chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 15 year old female who in approximately March 2007 was vaccinated, intramuscularly, into the deltoid, with a first dose of Gardasil concomitantly with a dose of Menactra. In approximately March 2007 the patient fainted. Subsequently, the patient recovered. Additional information has been requested.
Redness, shortness of breath, wheezing, dizziness, swelling, Anaphylactic shock
Patient received more than the recommended number of Pfizer COVID-19 vaccine doses. In total they received four doses of the vaccine.
Pt noticed silver dollar size, red, raised, itchy rash around yellow fever injection site (ALR). On 05/31/02 around 5pm, mother applied topical "anti-itch" cream for one day, no further c/o itchiness and rash is improving per mother.
Started with body aches like the flu, then fever which was 100.5 when checked late afternoon next day and feel it went up a little higher possibly to 101 during night. Fever broke at 5a.m. February 14.  Today, February 14, just feel wiped out but body aches are subsiding greatly.
Patient came in on Monday (8/17/15) complaining of redness around the injection site.
itching; pain in the right arm; huge and bulging welt and it was inflamed; pain in her stomach, above the navel; This spontaneous case was reported by a physician and describes the occurrence of ABDOMINAL PAIN UPPER (pain in her stomach, above the navel), PRURITUS (itching), PAIN IN EXTREMITY (pain in the right arm) and VACCINATION SITE SWELLING (huge and bulging welt and it was inflamed) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (morphine allergy) and Allergy to antibiotic (Keflex allergy). Concomitant products included FENOFIBRATE and CALCIUM, COLECALCIFEROL (CALCIUM +D3) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (pain in her stomach, above the navel). On an unknown date, the patient experienced PRURITUS (itching), PAIN IN EXTREMITY (pain in the right arm) and VACCINATION SITE SWELLING (huge and bulging welt and it was inflamed). The patient was treated with PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) ongoing since an unknown date for Depression, at a dose of 20 mg. At the time of the report, ABDOMINAL PAIN UPPER (pain in her stomach, above the navel), PRURITUS (itching), PAIN IN EXTREMITY (pain in the right arm) and VACCINATION SITE SWELLING (huge and bulging welt and it was inflamed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Additional information was provided that patient had felt uncomfortable with the facility where she had received vaccine because patient felt that they were hiding from her that which vaccine she had received.
passed away; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): 110772.  A 41 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: Unknown) at the age of 41 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "passed away". The patient date of death was unknown. The reported cause of death was "passed away". It was not reported if an autopsy was performed. Addition information: it was reported that: A 41-year-old patient who had no health problems, 48 hours after receiving the vaccine, he passed away.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away
This case was reported by a lawyer and described the occurrence of muscle weakness in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced weakness, fatigue, possible autoimmune disease, activities of daily living impaired, tingling, numbness, flu-like symptoms, headaches, possible memory loss and possible neurological problems. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 12 January 2009 via medical records. The subject was vaccinated with LYMERIX on 06 April 1999, 11 May 1999, and 25 May 2000. Between his second and third doses of LYMERIX, he developed "extreme" leg fatigue and muscle aches in his legs. In 2001 or 2002, he developed numbness in his left foot. he was reportedly advised that he might require intravenous immunoglobulin (IVIG) in the event that neuropathy progressed. The events were unresolved at the time of this report. The event of neuropathy was assessed by GSK to be medically significant.
They both developed fever blisters.; They both had fevers.; This spontaneous case was reported by a nurse and describes the occurrence of ORAL HERPES (They both developed fever blisters.) and PYREXIA (They both had fevers.) 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 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 10-Dec-2021, the patient experienced ORAL HERPES (They both developed fever blisters.) and PYREXIA (They both had fevers.). At the time of the report, ORAL HERPES (They both developed fever blisters.) and PYREXIA (They both had fevers.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.    This case was linked to MOD-2021-411071 (Patient Link).
This spontaneous report was received from a pharmacist via Regulatory Authority regarding a 27 year old male patient. Information on medical history, current conditions and concomitant therapies was not reported. On 20-JUN-2018, the patient was vaccinated with first dose of M-M-R II of lot # N005774 with an expiry date of 17-DEC-2019 via intramuscular route for prophylaxis (strength, anatomical location not reported). Other suspect therapies included sterile diluent of lot # N009799 with an expiry date of 29-NOV-2018, once via intramuscular route for reconstitution of M-M-R II. The pharmacist reported that the patient was advised to contact the pharmacy if he has an adverse experience, however, at the time of the report, the patient had not communicated any adverse experiences. Lot Number N009799 is not a valid lot for STERILE DILUENT.
Tired   headache bloody nose  Brain  Bleed Stroke 6/2/2021
Patient came in for a vaccination however after receiving a dose of Moderna vaccination, patient  informed staffed that he already received vaccination.  Researched records and patient received two doses of Pfizer vaccination from Agency.
ITCHING AROUND INJECTION SPOT. SOME SWELLING AND SLIGHT HEADACHE.
17 YEAR OLD RECEIVED TWO DOSES OF MODERNA COVID-19 VACCINE. 2/23/21 LOT # 010a21a 4/2/2021 LOT # 017B21A NO ADVERSE EFFECTS REPORTED
Pt recvd vax & approx day following vax pt exp fever, malaise, weakness & nausea;
Patient's stated her lips, throat and tongue felt numb (like she'd eaten a popsicle stick she described). her hands were also numb. her face and chest were flushed and had hives. She stated feeling like she was going to pass out. She was able to talk but  was taking deep breaths. She wanted to wait for a few minutes before we administered EpiPen as she was starting to feel better.  Emergency services was called and evaluated her. As her condition was improving well, they advised her to take Benadryl  and seek emergency care if symptoms worsened.
She had weakness to the point she wasn't able to bear weight on her extremities, confusion, chills, emesis,and fatigue.  She was sent to ER @ Hospital.  Continues with confusion and weakness as of 3/4/2021.
Had a seizure within 24 hours after receving the vacinne. No seizure history. 12/19/08-records received for DOS 9/22/08 C/O sore throat, seizures. Few weeks prior had a tonic/clonic gran mal seizure. Had scratchy throat 2 days prior to seizure.
Face was flushed; tingling in her cheeks, lips, and tongue - "that feeling you get when you apply those lip pumping lipsticks."; numbness in her cheeks, lips, and tongue - "that feeling you get when you apply those lip pumping lipsticks."; This spontaneous case was reported by a nurse and describes the occurrence of FLUSHING (Face was flushed), PARAESTHESIA ORAL (tingling in her cheeks, lips, and tongue - "that feeling you get when you apply those lip pumping lipsticks.") and HYPOAESTHESIA ORAL (numbness in her cheeks, lips, and tongue - "that feeling you get when you apply those lip pumping lipsticks.") in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 11A21A and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 2008 and Prediabetes. Concomitant products included LISINOPRIL from an unknown date to 23-Mar-2021 and LOSARTAN from 24-Mar-2021 to an unknown date for Hypertension, METFORMIN for Prediabetes, ZINC, ASCORBIC ACID (VIT C), DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID, TOCOPHEROL (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]), METHYL B COMPLEX and ACETYLCYSTEINE (NAC [ACETYLCYSTEINE]) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced FLUSHING (Face was flushed), PARAESTHESIA ORAL (tingling in her cheeks, lips, and tongue - "that feeling you get when you apply those lip pumping lipsticks.") and HYPOAESTHESIA ORAL (numbness in her cheeks, lips, and tongue - "that feeling you get when you apply those lip pumping lipsticks."). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. On 01-Mar-2021, FLUSHING (Face was flushed) and PARAESTHESIA ORAL (tingling in her cheeks, lips, and tongue - "that feeling you get when you apply those lip pumping lipsticks.") had resolved. At the time of the report, HYPOAESTHESIA ORAL (numbness in her cheeks, lips, and tongue - "that feeling you get when you apply those lip pumping lipsticks.") was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-208021 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Other relevant history, treatment drugs, concomitant medications and event were added.
This spontaneous report as received from a pharmacist refers to a currently 73 years old female patient with drug allergy to penicillin. The patient's medical history was not reported. On 27-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # K020185, expiration date: 27-JAN-2016, 0.65 ml, subcutaneous. No concomitant therapies were reported. On 21-APR-2015, the pharmacist saw the patient, and she had a dime size nodule present under the skin at the injection site. The nodule was not causing any pain or itchiness. It was not known exactly when was the nodule developed. The reporting pharmacist stated that the patient did not sought any medical attention. There was no treatment given for the adverse event. The outcome of the injection site nodule was reported as not recovered. The reporter did not provide a causality assessment for the event. Additional information has been requested.
Temp 103.0, severe headache, all over body & muscke aches, nausea, cough. Lasted for over 48 hours, then gradually decreased
Information has been received from a nurse practitioner concerning a 24 year old female with no illness at the time of vaccination, no drug allergies/reactions or pertinent medical history who on 02-OCT-2007 was vaccinated with a first dose GARDASIL vaccine in the left deltoid at 5 PM. On 10-DEC-2007, the patient had a second dose of GARDASIL vaccine (lot # 659441/1446U) in the left deltoid at 5 PM. On 10-APR-2008, the patient had a third dose of GARDASIL vaccine (lot# 659180/1758U) in the left deltoid at 9 AM. There was no concomitant medication. Subsequently, the patient reported tingling and numbness in fingers of both hands for 3 days after each administration of the vaccine. The symptoms resolved spontaneously. The patient was evaluated by her primary care physician after the second dose. Additional information is not expected.
Stood up after vaccine and then passed out. Evaluate by EMS BP 100/72 P 60.  Felt better. Went home with mom.
I have pain over and behind my left eye; My left arm pain and that is gone now; headache, it is not even a normal headach; pain in my head is just excruciating; dizzy spell on and off; body is aching; neck is stiff; I cannot hold water down/throwing up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE PAIN (I have pain over and behind my left eye), PAIN IN EXTREMITY (My left arm pain and that is gone now), HEADACHE (headache, it is not even a normal headach), HEADACHE (pain in my head is just excruciating) and DIZZINESS (dizzy spell on and off) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced EYE PAIN (I have pain over and behind my left eye), PAIN IN EXTREMITY (My left arm pain and that is gone now), HEADACHE (headache, it is not even a normal headach), HEADACHE (pain in my head is just excruciating), DIZZINESS (dizzy spell on and off), PAIN (body is aching), MUSCULOSKELETAL STIFFNESS (neck is stiff) and VOMITING (I cannot hold water down/throwing up). At the time of the report, EYE PAIN (I have pain over and behind my left eye), HEADACHE (headache, it is not even a normal headach), HEADACHE (pain in my head is just excruciating), DIZZINESS (dizzy spell on and off), PAIN (body is aching), MUSCULOSKELETAL STIFFNESS (neck is stiff) and VOMITING (I cannot hold water down/throwing up) outcome was unknown and PAIN IN EXTREMITY (My left arm pain and that is gone now) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No corrective treatment  was reported. The patient had consulted her Health care provider (HCP), and her HCP doesn't had any information.   Reporter did not allow further contact
heart murmur; Eye pressure elevated; Gaining weight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4618823.  A 71-year-old male 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. The following information was reported: CARDIAC MURMUR (non-serious), outcome "not recovered", described as "heart murmur"; INTRAOCULAR PRESSURE INCREASED (non-serious), outcome "not recovered", described as "Eye pressure elevated"; WEIGHT INCREASED (non-serious), outcome "not recovered", described as "Gaining weight". Relevant laboratory tests and procedures are available in the appropriate section.  Addition information: Patient's concomitant medication included: was not reported. It was reported that: we have no further information regarding the reported event(s) described above. Any additional material information received will be forwarded to you in accordance with policies and procedures. On unknown date, patient started therapy with COVID-19 VACCINE for COVID-19. On unknown date, it was reported that patient experienced: Heart murmur, Eye pressure elevated, Gaining weight.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ITCHY EYES, COUGHING, SEVERE HEADACHE, SLIGHT FEVER, VOMITING.
At 0030 (about 12 hours after receiving shot), awoke to sudden development of severe epigastric pain, severe headache, fever (temp 101 F, maximum later at 102 F), and rigors. Rigors quickly abated, while abdominal pain, fever and headache maintained for next 12 to 14 hours. Abdominal pain was unrelenting, could not sit up, work, sleep, or interact. Mild nausea, no vomiting or diarrhea. Pulse ox 99%, pulse in the high 90s (baseline 50s). Took 325 mg acetaminophen at about 1100 (11 hours after symptom onset) with mild relief. Experienced more relief by about 1500. Was able to eat a small meal about 1700. Mild post-flu-like symptoms the next day, and no symptoms after that.
This spontaneous report as received from a licensed nurse practitioner refers to a multiple patients of unknown age and gender. The patents' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 22-SEP-2016 or 23-SEP-2016, the patents were inadvertently vaccinated with an improperly stored dose of M-M-R II (therapy type, dose, route of administration, lot # and expiration date were not reported). The administered doses of vaccines were exposed to a temperature of 1 Celsius degrees, for 1 hour and 46 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Headache; Chills; Fever; Sore Throat; Body aches; This is a spontaneous report from a contactable Nurse.  A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number and expiration date unknown) intramuscularly on 20Jan2021 (at the age of 49-years-old) as a single dose for COVID-19 vaccination.  The patient's medical history was not reported. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE on 30Dec2020. Prior to vaccination, the patient had not been diagnosed with COVID-19. The patient was administered the vaccine in a Nursing Home/Senior Living Facility. The patient's concomitant medications were not reported. On 20Jan2021 at 11:00 the patient experienced headache, chills, fever, sore throat, and body aches. Treatment was not received for the events. The clinical outcome of headache, chills, fever, sore throat, and body aches was reported as not recovered. It was also reported that since the vaccination the patient has not been tested for COVID-19.
Wife noticed while at H.D. Pt was slurring some words. This progressively worsened throughout the day until going to hospital around 2-2:30pm was admitted to the hospital. No paralysis, no pain, movement ok in all extremities, just slurred speech. Able to write his thoughts down. 12/14/09 DC summary and hospital records received for DOS 12/01/09-12/04/09. Approx. 1 week prior to admission, pt. began noticing episodes where he had trouble speaking.  These periods would come and go but on the morning of admission symptoms were continuous. Hospital course included dialysis maintenance; endocrine, nephrology, and neurology consults.  Discharged home with continued slurred speech, but improved from time of admission.    DC DX: Left parietal CVA causing expressive aphasia
pt recv vax & devel an inj site rxn characterized by redness, pain, & warmth;
Patient developed unilateral facial swelling of his L cheek and L eyelid, he has some flushing of bilateral cheeks as well. Treating with BENADRYL. He has no other symptoms and is otherwise well appearing.
red arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red arm). At the time of the report, ERYTHEMA (red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received from a physician concerning a 38 year old male who on 19-MAR-2008 was vaccinated intramuscularly with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 659147/1381U). On 23-MAR-2008 the patient developed swelling and discomfort from the injection site down to his elbow after receiving the pneumococcal 23v polysaccharide vaccine. The patient was evaluated initially at an urgent care clinic and then was seen at the physician's office and treated with cephalexin (KEFLEX). No diagnostic laboratory testing was performed. The patient recovered on an unspecified date. No product quality complaint was involved. This is one of three cases received by the same source. Additional information has been requested.
Pt was on the schedule or a covid vaccine--she wanted the Pfizer vaccine. When she came in she was actually given the bivalent vaccine and she had not received and previous vaccines for covid before.  Was later determined that patient should receive primary series as well, and received primary dose on 2/13/23.