chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Leg pain in lower left lane; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 24Mar2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included varicose veins in lower left leg. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ramipril (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and sertraline (MANUFACTURER UNKNOWN) all were taken for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient experienced leg pain in lower left lane. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of event leg pain in lower left lane which included unspecified treatment and the patient had ultrasound of leg. On an unknown date, the patient underwent ultrasound scan and the result was unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event leg pain in lower left lane was not resolved at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
heart attack; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset Jul2022, outcome "unknown", described as "heart attack". The event "heart attack" required physician office visit. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300114139 same patient/product, different dose/event;
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An 89-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single at the age of 89 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09Feb2021 as dose 1, single (Batch/Lot number: unknown), on 09Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CKD, stage 3" (unspecified if ongoing), notes: Stage 3; "HTN" (unspecified if ongoing); "type 2 DM" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing); "obesity" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: GLIPIZIDE oral; CITALOPRAM oral; FOSAMAX oral; LEVOTHYROXINE oral; LISINOPRIL oral; MAGNESIA [MAGNESIUM OXIDE] oral; Multivitamin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: patient received anti viral details product-COVID 19 Treatment orally from 14Jun2022 to 19Jun2022. Adverse event covid rebound on 24Jun2022; completed paxlovid 20Jun2022, renal dosing, and felt improved while taking, then normal for 2 to 3 days, then full symptom recurrence 25Jun2022 and repeat covid testing was positive 25Jun22 by antigen. Patient received treatment including telemedicine follow up, extended home isolation.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the available information in the case, the causal association between the event Drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Patient tested negative on Day 7 and 10 after taking Paxlovid again re-tested positive on Day 14; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested negative on Day 7 and 10 after taking Paxlovid again re-tested positive on Day 14) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression and Drug allergy (unknown drug history.). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, the patient experienced COVID-19 (Patient tested negative on Day 7 and 10 after taking Paxlovid again re-tested positive on Day 14). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient tested negative on Day 7 and 10 after taking Paxlovid again re-tested positive on Day 14) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 23-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 27-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient did receive a COVID-19 Vaccine previously.  Company comment: This spontaneous case concerns a 63-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred approximately 6 months after the administration of a dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 15-May to 20-May. Patient tested negative on day 7 and 10 after taking Paxlovid. Patient again tested positive on day 14. Patient received 2 more doses of mRNA-1273 vaccine prior to the last dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred approximately 6 months after the administration of a dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 15-May to 20-May. Patient tested negative on day 7 and 10 after taking Paxlovid. Patient again tested positive on day 14. Patient received 2 more doses of mRNA-1273 vaccine prior to the last dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
1. Sore throat  2. Fever, unspecified fever cause  3. Tonsillitis
nausea,  rash, itchy throat, fatigue -    prednisone - Pepcid - Benadryl  & Tylenol for 4 days around the clock
Headache, chills, low grade fever, tiredness, body aches/pains. Pain at inj. Site.  Had all of these symptoms up until 12 noon in 4/5/21
joint pain; rash; red; swollen; mild arm pain near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild arm pain near the injection site), ARTHRALGIA (joint pain), VACCINATION SITE RASH (rash), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033620A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (mild arm pain near the injection site). On 19-Jan-2021, the patient experienced ARTHRALGIA (joint pain), VACCINATION SITE RASH (rash), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen). On 22-Jan-2021, VACCINATION SITE PAIN (mild arm pain near the injection site), ARTHRALGIA (joint pain), VACCINATION SITE RASH (rash), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
received a second dose of Shingrix at less than the recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number 33A2Z, expiry date 25-OCT-2024) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 29 June 2023).   On 02-AUG-2023, the patient received the 2nd dose of Shingrix. On 02-AUG-2023, 34 days after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: received a second dose of Shingrix at less than the recommended interval). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 07-AUG-2023 The reporter stated that patient accidentally received second shot of Shingrix less than the recommended interval. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule. The reporter consent to follow up.
Chest pain; Lightheaded and dizzy; threw-up once; whole body tensed up/couldn't move her hands due to being stiff and tense/legs tensed up as well; couldn't move her hands due to being stiff and tense; tingling sensation as if asleep; Dry cough/the cough was on and off; This is a spontaneous report from a contactable consumer (patient). A 36-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 28Jul2021 15:00 (Batch/lot number unknown), at age 36 years old, as dose 1, single, for COVID-19 immunisation, at an urgent care center. The patient was not pregnant at the time of vaccination. Relevant medical history included narcolepsy, hypothyroidism, anxiety, anemia, G.E.R.D. (gastrooesophageal reflux disease), vitamins D deficiency, and allergies to metal, soap, laundry detergent, lotions, all from unknown dates, not reported if ongoing or not. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jul2021 15:00 (also reported as "about a minute or two after received the vaccine"), the patient became lightheaded and dizzy, threw-up once, her whole body tensed up to where she couldn't move her hands due to being stiff and tense, her legs tensed up as well and had tingling sensation as if asleep. On the same day, 28Jul2021, the patient had dry cough, the cough was on and off. The events resulted to emergency room and physician's office visits. The patient received oral BENADRYL and most of the tenseness released. The patient received more BENADRYL through an IV and sodium chloride. The patient underwent blood tests on 28Jul2021 with unknown results. "Chest drag" (as reported) was done. Most symptoms resolved except for dizziness, lightheadedness and on and off dry cough. The patient was then released home. The patient was not hospitalized. On 29Jul2021, the next day, the patient had on and off chest pain, the other events resolved. The patient recovered from the events threw-up once, whole body tensed up/couldn't move her hands due to being stiff and tense/legs tensed up as well, couldn't move her hands due to being stiff and tense, and tingling sensation as if asleep on 28Jul2021; from lightheaded and dizzy and dry cough/the cough was on and off on 29Jul2021. The outcome of chest pain was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Very dizzy; Very Weak; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Very dizzy) and ASTHENIA (Very Weak) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): unknown.     MEDICAL HISTORY (Patient): Concurrent medical conditions included Diabetes. Concomitant products included LISINOPRIL for Blood pressure management, METFORMIN for Diabetes, DICYCLOMINE [DICYCLOVERINE] and ATORVASTATIN for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced DIZZINESS (Very dizzy) and ASTHENIA (Very Weak). On 15-Jan-2021, DIZZINESS (Very dizzy) and ASTHENIA (Very Weak) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Patient had several drinks after vaccination.  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.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up received  on 12MAY2021 and did not contain any significant information; 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.
approximately two hours after receiving my vaccination my left ear swelled, a hive came out on my left cheek and my upper lip swelled. The swelling stayed itchy for about 3 hours
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "79-year-old male with a past medical history significant for coronary artery disease, CVA with residual left-sided weakness, CKD stage 3 who presented with 1 week of generalized malaise, weakness and falls.  Patient was diagnosed with COVID-19 infection and frequent falls.  On admission patient was also found to have rhabdomyolysis with acute hypoxic respiratory failure at most requiring 3 L of nasal cannula.  During the hospital course, 3 L of nasal cannula was weaned down to room air, patient no longer exhibited signs of acute hypoxic respiratory failure.  Patient was treated with IV rehydration and CPK trended down as well.  Statin was held during this time and will defer to PCP for restarting.  Of note with frequent falls, patient did have significant back pain limiting physical therapy occupational therapy until pain was controlled.  He was found to have a T12 compression fracture, patient was evaluated for inpatient rehab and was accepted, however it was noted that the patient will minimize pain if not prompted prior to therapy sessions.  Patient was discharged with Tylenol and Percocet for pain control prior to working with therapies.  Patient was stable for discharge on the morning of transfer."
has developed a kidney stone; hardness around the injection site; redness around the injection site; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEPHROLITHIASIS (has developed a kidney stone) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) 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 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 24-Mar-2021, the patient experienced NEPHROLITHIASIS (has developed a kidney stone) (seriousness criterion medically significant), INJECTION SITE INDURATION (hardness around the injection site), INJECTION SITE ERYTHEMA (redness around the injection site) and FATIGUE (fatigue).   At the time of the report, NEPHROLITHIASIS (has developed a kidney stone) had not resolved and INJECTION SITE INDURATION (hardness around the injection site), INJECTION SITE ERYTHEMA (redness around the injection site) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Keflex for kidney stones.; Sender's Comments: Based on the known etiology and timing to diagnosis of nephrolithiasis, a causal relationship with the administration of mRNA-1273 is assessed as unlikely. The other events of hardness and redness around the injection and fatigue are temporarily associated with mRNA-1273 administration and consistent with the known safety profile of the vaccine.  Hence, causal association cannot be excluded.
Assessment and Plan Patient is a 51 y.o. male patient of Physician No with history of diabetes, ankylosing spondylitis presented to Hospital with fevers, weakness.   Covid-19 Virus Infection Pneumonia Gram negative suspected Sepsis Date of onset of symptoms: 04/14 Symptoms present on admission: Yes, sore throat, productive cough, loss of voice, fever. Fever of 101.5 with tachycardia and leukocytosis of 17K on arrival. Date of covid positive test: 04/16 Imaging: CTPA with RLL clustered nodular opacity Oxygen requirements on admission: none Current oxygen requirements: none Medical therapy: Not a candidate for steroids/remdesivir. Paxlovid X5 days Consultants following: ID Anticipated special isol Anticipated special isolation end date: 04/23. Discharged with azithromycin and cefdinir   AKI Creatinine 1.98, BUN 16. Likely secondary to sepsis in the setting of metformin, indomethacin use.(Patient also received contrast study). Improving creat, 1. today Hold indomethacin at dishcarge   Diabetes type 2 On metformin at home Hold metformin, A1C 6.6 SSI Ankylosing spondylitis On chronic indomethacin. Given AKI would recommend discontinuation of indomethacin. Discussed with PCP.   Thyroid nodule Right thyroid lobe nodule measuring 3.8 cm noted on CTPA study. TSH wnl. Recommend thyroid ultrasound as outpatient.   Clustered nodular opacities in the right lower lobe Likely inflammatory, on abx. Elevated procalcitonin. Follow-up CT chest recommended in 6 weeks as outpatient. F/U with PCP.
The next day experienced migraine and arm soreness for approximately 24 hours.   Today, 5/25/21 patient woke at 4am to dizziness that has continued throughout the morning, 8am.  Patient is alert and virtual learning.
Within 24 hours after flu shot, had fever of 103 degrees F, dry heaves, dizziness and fatigue lasted 24 hours.  Weight loss since vaccine from reported weight of 140 to 118.  Started 12 size jeans now at size 7. No appetite and constantly tired.
The issue was with right arm only (pneumovax shot) and she said doctor treated her for cellulitis and localized allergic response with redness,swelling and warm to touch. Patient said she did not feel well and the arm was swelling and hurting so she went to ER and they admitted her and kept her for a couple of days. She is doing better now but still has some redness and warm to touch and doc sent her home with antibiotic script.
Sore throat; Severe congestion a runny nose; Severe congestion a runny nose; Headache; Fatigue; 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 (BNT162B2), administration date 08May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SIngle), for COVID-19 immunisation. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 09May2021, outcome "unknown", described as "Sore throat"; RHINORRHOEA (non-serious), NASAL CONGESTION (non-serious) all with onset 09May2021, outcome "unknown" and all described as "Severe congestion a runny nose"; HEADACHE (non-serious) with onset 09May2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset 09May2021, outcome "unknown", described as "Fatigue".  Additional Information: The reporter stated that their daughter who is 30 which was not clarified had her second Pfizer vaccine shot yesterday and this morning she woke up with sore throat, severe congestion a runny nose, headache and fatigue.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She is congested again, crying and shaking her head with no fever. Bad wheezing. Began having bowel issues, constipation, and hemorrhoids.
Client was administered COVID vaccine 4/28/2021 and it was later discovered that he had received a covid vaccine days prior to this administration.  Client did not remember at the time of the vaccine and answered "no" to ever receiving the vaccine prior to this RN administering the vaccine.
Pt recv vax 7July95 SC  3Jan98 pt presented w/chickenpox.10 lesions on back, 1 on the face. Scabbed raised vesicles. No tx necessary. 10Jan98 Pt recovered.
Slight dizziness after 2nd dose; Little Soreness in arm after 2nd dose; Headache after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Slight dizziness after 2nd dose), PAIN IN EXTREMITY (Little Soreness in arm after 2nd dose) and HEADACHE (Headache after 2nd dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 12-Apr-2021, the patient experienced DIZZINESS (Slight dizziness after 2nd dose), PAIN IN EXTREMITY (Little Soreness in arm after 2nd dose) and HEADACHE (Headache after 2nd dose). At the time of the report, DIZZINESS (Slight dizziness after 2nd dose), PAIN IN EXTREMITY (Little Soreness in arm after 2nd dose) and HEADACHE (Headache after 2nd dose) had not resolved.            Reporter did not allow further contact
Increased heart rate up to 120 bpm, dizziness/vertigo, nausea, stinging/burning at site. Symptoms started within 30 min. post injection and lasted for 2 days.
2-1/2-3" raised red area at site. Hot to touch, tender, firm. Complained of headache.
2-15-17 fever x 2 days rash x 1 week under chin both arm and legs. Moderate rash, redness petechiae noted to both cheeks, arms and legs.