chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient felt dizzy after receiving the vaccine.Fell down and hit his head on the floor.He then regained consciousness and sat up in his chair. Emergency services were contacted. Patient refused to leave with emergency services.
Diarrhea; Nausea; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CR8734) via an unspecified route of administration in the right arm on 05Apr2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), ergocalciferol (VIT D) and multivitamin (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 08Mar2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021, the patient experienced diarrhea, nausea and shortness of breath. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea, nausea and shortness of breath were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race, and ethnic origin. 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 and expiry unknown) dose, start therapy date were not reported, 1 total, administered 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, few months after receiving vaccine, the patient was diagnosed with Covid-19 (suspected clinical vaccination failure, and suspected covid-19 infection), lab test date and name unspecified.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210850450-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
No Adverse event, vaccine was given to 11 year old, outside of recommended age guidelines.
Adverse events: Extreme chest pain, couldn?t move arms very much, hands went numb and tingly, throat pain Treatment: went to the doctors and the hospital and have tried over the counter pain medicine which didn?t work, prescribed prednisone which didn?t work, prescribed naproxen 500 which didn?t work, prescribed famotidine which didn?t work, all blood and heart and lung tests came back fine  Outcome: still in a lot of pain and nothing is helping and nobody can figure out what is wrong
Supraclavicular Lymphadenopathy at the ipsilateral side of injection site.   Slight L arm soreness, not severe. Denies fevers/Nausea/Vomiting
got the shingle shot, still got shingles/ Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she got the shingle shot and still got shingles. The reporter also stated that you could still get shingles with the shot. Emergency room doctor told him/her that it was like getting the vaccine not getting Covid which you could still get with the shot. Follow up was not possible as no contact details were provided. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting.
Within 15 minutes muscle spasms. At 20 min after administered dose hives and itchiness. All mucus membranes affected. At an hour or so swelling of the left eyelid began. Took a lot of benadryl, effects eased and swelling reversed. Swelling came back overnight. Eyelids, cheeks, tongue, gums, lips, left arm and hand swollen.  Have taken more benadryl
This spontaneous report as received from a nurse refers to unknown number of patients of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that unknown number of patients were vaccinated with GARDASIL (dose strength, route not reported) that had been improperly stored approximately on an unknown date in July 2014 (reported as between 09-JUL-2014 and 16-JUL-2014). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of the several reports received from the same source. Additional information has been requested.
Patient has red rash across chest/back/groin/hair line Dx Chicken pox Treatment anti-itch cream
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "HTN" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: 01Nov2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxlovid. The patient was taking other medication Amlodipine within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 40 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "POTS" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST, start date: 05Jan2021; IVABRADINE, start date: 10Oct2022; METHYLPHENIDATE, start date: 07Mar2022; FEXOFENADINE, start date: 01Oct2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Sep2022 at 14:00, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 27Jan2023 to 01Feb2023.
Pt presented with hives on face that spread to limbs and trunk. Pin-point rash on stomach. No respiratory issues. Pt given epinephrine.
Immediate itchiness lasted 4 days. Hot and red lasted 4 days. Large swelling lasted 4 days. The symptoms are ongoing.
Patient came in for Covid-19 Moderna vaccine, received vaccine @ 0804, while monitoring patient @ approx 0814 patient reported symptoms of flushing. VSS O2 sat 97%, BP 139/84 & HR 73 After 15 minutes of monitoring patient reported symptoms resolved and was able to report back to work.
Very large Swollen lymph nodes around collar bone with pain whenever it is touched or if I move my left arm or turn my neck to that side. Pain/tenderness going up into neck.
Client complaining left forearm and hand tingle. Feels like it is falling asleep. EMS evaluated she stayed an extra 10 minutes and given exercise to decrease tension.
My menstruation cycle began on March 28, approximately 15 days after my second COVID-19 vaccine. I have been experiencing a longer and heavier period than what is considered normal for me.
I started getting symptoms on the 11th, I was tired than usual, kind of sore throat and congestion. I felt it was cold, but I tested rapid at home, and it was positive the next day. My daughter had been positive a week ago before me.  So, I was sure that I had contracted it. By this time, I was feeling very nauseous. I contacted a telehealth clinic and She said because of my age I get Paxlovid. I stated it on the 13th of February. It was fine and started feeling better within 24 hours. I felt progressively better that week.
Information has been received from a physician concerning a 20 wk old male with a history of premature birth who on 15Jun06 was vaccinated PO with a 2.0mL dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot 652964/0145F). Concomitant vaccinations administered on that same day included a dose of diphtheria toxoid (+) hep B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3 component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (Pediarix), Hib conj vaccine (manf unk) and pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar).  The physician reported that on 15Jun06, an hour after vaccination,  the pt woke up crying and could not be controlled. The pt acted as if his stomach hurt, and cried more after nursing. The pt's lower extremities also became swollen and his legs had a blue color. It was unk if medical attention was sought and no lab/diagnostic tests were performed. On that same day, two hrs after onset, the pt's symptoms resolved on therapy (unspecified). Additional information has been requested. Medical attention was not sought. At the time of this report, the outcome was unk. Additional information has been requested.
Could not speak words as I thought them, ran 2° fever, aches, chills, but headache so splitting & so "light sensitive", I thought I had a mild stroke. Could not function to get medical help for 2 days & still have lingering splitting headaches with extreme lethargy, stiffness in neck, and no strength. Could this have made heart condition worse? I have a LBBB, 30% E.F. and congestive heart failure. I just turned 65 in Jan. 2016.
On March 2, 2023, I had cough and heavy nasal discharge. We went to the store and picked up over the counter medication, ibuprofen, FLONASE for symptom relief. We thought we were having allergies. We decided to go to the clinic to go see the doctor on 03/04/2023. They tested us for COVID-19 and it was a strong positive and for Flu and it was negative. The doctor said he could prescribe the PAXLOVID but he did not recommend it because of my health condition, and I was not that sick. And he said stay quarantined for the next 5 days. I had a productive cough, and I had an extreme amount of nasal discharge. The nasal discharge was not green it was just regular. I also had nasal congestion. I did not have a fever. I did not lose my sense of smell and taste. Having as many shots that I had, I felt it kept my COVID-19 infection from getting worse.
Fever, Rash all over the body, Headache, Muscle Pain, Back Pain, Tiredness, Injection site redness and pain.
Patient was given 2 Pfizer COVID vaccine doses instead of one Pfizer COVID vaccine and one Flu vaccine dose.
All over stinging, tingling some numbness. Face ,arms,torso,legs Started after leaving pharmacy. Took benadryl. Continued through next day.  Didn't worsen, but still continues. Some stinging like bug bites. Nerve pain
Day after injection patient developed a temperature of 102.2. Mother called hospital and was advised to give Tylenol.  Patient hospitalized 2 weeks after the event.
Information has been received from a health professional concerning her daughter with no allergies or medical history who was vaccinated in another physician's office with her first dose of Gardasil.  Subsequently the patient experienced a rash.  The patient's physician suggested the patient not receive succeeding doses of Gardasil because she was allergic to the preservative.  The representative told the health professional that there was no preservative in Gardasil.  Therapy with human papillomavirus vaccine was discontinued.  The patient's outcome was not provided and she sought unspecified medical attention.  Additional information has been requested.
My son broke out with lots of chicken pox all over his body and face on the 7th day from the day the vaccine was administered (3-10-2003).  No fever just severe marks all over.
infection in his lungs/pneumonia; abscess on his lungs; started feeling sick the second week after the vaccine/couldn't do anything; night sweats; Swallowing difficult; back pain; lost weight; fever; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (infection in his lungs/pneumonia) and LUNG ABSCESS (abscess on his lungs) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Splenectomy in 1991. Concomitant products included ATORVASTATIN for Cholesterol, GABAPENTIN for Nerve pain, WARFARIN and TRAMADOL for an unknown indication.    On 12-Jul-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 PNEUMONIA (infection in his lungs/pneumonia) (seriousness criteria hospitalization prolonged and medically significant), LUNG ABSCESS (abscess on his lungs) (seriousness criteria hospitalization prolonged and medically significant), MALAISE (started feeling sick the second week after the vaccine/couldn't do anything), NIGHT SWEATS (night sweats), DYSPHAGIA (Swallowing difficult), BACK PAIN (back pain), WEIGHT DECREASED (lost weight) and PYREXIA (fever). The patient was hospitalized from 31-Jul-2021 to 05-Aug-2021 due to LUNG ABSCESS and PNEUMONIA. At the time of the report, PNEUMONIA (infection in his lungs/pneumonia), LUNG ABSCESS (abscess on his lungs), MALAISE (started feeling sick the second week after the vaccine/couldn't do anything), NIGHT SWEATS (night sweats), DYSPHAGIA (Swallowing difficult), BACK PAIN (back pain), WEIGHT DECREASED (lost weight) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient should have never gotten the vaccine because he doesn't have a spleen it was removed in 1991 was reported.  Patient went to the doctor on 30-Jul-2021 and the emergency room on 31-Jul-2021 was reported.  Treatment medication was not reported. Concomitant includes cholesterol meds, atorvastatin and blood pressure med was reported.  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.; 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.
Day after vaccine given; developed erythema of thighs & swelling rash on arms & legs by next day. Arms & legs were swollen & puffy skin whitish. Went to U/C given hydrocortisone to apply dx with immunization reaction (thighs) 10-25 skin peeling like sunburn now. Skin arms & legs very dry. Had brief episode lasted seconds mom thought she heard a wheeze - gasp then was fine 10/22 pm.
Low grade fever 99.9, fatigue, body aches, headache, chest congestion for about 30 minutes, significant pain in infection site. Did not experience any issues after first dose
Shortly thereafter he got dizzy; falling; disoriented; he has right upper extremity tremors; This serious case was reported by a physician via call center representative and described the occurrence of dizziness in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, immediately after receiving Shingrix, the patient experienced dizziness (Verbatim: Shortly thereafter he got dizzy) (serious criteria hospitalization), fall (Verbatim: falling) (serious criteria hospitalization), disorientation (Verbatim: disoriented) (serious criteria hospitalization) and tremor limb (Verbatim: he has right upper extremity tremors) (serious criteria hospitalization). The outcome of the dizziness, fall, disorientation and tremor limb were unknown.   It was unknown if the reporter considered the dizziness, fall, disorientation and tremor limb to be related to Shingrix.     It was unknown if the company considered the dizziness, fall, disorientation and tremor limb to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-OCT-2023 The healthcare professional stated that he had 2 patients to report. The reporter stated that the patient got Shingrix (did not have date) and shortly thereafter he got dizzy, falling, and disoriented. The patient also mentioned he had right upper extremity tremors.  This report 1 of 2. The reporter consented to follow up. This case had been linked with US2023144346 due to same reporter.; Sender's Comments:  US-GSK-US2023144346:Patient 1 of 2
3:19pm: vaccine administration 3:30pm: patient developed numbness and tingling in right arm first (side of injection) and then left arm  3:40pm: patient then developed itching in his throat 3:45pm: patient developed chest pressure sensation (as if something is pressing on his chest) and then he described that his throat felt  more "clogged" 3:45pm: epinephrine 0.3 mg injected into left thigh and 911 was called 3:50pm: EMT arrived and transported patient to local ED After arrival at Hospital ED, patient was assessed and was found to be stable with no further symptoms.
Daughter's arm was bruised for weeks after and it looked yellow and it got kind of itchy.; Daughter's arm was bruised for weeks after and it looked yellow and it got kind of itchy.; Daughter's arm was bruised for weeks after and it looked yellow and it got kind of itchy.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE BRUISING (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE DISCOLOURATION (non-serious), outcome "unknown" and all described as "Daughter's arm was bruised for weeks after and it looked yellow and it got kind of itchy.". Additional information: Caller reports her Daughter had bruising and it stayed yellow. Caller states she doesn't know if her Daughter has still gotten rid of it.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
PHARMACIST ON DUTY DID NOT DILUTE THE PFIZER VACCINE PRIOR TO ADMINSITERING AND INJECTING 0.3 MLS OF THE UNDILUTED PFIZER DOSE. PT DENIED ANY ADVERSE REACTIONS.
This is a spontaneous report received from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 45-year-old male patient received bnt162b2 (BNT162B2) on 02Jun2022 as dose 3 (booster), single (Lot number: FJ5683), in left arm, for COVID-19 immunization. The patient's relevant medical history was not reported. The patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EL3247; Anatomical site: Left arm), administration date: 04Mar2021, when the patient was 44 years old, for COVID-19 immunization and Bnt162b2 (DOSE 2, SINGLE; Lot number: HEP6955; Anatomical site: Left arm), administration date: 25Mar2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 02Jun2022, outcome "not recovered", described as "Fever 102.5"; PAIN IN EXTREMITY (non-serious) with onset 02Jun2022, outcome "not recovered", described as "Left arm pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia and pain in extremity. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment included ADVIL and TYLENOL for PYREXIA and PAIN IN EXTREMITY. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 26-MAR-2018, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, lot# and expiration date were not provided) for prophylaxis. Later on 08-NOV-2018, and 12-JAN-2019 the patient was administered with the subsequent doses of GARDASIL 9. No adverse effects reported.