221 (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.
Case number PHEH2016US023397 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 47 year old patient whose gender was not specified. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 30 Jan 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
Resident received 1st Booster dose 2 months early.  No adverse effects noted.
Early September tingling in hands & feet. Symptoms moved up body. Muscle weakness end of September that became progressive * DX CIDP treatment IVIG.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 28-NOV-2016, the patient was inadvertently administered an expired dose of VARIVAX (lot # K021937, expiration date 10-NOV-2016, dose and route not reported) for prophylaxis. No adverse effect was reported. Additional information has been requested.
Very ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  An elderly female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Very ill".  Additional information: When patient had Pfizer booster, she became very ill for 3 months; would not use Pfizer again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Temperature 100.5 - 101.5 Chills/shaking Nausea/ Vomiting Muscle Aches No appetite/ couldn't keep anything down The above started approximately 2.5 days after receiving vaccine and lasted approximately 4 days. Localized redness/soreness/bruising - 3 wks
She passed out after receiving the vaccine; Her BP is been affected.; This is a spontaneous report from a Pfizer-Sponsored Program. A contactable consumer (patient mother) reported that a female patient (reporter's daughter) of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported, and concomitant medications included "DepoVera" a birth control pills every three months. patient passed out after receiving the vaccine. Her BP is been affected. It's been four weeks. The doctor thinks its age related because she's 15. 52% percent of females will have this type of reaction. The doctor blames it on something else. She had received been receiving DepoVera a birth control pills every three months. She never passed out from that. The doctor doesn't want to report anything because they think the adverse events are not related to the vaccine. Outcome of the events was unknown.   The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events  and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
1 week later c/o intermittent burning pain in chest when eating or taking a deep breath. Sometimes feels like heart is being squeezed.  No fever, no chills.  Does not feel like heart is beating funny. Has not stopped him from normal activities like working out or playing baseball.
Left arm pain, swelling to injection site. Body ache, fever 101 (oral), headache, itchy sore throat, nausea 2/4/15 1930 - felt worse.
a male patient received the pneumonia shot 12 days after the first dose of the vaccine; he had died; This is a spontaneous report from a contactable consumer or other non hcp.   A 76 years old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID 19 immunisation and received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration on an unspecified date 12 days after bnt162b2 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  Information on lot and batch number has been requested.  Follow-up: (08Feb2021): Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: a male patient received the pneumonia shot 12 days after the first dose of the vaccine; he had died
Knots within the palms of their left hands; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (Knots within the palms of their left hands) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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 LIMB MASS (Knots within the palms of their left hands). At the time of the report, LIMB MASS (Knots within the palms of their left hands) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-272927 (Patient Link).
Pt recvd a series of Engerix-B doses & did not respond; extra booster doses were administered;
Moderna COVID-19 Vaccine  - Tingling in lips, cheeks, and forehead. Symptom resolved itself after approx 8 hrs.
COLD; CHILLS; NAUSEA; This spontaneous report received from a consumer concerned a 35 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced fever and muscle pain when treated with tetanus vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced cold. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, cold, and nausea. This report was non-serious.
chills; body aches; headache; little tired; fever; This is a spontaneous report received from a non-contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: Unknown), via an unspecified route of administration on 16Mar2021 as dose number unknown, single for COVID-19 immunization. Medical history of the patient and concomitant medications was not reported. It was unknown that prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination. On 16Mar2021, patient experienced little tiredness and had fever of 99.6 and experienced fever, chills, body aches and headache (17Mar2021), super tired and took nap on day 2 and day 3 day. She had a little tired on and off but that's it so far, then and fever again 99.6 so she had taken Advil now then Day 2 she had Fever, chills, body aches, headache, super tired and took a one hour nap at lunch and again at 7PM, Day 3 she had fever and Chills and nap one hour nap at 6PM, Day 3 she had perfectly fine all back to normal and she was super healthy so it kicked her butt. The patient had taken Advil as a treatment for tiredness and fever. Therapeutic measures were taken as a result of little tired, fever. The patient underwent lab tests and procedures which included fever: 99.6 on 16Mar2021. The clinical outcome of events was recovered on 18Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-Up (23Jun2021): Amendment: This follow-up report is being submitted to amend previously reported information:  1. Protect Confidentiality ticked since reporter is patient.  2. patient's initial added as UNKNOWN since patient's name is unknown. 3. Country added in patient tab.  4. dose number leave blank and Dose Description added as DOSE NUMBER UNKNOWN, SINGLE. 5. leading sentence updated to a non-contactable consumer. 6. final sentence updated to No follow-up attempts are possible; information about lot/batch number cannot be obtained. Reported Event: a little tired on and off but that's it so far, then and fever again 99.6 so I was taking Advil now then Day 2 Fever, chills, body aches, headache, super tired and took a one hour nap at lunch and again at 7PM, Day 3 Fever and Chills and nap one hour nap at 6PM, Day 3 perfectly fine all back to normal and I was super healthy so it kicked my butt
Arm pain, widespread joint and muscle pain beginning 10 hours after shot and continuing for 36 hours; chills, shakiness, lightheadedness, sleepiness beginning at 12 hours after shot and lasting til 48 hours after shot; excessive night sweating
This spontaneous report was received from a nurse refers to a 22 year old female patient. On 08-AUG-2014 the patient was vaccinated with GARDASIL dose 2, 0.5ml, intramuscular in the patient's left arm (lot # was not reported). It was reported that the patient got her first dose of GARDASIL on 08-AUG-2013 and the second dose, one year after she received the first dose GARDASIL. No adverse effects were reported. Additional information is not expected due to the reporter did not want to be contacted again.
Patient is a 86 y.o. female with a history of COPD, HTN, and HLD who presented to RMH 5/1/2023 with dyspnea. Patient found to be COVID positive requiring oxygen on discharge.    1. COVID Infection: without pneumonia. Presented with four days of generalized weakness, congestion and not positive test date 5/1/23. Fully vaccinated. CXR with minimal hazy interstitial opacity in the left lung base with trace left pleural effusion. Remdesivir discontinued. Decadron continued on discharge.  2. Acute Hypoxic Respiratory Failure: required 2L NC on admission with initial oxygen saturation of 87% per ED notes. Endorsed she has needed O2 in the setting of COPD but was never arranged. Patient qualified for home oxygen and arranged per CM on discharge.  3. COPD: per history. Not in exacerbation. Suspect will need chronic home oxygen, arranged on discharge. Inhalers initiated.  4. Malnutrition: moderate malnutrition without cachexia. BMI 21 on admission. Encouraged PO intake.
Shingles; Inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 183 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The patient had shingles 6 months after the first dose. The reporter stated a patient was due for the second dose of vaccine, which led to incomplete course of vaccination.  The specialist neglected to obtain additional information and no further details were provided by reporter on the call. The reporter consented to follow up.
Shingle to nose and forehead within week after getting vaccine, Saw their provider and got Valtrex with resolution of shingles
Narrative: An error occurred while administering the Moderna Bivalent booster on 10/05/2022. Patient was given .25mL instead of the full dose of 0.5mL vaccine. Patient was return to campus for an addition.25mL dose on 10/06/2022.
Uncontrollable finger jumping,  alot of pain and very unstable on feet and legs
Initial local reaction of redness, swelling pain. However, after local reaction resolved, hyperpigmentation of left upper arm has persisted for 1 month.   Hyperpigmentation varies through the day.  No swelling, fever, pain, limitation in arm movement.
Shortly after I received the  shot I noticed that the injection site itched. Later that same day I removed the bandaid before showering and noticed the site was swollen, red, itchy and hard and a bit warm to the touch.  I took an acetaminophen that night. The next day I started feeling achy and did have a 99.2 temperature.  I took two more acetaminophen throughout the day.  I also  applied topical Benadryl to the raised red area. I did not take an oral Benadryl or antihistamine.  Today ( the day of this report) my achiness is gone,  but my arm is still the same.
pt devel mild rash;mom devel shingles 3-4 wk p/vax;had close body contact w/child while child had rash (in the shower);no reports of caretakers getting shingles during clinical trials w/varivax;
Patient encounter tingling sensation on injection site administered by a HCP on the Left arm. our Medical assistant took vitals at 11 am  Blood Pressure: 140/62 Oxygen:98% Pulse:66. Final Vitals were Blood Pressure;138/68 Oxygen;98% Pulse:61.