chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red, raised area 3 inches in diameter around injection site; Red, raised area 3 inches in diameter around injection site; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site swelling in a 11-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo (intramuscular, unknown arm). On an unknown date, an unknown time after receiving Menveo, the patient experienced injection site swelling (Verbatim: Red, raised area 3 inches in diameter around injection site) and injection site erythema (Verbatim: Red, raised area 3 inches in diameter around injection site). The outcome of the injection site swelling and injection site erythema were unknown.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Menveo.     It was unknown if the company considered the injection site swelling and injection site erythema to be related to Menveo.   Additional Information: GSK Receipt Date: 20-JUL-2023 The reporter consented to follow up.
4 Patients who received Moderna Covid-19 vaccine 12 hours after the vial had first been used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 Patients who received Moderna Covid-19 vaccine 12 hours after the vial had first been used) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 Patients who received Moderna Covid-19 vaccine 12 hours after the vial had first been used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 Patients who received Moderna Covid-19 vaccine 12 hours after the vial had first been used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported. Patient did not complain of any other adverse reactions. No treatment were reported.   This case was linked to MOD-2022-540270 (Patient Link).
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 at 11:00 as dose 4 (booster), single (Lot number: BI635342) at the age of 63 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high. Concomitant medication(s) included: LISINOPRIL; HCTZ. Vaccination history included: BNT162b2 (Dose: 1, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL0140), administration date: 22Dec2020, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (Dose: 2, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL0140), administration date: 12Jan2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (Dose: 3, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: FF8841), administration date: 08Oct2021, when the patient was 62-year-old, for COVID-19 immunization.  The information on the batch/lot number for BNT162B2, BNT162B2 OMI BA.4-5 has been requested and will be submitted if and when received. Specific relevant test for thromboembolic events with thrombocytopenia: None. Comments/Narrative: I had the 3rd booster at withheld on 08Nov2022 around 11:00 AM. At 2:00 AM (09Nov2022) I awake with nausea, chills, vomiting and diarrhea. This lasted until 7 AM, As I was sent home from work due to the side effects, was still a bit nauseous on Thursday, 10Nov2022. By Friday, all side effects had ended (11Nov2022).
Felt like I had the flu; A racing heart beat and a pounding heart that lasted all day.; This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA (Felt like I had the flu) and PALPITATIONS (A racing heart beat and a pounding heart that lasted all day.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arrhythmia (Arrhythmia problem).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced INFLUENZA (Felt like I had the flu) and PALPITATIONS (A racing heart beat and a pounding heart that lasted all day.). At the time of the report, INFLUENZA (Felt like I had the flu) outcome was unknown and PALPITATIONS (A racing heart beat and a pounding heart that lasted all day.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Dose date captured as per narrative No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-322729 (Patient Link).
Chickenpox vaccine breakthrough. Diagnosed with varicella by DR. in our office on 11/3/05. Developed rash 11/2/05. Had approximately 5 lesions in genital area some papules, some vesicles, some crusted. no fever. Had varicella vaccine 5/7/01.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (lots of body ache), CHILLS (Chills) and PYREXIA (fever 101.5 last night, today 99.6) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.  Concomitant products included ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), Ocuvite 50+, SPIRONOLACTONE, PREDNISONE, HYDROCHLOROTHIAZIDE, IRBESARTAN, ESOMEPRAZOLE, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA TM), ATORVASTATIN, TAMSULOSIN, Breo, UMECLIDINIUM BROMIDE (INCRUSE) and MEBEVERINE for an unknown indication.    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 PAIN (lots of body ache), CHILLS (Chills) and PYREXIA (fever 101.5 last night, today 99.6). At the time of the report, PAIN (lots of body ache), CHILLS (Chills) and PYREXIA (fever 101.5 last night, today 99.6) outcome was unknown.        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.   No treatment medications were provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
This spontaneous report as received from a consumer (patients mother) refers to her daughter (11 years old). the patient was vaccinated with GARDASIL injection first shot on 23-APR-2013, second sot on 25-JUL-2013 and third shot on 08-OCT-2013. No adverse effect reported. Additional information has been requested.
Right arm has been aching ever since states patient. No numbness, tingling, she had good ROM, good color and pulse good flexion and extension of Right arm. After she saw her Doctor she told us that he felt the injection was to close to the shoulder. She was told to ice the arm and shoulder take anti-inflammatories for the next 4-6 weeks. If not better an MRI would need to be done. We have kept in touch with patient and as of January 27, 2010 she feels she is getting better and that she will call her Doctor and she what the next step will be. No MRI done as of this date.
Developed h.a., fever 101.7, chills, malaise, local soreness LA 12-24 hours after administration of vaccines. Had colposcopy 10am the morning of vaccines; reported sxs to both clinics - has F/U appt for colposcopy 8/16/07 - recommended antipyretics and cold compress. TC to pt: 8/16 for F/U: Message taken. TC from pt: 8/16 - feels better - fever gone, soreness in arm improving.
Extreme body aches, fever.,Nausea, weakness, chills. It got worse as the day went on. I canceled my day and stayed in bed. I felt better the following day.
Temporary loss of hearing or responding. Stopped turning towards my voice. Did not respond til she saw me. Reacted to no loud noises like she did before vaccines were given.
Patient reports that she did not have any issues after the first Covid19 Pfizer vaccine but 5 minute after her second dose she felt like it was hard to swallow. She attributed this to excitement from completing vaccine series and finished her 15 minute wait time. She went home but it became harder to swallow and she felt like her chest was "heavy" and she became short of breathe walking up stairs. She took fexofenadine 180mg and cetirizine 10mg and  filed a report with the CDC. Her symptoms resolved and she slept. The morning after her vaccine she felt fine and went for a 6 mile run. She called vaccine clinic to see what kind of follow up she needed to completed and was asked to contact PCP and employee health.  She presented to PCP that day (day after second vaccine) who reported ongoing symptoms of moderate chest tightness and some throat discomfort. Given prescription for Medrol dose pack, albuterol inhaler, and EpiPen and instructions on when to present for care.
Mom called 3 days after vaccine appt, stating client had a rxn to vaccines, unsure which.  Mom states client developed hives all over body, LA was swollen, had hard ball, and redness.  Mom stated Friday (11/17/23 day of injections) client took a nap and woke up around 6 or 7 p.m. and had a ?lock jaw,? and no further info was given, unsure how long client had ?lockjaw.?  Mom did not take client to urgent care or ED, and did not state when rxn started.   Mom has not returned calls to follow up on onset and duration, unsure if client is still having s/sx's.
Pt reports receiving  two covid vaccines. No access to records. Pt was admitted and tested positive for covid infection
received kinrix on 09-22-09 l thigh and started with area of induraion about 2 inches in diameter on 09-23-09 and on 09-24-09 induration enlarged to 10 inches. no other complaints. given benadryl and prednisone.
This spontaneous report was received from a medical assistant concerning a 65 year old female patient. Patient current conditions included asthma, allergies, insomnia, chronic sinusitis and osteoporosis. On 31-AUG-2012, the patient was vaccinated with a dose of PNEUMOVAX23 intramuscularly. Lot number and expiry date was provided as 0491AE and 15-SEP-2013. Concomitant medications included FLOVENT, AMBIEN, SEREVENT, theophyline, ASTELIN, FLONASE, ALLEGRA, calcium (unspecified) (+) vitamin D (unspecified), omega-3 marine triglycerides (fish oil) and aspirin. On 01-SEP-2012, the patient experienced pneumonia, fever of 103 Fahrenheit (F), swelling and redness in the left arm at the injection site. The patient came to the physician office. Treatment was provided with ZITHROMAX and ADVIL. On an unknown date, chest X-Ray was performed and the result was unknown at the time of reporting. A lot check was requested. The patient was recovering from all the events. The relatedness for all the events was unknown for PNEUMOVAX23. Additional information has been requested.
No immediate adverse outcome however, pt is PREGNANT and vaccine was given inadvertently.  EDC 8/24/22
In addition to muscle pain at the site of the injection that I typically have from my annual flu shot, this was intense injection site pain.  I also had a very high fever, chills, body aches, joint pain (knee), severe headache, nausea, and intestinal cramping.   Tylenol  (2 tablets) every 4 hours beginning at 7:00 am the following morning helped keep me from heading to the emergency room.
This case was forwarded by Crucell, No: CVAE-047-02012 An initial report was received from a nurse on 13.Dec.2012 and concerns a 34-year-old male who, on 11.Dec.2012, had received the first administration of VIVOTIF (batch no: 3000128). The patient's medical history and concomitant medications were not reported. On 11.Dec.2012, in the evening following the first administration of VIVOTIF, the patient experienced leg cramps. No further information was reported. At the time of reporting, the event was ongoing. The event was considered to be non-serious.
Patient states 10 days after injection a sharp jab-like pain occurred at the injection site and radiated down to her wrist, pain dissipated as it traveled. Patient then noticed she felt a knot under the skin where the pain occurred at the injection site. Patient states this occurs on and off since that date and came into the pharmacy on 12/22/2015, where she received the vaccine, to report this to the pharmacist who administered the vaccine. She stated the most recent incident was earlier that day while driving. There is no numbness in fingers and was clear that pain stopped at wrist.
Patient said she developed body aches/fever and chills and after 5 hours her son took her to emergency room where she was given an antibiotic for a leg infection and they were unable to get oxygen levels normalized and her blood pressure had dropped so they admitted her.
Febrile seizure while awaiting airline travel.  Became stiff and eyes rolled back.  Transported to ER.  Fever to 103. Episode lasted 15 minutes with 30-60 minutes post-ictal somnolence.
9 days, post vax, pt had multiple partial seizures, including abnormal movement with fever and vocalizations with flapping of arms. Apparent seizing resolved after about 7 days.
Had shingles after received Shingrix/Suspected vaccination failure; Shingles on face; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 89-year-old 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 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 3 years after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Had shingles after received Shingrix/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on face). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 17-MAY-2023 The reporter reported that the patient received second dose of Shingrix vaccine and after 3 years experienced shingles on her face. This case was considered as suspected vaccination failure as laboratory confirmation regarding shingles were unknown at the time of reporting.  The reporter did consent to follow up.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 18-FEB-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Dizziness starting a few hours after shot, but gone a few hours later, mild; same for upset stomach and mild nausea, diarrhea around midnight after the shot and again the following morning, general tiredness for next two days or so, some mild confusion, and some general muscle soreness for the day following the shot.
It was not given in the center of the arm/ received an injection too far back than recommended from the injection site/chance that it went subcutaneously; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (It was not given in the center of the arm/ received an injection too far back than recommended from the injection site/chance that it went subcutaneously) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 09-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (It was not given in the center of the arm/ received an injection too far back than recommended from the injection site/chance that it went subcutaneously). On 09-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (It was not given in the center of the arm/ received an injection too far back than recommended from the injection site/chance that it went subcutaneously) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   concomitant medications were not provided.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up information received on 15-Jul -2021and does not contain any new information.; Reporter's Comments: This report refers to a case of inappropriate route of vaccination for mRNA-1273, lot # unknown with no associated AEs
muscle pains; Woke up with top of feet burning; shortness of breath; dizziness; fatigue; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 (Lot number: FF2587) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Surface eye drops" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, Batch/Lot No: Ff2587, expiry date unknown, Location of injection: Arm Left, route of administration unknown), administration date: 21Oct2021, when the patient was 46 years old, for COVID-19 immunization.  The following information was reported: MYALGIA (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "muscle pains"; BURNING SENSATION (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "Woke up with top of feet burning"; DYSPNOEA (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "shortness of breath"; DIZZINESS (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "dizziness"; FATIGUE (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "fatigue"; PAIN IN EXTREMITY (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "sore arm". Therapeutic measures were not taken as a result of myalgia, burning sensation, dyspnoea, dizziness, fatigue, pain in extremity.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. Reportedly the patient was not tested for covid post vaccination. It was reported that the COVID-19 vaccine was administered to patient at doctor's office/urgent care.  No follow-up attempts are possible. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA Both arms are very heavy feeling
Abdominal pain began on Tuesday night 3-23 and continued Wednesday 3-24 where I went to Urgent care and then to ER where I was diagnosed with appendicitis and had appendectomy performed early morning on 3-25 at Hospital.
This spontaneous report as received from a patient's mother refers to her daughter of unknown age, who on an unknown date was vaccinated with a dose of M-M-R II (lot#, dose and route not reported). On an unknown date the patient experienced fever of 105. The outcome of patient was not reported. The relatedness for fever of 105 was not reported for M-M-R II. This is one of several reports received from the same source. Additional information has been requested.
Headache, fever/chills, fatigue, elevated heart rate all dissipated in approximately three (3) days. Above reactions were accompanied by significant ringing in both ears, which has not decreased in intensity to this point.
Rapid heart rate; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart rate) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arrhythmia. Concomitant products included APIXABAN (ELIQUIS), VALSARTAN, AMLODIPINE, CHLORTALIDONE (CHLORTHALIDONE), DEXLANSOPRAZOLE (DEXILANT), ATORVASTATIN, ZINC and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced HEART RATE INCREASED (Rapid heart rate). At the time of the report, HEART RATE INCREASED (Rapid heart rate) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Heart rate: 145 (abnormal) 145, getting rapid heart beat..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported.  Patient had ECG device attached continuously but no cause was determined.   This case was linked to MOD-2021-385670 (Patient Link).