chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain; Injection site redness; Body wide myalgias (in back and lower legs); Shivering; Take a 1.5 hour nap during the day; Dose 1 in series on 22Jan2020 / dosage #2 was 23Sep2020; This case was reported by a nurse and described the occurrence of drug dose administration interval too long in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hypothyroidism. Concurrent medical conditions included penicillin allergy. Concomitant products included levothyroxine sodium (Synthroid).   On 23rd September 2020, the patient received the 2nd dose of Shingrix. On 23rd September 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 24th September 2020, the patient experienced injection site pain, injection site erythema, myalgia, shivering and somnolence. On an unknown date, the outcome of the drug dose administration interval too long, injection site pain, injection site erythema, myalgia, shivering and somnolence were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, myalgia, shivering and somnolence to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. It was reported that 51 years female patient recived the 2nd shingrix vaccine on 23rd September 2020 in left deltoid, and experienced body wide myalgias (especially in back and lower legs), injection site redness and pain, and shivering. Also patient mentioned that she was able to complete myhernormal routine-exercise, work, caring for home, however she had to take a 1.5 hour nap during the day which is uncharacteristic for her. It was reported that patient was using Synthroid 50mcg dose concomitantly. Patient had hyperthyroid in past, and currently she has PCN allergy. This case has been linked with US2020AMR193698 The reporter consented to follow up.  Note: The Synthroid's daily dose of 50mcg was removed from the structured fields to allow the e VAERS PADER report to be ack.
rashes on their hands; Accidental Exposure/reported rashes on their hand from accidentally gettig vaccine on them; Accidental Exposure; This case was reported by a nurse via call center representative and described the occurrence of rash in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the rash, exposure via skin contact and inadvertent exposure to vaccine were unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information was received as follows: The age group was not reported but was captured as Adult as per vaccine indication. Nurse on the chat reported some of their coworkers who give the vaccine had reported rashes on their hand from accidentally getting the vaccine on them.This led to exposure via skin contact and inadvertent exposure to vaccine.
Some nausea 3 hours after injection, resolved after 4 hours. Sudden severe nausea and vomiting begging 01/27/2021 at 12am (14 hours after vaccination), 2 am, and 4 am. Fever of 101.7 F at 6 am with chills, body aches, and headache, without nausea or vomiting. Treated with 2 x 325mg Tylenol. Fever broke around 12pm 01/27/2021.
Swelling and fever in the top muscle on the left arm. Swelling on the right of face and weakness.
Chills, uncontrollable shacking, nausea, extreme fatigue, on and off headaches,
Right thigh outer aspects, cellulitis 12 X 13 cm + center area firm, blanching, all erythematous. Started Tuesday had some fever.
Flublok was administered to a 15 year old with no reported adverse event; Initial information received on 25-Jan-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 15 years old and unknown gender patient for whom flublok was administered to a 15 year old with no reported adverse event while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE at an unknown dose (lot number, expiry date, strength, form, frequency: not reported) via unknown route in unknown administration site for immunisation.  On an unknown date the patient developed a non-serious event "Flublok was administered to a 15 year old with no reported adverse event" (product use issue) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Flublok was administered to a 15 year old with no reported adverse event).  At time of reporting, the outcome was Unknown for the event flublok was administered to a 15 year old with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On 10/11, Dad called. He states child hasn't ate well for 2 days. Denies any cough, runny nose or pain. Has fever of 103.6 under her arm. He gave Tylenol Cold Med at 7:30a.m. He denies any jerking or staring. At 10:30a.m., Mom states her
Fever 102.2°F; bad headache; Rush too in the site of injection; chills; body ache; throw up.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 102.2°F), HEADACHE (bad headache), VACCINATION SITE RASH (Rush too in the site of injection), CHILLS (chills) and MYALGIA (body ache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (Fever 102.2°F), HEADACHE (bad headache), VACCINATION SITE RASH (Rush too in the site of injection), CHILLS (chills), MYALGIA (body ache) and VOMITING (throw up.). On 11-Feb-2021, PYREXIA (Fever 102.2°F) had resolved. At the time of the report, HEADACHE (bad headache), VACCINATION SITE RASH (Rush too in the site of injection), CHILLS (chills), MYALGIA (body ache) and VOMITING (throw up.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 102.2 (High) 102.2°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: NNI; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Had to leave work; Had to leave work sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and inability to work. On an unknown date, the outcome of the sickness and inability to work were recovered/resolved.   It was unknown if the reporter considered the sickness and inability to work to be related to Shingles vaccine.     Additional Information: GSK receipt date: 25-DEC-2022 Reporter's comment:  This case was reported by a consumer via interactive digital media. The patient said 2nd one was known to make you sick for 1 day first time in years he/she had to leave work sick. Additional supportive information:  Follow up would not possible, as no contact details were available.
EXTREME PAIN WITH THE INJECTION WHICH WAS VERY HIGH UP IN THE SHOULDER, BUT IMMEDIATE INABILITY TO MOVE THE SHOULDER
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L032391, expiration date reported as 26-AUG-2017, lot # L046884, expiration date reported as 23-NOV-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 8.8 degrees Fahrenheit for 7 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports from the same reporter. Additional information has been requested.
Today, four days after the injection, I have a rash on my lower legs and a little on my right forearm.
M om stated patient is having redness, warm to touch and spreading redness up the patient leg. The patient is lumping on the leg. Patient do not have a fever at this time.  The injection site is the left thigh.
Pt was found in his crib at daycare on 10/10/1997, having died from SIDS. Doctor spoke with other doctor on 10/15/1997, who said that the autopsy confirmed SIDS.
Pt was given a high dose flu shot when he already had a high dose flu shot already the season
Abdominal pain; diarrhea; anal bleeding; Difficulty urinating; loss of appetite; Chills; This is a spontaneous report from a contactable consumer. This 58-year-old male consumer reported that: A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 02:30 (at the age of 58-years-old) as a single dose for covid-19 immunization. Medical history included none. There were no concomitant medications. The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021, the patient experienced abdominal pain and diarrhea, anal bleeding, difficulty urinating, loss of appetite, chills. The patient did not receive any treatment. Outcome of the event was recovering, at the time of this report. No follow-up attempts are possible. No further information is expected.
angio edema flair; chills; sweats; severe headache; body aches; nausea; diarrhea; I also developed a discomfort/ ache in my left chest; I also developed a discomfort/ ache in my left chest; swelling to face; swelling to face, hands and feet; fatigue; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: Fc3184) via unspecified route in left arm single dose for COVID-19 immunisation on 27Aug2021, 10:45 AM, at 58-year-old. Medical history included angio edema, COVID-19 from Dec2020.  Concomitant medications included hydroxyzine pamoate 50 mg; famotidine 10mg daily. No other vaccine in four weeks. 3 days after first vaccine (30Aug2021, 04:30 AM), the patient had an angio edema flair (I have not had one since last March when the patient started taking hydroxyzine and famotidine daily), the patient did also have COVID like symptoms including chills, sweats, severe headache, body aches, nausea and diarrhea but most resolved by day 4 (31Aug2021) except the severe headache. The patient also developed a discomfort/ ache in left chest? The patient was now past day 5 and the angio edema, which also included swelling to face, hands and feet, severe headache, chest discomfort and fatigue continue. Events resulted in doctor or other healthcare professional office/clinic visit. Treatment included: prednisone, hydroxyzine, Pepcid. COVID tested post vaccination (Nasal Swab) on 24Aug2021 (as reported, pending clarification) resulted in negative. Outcome of the events chills, sweats, body aches, nausea and diarrhea was resolved; outcome of the other events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of angioedema flair cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
aches, chills , severe pain under left arm (lymph nodes) all upon waking up
14 patients were vaccinated on 06Apr2022,Expiration date: 02Apr2022; Expired dose administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) and PRODUCT STORAGE ERROR (14 patients were vaccinated on 06Apr2022,Expiration date: 02Apr2022) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (14 patients were vaccinated on 06Apr2022,Expiration date: 02Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) and PRODUCT STORAGE ERROR (14 patients were vaccinated on 06Apr2022,Expiration date: 02Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.     Date the vial was initially stored in the refrigerator was on 14-MAR-2022.  No treatment information was reported.
couldn´t get out of bed; her skin was so tight / though it was gonna rip; Inappropriate age at vaccine administration; This case was reported by a nurse via other manufacturer and described the occurrence of mobility decreased in a child female patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   The patient's past medical history included fluid retention (Family History), heart disorder (Family History) and heartbeats irregular (Family History). Concurrent medical conditions included asthma (Family History) (mother uses three inhaler a day since 2000), allergy to animal (Family History) (cat and dogs) and allergy (Family History) (Horse serum).   On an unknown date, the patient received DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced mobility decreased, skin tightness and inappropriate age at vaccine administration. On an unknown date, the outcome of the mobility decreased, skin tightness and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the mobility decreased and skin tightness to be related to DTP vaccine.  Additional details were provided as follows: The case was reported by patient's parent. Age at vaccination was not reported. The patient's parent had received Flu vaccine, Pneumonia vaccine and Tetanus vaccine. The patient's parent received concomitant medication included salbutamol sulphate (Albuterol), salmeterol xinafoate (Serevent), budesonide (Pulmicort) and torasemide.  The reporter stated that her daughter received DTP vaccine when she was 8 or 9 years old and the shot was delayed as the patient could not get out of bed, her skin was too tight as it gonna rip. The case was linked with the case US2021AMR022067 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR022067:same reporter
Patient received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.  Concomitant products included IBUPROFEN, ASPIRIN [ACETYLSALICYLIC ACID] and METFORMIN for an unknown indication. On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine). On 08-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.
This study case was received from the investigator on 21 November 2012. A 21-year-old female subject, with no relevant past medical history, had received the following vaccinations on 08 November 2012: ACAM2000 (lot number and route not reported) in the right arm and anthrax vaccine (manufacturer, lot number, route and site not reported). Four days post-vaccination on 12 November 2012, the subject experienced pleuritic chest pressure and shortness of breath. The symptoms were not exacerbated by exercise and the subject was otherwise asymptomatic. On 21 November 2012, the subject's rapid troponin was negative and ECG was abnormal. Symptoms resolved eight days after onset on 20 November 2012. No further information was available at the time of the report. The subject's outcome was recovered. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: None.
LUMP IN THE ARM AT INJECTION SITE; FEVER; REDNESS AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and latex allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced redness at injection site. On 12-MAR-2021, the subject experienced lump in the arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and redness at injection site on MAR-2021, and had not recovered from lump in the arm at injection site. This report was non-serious.
she had like with her 1st dose and her 2nd dose a very sore arm; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 56-year-old female patient received BNT162B2 (BNT162B2), administered in arm right, administration date 11Mar2021 (Lot number: EN6199, Expiration Date: Jun2021) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing); "Tennis elbow" (unspecified if ongoing), notes: Tennis elbow; "moderate carpal tunnel" (unspecified if ongoing), notes: both right and left. The patient took concomitant medications. Past drug history included: Flagyl, reaction(s): "allergic reaction to  Flagyl", notes: She had an allergic reaction to  Flagyl, probably 10 -15 years ago.; Flagyl, reaction(s): "rash", notes: She had a rash with Flagyl, probably 10 -15 years ago. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "recovered" (12Mar2021), described as "she had like with her 1st dose and her 2nd dose a very sore arm". Therapeutic measures were taken as a result of pain in extremity. Additional Information: The patient stated her weight is about 140-145 (unknown units). The patient stated she had like with her 1st dose and her 2nd dose a very sore arm. With the 1st shot it also started immediately after and went away about 24 hours, that it was not days or anything. The patient stated that with the 1st dose she did not take the medication for her arthritis in shoulder, and she took vitamins. After the first dose she took Tylenol 500mg. The adverse events did not require emergency room nor physician office visit. The patient had an allergic reaction to Flagyl, and she had a rash, and it was so many years ago probably 10 - 15 years ago.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021360066 same patient, different vaccine doses/events
Pt had fever and body ache starting 10 PM on 11/15/21 same day as vaccine. Patient also had swollen lymph node
Information has been received from a medical assistant concerning a 19 year old female who in August 2007, was vaccinated IM with the first dose of Gardasil vaccine. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently, the patient experienced fever, chills and nausea. No medical attention was sought. Subsequently, the patient recovered from fever, chills and nausea. No product quality complaint was involved. Additional information has been requested.
fever of 101.4; very very achy; very cold; very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (very very achy), NASOPHARYNGITIS (very cold), FATIGUE (very tired) and PYREXIA (fever of 101.4) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 001L20A) for COVID-19 vaccination.     No medical history was provided.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 16-Mar-2021, the patient experienced PAIN (very very achy), NASOPHARYNGITIS (very cold) and FATIGUE (very tired). On 17-Mar-2021, the patient experienced PYREXIA (fever of 101.4). At the time of the report, PAIN (very very achy), NASOPHARYNGITIS (very cold), FATIGUE (very tired) and PYREXIA (fever of 101.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 101.4 (High) Fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Additional Information received included no new significant Information On 22-Jul-2021: Possible NNI.