chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse effects reported; The patient received improperly stored vaccine; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.    On 21-NOV-2019, the patient was vaccinated with improperly stored dose (product storage error) of Hepatitis A Vaccine, Inactivated (VAQTA) lot number S009943, expiration date 26-JUL-2019 for prophylaxis (dose and route of administration was not reported). There was no additional adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 Fahrenheit (°F) /9 Celsius (°C) (51.8 °F) degrees Fahrenheit  for 1 hour 25  minutes. Data logger was involved. There were no previous excursions reported.
Severe menstraul bleeding and cramping for over 4 days when I am entering menopause and I do not have a menstraul cycle (or if I do it is very light and lasts 1/2 a day.
Vaccine was stored in the freezer for 19 days, instead of 14 days. The vaccine was supposed to be removed from the freezer on 5/27 and placed in the fridge however it was not and was stored in the freezer and given to the patient.
Fatigue,  chills, headache,  pain at injection site, nausea, body aches
Pt complained of body aches, teeth aching, sore arm, pain going up neck, and not feeling well. Fourty-eight hours after she received the shot she developed fluid filled blisters along her right leg.
itchy today is worse is up and down arm; rash in both arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy today is worse is up and down arm) and RASH (rash in both arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced RASH (rash in both arm). On an unknown date, the patient experienced PRURITUS (itchy today is worse is up and down arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash over arms and Itching, at a dose of UNK dosage form. At the time of the report, PRURITUS (itchy today is worse is up and down arm) and RASH (rash in both arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  10/12 hours later the vaccination, started a rash in both arm, mentioned it was itchy; today was worse up and down arm.
3-4 hours after vaccines - uncontrollable crying, turned red then went limp, unresponsive & movements, x3 times. Ok after TYLENOL.
left arm injection site swelling & redness started to get bigger by the end of the night of 3/11/2022 Narrative:
Eyes swelling; Face swelling; Runny nose; Hot at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eyes swelling), SWELLING FACE (Face swelling), RHINORRHOEA (Runny nose), INJECTION SITE WARMTH (Hot at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine. Concurrent medical conditions included Anxiety and Depression.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced EYE SWELLING (Eyes swelling), SWELLING FACE (Face swelling), RHINORRHOEA (Runny nose), INJECTION SITE WARMTH (Hot at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) for Allergy, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency. On 31-Dec-2020, EYE SWELLING (Eyes swelling) and SWELLING FACE (Face swelling) had resolved. At the time of the report, RHINORRHOEA (Runny nose), INJECTION SITE WARMTH (Hot at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant  medication includes antianxiety , depression and migraine medication .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Vaccinations received 14-Jan-2021, 04-Feb-2021, 05-Oct-2021, and bivalent 19-Sep-2022.  Symptoms began 14-Nov-2022; first positive test 16-Nov-2022.  Symptoms included severe sore throat for 5 days; sporadic phlegmy coughing for 12 days; laryngitis for 2 weeks.  Tested positive until 27-Nov-2022.   Used Tessalon Perles (Benzonatate) for cough; Mucinex for congestion.   Doctor refused to prescribe Paxlovid due to kidney damage concerns (potential side effect).
At 08:22, post vaccination, patient c/o heart palpitations, radial HR 103. 08:23 ice pack placed on neck, apple juice and water given to patient. 08:25: B/P 148/86. Patient c/o mild SOB but no obvious respiratory distress. 08:27 HR 92/irregular and offered EMS but he declined. 08:34 continued to be monitored. Reporter had patient perform slow, deep breaths to attempt to slow his heart rate; also offered EMS, but patient declined. 08:45 HR 80/regular. 08:47 B/P 126/78, asked patient to wait 10 more minutes to monitor patient. 09:00 patient states he felt better and left site. RN made aware.
Wed. pm started with swelling at site of injection. Thurs. am at 08:30 site of injection size of quarter. Red and hot to touch. Fri. am at 09:00, pt had joint pain, body ache, HA, no energy. Sun. 03/01/2003 pt Sx resolved by afternoon and site of injection no longer swollen.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. Vaccine was in thaw state (2 to 8 degree Celsius) from about 24-Dec-2021. Dose was given at 06-Feb-2022 09:41:39  No treatment medication was reported by reporter.
PT PRESENTED TO THE OFFICE THE DAY AFTER THE VACCINE WAS GIVEN. PT HAD A RED AND TENDER LEFT THIGH WITH PAPULES EXTENDING DOWN THE LEFT LEG. TREATED WITH PREDNISOLONE, HYDROXYZINE AND TRIAMCINOLONE CREAM. FOLLOWED UP IN 1 DAY.  PT HAD SWELLING AND ENDURATION WITH PAPULES, ERYTHEMA AND WARMTH TO THE AREA IS SLIGHTLY WORSE. PT IS TO FOLLOW UP IN 3 DAYS
Patient complained of feeling dizzy about 5 minutes after 2nd dose of Pfizer. She sat next to a nurse. Blood pressure 91/43. Suddenly patient was unresponsive. Assisted to the floor, feet elevated. Doctor on call arrived. Second blood pressure 108/64. Patient became verbally responsive. Transferred to the doctors office via gurney for further observation. Discharged soon with her husband  after when her symptoms resolved.
Lymph nodes under Right arm swelled and it was painful down my whole arm.  Swelling and pain was even into the right side of my breast.  I also had some loose stool.  These lasted about 2 weeks.  I used ice packs under my arm and on my breast and that helped quite a bit.  The swelling went down a bit every day but was still a bit painful.  I still have a bit of pain but nothing extreme like before.  I had no fever, nausea, or pain in any other part of my body.
6PM became irritable, uncontrollable crying 10PM episode lethary, elevated temp;
TIA 3/16/2021 and moderate stroke on 3/18/2021 resulting in ischemic area left temporal and occipital lobe. Injury affecting speech, memory, and cognitive abilities.  unable to live independently as prior to the event.
presented to ED with seizure due to hypoglycemic coma;  hx of type 2 diabetes, CVA; experienced fever, positive COVID test; pneumonia due to COVID, with hypoglycemic coma and secondary acute hypoxemia respiratory failure
Information has been received from a nurse concerning a 48 year old disabled male patient, with asthma and  an allergy to methotrexate, who on Jan 6, 2003 was vaccinated intramuscularly into the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (lot#644217/1026M). Concomitant therapy included albuterol "nebulizations", albuterol (Ventolin), lansprazole (Prevacid), MgCl (Slow-Mag), potassium chloride (Klor-Con), prednisone, fluticasone prpionate and salmeterol xinafoate (Advair Diskus) and sucralfate (Carafate). It was reported that the patient developed a large, red, swollen area at the injection site on Jan 8, 2003. On Jan 09, 2003 the patient came to the office complaining of an injection site reaction. According to the reporting, the patient had a large, swollen, red area at the injection site (3.5 - 4 inches in diameter) which was painful and itchy. Patient did not have a fever and was diagnosed with cellulitis. Subsequently, the patient was started ontherapy with cefprozil (Cefzil) 500mg twice a day for 10 days. The patients symptoms resolved after approximately 2 weeks. Additional information from a registered nurse indicates that she did not think that the event would have resulted in death, a life threatening illness, hospitalization, or a significant disability if left untreated. Additional information is not expected.
Patient had flu vaccine and watched her for 15 minutes since she had history of syncope with her 11 years vaccines. Patient was trying get up in the bed and felt dizzy, looked very pale, back to bed and never loss the consciousness. Checked HR and BP, HR dropped to 40s for few second with weak pulse. BP at 80/60s, called 911 and but the HR back to 50s and skin color back and BP stayed 80/60s, so cancelled the 911 call. Watched the patient for next 30 minutes . HR back to 60-70s and BP stayed 80/60s. Denies any nausea but did complaint about stomach pain.  Patient left the clinic with Mother.
This spontaneous report as received from a nurse refers to a 6 month old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-MAY-2015, the patient was inadvertently administered the first dose of oral, ROTATEQ (strength, dose, route and lot number or batch number unspecified) (inappropriate schedule of drug administration). No concomitant medication was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. The outcome of the event was unknown. The reporter's causality for the event was unknown. Additional information has been requested.
I peed out blood; I haven't had period in over a year; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A patient of unspecified age and gender received 1st dose of bnt162b2 (Pfizer BioNTech COVID-19 Vaccine, Lot Number: EW0183; Expiration Date: 31Aug2021), via an unspecified route of administration on 13Aug2021 as Dose 1, Single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced peed out blood; not had period in over a year on 15Aug2021.Consumer was provided with the number of Pfizer Medical Information Department was requested to select option 3, timings as 8 am to 8 pm on Monday to Friday as per EST. When asked for reporter, it was stated as cardiac technician (Further not clarified hence captured as consumer or other non-health care professional in tab). Consumer was informed to file a safety report as the consumer experienced side effect after receiving the vaccine. Further probing could not be done as consumer was unwilling to share any further information. Hence, limited information was available over the call. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected
Hospitalization for shortness of breath due to COVID-19 on dates 11/8/22- still hospitalized. Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Adverse event was ring shaped hives on the abdomen that lasted for four weeks, they gradually fade away during this 4 week period without any treatment.
This spontaneous retrospective pregnancy report as received from an approximately 19 year old female patient with no drug reactions or pertinent medical history. The patient was vaccinated with the first dose of GARDASIL (Lot # and route not reported) in the upper left arm in August or September 2012. There was no concomitant medication. The patient found out she was pregnancy after the administration of the vaccine. The patient did not receive the 2nd and 3rd dose of GARDASIL. The patient did not suffer any adverse effects, and was reporting the event only at the time of reference point upon advisement from her current pediatrician. The patient had a successful pregnancy and delivered on 25-MAR-2013. The patient's LMP was approximately on 18-JUN-2012. The patient didn't seek medical attention. No treatment was given. No lab diagnostics studies were performed. At the time of reporting, the patient felt fine. Additional information has been requested.
complaints: dizziness BP: 131/71 HR: 76 Sp02: 95%  Reports feeling better 10min later, refused transfer to ER for further eval. Patient appeared stable Seen and cleared by EMS
pt recvd vax 21JUN91 & 24JUN devel low grade fever & redness around inject site; no limping;
they found yellowish fluid which they thought was an infection, ear pain in his right ear, slight dizziness; overall had manageable energy level to work and appetite; flu-like symptoms; stomach problems; slight diarrhea; sweating; spent more of the day sleeping; had no appetite just drinking fluids; nausea; chills; experienced hearing loss in his right ear; soreness; A Spontaneous report from was received from a Healthcare professional, concerning a 65-year-old male patient, who received Moderna's COVID-19 vaccine experienced multiple symptoms.  Patient had a history of cholesterol and high blood pressure. It was reported that patient used Lipitor, Fish oil, cholesterol medications and high blood pressure medications as concomitant product.  On 01Feb2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (unknown lot number) via unspecified route on left arm for COVID-19 infection prophylaxis.  On 02Feb2021, within 24 hours, he had right ear pain and following day, he developed hearing loss, slight dizziness but overall had manageable energy level to work and appetite. On the 04 FEB 2021, he had flu-like symptoms, light headed, G.I discomfort, nausea, slight diarrhea, sweating, chills, with continuous hearing impairment, spent most of time sleeping, had no appetite and was just drinking fluids. Next few days slowly gained energy and appetite back.  On the 08 FEB 2021, felt really uncomfortable in his ear, still feeling nausea. At urgent care to yellowish discharge from the  ear was assumed as infection and treated with Amoxil and Flonase. He recovered the flu-like symptoms except his hearing loss. He was referred to an ear specialist by primary to evaluate the hearing loss.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was considered to be unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Had chest pains and tinnitus after the 12/15/2021 shot. Visited doctor. No treatment recommended. Moderna 037B21A 4/08/2021; Moderna 006C21A 5/06/2021; Moderna 069H21A 12/15/2021.
pt developed SIRVA per patient - ended up going to urgent care next morning on 9/29/23 around noon
About 4 months after the first Shringrex vaccine on 2/24/20 had more joint pain than normal.  Received the 2nd dose of Shringrex in 8/26/20 & about 10 days later had severe shoulder, hip, & neck pain so much that I could not get out of bed & couldn't left my arm to dress myself.  Was later diagnosed with Polymyalgia Rheumatica & prescribed Prednisone. Still trying to taper but keep getting flare ups.
08/10/2021 that night I had a serve headache, nausea, upset stomach for three days 08/11/2021 sinus inflammation.
Sharp Headaches, Short Term on left side of skull above the ear. Duration of events last about 10 to 15 seconds. Can not determine any triggers to innate. Events come any time. from a few a day to none for a few days.
4/24/03 am mom reported redness & swelling at site.  Advised with standard comfort measures to use & call back PRN.  On 4/25/03 pm mom reports more pain @ site, more redness & "bullseye" configuration at site.  Mom says she called PMD (Primary Care Center) advised to go to hospital ER.  child treated at ER with po prednisone, RX given for Amoxil 250mg/5ml & motrin & Benedryl every 6 hours.
Within 24 hours of  receiving  the second dose my right arm was very swollen, with a red ring around injection site. The muscle was very swollen compared to my left arm and very painful. Within 48 hours I noticed hives on my chest, stomach, upper and lower back, and shoulders. It has been over a week since the shot and I still have the body rash. It has not diminished in appear all. The hives do not itch though.  Injection site continues to itch on right arm. I have applied hydrocortisone and took over the counter Benadryl a few times and rash is still present.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  TRANSIENT CEREBRAL ISCHEMIA ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY
ITCHING ON FACE, CHEST, ARMS. THROAT FELT TIGHT, AND CHEST TIGHT, TONGUE NUMB. PATIENT RETURNED TO THE ER THE SAME EVENING COMPLAINED OF SHORTNESS OF BREATH, TIGHTENING IN THROAT. VACCINE ADMINISTERED WAS GARDISIL (HPV) MFG MERK
Pt recv vax on 1/11/99; on 1/15/99 pt exp pruritic rash on arms, anterior chest, groin to knees & back x 2.5 wk; tx=Benadryl
sleepiness; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious), outcome "recovered" (reported as no more than 3 days), described as "sleepiness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101333935 same reporter/drug/AE, different patient; INC-202101333934 same reporter/drug/AE, different patient
No additional adverse events reported; Caller reports that PNEUMOV AX 23 was given to a 2 month old in error/ Caller reports that PREVNAR 13 was intended to be given to the patient and that this error occurred due to miscommunication; This spontaneous report was received from a medical assistant, referring to a 2-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 11-AUG-2021, the patient was vaccinated in error with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number T020639 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent) prefilled syringe, expiration date reported and upon internal validation established as 13-MAR-2022) as prophylaxis, however, the reporter stated that pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) was intended to be given to the patient and that this error occurred due to miscommunication (wrong product administered). Additionally, the reporter was inquiring about the contraindications to the use of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in this population. No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T020639; expirationdate: 13-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
I have had severe pain in my shoulder and can't move my arm away from body.  I think my shot was given up to high; it was near top of shoulder.
Rash on face and under eyes (cheek area) noted 2 days after vaccines were given. 3/9/14 seen by PCP, no treatment, rash was gone.
Patient received a dose of Moderna vaccine at the age of 17 years.  The dose was administered to a patient that was ineligible.   No adverse events were reported, but an administration error occurred.
This spontaneous report as received from a medical assistant refers to 16 unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored PROQUAD lot # M001152, expiry date: 05-JUL-2017 (also reported as 05-JUL-2107), (dose#, route and site of administration not reported). Concomitant medication was not mentioned. No adverse effects were reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the six reports received from the same reporter.