chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pulled from the frozen at 9:49 to the fridge,then form the fridge it was pulled out at 10:00 am. And then it was given to patient at 10:45; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of PRODUCT STORAGE ERROR (Pulled from the frozen at 9:49 to the fridge, then form the fridge it was pulled out at 10:00 am. And then it was given to patient at 10:45) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis. 43 tNo Medical History information was reported.    On 07-Nov-2022 at 10:45 AM, the patient received 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 PRODUCT STORAGE ERROR (Pulled from the frozen at 9:49 to the fridge,then form the fridge it was pulled out at 10:00 am. And then it was given to patient at 10:45) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Pulled from the frozen at 9:49 to the fridge,then form the fridge it was pulled out at 10:00 am. And then it was given to patient at 10:45) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Pulled from the frozen at 9:49 to the fridge,then form the fridge it was pulled out at 10:00 am. And then it was given to patient at 10:45).    No concomitant medications was provided. No treatment medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Nov-2022: Non-significant follow up- Occupation of reporter updated.
Injection 2 on 2/5/2021: small red rash around injection within 12 hours of injection nausea started at 4:00 PM NEXT DAY sore throat started the evening of 2/6/2021 by evening of 2/6/21 red rash grew to approx 2 inches all the way around the injection site and became more itchy
This spontaneous report as received from the registered nurse via Medical Record refers to a currently 13 month old male patient with eczema and no known drug allergies (NKDA). On 19-MAR-2013, the patient was vaccinated with the first dose of HepB (unspecified) for HepB. On 20-MAY-2013, the patient was vaccinated with the first dose (also reported as second dose) of PEDIARIX for DTP/aP; First dose of PREVNAR 13 for PCV; First dose of ROTARIX for Rotavirus; First ACTHIB for Hib. On 23-JUL-2013, the patient was vaccinated with the second dose of DAPTACEL for DTP/aP; Second dose of ACTHIB for Hib; Second dose of PREVNAR 13 for PCV; Second dose of ROTARIX for Rotavirus. On 20-SEP-2013, the patient was vaccinated with the second (also reported as third) dose of PEDIARIX for DTP/aP; Third dose of ACTHIB for Hib; third dose of PREVNAR 13 for PCV. On 11-DEC-2013, the patient was vaccinated with the third dose of IPOL for Polio. On 26-MAR-2014 at 10:05:46 am the patient was vaccinated with the first dose of PROQUAD (lot # J015312, expiry date: 03-JUN-2015) (dose and route of administration not reported) which was stored improperly, exposed to 42F for 4 weeks. It was reported that the patient did not seek medical attention. On the same date, the patient was vaccinated concomitantly with the first dose of HAVRIX for HepA; Fourth dose of PEDVAXHIB for Hib; Fourth dose of PREVNAR 13 for PCV and VARIVAX (Merck) for Varicella. This is one of several reports from the same source. Pediatric medical records were received and reviewed; no adverse experiences related to the prenatal exposure or to other Merck Products were identified. All available medical records will be provided upon request.
PENTACEl was given today and expired on Saturday with no reported adverse event; Initial information received on 27-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient who received Diphtheria, Tetanus, AC Pertussis, IPV AND HIB Vaccine [Pentacel (Vero)] which was given today and expired on saturday with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus vaccine live oral 1V (Rotarix) for Prophylactic vaccination; and Pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 27-Feb-2023, the patient received a dose of 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test--0.5ml of suspect Diphtheria, Tetanus, AC Pertussis, IPV AND HIB Vaccine Suspension for injection which was expired on saturday with no reported adverse event (expired product administered) of standard strength for one day (QD) (lot: UJ614AAA, expiry date: 25-Feb-2023) via intramuscular route in the right thigh for Immunization.  Action taken: not applicable.  Outcome: Unknown.  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.
C/O feeling flushed at 15 min post injection mark. Skin pink warm and slightly diaphoretic vital signs 150/80;  Denies SOB, itching, numbness/tingling to throat and mouth.   Patient observationextended for additional 30 min.   Vital signs after 25 min observation; 138/99-55-16-100%. Vital signs after additional 30 min = 138/83-50-16-99%. Patient drank apple juice and symptoms completely resolved. Advised to proceed to nearest ER  if s/s return.
Had febrile seizure 13NOV91; MD felt pt had ?OM & CXR showed pneumonia; pt treated/released form ER;
itching; break out in hives; lips and eyes blew up; face broke out; her lips and eyes blew up; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), URTICARIA (break out in hives), LIP SWELLING (lips and eyes blew up), ACNE (face broke out) and EYE SWELLING (her lips and eyes blew up) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-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 an unknown date, the patient experienced PRURITUS (itching), URTICARIA (break out in hives), LIP SWELLING (lips and eyes blew up), ACNE (face broke out) and EYE SWELLING (her lips and eyes blew up). At the time of the report, PRURITUS (itching), URTICARIA (break out in hives), LIP SWELLING (lips and eyes blew up), ACNE (face broke out) and EYE SWELLING (her lips and eyes blew up) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Left breast pain; Sore throat; Sore ear; Itchiness in ear; Itchiness in throat; Eyes are watery and itchy; Lymph nodes under her arm pit was swollen and painful; Fatigue; Arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting), BREAST PAIN (Left breast pain), OROPHARYNGEAL PAIN (Sore throat), EAR PAIN (Sore ear) and PRURITUS (Itchiness in ear) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting). On 22-Mar-2021, the patient experienced BREAST PAIN (Left breast pain), OROPHARYNGEAL PAIN (Sore throat), EAR PAIN (Sore ear), PRURITUS (Itchiness in ear), THROAT IRRITATION (Itchiness in throat), EYE PRURITUS (Eyes are watery and itchy), LYMPHADENOPATHY (Lymph nodes under her arm pit was swollen and painful) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Tylenol every 4 hours. At the time of the report, PAIN IN EXTREMITY (Arm was hurting) was resolving, BREAST PAIN (Left breast pain), OROPHARYNGEAL PAIN (Sore throat), EAR PAIN (Sore ear), PRURITUS (Itchiness in ear), THROAT IRRITATION (Itchiness in throat), EYE PRURITUS (Eyes are watery and itchy) and FATIGUE (Fatigue) outcome was unknown and LYMPHADENOPATHY (Lymph nodes under her arm pit was swollen and painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 18-OCT-2017, the patient was vaccinated with improperly stored doses of VAQTA lot # N019924, expiration date 02-SEP-2018, orally, for prophylaxis (strength, dose and frequency were not reported). The temperature/Time frame was 34.8°F for 8 hours 23 minutes and 34.8°F for 8 hours 15 minutes. The previous temperature excursion was 47.6°F for 5 minutes. There was a data logger involved. No adverse effects reported. This is one of several cases from the same source. Sender's Comments: US-009507513-1710USA010312: US-009507513-1710USA010653: US-009507513-1710USA010654: US-009507513-1710USA010655.
Narrative: 26yr male was admitted to the agency hospital on 10/12 with COVID sx (fever/weakness/SOB/cough/lost taste and smell) since 10/8 in the setting of recently being diagnosed with COVID(10/10/2021). High risk condition for severe COVID disease: obesity (BMI 43). COVID Therapeutics: Dexamethasone 6mg daily, remdesivir x5 doses, and INV baricitinib 4mg daily. Rapidly increasing oxygen supplementation from 1L NC to requiring high flow O2 within 5 days of hospitalization. Hospitalization stay: 12 days COVID Vaccination Status: Janssen 5/2021
Got tested and came positive after receiving first vaccine; Got tested and came positive after receiving first vaccine; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported similar events in two patients. This is the first of two reports.  A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not reported), intramuscular on 10Jan2021 at single dose for COVID-19 immunization. Medical history included asthma. Concomitant medication included vitamins nos. It was reported that both the patient and her husband received the Pfizer Vaccine on 10Jan2021; and they had reaction to it. They both both had bad arm swelling and pain. Her was worst she couldn't even lift or move her arm. At first, they just thought it was a reaction as they read reactions could be and then she started to get small cough but by Friday, her husband went and got tested and on Wednesday he was tested positive and this is after the vaccine and then he got the results and it said he was positive. So, Saturday, they both went and got tested, they did the rapid and they did what they call the PCR, and they both came positive for both of them and this was after they receive the first vaccine. So, she thought they need to know that they got sick and it was after the vaccine. The patient needed to ask a question as they were supposed to go for their second vaccine on 31Jan2021 and do they do it even though they got sick. They knew they were claiming that they can't get sick because of the vaccine but it's very ironic that they did get this. They had been following CBC guidelines, both her husband and the patient because they are older and they wear mask all the time and they did everything they needed to and they could not understand how they got this. The patient underwent lab tests and procedures which included Rapid and PCR: positive in Jan2021. Therapeutic measures were taken as a result of "bad arm swelling and pain; worst she couldn't even lift or move her arm" which included treatment with Tylenol. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092094 same reporter and drug, similar events in a different patient
Developed large red, swollen, pruritic area at injection site, immediately. Had mild itching all over and hot flashes. Took BENADRYL and TYLENOL.
COVID arm that has been present for 12 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm that has been present for 12 days) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm that has been present for 12 days). At the time of the report, VACCINATION SITE REACTION (COVID arm that has been present for 12 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
loss of consciousness; He started foaming at the mouth; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (loss of consciousness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (loss of consciousness) (seriousness criterion medically significant) and FOAMING AT MOUTH (He started foaming at the mouth). At the time of the report, LOSS OF CONSCIOUSNESS (loss of consciousness) and FOAMING AT MOUTH (He started foaming at the mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Tested positive for Covid 19 after first dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Tested positive for Covid 19 after first dose of the Moderna Covid 19 vaccine) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     The patient had no allergies.     On 31-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for Covid 19 after first dose of the Moderna Covid 19 vaccine). At the time of the report, COVID-19 (Tested positive for Covid 19 after first dose of the Moderna Covid 19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2022, SARS-CoV-2 test: (Positive) Tested positive for Covid 19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. The patients mother reported on 28-Sep-2022, the patient was supposed to receive the second dose of the vaccine.The mother cancelled the appointment, but would like to know how long must her son wait to get his second dose. No treatment medications were provided by the reporter.
I have been experiencing bloody noses.  They come on suddenly and usually last approximately 15-20 minutes. I have had as many as 3 in one day and then other days none at all.  I do not know if this is related to my Covid 19 Vaccines, but I have not had any nose bleeds in over 40 years, so this was unusual.
Patient received 0.3mL of undiluted Pfizer vaccination. Patient housed in medical for observation of any adverse reactions. Scheduled monitoring of SpO2 and lung sounds per medical director.
This spontaneous report was received from a physician via field employee, refers to a 18 year old female patient. Medical history was not reported. In January 2011 the patient was vaccinated with GARDASIL dose 3, dosage, lot number and strength were not reported, for prevention of human papilloma virus (HPV). Concomitant therapy was not reported. The physician informed that on 25-JAN-2011 the patient presented to his office with a joint pain, also reported that the patient was diagnosed with rheumatoid arthritis on an unspecified date in February 2011. The patient sought medical attention by a physician's office visit. The outcome of the event was reported as not recovered. Additional information has been requested.
This spontaneous report as received from a 65 year old female patient with blood pressure and cholesterol, reporting on herself. The patient had no known drug reactions/allergies. On 06-MAY-2014, the patient received one single shot of ZOSTAVAX, SC, (lot # and expiration date were not provided). Co-suspect therapy was not provided. Concomitant therapies included aspirin, unspecified blood pressure and cholesterol medications (therapies not provided). It was reported that on 06-MAY-2014, after receiving ZOSTAVAX, the patient developed a large red mark about the size of a quarter that did not itch on her arm. The patient also reported it took about a month for the mark to completely go away. The patient did not receive any treatment for the event. The patient sought unspecified medical attention. At the time of the report the patient had recovered. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Severe migraine; Body aches; Cough that got worse; Slight fever; Nauseated; diarrhea; Just wanted to sleep; Made her asthma worse; This is a spontaneous report from a contactable consumer or other non hcp (patient) reported herself. A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: Ep7533; expiration date was not reported), via an unspecified route of administration, in left arm 02Apr2021 at 09:00 (at the age of 32-years-old) as dose 1, single for covid-19 immunization. Medical history included asthma. The patient previously took Morphine and experienced Known allergies: Morphine. The patient previously received gardasil vaccine from an unknown date and unknown if ongoing and experienced Known allergies: gardasil vaccine. Concomitant medications were reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not receive any other medications within two weeks of vaccination. On 02Apr2021 at 09:00, patient experienced severe migraine and body aches both times; cough that got worse; slight fever; nauseated; had diarrhea; just wanted to sleep and made her asthma worse. Facility type vaccine administered was reported as public health clinic/veterans administration facility. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient was scheduled for second vaccine on 23Apr2021. Therapeutic measures were reported as no, except for event asthma, patient using her rescue inhaler more frequently. The outcome of event cough that got worse was reported as not recovered, while all remaining events was reported as recovering. No follow-up attempts are needed. No further information is expected.
Headache, arm soreness, loss of appetite. Starting at 2100 on 10/28/11 vomiting q 20min. for 30 hours, started arm cellulitis. Visited ER 10/29/11.
This case was reported by a consumer via call center representative and described the occurrence of tinnitus in a 71-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included multiple allergies and asthma. Concomitant products included FLONASE, SINGULAIR and FLOVENT. On 5th May 2018 16:30, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced tinnitus, injection site discoloration, tiredness, attention impaired, cough, nasal congestion, allergy aggravated and runny nose. On an unknown date, the outcome of the tinnitus, tiredness and attention impaired were recovering/resolving and the outcome of the injection site discoloration, cough and nasal congestion were recovered/resolved and the outcome of the allergy aggravated and runny nose were unknown. It was unknown if the reporter considered the tinnitus, injection site discoloration, tiredness, attention impaired, cough, nasal congestion, allergy aggravated and runny nose to be related to SHINGRIX. Additional details were provided as follows: The patient stated that she experienced tinnitus within 24 to 30 hours post vaccination. The patient used to hear loud noises that woke her up in the middle of night and it had decreased over time but she did still hears buzzing in her ears time to time. The patient had allergies and asthma. After receiving the vaccine her allergies were exaggerated since she started coughing a lot of fluid and felt congested. When the patient woke up in the morning as she put her head down, fluid started coming out of her nose, felt tired and her attention was impaired. At the time of reporting, the patient had recovered from her congestion and coughing now but she was still recovering from tiredness and impaired attention. Due to her tinnitus she was referred to see otolaryngology (ENT) specialist by her doctor on 6th June 2018. The patient had a blue and black mark at the injection site which lasted for total of 10 days. The patient had denied permission to contact their physician and her regular physician was on vacation. The patient would follow up with her physician. No further details were provided.
Prior to vaccine patient was asymptomatic. He was observed overnight in the hospital 2 weeks prior for SARS-CoV-2 infection but did not require treatment or oxygen.  The day after vaccination he felt weak, and had decreased PO intake. He lives alone. Presented to ED initially because he was not able to check his blood sugars for a week and was feeling weak. He was found to have acute kidney injury on top of his CKD. After fluids and increased PO intake the AKI improved over the course of a week.