chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid-19; very sick (Dose 2: 23-OCT-2022; Covid-19 positive:10-FEB-2023); Covid-19; Got very sick; This non-serious, initial spontaneous safety report was received by Novavax on 19-FEB-2023 from a consumer via the customer experience center.  A female of an unspecified age and race was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 1 and dose 2 on unspecified dates.  It was reported the individual was very healthy and not immune compromised at all; no additional medical history was reported.   No concomitant medications were reported.  On an unspecified day in FEB-2023, after vaccination (about a week prior to reporting), the individual experienced Covid-19; very sick (PT: COVID-19). It was reported that the individual was not hospitalized but did go to the emergency room where she worked.   At the time of reporting, the event outcome of COVID-19 was unknown.  Lot number was not provided in the report.  On 21-FEB-2023, significant additional information was received from a consumer. The consumer reported the dates she received Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 1 as 24-SEP-2022 and dose 2 as 23-OCT-2022 at a pharmacy. The lot number for both doses were reported. Additionally, the individual provided the following lab test: SARS-CoV-2 test (Result: Virus detected; 10-FEB-2023). After additional information about the timeline of events was reported, the PT: COVID-19 was changed to PT: Breakthrough COVID-19. On 10-FEB-2023, the individual experienced covid-19(PT: Breakthrough COVID-19), and they got very sick (PT: Illness) on an unspecified date in FEB-2023. Therefore on 24-SEP-2022, the individual experienced covid-19 (PT: Vaccination failure). At the time of reporting, the event outcomes of Breakthrough COVID-19 and Illness were unknown and Vaccination failure was recovered/resolved and event stop date was 24-SEP-2022. No other additional information was reported.  On 03-MAR-2023, a significant case correction with Day 0 of 19-FEB-2023 was identified. The following information was updated: The event Vaccination failure was updated to be serious (Serious: Medically Significant) and this case was upgraded to serious. The reporter causality was updated to Related' and the onset from last dose' for the event Vaccination failure was updated to be 1 day.; Sender's Comments: This 56 year-old female experienced: Vaccination failure, Breakthrough COVID-19 and Illness after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Vaccination failure was assessed as serious. The events Breakthrough COVID-19 and Illness were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
AE: HSV-1 outbreak. Painful sores all over mouth (tongue, palate, lips, gums). Low-grade fever, swollen lymph nodes, night sweats Treatment: Valacyclovir starting at day 7 of symptoms, Magic Mouthwash for pain to enable eating and drinking. IV fluids to prevent dehydration. Outcome: Ongoing
Started to have weird body weakness sensation associated with mild nausea when I lay down at night.  Almost every night.  As soon as I lay flat. Comes in waves. Causing me having problems falling asleep.   Also happens when I tried to fall back to sleep.  Mostly when I am about to fall asleep.  During the day I am ok if I am upright.  No fever or other symptoms.  Getting insomnia from it every night.
pt recv vax;devel fever;very fussy;tx w/ apap x 2 days;fever subsided;reappeared 9jul, red fine rash appeared on face,stomach & back,neck region;child also has had 1 loose stool;since 3jul MD has been contacted;
less raised but oddly hot and itchy; less raised but oddly hot and itchy; less raised but oddly hot and itchy; the injection site became red and swollen (half dollar size); fatigued; the injection site became red and swollen (half dollar size); the injection site became red and swollen (half dollar size); This is a spontaneous report from a contactable consumer. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 21Apr2021 as (At the age of 49-years) DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that a 49-years-old female patient received her 2nd PFE covid vaccine yesterday. On 22Apr2021 patient experienced in the morning the injection site became red and swollen (half dollar size) and she had fatigued, On 24Apr2021 less raised but oddly hot and itchy. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
SWOLLEN GLANDS; This spontaneous report received from a consumer via Pfizer on 09-JUL-2021 and concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced swollen glands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen glands. This report was non-serious.
Patient is a 85 y.o. female admitted to the hospital on 10/21/2022 for COVID-19.    Discharge Diagnosis and Associated Hospital Course   Acute respiratory failure with hypoxia, resolved  ? Likely due to COVID-19 pneumonia ? Oxygen saturation on 86% on room air at presentation, currently 96% on RA   COVID-19 infection ? Symptoms started approximately a week prior to arrival and progressively worsened over the last 3 days prior to admission ?Positive COVID-19 screening test on 10/21/2022 ? Vaccinated and boosted.  Last vaccine 9/29/2022 ? Chest x-ray does not show any definitive infiltrate ? Currently saturating 96% on RA ? Steroids: Decadron 10 mg daily, home on prednisone burst given underlying bronchiectasis  ? Antiviral: Remdesivir received one dose, no further doses needed as she is much improved and no longer requiring oxygen  ? DVT prophylaxis: Lovenox   Essential hypertension ? Chronic and stable ? Continue home metoprolol, triamterene?hydrochlorothiazide, amlodipine   Mild persistent intermittent asthma ? Fairly well controlled ? Compliant with home Advair and rescue inhaler ? Continue home inhalers  Diabetes mellitus type 2 with CKD stage III ? Chronic and stable ? Hemoglobin A1c 6.4 ? Compliant with home metformin ? Hold metformin ? Continue insulin sliding scale and diabetic diet ? Monitor blood glucose closely in the setting of steroids   Chronic kidney disease stage IIIa ? Creatinine remains stable at around 1.1 ? Avoid nephrotoxic agents and renally dose medications as appropriate ? Recommend continued outpatient follow-up with PCP Hyperlipidemia ? Continue home statin   History of bronchiectasis ? Uncomplicated - discharged with steroid taper as above    GERD without esophagitis ? Continue home PPI
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored VAQTA (lot # M021124, expiry date: 02-FEB-2018) (route: intramuscular). The vaccine was stored at a temperature of 32 F for 15 minutes and at 31 F for 15 minutes. There was no previous temperature excursion. Digital data logger was involved. No symptoms were reported. The outcome of the events was unknown. This is one of the three reports received from the same reporter. Additional information has been requested.
Symptoms started to show after 6 hours from having vaccine administered.  Patient had stiffness (unable to sit back down from standing position), blank stare, depressed breathing and fever.  Transferred to ER, seizures were witnessed.  IV Keppra was initiated. Patient was discharged after 2 days and followed up with primary care provider in clinic.  Primary provider documented that cellulitis is noted in right arm and antibiotic has been initiated.
Rash presenting one week later at injection site, approximately 4 inches by 5 inches. Red, itchy, hard.
Pt recv vax on 9/9/98; subsequently pt exp flu-like sxs w/ fever, head &chest congestion for 2 wk.
Administered at 130pm, report completed per HR dept. 314pm. Staff reported Heart racing, throat swelling, chest tight, and hard to breath. Witness reported actively wheezing and face was red. Went to Employee Health Doctor, followed up by ER visit. Has not returned to work as of 03-31- reported will have ER doctors note upon return.
Dizzy during observation period immediately after vaccine administration during occupational vaccine drive.  Then the patient still decided to go back to work.  Upon going back to work was noted to be flushed in the face.  And was noted to have high blood pressure.  Ultimately was sent to on-site ER for evaluation.  Upon questioning, unclear if patient ate or drank prior to administration.
Expired vaccine used; 0.3 ml administered as booster; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and OVERDOSE (0.3 ml administered as booster) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 047B21A and 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Dyslipidemia (start date of dyslipidemia was in 2022) and Depression since 2020.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .3 milliliter. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and OVERDOSE (0.3 ml administered as booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and OVERDOSE (0.3 ml administered as booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown that, the patient was tested positive for COVID-19 or not. No concomitant and treatment medications were reported. No adverse event was reported and the patient did not seek any medical care.
He is now experiencing injection site reactions: lump, warmth and pain; He is now experiencing injection site reactions: lump, warmth and pain; He is now experiencing injection site reactions: lump, warmth and pain; This is a spontaneous case from, initially reported by other health professional to agency (reference number: SEQ19-05067) on 18-Oct-2019 and additional information received on 21-Oct-2019 (being processed together), concerning a male patient of unspecified age.  The patient's medical history and concomitant medications were not reported.  On 16-Oct-2019, the patient was administered Afluria Quadrivalent [influenza vaccine; dose, batch number, expiration date, route of administration and anatomical location: not reported] for unknown indication.   On unspecified date at Oct-2019, the patient experienced injection site reactions: lump, warmth and pain. No further details were provided.  At the time of initial reporting, the patient had not recovered from the events.  The case was assessed as non-serious.  The reporter did not provide causality assessment.  Company comment: The patient experienced vaccination site warmth, vaccination site mass and vaccination site pain after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site mass and vaccination site pain after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Within 15 min of receiving the 2nd shot of the Pfizer COVID vaccination, I was extremely dizzy. The dizzy spells have continued off and on to present. Within 1 hr of receiving the vaccine, I had terrible joint pain in all my joints and got and continue to get severe muscle cramps especially in my legs and cramps in my toes and ankles, and fingers as well.  I also have muscle weakness that developed at that same time and continues.  I can no longer walk upstairs without pulling on railing for assistance or setting clothes basket (for example) on each step and using it like a walker for assist. I was told body aches were "normal" but would pass. This has all persisted for a little over a year with no improvement and worse at times.  I did not have these issues until I got the 2nd COVID injection. Just recently told by my Dr to report it.  I have not taken any of the booster shots due to continued issues since the original 2nd injection.  I was required to get the COVID vaccine to keep my job.
Itching hands, arms, and neck. Benadryl 50 mg given - no relief with meds after 40 minutes. Sent to ED for evaluation.
somewhat hard; redness; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (somewhat hard), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE INDURATION (somewhat hard) and VACCINATION SITE SWELLING (swollen). 18-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (somewhat hard), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swollen) outcome was unknown.            Concomitant products was not reported by the reporter.   This case was linked to MOD-2021-018417 (Patient Link).
Arm was black and blue; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Arm was black and blue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN, ATORVASTATIN, METOPROLOL, METFORMIN and LEVOTHYROXINE.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced SKIN DISCOLOURATION (Arm was black and blue). At the time of the report, SKIN DISCOLOURATION (Arm was black and blue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
A non-serious spontaneous report of administration of FLUMIST to a 53-year-old female was received from a patient/consumer. Neither relevant medical history nor concomitant medications have been reported for this patient. There was no adverse event associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.
Moderna Vaccine given at age 17.  No medical adverse reactions.  Boost dose given 4/27/2021.  Parent aware.
partial dose; syringe was faulty; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jul-2021 and was forwarded to Moderna on 20-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (partial dose) and DEVICE CONNECTION ISSUE (syringe was faulty) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, 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 experienced UNDERDOSE (partial dose) and DEVICE CONNECTION ISSUE (syringe was faulty). At the time of the report, UNDERDOSE (partial dose) and DEVICE CONNECTION ISSUE (syringe was faulty) outcome was unknown.            Concomitant product was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Rash 3 inches below injection site that resembles shingles.  Also rash between fingers and on forearm developed over the next two days on the same arm as the one that received the injection.
Sinus congestion; Flu like symptoms; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUS CONGESTION (Sinus congestion), INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In September 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache). On an unknown date, the patient experienced SINUS CONGESTION (Sinus congestion). In 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, SINUS CONGESTION (Sinus congestion) and HEADACHE (Headache) was resolving.            Concomitant medication was not reported.  In Sep-2021, the patient experienced severe headaches after took Moderna vaccines both times and flu like symptoms after Moderna vaccines. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Pt received Pfizer Covid 19 vaccine 7 days prior to scheduled second dose due to a miss calculation on timing. No treatment or symptoms reported.
Stuffed Ear (Clogged); Stiff Neck; Achy; Chills; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff Neck), PAIN (Achy), EAR DISCOMFORT (Stuffed Ear (Clogged)), CHILLS (Chills) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN (Achy), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). On 17-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff Neck) and EAR DISCOMFORT (Stuffed Ear (Clogged)). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. On 16-Feb-2021, PAIN (Achy), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff Neck) and EAR DISCOMFORT (Stuffed Ear (Clogged)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reported.
Fainting; This case was reported by a physician via sales rep and described the occurrence of fainting in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   In July 2019, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. In July 2019, less than an hour after receiving Bexsero, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the fainting was unknown.   It was unknown if the reporter considered the fainting to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero sometime in the last week from the reporting date. The patient fainted after vaccination of Bexsero. The reporter stated that, a protocol was made in place to make patients wait at least 15 minutes following vaccination due to this event. This case has been linked to US2019133846, reported by the same reporter.
About 3 hours after the injection, I began to feel like my asthma was acting up and felt itchy on my face so took my inhaler and a zyrtec, which helped.  Then 8 days after the shot, I got a raised, firm, red, and extremely itchy circle around the injection site. I contacted my doctor who advised antihistamine. I took another zyrtec,  This lasted for about 48hrs and now (4 days after it began) it is still a bit itchy, but not visible anymore.
Case number PHEH2014US024788, is an initial spontaneous report received from a medical assistant on 09 Dec 2014, with a follow up report received from the medical assistant on 09 Feb 2015. This report refers to a 67-year-old female patient. Historical condition was not reported. Concurrent conditions included diabetes, hypercholesterolemia and hypothyroidism. No concomitant medication was reported. She was vaccinated only with the MenCYW-135 liquid component of MENVEO (batch number: X14041) without being reconstituted with MenA, intramuscularly in left deltoid on 09 Dec 2014 at around 1:30 PM. Patient did not experience any adverse event following this administration error. Follow up report received from the medical assistant on 09 Feb 2015: Updated patient demographics, vaccination details and reporter's statement in the narrative.
Approx. 12 small blister-type lesions, possibly modified chickenpox.
Arm pain (aside from pain at injection site). Patient states 1 month of arm/bone pain. Has sought medical treatment at 2 facilities and will go to an orthopaedist soon.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/23/21, 3/2/21, and 10/27/21. PMHx CKD4, renal transplant, AF, DM2. Presented 12/17/21 for hemoptysis, SOB and AMS. Admitted for heart failure, COVID-19, pulmonary edema, acute on chronic CHF & acute on chronic renal failure. On 12/21/21 transferred due to worsening renal function, intubated 12/26/21 c/b L pneumo. Tx'd w/dexamethasone, diuretics, and antibiotics. Expired 12/31/21. Patient's respiratory status declined requiring intubation on 12/26/21. Patient subsequently became hypotensive requiring multiple pressors and family ultimately decided to withdraw care. Code status changed to DNR-AND and the patient passed away at 00:48 on 12/31/21.