chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced injection pain.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 60-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Prior to vaccination, the patient was diagnosed with COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for COVID-19 immunization. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 29Oct2023, outcome "recovered" (Oct2023), described as "Patient experienced injection pain.". Therapeutic measures were not taken as a result of injection site pain.  Additional information: Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, NauseaVomiting, chills, fatigue Narrative:  Other Relevant History:
Mom states quarter-sized area of erythema noticed 1 hour after receiving shot. No fever, no c/o pain/ discomfort. Area now measures 10 cm x 18 1/2 cm of firm erythema.
Erythema, induration, fevers, myalgias, cellulitis, red - orange urine.
She got her vaccine, was supposed to get the booster COVID but gave her the flu vaccine.  She had pain in her heart and got home and started having severe lower back pain.  This lasted for 2 days.  Then she had pain in her lymph nodes in her left armpit, very painful.  She was groggy the 2nd day, and then felt a little bit better.  On Saturday she had diarrhea and vomiting, could not eat and kept telling her that she was supposed to be lethargic.  Yesterday she felt like she had diarrhea and there was blood in her stool, which was not listed as a side effect on the CDC website.  She went to the UC and she said that her body was going through antibodies and does not know if the blood was antibodies trying to flush itself out.  She noticed it first in the toilet, and then when she wiped . According the UC where she took a stool specimen and said that there was a pretty good amount of blood in her stool, but did not warrant any other testing.  They did not send it for culture.  She has been pretty much sleeping, resting and hasn't really used the bathroom again as she has not had much to eat other than broth and Jello.  Her stomach is hurting, the girl in the ER felt stomach pressure and sensitivity in her stomach, but felt that because the flu shot goes to the GI tract and that maybe it was related to that.  The pressure underneath the arm is still there and has not subsided.  She has called her PCP, but they have not called her back yet.  The ER/UC did not give her anything to take for her symptoms.
impaired vision; Severe headache that impaired vision and stability; stability with no prior history of migraine.; neck and shoulder pain.; Ongoing vertigo; panic attack; ongoing diarrhoea; Severe headache; shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 39-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ew0181) via an unspecified route of administration in left arm on 24Jun2021 at 13:00 (at the age of 39-years-old) as dose 1, single for covid-19 immunization. Medical history included hypothyroidism, thyroid cancer, irritable bowel syndrome, degenerative disc disease all started from an unknown date and unknown if ongoing. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient received other medications within two weeks of vaccination as concomitant medications included levothyroxine (LEVOTHYROXINE); rifaximin (RIFAXIMIN); bifidobacterium breve, bifidobacterium infantis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus bulgaricus, lactobacillus paracasei, lactobacillus plantarum, streptococcus thermophilus (VISBIOME) all taken for an unspecified indication, start and stop date were not reported. On 16Jul2021 at 15:00, the patient experienced severe headache that impaired vision and stability with no prior history of migraine, accompanied by neck and shoulder pain, ongoing vertigo, panic attacks, sudden onset and ongoing diarrhoea. She was advised to go to emergency room immediately for evaluation. These events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit. Therapeutic measures were taken as a result of all events with pain relief and Benadryl. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody nasal swab test negative on 20Jul2021. The outcome of all events was reported as resolving.  Follow-up attempts are completed. No further information expected.
QUADRACEL given to a 9 year old female /No AE; Initial information was received on 11-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional (medical assistant).  This case involves a 9 years old female patient who received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL]lot C5688AA, expiry date 26-Nov-21 via intramuscular route in the left deltoid for prophylactic vaccination on 11-Sep-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  No adverse event symptoms 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 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-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9, lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-month-old patient of unknown gender. On 27-FEB-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot number N034005 (expiration date 31-JAN-2020) and a dose of VARIVAX, lot number N021720 (expiration date: 10-AUG-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
As reported by patient's home health nurse patient started with confusion and hallucinations that were found to be seizures on 6/17/2021. The ER also stated she had a stroke, but then a secondary Hospital stated she did not upon further evaluation per the patient's family. So far, no health care providers can come to decision on the cause of the seizures based on all the tests they have done so far. Patient has seizure every time she stands and has developed limited function of left leg.
About 12 hours post vaccine I experienced headache, fatigue, muscle aches, and chills. About 48 hours post vaccine developed rash - raised red swollen area around where the vaccine was given. The area was hot to the touch and very itchy. Currently great than 72 hours post vaccine and rash is still there and still hot and itchy.
This spontaneous report as received from a nurse refers to an 11 months 8 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ is # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Allergic reaction to another country's food about 15 min after eating, has never been allergic to this. Then felt that she was light headed. Took benedryl to treat. By next morning was normal.    3 days after vx, felt completely similar to having the flu, lasted a couple of days. Then a total of 5 days after booster had a large welt and was diagnosed with Shingles.   Two months after vx, she had severe joint pain in her wrist and was it was swollen. She went to her Dr. and had MRI of wrist. Still waiting for the results.
Stated she received her Covid Vaccine #1 on 12/19/2020 in the morning, after a few hours of working she developed pain in her Left upper arm, shoulder & neck which she described as "excruciating" 8/10 pain along with all of the areas being hot to touch. .She called out of work on Sunday 12/20 in hopes that it would feel better, On 12/29 she had a Zoom visit with her PCP r/t the pain not going away and not being relieved by Ibuprofen. PCP ordered Muscle Relaxer & "High Dose Ibuprofen" Her PCP put her out through 1/5/2021 when she will be re-evaluated.
SHAKING; CAN NOT STAND; DIZZY; SWEATING; HOT AND COLD; PAIN ALL IN BODY; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight was 200 pounds, and height was 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: 203A21A expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced shaking. On 05-JUN-2021, the subject experienced can not stand. On 05-JUN-2021, the subject experienced dizzy. On 05-JUN-2021, the subject experienced sweating. On 05-JUN-2021, the subject experienced hot and cold. On 05-JUN-2021, the subject experienced pain all in body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking, can not stand, dizzy, sweating, hot and cold, and pain all in body. This report was non-serious.
Fever 102.2 for days. Shortness of breath. Sweating and chills. Severe body aching. Severe fatigue. Severe Pain on injection site (right arm). Lightheaded frequently. Water body retention.
Patient was given a Covid - 19 bivalent vaccine on 12/15/22 at 1pm. The vaccine she was given had been drawn up the day before 10/14/22 at 9:30am, so this vaccine was expired and should not have been given.  We have contacted patient she was fine and will schedule an appointment to get this vaccine re done.
TONGUE PAIN AND BLISTERS,  LIP SORES, SORES INSIDE CHEEK, DIFFICULTY EATING AND CHEWING
"I" have chills; Runny nose; Light headedness; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 28Feb2021 at 14:45 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and pravastatin (MANUFACTURER UNKNOWN); both from an unknown start date for an unknown indication and unknown if ongoing. The patient previously received acetylsalicylic acid (ASPIRIN) and codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the left arm on 07Feb2021 at 14:45 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. On 01Mar2021 at 08:00, the patient experienced chills, runny nose, light headedness and muscle pain. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, runny nose, light headedness and muscle pain were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
G45.9 TRANSIENT CEREBRAL ISCHEMIA 3/29/2023 HTN (HYPERTENSION) I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 3/29/2023 HTN (HYPERTENSION) I63.9 REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 4/11/2023 HTN (HYPERTENSION)
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (dose, route, lot # and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Week 1 - Mild headache within hours. Some neck vertebrae cracking 24 hours later. Week 2&3 - All day severe headache, pins&needles in arms/hands, white noise in ears.  Week 4 - Once a day severe headache (in morning), white noise in ears, lots of neck vertebrae cracking. Week 5 - Intermittent strong headache, some white noise in ears.
I got the vaccine on June 12th  and, regardless, I got infected with COVID19 on July 8th. During my time with COVID19 I experienced symptoms such as fever, muscle pain, bodyache, headache, cough, sore throat, loss of smell and taste and tiredness. I just finished my 10-day quarantine.
The shot was given at 2:00pm Oct. 25 and by 9:00pm. I was ache in my neck and back with a low grade fever.
She got her vaccine, a few hours later around 9-10:00 Am her arm started to feel numb.  She went to sleep and woke up and her back was broken out and she could not move her arm or lift it.  Her back was really itchy.  Her boyfriend took a picture of it, and it looked like a lot of bump all over her back, the back of her arm and was really itchy and scaly.  She went to the pharmacy and asked them and showed them the rash and was told to go to the doctor.  She went to the doctor and was told to put cream on it to stop the itch, and put vitamin E oil on it and vasoline, and it eventually helped.  She detoxed from the vaccine by drinking aloe vera and flushed her system to get rid of the toxins from the vaccine.  A week later she was better.
I received my first vaccination on 12/28/2020, given very high in my right arm.  I noticed a tingling in my left arm within the first 15 minutes of the injection.  As I worked the rest of my evening shift, the tingling continued.  The next morning, my left arm was numb from the shoulder to the fingertips.  I could move my fingers and arm, but could not feel pain, hot or cold.  I called the employee health nurse, who told me that most symptoms resolve in 24 hours.  I took a day off and rested the arm.  The feeling came back gradually in the afternoon.  However, my hand was numb the following two mornings.  The symptoms resolved in 72 hours.
Extreme chills and sweats from 9:00pm-5:00am. Headache, fever of 100.7 for majority of the night.
Was seen in the ER on 04/08/2021 for left calf and leg pain. He stated that symptoms started a few days before but worse on the visit date. He has had hx of 3 other DVTs in the past. Denies sob
DTap #5 administered to left Deltoid 9/1/09, upper arm became swollen/red very tight and painful. Taken to Emergency Room by mother 9/2/09 (as clinic was closed), where Prednisone was prescribed. Reaction resolved as stated by mother on 9/3/09.
Large localized reaction to DTaP erythema, induration, tender 4 cm. No treatment.
Patient had minor rash on face and neck was given benedryl 1 1/2 tsp. (lot#6B08 exp:2/09) by G. Ernise, RN. Served patient, no other /further adverse reaction noted. Instructed parent to go to emergency room if side effects/ adverse reaction, Reemerge.
I had violent vomiting and diarrhea from 7 pm until 4 am the next morning. 10 days after the booster shot, I developed Bell's palsy.
Injection sight is warm, swollen, and itches 12 days after receiving first  dose.
I started feeling really cold, I had a constant headache that persist to this day. I had coughing, fever, diarrhea, vomiting, my finger joints hurt, I got congestion and still have some congestion to this day. I called the doctor and we discussed my taking the antiviral, with the side affects and my health conditions we decided against it. The first week of me having COVID-19 I could not work, the second week I could work for a couple hours a day. I got dehydrated during the second week.  I had to have a travel nurse come in to give me IV hydration. By day thirteen, I finally tested negative. I did not lose my sense of smell but my sense of taste has been altered, everything I try to eat taste horrible.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Sep2021 as dose 1, single (Lot number: FE3592), in left arm and on 08Oct2021 at 13:15 as dose 2, single (Lot number: FF8839) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "esophageal ca" (unspecified if ongoing), notes: other medical history: esophageal ca; "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 25Apr2022, stop date: 09May2022; DEXAMETHASONE, start date: 05May2022, stop date: 06May2022; OMEPRAZOLE, start date: 25Apr2022, stop date: 09May2022; FERROUS [IRON], start date: 25Apr2022, stop date: 09May2022; ZINC [ZINC SULFATE], start date: 25Apr2022, stop date: 09May2022; VITAMIN B-12, start date: 25Apr2022, stop date: 09May2022; KEYTRUDA, start date: 04May2022, stop date: 04May2022; ALOXI, start date: 04May2022, stop date: 04May2022; LEUCOVORIN [FOLINIC ACID], start date: 04May2022, stop date: 04May2022; OXALIPLATIN, start date: 04May2022, stop date: 04May2022; ADRUCIL, start date: 04May2022, stop date: 06May2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as yes. Did you/the patient previously receive a COVID-19 Vaccine was reported as yes.
got the flu every year; Initial information was received on 03-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves an unknown demographic patient (unknown age and unknown gender) who experienced got the flu every year (influenza), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got the flu every year (influenza) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was not reported if the patient received a corrective treatment for the event (got the flu every year).  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
*Following patient's first Moderna vaccination (8/13/21), he developed pain and swelling in his left lower extremity which started on 8/21/21. A D-dimer was completed which was negative. An US was then obtained on 8/25/21 which showed a gastrocnemius thrombus extending into the popliteal vein. Pt was encouraged to present to the ED and was started on xarelto on 8/25/21.  *Following patient's second Moderna vaccination (9/10/21), he developed severe body aches, fevers, chest pain and SOB. Patient presented to the ED on 9/13/21  Pain worsened with lying flat. Leaning forward did not alleviate the pain. Pt notes that he initially thought he had bad reflux, then it felt like a cracking chest pressure. He has felt very uncomfortable lying flat with coughing and SOB. He also notes some bloating, diaphoresis, and lightheadedness. Patient was provided with ibuprofen 600mg PO TID along with colchicine 0.6mg 1 tab PO BID. On 9/14/21, he continued to have symptoms only with increased movement, otherwise his symptoms were improving. He continued to have diaphoresis. Plan is to continue colchicine x3 mos along with ibuprofen for the next 2 weeks, then taper down.