chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever of 101; nausea; dry heaves; so sick; could not get out of bed; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (fatigue), PYREXIA (fever of 101), NAUSEA (nausea) and RETCHING (dry heaves) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003b21a) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced HEADACHE (headache) and FATIGUE (fatigue). On 07-Apr-2021, the patient experienced PYREXIA (fever of 101), NAUSEA (nausea), RETCHING (dry heaves), ILLNESS (so sick) and ASTHENIA (could not get out of bed). On 01-Apr-2021, HEADACHE (headache) and FATIGUE (fatigue) had resolved. On 08-Apr-2021, PYREXIA (fever of 101), NAUSEA (nausea), RETCHING (dry heaves), ILLNESS (so sick) and ASTHENIA (could not get out of bed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Body temperature increased: 101 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Non-significant follow up appended.
pt experience redness and swelling at the injection site. the size of red spot had increased over the week, pt did speak with provider and then came in to the pharmacy for us to look at. through discussion she was monitoring the size of rash and has been increasing. pt did also state she took Benadryl without improvement.
11AM returned to clinic 15min post vax;eyes watery & puffy, swollen bilat pt examined by MD;pt was given epi;instructed to take DPH q 4-6 PRN;
Approximately 2 months, I began experiencing tremors and they increased in severity and frequency. I had tremors pre vaccine but the worsened greatly. Began experiencing sleep disturbances. Went from 5-7 hours per night to 3-4 hours per night. Also, began experiencing fatigue, malaise, and depression. Has tried melatonin and GABA for sleeplessness with minor improvements. Has seen neurologist regarding tremors. Symptoms are consistent with familial tremor.
Patient developed an exanthematous rash 2 weeks after receiving MMR vaccine. History complicated by the fact that he was 7 days into Amoxicillin dosing for AOM as well. Discussed symptomatic treatment with TYLENOL and MOTRIN. Encourage fluids and rest. F/U if symptoms increase or prn.
1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat.                  75mg Benadryl taken orally.     - 1 hour later dizziness, heart rate 44, lost voice, face looked swollen.     - 5 hours after vaccine administered went to outpatient clinic, heart rate 48 there.     - After 1 hour, heart rate 120, sweaty, dyspnea and went to Emergency Room.  1/27/21-Amitted to Hospital -Given Solumedrol, Benadryl and Pepcid. Slowly improved. 1/29/21-Discharged Home on Pepcid 20mg BID x15 Days and PRN Benadryl.  2/8/21-Returned to work, but still has to take Benadryl daily for rash and uses Albuterol inhaler intermittently for "tightness" in throat.
4/13/2022- PM: Presents to ED: c/o SOB, weakness and dizziness x 2 days. Dx with COVID 19 on 4/4. Vitals: BP 81/61. WBC: 13.2 CRP:4.3 BUN:63 creatnine:3.8  eGFR:17 CXR:Pulmonary changes consistent with COPD.  Admit COPD exacerbation s/t Covid and medical deconditioning.  Start solumedrol and doxycycline an nebs. Beyond window for remdesvir and is not requiring 02.  4/16/2022- BUN:54 Creatnine 2.5 improved. WBC:12.3   O2 sat stable on RA.  BP:171/90. Discharged to home with hospital at home services.
Patient received 3 doses of Pfizer vaccine ( does 1 Feb 20,2021, dose 2 Mar 12,2021, and dose 3 Apr 20, 2021), Patient resides in nursing home and they escorted patient to clinic on 4/20/2021. Patient did not have CDC card to verify 2 previous doses.
Patient came into pharmacy on Friday, January 20th asking for the second dose of the Shingrix vaccine; her first shot was given on 9/30/22 by a pharmacist here at pharmacy. She asked for second vaccine to Pharmacist; Pharmacist asked her "do you have any plans for tomorrow? It is very likely that you might not feel well the day after your second shot." She told RPh, "I don't have a caregiver on the weekends; thank you for telling me. I will come on Monday when you are here." Monday, January 23rd, she came back to the store. Pharmacist went out to talk to her around 2PM and told her "Before I mix this up, I wanted to let you know that you might have a fever, flu-like symptoms, and pain." They then discussed Tylenol usage for fever and pain and voltaren gel for joint pain. Patient informed RPh that she used to take "voltaren back when it was a pill a long time ago". RPh talked with patient for 10 minute after the vaccine to make sure she was fine. Patient reported no symptoms at the time.   Patient called pharmacy the next morning (1/24/23) and spoke with RPh. She reported that she was shivering, started feeling sick last night. Patient reports pain all over, joints, legs, and she feels sick to her stomach and drank ginger ale. Patient has notified her physician.
Pt administered vaccine at 1413, at around 1430 pt started feeling flushed, nauseous, and pruritic, pt vomited x1 and felt marginally improved, but still had pruritic erythematous rash on chest. Pt's vitals at 1440 were 99% spO2, HR 120, BP 142/93, patient was protecting airway, oropharynx clear, denied dyspnea or SOB. Pt was not administered any benadryl as she has an allergy to it. Patient was observed by a medic and felt much better by 1500, vitals then were 100% spO2, HR 109, BP 128/82, RR 12, no audible wheezes, no acute distress. Patient was given some water to drink, given ER precautions, and allowed to leave with her son.
About 40 mins after the injection, I was beyond extremely tired. Extreme body aches, nausea, dizziness and migraine followed shortly after. I felt to have more of an agitated PVC, PAC and tachycardia activity than usual.  This lasted Friday 1/8 through all day Sunday 1/10. On 1/11 I only suffered from the migraine.  A very sore arm was only during the first night and alleviated on Saturday afternoon.
Original symptoms presented as possible sinus infection, with no congestion, just sinus pressure at bridge of nose and around the eyes.  Moved into dizziness/equilibrium issues, some brain fog, fullness/ache in ears.  Occasional headache, normally due to sinus pressure, and ringing in ears.
Discharge Provider: MD  Primary Care Provider: MD  Admission date: 12/19/2022 Discharge Date: 12/21/2022 Covid positive date: 12/19/2022 PRESENTING PROBLEM:  COVID [U07.1] Toxic metabolic encephalopathy [G92.8]   HOSPITAL COURSE: 92-year-old gentleman with medical history of chronic obstructive pulmonary disease/asthma, gout, hypertension, cognitive impairment and BPH presenting with encephalopathy 12/19.  Patient was found to be positive for influenza A and COVID 19. Patient did not require any supplemental oxygen, No signs of respiratory distress thus He was not started on steroids/antivirals.  His encephalopathy was considered metabolic in the setting of viral infections, delirium due to underlying history of cognitive impairment.  12/20 patient had a witnessed fall in his room when he wanted to go use the restroom and refused to get assistance from hospital staff.  Patient did not hit his head or lost consciousness.  Underwent noncontrast CT head that did not show any intracranial hemorrhage or acute intracranial abnormality, showed mild white matter hypoattenuation consistent with chronic microvascular ischemic disease and mild cerebral/cerebellar atrophy.  CT spine showed mild T2 endplate compression fracture and moderate degenerative changes foraminal stenosis at multiple levels.  Patient did not have any pain or tenderness in the spine.  No focal deficits.  Moving all extremities spontaneously.  Discussed with Dr. from Ortho who did not recommend any brace since patient not having any symptoms.  PT/OT evaluated, recommended discharge home with home health.  SLP evaluated, patient found to have severe cognitive-communication impairment.  Patient will require distant 24 hour supervision.  He lives with his wife at home.  Discussed with wife that given his severe cognitive impairment, any subtle changes including infections can cause significant decline in mental status.  Informed that he will need to be formally assessed for dementia by Neurology/neuropsychology.  Informed by his PCP will be able to send referrals for that.  Discussed with wife how comfortable she be taking him.  His wife stated that she would be okay taking him home.  Her brother lives about 20 minutes away and can be at their house if she needs extra help.  Mover our Case Management provided extensive list of resources in case if family wants to pursue long-term placement for patient given his dementia. Patient was discharged home in stable condition. All questions from the family answered
36 weeks and 2 days pregnant at the time of 2nd dose vaccine. EDD 10/24/2021. According to ultrasound baby weight is 79 percentile. There in polyhydramniosis. One elevated glucose level during 3 hours GTT
Not sure if related at all but patient got up the next morning and said she passed out on the way to the restroom. She went back to bed and her mother tried to give her some ice and water and she threw that up. Her mother said the patient went to sleep and felt better later on and is doing fine now.
ELEVATED TEMP OF 100.5, DIZZINESS, HEADACHE, GENERAL BODY ACHES, FATIGUE.
Vaccine administered on 9/8/21. On 9/10/21 @2000 MDs O2 SAT DROPPED TO 83%. TEMP 101.9*F., ON 9/11 SHE DEVELOPED A TEMP OF 103.1*F, O2 SAT DROPPED TO LOW 80s. VITAL DONE, BGs DONE, CRITICAL HIGH BG OF 1039.  WBCs ALSO ELEVATED. MD SENT TO HOSPITAL  WHWERE SHE STAYED FOR 6 DAYS, RETURNING 9/17. NOW CURRENTLY REQUIRES INSULIN TO MAINTAIN BGs. PREVIOUSLY NOT AN ANY DIABETIC MEDS.
Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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 (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    No concomitant medications was reported. No treatment drug details was reported. This case contains information of 17th out of 18 patients as described by the reporter. (6 patients-dose 2).   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
fever and body aches post her moderna covid vaccine yesterday (16-Nov-2021); fever and body aches post her moderna covid vaccine yesterday (16-Nov-2021); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever and body aches post her moderna covid vaccine yesterday (16-Nov-2021)) and MYALGIA (fever and body aches post her moderna covid vaccine yesterday (16-Nov-2021)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Asthma.    The patient's past medical history, medical treatments and family history were not provided.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started DUPILUMAB (DUPIXENT) (unknown route) via pre-filled pen. On 16-Nov-2021, the patient experienced PYREXIA (fever and body aches post her moderna covid vaccine yesterday (16-Nov-2021)) and MYALGIA (fever and body aches post her moderna covid vaccine yesterday (16-Nov-2021)). At the time of the report, PYREXIA (fever and body aches post her moderna covid vaccine yesterday (16-Nov-2021)) and MYALGIA (fever and body aches post her moderna covid vaccine yesterday (16-Nov-2021)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient experienced events while being treated with Dupilumab and Elasomeran.  On 16-NOV-2021 the patient experienced fever and body aches post her Moderna COVID vaccine yesterday(16-Nov-2021), (unknown latency) following the first dose intake and Elasomeran.  It was not reported if the patient received a corrective treatment for the events.  Treatment medications were not provided.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Arm pain; Sweating; Shaky hands; Loss of coordination; Heaviness of limbs; Fatigue; Headache; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 at 15:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing and testosterone phenylpropionate (TESTOSTERONE) taken for hormone replacement therapy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 15:45, about a minute after the first shot, the patient experienced the following: arm pain, sweating, shaky hands, loss of coordination, heaviness of limbs, fatigue and also experienced a headache and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain, sweating, shaky hands, loss of coordination, heaviness of limbs, fatigue, headache and nausea was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
During interpretation understood patient had not had the vaccine or the disease.  Upon discussing  the other child's vaccines and the need for varicella immunization the mom stated she " that both of the girls may have had chicken pox at the same time".  Vaccine had already been administered to one when being asked about the disease at the beginning of the visit and reviewing the vaccines needed to today.  No side effects, the parent verbalized understanding that this will not do harm but was an unnecessary vaccine.
nausea persistent diarrhea for 1wk;supportive treatment;possible viral gastroenteritis;
Initial report received from a health care provider on 10/26/05. A 45 year old female, with an allergy to Iodine and no pre-existing medical conditions, received an injection of Fluzone, lot number U1802BA, on 10/25/05. Annual previous doses of Fluzone were reported with no adverse event following prior vaccination. The route and site of administration were not reported. Ten minutes post-vaccination, the patient developed hoarseness, a tickle in her throat and nasal stuffiness. Twenty minutes post vaccination, she developed a cough with sputum. She was medicated with an epinephrine pen and examined in an emergency room. The patient was thereafter admitted to an intensive care unit. Relevant diagnostic/laboratory tests not reported. At the time of vaccination, other medications were unknown and illness was denied. At the time of this report, the patient remained hospitalized and had not recovered.
Within 1-2 minutes of receiving the vaccine, I experienced paresthesias from my diaphragm to my toes and an overall sense of "something is wrong here." I was walking around the office to pass the time and felt that my legs were going to buckle if I didn't sit down. Sat & continued to experience the paresthesias & sense of "uh-oh." Finally reported symptoms to staff. When checked out by RN, had a lowered BP and an increased heart rate. After an hour, I felt that I could walk again & went home. Symptoms resolved after another few hours.
his wife says it's like measles; everything the doctors gave him made it worse; a rash that spread to all over his body/around his back/around his neck/around his head; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MEASLES (his wife says it's like measles) in an 85-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 (No medical history reported.). Concomitant products included TAMSULOSIN for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MEASLES (his wife says it's like measles) (seriousness criterion medically significant), CONDITION AGGRAVATED (everything the doctors gave him made it worse) and RASH (a rash that spread to all over his body/around his back/around his neck/around his head). At the time of the report, MEASLES (his wife says it's like measles), CONDITION AGGRAVATED (everything the doctors gave him made it worse) and RASH (a rash that spread to all over his body/around his back/around his neck/around his head) outcome was unknown.            The patient received the 1st dose of vaccine 3 weeks before 2nd dose and 2nd dose a few weeks ago. Treatment included unspecified antibiotics and steroid creams.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Numbness to Right side of face, right hand; severe pain upper right back and under arm; severe pain upper right back and under arm; This is a spontaneous report from a contactable Consumer (patient). A 51-year-old non-pregnant female patient (not pregnant at time of vaccination) received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration in arm right on 07Oct2021 (age at the time of vaccination 51 years) as dose 3 (booster), single for COVID-19 immunization. Medical history included hypothyroidism, high blood pressure, obesity, migraines and psoriasis. The patient previously took penicillin, Levaquin, Omnicef and Fluticasone and experienced drug allergy. The patient had Mango allergy and Pistachio allergy. The patient previously took flu vaccine (other vaccine 4 weeks) via an unspecified route of administration in right arm on 28Sep2021. The patient historical vaccine included received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration in right arm on 01Apr2021 (age at the time of vaccination 51 years) as dose 2, single and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration in right arm on 11Mar2021 (age at the time of vaccination 51 years) as dose 1, single for COVID-19 immunization. No COVID prior vaccination and no COVID tested post vaccination. On 07Oct2021 17:00, the patient experienced numbness to right side of face and severe pain upper right back and under arm. No treatment received for the events. The seriousness of the events was non-serious. The outcome of the events was recovering.   No Follow-up attempts are possible. Information about lot/batch number cannot be Obtained.
Patient was given a 3rd dose of Pfizer vaccination prior to the 6 month interval. Patient's second shot was received on 8/17/21 and teh 3rd dose was administered on 11/23/21
Information has been received from an article on the internet, from a consumer concerning her daughter who was vaccinated with a dose of GARDASIL. The mother stated that her daughter was now sick after the GARDASIL vaccination and had warts on her hands and feet. This is one of several cases from the same source. Attempts to verify the existence of an identifiable patient have been unsuccessful.
rash is mildly itchy; rash with a bump with small bumps around it on arms and legs/rash on middle of his forearm/ bumps on both legs and both arms; arm was sore for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore for a couple of days), RASH PRURITIC (rash is mildly itchy) and RASH (rash with a bump with small bumps around it on arms and legs/rash on middle of his forearm/ bumps on both legs and both arms) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028a21a) for COVID-19 vaccination.     Concomitant products included LOSARTAN, AMLODIPINE, LEVOTHYROXINE SODIUM (SYNTHROID), ESCITALOPRAM OXALATE (LEXAPRO) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore for a couple of days). On 01-Apr-2021, the patient experienced RASH PRURITIC (rash is mildly itchy) and RASH (rash with a bump with small bumps around it on arms and legs/rash on middle of his forearm/ bumps on both legs and both arms). On 29-Mar-2021, PAIN IN EXTREMITY (arm was sore for a couple of days) had resolved. At the time of the report, RASH PRURITIC (rash is mildly itchy) and RASH (rash with a bump with small bumps around it on arms and legs/rash on middle of his forearm/ bumps on both legs and both arms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were reported.