chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer vaccine was administered outside - reported by patient-  NO LOT NUMBER WERE SUPPLIED G40.89 FOCAL MOTOR SEIZURE 4/4/2023 CESAREAN DELIVERY G40.909 EPILEPSY, UNSPECIFIED 10/27/2021 CESAREAN DELIVERY
nausea; run diwn; nose bleed; diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), FATIGUE (run diwn), EPISTAXIS (nose bleed) and DIARRHOEA (diarrhoea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Percodan), Food allergy (Tomatoes), Food allergy (Strawberries) and COPD. Concomitant products included ALPRAZOLAM for Anxiety, ALENDRONATE SODIUM (FOSAMAX), LAMOTRIGINE (LAMICTAL), METOPROLOL SUCCINATE (TOPROL XL) and PREDNISONE for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea), FATIGUE (run diwn), EPISTAXIS (nose bleed) and DIARRHOEA (diarrhoea). At the time of the report, NAUSEA (nausea), FATIGUE (run diwn) and DIARRHOEA (diarrhoea) had not resolved and EPISTAXIS (nose bleed) had resolved. Not Provided          No treatment information was reported.   This case was linked to MOD-2021-089419.
expired dose of Daptacel was inadvertently administered; Initial information received on 24-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old male patient who experienced expired dose of HEPATITIS A and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]was inadvertently administered (Expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.   Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 24-Feb-2020, the patient received a 0.5mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5367AA via intramuscular route in the right thigh.  This is a case of actual medication error due to expired product administered.  At the time of this 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 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.
Day three developed papular rash on both forearms mild. Rash has progressed to confluent macularpapular rash.  Itchy.  Isolated to forearms and now hands.  No rash anywhere else.  No other systemic signs of symptoms.
This is a spontaneous report received from a contactable consumer (patient). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Feb 27, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunization. The patient developed lymphadenopathy/swollen lymph nodes and myalgia/muscle pain, with outcome of unknown. Additional information: She received the second dose on Feb 27, 2021 and experienced swollen lymph nodes and muscle pain. No follow-up attempts possible. No further information expected.
aching generalized 21OCT97 p/vax;nausea x 3 days;drainage sinus productive;temp did not take temp, diarrhea;
She had a side effect on her legs with the previous vaccine; 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 female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Allergic to citric acid, reaction(s): "She said she is allergic to citric acid"; Allergic to citric acid, reaction(s): "her throat closes". The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "She had a side effect on her legs with the previous vaccine".  Additional information: Caller was asking about the bivalent vaccine, she heard there are two new ingredients added so she was wondering if those contain citric acid. She said she was allergic to citric acid. If she gets citric acid, her throat closes. She said that, she had a side effect on her legs with the previous vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
4 large hives while driving home (within 30-40 minutes of vaccination).  Took NSAID (no antihistamine on hand) and resolved in 3-4 hours.  No respiratory compromise or hypotension, just some fatigue and itching.
Information has been received through the Pregnancy Registry for GARDASIL through a nurse practitioner concerning a 15 year old white, non-smoker female, with acne and no previous pregnancies, who on 02-AUG-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot #657006/0188U).  Concomitant therapy included ORTHO EVRA and "minocycline".  Subsequently, the patient found out she was pregnant (LMP = 22-JUN-2007).  The patient had an ultrasound (not further specified).  The patient sought unspecified medical attention.  Follow-up information received 10-APR-2008 from the physician reported that on 01-NOV-2007, the patient had an ultrasound which was normal except "small venous lakes in the placenta".  The reporter also indicated that the patient had stopped therapy with ORTHO EVRA (date not specified).  From November 2007 until present, the patient has been on prenatal vitamins (not further specified).  The patient discontinued treatment with minocycline for acne in November 2007.  On 04-Jan-2008, the patient was given a flu shot (not further specified).  There were no complications during pregnancy.  On 02-Mar-2008, the patient delivered a female infant, 5 pounds, 7 ounces, 18 1/4 inches long, and an apgar score of 8/9.  Delivery was 36 weeks and 2 days from LMP.  The infant had no congenital anomalies, no complications or abnormalities, and there were no complications during labor and delivery.  No additional information is expected.
people who got the shingles after getting the shingle shot /suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter know the people who got the shingles after getting the shingle shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Daptacel was given 4 days after the Expiry date/no ae; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 month old female patient who received 0.5 mL expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5367AA, of Expiration date: 30-Jan-2020) via intramuscular route in the right thigh for prophylactic vaccination on 04-Feb-2020 (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient recieved HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  At the time of reporting the patient had no adverse event.  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.
Low grade fever, bad head ache, achy, large swollen arm at injection site (about silver dollar size, hard raised about 1/4-1/2 of an inch, very tired.
red raised area approx 5cm diam around inj site, warm to touch;pt's temp 98.6 orally;states pain @ inj site radiating into lt shoulder & neck, deniesnuchal stiffness;states had severe h/a this AM rellieved w/APAP
Began feeling lightheaded after vaccine. Felt like "cold sweat". Experiencing some SOB. No history MI. Family History of MI.  Transported Medical Center.
Information has been received from a physician concerning a 6 month old female, with no medical history, who on 03 Oct 2006 was vaccinated with one 2ml oral dose of Rotavirus vaccine (lot 655050/0778F). There was no concomitant medication. On 30 Oct 2006 the patient experienced diarrhea. It was reported that it was later determined that she had rotavirus. It was unknown of it was wild type rotavirus or vaccine strain. At the time of the  report the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
My symptoms started on April 24, 2018. My eyes would not focus, my gait was off, and I was slurring my words. On April 25, 2018 I went to the doctors and then the ER. At the ER I did a head MRI which came out clear. On April 26, 2018 I went to see a neurologist. When walking to the neurologist appointment I fell and I could not lift myself up. Two workers had to lift me up and put me in a wheelchair because my leg muscles were too weak to support me. The neurologist recommended that I check into the ER to do more blood tests and be observed. In the ER I had multiple blood tests done and did a spine MRI that was clear. My symptoms also got worse while in the ER. I could not walk without a walker, lift myself out of bed or off the toilet. I spent the night in the ER and was released the next day April 27, 2018. The doctors told me my symptoms were caused by stress and recommended that I see a psychiatrist and scheduled PT to come to my house. From April 27 to the middle of May I could not chew because my jaw muscles were not responding. I could not do basic motor functions like brush my hair because my arms did not respond properly. My leg muscles were still weak so I could not go upstairs or walk without a walker. I also needed to use a commode to be able to get off the toilet. I had PT appointments for 3 weeks once a week. The PT appointments focused on strengthening my muscles. From the end of May until June 19, 2018 my symptoms slowly got better. I got stronger and was able to walk without a walker, chew food, and do basic motor functions again.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: patient passed out due to anxiety-Mild, Systemic: Flushed / Sweating-Mild
Myalgia in arm and shoulder, loss of range of motion affecting daily activities (eg. inability to dress, discomfort while sleeping, etc) and shooting pain with pressure/touch. These effects have lasted more than 6 months since injection.
Sensorineural hearing loss (sudden hearing loss in right ear) concurrent with labyrinthitis. Late evening preparing for bed on March 3, 2021 experienced a ringing in right ear. Awoke at 3:30 am on March 4 with severe vertigo, no hearing in right ear. Required ED visit to stabilize, MRI and scans ruled out stroke or other brain issues, thus dx as labyrinthitis. Sent home with Meclizine and instruction to visit with primary care as soon as possible. Started 10 trial of oral Prednisone at 60 mg daily on March 12. Signs of vertigo, mostly unsteadiness and having to walk with cane, and some vision impairment and inability to focus continued at least seven weeks, just recently having finally cleared. However, following three intratympanic injections of Prednisone, I still have total hearing loss in the right ear.
Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing.
Nervous reaction where I can't stop my arms and head from shaking.; This is a spontaneous report from a contactable consumer (patient).    This 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 12Feb2021 12:00 (Lot Number: EN5318) as single dose (at 45 years old) for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. Concomitant medications included atorvastatin, ramipril, venlafaxine, vitamin D nos, all taken for an unspecified indication, start and stop date were not reported. Previously the patient received the first dose of BNT162B2 (Lot Number: EL1283) on 22Jan2021 in the left arm for COVID-19 immunisation. On 12Feb2021 23:30 , the patient experienced nervous reaction where I can't stop my arms and head from shaking. with outcome of not recovered. No treatment was received. The vaccine was administered at Public clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.   Follow-up attempts completed. No further information expected.
A mother reported that her son received a dose of Orimune in 1997 and has subsequently experienced unspecified problems.
severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol. Concomitant products included SIMVASTATIN for High cholesterol.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 12-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea). At the time of the report, DIARRHOEA (severe diarrhea) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-048259 (Patient Link).
a very mild fever of 99.5 degrees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 52-year-old male patient received BNT162b2 (COMIRNATY), on 16Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (dose1), for COVID-19 immunization; Covid-19 vaccine (dose2), for COVID-19 immunization; Covid-19 vaccine (dose3), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset Jul2022, outcome "recovered" (Jul2022), described as "a very mild fever of 99.5 degrees". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Approximately 18 hours post-dose, he registered a very mild fever of 99.5 degrees. Later that afternoon, it spiked to 101.1 then decreased over the next couple of hours and was normal at 97.9 at 24 hours post dose. No underlying medical conditions and no medications taken daily except multivitamin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient rc'd vaccines on 12/23 and 1/13 was swabbed and positive for covid on 1/14
This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown age and gender. Medical history was not reported. On 07-JUL-2014 the patient was vaccinated with ZOSTAVAX 1 vial of 1, almost 0.6 ml, lot number, expiration date and route were not reported. Concomitant therapy was not reported. The pharmacist informed that on 07-JUL-2014, she reconstituted ZOSTAVAX with sterile water diluent and ZOSTAVAX vial which resulted in an under filled vial of almost 0.6 instead of the required 0.65. The vaccination was still given to the patient. No adverse symptoms were reported. The patient did not seek medical attention. Follow up information was received from the pharmacist which reported that the 74 year old male patient received full ZOSTAVAX dose. The under dose was diluent only. A PQC was filed. This is one of several reports from the same source. Additional information has been requested.
fever (101.3 F), chills, very mild headache, very mild chest tightness, body aches. Started around 1:00 AM Monday (15 hours after administration). Took tylenol 1000 mg every 4-6 hours. Fever resolved around 4:30 PM Monday. Body aches resolved around 10:00 PM Monday night. Symptoms fully resolved by Tuesday
Reaction from Daptacel vaccine. Left thigh is red, swollen, warm to touch. Measures 19.5cm by 7 cm in size. Right thigh has same sx's and measures 5cm x 5cm in size.
Pt complained of muscle pain after influenza shot, described like she was given a tetanus shot. 2 days later she felt more of an ache, she went to a physician 2/12/15 who said she could have bursitis and referred her to an orthopedic surgeon and MRI. She was given tramadol, NSAIDS and told to ice. She has follow up in March.
Cellulitis @ site of inject & distally to forearm; ATB tx thru local ER caused marked improvment by re-eval on 11MAY92;
rt arm red, swollen & warm to touch from elbow down to wrist;T98;tx Ceftin & then Keftabs & cool compresses;
The patient is 14 years old and received the Pfizer pediatric dosage by administering RN.
Information has been received from a physician concerning a 25 year old female with cardiovascular disorder and a history of AV node surgery who on 01-AUG-2007 was vaccinated with the first dose of GARDASIL. There was no illness reported at the time of vaccination. On approximately 01-AUG-2007, after getting the first dose of GARDASIL, the patient experienced a supraventricular tachycardia episode and sought unspecified medical attention. On approximately 01-OCT-2007, after getting the second dose of GARDASIL, the patient experienced a supraventricular tachycardia episode. The physician stated that patient denied for the third dose. The patient outcome was unknown. additional information has been requested.
Rash; swollen face; eyes swollen almost shut; dry, scaly skin on eyelids & undereyes; SOB, extreme trouble breathing; post nasal drip; lung congestion.
Left arm swelled, red, hot, rash like area that ws 5 inches by 4 inches.
pt became limp, fell off chair & had jerky movements of arms & legs; pt lost consciousness a few moments & awoke startled & unable to remember what had just happened; pt taken to ER:
Patient came for second dose Pfizer COVID vaccine at location.  He got his vaccine at 315pm.  Immediately following the immunization he had a vaso-vagal reaction.  He became light-headed, diaphoretic and pale.  Dr. examined him and he was walked to a litter to lay down.  He was given an ice pack and water.  His legs were lifted.  He felt better after laying down.  He left for home at 235pm after the symptoms resolved.
- Teeth nerve pain  - Extreem thirst - Swelling and warm hands and feet and aching - Ear pain and tinnitus and muffled sound (hearing loss) - Neck pain - Lower Back pain (4/19) - Middle back pain - Hiccups - Dry leathery skin (skin around fingernails and toenails peeled, hang nails (toes and fingers), lips cracked peeled overall skin looked dry wrinkled) no amount of oil or lotion helped.  - Mouth painful blisters in the back that never popped just went away - Narcolepsy like tired episodes 35 minutes after vaccine 2x since - Dizzy when standing (evening of vaccine) - Knee patella dislocated and both knees seem unstable like they are going to dislocate entirely when leg is twisted like turning. - Tender to the touch and pain under left rib cage   4/13/21 one episode of narcolepsy weird tire episode that lasted a total of maybe 10 minutes with complete waking up just as I laid down to nap. Right arm hurt but not bad. Chills with a temperature of 97.1F and later was drenched in sweat with a temperature of 97.8F. Woke up super thirsty and was so thirsty for several days drinking 1.5 gallons of water and still being thirsty even when I tried some salt pills.   4/16/21 Really red, swollen and itchy eyes (allergies) with sinus headache 4/17/21 lower back went out slowly all day till I was stuck in bed with ice. Right arm tingling like pins and needles. Lips super dry cracking and peeling.  5/14/21 started prednisone