chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FETAL EXPOSURE DURING PREGNANCY; CLEFT LIP; This solicited pregnancy report received from a consumer concerned an infant male of an unspecified age, race and ethnic origin. The patient was enrolled in a non-company sponsored study: COVID 19 Vaccines International Pregnancy Exposure Registry number: C01653). The patient's weight was 3.26 kilograms, and height was 20 inches. No concurrent conditions were reported. The mother of the baby had no relevant medical history. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number: 1805020 expiry: unknown) dose was not reported, 1 total administered on 12-MAR-2021 for covid-19 immunisation. No concomitant medications were reported.  On 12-MAR-2021, the patient had a cleft lip due to fetal exposure during pregnancy. On an unspecified date in JUL-2021, A Laboratory test was conducted, an Acoustic stimulation tests (NR: not provided) Result: The baby passed the hearing test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cleft lip and fetal exposure during pregnancy was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and fetal exposure during pregnancy, and cleft lip as not related. Company causality between Covid-19 vaccine ad26.cov2.s and fetal exposure during pregnancy assessed as not related and Cleft lip assessed as related This report was serious (Congenital Anomaly/Birth Defect, and Other Medically Important Condition). This parent/child case is linked to 20210762291.; Sender's Comments: V0: 20210958770-COVID-19 VACCINE AD26.COV2.S-cleft lip. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210958770-COVID-19 VACCINE AD26.COV2.S-fetal exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Weakness; sick all over; feel achy; Irritated throat; Coughing; soar arm; Fever; exhaustion/tired/Feel faint exhaustion/extremely tired; Dizziness/light headed; Feel faint; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness/light headed), PRESYNCOPE (Feel faint), ASTHENIA (Weakness), PAIN IN EXTREMITY (soar arm) and FATIGUE (exhaustion/tired/Feel faint exhaustion/extremely tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic. Concomitant products included MULTIVITAMINS [VITAMINS NOS], CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), ESSENTIAL OILS NOS and PANTOPRAZOLE for an unknown indication.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced DIZZINESS (Dizziness/light headed), PRESYNCOPE (Feel faint), FATIGUE (exhaustion/tired/Feel faint exhaustion/extremely tired) and HEADACHE (slight headache). On 11-Aug-2021, the patient experienced PAIN IN EXTREMITY (soar arm) and PYREXIA (Fever). On an unknown date, the patient experienced ASTHENIA (Weakness), ILLNESS (sick all over), MYALGIA (feel achy), THROAT IRRITATION (Irritated throat) and COUGH (Coughing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Aug-2021, DIZZINESS (Dizziness/light headed), PRESYNCOPE (Feel faint), FATIGUE (exhaustion/tired/Feel faint exhaustion/extremely tired) and HEADACHE (slight headache) had resolved. At the time of the report, ASTHENIA (Weakness), PAIN IN EXTREMITY (soar arm) and PYREXIA (Fever) had not resolved and ILLNESS (sick all over), MYALGIA (feel achy), THROAT IRRITATION (Irritated throat) and COUGH (Coughing) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: under 101 (High) under 101.     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.   patient was ingesting DoTERRA essential oils each day to detox from heavy metals and other toxins. Cilantro, frankincense, coriander, cinnamon, lemon,cardamom and a couple of other blends. -5 drops of each. patient has not taken any vitamins and supplements for 2 days other than turmeric, probiotic, Zyrtec. He said he will will resume all vitamins, supplements tomorrow-day4. Dizzy, lite headed, weak were recovered with Ongoing slightly   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow up  received on 12-AUG-2021 ,contains patient demographics, allergies, Batch no,concomitant medication and events. On 12-Aug-2021: Significant follow-up appended as events added
Pain on the injected arm started one hour after the shot but got worst after a few hours. The pain was very intense for the first 24 h and gradually improve after that until on the third day after the shot is was completely gone.  Also the first night I felt weak, had chills, and a temperature of 99.6. Those symptoms were gone the next morning.
TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious.
Increasing  joint and muscular pain that is unusual and more than normal.  Elbow, shoulder and knee pain are worse than usual.  Chest muscles are tight at the shoulder junction...feel like they want to tear when attempting to exercise.  Pain, joint popping/crackling has been consistent and more prevalent ever since being  fully vaccinated (for the last month and a half).
pt screaming for 34 hrs afternoon vax was given; no fever;APAP, comfort measures;
Client came to clinic at 4pm on 10/19/18 with parents. Parents concerned about swelling, redness and warmth at injection site. Mom had just noticed the swelling that morning. Advised to use cold compress. To outline swollen area with ink and if swelling spread further or symptoms of fever, difficulty breathing, hives to go directly to urgent care or ED.
patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine.1; No other adverse events were reported; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine.1) and NO ADVERSE EVENT (No other adverse events were reported) in an adult female patient 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine.1) and NO ADVERSE EVENT (No other adverse events were reported). At the time of the report, UNDERDOSE (patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine.1) and NO ADVERSE EVENT (No other adverse events were reported) 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 other adverse events were reported) to be not related. No further causality assessment was provided for UNDERDOSE (patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine.1).    Concomitant medication not reported. Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-727279 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727279:Case
Moderate headache, fever, myalgia. The latter two lasted 2 days after vaccine, the headache lasted about 2.5 days after vaccine. I was back to normal after the weekend (about 3 days later). Some mild fatigue and feeling ?off? occurred as well during that 2.5 day period. Took some ibuprofen and that helped a little bit, otherwise just took it easy and recovered pretty quickly (relatively).
Leg weakness; very tired; body aches; stomach pain; headache; wheezing; shortness of breathe; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 15:45 (Lot number: EW0177) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing), notes: Event verbatim: asthma, osteoarthritis, fibromyalgia; "osteoarthritis" (unspecified if ongoing), notes: Event verbatim: asthma, osteoarthritis, fibromyalgia; "fibromyalgia" (unspecified if ongoing), notes: Event verbatim: asthma, osteoarthritis, fibromyalgia. Concomitant medication(s) included: GABAPENTIN, start date: 18Aug2021. Vaccination history included: Bnt162b2 (1st dose, Lot number: 30145BA, Administration time: 15:45), administration date: 18Aug2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "Leg weakness"; FATIGUE (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "very tired"; PAIN (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "body aches"; ABDOMINAL PAIN UPPER (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "stomach pain"; HEADACHE (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "headache"; WHEEZING (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "wheezing"; DYSPNOEA (non-serious) with onset 25Sep2021, outcome "recovered with sequelae" (Sep2021), described as "shortness of breathe".  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with Covid-19 prior to and patient was not tested to covid-19 since the vaccination. Patient did not had any allergies. No follow-up attempts are possible. No further information is expected.
PT felt dizzy and sleepy. Wife at bedside. Did not take his medications today. O2 saturations were 88-90%. Advised to go to ER with EMS. Pt refused. Pt walked out of building, not even completing observation period.
Dizziness; headaches; severe total body aches; nerve pain; nausea; fatigue; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 (Batch/Lot Number: ER8737) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no medical history and there were no concomitant medications. There were no other vaccine in four weeks and no other medication in two weeks. The patient had no Covid prior vaccination and was covid tested post vaccination (Nasal Swab: PCR) on 15Apr2021 with Negative result. It was reported that the patient experienced Dizziness, headaches, severe total body aches, nerve pain, nausea, and fatigue on 09Apr2021. The events resulted in: Doctor or other healthcare professional office/ clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The events were treated (also reported as ER visits, PCP visits, and several specialists). The outcome of the events was not recovered.
Pt received vax on 1/15/00. On 1/17/00 r/arm was red and hot.  Pt saw MD and it measure 9cm x 11cm red, hot and slight swelling.  Red area marked with pen, Pt to take temp and if redness goes beyond pen marks, come in immediately.
Information has been received from a health professional concerning a 46 year old female with penicillin allergy who on 08-FEB-2007 was vaccinated with MMR. Approximately 10-14 days after vaccination, the patient experienced swelling in her jaw, her left neck and ear. Subsequently, the patient recovered from her experiences. Medical attention was sought. An antibody titer was drawn, but results were not available. Additional information has been requested.
Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  Patient received dose from vials refrigerated on 07-MAY-2021.
Redness, swelling, itching and tenderness at the site of injection in left left posterior upper arm. In a linear fashion extending inferiority approximately 10 cm.
I had increased urgency to urinate. I had a lot of back pain and felt bloated as well. I wasn't sure if I had a urinary tract infection or bladder infection. Drs. office ran tests for me and everything came back ok. Heat and rest seemed to help.  I was in the process of also changing some of my supplements at that time so we are not sure if that had an effect on it.
client alerted that she developed a headache and dizziness about 1 hour after she received the first dose of COVID vaccine Pfizer. The client stated the headache and dizziness lasted 1.5 days. The client did not seek formal medical care for the headache or dizziness. The client stated she did take Advil for symptomatic relief. The client stated she did eat prior to her first COVID vaccine and did eat today. The client noted approximately one week after receiving the COVID vaccine she developed chest pressure, mild shortness of breath, and felt "hot." The client stated these symptoms lasted for a few days. She also stated she developed diarrhea about 7 days after receiving the first COVID vaccine, which lasted about 2 weeks. The client stated she received negative COVID test results on 07/01/21. The client did not seek formal medical care for these symptoms. The client denies any chronic conditions. She takes oral birth control pills. The client has a history of dust allergies which cause her to "sneeze." The client was provided a water and Pringles snack, she started drinking the water. The client received 2nd COVID vaccine Pfizer Lot#EW0187 at 5:01PM. The client ambulated to the observation area and sat in the anti-gravity chair upon arrival. At 5:20 EMT Bustamante inquired how the client was feeling and the client reported feeling nausea. RN Withers responded. The client denied any s/s of anaphylaxis. Vitals obtained at 5:21 PM were as follows: BP 130/70 and HR 76. The client was provided an emesis bag. The client stated she last ate around 12:00PM. The client continued to drink water. Vitals obtained at 5:31 were as follows: BP 126/70 and HR 68. The client stated the "water is helping" with nausea. The client denied any dizziness, SOB, or headache. RN Withers reinforced education regarding s/s of anaphylaxis, when to seek EMS, V-safe, recommendation to follow up with PCP, common side effects following COVID vaccination, and to continue drinking water. The client voiced understanding of this. RN Withers escorted the client to the parking lot at 5:42. The client ambulated unassisted with a steady gait and was observed entering a personal vehicle at 5:42 PM.
~30 minutes after vaccination, patient reported lightheadedness, difficulty swallowing, SOB, feeling flushed, pallor, bilateral arm tingling, brief chest pain and tremors. Symptoms lasted approximately 30 minutes and then resolved. Benadryl given after resolution of acute symptoms. Reported a metallic taste in her mouth immediately after receiving the COVID vaccine (dose #1). Had uneventful 15 minute recovery period immediately after vaccination.
Initial report was received 12 October 2010 from a health care professional. A 67-year-old female patient with no concurrent illness, had received an intramuscular injection of FLUZONE HIGH-DOSE No Preservative 2010-2011, lot number U3607AA on 30 September 2010, and 11 days (also reported as 10 days) after vaccination, she experienced symptoms of partial amnesia, lapses in memory. The patient was seen in the emergency room and cleared of a diagnosis of a stroke. CT scan was normal. The patient had not received any other vaccines within four weeks of vaccination. The patient had a past history of hypertension, "thyroid", and brain surgery two years ago at which time a facial nerve was wrapped in Teflon. Concomitant medications included SENTRALINE, LISINOPRIL, HCTZ and Synthroid. It was further reported that the patient experienced these same symptoms previously (date not reported), and per the reporter, it was unclear if the symptoms were related to a previous Influenza vaccine. Outcome was not recovered. Documents held by sender: none.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. On an unknown date the patients were inadvertently vaccinated with ROTATEQ which had been improperly stored (lot#, expiration date, frequency, dose and route were unknown). And no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient started experiencing heart rhythm irregularities in July.  She was seen by a doctor and prescribed medications. She believes this to be related to her shingles shot on May 30,2023.
They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A and 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medications were reported. Patient received Moderna vaccine beyond the 30 days beyond use date. Beyond use date for lot 053C21A was 01-Jul-2021 (Vaccine received on 28-Jul-2021) and for lot 042J21A was 17-Feb-2022 (vaccine received on 02-Mar-2022). No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Non significant Follow up; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Started on October 7 with muscle pain in low back with radiating pain down legs, October 8th more back pain with it between low neck and shoulder pains radiating down arms.  October 9 skin sensitivity around chest line and on legs as well.  October 10-15 increase in muscle pain unable to sleep.  October 15 facial numbness started on right side, went to ER labs/imaging ok and discharged.  October 16 increases pain in muscles in legs and now facial drooping.  October 19 checking into ER unable to sleep due to pain in legs, back, and head, probable Bell's Palsy on right side of face.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 05-FEB-2016, the patient was inadvertently vaccinated with an expired dose of VAQTA (lot # K001296, expiration date 15-JAN-2016, exact dose and route of administration were not reported). No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
experiencing shortness of breath; Initial information received on 20-Oct-2023 and live follow up received on same date both were processed together regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 60 years old male patient who experienced experiencing shortness of breath while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Diabetic.   On 05-Oct-2023, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot, formulation, strength, and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On 19-OCT-2023 the patient developed a non-serious experiencing shortness of breath (dyspnoea) (latency 14 days). Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (experiencing shortness of breath).  At time of reporting, the outcome was Unknown for the event experiencing shortness of breath.
11:15 itching on chest, arms and back.  Red rash across nose and cheeks.  Followed standing orders:  BENADRYL 4 tsp. PO given.