chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She tested positive for influenza A; Fever; This spontaneous case was received on 04-Oct-2022 from other non-healthcare professional (patient's mother) (reference number: SEQW22-03964) with additional documents received on the same date (reference numbers: SEQW22-03958) (being processed together), reported by other non-healthcare professional and concerned a 5-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 09-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported) for prevention of influenza. The batch number reported was 308432.  On 01-Oct-2022, 11 months and 22 days after receiving Flucelvax Quadrivalent, the patient was tested positive for influenza A. The patient was prescribed generic Tamiflu (oseltamivir) from her Pediatrician.  On an unspecified date in Oct-2022, the patient experienced fever.   Since 02-Oct-2022, the patient had been fever free.   At the time of initial reporting on 04-Oct-2022, the patient was recovering from the event of 'influenza A virus infection' since she was better now.   The reporter did not provide a causality assessment.  The event of 'Influenza A virus infection' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 5-year-old, female patient was vaccinated with Flucelvax Quadrivalent. Eleven months and 22 days following vaccination, the patient tested positive for influenza A. In addition, the patient developed fever. Causal role of the suspect vaccine is assessed as not related, due to chronological implausibility.; Sender's Comments: A 5-year-old, female patient was vaccinated with Flucelvax Quadrivalent. Eleven months and 22 days following vaccination, the patient tested positive for influenza A. In addition, the patient developed fever. Causal role of the suspect vaccine is assessed as not related, due to chronological implausibility.
chill; fever; This is a spontaneous report received from a non-contactable reporter (consumer). An elderly male patient in his early 70s received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, the patient experienced chills and fever. Clinical outcome of the events chills and fever was unknown.    Follow-up attempts are not possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of COMVAX injection (lot # J013884, expiry date 19-AUG-2016; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality compliant (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
mesenteric vein thrombosis, has been transferred to outside hospital for thrombectomy at time of this report
he was drinking lots of water; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (he was drinking lots of water) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, METOPROLOL TARTRATE, LOVASTATIN, CLOPIDOGREL, FINASTERIDE, MONTELUKAST, FUROSEMIDE, FELODIPINE, BUSPIRONE, SPIRONOLACTONE, DOXAZOSIN MESYLATE, LABETALOL, ASA and IRON 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THIRST (he was drinking lots of water). At the time of the report, THIRST (he was drinking lots of water) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) Blood Pressure has gone up since first dose.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication taken by the patient included thiazine. No treatment information was provided.   This case was linked to MOD-2021-089099 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up information received on 26-May-2021 and contains no new information.
Fever 103.2 12-31-10 vomiting 12-31-10 X 2 mother described spots that looked like hives, states it was not a rash x 2 days.
Dizziness, Myalgia, 6 hours after vaccination fatigue, sore arms, chills, 100 F, Tylenol 500mg 6pm 12am, 8am due HA persist one lymph node, usually with any vaccine incl flu x 1 month - 3 mos Narrative:
My right eyelid drops for a second or two and then normalizes.  This happens multiple times a day.
Hives five days post shot Swelling in bilateral feet six days post shot Increased heart rate immediately post shot  Tongue tingling/numbness within 15 minute post shot  Minor headache and nausea 45 minutes post shot  (heart rate (subsided within 10 minutes or less) , tongue issue, headache nausea all subsided within one hour)
a 51 y.o. female with a PMH of ALL on active treatment, anemia, type 1 diabetes on insulin pump, HTN, Sjogren's syndrome, Parkinson's disease, chronic nausea complicated by GERD with esophagitis, gastroparesis, active chemo regimen, sleep apnea, anxiety, and vitamin D who presents with a chief complaint of worsening symptoms regarding COVID. She states that she was diagnosed on 09/17 but has had symptoms for one week since coming to the ER and reports that she was told to come for further work-up. She states that she initially thought her fatigue was caused by recent chemo infusion (10 days ago) but it continued, and her symptoms worsened throughout the week. She reports that she began to have shortness of breath, chest pain, cough, fever (patient reports it was 103), diaphoresis that began 3-4 days ago.   Respiratory: Positive for cough, chest tightness, shortness of breath and wheezing.   Cardiovascular: Positive for chest pain and leg swelling. Negative for palpitations.   Acute Hypoxic Respiratory Failure secondary to COVID-19 infection | Immunocompromised due to dasatinib therapy  - Diagnosed on 09/17, symptomatic starting 09/12. On admission, dexamethasone and remdesivir were prescribed. Given her immunocompromised state, infectious disease was consulted for consideration of prolonged remdesivir course. She received supportive care with supplemental oxygen, albuterol and anti-tussive medications as needed. Per ID recommendations she was continued on remdesivir for the duration of her stay, 8 days, during which time her inflammatory markers were trended and noted to steadily fall. On day 8 of hospitalization patient no longer required supplemental oxygen at rest or with ambulation. She welcomed and requested discharge and was given strict return precautions. She was discharged to complete 3 additional days of dexamethasone, for 10d total as well as with antitussive medications and albuterol to use as needed.   Discharged home
Large 6? painful welt lasting up to two days after first injection. Possible delayed allergic reaction in the form of an itchy and painful rash on left arm in crease and near injection site. Rash traveled to right arm, hands, neck, earlobes, tip of nose, chin area.
Information has been received from a health professional concerning a 3 year old white male with no allergies or medical history who on 30-Jan-2002 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccine that day included a dose of poliovirus vaccine. There was no illness at the time of vaccination. On 23-Aug-2004 the patient awoke from his nap with red spots. On 24-Aug-2004 the patient was seen in the office with red vesicles on his trunk. A few of the vesicles had begun to open. At this time there are less than 25 lesions, however new lesions are still emerging. It was noted that the patient's mother currently has a case of shingles. No treatment was given at this time. No product quality complaint was involved.  Follow-up information from a physician indicated that the child developed "varicella disease (chicken pox)" on 22-Aug-2004. The child had a doctor appointment on 23-Aug-2004 when the clinical diagnosis was made. The patient recovered  Additional information is not expected.
Product Temperature Excursion Issue; Initial Report Received on 06-Sep-2022, 07-Sep-2022, 09-Sep-2022, 12-Sep-2022, 13-Sep-2022 and 15-Sep-2022  A pharmacist reported that a 28-year-old patient (gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue. Follow-up information was provided by a different pharmacist from the same pharmacy.  Medical history, concomitant medications, and allergies at the time of vaccination were unknown.  On 03-Sep-2022, the patient received a dose of HEPLISAV-B (Lot # 937783, expiration date 29-Sep-2023, NDC # 43528-0003-05) intramuscularly in the left arm. It was discovered later that "over the past 10 days, the thermometer record showed that occasionally, the temperature of the HEPLISAV-B vaccine went up to 50°F and then went back down again." This patient was given the HEPLISAV-B vaccine during this time. The initial reporter was unaware of any adverse effects reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
This spontaneous report was received from a medical assistant referring to a 7 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 25-MAY-2018, the patient was accidentally vaccinated with one dose of GARDASIL 9 intramuscularly, lot# M028323, expiration date 26-SEP-2018, for prophylaxis (strength, dose, route and frequency were not reported). The medical assistant reported it was her mistake and had nothing to do with the vaccine. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1805USA013148.
12 -36 hours after vaccination:  Fever (99-101F), chills, joint pain, hot flushes, headache, diarrhea - resolved after 48 hours 48 hours after vaccination:  mouth sores
10/10 pt began falling/progressive difficulty walking/standing. Admitted to hosp 10/15-10/18. PE: distal/proximal leg weakness, absent DTR's, NI sensation, slow gait w/o ataxia. Pt improved/sx resolved spontaneously.
itch; Vaccination site pain; Diarrhea; Shingles (Herpes Zoster)/ She said that it was shingles; hives; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), DIARRHOEA (Diarrhea), HERPES ZOSTER (Shingles (Herpes Zoster)/ She said that it was shingles), URTICARIA (hives) and PRURITUS (itch) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Raynaud's syndrome (The patient was diagnosed 10 years ago. The patient is stable and is not on any medication.). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, EZETIMIBE (ZETIA) for an unknown indication.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), DIARRHOEA (Diarrhea), HERPES ZOSTER (Shingles (Herpes Zoster)/ She said that it was shingles) and URTICARIA (hives). On 16-Jun-2021, the patient experienced PRURITUS (itch). The patient was treated with VALACYCLOVIR [VALACICLOVIR] from 20-May-2021 to 03-Jun-2021 at a dose of 1 g three times a day. On 21-May-2021, VACCINATION SITE PAIN (Vaccination site pain) and DIARRHOEA (Diarrhea) had resolved. At the time of the report, HERPES ZOSTER (Shingles (Herpes Zoster)/ She said that it was shingles) and PRURITUS (itch) had not resolved and URTICARIA (hives) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Zyrtec was mentioned as over the counter medication and Patient took aspirin 81 mg as concomitant product  was mentioned as low dose. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-083015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received and contains information about concomitant medication and its indications, treatment medication start date and stop date and new events.
This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 34-year-old male patient who received HAVRIX (batch number 793JR, expiry date February 2016). Concomitant products included HAVRIX and ENGERIX B. On 25th June 2014, the patient received the 2nd dose of HAVRIX. On 25th June 2014, an unknown time after receiving HAVRIX, the patient experienced drug dose administration interval too long. (Dechallenge was unknown). Rechallenge with HAVRIX was unknown. On an unknown date, the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the drug dose administration interval too long to be related to HAVRIX. Additional information: Per HCP, client was inadvertently given 2nd dose of HAVRIX too soon which led to maladministration.
Shakiness legs + arms heaviness arm R where shot administered nausea + dizziness.
Painful sores in mouth, on tongue, cheek, gums. Has been there got worse on day 5 after vaccine
[Covid Vaccine Pfizer] use for COVID-19 under Emergency Use Authorization (EUA): Covid-19 Pneumonia
Patient received booster dose instead of full dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received booster dose instead of full dose) in a  patient of an unknown age and gender 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 ACCIDENTAL UNDERDOSE (Patient received booster dose instead of full dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received booster dose instead of full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult 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 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant medication was not reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment drug was not reported. This case was for the 9th patient out of 190 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
Patient developed fever of 103 on 10/16/18. Patient went to ED, came down to 98 degrees without medication.
Information has been received from a physician concerning a 5 month old 14 lb white/hispanic female with no pre-existing allergies, birth defects, or medical conditions who on 22-DEC-2007 at approx. 1700 hrs. Received a first subcutaneous 0.5 ml dose in the left leg of varicella virus vaccine live (Oka/Merck) (lot#658020/0826U). Concomitant vaccinations included a second dose in the right deltoid of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (C2760AA, specific vaccine not specified), a second dose in the right thigh of hepatitis B virus vaccine rHBsAg (yeast) (lot# 654746/1245F), a second dose in the right deltoid of pneumococcal 23v polysaccharide vaccine (manufacturer unknown), and a second oral dose of ROTATEQ vaccine live (human-bovine) (655483/111F). Illness at the time of the vaccinations was reported as mild upper respiratory infection (URI) symptoms, rhinorrhea, and cough. There were no adverse events following prior vaccination. It was indicated that on 09-JAN-2008, the patient developed bronchiolitis that did not require hospitalization. It was noted that the symptoms seemed to have been developing prior to vaccination. There were no relevant diagnostic tests or laboratory studies performed. On an unspecified date, the patient had recovered. A product quality complaint was not reported. Additional information is not expected.
Patient states 30 seconds after the injection, she began to feel nauseated. She stated the following symptoms came on "Like a wave": Dizziness, light headedness, ears ringing, sound pulsing, and her vision began to go black. She described the field of vision closing like that of a loony toons show ending (coming from the outside in).   Patient was found to have her eyes closed, hyperventilating at a rate of 28 breaths per minute. Ice pack placed on her neck. She was coached to slow her breathing, instructed to hold her breath for 10 seconds, then to release it slowly. She did this for 3 minutes. She related her body felt tingly all over. Encouraged patient to continue the slow breathing. As patient began to feel better, she related that she has a known needle phobia. She expressed that she becomes anxious even when she is not the one receiving a shot, and this fear stems from a traumatic experience of her son having a seizure after a shot. She works at a school and when they do first aid training and cover the diabetes section, the pictures of needles make her anxious. Patient provided with therapeutic communication, encouraged to discuss fears with her counselor. Patient remained seated in clinic until she felt well enough for her husband to drive her home.
After the vacination she was sleepy, and throat started swelling.  Two or so days later she started itching.  Then, she developed a rash/lesions all over her body.  With the rash came a low grade fever.  The doctor said it is an allergic reaction to something.
The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 4 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 03-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
10 hours after injection, mild flu-like symptoms of nausea and light headedness, slight muscle aches through midnight.  Went away in the morning of May 17th, and gone by noon (24 hours after injection).
At 4:47 PM a rapid response was called , the Team responded and the adult employee refused care.  At 5:16 PM a code 99 was called and the Team responded to find an adult patient with left sided weakness and left facil droop.  VS BP 151/96, HR 95, RR 26, O2Sat 99%, Galsco Coma Score 11; The patient was aphasic and unable to give a HX, co-workers related extensive history including lymphoma and TIA.  Patient transported emergently with critical care transport team and physician to adult facility. 10/30/09 DC summary received for date 10/20/09 to 10/23/09. DC DX: Stroke. Pt. d/c to rehab facility.  11/5/2009 hospital records for ED 10/20/2009 and MR for 10/20-10-23/2009. Patient with c/o's syncope, lt hemiparesis, lt facial droop, aphasia, and dysphagia. Neuro exam abnormal: sensory absent on lt, dec strength. Tx: admit, IVF, dx testing.