chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After patient received Pfizer covid vaccination she sat down in the observation area. Patient's boyfriend inform pharmacy staff that she felt sweaty, dizzy and light headed. 911 was called but patient refused medical attention. Patient felt better in minutes and after 30 minutes patient went home
A report was received from a health care professional on 12/11/03 concerning 2 or 3 vaccinees of unknown sex and less than 4 years of age who inadvertently received Fluvirin on 12/8/03. On 12/8/03, 2 or 3 vaccinees inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Second dose received on day 21 after the first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received on day 21 after the first dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A and 028K21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received on day 21 after the first dose). On 27-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received on day 21 after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
Patient developed a swollen arm the morning after the shot was given and it spread to entire arm and neck. A knot formed on neck and spiked a fever. Has been 48 hours since vaccine and has not improved. Recommended that she reach out to PCP.
a patient received a dose of Flublok instead of Fluzone Quadrivalent/ No AE; A 11 years old patient received a dose of FLUBLOK QUADRIVALENT vaccine/ No AE; Initial information was received on 18-Sep-2020 regarding an unsolicited valid non-serious case from nurse. This case is linked to cases 2020SA258133 and 2020SA258275.  This case involves an 11 years old female patient who accidentally was administrated with a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot UJ455AAA, expiration date: 17-Mar-2021) via unknown route in left deltoid on 17-Sep-2020 for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered & product administered to patient of inappropriate age).  Medical history, past medical treatments, past vaccinations and family history were not provided.  No concomitant vaccines was given to the patient.  This was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Severe local erythema, swelling and pain within 24 hours of vaccine. Worsening with right thigh axillary tenderness and lymph node enlargement.
C/O redness and itching at site. Denies any SOA or itching elsewhere. Monitored for approx 1 hr. Pt called and mom is coming to pick her up after calling pediatrician.
Cough; nausea; muscle soreness; tiredness; sore throat; weak; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 29Mar2021 at 14:00 (at the age of 21-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient had no known allergies. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN) from an unknown date to an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 16:00, the patient experienced cough, nausea, muscle soreness, tiredness, sore throat and weak. Therapeutic measures were not taken as a result of the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, emergency room/dep artment or urgent care. The clinical outcome of the events cough, nausea, muscle soreness, tiredness, sore throat and weak was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: updated lead statement and medical history data.
like somebody punched them in the arm/felt the same thing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (like somebody punched them in the arm/felt the same thing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (like somebody punched them in the arm/felt the same thing). At the time of the report, VACCINATION SITE DISCOMFORT (like somebody punched them in the arm/felt the same thing) had resolved.            No concomitant medications were reported.  After the booster patient felt the same thing like somebody punched them in the arm and it cleared up in 3 - 4 days.  No treatment medications were reported.   This case was linked to MOD-2022-522811, MOD-2022-523033 (Patient Link).
THROAT DEVELOPED A TICKLE, 4 HOURS LATER THROAT FELT ITCHY, RASPY VOICE. EVALUATED IN AN CARE SETING. EPI SHOT GIVEN, IV MEDS, AND A PRESCRIPTION SENT WITH THE INDIVIDUAL.
"Covid arm": Swollen, red and itchy. Iced site, took Tylenol
5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date) in a 51-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 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date). On 19-Jan-2022, EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 16 Dec 2021 vial was initially stored in the refrigerator. The Moderna Covid-19 Vaccine was given past the beyond use date of 15 Jan 2022. The vial did not undergone any temperature excursions.  No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
This spontaneous report as received from a Medical Assistant who refers to multiple unknown patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were administered multiple unspecified vaccines of improperly stored doses of VAQTA lot # M001815, expiration date 20-SEP-2017 (dosing details were not reported), GARDASIL 9 lot # M007764, expiration date 30-JAN-2018 (dosing details were not reported) (refer to MARRS # 1611USA000221 and RECOMBIVAX HB lot # M001578, expiration date 21-NOV-2018 (refer to MARRS # 1611USA000222) and lot # M010212, expiration date 21-JAN-2019 (refer to MARRS # 1611USA000223) (dosing details were not reported). The vaccines were exposed to temperatures ranging from 33F to 35F for cumulative total time frame of 72 hours out of recommended storage range. There were no previous excursions reported. The data logger was reported as yes. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Vaccine was mixed with  0.9% sodium chloride, however 1.6 mL was used instead of 1.8mL. Vaccine was too concentrated by 0.2mL
Feel dizzy; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Feel dizzy) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.  On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 10-Feb-2021, the patient experienced DIZZINESS (Feel dizzy). On 10-Feb-2021, DIZZINESS (Feel dizzy) had resolved. Not Provided    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.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the 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.
7/7/21 Fever of 101.2, swollen of upper and lower lips - Called UCM , I was prescribed Prednisone. 7/8/21 No fever, swelling of lips subsided ,  had swollen of face ( both checks and around the eyes) , called UCM , changed Prednisone to MethylPrednisone (I finished the last dose on 7/13) and added Benadryl 50mg 4x a day.
Redness noted around and below injection site aprox 17cm X 26cm (at longest length). Hardness noted at injection site aprox 7cm X 12cm.  Advised to apply cold compresses and oral Benadryl. Pt to notify MD if redness enlarges area, swelling/pain/heat at site, or fever of 100.5 or greater. Pt verbalized understanding.
2nd dose given less than 21 days after 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given less than 21 days after 1st dose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given less than 21 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given less than 21 days after 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   MD told patient to get 3rd dose  Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
Patient reported itching throat altered sensation in mouth and throat. Benadryl 25 mg administered. reassessed half hour later. Patient was fine and able to drive home. no shortness of breath nor respiratory distress.
Pt received dose 1 of Pfizer covid vaccine, and immediately upon trying to stand, experienced lightheadedness and said her vision blacked out briefly.  She then stated she had lip numbness and lower face numbness.  Pt further stated her BP sometimes drops rapidly and causes her to pass out, but she never experienced it with a vaccine previously.  Pt requested Gatorade and was monitored for 30 minutes, at which time she stated she was fine, and left with spouse.
Blowing his nose a lot; Sore throat; Soreness in his injection site; Malaise feeling; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Malaise feeling), NASAL CONGESTION (Blowing his nose a lot), OROPHARYNGEAL PAIN (Sore throat) and INJECTION SITE PAIN (Soreness in his injection site) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included COVID-19 in January 2022 and COVID-19 in May 2022. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1) on 02-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2) on 29-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE (Dose 3) on 17-Nov-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Drug allergy (sulfa).    On 29-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-May-2023, the patient experienced MALAISE (Malaise feeling), OROPHARYNGEAL PAIN (Sore throat) and INJECTION SITE PAIN (Soreness in his injection site). On an unknown date, the patient experienced NASAL CONGESTION (Blowing his nose a lot). On 03-May-2023, OROPHARYNGEAL PAIN (Sore throat) had resolved. At the time of the report, MALAISE (Malaise feeling) and INJECTION SITE PAIN (Soreness in his injection site) had not resolved and NASAL CONGESTION (Blowing his nose a lot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Patient had COVID twice. Both times it started with a sore throat. The last time patient caught COVID and tested negative at the hospital at the emergency room. Patient called his doctor two months later. They did an antibody test, and the doctor told patient had COVID two months ago. Patient had to see neuro because of the side effects from the second time he caught COVID. Patient had all kinds of side effects. The patient states didn't had any side effects from Pfizer doses.  No treatment medication was provided.
105 fever night that vaccines given.  Vaccines given 1-17-09 @ 3 hours am (approx.  Seen at ED 1-12-09 @ 11pm with 105 fever.
2-3-2021 pt reported to ER c/o dyspnea, A-fib HR 91, SARSCoV2 RNA test positive in ER, dyspnea on exertion occasional cough, pt admitted to medical surgical floor with acute systolic CHF and COVID-19 with bronchitis, pt was discharged to a nursing home for rehab
IRREGULAR RAPID HEARTBEAT, DIFFICULTY BREATHING/SHORTNESS OF BREATH, BLOOD PRESSURE SHOT UP, SWELLING & TINGLING OF FACE, MOUTH INSIDE & OUT LIPS, OUTER EARS, LEGS, DIFFICULTY WALKING, HAND TREMORS, SEVERE HEADACHE AND PAIN BEHIND EYES, NAUSA, SEVERE FATIGUE, UPPER BACK PAIN, BLURRY VISION
Rt thigh with redness, edema and increased warmth especially top part of the thigh near the groin. Involves the entire front of the thigh and goes to the back of the thigh. The rash has been occurring for 2 days. Fever for 2 days.
I had general malaise, chills, fever, I used a home COVID-19 test that came back positive. I called my doctor's office COVID-19 hotline, I was directed to a nurse practitioner. We discussed my symptoms, I was prescribed PAXLOVID. I started feeling better within a few days, I was able to come home from vacation within a few days. Once home I started feeling ill again, I got rebound COVID-19. I called my doctor and was advised to get rest, drink plenty of fluids.
After 2 hours my arm was so sore I could not movelm by itself. I had a fever, chills, nausea, nasal congestion, boydyaches. I slept for 12 hours straight. Did not eat for 24 hours. The next day I still slept all day and finally the symtoms subsided on Sunday evening.  I felt terrible and almost had my daughter take me to the emergency room. If I had been a caregiver I would not have been able to take care of anyone
received 1st dose of Moderna COVID Vaccine on 27Jan2021/ received 2nd dose of Moderna COVID Vaccine today; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 1st dose of Moderna COVID Vaccine on 27Jan2021/ received 2nd dose of Moderna COVID Vaccine today) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 045A214A) for an unknown indication.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 1st dose of Moderna COVID Vaccine on 27Jan2021/ received 2nd dose of Moderna COVID Vaccine today). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 1st dose of Moderna COVID Vaccine on 27Jan2021/ received 2nd dose of Moderna COVID Vaccine today) had resolved.            No concomitant medications reported by investigator o No treatment medications provided by the reporter.
36 hours after 2nd Pfizer booster I had ringing/roaring in Rt. ear and sudden loss of hearing.  Went to urgent care and was instructed to go to emergency room where Dr.  on call ENT advised to begin steroid therapy.  Followed up with Dr.  on6/20/22. Hearing test performed by audiologist.  result Profound hearing loss in Rt. ear.
she had neck pain; stiffness in that area; she was dizzy; shoulder pain; muscle pain radiated up to her neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (she had neck pain), MUSCULOSKELETAL STIFFNESS (stiffness in that area), DIZZINESS (she was dizzy), ARTHRALGIA (shoulder pain) and MYALGIA (muscle pain radiated up to her neck) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced NECK PAIN (she had neck pain), MUSCULOSKELETAL STIFFNESS (stiffness in that area), DIZZINESS (she was dizzy), ARTHRALGIA (shoulder pain) and MYALGIA (muscle pain radiated up to her neck). At the time of the report, NECK PAIN (she had neck pain), MUSCULOSKELETAL STIFFNESS (stiffness in that area), DIZZINESS (she was dizzy), ARTHRALGIA (shoulder pain) and MYALGIA (muscle pain radiated up to her neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided. Weight of the patient is reported to be as 126 (unknown unit)   This case was linked to MOD-2022-442077 (Patient Link).
GIVEN AT AGE OF 61 YEARS. NO ADVERSE REACTION REPORTED/ASSESSED FROM PATIENT.
Approximately 10 minutes after receiving immunizations (listed below) the patient C/O difficulty breathing.  Upon examination patient was anxious and throat appeared swollen.  (pt had been sick with sore throat for several days).  Patient was taken to an acute care area, upon exam it was noted that patient had clear lower airways, but seemed to have tightening of upper airways.  Epinepherine given IM, Benadryl 50mg IVP and Solumedrol 120mg IVP.  Pt continued to have o2 sat of 100% on room air.  BP 134/68 HR 64 RR 18.  The patient was transported to ER via ambulance for risk of compromised airway.  The patient was discharged from the ER and was seen in clinic the following day for f/u exam.  Patient is encouraged to follow up with primary care provider for possible allergy workup.
Headache, Arthralgia, CoughWheeze, Rash, ErythemaMultiform, UrticariaPruritus, faigue, injection site soreness, diaphoresis, neck soreness Narrative:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 22-JUL-2013, the patient was vaccinated with the first dose of PEDVAXHIB 0.5 ml for each dose, intramuscular. The second dose was administered on 26-SEP-2013, and the third dose was administered on 03-DEC-2013. Lot number was not reported for any dose. No co-suspect and concomitant therapies were reported. The nurse stated that patient received doses of PEDVAXHIB at 2 months, 4 months, then third dose at 7 month (on 03-DEC-2013) but before 12 months. No adverse effects were reported. Additional information has been requested.
elevated blood pressure; diarrhea; discoloured stool; a little cramping; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events elevated blood pressure, diarrhea, discoloured stool, a little cramping.  The patient's medical history was not provided. Concomitant medications reported were Lisinopril, Potassium, Hydrochlorothiazide, Fenofibrate for drug use for unknown indication.  On 23 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 24 Feb 2021, the patient experienced the event(s) elevated blood pressure, diarrhea, discoloured stool, a little cramping.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), elevated blood pressure, diarrhea, discoloured stool, a little cramping was unknown.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: patient says shot was given too high and thinks it was given in the bursa, this has caused a lot of sweeling and pain.