chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was moved to refrigerator on 06/Oct/21. Total duration of temperature excursion is 4 hours.
About 12 hours after second vaccine, developed flu like symptoms, including fever (102-103), chills, body aches, fatigue, headache, mild nausea.  Symptoms lasted almost 24 hours.  Previous COVID patient, October, 2020.
Pt recvd 1st dose of Hep B vax on 16APR91 & on 4JUN91 devel nausea, malaise, myalgia, & chills w/t101; tx Keflex for the next 7 days; 13JUN91 revealed segmented neutrophils 77, Bands 1, lymphocytes 21, monocytes 1, & ESR of 60;
Devel nausea & vomiting, 7 days post vax devel paresthesia & vision loss in lt eye;
Initial report received from healthcare professional on 02 DEC 2014. A 41-year-old female patient, whose concomitant medications were not reported, had received an intramuscular dose of FLUZONE (batch number: UT188AD, expiry: 30 JUN 2015, dose, dose number not reported) in left deltoid, on 30 SEP 2014. The patient had previously vaccinated with influenza vaccine two times and post vaccination experienced adverse reactions dizziness, heart palpitations, vomiting and elevated blood pressure. The patient had a medical history of allergies to latex, augmentin, environmental allergy and history of elevated blood pressure. It was reported that one hour after vaccination (vaccination on 30 SEP 2014), the patient experienced dizziness, heart palpitations, vomiting and elevated blood pressure. Lab details and corrective treatments were not reported. It was reported that dizziness resolved the next day and she felt draggy and later all symptoms resolved on unspecified date. The outcome of the event was reported as resolved. Documents held by sender: none.
left face and ear were red and hot; left face and ear were red and hot; She got scared; side where the injection was given on her face felt like NOVOCAINE wearing out after the dentist/left side of the face cheeks to eye felt numb tingling, it felt different/like it was numb but not numb; left side of the face cheeks to eye felt numb tingling, it felt different; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EZ9262), via an unspecified route of administration in the left arm on 25Jan2021 10:00 at a single dose for COVID-19 immunization. The patient's medical history included high cholesterol diagnosed a few years ago. Concomitant medication included atorvastatin for high cholesterol. The patient took the vaccine yesterday (25Jan2021) and the side where the injection was given on her face felt like procaine hydrochloride (NOVOCAINE) wearing out after the dentist and she doesn't see this listed on the sheet given. The left side of the face cheeks to eye felt numb tingling, it felt different. She wants to know if it's normal. She got the shot at 25Jan2021 10:00 and by 25Jan2021 17:00, her left face and ear were red and hot. Then, she felt her face. It felt like procaine hydrochloride wearing out after the dentist, like it was numb but not numb. She got scared and got up and looked at herself to see how it looked and there was no change. She scratched both sides of her face and they felt the same. It continued all night. This morning (26Jan2021), she thought it went away but she felt it all over again, not as much. She is not burning up, not like yesterday. She did not take her temperature; she should have to see if she had a low grade fever. Outcome of the event "she was scared" was unknown while of the remaining events was recovering.
Sore right arm at injection site. Large inflamed bruising radially around upper arm, right arm.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of PROQUAD (lot # N014758, expiration date 08-NOV-2018) (dose and route were not reported) for prophylaxis. Concomitant therapies included sterile diluent. The vaccine was exposed from -14 degree Celsius (°C) to -10 degree Celsius (°C) for 4 hours and 45 minutes. There was previous temperature excursion from -9°C to 8°C for 6 hours and 26 minutes. The call was made because there was a "data logger". No adverse effects reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA008045.
Pt has allergic reaction w/ her 1st dose.  She was in the middle of her  graded COVID-19 Challenge (dose 2) under a physician's supervision. Pt just received 0.03ml (10% ) of full dose. Pt then started experiencing increased mucus in her throat, clearing of throat, and states that her ears feel weird about 11 minutes later. Her Vitals  at  this time were 168/78, 85 HR, 14Resp, 100% Spo2. 5 minutes later another set of vital signs were taken at 152/84, 86 HR, 16 resp, 95% Spo2.  EPi 0.3 mg was administered immediately.  Pt states  that her throat feels better about 3 minutes later, but her chest still feels irritated. Her Spo2 was up to 100% at this time.  Pt then stated that she is starting to feel shortness breath after using the bathroom. Pt is then transferred directly to the ER .
This spontaneous report has been received from a physician via a company representative concerning an adult female patient of approximately 40 years old reported as "about 40 years old". The patient's concurrent conditions, pertinent medical history and drug reactions/allergies were unknown by reporter. On an unknown date, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX injection, (lot #, expiration date, strength, route of administration and dose were not provided). There was no concomitant therapy reported. On an unknown date, after receiving the dose of (Oka/Merck) VARIVAX the patient developed shingles. The patient sought medical attention by visiting the physician. However, it was unknown by reporter if the patient received treatment for the adverse event and also if there were laboratories performed. At the reporting time, the outcome of shingles was not reported. The causal assessment of shingles to (Oka/Merck) VARIVAX was not provided. Additional information has been requested.
On 3/25/00 after the vax, the pt experienced a small amount of bleeding, a dime sized lump under the skin which progressed to a quarter size within minutes, and became swollen, By the time the pt left the office the area was 2 x 3 inches and was red and swollen. She was treated with ice and Benadryl. Subsequently she recovered. No further information is available.
Patient described fever of 100.6, redness, swelling, itching at site of injection.
Pt reported mild dizziness. Denied other symptoms. Pt declined juice or water.  Pt reported feeling better and left to home with wife.
Very very slight little sensation enough to know that there is something; Very sharp pain in the pelvis area; Lethargic, like a zombie, very tired; Lethargic, like a zombie, very tired; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic, like a zombie, very tired), FATIGUE (Lethargic, like a zombie, very tired), PELVIC PAIN (Very sharp pain in the pelvis area) and DISCOMFORT (Very very slight little sensation enough to know that there is something) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced LETHARGY (Lethargic, like a zombie, very tired) and FATIGUE (Lethargic, like a zombie, very tired). On 28-Jan-2021, the patient experienced PELVIC PAIN (Very sharp pain in the pelvis area). On 02-Feb-2021, the patient experienced DISCOMFORT (Very very slight little sensation enough to know that there is something). On 29-Jan-2021, PELVIC PAIN (Very sharp pain in the pelvis area) had resolved. On 02-Feb-2021, DISCOMFORT (Very very slight little sensation enough to know that there is something) had resolved. At the time of the report, LETHARGY (Lethargic, like a zombie, very tired) and FATIGUE (Lethargic, like a zombie, very tired) outcome was unknown. Not Provided          Reporter did not allow further contact
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: initial negative test after Paxlovid; positive, notes: tested positive 8 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT GOT CLAMMY FELT WARM..PLACED COLD PACKS ON NECK/WRISTS/ SYMPTOS RESOLVED..HAD PATIENT WAIT 30 MIN AFTER FEELING BETTER..SPOUSE WAS WITH PATIENT
numbness and tingling on tip of tongue, numbness and tingling of arms, after 10 - 15 minutes complaint of numbness and tingling of legs, after 30 minutes pain upper left chest near arm pit. Benadryl 25 mg po given, patient opted to go to ER for observation.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with a dose of improperly stored ROTATEQ (incorrect product storage) (lot number L033548, expiry date 14-MAY-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. It was reported that the ROTATEQ was exposed to a temperature of 33.8 degrees Fahrenheit for 16 hours, 51.6 degrees Fahrenheit for 16 hours, 33.6 degrees Fahrenheit for 16 hours and 34.1 degree Fahrenheit for 16 hours. There was no previous temperature excursions. It was reported that this case was reported due to a data logger. The action taken with the therapy with ROTATEQ was unknown. The outcome of events was unknown. There was no product quality complaint reported. This case number US-009507513-1606USA005776 via same reporter link. Additional information has been requested.
Rash next to injection site, small circular patches, slightly raised, mildly itchy and tender for about 24 hours. Faded by the next day and resolved quickly. Only other symptoms since the shot were fatigue and arm soreness.
pt recv vax 2SEP97 & 3SEP97 pt exp rash on arms & stomach that lasted for approx 10 days;
This spontaneous case was reported by a nurse and describes the occurrence of EPISTAXIS (Couple of nosebleeds 3 days postvaccination) 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 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced EPISTAXIS (Couple of nosebleeds 3 days postvaccination). At the time of the report, EPISTAXIS (Couple of nosebleeds 3 days postvaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Patient experienced the event 3 days post vaccination.
Received the 1st dose, and Have not received the 2nd dose of the Moderna vaccine yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received the 1st dose, and Have not received the 2nd dose of the Moderna vaccine yet) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension and Cholesterol.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the 1st dose, and Have not received the 2nd dose of the Moderna vaccine yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received the 1st dose, and Have not received the 2nd dose of the Moderna vaccine yet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include Diabetic medication, blood pressure medication, Cholesterol medication. No treatment medication details was reported.
administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug details were reported. Pharmacist's stated that the beyond the use date is 09Dec2021 at 10:00PM . These were all booster doses given at 0.25ml, intramuscularly. Lot number/Expiration date -067F21A; 31Dec2069.  No treatment details were reported.
Pt recvd 3rd dose of vax on 20MAY92 7 approx 2 hrs following vax pt devel redness w/itching on the face, arms, & trunk; treated w/Epi; seen in ER;
Sign & symptoms of syncope noted after 15 mins. shot check, occur at 5:05pm, then O2 stat check (98%) and pulse 86 also patient reevaluated per Dr.
pain through the whole night; This is a Spontaneous report from a Pfizer Sponsored Pfizer Rx Pathways Program. A contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain through the whole night on 14Apr2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician and a registered nurse concerning a 16 year old female with no medical history or allergies, who on 08-MAR-2007 was vaccinated with a second dose of Gardasil. There was no concomitant medication. Two days after vaccination, the patient developed a rash all over her body. On 12-MAR-2007 the patient went to her primary care physician's office and was diagnosed with erythema multiforme. The patient was treated with a dose pack of methylprednisolone (MEDROL) and subsequently recovered. No product quality complaint was involved. Additional information has been requested.  Additional information is not expected.
Pt recvd vax & devel fever, h/a, malaise, & myalgia;adm to hosp, MD made dx of UTI;MD stated this illness was unrelated to vax
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX. On 20th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, headache, fatigue, feeling cold and shivering. On an unknown date, the outcome of the pain in arm, headache, fatigue, feeling cold and shivering were unknown. It was unknown if the reporter considered the pain in arm, headache, fatigue, feeling cold and shivering to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist told the patient that her arm would be sore and the patient stated that it was sore but she also experienced other side effects like headache, fatigue, and feeling very cold or shivery that night when she went to bed. The reporter stated that she knew these were listed as side effects but she want to be sure there was no contraindication for her to get the 2nd dose of SHINGRIX in 2 months.
This spontaneous report was received from a nurse concerning a patient of unknown gender and age. On 18-JUN-2015 the patient was inadvertently vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # L001326; expiration date: 13-JAN-2017) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Pt with tonic/clonic seizure X 4 minutes at home within 1-2 days of immunization, self resolved. Evaluated in ER and looked well.
late localized reaction - redness that measures 4 cm x 2cm, with warmth and induration
nausea, headaches, muscle aches, chills... ongoing at the time of this writing (24+ hours). NO FEVER
sinus tachycardia of 135 bpm for 4 hours starting on 4/25/2021 at 1:00 am, sinus tachycardia continued for 3 days around 100 bpm for three days.
Patient received DTaP to RD on 6/19/06. Returned to clinic 6/21/06 for PPD reading. RD red, raised, swollen, warm to touch approximately 25cm width, 19cm length. Benadryl, Tylenol, Motrin, Orapred, Zithromax.
Pt called at 8:25am on 4/20/21 complaining of cough, runny nose and sore throat after getting second dose Pfizer on 4/19/21 and requests covid19 test. Scheduled pt with doctor for telephone appt today at 1:20pm regarding symptoms and for covid19 test. patient did not pick up phone call after multiple attempts.
Pt recv third dose of vax on 9/13/93 and on 9/26/93 pt exp rheumatoid arthritis.  Pt exp stiff fingers, couldn't move fingers, loss of strength, and could not lift a glass.  As of 2/10/94 pt is in remission from the arthritis.
Case number PHEH2016US023353, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 46 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in left arm on 01 Dec 2015. On 01 Dec 2015, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error.
5 minutes after my 2nd dose vaccination, I experienced the following: shortness of breath, flushed face, chills, nausea. Overall I experienced these symptoms for 3 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROGESTERON, start date: 01Oct2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (28Jul2022) Negative, notes: I tested negative on Thu 28Jul; (01Aug2022) Positive, notes: tested positive to covid again on Monday 01Aug. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course included paxlovid was used in treatment of COVID-19 from 23Jul2022 to 27Jul2022. After finishing the 5 day treatment she tested negative on Thu 28Jul. Symptoms starting to reappear on Sat 30Jul and tested positive to covid again on Monday 01Aug.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.