chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick for 7 days /in bed for 4 days; 101°F fever; large muscle pain; joint pain; lymph nodes under the left arm swelled till the ribs; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 7 days /in bed for 4 days), PYREXIA (101°F fever), MYALGIA (large muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes under the left arm swelled till the ribs) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced ILLNESS (sick for 7 days /in bed for 4 days), PYREXIA (101°F fever), MYALGIA (large muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes under the left arm swelled till the ribs). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) ongoing from April 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (sick for 7 days /in bed for 4 days), PYREXIA (101°F fever), MYALGIA (large muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes under the left arm swelled till the ribs) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 101 (High) 101°F fever..         Concomitant information was not reported.   This case was linked to MOD-2021-404059 (Patient Link).
Wednesday morning at 7:45, vomiting. Thursday Diarrhea in morning and vomiting at 11pm. No fever or other signs of illness.
Headache began appx. one hour after injection lasting into the following day. On April 4th, numerous hair follicle size red bumps appeared. Bumps itched. Several bumps subsequently grew in size into a noticeable, small rash. Rash/bumps are mostly located in armpits, neck, inside of elbow and other "pit" skin areas. No topical cream or itch relief treatment is effective. Rashes continue to grow slowly in size but greater in number.
PATIENT DEVELOPED SHINGLES RASH FEW DAYS LATER. HE HAS SEEN MD AND RECEIVED ANTI VIRAL MEDICATION.
Please see attached patient documentation. 9/29/09 PCP Medical records, ER visits, and consults received DOS 2/18/08 to 5/4/09. Assessment: Seronegative Rheumatoid Arthritis.   Carpal Tunnel Syndrome. Thoracic outlet syndrome. Wrist surgery - carpal tunnel release. Fall, severe coccygeal pain. Hand pain interfering with sleep. Painful bumps on neck. Seen at ER for bilateral upper extremity pain and paresthesias on 9/6/08. Productive cough, sore throat, ears feel full, fever. Pain in knee. Migrating pain. Bronchitis, sinusitis, polymyalgia rheumatica. Recurrent hand symptoms. Legs heavy and weak. Morning stiffness. Weight gain. Anserine Bursitis. Synovitis multiple joints.
pt recv vax & devel n/v, diarrhea & cramping w/in 3 days of vax;this if 1 of 6 pt, out of 30 vaccinees from this facility to exp this rxn;
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history and drug reaction or allergies were not provided. On unknown dates in 2017 (reported as "on unspecified dates since 12-FEB-2017"), the patients were vaccinated with improperly stored doses of PEDVAXHIB injection, lot # M032149 with expiry date 18-APR-2019 (exact dose and route af administration were not reported). The doses were exposed to the temperature between 0 and 1 degrees Celsius (0.5 degrees Celsius) for 3 hours and 55 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA005924.
I am a AML Leukemia patient. I had a Bone Marrow Transplant on 11/16/2018. My donor was a 23 year old Male. After the second vaccine, I had severe reactions. I had pericarditis, dizziness, headache, and fatigue. The pericarditis was treated and lasted about a month. The other conditions lasted 2 months. I thought that this information was important since I am an older female but had immune system of 23yr old male and the pericarditis is usually more common in young males.
patient administered a Daptacel vaccine on 17-May-2019, with expiration date  16-May-2019; Initial information received on 17-May-2019 regarding an unsolicited valid non-serious case received from a physician by phone.  This case involves a 19 months old female patient who was vaccinated with an expired 0.5 ml fourth dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5202AA and expiry date: 16-May-2019) via intramuscular route in the right thigh on 17-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
I felt like I had a head cold, sore throat, itchy eyes, and very tired. I tested and it was negative and then I tested the next day and it was positive. I had a lot of diarrhea.  I was prescribed Paxlovid and took it for five days.
Phone from Mom. She states that patient had a reaction to the TRUMENBA vaccine that she had on Wed last week. Swelling and redness at the injection site, fever and body aches the next day and headache. Mom states that she did some research and found that people with latex allergies have more trouble with this vaccine. She said that patient has a latex allergy but I don't see it in the chart. Mom said she just wanted to make you aware if this.
Pt waited 15 minutes then said it felt like she was having an anxiety attack. She said she has a history of anxiety. She went home and called me at pharmacy. She said she had red blotches but no rash or itching. She asked if she could take BENADRYL, I said yes.
Generalized pain in area of immunization. Has persisted for about 2 weeks. Has not decreased and is not helped by OTC pain medication.
tested positive for COVID after receiving the COVID vaccine; This is a spontaneous report from a contactable consumer. This consumer reported same event for three patients. This is the third of three reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 16Feb2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID after receiving the COVID vaccine. The patient had the COVID vaccine this morning (16Feb2021) and tested positive for COVID on 16Feb2021. The outcome of the event was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021200814 same reporter/drug/event, different patients; PFIZER INC-2021200823 same reporter/drug/event, different patients
I got up at 3:00 a.m. (11 hours after receiving the vaccination) to get a drink of water.  I lost consciousness suddenly, resulting in a face plant on tile floor, which caused serious facial and dental injuries.    While attending to my injuries, my husband also experienced loss of consciousness and convulsions (three times).  He has submitted his own paperwork.
Chest pain, tachycardia greater than 125 at rest, irregular heart beat, dizziness at rest.
No additional adverse events; patient received V AQTA pediatric dose instead of adult dose.; patient received V AQTA pediatric dose instead of adult dose.; This spontaneous report as received from a nurse refer to a patient of unknown age. No information regarding the patient's medical history, concomitant medication and concurrent conditions was provided. On 21-NOV-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # S021092 for prophylaxis. The patient received pediatric dose instead of adult dose. No additional adverse event was reported.
Patient received the vaccine and felt fine. Within a minute patient began to have a seizure which lasted roughly 30 seconds. Patient stated had not had a history of seizures before receiving vaccination. Also, patient stated no medical conditions to date.
in and out of consciousness; blood pressure was 170/112; severe chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (in and out of consciousness) and HYPERTENSION (blood pressure was 170/112) in a 98-year-old female 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 UTI and Chronic heart failure. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (in and out of consciousness) (seriousness criteria hospitalization prolonged and medically significant), HYPERTENSION (blood pressure was 170/112) (seriousness criterion hospitalization prolonged) and CHILLS (severe chills). At the time of the report, LOSS OF CONSCIOUSNESS (in and out of consciousness), HYPERTENSION (blood pressure was 170/112) and CHILLS (severe chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 170/112 (High) Increased.         No treatment information was provided.  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. Patients underlying chronic heart failure and advanced age are confounders.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up information was received on 27-Apr-2021 contains information regarding follow-up consent (follow-up and consent was denied for follow-up).; 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. Patients underlying chronic heart failure and advanced age are confounders.
Swollen 1 inch from injection site;chills on the site, red& painful five days after vaccination
Fever, spiking to 103, maintaining at 101 with ibuprofen for 24+ hours
FEVERS 102-104 FOR 3 DAYS, THROMBOCYTOPENIA TO LOW OF 64,000 ON 12/14/19 -> IMPROVED 105,000 ON 12/15/19, PROGRESSIVE (L) DELTOID ERYTHEMA. TREATED WITH CLINDAMYCIN FOR CELLULITIS
The next day my hands were aching, and I was very tired. I just wasn't feeling very well at all. I had mild nausea, headaches, and body aches. My hand was the worst part. They were aching really bad. On Friday, I noticed my arm was sore, but it wasn't bad. On Saturday morning, I woke up to take some medication, and when I went back to bed, I had a serious case of Vertigo that made me vomit. I was unable to do anything the rest of the day. I called my doctor, and they called in meclizine, and ZOFRAN. I am still dealing with this at this time.
Pt recv vax on 1/21/99; on same day pt exp head & upper neck redness; tx=Benadryl PO
After my second COVID shot on August 6, 2021 I wasn?t feeling well on August 17, 2021 I was having difficulty breathing with sever right sided lung pain my with transported me to ER.
This spontaneous case reported by a consumer, describes the occurrence of SARS-CoV-2 positive test (tested positive/must have already had COVID-19 when got the shot although didn't know it) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Aug 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 23, 2021, patient experienced SARS-CoV-2 positive test (tested positive/must have already had COVID-19 when got the shot although didn't know it). At the time of the report, SARS-CoV-2 positive test (tested positive/must have already had COVID-19 when got the shot although didn't know it) outcome: unknown. Diagnostic results: On Aug 23, 2021, SARS-CoV-2 positive test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information not provided. Patient received antibodies on August 26. This case linked to MOD-2021-319706 (patient link).
She had a history of vasovagal response & let me know ahead of time. Mom was also present. I got an ice pack, crackers, hard candy & water ready for her. Had her sit in a seat with feet elevated.  A few minutes post she said she could feel it coming on & lost consciousness for about 15 seconds. She came back to & we put an ice pack on her neck. Mom & I had her lay on the floor with feet elevated & ice pack on the back of her head. Her color came back & she asked for some water. She said she was much better & we let her lay there for the 15 minutes. Mom & her left 30 minutes after
Pt recv vax 10MAR98 devel redness, swelling and pain at the injection site. On 12MAR98 pt exp a fever of 101 degrees F. The pt was afebrile by 14MAR98. Pt recovered on 16MAR98.
At two months he received shots everything seemed fine. At four months he received shots and reacted to one of the shots. They gave him the shot again at six months and he is reacting again. The reaction is done in phases. It turned red, looks like a blister the previous one drained and left a black and blue scar. The second one still has not drained. Nothing has been done and I have made multipule appointments to discuss this with doctors.
Information has been received from a pharmacy technician concerning a multiple unspecified patients (unknown ages and genders). The patients pertinent medical history and concurrent conditions were not informed. It was reported that on multiple unspecified dates, the patients received improperly stored doses of ROTATEQ, lot # L048854, expiration date 31-AUG-2017, (dose was not provided), administered per oral route. Concomitant therapies were not informed. The temperature was 48 F and the time frame 12 hours 20 minutes. There was no a previous temperature excursion or call because of a data logger. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of two reports from the same source (MARRS # 1609USA009557).
Situation: The patient came in for his first Moderna vaccination. Background: N/A Assessment: This nurse was called by Dr. to assist with a patient in the vaccination area that showed symptoms of a vasovagal reaction. The patient was transferred to a gurney in a supine position and wheeled to the observation area to be examined by Dr.  He appears to be clammy.  Vital signs at 1600: 112/80, P 68, O2 Sat 98% on RA.  Vital signs at 1612: 117/73, P 68, O2 Sat 97% on RA, Vital signs at 1622: 125/74, P 70, O2 Sat 98% on RA. The patient states he is feeling back to normal. Recommendation: The patient was released by Dr.
NAUSEA/VOMITING, GENERAL FEELING OF BEING UNWELL STARTING 8 HOURS AFTER INJECTION. STARTED TO RESOLVE BE EARLY AFTERNOON.
Foggy eye site, Migraine.  patient took Tylenol Ibuprofen and Advil Cold/Sinus
Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 29-JAN-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcomes of events reported were unknown. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Information has been received from a school nurse (registered nurse concerning a high school aged female who was vaccinated with a dose of GARDASIL. On an unspecified date, after receiving GARDASIL, the patient developed aluminum poisoning. The patient sought unspecified medical attention. Additional information was received from the school nurse and an office manager concerning the 15 year old high school female who on 31-JUL-2007 was vaccinated with the first dose of GARDASIL (lot #: 658094/0524U), on 5-OCT-2008 was vaccinated with the second dose (lot # : 658282/0929U) and on 6-FEB-2008 was vaccinated with the third dose (lot #: 659657/1487U). It was reported that the patient did not have poisoning but had a reaction to GARDASIL. This is one of several report received from the same source. Additional information has been requested.  5/1/09 Received PCP vaccine & medical records of 7/31/07-11/24/08 FINAL DX: none provided Records reveal patient experienced good health on 7/31/07 & 8/5/08.  RTC 9/26/08 & 11/14/08 w/abdominal pain & nausea.  Dx w/GERD.  RTC 11/24 w/strep pharyngitis
This spontaneous report was received from a Certified Medical Assistant refers to a female patient of unknown age. On 17-DEC-2013 the patient was vaccinated with first dose of GARDASIL intramuscularly. On an unknown date, the patient declined to receive a second dose of GARDASIL. No adverse events were reported. No further AE information was reported. Follow up information has been received on 01-APR-2014 from the physician concerning the 18 year old female patient with emotional immaturity, depression and long history of emotional problems. Physician reported that on 03-MAR-2014 at 4:45 p.m. the second dose of GARDASIL was not administered due to needle was contaminated. Physician also reported that no harm to patient only emotional upset on the same date at 4:45 p.m. It was reported that needle never touched patient. It was also reported that patient refused vaccine. No illness at time of vaccination was reported. The outcome of emotional upset was unknown. Additional information is not expected.
Vaccination site warmth; Vaccination site erythema; Vaccination site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site pruritus) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site pruritus). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site pruritus) 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.
pt recvd vax 23FEB93; 12MAY93 a blood culture was pos for Haemophilus influenzae type A & the MD reported pt devel invasive haemophilus influenzae type A disease;
pt recv vax 3OCT97 & onset of sx same day 6PM pt devel rash, dizzy, fever, sore neck, glands hurt, feels bad since Saturday AM;
Round red mark on the injection site; A spontaneous report was received from a consumer, concerning a 97-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed round red mark on the injection site/vaccination site erythema.   The patient's medical history was not provided. No concomitant product use was provided.  The patient received their first of two planned doses of mRNA-1273 (batch number: not provided) on an unspecified date.   On 01 Feb 2021, approximately 5 days, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 06 Feb 2021, post vaccination the patient developed a round red mark on the injection site.   The seriousness criteria for the event round red mark on the injection site.   Treatment information was not provided.   The outcome of the event, round red mark on the injection site/ vaccination site erythema was considered unknown.; Reporter's Comments: This case concerns a 97-year-old female who had a medically significant and serious expected event of Vaccination site erythema.  The events occurred 5 days after the second dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on 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.
Started with some redness, swelling, minor rash, and warmth at site of injection. Progressed to more severe redness, swelling and over a larger area. Also, pt started complaining of numbness down her arm, side and leg on the same side as where she received the vaccination.
Patient has experienced right hand swelling, as well as redness and itching on neck, face and around the eyes.
This case was reported by a physician via a sales representative and described the occurrence of dizziness in a 28-year-old male subject who was vaccinated with TWINRIX, GlaxoSmithKline.  On 30 June 2008 the subject received 1st dose of TWINRIX at 0.5 ml.  On 30 June 2008, less than one day after vaccination with TWINRIX, the subject experienced dizziness, pallor, nausea, lethargy, was foggy minded and had to lie down after receiving TWINRIX.  This was considered to be a systemic reaction.  The subject was given something to drink and had normal vital signs.  He was unable to drive and was advised to visit the emergency room.  The physician considered the events were disabling and clinically significant (or requiring intervention).  At the time of reporting the outcome of the events was unspecified.  The physician considered the events of dizziness, pallor, nausea and foggy minded to be probably related to vaccination with TWINRIX.
no adverse effect; a 7 month old infant received a first dose of Rotateq on 12-SEP-2019; This spontaneous report was received from a medical assistant and refers to a 7-month-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-SEP-2019, the infant was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, orally, lot # R035374 and expiration date 15-SEP-2020 (exact dose was not reported) for prophylaxis, outside of prescribing information. No adverse effect was reported.