chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered greater than 12 hours after initial vial puncture; Vial was not stored in refrigerator and administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture) and PRODUCT STORAGE ERROR (Vial was not stored in refrigerator and administered to patient) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Aug-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) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture) and PRODUCT STORAGE ERROR (Vial was not stored in refrigerator and administered to patient). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture) and PRODUCT STORAGE ERROR (Vial was not stored in refrigerator and administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided No treatment medication information was provided
The patient states her arm, where she got the shot, it's still sore.; There's a little white round circle.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The patient states her arm, where she got the shot, it's still sore.) and VACCINATION SITE DISCOLOURATION (There's a little white round circle.) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose, lot EN6204) on 17-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd dose, lot AR8733) on 08-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (4th dose Pfizer and lot FJ6369) on 02-May-2022; for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (3rd dose Moderna (booster) and lot 939905) on 05-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 24-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (The patient states her arm, where she got the shot, it's still sore.) and VACCINATION SITE DISCOLOURATION (There's a little white round circle.). At the time of the report, VACCINATION SITE PAIN (The patient states her arm, where she got the shot, it's still sore.) and VACCINATION SITE DISCOLOURATION (There's a little white round circle.) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. No treatment medicine were reported.
This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (lot number was not reported) dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced myocarditis on an unspecified date. The reporting physician requested information on incidence of myocarditis with Covid-19 vaccine. The outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "Myocarditis" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available. 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.
pt recvd vax 30SEP93 & 4NOV93 presented w/ a wk history of chest discomfort; PE had a new pericardial friction rub; EKG was unchanged; pt was treated w/ASA & improved; reporter states that viral pericarditis was not ruled out in this pt;
Same day post vax, the vaccinee experienced local redness, and redness around the face, arms, and legs which lasted 10 minutes. The vaccinee was anxious, extremely fussy, and constantly alarmed. She was hospitalized for dehydration overnight. She was observed and treated with Benadryl.
Vomiting and fever on 11/15.  11/18 mouth hurting and sores in mouth.  11/19 rash all over. Saw MD.  Tested for strep.  R/O Hand/foot/mouth disease.  Not sure if a reaction to shots or not.
This spontaneous report was received from a medical assistant, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. Since on an unknown date, an unspecified number of improperly stored doses of M-M-R II (lot # L002873, rHA status, expiration date 27-JAN-2017) were administered to an unspecified number of patients. No adverse effects have been reported. The reporter stated that there was not product quality complaints involved. This is one of several cases from the same reporter. Additional information is not expected, because the reporter refused additional contact.
pt recvd vax, exp pneumonia, flu-like sxs & urinary tract infect; on 26oct94, presented w/ chills, fever, body aches & feeling weak; looked very pale;94;while hosp,devel pneumonia & MD felt derived from a staphylococcus infect;
Headache, Fever,  Chills, Fatigue Narrative:  Other Relevant History:
Patient called the pharmacy September 28, 2022  to inform them that after her influenza vaccine, she was experiencing severe pain (pain of 9-10 on a 1-10 scale) in her arm and was having difficulty raising her arm and shoulder. Pain was not responding to OTC Advil or Tylenol. Pharmacist encouraged patient to try Aleve and patient responded that she already tried it. Patient asked if adverse effect warranted going to the hospital or emergency department and the pharmacist replied no. Patient stated that she would call her primary physician about the adverse effects.
Red rash, itching and swelling at injection site.  All symptoms ceased after about 6 days
Development within 1 hour of injection of a large, very warm,  erythema and swelling of an avocado size with discomfort  lasting the full day.  Swelling and discomfort improve within 24 hours although persitent of a mild swelling and   large erythema at day 3. No adenopathies .No fever.
This non-valid spontaneous report was received from a nurse referring to multiple patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # N021572, expiration date: 01-MAY-2020 and, lot # N014470, expiration date: 17-JUN-2019, lot# N017833, expiration date: 16-NOV-2019, dose and route of administration were not provided) for prophylaxis. The doses were exposed to a temperature excursion of 9 degrees Celsius to 25 degrees Celsius during unknown period of time. The temperature excursion was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. Product quality complaint (PQC) was not reported.
Administered Moderna Booster at 13:12.  Approximately 13:30 patient presented with shallow breathing, caregiver stated patient reported difficulty breathing and is breathing abnormally.  Caregiver requesting RN to assess.     O2Sat 93% on room air.  Started patient on O2, 2L via nasal cannula.  Denies chest pain, headache, pain, dizziness. Patient on O2 2.5L via NC at home. Does not travel with portable O2.   13:32 BP 88/55, HR 66, O2Sat 97% on 2L via NC.  Caregiver states Home BP readings 110s systolic.   13:36 BP 83/55, HR 67, O2 Sat 98% on 2L via NC.  patient reports breathing improved to baseline. 13:36 MD arrived in clinic.  Reviewed chart, stated patient's BP baseline is low and BP acceptable, heart murmur present.  Instructed patient to drink water, continue to monitor, remove O2 and monitor vitals. 13:40 BP 87/59, HR 65, O2Sat 100% 2L. 13:42 patient drank 8 oz of water, removed nasal cannula.  13:45 BP 99/61, HR 67, O2Sat 96% RA.  Patient stated "I feel great" Denies difficulty breathing, CP.   13:53 BP 103/64, HR 65, 97% RA 13:58 Escorted patient to car, reviewed to call 911 and seek immediate medical attention with difficulty breathing, chest pain other life threatening symptoms.  Verbalized understanding.
Had vaccines in office 3-22-2013 AM. Woke with raised blotchy rash on legs and buttocks. Rash was itchy. Told to give Benadryl (phone advice) qid. Hives cleared, returned next day. P Benadryl stopped. Alert. Active. Was breathing comfortably.
Heavy period that lasted 10 days, heavy bleeding and clots, still mild spotting on day 12
Moderna inadvertently  given to client under 18 y/o.  Non adverse events known. Left message with parent.
Patient received third dose of Pfizer vaccine 5 weeks and 5 days after receiving the second dose. No signs and symptoms noted at this time.
NAUSEA, TIREDNESS, BODY ACHES, SORENESS IN INJECTION AREA
COVID ARM- PATIENT DEVELOPED A RED, SWOLLEN, ITCHY LUMP AT INJECTION SITE WEEKS AFTER VACCINATION
Breakthrough case admission (observation) after three vaccines: Pfizer 3/29/21  Lot# ER8734;  Pfizer 4/19/21  Lot# EW0161;  Pfizer 12/29/21 Lot# FJ8762.
Patient called and left voicemail she woke up during the night after her first COVID-19 Moderna vaccine with rapid heart rate 130bpm and high blood pressue, but did not elaborate what high blood pressure was.   Said after that she has felt fine.
Second dose administered on day 21 after the first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered on day 21 after the first dose) in a 9-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1414B and AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered on day 21 after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered on day 21 after the first dose) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported.  No Treatment medication reported.
walking problems; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (walking problems) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (walking problems). At the time of the report, GAIT DISTURBANCE (walking problems) outcome was unknown.            No concomitant medications were reported. No treatment related information has been reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: Patient's Gender related information has been received.
Itching on the face after after first booster and facial filler; Swelled up Face after first booster and facial filler; Delayed reaction after first booster and facial filler; second dose of primary series administered on 19-Apr-2021 and 1st booster was administered on 19-Aug-2021; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on the face after after first booster and facial filler), SWELLING FACE (Swelled up Face after first booster and facial filler), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of primary series administered on 19-Apr-2021 and 1st booster was administered on 19-Aug-2021) and HYPERSENSITIVITY (Delayed reaction after first booster and facial filler) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A, 044B21A and 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 05-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 19-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of primary series administered on 19-Apr-2021 and 1st booster was administered on 19-Aug-2021). On 28-Feb-2022, the patient experienced PRURITUS (Itching on the face after after first booster and facial filler), SWELLING FACE (Swelled up Face after first booster and facial filler) and HYPERSENSITIVITY (Delayed reaction after first booster and facial filler). On 21-Mar-2022, PRURITUS (Itching on the face after after first booster and facial filler), SWELLING FACE (Swelled up Face after first booster and facial filler) and HYPERSENSITIVITY (Delayed reaction after first booster and facial filler) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of primary series administered on 19-Apr-2021 and 1st booster was administered on 19-Aug-2021) outcome was unknown.            No concomitant medication was reported by the reporter.  Patient received Juviderm and Sculctra Facial Fillers in the face on DEC2021  No treatment medication was reported by the reporter.
Vaccine given  2/17/2021.  Client developed soreness in arm and shoulder area and chills post vaccine, joint achiness on day 2 post vaccine.  On 2/21, client developed lower back and flank pain bilaterally which progressively got worse and continues yet on 2/24.  Client rates pain a 6 or 7.  Pain is constant.  Pain will decrease to a 2 or 3 following Aleve.  Denies blood in urine, urgency, burning with urination or difficulty starting urine stream.  States bowel movements have been normal.  States discomfort is not like a pulled muscle sensation.  Has had temperature in the 99 degree range.  Client started Potassium supplement on 2/22 thinking it may help but has had no relief.  Pain continues as of time of report.
area of redness, edema. warm to touch on right thigh - cellulitis - is on abx - Augmentin ES. No trouble walking
Post vaccine, patient's right thigh became red and swollen. Patient's mother treated with cold packs and NSAIDS. Remained extremely swollen for 3 days. This rxn has happened with every DTAP shot but this was the most extreme.
Witnessed Cardiac arrest at home. No bystander CPR; +30 min transport time, unsuccessful resuscitation. Code called upon arrival to hospital
After day 7, I developed a red , swollen and warm area at the site of injection and on my upper arm.
No additional AEs; The nurse reported that a dose of PNEUMOVAX 23 that was expired was administered to a patient.  No additional AE's and no PQC's were reported.; This spontaneous report was received from licensed practical nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medication, and drug reactions or allergies were not reported.  On 08-FEB-2023, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 1 dosage form (reported as product quantity: 1), lot # U018309, expiration date: 08-JAN-2023, administered as directed to prevent pneumococcal infection (strength, route of administration, and anatomical location were not provided) (expired product administered). No additional adverse events were reported (no adverse event).
Patient felt little headache for the whole entire day for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Patient felt little headache for the whole entire day for 3 days) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 11-Mar-2021, the patient experienced HEADACHE (Patient felt little headache for the whole entire day for 3 days). At the time of the report, HEADACHE (Patient felt little headache for the whole entire day for 3 days) had resolved.
arm is tender; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cardiac pacemaker malfunction (Failed Electrode in Heart). Concomitant products included cyanocobalamin (B12 Injection).   On 1st June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st June 2020, immediately after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: Approximately 10:30AM The patient received 1st dose of Shingrix  and experienced arm was tender since the injection.  The reporter did consent to follow up.
Low-grade fever for fiveweeks, starting on the day of mysecond dose; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 19Mar2021 at 09:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included finasteride (PROPECIA) and doxycycline (MANUFACTURER UNKNOWN) from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number; EN6200) via an unspecified route of administration in the left arm on 26Feb2021 at 8:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 19Mar2021 at 18:00, the patient experienced a low-grade fever for five weeks, starting on the day of second dose. The patient reported that the fever was not subsided, that was highly unusual since the patient had no cold, flu, or fever of any sort in over 10 years and the patient was in overall excellent health. For the first 4.5 weeks, the patient took paracetamol (TYLENOL) to reduce the fever, but the fever would not fully go away. The patient doctor had a complete blood count (CBC) performed, and it detected nothing abnormal, in the last two days, doctor prescribed a course of prednisone (MANUFACTURER UNKNOWN) to counteract what thought might be an overactive immune response. In the first day of the course, fever was greatly increased, and so patient doctor told not to take any more prednisone and the fever remained. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures on an unknown date in 2021, which included complete blood count (CBC) and the result was nothing abnormal. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of a low-grade fever for five weeks, which included treatment with paracetamol (TYLENOL) and prednisone (MANUFACTURER UNKNOWN) for one day. The clinical outcome of event a low-grade fever for five weeks was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Started coughing with lots of thick phlegm continued to get worse during the week, went to the Dr the following Sunday (10/30). Tuesday (11/1) developed laryngitis and still have today (11/6).
got the flu; Initial information received on 31-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves adult patient who got the flu (influenza), while he/she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received any corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Second DTAP given singly due to previous rash within 30 minutes after 1st vaccination, and fever.  Approximately 3 minutes after injection red papules blanching noted to face and trunk.  Resolved after Benadryl.  No fever noted.
Pt received Dtap on 4/7/21 and grandmother (guardian) called Thursday to say she took pt to ER Wednesday evening due to a large warm, hard, red rash on pt's left leg. Pt treated ER for cellulite. Slowly resolving rash. Rash described as large as a softball. *another pt had reaction- Dtap common factor.
Called to assist pt after hep B injection (in left deltoid at 14:40) at 16:10 c/o pounding headache. L frontal, s radiation, eligibly diaphoretic, moist skin, blistered arms warm ( ie Reynauld's disease). Right arm BP 160/70, 72 R radial pulse regular/strong. LA 180/90, radial pulse 72 reg, 5 minutes later headache not pounding, just throbbing, somewhat subsiding. At 16:20 BP R 150/82, L 140/88. Status: she hasn't had a headache in over a year.
Eight days after my first injection, the injection site became swollen, hot to the touch, and extremely large bump appeared.