chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Congestion; Felt Terrible/the caller states she kind of lost the days; COVID/She definetly had a postive COVID-19 test; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (Congestion), FEELING ABNORMAL (Felt Terrible/the caller states she kind of lost the days) and COVID-19 (COVID/She definetly had a postive COVID-19 test) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PREGABALIN (LYRICA) capsule for Fibromyalgia.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and PREGABALIN (LYRICA) (Oral) 150 milligram twice a day. On an unknown date, the patient experienced NASAL CONGESTION (Congestion), FEELING ABNORMAL (Felt Terrible/the caller states she kind of lost the days) and COVID-19 (COVID/She definetly had a postive COVID-19 test). At the time of the report, NASAL CONGESTION (Congestion) and FEELING ABNORMAL (Felt Terrible/the caller states she kind of lost the days) had not resolved and COVID-19 (COVID/She definetly had a postive COVID-19 test) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Had positive COVID test which was about two weeks ago..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient weight was reported as 68.04 kgs.  Patient states she is 10x better but didn't start getting better till today. symptoms had lasted for four days. She is a lot better now.  Patient stated that she had not had any problems with the medication Lyrica. she did not noticed anything but felt terrible.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
shot site w/9cm x 12 1/2 cm area of warmth, redness, induration
Bumps; Another attack of hives; hives all over my body; Body is itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over my body), PRURITUS (Body is itching), NODULE (Bumps) and URTICARIA (Another attack of hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced URTICARIA (hives all over my body) and PRURITUS (Body is itching). On 20-Mar-2021, the patient experienced URTICARIA (Another attack of hives). On an unknown date, the patient experienced NODULE (Bumps). On 16-Mar-2021, PRURITUS (Body is itching) had resolved. At the time of the report, URTICARIA (hives all over my body) outcome was unknown and NODULE (Bumps) and URTICARIA (Another attack of hives) had not resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  The action taken with mRNA-1273 with the events was considered as not applicable  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
fainting; fatigue; muscle aches; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (fainting) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 046L21A and 025L21B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder and Hashimoto's disease.   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, received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYNCOPE (fainting) (seriousness criterion medically significant), FATIGUE (fatigue) and MYALGIA (muscle aches). At the time of the report, SYNCOPE (fainting), FATIGUE (fatigue) and MYALGIA (muscle aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: fluctuating for her abnormally. On an unknown date, Vitamin B12: vitamin B12 deficiency. On an unknown date, Vitamin D: vitamin D deficiency.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported. Company comment This spontaneous case concerns a 61-year-old female patient with medical history of Thyroid issues all her life and Hashimoto diagnosis, who experienced the serious (medically significant), unexpected event of Syncope. The patient received the first and second doses of mRNA-1273.222 (BA.4/BA.5). The event onset date and vaccination date were not provided, thus, exact latency between vaccination and onset of the events could not be assessed. Other non-serious events include fatigue and muscle aches that could be associated with D3 deficiency, B12 deficiency and the medical history of Hashimoto. It was reported that she was seeking treatment through her HCP. No further clinical information was provided for medical review. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) is not affected by this report.
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 64-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Mar-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Apr-2022,  after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient had previously received Moderna vaccines first dose on 13-MAR-2021, Lot no. 001B21A, second Dose on 10-APR-2021, Lot no. 038B21A third Dose on 12DEC2021, Lot no. 031H21A. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-745332, US-MODERNATX, INC.-MOD-2023-745333 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745332:Husband case (MASTER CASE) US-MODERNATX, INC.-MOD-2023-745333:Wife case
Pt recvd 2 doses of Engerix-B & on JUL92 & 21AUG92; 22AUG92 pt exp severe dyspepsia, weakness, h/a, nausea, vomiting, myalgia & somnolence;
Measle like rash started 24 hrs after the 2nd Moderna vaccine received.  Rash started on legs focused around ankles and knees.  Rash spread in the following hours into the next day onto other areas of legs and arms.  48 hrs after vaccine, chills and then fever of 100.5.  This lasted 4 hrs and fever gone the next morning.  Rash changed from measle like to flat red spots that resembled burns.  used topical cream and benadryl  to control itch and rash.  Reaction led to swelling into index fingers then to left ankle followed by toes then into other fingers.  Focal of swelling was in index fingers.  Pain when touching joint s in fingers and ankle, arthritic feeling and very stiff, panful and swollen.  Toe swelling focus on 2nd toe, redness on right 2nd toe.  Taking Aleve to assist with selling after 48 hrs on vaccine.  Meds taken Tylenol for fever, Aleve for pain and swelling, topic steroid cream for rash
Employee reported onset of headache 24 hours later, with additional tension near the TMJ b/l. Additionally, employee feels his blood pressure is labile.
received the vaccine after the 6 hour vial puncture expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the vaccine after the 6 hour vial puncture expiry) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received the vaccine after the 6 hour vial puncture expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received the vaccine after the 6 hour vial puncture expiry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 012M20A)  with no associated AEs.
Felt flushed after receiving injection-Dissipated after a few minutes.  Arm soreness later in day in arm injected.  Next day-mild headache, chills, temp 100.2, very tired, arm soreness 2nd day-mild headache, temp 100.3, very tired, lymph node tenderness and swelling in left axilla, arm sorenes 3rd day- tired but not as noticeable, noticeable discomfort in left axilla with swollen lymph nodes 9th day-still with slight injection site soreness and still with noticeable and persistent discomfort in left axilla lymph nodes tender and swollen
Pt recv vax on 1/28/99; post vax pt exp swollen upper LA, urticaria, warmth to area; tx=Benadryl IM & Benadryl PO
Pt had flushing of leg where Prevnar and Hib were given. Within 5 mins there was a flat non pruritic lacey flush of about 5cm area. Within 15 min everything gone. Your officials called next day and left message and no one responded. Is this a known or serious reaction
Information has been received from a physician Assistant and a Licensed Practical Nurse concerning a 16 and half years old female with familial risk factor who was vaccinated with three doses of GARDASIL ON 11-APR-2008, 13-JUN-2008 and 9-JAN-2009. Concomitant therapy included ALASE. The patient had no known drug allergies. On 25-AUG-2008 the patient experienced syncope and was sent to the emergency room (hospital name unknown). At the patient's office visit on 16-JAN-2009 it was reported that on 14-JAN-2009 the patient felt dizzy while driving (with a sibling as passenger), she pulled over then blacked out. On 16-JAN-2009 the patient had CT scan and EEG done and CT scan results were normal but EEG results were abnormal and it showed that she underlying predisposition for seizures. It was known that the patient had a "family history of seizure disorder". The patient was referred to Neurologist. The neurologist did not wish to provide any information on this case. A nurse at the county health department reported that the patient was not in their system. Therefore, lot #'s could not be provided. The patient's experience was not felt to be life-threatening. The patient's status was listed as recovering. The health care professionals contacted during telephone follow up could not supply the following information: lot numbers and hospital name (ER visited 25-AUG-2008). No further information is available at this time.  6/23/09 Neurological consult received DOS 4/02/09. Assessment: seizures, syncope. Patient c/o of an episode consisting of stomach hurting, sweating, feeling hot. Pale and unable to recall subsequent events. Lost conciousness. Also slumped over once while driving and had car wreck. Lightheadedness. Episodes of staring. Myoclonic jerks while sleeping. Sleeps a lot, recent weight gain, distractible. ICD-9 Codes: Spells 780.39, Abnormal EEG 794.02, Syncope 780.2, R/O Epilepsy 345.90   6/29/09 Medical records received DOS 8/07/08 to 4/08/09 Assessment: Cephalgia and Syncope. Patient presents with abdominal and pelvic pain. Menorrhagia. Later "passed out/blacked" out while driving. Plantar warts - cryosurgery, electrosurgery. Syncope, cough, cephalgia, emesis, fever. Nasal congestion and sinus pain. Serous effusion - ears. URI. HPV Dose #1 - 4/11/08, HPV Dose #2 - 6/13/08, HPV Dose #3 - 1/9/09
A non-serious spontaneous report of gave half the total dose of FLUIST was received from a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Pt received pneumococcal vaccine on 8/23/11, has generalized redness and induration, (+) heat, tenderness at site & extending to right upper arm. VS 98.5 - 89 - 20 - 123/73.
This spontaneous case reported by a nurse, describes the occurrence of vaccination site warmth (arm had heat around the site), pyrexia (fever), vaccination site swelling (arm had swelling around the site) and vaccination site erythema (arm had redness around the site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. No medical history reported. On Jan 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 12, 2021, patient experienced vaccination site warmth (arm had heat around the site), vaccination site swelling (arm had swelling around the site) and vaccination site erythema (arm had redness around the site). On an unknown date, patient experienced pyrexia (fever). At the time of the report, vaccination site warmth (arm had heat around the site), pyrexia (fever), vaccination site swelling (arm had swelling around the site) and vaccination site erythema (arm had redness around the site) outcome unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments or concomitant product use. Treatment medications included unspecified steroids and clindamycin. 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.
This is one case out of a cumulative total of 210 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 23 August 2013. These 210 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 23 August 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL (lot numbers not reported) on 21 January 2011, 01 April 2011, 06 June 2011, and on 25 April 2012. The subject developed a cough on 29 July 2013, approximately 15 months after the last dose, and a paroxysmal cough without a whoop on 03 August 2013. The subject also developed cold like symptoms on 29 July 2013. Laboratory testing included positive PCR on 01 August 2013. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 01 August 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 12 August 2013, the subject's cough had resolved. The duration of the cough was reported at that time as 14 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
9/14 - going to bed extremely sore arm.  9/15 - 5 AM to urgent care Rx pain MED.  9/15 - Small amount of redness - pencil eraser size.  9/16 - silver dollar size redness - no discharge, minimal swelling, to ER Rx antibiotics, no explanation given.  To PCP - Dx cellulitis - allergic reaction, viral syndrome.  Fever 102.7 very fatigued, H/A extreme pain.
Received 2nd vaccine on 2/14/21 and on 2/16 started having pain in the right ear. Went to ICC on 2/18/21 and diagnosed with right otitis media with effusion
History of vasovaginal. Pt. presented feeling lightheaded. Pt. stated she has a history of vasovagel u/injections. Pt. was moved to privacy treatment area and was A/Ox4  3 sets of vitals were taken. Pt was monitored for 30 min and released to home. Pt was advised to seek further medical assistance if needed; Pt stated she has a fear of needles. Pt. presented as light-headed. Pt stated she has a history VasoVagel reactors with needles. Pt as ambulatory and A/OXY. Pt was moved to private treatment and monitored with 3 sets of vital taken. Pt was monitored for 30 and started she felt hot. Pt was released to home and advised to seak additional medical attention if needed.
post exposure resulting in low titre levels, booster dose was administered and titres were drawn again showing below normal levels; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist and transmitted to Sanofi on 01-Dec-2020.  This case involved a female patient with unknown age who received RABIES (HDC) VACCINE [IMOVAX RABIES] post exposure resulting in low titre levels, also booster dose was administered and titres were drawn again showing below normal levels (complement factor decreased).  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   On 24-Jul-2020, the patient received a 0.1 ml of first dose of suspect RABIES (HDC) VACCINE (lot R1C713M, expiry date: 30-Apr-2021), on 27-Jul-2020 she received a 0.1 ml of second dose (lot number and expiry date not reported), on 31-Jul-2020 she also received a 0.1 ml of third dose (lot R1C715M, expiry date: 30-Apr-2021) and on 07-Aug-2020 she received a 0.1 ml of forth dose (lot R1C71, expiry date: 30-Apr-2021), via unknown route in unknown administration site as post exposure immunization.  On an unknown date, first titre was drawn and the result showed low titer levels (complement factor decreased).  On 05-Sep-2020, the patient received a 0.1 ml of first dose of suspect RABIES (HDC) VACCINE (lot: 966650, expiry date: 30-Apr-2021) via unknown route in unknown administration site as post exposure immunization.  On 04-Nov-2020, second titres were drawn and resulted on 19-Nov-2020 with below limit quantifiable Rapid Fluorescent Focus Inhibition Test (RFFIT) end point test (complement factor decreased).  Final diagnosis was complement factor decreased.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.
Arm is still very sore; Can barely turn my head; Neck pain; Chills; Low fever; Back muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is still very sore), HYPOKINESIA (Can barely turn my head), NECK PAIN (Neck pain), CHILLS (Chills) and PYREXIA (Low fever) in a female patient of an unknown age 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 COVID-19 (Recovered in two weeks without medical intervention.) on 03-Jan-2021.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Arm is still very sore), HYPOKINESIA (Can barely turn my head), NECK PAIN (Neck pain), CHILLS (Chills), PYREXIA (Low fever) and MYALGIA (Back muscle pain). In March 2021, CHILLS (Chills) and PYREXIA (Low fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm is still very sore), HYPOKINESIA (Can barely turn my head), NECK PAIN (Neck pain) and MYALGIA (Back muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced HEADACHE (headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 1 dosage form once a day. In May 2021, HEADACHE (headache) and CHILLS (chills) had resolved.            No medical history was provided by the reporter No concomitant medications reported.   This case was linked to MOD-2021-415850, MOD-2021-415852 (Patient Link).
began w/ change in level of mental status by 5:30 pm the day of vax,  and then progressed to high fever of 104, heaviness in legs,unable to walk/stand, cognition foggy, unbalanced. Left sided arm/leg mobilitylimited. Jaw, head, ear and neck pain radiating up to left arm into head.  Next day after vaxx (Thurs 1/7/2021) woke up thinking it would have resolved and was worse, shaking chills, fever still elevated, face swollen and hot, difficult to stand up straight, heavy limbs and unable to walk normally. This lasted all day, very fatigued almost a change is mental alertness as well. Tried to stay hydrated, took tylenol and motrin alternatively all day, loss of taste and smell, could not focus to read anything all day and into evening of 1/7/2021.  At about 830 pm on 1/7/2021, began to feel slight improvement in balance and cognition. Went to bed early and woke up about 2 or 3 am on 1/8/2021 drenched from fever breaking I suspect. Rash on face after fever broke. Continued with tylenol and motrin and hydration, gradual improvement into early morning of 1/8/2021 and by the afternoon, I was very much improved. However, lingering parastethesias in left jaw, neck, ear and into left arm and fingers, even today 1/11/2020.