chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient approached my station and appeared to be extremely nervous. I had her sit in a chair before administering her H1N1 vacc. She stated she was "scared" I administered vacc immediately observed patient staring and no response on command. EMS assisted patient to a COT and paramedics transported. Pt had brain injury this summer (2009) per school nurse.  12/02 and 12/07 Medical records and discharge summary for DOS 111/5-11/6.  Final DX: Syncope, developemental dealay (NOS)  C/O seizure like episode immediatley s/p vaccine.  Had awarness but could only   stare. Transient dizziness after.  No post ictal. Macular papular rash neck and sternum. Exzema. Syncope vs seizure w/LOC.  PE wnl.  D/C to home.
Although I had symptoms of Erythromelalgia prior to the vaccine, flares have increased over last few weeks. Symptoms include daily: 1) Erythromelalgia flares (numbness, redness, searing heat from hands and feet, particularly in PM) 2) peripheral neuropathy (wrist, hands, knuckles, feet).  3)Joint pain, numbness, and swelling (knees, wrists, knuckles)
No strength and weakness in arms. Notable the right arm.; Half dollar sized circles on arms, legs and face.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 29Apr2021 at 11:00 (at the age of 44-year-old), as a single dose for COVID-19 immunisation. Medical history included circulation issues. Concomitant medications included methylphenidate hydrochloride (CONCERTA) and alprazolam (XANAX) started on an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Apr2021 at 18:30, the patient experienced half dollar sized circles on arms, legs and face; no strength and weakness in arms and was notable in the right arm. The clinical outcome of the event half dollar sized circles on arms, legs and face; no strength and weakness in arms and notable the right arm was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 14-NOV-2018, the patient was vaccinated with a dose of VAQTA, which was after its labeled expiration date (25/0.5, lot # N026997, expiration date 10-NOV-2018, intramuscularly) for prophylaxis. No adverse effects were reported.
Awakened from sleep about 2:20am by extemely Itchy/stinging inflamed area on left upper arm & progressing around front towards underarm;  then progressing to right upper arm and shoulder towards front underarm.   Intermittent stinging mildly itchy  sensations on chin, head and extremities Took 1 Benedryl liquigel and applied cortizone cream to all red inflamed  itchy areas on upper arms and towards front underarm areas. Felt some relief about 20 - 30 minutes later and was able to sleep.  Following morning awoke at abt 8:30 am, and the inflamed areas were mostly gone.  Some pinkness on skin, and still felt random sensations of stinging on limbs Took 1 Zyrtek 10 mg tablet at 9:30am. Outcome, time course still pending
Systemic: Dizziness / Lightheadness-Mild, Additional Details: left VM, He is called back , said he is feeling ok
No Adverse Event; HCP stated they accidentally administered 1 dose of Moderna COVID-19 vaccine Bivalent presentation from dark pink cap on 25 APR 2023 to a 7 months old patient that was not previously vaccinated.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 vaccine Bivalent presentation from dark pink cap on 25 APR 2023 to a 7 months old patient that was not previously vaccinated.) and NO ADVERSE EVENT (No Adverse Event) in a 7-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     It was reported that patient had no known conditions.  Previously administered products included for Product used for unknown indication: PEDIARIX, Rotavirus, PNEUMOCOCCAL CONJUGATE VACCINE (PCV13) and HAEMOPHILUS INFLUENZAE TYPE B (Hib). Past adverse reactions to the above products included No adverse event with HAEMOPHILUS INFLUENZAE TYPE B, PEDIARIX, PNEUMOCOCCAL CONJUGATE VACCINE and Rotavirus.    On 25-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 25-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 vaccine Bivalent presentation from dark pink cap on 25 APR 2023 to a 7 months old patient that was not previously vaccinated.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 vaccine Bivalent presentation from dark pink cap on 25 APR 2023 to a 7 months old patient that was not previously vaccinated.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 vaccine Bivalent presentation from dark pink cap on 25 APR 2023 to a 7 months old patient that was not previously vaccinated.).    Concomitant drugs were not reported. It was reported that patient had all the Pediarix, Hib, PCV13. Rotavirus vaccine on the same day. No other adverse events were reported. Treatment medications were not provided.
Rash All Over His Body; Soreness in the Injection Site; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (Soreness in the Injection Site) and RASH (Rash All Over His Body) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE PAIN (Soreness in the Injection Site). On 20-Jan-2021, the patient experienced RASH (Rash All Over His Body). On 15-Jan-2021, INJECTION SITE PAIN (Soreness in the Injection Site) had resolved. At the time of the report, RASH (Rash All Over His Body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Systemic: Fainting / Unresponsive-Mild, Additional Details: 5 MINUTES POST VACCINATION, PATIENT FAINTED BUT BUT REMAINED CONSCIOUSNESS.  PT WAS INSTRUCTED TO LIE FLAT WITH ELEVATED FEET. FAMILY MEMBER CALLED 911 AND HE WAS TAKEN TO ER.  NEXT DAY, SISTER INFORMED PHARMACY THAT HE WAS RELEASED SAME DAY, AND HE WAS RESTING AT HOME.
Immunization given 9/12/11; sx began 9/15/11: nausea, headache, sweating but no fever; sneezing & dizziness on standing, naproxen relieves headache; ZOFRAN is not helping nausea.
Itching; Red around upper chest; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0183) via an unspecified route of administration in the arm left on 12May2021 at 14:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medications included lisinopril dihydrate (LISINOPRIL) for unknown indication. The patient reported that he was taking medication for high blood pressure which was unspecified. The patient previously took compazine (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16May2021 at 10:00, the patient experienced itching and red around upper chest. Therapeutic measures were not taken as a result of these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event itching and red around upper chest was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient described numbness and tingling in her left arm that lasted a few hours after the vaccination.  It resolved after a couple of hours.
Breakthrough case admission after 2 vaccines Moderna 4/28/21 Lot# 016C21A;  Moderna 5/26/21 Lot# 022B21A
Started tunnel-vision with muffled hearing; lost feeling from neck down; got lightheaded with headache. He had loss of direction and weakness, and felt like he was going to blackout. He looked pale and felt cool to the touch. The shot giver (nurse?) took him to back room, had him lie down, and elevated his legs. Within about 5 minutes he started recovering. He was completely recovered in 20 minutes.
Heart palpitations/fluttering about 7 hours after vaccine, followed by cold sweat. No side effects on second dose.   Insomnia that has lasted about 3 months but has finally abated. Sleep phase was delayed by about 4 hours, ie not sleepy until 3a, not awake until noon.
This spontaneous report as received from a physician via an unspecified reporter through a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 24-SEP-2014, the patient was vaccinated with VAQTA "25U/.5ML 10x1(ped), lot # J000985 with expiration date 20-AUG-2015 (route of administration unknown), which was stored at 1 Celsius Degrees for 48 hours. The storage criteria and the type of excursion was refrigerator (R) and the vaccine status was reported as "in excursion". There were no concomitant therapies and adverse effects reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Started with cough, progressed to face swelling and trouble breathing.  patient was transported by ambulance to the hospital around 6:00pm  on 9/5/2020.
This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (potential adverse reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. 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 ADVERSE EVENT (potential adverse reaction). At the time of the report, ADVERSE EVENT (potential adverse reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Chills with the first shot; Fever; Headache; This is a spontaneous report from a contactable consumer or other non health care professional. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, reporter was reporting adverse event and mentions her daughter's brother had chills with the first shot, fever, a headache and he was down for a couple of days. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
in 56 years only had flu like symptoms 3 times, within days of getting a flu shot; Initial information regarding this unsolicited valid non-serious media  case received from a consumer (patient) and transmitted to Sanofi on 08-Dec-2020.  This case involved a patient who experienced flu like symptoms, after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu like symptoms ((influenza like illness) 3 times, within days of getting a flu shot, unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was influenza like illness.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case
(Rt) Deltoid vaccine site swollen, erythematous, warm to touch. Evaluated 8/14/09. Area nontender now. Recommend warm compress. Localize vaccine reaction.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No treatment information provided.
Notified by office LVN that manager contacted her regarding employee's description of numbness to face following administration of vaccine. No further information is currently available regarding date of onset, severity etc. The employee did indicate she did not see a physician for lack of insurance benefits. She continues to work at this time. The event was not observed in Occupational Health.
Weakness, achy joints, dizziness. Missed 2 days of work to recover.
herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 83-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 12-MAY-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a physician for the following injuries resulting from patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster. At the time of the report, the outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Swelling with redness , tenderness , warm to touch , painful, swollen area is  large as the palm of my hand .
DTAP/IPV/PREVNAR given on 07/30/2003.  Seen on 08/01/2003 has grapefruit size redness and swelling on right thigh around DTAP site.  TEMPERATURE: 96F.
ER visit for gangrenous toe. Patient was admitted 10 days later with peripheral artery disease, had surgery and passed away. These visits were within 6 weeks of receiving the COVID vaccine.
muscle spasms; knees and legs weak; right upper back pain and pressure when she takes deep breath; joint pain; upper chest rash; muscle soreness all around her body; headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (right upper back pain and pressure when she takes deep breath), MUSCLE SPASMS (muscle spasms), MUSCULAR WEAKNESS (knees and legs weak), RASH (upper chest rash) and MYALGIA (muscle soreness all around her body) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus syndrome. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), HYDROXYCHLOROQUINE, CLONAZEPAM, OMEPRAZOLE, CARVEDILOL, GABAPENTIN, CALCIUM, MULTIVITAMIN [VITAMINS NOS], SIMVASTATIN, VITAMIN B12 NOS, PREDNISONE, INSULIN, PARACETAMOL (TYLENOL) and NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced RASH (upper chest rash), MYALGIA (muscle soreness all around her body) and HEADACHE (headache). On 03-Mar-2021, the patient experienced BACK PAIN (right upper back pain and pressure when she takes deep breath) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced MUSCLE SPASMS (muscle spasms) and MUSCULAR WEAKNESS (knees and legs weak). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Pain, at a dose of 1 dosage form. At the time of the report, BACK PAIN (right upper back pain and pressure when she takes deep breath), MUSCLE SPASMS (muscle spasms), MUSCULAR WEAKNESS (knees and legs weak), MYALGIA (muscle soreness all around her body), HEADACHE (headache) and ARTHRALGIA (joint pain) outcome was unknown and RASH (upper chest rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Hair loss; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: (Batch/Lot Number: ER8727; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 at 14:25 (at the age of 49-years-old) as dose 1, single for covid-19 immunisation. History of all previous immunizations with the Pfizer vaccine considered as suspect was none. The patient medical history and concomitant medications were not reported. Patient History was none. Family Medical History Relevant to AE was none. The patient experienced hair loss on 28Mar2021. Reporter seriousness for the event was unspecified. She commented she works in Phlebotomy. She commented she filed a E-report online on 22Apr2021 and has not heard or received a response from anyone. She further clarified she completed a VAERS report online. She confirmed she has not complete a safety report with Pfizer directly yet.  She clarified the adverse event experienced as hair loss. She noticed it in the morning before noon. Her second dose she received on 14Apr2021, Lot: ER8729 Exp: 31Jul2021, administered in left arm. Her appointment for second shot was at 2:30 PM. She also added, she was using a skin cream that at first thought could have been the cause of the hair loss. However, her Dermatologist said it was not it because this skin cream is supposed to help hair loss. She did not have name of skin cream to provide. Vaccination Facility Type- Hospital. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. The event did not cause Emergency Room. She visted Physician's Office. She went to Dermatologist. She was going through injections in her head now as treatment. Prior Vaccinations within 4 weeks was none. AEs following prior vaccinations was reported as no. She wanted to know what usually is the next step when something like this happen. She was requesting or wanting follow-up about. She mentioned she just wanted someone to contact her and follow-up directly regarding this. No additional details provided. She wanted to speak to someone directly. Outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
localized rash on the left arm to forearm with scattered rash noted on legs as well after second vaccine
Fever of 105, tonic clonic seizure, vomited 1 x and responded normally.
(L) lateral thigh with slight induration, erythema 10 x 15 cm.
Patient stated he has blood in his urine the evening following vaccination. He went to the doctor and they ran tests and found nothing wrong. About a month later, he reports to us in addition to blood in urine (which resolved in a few days), he now cannot urinate. He went to the doctor again and was given tamsulosin and doxycycline.
6-7hours after receiving the moderna Covid shot #1, I felt tingling and numbness down left arm. It progressed to my left shoulder and neck. My face went completely numb. Later the evening my whole left side of the body was tingling and numb. I am now three days later and the numbness is still in my face and random patches (left forearm and left shoulder and neck). Went to dr appt today to report and follow up with them.
Had my blood pressure 190/97 and pulse was 83 for 5 hours; A spontaneous report was received from a consumer concerning a 62 years old male patient who experienced a blood pressure 190/97 (blood pressure increased).  The patient's medical history included pacemaker insertion. Concomitant medications included metoprolol, lisinopril, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, and salbutamol sulfate.  On 05 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 05 Mar 2021, the patient experienced a blood pressure reading of 190/97 and his pulse was 83 for 5 hours. The patient called his cardiologist who placed a pacer in his heart, and he was advised to take an extra dose of metoprolol, 20 minutes later RR went down to 180.  Treatment included extra dose of Metoprolol (05 Mar 2021).  Action taken with mRNA-1273 in response to the event was not reported.   The event, a blood pressure 190/97 (blood pressure increased), was considered recovering.
About 12 hours post vaccination: stomach cramps and diarrhea, then about 18 hours post vaccination: muscle aches, chills, fever (up to 101.8 at one point), swollen lymph nodes. Now, almost 48 hours later: the muscle aches still remain, and the swollen lymph nodes have gotten worse. There is large, discolored swollen area under my left arm (the arm I got the vaccine in) and it is very very sore. I can?t put my arm all the way down because it is so swollen under there