chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 22 year old female who was vaccinated with a dose of Gardasil vaccine (yeast). Subsequently, after receiving the vaccination, the patient developed red lesions around the injection site on her arm. On an unspecified date, the patient recovered. Additional information has been requested.
PT EXPIRED FROM COVID-19 ON 9/5/2021; BREAKTHROUGH CASE
Lack of Response- information has been received from a health care professional concerning a 2 year old patient who on 23 Oct 1998 was vaccinated withvaricella virus vaccine live.  It was noted that on 16 oct 1998 the patient received a dose of measles- mumps - rubella vaccina (MSD) susequently the patient sought unspecified medical attention and was found to have a negative varicella titer.  additional information has been requested.
inflammation of joints in hands, feet, stiffness of shoulder, knees, wrists & finger joints;
Day after vaccination 8/11 developed frequent but intermittent chest pain and shortness of breath.  8/12 developed tingling in palms and finger left hand  and pain in shoulder into neck on the left side. Also continued to have the chest pain and shortness of breath, but not as often.
Right shoulder and arm have been painful and getting progressively worse since vaccination. Went to urgent care and was diagnosed with bursitis in my left shoulder. No other events that might have caused the pain.
Severe Joint and muscle aches, fever, chills, loss of appetite, night sweats, severe headache, extreme fatigue. Symptoms started 8 hours after injection and persisted for 3 days. Took Tylenol as needed for fever and pain. Extreme fatigue kept me immobilized for those 3 days.
itching and swelling at site of injection (left upper arm) 24 hours after injection. Subsequently developed diffuse itch from head to lower torso, Halo-type headache.No photophobia, phonophobia, hives, throat tightness, wheezing, chest congestion or shortness of breath.
April 12th - 4:30 pm and on - I was very tired and groggy April 13th - 7:30 am until 10:00 pm - I had a headache, nausea, no appetite, chills, fever up to 101.6, constipated and overall felt crappy - slept most of the day. I took Tylenol as advised by the medical center to help reduce the fever and aid injection site tenderness. April 14th - 7:15 am - 11:00 pm - I had a headache (not as bad as previous day, nausea, no appetite, chills, fever up to 99.4, constipated and overall felt crappy - slept a bit less than previous day. Between 2:00 am and 6:00 am, I believe the fever broke - sweats were consistent. I took Tylenol as advised by the medical center to help reduce the fever and aid injection site tenderness. April 15th - 7-20 am - current - All above listed symptoms have gone away. I also had a bowel movement twice today. I feel a bit tired but almost back to normal.
Pt reports that by the morning after the 2nd dose of Moderna, his left arm was feeling more tight and swollen.  Pt denies any c/o  itching.  States that this shot seemed "like it hurt more" than the first shot.   Pt reports that he did apply ice to the injection area as well as OTC steriod cream and that nothing was helping.  He was also elevating the left arm to try and reduce the swelling. RN
A report has been received from a Pharmacist concerning a 10 year old, Female patient who had been receiving Nasal FLUMIST Quadrivalent (Intranasal). FULMIST Quadrivalent started on an unknown date. On 15-FEB-2016 pharmacist administered expired FLUMIST Quadrivalent. The outcome of the event of administration of expired FLUMIST was unknown. The report was considered to be non-serious. The reporter and company physician considered that event of administration of expired FLUMIST to be unrelated to FLUMIST Quadrivalent.
This spontaneous report has been received from a Registered Nurse referring to a 4 years old female patient. The patient did not have any pre-existing physician-diagnosed allergy, birth defects, medical conditions or illness at time of vaccination. On 20-SEP-2018, the patient was vaccinated with M-M-R II lot # R011217, expiration date: 15-OCT-2019, subcutaneously (SC) in the left thigh (LT); she was also vaccinated that day with influenza virus vaccine (unspecified) lot # UJ012AD (expiration date not provided), intramuscular (IM) in the right thigh (RT); and diphtheria toxoid (+) pertussis acellular 1-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (DTAP-IPV) lot # C5497AA (expiration date not provided), IM RT both manufactured by Sanofi. All the vaccines were administered for prophylaxis and purchased with private funds. The administered doses of the vaccines experienced a freezer temperature excursion (not specified) (product storage error) as recorded from a digital data logger which occurred at the time of storage in clinical practice. None adverse effects were reported. (conflicting information reported that the patient received an unspecified treatment for the "none" experience). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1809USA010598: US-009507513-1901USA002765: US-009507513-1901USA002758: US-009507513-1901USA002759: US-009507513-1901USA002760: US-009507513-1901USA002761: US-009507513-1901USA002762: US-009507513-1901USA002763: US-009507513-1901USA002764: US-009507513-1901USA002755: US-009507513-1901USA002754: US-009507513-1901USA002753: US-009507513-1901USA002757:
About 10-15 minutes after receiving vaccine patient reported that her heart began to race and throat began to swell.
Vaccine was placed in freexer on 12/6 and pulled out of freezer on 1/3/22.
The reporter causality is not provided. Case reference MEDI-0002521 is a spontaneous case report sent by consumer which refers to male aged 49 years. The male received FluMist on Nov 23 2004 at 4pm. ON Nov 25 2004, the male stated he was achy all over and had a headache, By the following day the reporter stated he had the full blown flu. On Nov 26 2004 he had light chills that became worse by Nov 27 2004. He stated his chills were so severe on Nov 27 2004 that he had to wear a coat while indoors. He used ibuprofen for treatment. By Dec 02 2004 all events excluding loss of appetite had resolved. The reporter stated his appetite returned on Dec 05 2004.
I had severe weakness, joint pain, and body aches. I could barely get myself out of bed or get up to go to the bathroom. The symptoms were reminiscent of having pneumonia. I went to the doctor that following Monday. I continued to use Tylenol.  Last month, I've been having cognitive issues and I was blacking out. I went to the hospital and it was discovered that I had an aneurysm. I was hospitalized for 3 days. I am actually going to see a neurologist tomorrow.
March 3, 2021-Sore injection site of right arm March 4th- Injection site slightly sore March 5th -sore left calf  March 6th- Sore left calf a little more so March 7th- Outside left calf hot to touch & back of calf red and sore. March 8th- Same as above, and I put doterra Deep Blue ointment on it, and it relieved the heat and pain Redness is gone March 9th -Left side of body joints ached.  left calf aches/applied Deep blue ointment and a Pain relief ointment .  Feels a lot better March 10th- Redness gone, but still feels sore March 11th- Left leg Calf feels a lot better, I put on the ointment again.  Deep Blue, and Frank Woods Pain Relief ointment. March 12- Left calf a little sore.  No heat .  Now my left eye has a light grey spot in it.  I can see around it. March 13-Eye's don't feel right.  I still have the light gray floater in the left eye.
Pt recvd Engerix-B & devel nausea for 3 days & a yeast infection; tx w/Asajel; devel vaginal discharge; 27AMR92 2nd dose of Engerix-B; also nausea, vomiting & severe vaginal yeast infect; seen by MD;
Eczema on hands, swollen arm, nausea, vomiting, fatigue, dizziness
This spontaneous report was received from a pharmacist as conveyed by the physician regarding a female patient of unknown age. The patient's medical history included an episode of ocular shingles on an unspecified date. The patient concurrent conditions and concomitant therapies unknown. It was unknown if the patient had drug reactions/allergies. On an unknown date (Also reported as 2.5 years later), the patient was vaccinated with a dose of ZOSTAVAX (Strength, frequency, anatomical location, route, lot # and expiry date were not reported) for prophylaxis. On an unknown date, 2.5 years later, the patient was diagnosed with ocular shingles for the second time. It was unknown if the patient received any treatment. It was unknown if any lab diagnostics/studies were performed. There was no product quality complaint (PQC) associated with this report. The outcome of the event of ophthalmic herpes zoster was reported to be recovered. The causality assessment was not provided. Upon internal review, the event of ophthalmic herpes zoster was determined to be medically significant.
This case was reported by a physician via sales rep and described the occurrence of headache in a 16-year-old female patient who received BEXSERO. On 3rd October 2016, the patient received the 1st dose of BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced headache and nausea. On an unknown date, the outcome of the headache and nausea were unknown. It was unknown if the reporter considered the headache and nausea to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in right arm. No further information was provided. This case has been linked with case US2016GSK166854, reported the same reporter for the same patient.
Reaction with fever, neck and shoulder pain and stiffness, redness and swelling to face and upper body. No meningismus. No weakness or neurological deficits. Got better with Benadryl 50mg IM. Will be continued on Claritin 10mg 1 tablet daily x 7 days.
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills that lasted one day.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced CHILLS (Chills that lasted one day.). On 20-Jan-2021, CHILLS (Chills that lasted one day.) had resolved. Not Provided. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant and treatment medications were reported. Treatment information provided included none. Action taken with mRNA-1273 in response to the events was not applicable.
After receiving vaccine on 09/27/2017, patient noticed severe rash 10 days after on her left arm and on her left leg. She experienced red and itchy skin, with slight inflammation.
Pt recvd 1st dose of Hep B vax 4NOV91 & the following day pt exp nausea, body aches, & devel swelling of eyes & face; Presented to ER & tx w/unspecified prescription drugs; @ the time of the report pt recovered;
This spontaneous report as received from a nurse refers to a patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 30-MAR-2017, the patient was vaccinated with an expired dose of GARDASIL injection (confirmed not GARDASIL 9) with lot # L039066 and expiration date: 30-MAR-2017 (dose and route of administration were not provided). No adverse symptoms were reported. The nurse stated, the dose of GARDASIL did not has any previous temperature excursions. Additional information has been requested.
Hives - red flat swollen patches from left arm above elbow , shoulder, back of neck, mid back, right shoulder, above elbow, front collar bone.  Two spots on left hand and one spot on right hand
This spontaneous report as received from a certified medical assistant reporting on a patient of unknown age and gender who on 20-MAR-2012, was vaccinated IM with the first dose of VAQTA (lot# not reported). On 28-AUG-2012, the patient was vaccinated IM with the second dose of VAQTA (lot# not reported). The medical assistant noted that the second dose was administered "about three weeks too early". No adverse effect was reported. Additional information has been requested.
fast heart beat; chills; not able to sleep; shaken up without any temperature; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heart beat), CHILLS (chills), INSOMNIA (not able to sleep) and TREMOR (shaken up without any temperature) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Dose 1. On 15-Feb-2021, the patient experienced HEART RATE INCREASED (fast heart beat), CHILLS (chills), INSOMNIA (not able to sleep) and TREMOR (shaken up without any temperature). At the time of the report, HEART RATE INCREASED (fast heart beat), CHILLS (chills) and INSOMNIA (not able to sleep) outcome was unknown and TREMOR (shaken up without any temperature) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment or concomitant medications were reported.   Reporter did not allow further contact
diarrhea; Lost of appetite; extreme tired; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DECREASED APPETITE (Lost of appetite), FATIGUE (extreme tired) and MYALGIA (muscle aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced FATIGUE (extreme tired) and MYALGIA (muscle aches). On 09-Feb-2021, the patient experienced DIARRHOEA (diarrhea) and DECREASED APPETITE (Lost of appetite). On 09-Feb-2021, FATIGUE (extreme tired) and MYALGIA (muscle aches) had resolved. On 10-Feb-2021, DIARRHOEA (diarrhea) and DECREASED APPETITE (Lost of appetite) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
He got COVID19 after his first shot; He got COVID19 after his first shot; This is a spontaneous report from a contactable pharmacist via a Medical information team. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got COVID19 after his first shot, followed by an antibody therapy. He has to wait 90 days before getting his second shot. Seriousness of the events was considered as medically significant. The outcome of events was unknown.  Information about lot/batch has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 or comirnaty to the reported event Drug ineffective and covid-19 cannot be ruled out.But also consider relevant medical history and concomitant drug history.
Red rash at injection site - very itchy.  Appeared on the 4th day after injection lasted 4 days; the first day being the most reaction and each day thereafter the itchyness lessened.
This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph node in clavicle area became very enlarged and swollen/ lymph node swelling in the clavicle area) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011J20A) for COVID-19 vaccination. Concurrent medical conditions included Migraine, Drug allergy (Allergy to erythromycin (stomach upset) reported.), Drug allergy (Allergy to codeine (hives) reported.) and Allergy (Allergy to medical tape (hives) reported.). Concomitant products included ESTRADIOL for Hormone therapy, ALMOTRIPTAN MALATE (AXERT) for Migraine, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and FLUTICASONE for Seasonal allergy. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced LYMPHADENOPATHY (lymph node in clavicle area became very enlarged and swollen/ lymph node swelling in the clavicle area). On 01-Mar-2021, LYMPHADENOPATHY (lymph node in clavicle area became very enlarged and swollen/ lymph node swelling in the clavicle area) had resolved. Treatment information not reported. This case was linked to MOD-2021-007607. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received and concomitant medication was added.
Noticed blood on her skin after they removed the needle; IMOVAX should not be injected into a blood vessel; Initial information received on 30-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non health care professional via Information (under the reference 00792602).  This case involves a female patient (unknown age) who had noticed blood on her skin after they removed the needle (vaccination site haemorrhage) after receiving RABIES (HDC) VACCINE [IMOVAX RABIES] and while treated with HUMAN RABIES IMMUNOGLOBULIN [IMOGAM RABIES-HT] (incorrect route of product administration).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect IMOVAX RABIES (lot number and expiration date not provided) via unknown route in the left arm for unknown indication and a dose of suspect IMOGAM RABIES-HT (Solution for injection dosage, lot number and expiration date not provided) via unknown route in left thigh for unknown indication.  On an unknown date the patient noticed blood on her skin after they removed the needle (vaccination site haemorrhage, non serious) (unknown latency) following the administration of HUMAN RABIES IMMUNOGLOBULIN and IMOVAX RABIES.  It was an actual medication error due to incorrect route of vaccine administration (latency same day).  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the events.  It was reported "she received IMOVAX and IMOGAM at an emergency room. Caller states after receiving IMOVAX and IMOGAM, everything has been "fine". Caller states she was researching what she should and should not do after receiving these products. Caller states in her research, it was mentioned that IMOVAX should not be injected into a blood vessel; states after she received IMOVAX, she noticed blood on her skin after they removed the needle; states she did not note blood or discoloration in syringe; caller asks if this is okay."  There will be no information on the batch number for this case.  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.
SKIN BLISTER Narrative:  Small skin blister after COVID vaccine PFIZER 1st dose. Patient had no known allergies.
Received series of rabies vaccine for bite of ferral cat which occurred abroad.  Received vaccination 5/24/06, 5/27/06,5/31, 6/7, 6/21 around 7/25/06 developed pain, left deltoid at site of injection.  Muscle pain in same arm and burning sensation in upper arm.  Approximately 8/1/06 developed low grade fever, sore throat, headache, anxiety.  Seen by medical profession in late July and again 8/14 or 15
I met with the family to administer 2nd vaccine to son , on  3/15/22. Via interpreter and from the father and the son, I was told that his other son was about to turn 12 and he really needed the vaccine today as they didn't know when they might be able to get it if they didn't get it now. The father and the child, both gave a DOB and said he was going to be 12.  Due to the circumstances and the urgency from father I administered the first Pfizer vaccine. Today I went back to give the 2nd shot and the interpreter that was interpreting said the child's birthday year was and the child had just turned 11. The father continued to  insist the child was 12....Advised the father that the child received the wrong dose of vaccine and for his 2nd vaccine needs to get the appropriate Pfizer vaccine for children 12 and under. The child had no adverse side effects other than a sore arm. Father expressed understanding and a plan was made to administer the appropriate dose of vaccine in the future.
I developed a drooping eye 2 days after my COVID-19 Moderna booster vaccine. After speaking to my doctor's office, I went to the ER and diagnosed with Bell's palsy.
edema, redness at site. Flu shot given 11/14/06 2:45pm. Mom called doctor 11/15/06 8:20am to report welts at injection site. Patient has received flu shot in past without incident. Benadryl given when seen in office 11/15/06.  11/16/06 now taking Zyrtec.
Pt was sick for 3 days. Pt experienced body ache and drugged feeling. 12/24/2001: As of today the pt is feeling well. This is the first time she had received the flu vaccine.
PFIZER-BIONTECH COVID-19 VACCINE EUA.  ADMINISTRATION ERROR:   Resident documented as receiving 3 doses of vaccine.  First dose of Pfizer COVID-19 vaccine on 1/12/21.  Second dose documented on 2/2/21.  Resident was vaccinated on 2/23/21 with paperwork showing only had 1 dose previously.  Patient has no adverse reactions reported to date.
fever; sore muscles and joints; sore muscles and joints; This is a spontaneous report from a non-contactable consumer. A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 16Mar2021 16:00  as dose number unknown, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced fever, sore muscles and joints on 17Mar2021. The treatment given for the events was unknown. The outcome of the events was recovering.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
child developed redness and swelling at injection site within 24 hours of receiving Varicella vaccine. Advised to use cool wet washcloth on affected area and to give Tylenol or Motrin for inflammation or discomfort. Caregiver did give the child Benadryl with no resolution of symptoms.