chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No concomitant medications were reported.   Company comment-This spontaneous case concerns a female patient aged 28 years with no medical history reported, who experienced the unexpected non-serious AESI of Covid 19 that occurred on an unknown date in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination dates nor event onset date was disclosed. Patient had received initial two doses and a booster dose of same vaccine on unknown dates. No further information on risk factors, detailed clinical course, investigations, treatment received was available in the report. Patient took Paxlovid as treatment. Outcome of the event Covid 19 was unknown at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient aged 28 years with no medical history reported, who experienced the unexpected non-serious AESI of Covid 19 that occurred on an unknown date in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination dates nor event onset date was disclosed. Patient had received initial two doses and a booster dose of same vaccine on unknown dates. No further information on risk factors, detailed clinical course, investigations, treatment received was available in the report. Patient took Paxlovid as treatment. Outcome of the event Covid 19 was unknown at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient was given the vaccine using a 5/8'' needle instead of recommended 1'' needle. Patient plans to return to pharmacy for revaccination.
Fluzone given IM right deltoid 3/27/07. Presents to health department this AM with localized redness and induration of 4 cm. Circular area right deltoid with c/o pain. Able to move arm easily. I to use warm packs and Tylenol - return 3/30 if worse. School nurse also notified to check today and monitor.
3 days post vax pt developed itch over body; P/2 days took DPH (OTC); Itch gone p/2 days; No rxn p/2nd dose;
Pt. stated that injection was painful when administered, & has been sore ever since. It's been one month since inj. She also stated that she thinks I may have injected into her synovial joint. No tx yet.
First, I am unclear of the specific influenza shot I received - there were a number of selections on this site. All I know is that I received the 2019 flu shot. This was my first time receiving the flu shot. I received it at approximately 4:30 pm on 10/10. Up until the shot, my mental health status was normal and I was not experiencing any symptoms of depression or anxiety. By 8:00pm on 10/10, I was experiencing intense anxiety, accompanied by despair, fogginess, nausea, and feelings of dissociation. These symptoms peaked around 8:45pm on 10/10 and slowly diminished over the next day. On 10/12, I felt ?normal? again. The experience was intense and shocking. I went from being completely okay to in a very ?dark? place emotionally within a matter of minutes. 2 days later, my partner who also has depression and anxiety experienced something nearly identical, within the identical timeframe. It wasn?t until she had the same experience that I realized it wasn?t a ?fluke? for me and I decided to report this to hopefully help others be aware of these intense (albeit, temporary) side effects. My understanding is that the 2019 flu shot is different in some ways than previous years, so I?m wondering if these side effects have ever been reported before 2019.
Patient who received expired doses of the Moderna COVID vaccine; Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  As per HCP the vials were set to expire on 12Feb2022 based on the stickers they were putting. The HCP was not sure and did not had the exact expiration date of the vial itself.  No treatment medications were reported.   This case was linked to MOD-2022-491348 (Patient Link).
Felt like I had covid.  Headache, nausea,light headed, hot and could not cool down.  Overall tried.  This was the next day after receiving vaccine.
Low grade fever (101.5) and moderate abdominal cramping for five days. Resolved without treatment.
Immediate dizzyness followed by headache.  Next day slight fever, fatigue, flare up of arthritis, swelling in ankles and by 3rd or 4th day, diarreha.  2nd dose had consult with on site doctor about my lingering symptoms.  Doctor asked me a few questions.  I already had Covid-19 back in January 14th, 2021.  Doctor determined i should be fine.  It got worse.   I honestly felt like i had Covid-19 all over again, only worse beccause I was vomiting the next morninng. I had all the same exact symptoms that I had originally in January, only worse, besides vometing, arthritis flare up, feel like I have carpal tunnel syndrom, couldn't do anything with my right hand for 2 days, and the swelling of ankles/feet and hands. Do not let me forget about the fatigue and shortness of breath.  I feel like i have been hit by a truck.  I even had the fever for 1 day.  It was only around 99, however, I naturally run at 97.7, so 99 is high for me.  Personally, I feel like I received the vaccine too soon after actually having Covid-19.  I am just praying that this arthritis and carpal tunnel symptoms go away.  Oh and the random shooting pains all through out my body.  I am still having that as well and it has been 8 days since my 2nd dose.
pt recvd MMR/Hep B 5FEB92 & on 7FEB93 had 90sec tonic/clonic generalized sz assoc w/fever;
loads of itching, like she had a bunch of insect bites/It didn't start until the middle of the night. She woke up with lots of itching,; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (loads of itching, like she had a bunch of insect bites/It didn't start until the middle of the night. She woke up with lots of itching,) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced PRURITUS (loads of itching, like she had a bunch of insect bites/It didn't start until the middle of the night. She woke up with lots of itching,). On 05-Nov-2021, PRURITUS (loads of itching, like she had a bunch of insect bites/It didn't start until the middle of the night. She woke up with lots of itching,) had resolved.            No concomitant and treatment medication information was reported. The patient had loads of itching, like had a bunch of insect bites. It didn't start until the middle of the night. She woke up with lots of itching, and it kept lasting until yesterday 04-Nov-2021. It was finally going away today 05-Nov-2021.
Pt woke up screaming high pitched, shaking, t104.7 R; crying lasted approx 1hr; called MD who insturcted to give APAP; mom states fever lasted approx 36 hrs;
Mild flu-like symptoms...achiness, slight fever, chills. Began approximately 12 hours after the shot and lasted for about 9 hours.
no additional AE; HCP reported AE on behalf of a patient who was administered expired PNEUMOVAX23 PFS to patien; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not reported.  On 09-NOV-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter (valid lot number W015900 [expiration date 20-OCT-2023]) (dose number, route of administration, frequency, vaccination scheme was not provided) (expired product administered). No temperature excursion (TEs) was reported, no symptoms reported. The healthcare provider (HCP) reported that the physician requested administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) to the patient but the HCP suspected that the patient should have received pneumococcal vaccine conj 20v (crm197) (PREVNAR 20), the HCP confirmed that the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered to the patient, as requested by the physician, the HCP did not make any indication that product confusion occurred as the requested vaccine was administered to the appropriate patient.   No additional adverse event (AE).
Information has been received from a nurse practitioner concerning a 79 year old female with hypothyroidism, hypercholesterolaemia, lupus erythematosus, hypertension, osteoporosis and allergic to "EES" and lisinopril (Refer to WAES # 0809USA01786) and a history of chickenpox in childhood who on 11-JUN-2007 was vaccinated with ZOSTER vaccine live (Oka/Merck), Lot # 657558/0461U, 0.65 mL, in her right deltoid, subcutaneously.  Concomitant therapy included ATENOLOL, LOVASTATIN (manufacturer unknown), SYNTHROID, PLAQUENTL, and RECLAST.  On 25-AUG-2008 the patient experienced shingles.  It was reported that the patient had vesicular rash with more than 20 lesions in her right T4 - T5 dermatome under breast.  The patient had severe pain and had a maxim of temperature of 98.6 degrees.  It was reported that the patient was not exposed recently to chickenpox or herpes ZOSTER, there was no direct fluorescent antibody done and there was no specimen collected for PCR.  The patient sought medical attention, contracted physician's office.  At the time of the report the patient recovered from shingles, but was still being treated with VICODIN and NEURONTIN.  Additional information has been requested.
Chest tightness and shortness of breath especially with exerbation x 2 days. Alert, NAD RR=8 shallow, afebrile, HR 100-104 regular, chest clear to ausc. no wheezes. Cor with SE.
COVID 19 Treatment; COVID 19 Treatment; Dose 3: Pfizer BNT162B2// Dose 1, 2, 4, 5: Moderna COVID-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 20Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 09Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm and on 06Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Oct2021, outcome "unknown", described as "Dose 3: Pfizer BNT162B2// Dose 1, 2, 4, 5: Moderna COVID-19 Vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid on 11Jan2023 to 15Jan2023.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a Medical Assistant regarding a 4 year old patient of unknown gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. There was no concomitant medication reported. On 07-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot number L011080, expiration date 01-OCT-2016, (dose and route were not reported). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sore injection site Light-headed Mild nausea Mild headache General feeling of unwellness
like a pressure on her head, like sinusitis; felt sick; wanted to vomit; chills; fever; felt pain in the arm of the injection; redness; headache; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS DISCOMFORT (like a pressure on her head, like sinusitis), INJECTION SITE PAIN (felt pain in the arm of the injection), INJECTION SITE ERYTHEMA (redness), HEADACHE (headache) and CHILLS (chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: HEPATITIS B VACCINE (last dose of the Hepatitis B vaccine) on 31-Dec-2020. Concurrent medical conditions included Type 2 diabetes mellitus, Cholesterol blood excessive and Blood pressure high. Concomitant products included BIOTIN for Hair loss, OMEPRAZOLE for Skin disorder, EMPAGLIFLOZIN (JARDIANCE) for Type 2 diabetes mellitus, ATORVASTATIN, TELMISARTAN, ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMIN D3 and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 04-Jan-2021, the patient experienced INJECTION SITE PAIN (felt pain in the arm of the injection), INJECTION SITE ERYTHEMA (redness) and HEADACHE (headache). On 05-Jan-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 06-Jan-2021, the patient experienced ILLNESS (felt sick) and NAUSEA (wanted to vomit). On 07-Jan-2021, the patient experienced PARANASAL SINUS DISCOMFORT (like a pressure on her head, like sinusitis). On 05-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, PARANASAL SINUS DISCOMFORT (like a pressure on her head, like sinusitis), INJECTION SITE ERYTHEMA (redness), CHILLS (chills), ILLNESS (felt sick) and NAUSEA (wanted to vomit) had resolved and INJECTION SITE PAIN (felt pain in the arm of the injection) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, COVID-19: positive absent (Positive) Positive twice..     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.   Treatment included Tylenol.; Sender's Comments: This case concerns an adult with PMH of COVID-19 had nonserious unexpected events of paranasal sinus discomfort, illness and expected pyrexia, chills, headache, nausea, injection site pain, injection site erythema. Event onset 3 days after first dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This is a spontaneous report from a contactable pharmacist. A 87-year-old female patient received PREVNAR 13; (NDC number: 0000197102; Lot R45377; Expiry Date: Dec2017), via an unspecified route of administration on 28Nov2016 at 0.5 ml, single on left deltoid  for immunisation. Medical history was none. Concomitant medication included tramadol 50 mg 4x/day, LIPITOR 10 mg daily, omeprazole 20 mg 2x/day, nortriptyline 10 mg 1x/day and buspirone 5 mg daily.  On 29Nov2016 the patient experienced stuffy and mucusy nose; on 05Dec2016 her arm was red around injection site. The outcome of the events was not recovered.
This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted), DIZZINESS (felt faint), PERIPHERAL SWELLING (arm starting to swell up), RASH ERYTHEMATOUS (arm has red patches) and PYREXIA (fever of 102) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced PYREXIA (fever of 102) and HEADACHE (really bad headaches). On an unknown date, the patient experienced SYNCOPE (fainted), DIZZINESS (felt faint), PERIPHERAL SWELLING (arm starting to swell up), RASH ERYTHEMATOUS (arm has red patches) and LYMPHADENOPATHY (glands under arms swollen up). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SYNCOPE (fainted), DIZZINESS (felt faint), PERIPHERAL SWELLING (arm starting to swell up), RASH ERYTHEMATOUS (arm has red patches), PYREXIA (fever of 102), HEADACHE (really bad headaches) and LYMPHADENOPATHY (glands under arms swollen up) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2021, Body temperature: 102 (High) 102. Concomitant medications were not provided.
Newborn began screaming, did not sleep well in first 48 hours kept screaming, difficulty administering tests, at 4 days old began sleeping through feedings, stopped pooping, Uric acid in diaper from dehydration, breathing slowed, heart rate slowed, diagnosed sepsis, no reasons found despite extensive testing on both mom and baby.
Pt is a 75 y.o. male with a history of dementia, CAD, HFrEF, HTN, sick sinus syndrome s/p PPM and recent COVID-19 who presented to medical facility with encephalopathy and a fever. Confirmed COVID-19 positive, met sepsis criteria. Found to have acute dural sinus thrombosis, AKI, hypernatremia. He was transferred to hospital 11/10/2022 for neurology evaluation. Course complicated by acute cholecystitis and need for PCT. Course further complicated by poor PO intake, palliative followed and eventually discharged   1. Acute Dural Sinus Thrombosis: CTH at hospital shows diffuse cerebral venous sinus thrombosis. Hospital CTH unchanged CVST, no intracranial hemorrhage, diffuse ventriculomegaly. CT venogram brain 11/12/22 with stable dural venous sinus thrombosis, possible right frontal centrum semiovale stroke. IV heparin infusion and transition to Pradaxa or Warfarin.  Transitioned heparin gtt to pradaxa 11/20/22. Neurology followed.  2. Acute cholecystitis: Abd pain complaints. CT abd 11/13/22 with acute cholecystitis. Positive HIDA 11/14/22. S/p PCT with VIR 11/15/22, culture NGTD. S/p IV Zosyn. GS followed, OP follow up. VIR recommended PCT exchanges every 2-3 months. 3. Malnutrition: patient with poor PO intake. RD followed. Discussed with wife 11/18/22, would be ok with PEG if intake does not improve. PO intake improved 4. Ventriculomegaly: noted on CTV 11/12/22, out of proportion with sulci, possibly related to advanced dementia vs normal pressure hydrocephalus. Neurology followed.   5. Acute Metabolic on Chronic Encephalopathy: Hx reportedly "advanced" dementia with agiation at baseline. Patient lethargic, weak, and AAOx1 on admit. Admit alcohol, UDS, B12/folate, TSH, RPR, HIV all unremarkable, Ammonia 48. Continued home mirtazapine, quetiapine. Palliative care followed, family wants time limited trial at SNF. Improved 6. Sepsis in setting COVID-19: Presented to hospital with T101.3, tachypnea, tachycardia. Positive for COVID on home test, unknown date. Secondary to acute cholecystitis as above. Hospital resp viral PCR: COVID-19 positive. Admit CXR, UA unremarkable, blood cultures NGTD. Resolved with IV abx as above. 7. AKI on CKD-2: Baseline Cr 0.9-1.2. OLH Cr 2.06, improved with IVF. However, Cr back to 1.6 11/15/22. Improved 8. Chronic HFrEF: Per history. TTE 4/6/22 with EF 44%, moderate AV sclerosis and mild AS, abnormal septal and apical WMA due to conduction abnormality. IVF given above.  9. SSS: s/p PPM.  10. CAD: LHC 2/2021 with DES placed for 90% RCA stenosis. Continued home aspirin, statin.  11. Code Status: DNR-CCA, DNI. Palliative followed, family wants time limited trial at SNF.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unspecified dates approximately in 2015, patients may have received RECOMBIVAX HB lot #: K006825, expiration date: 15-SEP-2016 and lot # reported as K026803, expiration date: 05-DEC-2015 (dose and route of administration were not reported) which were improperly stored at 12.9 Celsius degree for 90 hours on unspecified dates during the time frame of April 2015 to May 2015. There was no known adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received three vaccines (Havrix, Gardasil, Pfizer COVID-19) and passed out while remaining seated for about 5 seconds.  She regained consciousness quickly and was given water.  She remained seated for another 15 minutes with no concerns.  She did note afterwards that she had not eaten anything yet today.  Called the patient 30 minutes later after she left store and she was feeling back to perfectly normal.
I felt perfectly fine until day 5 Ever since I feel very dizzy like motion sickness and nauseous most of the time. I am very nervous this will never go away. I get hot and flushed and then that goes away and I'm chilled with goosebumps. I feel ill most of the day