chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3:20pm-patient c/o numbness and tingling in fingertips of left arm. Vital signs taken: 98.4-68-20-98/62. patient alert, oriented x 3. Denies SOB, dizziness or difficulty breathing. bottled water and crackers given. Requested patient wait another 10 mins to be observed.  3:30pm-vital signs: 98.4-70-20-108/60.  Remains alert, oriented x3. Denies SOB, dizziness or difficulty breathing. No signs of resp. distress noted. Pt. states feels no worse nd numbness and tingling the same. Pt. states he feels fine to go home and knows to go to ER if start to feel worse. 4:30pm- Called patient. Patient states he feels fine. Numbness and tingling is better.
PT EMPLOYEED AT SCHOOL AND REPORTED TO NURSES ASSISTANT WITH LEFT SIDE HEAVY FEELING AND LIGHT HEADEDNESS WITH B/P 185/99, P 88 NOTED. PT RECHECKED LATER WITH B/P 199/103, P 85 WITH C/O LETHARGY. REPORTED THAT PATIENT ALERT AND ORIENTED, CALM DURING EPISODE. SCHOOL RN AND PT HUSBAND CONTACTED IMMEDIATELY WITH REPORT OF PT CONDITION.  AT 1:40PM NURSE ASSISTANT CALLED HEALTH DEPARTMENT STAFF WITH REPORT DUE TO PT CONCERN AS TO WHETHER TO GO TO ER OR PHYSICIAN OFFICE DUE TO UNABLE TO REACH PHYSICIAN OFFICE FOR INSTRUCTION.  HEALTH DEPARTMENT NURSE INSTRUCTED SCHOOL NURSE ASSISTANT TO RECOMMEND PATIENT REPORT TO ER. HUSBAND TOOK PATIENT TO ER AND HEALTH DEPARTMENT STAFF ATTEMPTED TO FOLLOW UP WITH PATIENT MULTIPLE TIMES WITHOUT SUCCESS.  HEALTH DEPARTMENT NURSE SPOKE WITH SCHOOL NURSE ASSISTANT WHO REPORTED THAT ER PHYSICIAN PRIMARILY CONTRIBUTED THE EPISODE TO ANXIETY, NO TREATMENT PRESCRIBED.
Rash started in arm pits it was raised and red with white areas in the rash. When touched they blanched. On the morning of May 28 the rash covered her chest and stomach extended up her neck on the face, on the arms, in the diaper area and a small amount on her legs. As the day progressed the rash extended to her back and became more prominent on her legs and face. 16 mg of Benadryl was given on 27 may at bedtime. Benadryl was given again at 7pm on 28 may, 1230 on 29 may. Rash is currently better on chest stomach and back but worse on legs and face. Arms and neck remain unchanged. I (mother of patient) am a RN and this rash looks just like erythema multiforme. I emailed patient's pediatrician about the event and included a photo of the rash.
VACCINE ADMINISTERED AFTER THE 31DAY BEYOND USE DATE BUT BEFORE THE 45 DAY EXCURSION DATE.
pain in the area where the shot was given; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several hours after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporting for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The patient stated that, the Shingles vaccine itself did not hurt but after few hours, there was terrible pain in the area where the shot was given for about 3 days. The patient also stated that, it is best to get the Shingles vaccine rather than the shingles because it would be very painful, and you would be very uncomfortable.
Spots on my calves that come and go. (I have pictures) sudden irregular heartbeat. I am being evaluated by my doctor.
slightly nauseous; splitting headache yesterday; fatigue; muscle soreness; feeling very dizzy; feel like something is not right; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (slightly nauseous), HEADACHE (splitting headache yesterday), FATIGUE (fatigue), MYALGIA (muscle soreness) and DIZZINESS (feeling very dizzy) in a 56-year-old male patient 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.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (slightly nauseous), HEADACHE (splitting headache yesterday), FATIGUE (fatigue), MYALGIA (muscle soreness), DIZZINESS (feeling very dizzy) and FEELING ABNORMAL (feel like something is not right). At the time of the report, NAUSEA (slightly nauseous), HEADACHE (splitting headache yesterday), FATIGUE (fatigue), MYALGIA (muscle soreness), DIZZINESS (feeling very dizzy) and FEELING ABNORMAL (feel like something is not right) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
headache; chills; sweating;dizziness Remains dizzy, pupils are intermittent dilated, jaws are chatting uncontrollably, no chills.
No additional adverse event reported; first dose in January 2020, second dose in November 2021; This spontaneous report was received from the patient's brother referring to a 30 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  In "January 2020", the patient received the first shot of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) but due to Covid protocols her doctor's office pushed back vaccine appointments. For this reason, the patient received her second shot of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) the "last month" in November 2021. The patient's shot was almost one year late. No additional adverse event information reported. No product quality complaint involved.
Patient started feeling ill the evening of the vaccination and called the pharmacy the next day to report symptoms of light-headedness, dizziness, weak legs, shaking, shortness of breath, chills, and chest pain. I called patient back a few hours later and patient said he felt better and the chest pain went away. He later noted that it could have been his anxiety causing the pain. Patient had been taking ibuprofen, acetaminophen, and drink a lot of water for treatment. Patient did not feel is was necessary to see the doctor or emergency department.
Pt recvd Hep B vax & died p/receivng vax; @ the time of the report, cause of death was unk; No further details were provided;
INJECTION SITE PAIN & SWELLING, FATIGUE Narrative:  Other Relevant History:
Rash on her face / Rash on her neck; Lot of chills; Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), RASH (Rash on her face / Rash on her neck) and CHILLS (Lot of chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN (Pain). On 20-Mar-2021, the patient experienced CHILLS (Lot of chills). On 21-Mar-2021, the patient experienced RASH (Rash on her face / Rash on her neck). At the time of the report, PAIN (Pain), RASH (Rash on her face / Rash on her neck) and CHILLS (Lot of chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-053016 (Patient Link).
This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (Multiple sclerosis worse) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Back pain. Concurrent medical conditions included Pollen allergy and Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) and FAMPRIDINE (AMPYRA) for an unknown indication. On 09-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (Multiple sclerosis worse) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS (Multiple sclerosis worse) had not resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medication were not reported. The patient's concomitant medication included Balance of nature veggies, balance of nature fruits. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Info has been received from an LPN concerning a 13 year old Caucasian female pt with staph infection (12/12/90), asthma, bronchitis, GERD, and atopic dermatitis who on 12/12/90 (lot 17075) and on 9/9/94 (lot 608672/0660A), the the PM, was vaccinated with a 1st and 2nd dose of MMRII, respectively. It was noted that on 9/9/04, at the time of the 2nd vaccination, the pt had an allergic rhinitis and was being treated with (Prelone) from allergist. On 1/6/03, a titer done was negative for rubella. The pt was considered to be not recovered. Unspecified medical attention was sought. No product quality complaint involved. No further info is available.
1 week after the shot  my Lymph Node on the left side of my chin started to swell and become painful.  AN off share rash also appeared on my left forearm.-  The rash has mostly disappeared after 3-4 days.  The Lymph Node swelling has reduced, but remains somewhat painful even after 5 days. (Mostly like a sore throat today)
Flu Like Symptoms; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The patient experienced flu like symptoms that lasted for 2 weeks. No further details were provided.  The pharmacy tech was reporting adverse event for two patients. Thsi case has been linked with US2019158355, reported by the same reporter.
After 6 days developed severe itch on left leg and left arm. After 7 days developed red pimples on left leg and left arm. Used cortisone to relief itch.
Pt reports edema of face, fever, chills,headache, fatigue, sore throat.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Fetal demise at 8w3d, one day after receiving first covid vaccine dose.
Information has been received from a physician concerning a child who, about one year ago, in 2003, was vaccinated with a dose of varicella virus vaccine live. Recently, the patient presented with about 10 lesions which was thought to be break through chickenpox. The patient had no symptoms or fever. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
2 days after the vaccine I lost my taste and consulted with a pulmonologist who stated that was not side effect from vaccine as I thought and should be tested. Tested on 1/1/21 and was positive. At the day of the vaccine I had a slight temp (99.9F) I was also fatigued seemed like I was ran over by a truck, but I slept it off and next morning I was fine. I still can't smell and taste still is not the same.
Inflamed left upper arm (redness, swelling, itching) from injection site , traveling out and down (at present) -3 " wide x 5" long; headache, fatigue, body aches.
patient got a flu three days after getting the shot; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media from on 23-Dec-2020.  This case is linked to case 2020SA300682.   This case involves a patient of unknown demographics who got a flu three days after getting the shot (Influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included Influenza Vaccin for 2 years. The patient's medical history, medical treatment(s), concomitant medication 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 expiration date unknown) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date (latency unknown) after the administration of suspect the patient got a flu three days after getting the shot (Influenza).   It was not reported if the patient received a corrective treatment.  The outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Fevers, Chills, dizzy body aches, pain and swelling at the injection site
This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. Previously administered products included for Prophylactic vaccination: Janssen COVID-19 Vaccine (Batch no: 1808609, Expiry date : 06-Sep-2021 and anatomical site: left arm) on 23-Mar-2021. Past adverse reactions to the above products included No adverse reaction with Janssen COVID-19 Vaccine. On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2022, the patient experienced COUGH (dry cough) and HEADACHE (headache). At the time of the report, COUGH (dry cough) and HEADACHE (headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2022, SARS-CoV-2 antibody test: negative (Negative) Binax rapid test: negative. No concomitant drug information was provided. Causality for Janssen COVID-19 Vaccine both reporter and manufacturer for both the events was given as possible. No treatment drug information was reported. Reporter did not allow further contact.
Information has been received from a certified medical assistant concerning a 23 year old female with no drug allergies, who on 21-SEP-2007 was vaccinated with a first dose of Gardasil (lot# 654539/0742U).  Concomitant therapy included LUNESTA and lorazepam.  On 21-SEP-2007 the patient fainted  at 15:40 in the physician's office, at check out desk, and later that night the patient felt nauseous and had a headache.  On 25-SEP-2007 a follow-up phone call was made and the patient reported feeling fine.  The patient's blood pressure was taken and was stable.  No other symptoms were noted.  The patient reported tht this has not happened in a long time. The patient's vital signs were stable and there was no evidence of trauma. On 22-SEP-2007 the patient recovered from the headache and nausea. No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a certified medical assistant concerning a 23 year old female with no drug allergies, who on 21-SEP-2007 at 15:30 was vaccinated intramuscularly in the left upper arm with a first dose of GARDASIL vaccine (lot# 654539/0742U). On 21-SEP-2007 the patient recovered from fainting. Additional information is not expected.
This spontaneous report was received from a pharmacist referring to a 19 year old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, as an infant, the patient was vaccinated with series of an unspecified hepatitis b vaccine (manufacturer unknown) for prevention of Hepatitis B (dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patient's hepatitis B titre was negative (hepatitis b antibody negative). Therefore, the he restarted the series and, at the time of this report, he had received two doses of RECOMBIVAX HB, given four weeks apart on unspecified dates, with no adverse effects reported. The outcome of hepatitis b antibody negative was unknown at the time of this report. Causality relationship between the event and the unspecified hepatitis b vaccine (manufacturer unknown) was not reported. No product quality complaint was involved. Additional information has been requested.
Information received from a consumer on 23JAN2015. The consumer stated that on 21JAN2015 a fellow employee was administered a dose of BIOTHRAX (dose, lot, route not reported) which had expired on 20JAN2015.  No adverse events were reported. Further information not available. Sender's Comments: No adverse event reported; therefore the case is considered not assessable.
25JUL student reported started fever of 102, h/a, dizziness, itchy & stiffness of joints (knees & back & shoulders) from 23JUL-25JUL;temp was 97.6 25JUL 230PM;
Soreness at injection, felt extremely tired, and highest fever I have ever had in my life at 102.9 at which point I took Tylenol to lower my fever which still lasted  ranging between 102 and 101 for the next two days.  Followed by headache, stomachache, tiredness, and body aches for another day.  Honestly as a super healthy person who never really gets sick my odds at facing Covid 19 personally were slim that I would of had it as rough as my side effects were. Though I took it to protect others. I do hope we don?t have to get a shot ever year unless the side effects are minimized by then.
Initial unsolicited report received from a pharmacist (Director of Pharmacy)on 12 October 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE (batch number: UI669AA, expiration date: 30 June 2017 and site of administration was not reported) intramuscularly, 04 October 2016 (over the past month). Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medication was not reported. On 04 October 2016 (over the past month), same day following vaccination patient had localized reaction. On 06 October 2016, (reported as "over the past month"), two days following the vaccination, patient experienced localized redness and very itchy. Patient required emergency room (ER)/ doctor visit. Lab data and corrective treatment were not reported. Sought out treatment was reported as none. The outcome of the events was reported as unknown. List of documents held by sender: none.
Egg size lump in arm day after injection, lasting 3 days. Sore and red site. Then one left armpit lump 1+ months after second injection (March 10, 2021), 4-6 weeks later.
Red; Itchy; Patch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red), INJECTION SITE PRURITUS (Itchy) and RASH (Patch) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Red), INJECTION SITE PRURITUS (Itchy) and RASH (Patch). At the time of the report, INJECTION SITE ERYTHEMA (Red), INJECTION SITE PRURITUS (Itchy) and RASH (Patch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included Benadryl gel, Antihistamine
COVID 19 Treatment; COVID 19 Treatment; Dose: 4 BNT162B2, Dose: 3 MODERNA COVID-19 VACCINE; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 14Feb2022 at 13:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 72 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Jan2021 at 13:00 as dose 1, single (Lot number: 030L20A), in right arm, on 13Feb2021 at 13:00 as dose 2, single (Lot number: 042L20A), in right arm and on 24Aug2021 at 13:00 as dose 3 (booster), single (Lot number: 023C21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "overweight" (unspecified if ongoing); "known allergies: ARBs, angiotensin synthesis inhibitors" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Feb2022 at 13:00, outcome "not recovered", described as "Dose: 4 BNT162B2, Dose: 3 MODERNA COVID-19 VACCINE"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.