chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 5:50 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 5:50 PM, the patient experienced PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was moved from freezer to refrigerator on 19-Nov-2021, when the Moderna COVID 19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer, refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions were reported.   This case was linked to MOD-2021-402935 (Patient Link).
female patient received 1 injection of MMR II / 2 days after the injection, patient was confirmed to be pregnant; This spontaneous prospective pregnancy report as received from an office manager via a company representative refers to a female patient in her mid 30's (exact age not provided). The patient's medical history included pregnancy. No information regarding the patient's concomitant medications, drug reactions and allergies was provided.     On an unknown date in September 2019 (reported as two weeks ago), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), 1 dose, subcutaneously (exact dose, lot number and expiration date were not provided) that was reconstituted with sterile diluent, for prophylaxis. On an unknown date in 2019, 2 days after the vaccination, the patient was confirmed to be pregnant by an urinary test. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) was not reported. The pregnancy outcome was pending. The fetal outcome was unknown.
Mother reported child complaining of redness and itching at proquad injection site approximately 5 minutes after administeration.  Nurse observed redness and some swelling at site with no warmth felt.    Provider notified.  Per APRN, 1tsp of benadryl given to patient by mouth.  Provider re-examined child's site and symptoms.   Mother given provider's work email address to contact with any concerns over the weekend.   Nurse observed that redness at site had improved before discharge. patient was observed for 25 minutes in office.   Per APRN, mother emailed him on 5/07/2021 after 11pm with concerns for child's fever.  Provider followed up with child on 5/08/2021 via telephone call in the a.m.  Mother had reported calling an after hours nurse line and was told to alternate ibuprofen and tylenol every 4 hours and follow up with provider.   Nurse called mother on 5/11/2021.  Mother reported child's health has improved and scheduled follow up  appt with APRN for 5/13/2021.
On 08/22/2021 I developed hives covering my arms and legs. These lasted for approximately 24 hours. I again developed hives on 09/07/2021, 09/15/2021, and 09/22/2021. All times lasted approximately 24 hours, except for the last occurrence which lasted about 36 hours.
Improperly stored vaccines administered; Information has been received from an administrator referring to a male patient (reported as baby boy). Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 22-JUL-2021,  the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (strength, dose, frequency and route were unknown, lot # T022566, expiration date: 03-NOV-2022) that was improperly stored for prophylaxis (incorrect product storage).         The stored temperature was -1.4 degree Celsius.  The time frame was 1 hours There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2108USA001990: US-009507513-2108USA001815:
Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients might have received doses of improperly stored GARDASIL 9 (lot # M018819 with expiration date 28-MAY-2018; dose and route were not reported). The vaccine was exposed to 31 Fahrenheit for 40 minutes. There was no prior excursion. Data logger was unknown. NO adverse effects were reported. At the reporting time, the reporter did not sure if the vaccine was administered. This is one of several received from the same reporter. Additional information has been requested.
COVID-19 and Pneumonia; COVID-19 and Pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), on 28May2021 as dose 1, single (Lot number: Ew0180) and on 21Jun2021 as dose 2, single (Lot number: Ew0181) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 PNEUMONIA (hospitalization, medically significant) all with onset Oct2021, outcome "unknown" and all described as "COVID-19 and Pneumonia". The patient was hospitalized for drug ineffective, covid-19 pneumonia (start date: 20Oct2021, discharge date: 24Oct2021, hospitalization duration: 5 day(s)). The patient was admitted on 20Oct2021 to the Hospital, where he was diagnosed with COVID-19 and Pneumonia and was discharged on 24Oct2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300269477 same patient/product, different dose number/event;US-PFIZER INC-PV202300155552 same patient/product, different dose number/event;
Seizure (staring) caused by fever. (Stiffness, difficulty breathing, rapid heartbeat.) Lasting about 5-10 minutes. Treatment - alternate Tylenol and Motrin 1B for 48 hours.  Follow up 07/24/2002: "Information has been received from an investigator concerning an approximately 59 day old male who entered a study, titled "Open, controlled, randomized study on the safety of HEXAVAC compared to PENTACOQ and HBVAXPRO administered concimitantly at two separate sites at 2, 3, and 4 months of age; and on the safety of HEXAVAC administered as a booster dose to both groups during the second year of life.  On 06/21/2002, the patient was vaccinated with the first dose of hepatitis B vaccine recombinant (yeast)(batch # VA10038001), administered IM, in the left thigh.  Concomitant therapy, that same day, included the first dose of diphtheria toxoid (+) Haemophilus B conjugate vaccine (+) pertussis vaccine (+) poliovirus vaccine (+) tetanus toxoid (PENTACOQ)(batch #T1454-1), administered IM, in the right thigh.  Additional concomitant therapy included choleclaciferol (+) sodium fluoride (2YMADUO) PO, for prevention of rickets caries (therapy ongoing) and phytonadione (manufacturer unknown) PO, for prevention of newborn haemorrhagic disease (therapy ongoing).  On approximately 06/21/2002 (from D1 until D3) the patient developed "common fever".  The fever was treated with acetaminophen (Efferalgan) on 06/22/2002 (therapy duration unknown).  On 06/23/2002, and 06/14/2002 (from D3 to D4), the patient's fever bordered on 39 degrees, and was described as "severe".  The patient was developed anemia and leukipenia, of which the outcome is unknown.  Diagnostic laboratory testing results were as follows:  Hemoglobin 7.5 G/L, RBC 2,670,000, hematocrit 22.8, WBC 4,400, neutrophils 25%, lymphocytes 71%, monocytes 4%, platelets 338,000, iron 138, ESR, 26/60, CRP 6.6, and uring "sterile".  The investigator felt that the fever and "whinings" were "possible" related to study therapy.  It was also noted that the events were not related to therapy with cholecalciferol (+) sodium fluoride (ZYMADUO) or phytonadione (manufacturer unknown).  Subsequently, on 06/25/2002, the patient recovered.  Additional information is not expected.  Other business partners numbers include:  25105937, R020469, F2002-01751, & X00-AR21-402.
Nausea; Chills; This non-serious case was reported by a consumer and described the occurrence of nausea in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension, chronic obstructive pulmonary disease, depression and back pain. Concomitant products included fluticasone furoate + umeclidinium bromide + vilanterol trifenatate (Trelegy Ellipta), amlodipine besilate, pregabalin, buspirone and sertraline.   On 10-MAR-2023, the patient received the 1st dose of Shingrix. On 11-MAR-2023, 1 days after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea) and chills (Verbatim: Chills). The outcome of the nausea and chills were not resolved.   It was unknown if the reporter considered the nausea and chills to be related to Shingrix.     It was unknown if the company considered the nausea and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JUL-2023 The reporter was a caregiver. The symptoms were not treated. The reporter consented to follow up.
We were alerted by public health that this patient received the Janssen vaccine at a different location than our pharmacy on 3/8/21 on 8/5/21.  We provided a dose of Pfizer/BioNTech on 8/3/21 not knowing about the initial Janssen vaccine (patient did not indicate any previous vaccine on our VAR form).  Patient has not reported any adverse effects as of today's date.  We have also contacted patient to let them know that they will not need a second dose of Pfizer/BioNTech.
PATIENT HAD 102 DEGREE FEVER AND PAIN AT INJECTION SITE DAY ONE. PT REST AND FEVER WENT AWAY HOWEVER HIS RIGHT ARM IS SWOLLEN FROM HIS SHOULDER DOWN TO HIS HAND. HE ALSO MENTIONED HE WAS DOING YARD AND SCHRUB WORK SO I MENTIONES POSSIBLT GETTING BIT. HE SAIS HE FELT FINE I RECOMMENDED BENADRYL AND TO WATCH FOR FEVER. IF SWELLING DID NOT START GOING AWAY BY TOMORROW CONTACT MD.
Narrative: COVID infection following COVID vaccine series 03/02, Pfizer, dose #1 03/22, Pfizer, dose #2 09/17 COVID swab, result: detected 09/17 pt cc: cough, diarrhea, fatigue, fever, headache, loss of taste or smell, mualgias, nausea, rhinorrhea, sore throat exposure: unknown 09/17 SARS-COV-2 Variant Sequencing result: pending
Developed a pruritic rash on 10/14/13, which was 7 days after receiving Flu Mist vaccine on 10/7/13. Came to clinic 10/14/13 and was diagnosed with hives and treated with Benadryl. Came back to clinic 2 days later 10/16/13 and diagnosed with erythema multiforme rash, treated with Atarax. Patient has also developed cough and congestion in the interim. No fever.
Patient call me on 9-11-15 Friday afternoon and said his whole body ache. I call his primary doctor and I told the patient to go to the hospital. Patient was admitted with pneumonia. Patient was released from hosp on 9-14-15.
Case number PHEH2013US018995 is an initial spontaneous report received from a nurse on 05 Sep 2013 and a follow up report from the nurse received on 10 Oct 2013. This report refers to a 17-year-old male patient. His medical history and concomitant medication were not reported. His vaccination history included MENVEO vaccine on 27 Aug 2008, which was well tolerated. He was vaccinated with MENVEO (batch number: A12009, expiry date: 28 Feb 2014) at a dose of 0.5 ml intramuscularly in the right deltoid on 12 Aug 2013 (2:15). It was reported that MENVEO which reached 31 Fahrenheit for 3 days was subsequently administered to the patient. No adverse event was reported following this medication error. Follow up report from the nurse received on 10 Oct 2013: The vaccination history and vaccination site were added.
29Dec97 & 02Feb98 Pt recv 1 & 2nd dose of vax. Pt devel bruising  whole upper arm & a hard bump for 2 wk. w/the "size of a grapefruit"inject site. Felt like "a bad bee sting". MD felt Pt had had varicella in past. Pt claimed not.
muscle ache, nausea, headache/pressure and emesis x's 2 (bile)
New onset of multiple sclerosis with transverse myelitis with numbness and tingling in the extremities.  She subsequently had optic neuritis in 2022 and was officially diagnosed with multiple sclerosis 9/21/22  initial MRI brain does show some lesions typical of multiple sclerosis which may be older, so connection to vaccination is uncertain
Information has been received from a licensed practical nurse concerning a male adolescent who on 8/13/04 was vaccinated with a dose of varicella virus vaccine (lot # 647244/0897N). On 8/24/04, the patient presented with a red, swollen area at the injection site. Unspecified medical attention was sought. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested. The nurse also reported that the patient's adolescent sister developed a red, swollen area at the injection site after therapy with varicella virus vaccine live (WAES0409USA02187).
Armpit Pain when arm is raised for more than a minute or so (not every single time arms is raised for more than a minute).  -Started: the day after 2nd injection (still persists but is less severe)
Baby experienced high fever of 104 even after Tylenol was administered. Baby was screaming inconsolably for hours-all night and into next day. Saw provider next day to check breathing and reaction. Provider recommended I (mom) submit a VAERS report & u also asked provider to to submit their own VAERS report regarding reaction.
Dizziness; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and DIZZINESS (Dizziness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A2A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VERTIGO (Vertigo). On 13-Mar-2021, the patient experienced DIZZINESS (Dizziness). On 13-Mar-2021, VERTIGO (Vertigo) had resolved. At the time of the report, DIZZINESS (Dizziness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. treatment medication includes motion sickness medication. patient states she is feeling okay.   This case was linked to US-MODERNATX, INC.-MOD-2021-076267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Updated event outcome and treatment medication.
Less than 24 hours after receiving the vaccine I developed a fever over 102; chills, sweating, moderate headache, nausea, fatigue. Interestingly, these were the same symptoms I had when I contracted Covid in March 2020. I was tested and still had antibodies early January 2021. Fever resolved late on day two after the vax. However nausea & stomach pain last for 6 days, with one incident of vomiting on day three. Had low level headache and fatigue for 6 days.
Got COVID.  Tested positive with at-home test.  Nasty sore throat.  Took paxlovid.  Was better after three or four days.  Day five got sick all over again.  Bottom line - two-to-three weeks before feeling normal and testing negative with at home tests.
Client had one Varicella vaccine age 1 yr and at 12 dx'd with chickenpox.
This spontaneous report as received from office manager via a company representative refers to a multiple unspecified male patients of unknown age. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date the patients were vaccinated with GARDASIL 9 (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. On an unknown date the patients experienced a higher incidence of syncope after receiving GARDASIL 9. The outcome of syncope was unknown. The relationship between the event (syncope) and GARDASIL 9 was not provided. No product quality complaint was involved.
Severe pain right shoulder and right scapula; beginning to show signs of winged scapula.
Within 1-2 hours of receiving vaccine, hives started on ears and face - no respiratory difficulty noted.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: patient claimed to have experienced a large area of redness, swelling and pain around the site of injection (right arm) but says it has now cleared. no other issues reported.
Pt was admitted to hospital from hospice care with UTI on 4/16/21 after receiving 2nd dose of vaccine on 4/1/21. Patient passed on 4/21/21. Per guidelines, all hospitalizations are reported.
Fine papular rash to (B) upper legs anterior only. ? slight blanching. Almost appears like contact vs atopic derm.
1 week of generalized weakness, some increase in baseline cough and shortness of breath, found to be hypoxic requiring 3 L nasal cannula to maintain saturations- O2, decadron
ED Provider notes as follows: 31 y.o. female who  presented to the emergency department for rash similar to hives, onset last night. Patient has a past medical history significant for hives with fall allergies and when she had COVID-19 in October 2020. On Monday 09/27/21, patient endorses she received her second dose of the Pfizer vaccine. Over the next few days she felt fatigue and fever that was relieved with Tylenol and Aspirin. Late last night she experienced onset of an itchy and painful rash, consistent with her past experience with hives. She went to work this morning and experienced progressively worsening symptoms while walking outside. She noted shortness of breath, nausea, and her tongue feeling different, prompting this ED. In this ED, she reports nausea has resolved. Patient notes rash is tracking up the back of her neck and is also on her groin, abdomen, and bilateral arms/hands.Denies fever, cough, cold like symptoms, vomiting, diarrhea, abdominal pain, and urinary symptoms. Patient endorses with first Pfizer dose she experienced a nodule, although did not develop a rash like she is currently experiencing. No alcohol, recreational drug use, or cigarette use  Patient discharged from ED in stable condition with prescription for prednisone and famotidine.
Left arm swollen and hot, red and raised the size of a good sized hand. Inflammation below the injection site. Hot and painful. Patient applied ice off and on throughout the day today 10/23/18. She took 2 TYLENOL at 5:30pm today and a generic BENADRYL 25mg about at 6:15pm. Will watch and wait to see if BENADRYL helps at all. Will watch and wait until tomorrow to see if area decreases in size/inflammation response. If not better tomorrow am patient will contact primary care physician.
patient has allergy with tetanus and diphtheria toxoids; Initial information received on 19-Oct-2020 regarding an unsolicited valid non-serious courtesy case received from a consumer or non health care professional via Pfizer.    This case involves a patient who had allergy with DIPHTHERIA AND TETANUS TOXOIDS (allergy to vaccine).  The patient's medical history included lower respiratory tract infection, gastro esophageal reflux disease and gastrointestinal stromal tumor of stomach.  Patient also had lactose intolerance, milk allergy, chronic obstructive pulmonary disease and essential hypertension.  The patient's medical treatments, concomitant therapy, vaccinations and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had non-serious allergy with DIPHTHERIA AND TETANUS TOXOIDS (allergy to vaccine) (Unknown latency).  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Hives which look like raised looking bug bites; Itchiness in her lower back; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives which look like raised looking bug bites) and PRURITUS (Itchiness in her lower back) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced URTICARIA (Hives which look like raised looking bug bites) and PRURITUS (Itchiness in her lower back). At the time of the report, URTICARIA (Hives which look like raised looking bug bites) and PRURITUS (Itchiness in her lower back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Headache, Pale, Chills, Fever, Dizzy, Vomiting. Couldn't sleep and soaked a couple sets of sheets in sweat. Eventually got to sleep and woke up feeling much better. Symptoms over in 8hrs.
The joint at the base of my little finger swelled up rapidly, starting at about 2pm.  It became extremely painful.  Due to swelling and pain, I could not grasp with that hand.   That evening, I used ibuprofen and Aleve.  The swelling and pain was better in the morning of the next day.   Forty-eight hours after onset, the hand was essentially back to normal.