chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Presented with SOB, cough, fever; +covid 6 days PTA;  He required 3 L supplemental oxygen on admission.  Patient was treated with Remdesivir, systemic steroids and empiric antibiotics, lovenox, zinc.  He had gradual improvement in symptoms with treatment.  He continued to require 3 L supplemental throughout hospitalization.  Patient was able to ambulate without significant drop in his oxygenation.  Once Remdesivir was completed and home oxygen was arranged, patient was discharged home.  He was instructed to take baby aspirin daily in addition to prescribed steroid course.
Patient received 2nd Pfizer vaccine on 02/19/2021. She developed symptoms of loss of taste and smell, fever, and chest tightness on 08/29/2021. Positive for Covid-19 on 08/30/2021.
was allergic to it; 3rd round of shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy to vaccine in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergy to vaccine (Verbatim: was allergic to it) and shingles (Verbatim: 3rd round of shingles).  The outcome of the allergy to vaccine and shingles were not reported.   It was unknown if the reporter considered the allergy to vaccine and shingles to be related to Shingles vaccine.     It was unknown if the company considered the allergy to vaccine and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-Sept-2023 The case was received from the patient via interactive digital media. The patient called and stated that he or she got the first shot and was allergic to it. The patient had his or her 3rd round of shingles. The patient stated that he or she could not take the second.
PT parent reported. that 1 day after vaccines were given. the patient had a large, red rash where the vaccine was given. the parent described that the area was warm to touch, but unpainful to the child the rash has persited for 2-3 days and has not shrank.
Feels numbness left arm after vaccination given, no pain. Vital signs stable throughout. Evaluated by Dr. vitals stable after 15 minutes, advised to inform MD if condition worsens.
The patient elected to have the flu shot in her left arm, which has been amputated just below the elbow.  The patient is reporting nerve pain in the entire arm following the flu shot.  She also uses a diabetic freestyle libre sensor on this arm as well.
Localized reaction to (L) deltoid. Pt c/o pain, redness, swelling. Mom spoke to MD on call.
Patient was seen in office and given vaccine (Pneumovax 23) (10 am hour), 4 hours; (2 pm hour) after called office with concerns due to swelling in injection site and lump, which patient stated was warm to the touch. Patient was seen in Urgent care in the 6 Pm hour.  ER noted no fever, chills, nausea, vomiting or diarrhea. Patient was with some itching, redness and swelling in site area.
Information has been received from a physician via medical record concerning an 11 day old male with right congenital clubfoot who on 27-APR-2009 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). On 06-MAY-2009 the baby was taken to the emergency department by his mother. His mom described that the he had a "normal baby rash" in the nursery over his abdomen and face. Before his bath that day, mom took off onesie and noted increased erythema of the rash, with spread to arms as well. Mom described rash as red, and looking pimples, no blisters. Initially mom thought baby had heat rash as he had an onesie, sleeper and blanket on, but did not have tactile temperatures. No fever, congestion, cough, emesis or diarrhea. No one else with similar rash, no sick contacts. The baby had some increased crying that day, and took a longer nap than usual (4 hrs) but mom sometimes had to wake him for feeds and stated that she forgot to wake him that day. Otherwise, taking breast milk and formula supplementation (1-1.5 oz) q2h, wet diapers 7/day, BMs 2/day. The baby was an ex-39 weeker, 7 lb 15 oz, NSVD, normal pregnancy and home with mom. Physical exam showed that erythematous, maculopapular rash over chest, abdomen, decreased on arms and back. No rash on legs. The physician's impression was erythema toxicum neonatorum. The condition was stable. The baby was disposed to home and recommended to return to the ED if symptoms worsen or change, and follow up PCP. The physician reported the baby improved with the therapy. On 19-JUN-2009 at 15:21 the patient's mom called the office to report that the patient did not eat much that day and had not had a wet diaper since 09:00. She was advised to take the patient to the ER. It was not reported if the patient was taken to the ER. On 23-JUN-2009 the baby was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown), a dose of PREVNAR, a dose of ROTATEQ, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of Hib conj vaccine (unspecified carrier) and a dose of poliovirus vaccine inactivated (unspecified). Additional information is not expected.
11:00 AM Arm began hurting at the Fluarix Quad injection site and down arm. 11:20 AM Had difficulty raising my arm or using it for anything. Sleeping has been very difficult for 21 days.
IM Vaccine administration in the left deltoid followed the next day by left shoulder pain, which has persisted for greater than 1 month. Symptoms include pain and weakness with shoulder abduction above 90 degrees. She has received some relief with an intra-articular steroid injection and topical creams, but no resolution.
Diffuse red papular rash on chest and back of neck.   Recommended mom administer Benadryl prn for managment of rash along with adequate hydration, symptom monitoring, and temperature checks. If rash persists for >48 hours return for further evaluation.
Running nose, low grade fever and fussy.  Crying a lot and is not eating as much.
had fevers of 102F-103F; vomiting; This case was reported by a physician via sales rep and described the occurrence of fever in a child patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   In 2019, the patient received Fluarix Quadrivalent 2019-2020 season. In 2019, less than a week after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced fever and vomiting. On an unknown date, the outcome of the fever and vomiting were unknown.   It was unknown if the reporter considered the fever and vomiting to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The age at vaccination was not reported. The batch number was not reported. The physician stated that the patient age of 6 months to 5 years old received Fluarix Quadrivalent 2019-2020 season vaccine and within 24-48 hours the patient had fever of 102F-103F and vomiting.
Headache x 1 day; Significant fatigue x 4 days (persistent at time of visit)
RAISED AND RED AREA 2.5" BY 2" AT INJECTION SITE. MILD DISCOMFORT OF ELBOW ON SITE ARM. NO OTHER COMPLAINTS.
Client was given a fourth dose.  she was not eligible by age or condition.  There were no adverse effects
Pt developed fever around 6pm 1-14-11. Sleeping more , eating more.
neuropathy; pain on her skin on the left side of her rib cage with no rash; sensitive to the touch; This is a spontaneous report from a contactable consumer or other non hcp (the patient, reported for self)  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiration date: UNKNOWN), via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had earlier received first dose of BNT162B2 (COMIRNATY) on unknown date for COVID-19 immunisation. The patient enquired if there were any reports of skin pain by the left side of the rib cage or any reports of neuropathy. The experienced pain on her skin on the left side of her rib cage with no rash on an unspecified date. She stated it has gotten worse as the days go by and is sensitive to the touch. Last night, she took a Gabapentin thinking it may help. She started having this reaction 3 to 5 days after receiving the vaccine. Therapeutic measures were taken as a result of pain on her skin on the left side of her rib cage with no rash includes Gabapentin. The outcome for event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sepsis; appendicitis; intussusception of the distaileum; allergy attack; fever 100.6-102.6; Upset stomach; This is a spontaneous report from a contactable consumer (patient).  A 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Batch/Lot Number: EN6204) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Pending clarification) (Batch/Lot Number: ER8730) as SINGLE DOSE for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included breast cancer survivor, unspecified allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX) taken for immunisation on 12Feb2021. The patient received other medications within 2 weeks of vaccination. The patient experienced allergy attack, fever 100.6-102.6, upset stomach on 23May2021, on 26May2021 Computerised tomogram (CT) showed intussusception of the dista ileum. Went to emergency room (ER), treated for sepsis. Surgery 26May2021 showed appendix wrapped around small intestine forcing telescoping. Appendix and adhesions and lymph node removed. Biopsy showed appendicitis. Adverse events resulted in emergency room/department or urgent care and hospitalization. Patient was admitted to hospitalization for 3 days. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Covid test (Nasal Swab): negative on 26May2021, and Covid test (Saliva Test): negative on 25May2021. The outcome of the events was recovered.
It was reported that a 17 year old male pt received Typhim VI vaccination dose #2 on 1/4/01. Reportedly, a few days before 1/19/01, pt had complained to his mom about spasms in his right hand. On 1/19/01, after going to a high school play, the pt was driving home and had such a severe spasm in his right hand and arm, that he was unable to drive or steer the car and went off the road into a ditch. The pt sustained no injuries from the accident. Pt started taking Malaria pills on 3/5/01. Then on 3/12/01, he took 2 pills while in Haiti. While in Haiti, pt continued to have spasms on the right side of body, 1 of which was so severe, he fell to the ground, with his eyes rolled back, but was able to hear those around him and could respond verbally but was unable to move. When the spasm was over, he could move again. Pt was taken to his PMD when he returned. At that time, he was taken off his Malaria medication. Pt continues to have increasing dizziness, which is sometimes accompanied with headaches and neck stiffness. Pt described the dizziness as feeling like he is walking during an earthquake. The pt has been to a chiropractor more than once, after 1/19/01. Pt has also experienced high blood pressure, which fluctuates between high and normal. Besides the dizziness, client complained of blurred vision. He has an appt. with an eye specialist on 5/2/01. Pt has not had any cold, sinus infection, fever, nausea or vomiting. Pt has a nervous stomach and has bouts of diarrhea frequently. Pt has been checked for bowel problems with no specific bacteria or viral infections found. Pt was given Meclovir to treat dizziness and possible middle ear infection. Pt has had no spasms since returning from Haiti. The follow-up correspondence received on 05/11/2001, it was reported that the pt recovered from this experience. It was indicated that the pt has an appointment regarding his blurred vision. There was no MRI or neuro testing done for the dizziness and spasm.
AFTER RECEIVING FIRST DOSE OF MODERNA, PATIENT STOOD UP AND WALKED AWAY FROM VACCINE BOOTH. HE BECAME FAINT AND FELL TO THE FLOOR, HITTING HIS HEAD. HE DID NOT LOSE CONSCIOUSNESS BUT EMS WAS CONTACTED. BY THE TIME EMS ARRIVED, APPROXIMATELY 20 MINUTES LATER, PATIENT WAS SITTING IN CHAIR AND HAD A RAISED BUMP ON HEAD FROM FALL. HE STATED HE FELT FINE AND REFUSED EMS TREATMENT.
Dose #1 J-VAX given 2/10/09 (1cc given right deltoid subQ) @ 1300-1400. On 2/13/09, while at daycare, the patient had hallucinations (tactile of bugs). Extensive w/u in ER showed nothing metabolic as causative. Episodes continued x 7-8 last one @ 0400 2/16/09.
Swelling of her tongue; Swelling of her mouth; Chest felt tight; Nosebleed, intermittent; Intermittent headaches; Her crotch became swollen/swollen; Her crotch was of a magenta red color / the area of her crotch has faded in color but has not returned to skin tone color; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (Nosebleed, intermittent), SWELLING (Her crotch became swollen/swollen), SWOLLEN TONGUE (Swelling of her tongue), MOUTH SWELLING (Swelling of her mouth) and CHEST DISCOMFORT (Chest felt tight) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Tequin gave her a heart attack) and Diabetes mellitus.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced SWELLING (Her crotch became swollen/swollen) and SKIN DISCOLOURATION (Her crotch was of a magenta red color / the area of her crotch has faded in color but has not returned to skin tone color). On 25-Apr-2021, the patient experienced EPISTAXIS (Nosebleed, intermittent) and HEADACHE (Intermittent headaches). On 01-May-2021, the patient experienced SWOLLEN TONGUE (Swelling of her tongue), MOUTH SWELLING (Swelling of her mouth) and CHEST DISCOMFORT (Chest felt tight). At the time of the report, EPISTAXIS (Nosebleed, intermittent) and HEADACHE (Intermittent headaches) had not resolved, SWELLING (Her crotch became swollen/swollen), SWOLLEN TONGUE (Swelling of her tongue), MOUTH SWELLING (Swelling of her mouth) and CHEST DISCOMFORT (Chest felt tight) outcome was unknown and SKIN DISCOLOURATION (Her crotch was of a magenta red color / the area of her crotch has faded in color but has not returned to skin tone color) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provider by the reporter.  No treatment medications were taken.
Pt called pharmacy on morning or 9/8, 2 days after vaccination, complaining of swelling and redness to injection site.
Patient received Updated Pfizer Bivalent booster on 10/8/22 at the pharmacy. A second pharmacy also administered the bivalent booster on 10/27/22
At on 10/4/11 at 8:51 am pt received INFLUENZA vaccine. On 10/6/11 at 6:46 am pt called on-call RN c/o her arm is now red; warm with rash about size of egg where she had her flu shot. Called & pt needing MD appt at 3:30 with dr. Dx reaction, 10/11/11 resolved.
Burning sensation in the breast; She specified she then sees that her breast is still "tender"/ it feels tender; Swollen lymph node; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Burning sensation in the breast"; BREAST TENDERNESS (non-serious) with onset 2021, outcome "not recovered", described as "She specified she then sees that her breast is still "tender"/ it feels tender"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "not recovered", described as "Swollen lymph node". Therapeutic measures were taken as a result of breast tenderness.  Additional information: The patient asked if a burning sensation in the breast was reported as a side effect from Comirnaty, and if she had a swollen lymph node. She stated receiving the first dose 19Sep2021 and being scheduled for her second dose today. She explained ever since the first dose, her right breast has been "bothering" her. She described it as a "burning sensation in" the breast. She mentioned she "sometimes felt it and other times don't". She also said she sometimes had to feel her breast for her to know that her symptom is still there. She specified she then sees that her breast is still "tender". The patient expressed she did not feel comfortable taking the second dose before getting enough information and seeing her doctor. She specified having an appointment with her doctor this Monday. Unsuccessful warm-transfer attempted, patient disconnected before being conferenced in with agent. The patient asked why was it not recommended to have a mammogram following the receipt of Comirnaty. Response: Responded per section "Drug or Food Interaction/ Concomitant Administration"  from VR-Consumer Inquiry Management (Off-Label or No Info). No information retrieved from sections "4 CONTRAINDICATIONS" and "5 WARNINGS AND PRECAUTIONS",  PI, LAB-1448-1.0, Revised: Aug2021; and section "10 DRUG INTERACTIONS" from Full EUA PI, LAB-0157-8.0, Revised: 22Sep2021. Patient asked what was the longest time she could wait to get the second dose of Comirnaty without impacting it's efficacy or having to repeat the series. The patient expressed not wanting to receive the second dose as schedule given her reaction to the first dose. The patient hung up the call hence, warm transfer could not be done. Call back was done however, it was unsuccessful. Hence, limited information available over the call.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Mom called our office on 07-26-17 to with concerns of patient having a rash. Mom stated they are on vacation camping in the woods and when patient broke out with his rash she thought it was hives. He was still taking the Amoxicillin for his +Strep. Mom now concerned the rash no longer looked like hives, rash seemed itchy, rash was around his mouth and it would go away at night but would present back in the morning. He was Afebrile. No other symptoms on this day. Symptoms were discussed with Nurse Practitioner and Mom was advised probable viral rash, something related to environment most likely, continue to take Amoxicillin, may give OTC BENADRYL, if rash persists or worsens to take to local urgent care or ER.  Mom call office again on 07/27/17 stating rash became worse and they were currently in a local urgent care facility at Lake of the Ozarks in Missouri.  Urgent care doctor said the rash looked like Measles.  Mom said he was covered head to toe with red spots and he had so many they were touching.  His behavior was still normal.  Mom stated the urgent care doctor was consulting with another doctor to confirm if Measles.  Mom stated the urgent care doctor told her , push fluids, Tylenol for comfort, continue Benadryl PRN.
was reported to staff at Health Department that client passed away hours after receiving Moderna vaccine, also reported that client had multiple health conditions.
an 85 year old female to receive two doses of Fluzone high-Dose this season possibly due to the consumer not remembering the injection was already given, no adverse event; Initial information was received on 13-Dec-2019 and additional information on 16-Dec-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves an 84 year old female patient who was vaccinated with a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number UJ238AA and expiration date 14-Apr-2020) on an unknown date in Sep-2019 and also received 0.5 ml dose of same vaccine, 3-weeks later on an unknown date in Oct-2019 (lot number UJ283AB and expiration date 29-May-2020) via an intramuscular route in the left arm.  Medical history was not reported.  The patient did not receive any other vaccine.  It was an actual medication error case due to extra dose administered.  No adverse event was reported at the time of reporting.  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 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.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns an 81-year-old, elderly patient of unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 11-Oct-2018, the patient was administered FLUCELVAX QIVc (route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported) which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805495 was crossed linked to original cases 201804863 due to same reporter.
fever 4 1/2 days ago ( 6 days p/vax) fever ran for 3 days then a day later got a rash which has gotten worse;seen by provider 11 days p/vax for rash, runny nose, & OM w/temp of 98.9;
Patient started developing sore arm on 12/9/20.  She states that there was no redness or swelling and that there isn't a specific sore spot, but it's the whole arm.  She called to tell us about the soreness, we advised she contact her MD.  MD advised her to alternate between ice and heat.  She has been doing this but as of today's date, she still has the soreness.  She states that it is temporarily relived by ice/heat, but not long-lasting.
Hallucinations, Headache, Myalgia, Fever, chills, fatigue, foot pain Narrative: Headache, hallucinations, myalgia, fever, chills, fatigue, foot pain for 5 days. No answer for follow up.
Information has been received from a health care worker concerning a patient "over 55 or 60" years of age who "two weeks ago" was vaccinated with a dose of Pneumovax 23 (lot # 651399/0486F). Subsequently, the patient experienced redness and swelling at the site of injection. The patient was reportedly recovering. Additional information has been requested.
Within a couple minutes of receiving vaccine, patient experienced syncope and nausea. Patient fainted, but regained consciousness within a few minutes. His blood pressure was low and gradually increased after about 15 minutes. Throughout recovery he had some nausea, and was drinking juice to help recover. He was ultimately released with his mother approximately 30 minutes after receiving the vaccine. He was treated by a pediatrician on site at the clinic.