chrisvoncsefalvay/vaers-outcomes huggingface dataset:
OFF LABEL USE; JANSSEN COVID-19 VACCINE ADMINISTRATED TO A 15 YEARS OLD GIRL AS AN ACCIDENT; This spontaneous report received from a health care professional concerned a 15 year old female. 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: 202A21A, and expiry: 31-OCT-2021) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination.  On 16-SEP-2021, the patient experienced off label use. On 16-SEP-2021, the patient experienced janssen covid-19 vaccine administrated to a 15 years old girl as an accident. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and janssen covid-19 vaccine administrated to a 15 years old girl as an accident was not reported. This report was non-serious.
Pt was given 0.5 cc of pneumovax to right deltoid. Approx 5 hours later pt called with arm swelling, hot, painful. Told to put ice on it, take Benadryl. Call if any concerns.
Developed within 10 hours and lasted 36 hours  Severe body aches Fatigue  Metallic taste in mouth  Injection site pain that lasted 1 week  Fever of 104.3
Information has been received from a registered nurse concerning a 15 month old male with no known allergies who in 1992 was vaccinated with MMR II (dosage and lot number not provided). In 1991, 10-14 days post-vaccination, the pt developed a rash all over his body and fever. At that time, the pt had sought medical attention. Subsequently, the pt recovered from his symptoms. In June 2001, the 12 yea old male pediatric pt needs a second MMR II vaccination and the registered nurse inquired as to whether the child will experience the same events. Additional info has been requested.
WORSENING DIZZINESS, TIRED, SOMNOLENT, SEVERAL LOOSE STOOLS APPROX 15-18 HRS AFTER VACCINATION ADMINISTRATION.  SYMPTOMS RESOLVED WITHIN 36 HRS.
Golf ball size lump within 2 hours, no treatment at that time with achy. Now unable to move arm, weak, throbs like a toothache. Pain has increased and almost unbearable. Apt 12/13 with Dr.
Patient experienced swelling in facial cheeks, mouth, and tongue.  Did not seek medical treatment.
received an unapproved vaccine dose per her age. Should have received Pfizer (12 and older)
Blurrred vision; Made achey as well; Depressed; No appetite; Fatigue; 100 degree fever; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurrred vision), PAIN IN EXTREMITY (Made achey as well), DEPRESSION (Depressed), DECREASED APPETITE (No appetite) and FATIGUE (Fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (statins), Allergy to antibiotic (clindamycin) and Blood pressure high since 2018. Concomitant products included LOSARTAN from 2018 to an unknown date for Blood pressure high.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced FATIGUE (Fatigue) and PYREXIA (100 degree fever). On an unknown date, the patient experienced VISION BLURRED (Blurrred vision), PAIN IN EXTREMITY (Made achey as well), DEPRESSION (Depressed) and DECREASED APPETITE (No appetite). At the time of the report, VISION BLURRED (Blurrred vision), PAIN IN EXTREMITY (Made achey as well), DEPRESSION (Depressed) and DECREASED APPETITE (No appetite) outcome was unknown and FATIGUE (Fatigue) and PYREXIA (100 degree fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 100 (High) 100 degree fever.         Patient experienced achey as well with the addition of a 100 degree fever for about 3 days.She had fatigue and no appetite and felt depressed as well and suffer from some depression. She also seem to had blurred vision.  Treatment information was not provided by the reporter.    This case was linked to MOD-2021-030984 (Patient Link).
Hot to the touch; Itchy rash; Red rash; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Hot to the touch), RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced SKIN WARM (Hot to the touch), RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SKIN WARM (Hot to the touch), RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       List of concomitant medication were not given.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04-JUN-2021 contains No New information.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
First dose: vaccinated arm hurt and was really sore; she couldn't use her arm or lift anything; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 09:00 (Lot number: ER8729) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hernia surgery" (unspecified if ongoing), notes: Surgeries: She had a hernia surgery 10 years ago; "arthritic" (unspecified if ongoing), notes: She has joint problems with her toes/One of her toes sometimes feels like it is a little arthritic; "lack vitamin D" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3 taken for vitamin d deficiency; TURMERIC [CURCUMA LONGA] taken for arthralgia. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Apr2021, outcome "unknown", described as "First dose: vaccinated arm hurt and was really sore; she couldn't use her arm or lift anything".  Additional information: Patient says the first shot of Pfizer was excruciatingly painful in her vaccinated arm. For the first shot 07Apr2021 she had a really sore arm. She again reiterates her arm hurt with the first shot. She could not use her arm. She could not lift anything nor pick up a cup. Her painful arm after the first shot lasted at least for a couple of days. Vitamin D3; 8,000 IU (200mcg), every other day. She says she has been taking this vitamin for a very long time. Turmeric, 1,000 mg probably every other day. No investigation assessment. She says the two different pieces between the first round and second round of symptoms are that her hair does not hurt like it did with the first round, but the vaccinated arm hurts. Second dose on 28Apr2021 at about 9:00am, LOT number EW0176, left arm. Prior vaccinations (within 4 weeks) were none. Allergies: She mentions she gets sneezing fits with dust. She says there are times of the year when she was sneezing but it was not enough to make a note of it, she was just aware of it.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021569201 similar report from same reporter
about 5 minutes after vaccine while mother was showing the child a video of the child getting the vaccine then child fell to the floor.  The child was alert immediately. Upon arriving to the child she was hot and clammy.  Cold compress/icebag was placed on child's neck and sore spot on her head.  Five minutes later the childs pulse was 70 and temperature normal to the touch.    A call was placed to the family home about 6pm on the day of the immunization.  the mom said she is doing  okay; sore neck muscles and head hurts upon touching.
This 75 year old female hospice patient received the Covid shot on 3/24/21  died on 5/6/21.
Patient received a FLUZONE QUADRIVALENT that was later noted to have expired with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Global Medical Information (Reference number- 00855893) and transmitted to Sanofi on 12-Nov-2021.  This case involves a female patient (age unknown) who had received an expired INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (expired product administered).  The patient's medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   On 28-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED produced by Sanofi Pasteur (lot number: UJ477AA and expiry date: 30-Jun-2021) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "Staffer is calling back to provide name of an expired vaccine June 2021, that was given to another staffer on October 28. The staffer wants to know if she needs to get another shot. She is unsure if it was with or without preservatives. health care professional (HCP) states that on 10/28/2021, an employee at one of their sites received a FLUZONE QUADRIVALENT vaccine that was later noted to have expired. Caller states that she was not present, does not know if vaccine was from a multi-dose vial or single dose presentation. She also does not know the national drug code (NDC) or the injection site. Telephone connection was very bad, incomplete patient specifics collected. Treatment-will be repeated".  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 holder's compliance with the requirements set out in the 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.
Started 5/9/07 redness and hot to touch to LT arm. Swelling and redness from shoulder to 1" above elbow hurts to lift arm
pt recvd vax; unstoppable crying w/ sl body trembling,began 2 hrs p/ vax;lasted 23 hrs;T 98.4 not elev;to clinic & reported events;
"COVID Arm".   Swelling, tender, red, itchy rash at injection site.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 70.83 for dose administered on 17-Feb-2021, Vaccination time 01:01 PM. No concomitant medications were reported. Batch number 022M20A underwent temperature excursion on 17-Feb-2021 with temperature 22 degrees Fahrenheit from 09:00 Am. This vial was moved to fridge on 11-Feb-2021. beyond use date for the vial was reported as 13-Mar-2021. Product moved to clinic on 17-Feb-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Patient had pain once vaccine was given and has continued since  04/12/21  and hurts when lifting left arm (described like a bad toothache). Has taken Tylenol, Ibuprofen, and has iced but not alleviated pain.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Jul2021 12:00 (Lot number: EW0198) at the age of 41 years as dose 1, single and administered in arm right, administration date 11Aug2021 12:45 (Lot number: FA7485) as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure (Treated)" (unspecified if ongoing), notes: Treated. Concomitant medication(s) included: ZESTRIL. The following information was reported: VISUAL FIELD DEFECT (non-serious) with onset 25Jul2021, outcome "not recovered", described as "Blind Spot left eye". The event "blind spot left eye" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of visual field defect.
Mother reported her son had swollen lymph nodes on left armpit area after 2nd covid shot.
Pt c/o tennis ball diameter sized lump in his left armpit (same side as the shot) about 36 hours after the Moderna immunization.  Pt took OTC ibuprofen  to reduce swelling and pain, which did help (about 50% reduction)  He called the pharmacy to report the adverse effect on 2/26 and I advised him to contact his PCP to evaluate the lump.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        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.   No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Information has been received from a physician concerning a 16 week old female patient, who this summer of 2008 was vaccinated orally with the second dose of ROTATEQ, and within a week experienced irritability and had a blood on the stool. The patient was brought in the emergency room and was hospitalized. Patient was diagnosed of intussusception. The patient possibly underwent an ultrasound. Subsequently, the patient recovered. No further information is available.
Unclear if these are related to the vaccine, reporting here just in case.  1. Due to perceived increase in headache frequency in the Oct-Nov-Dec 2022 timeframe and vestibular issues (multi-hour vertigo), consulted a neurologist in Feb 2023. Suspicion of vestibular migraines. Responsive to Sumatriptan. Also began taking magnesium supplements.  2. During routine EKG (due to family history), diagnosed with Left Bundle Branch Block (LBBB) and wide QRS.
chills; low grade fever (100.5); joint pain; fatigue; This is a spontaneous report from a contactable consumer. This 54-year-old (at the time of vaccination) female consumer reported that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19, solution for injection, lot number; EL3247) via an unspecified route of administration on 10Feb2021 at 08:15 am at left arm at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Facility type vaccine was reported as hospital. Patient's medical history included known allergies; shrimp (unspecified dates). Past drug event included known allergies to tramadol and codeine (dates unspecified). Concomitant medications were not reported (if other vaccine in four weeks; no, other medications in two weeks- N/A). Patient experienced chills, low grade fever (100.5), joint pain, fatigue on 10Feb2021 at 08:00 pm. She felt like she had a "mini version" of COVID. Treatment for adverse event was not given. Patient had covid-19 prior to vaccination. Patient was not tested for covid-19 post vaccination. The outcome of events was recovered on an unknown date.
When I received my second shot of the Moderna vaccine on the morning of 4/13/21, I felt fine for most of the day.  Around 8:30 pm, I came down with the expected fever and fatigue. These symptoms lasted until around 6 pm of 4/14/21.  Then I started to feel better and assumed I was done reacting to the vaccine.  However, I was woken up that night by chest pains.  Because I was still fatigued, I would fall back asleep, but then my chest pains would get so bad that they would wake me up again.  I continued this cycle until about 5 am.  Trying to walk from one room to another was belabored and very painful, and I experienced some shortness of breath.  At that point, my husband, who is a physician, got up for work and I reported my symptoms to him.  He advised me to stay in bed and monitor myself and that if the symptoms had a dramatic escalation to call 911 for an ambulance.  I maintained that level of intense chest pain that remained manageable as long I stayed fairly still.  These symptoms lasted for approximately 2 days, finally resolving by the morning of 4/17/21.  Then they just disappeared.  I have felt fine since.
About 10 hours after the injection I started with fever, chills nausea and vomiting.  Fever up to 102.1 with Advil.
Fatigue; Dull headache; Small lump behind right ear; Dull sensation in right ear area; Nausea; Extreme dizziness; Tightness in chest; Slight weakness in legs; Dry lips; Hazy vision in right eye; Difficulty swallowing; Involuntary jerky movements in legs; Waves of nausea and brain fog; This is a spontaneous report from a contactable consumer (patient).  A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 10May2021 11:00 (Batch/Lot Number: EW0168) as single dose for COVID-19 immunisation. Medical history included known allergies to sulfa and penicillin. Concomitant medications included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported; vitamin D3 taken for an unspecified indication, start and stop date were not reported; vitamin C taken for an unspecified indication, start and stop date were not reported; rhodiola rosea (RHODIOLA) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 19Apr2021 11:30 (Lot Number: 8735) for COVID-19 immunisation. On 13May2021 17:30, the patient experienced dull sensation in right ear area, nausea, extreme dizziness, tightness in chest, slight weakness in legs, dry lips, hazy vision in right eye, difficulty swallowing, involuntary jerky movements in legs, waves of nausea and brain fog. At 6:45PM brain fog lifted. At 19:15 small lump behind right ear appeared. Pulse was 72-75. Similar experience on 14May2021 starting roughly same time with dull headache. On 15May2021, similar symptoms starting at 15:00 with lower intensity; very fatigued throughout. On 17May2021, fatigue and dizziness. All the events were non-serious. The events hazy vision in right eye, difficulty swallowing, involuntary jerky movements in legs, waves of nausea and brain fog, small lump behind right ear, dull headache and fatigue required Emergency Room visit. The patient did not receive corrective treatments. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered with sequel from the events on an unspecified date.  Follow-up attempts completed. No further information expected.