chrisvoncsefalvay/vaers-outcomes huggingface dataset:
minimal tenderness in his arm; He also experianced some fatigue; Patient received the "Moderna booster dose" (third dose) / patient received three doses of the Moderna covid-19 /did not realize he had received the vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received the "Moderna booster dose" (third dose) / patient received three doses of the Moderna covid-19 /did not realize he had received the vaccine), TENDERNESS (minimal tenderness in his arm) and FATIGUE (He also experianced some fatigue) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A, 028620A and 050C21A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation and Stent insertion NOS (2 heart stent). Concurrent medical conditions included Polymyalgia rheumatica and Hypertension. Concomitant products included PREDNISONE for Polymyalgia rheumatica, APIXABAN (ELIQUIS), ATENOLOL, LISINOPRIL and FEBUXOSTAT (ULORIC) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jul-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received the "Moderna booster dose" (third dose) / patient received three doses of the Moderna covid-19 /did not realize he had received the vaccine). On an unknown date, the patient experienced TENDERNESS (minimal tenderness in his arm) and FATIGUE (He also experianced some fatigue). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received the "Moderna booster dose" (third dose) / patient received three doses of the Moderna covid-19 /did not realize he had received the vaccine) had resolved and TENDERNESS (minimal tenderness in his arm) and FATIGUE (He also experianced some fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-209097 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Follow-up received, updated events and concomitant medications; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021 at 10:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 10:00 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 71.85.  Concomitant products were not provided.  On 08-Feb-2021, excursion time was 10 AM and 11 AM  and temperature was 29 and 35 respectively, total doses given for the day was 30, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 02-Feb-2021, vial was moved to clinic on 08-Feb-2021. 03 vial was moved to clinic on 08-Feb-2021. Vaccine BUD date was 04-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
After the vaccine, my arm was sore and I was tired for 24 hours. I started feeling systems July 5 and test positive on July 6 with the COVID-19 test. My symptoms sore throat, sneezing, fatigue, runny nose and some coughing. I had a telehealth visit with provider and they wrote prescription for PAXLOVID. I started feeling better.
fatigue; This non-serious case was reported by a nurse via sales rep and described the occurrence of fatigue in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fatigue (Verbatim: fatigue).  The outcome of the fatigue was not reported.   It was unknown if the reporter considered the fatigue to be related to Arexvy.     It was unknown if the company considered the fatigue to be related to Arexvy.   Additional Information: GSK Receipt date: 26-SEP-2023 A nurse reported that the patient was recommended to get Arexvy by her pulmonologist and got the vaccine but reported fatigue to her primary care provider. No additional details are available related to the time the vaccine was given to the time the patient asked about fatigue. The reporter did not agree to follow up from GSK.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 59-year-old female patient who received SHINGRIX (batch number KB99G, expiry date 22nd February 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose, no adverse events). On 11th September 2018, the patient received the 2nd dose of SHINGRIX(intramuscular) 50 ug. On 11th September 2018, less than a day after receiving SHINGRIX, the patient experienced fever, general body pain, stiff neck and chills. On an unknown date, the outcome of the fever, general body pain, stiff neck and chills were recovered/resolved. It was unknown if the reporter considered the fever, general body pain, stiff neck and chills to be related to SHINGRIX. Additional details were reported as follows: The patient experienced fever, chills, body aches and stiff neck after receiving a dose of SHINGRIX. The symptoms lasted 3 to 4 days, during which time she could not get out of bed. The patient did not have these symptoms after the 1st dose. The 1st dose was not administered at the present pharmacy where 2nd dose was administered.
Rapid heart rate, Fever, Chills, Sweats, extreme pain in lymph nodes under arm, arm pain, left side pain, body aches, headache, ear pain, sore throat, chest pain, extreme fatigue, shortness of breath
This spontaneous report as received from a nurse refers to a patient of unknown age. On 06-JUN-2017 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M031802, oral) for prophylaxis. Concomitant therapies included PREVNAR 13 and HIB CONJ VACCINE (UNSPECIFIED CARRIER). No adverse event was reported. This is one of several reports received from the same reporter. Follow up information has been received on 13-SEP-2017 from the nurse referring to the 9 weeks old male patient. It was reported that the refrigerator was out of temperature range. This is a corrected report. This report was previously submitted with the incorrect Worldwide unique case identification number 'US-009507513-1707USA006507', and this new follow-up submission is to provide the correct identification number 'US-009507513-1708USA006959'. 'US-009507513-1707USA006507' is an existing case, therefore this safety report is not being nullified, just updated to reflect correct Worldwide Unique Identifier. Sender's Comments: US-009507513-1707USA006507.
Around 6PM my arm was very swollen and the injection side was swollen, it was very painful the pain continued throughout the night. It was impossible to sleep. Then I used cold compress and the next day I started taking Motrin to help with the pain. The swelling started going down after 2 days and the pain was present for about 3 for days. The pain was excruciating, nothing like the flu shot pain or anything like that.
Pt had itchiness all over the body but more on the upper part of the body including chest, arms, ears, and face.  These symptoms lasted for 2 days.  She says it was mild and she did not break out. There were no hives or shortness of breath.  Patient used claritin on day 2 and it went away after 1 dose.
On Friday 4/9/2021 i started sneezing and then lead to some nasal congestion into the weekend. On Monday 4/12/2021 around 4pm, I noticed that i had lost some part of my sense of smell and taste. On 4/13/2021, I noticed my sense of smell and taste were completely gone and i got myself tested and it came back positive. I did the Rapid Test and it came back positive for Covid.
Very aggressive chronic hives almost daily. Has been on multiple types of antihistamine medications since, with some days not being affective.
3/27/03 102.5 degrees fever day after shots, cranky until Sat. noc. 3 days after shots got congested, cough. Sun-lethargic, feverish, cough, congestion. Rash 9 days later got worse. Day 13 rash resolving. No fever. (+) cough (+) diarrhea.
Mass around injection site; Center of injection site had deeper color; Light headedness; Muscle Cramping; Unable to stand; Heart racing; Rash at injection site; Injection site was red; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), VACCINATION SITE MASS (Mass around injection site), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE DISCOLOURATION (Center of injection site had deeper color) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), VACCINATION SITE MASS (Mass around injection site), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE DISCOLOURATION (Center of injection site had deeper color), VACCINATION SITE RASH (Rash at injection site), DIZZINESS (Light headedness), MUSCLE SPASMS (Muscle Cramping), DYSSTASIA (Unable to stand) and PALPITATIONS (Heart racing). At the time of the report, CHILLS (Chills), HEADACHE (Headache), VACCINATION SITE MASS (Mass around injection site), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE DISCOLOURATION (Center of injection site had deeper color), VACCINATION SITE RASH (Rash at injection site), DIZZINESS (Light headedness), MUSCLE SPASMS (Muscle Cramping), DYSSTASIA (Unable to stand) and PALPITATIONS (Heart racing) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Information has been received from a physician concerning a female patient who received GARDASIL (therapy date, route, site unknown) and fainted. The patient's medical history and concomitant therapy were unspecified. The patient did not seek medical attention. At the time of this report, the patient had recovered. No further information is available.
she states she has had sore throat, cough, fatigue that began on 08/07. PUI went to her provider and was also diagnosed with bronchitis and put on steroids. On 08/23, PUI went to ER due to having trouble breathing, her o2 stats were at 77% so she was hospitalized. PUI diagnosed with acute respiratory failure and covid pneumonia. Patient is fully vaccinated.
Anaphylaxis Narrative: Employee continued on day 3 with hives and swollen lips. she went to ER at which time her throat became itchy. She was give IV benadryl, steroids. Ephinephrine adm. She was discharged hours later and may return to work on Monday.
Patient administered pediatric Pfizer vaccine (5 to 11 years old). It is not strong enough to get protection. Patient contacted for revaccination but has not yet came back.
Severe arm, leg, neck pain all on right side of body.; Severe arm, leg, neck pain all on right side of body.; Severe headache; Chills; Overall body pain; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12May2021 (at the age of 23-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma and known allergy to penicillin. 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 COVID vaccine. Concomitant medications were not reported. On 13May2021, the patient experienced severe arm, leg, neck pain all on right side of body, severe headache, chills and overall body pain. 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 severe arm, leg, neck pain all on right side of body, severe headache, chills and overall body pain were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial unsolicited case received from consumer (patient) via social media on 10-Oct-2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188850, 2016SA188851. (Same source/site, same vaccine). This case involves a patient (age and gender unknown) who was vaccinated with a dose of FLU SHOT (manufacturer: unknown, batch number, expiry date, route, and dose in series: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient got sick. The patient reported that every time patient took flu shot, he got sick. Patient's lab data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
her rheumatoid arthritis has been worse since the shots, flare up with her rheumatoid arthritis; He has left the house because his wife is still in bed; This is a spontaneous report from a contactable consumer (patient husband) via a Pfizer sponsored program.  A 76-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Mar2021 and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Feb2021 as a single dose for COVID-19 immunization. The patient medical history included ongoing rheumatoid arthritis. Concomitant medication included tofacitinib citrate (XELJANZ XR) 11mg tablets for Rheumatoid arthritis. She was off of her Xeljanz XR for 7-8 days before and 4-5 days after both COVID shots.On an unspecified date in 2021, the patient experienced rheumatoid arthritis has been worse since the shots and more pain with her rheumatoid arthritis since the shots, she was just having a flare up, her husband has left the house because she was still in bed. He doesn't think this was any different than normal and he just wants to let it go and was needed to speak with her Rheumatoid Arthritis doctor, but he has been off this whole week and usually, they can get Xeljanz XR from the doctor to tide them over until the paperwork is done. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
"Janssen COVID-19 Vaccine EUA" Night of April 4th, severe headache began at 9pm.  Took an Aleve, but it did not help.  Went to bed to sleep it off.  Woke up and the headache was gone the next morning.  Have not had any more headaches.  Experienced muscle soreness in arm of injection and at the injection spot.  Then whole body muscle soreness/heaviness began on April 5th for 3 days.  I had swelling in both legs for only one day, on April 12th. First day I noticed I was experiencing shortness of breath was April 6th.  Became out of breath walking a small incline.  Shortness of breath continues to current, April 16th, perhaps a bit worse, where I seem that a natural breath requires a bit of work. So far, I have no
Chest pressure, anxiety, headache, shortness of breath, dizziness starting 15 minutes after vaccination. Monitored and offered ED but refused.
headaches worsened; headaches worsened; dizziness; Brain foggness has increased; Getting through the day to complete work or even basic tasks is very difficult.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 13:00 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: if covid prior vaccination- Yes; "known allergies: cilians" (unspecified if ongoing), notes: known allergies: cilians. The patient took concomitant medications. Vaccination history included: Bnt162b2 ({product=COVID 19, lot unknown=False,, dose number=1}]), for COVID-19 Immunization, reaction(s): "Dizziness", "Headache", "Migraine", "Pain", "Vomiting". The following information was reported: HEADACHE (non-serious), CONDITION AGGRAVATED (non-serious), outcome "not recovered" and all described as "headaches worsened"; DIZZINESS (non-serious), outcome "not recovered", described as "dizziness"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Brain foggness has increased"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "Getting through the day to complete work or even basic tasks is very difficult.". The events "headaches worsened", "headaches worsened", "dizziness", "brain foggness has increased" and "getting through the day to complete work or even basic tasks is very difficult." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, condition aggravated, dizziness, feeling abnormal, loss of personal independence in daily activities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician via a company representative concerning an approximately 64 year old male patient. On 18-SEP-2013, the patient was vaccinated with 0.5 milliliter (ml) of PNEUMOVAX23 (lot number and expiry date unspecified), intramuscularly in an unspecified arm. Other suspect therapy included Influenza virus vaccine (manufacturer unknown) (lot number, expiry date, dose and route unspecified) administered on 18-SEP-2013 in the same arm (unspecified). No concomitant therapy was reported. Approximately on an unknown date in September 2013, the patient experienced fever, arm was hot to touch, red streaks up their arm and neck and injection site area was hard to the touch. The patient sought medical attention. Physician noted that the patient went to an unspecified urgent care facility over the weekend and he was treated with cephalexin and BENADRYL but did not specify if patient needed to be treated for more than a day. The patient was seen by the physician on 23-SEP-2013 and was given a shot of ROCEPHIN and BACTRIM for additional treatment. It was unspecified if any lab tests were performed. The outcome of all the events was unknown. The relatedness for all the events was unknown for PNEUMOVAX23 and Influenza virus vaccine (manufacturer unknown). Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On 26-AUG-2014 the patient was vaccinated with PNEUMOVAX23, intramuscular (dosing regimen/lot # unspecified). Concomitant therapy was not reported. On 26-AUG-2014 the pharmacist reported that she inadvertently administered PNEUMOVAX23 which had expired on 10-AUG-2014. No adverse effects reported. There was no product quality complaint involved. The outcome of she inadvertently administered PNEUMOVAX23 which had expired on 10-AUG-2014 was unknown. Additional information has been requested.
Burning, tingling sensation at right anterior rib cage. 48 - 72 hrs later developed vesicles on skin in area.  Seen on 01/25/2010 with grouped vesicular lesions to anterior thorax in the T5 dermatomal pattern. Pt had cultures taken and given rx of Valtrex 1gram 3 x a day for 7 days.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On unknown dates, the patients were vaccinated with VARIVAX lot # M004326, expiry date 25-JAN-2017 (route of administration, dose and dose number were not reported). Temperature was 56 Fahrenheit degrees, for 2 hours, data logger was not involved, there was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006317.
Patient given second Pfizer vaccine after 1st dose given 8/24/21. No adverse outcomes. No treatments needed.