chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very sick to my stomach; retching/dry heaves; very sore arm; dehydration; vomiting/ like a kid that went out drinking and threwup alcohol; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (very sick to my stomach), RETCHING (retching/dry heaves), PAIN IN EXTREMITY (very sore arm), DEHYDRATION (dehydration) and VOMITING (vomiting/ like a kid that went out drinking and threwup alcohol) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Menopausal in January 2011 and Surgery. Concurrent medical conditions included Bone disorder and Joint disorder.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (very sick to my stomach), RETCHING (retching/dry heaves), PAIN IN EXTREMITY (very sore arm), DEHYDRATION (dehydration) and VOMITING (vomiting/ like a kid that went out drinking and threwup alcohol). At the time of the report, ABDOMINAL DISCOMFORT (very sick to my stomach), RETCHING (retching/dry heaves), PAIN IN EXTREMITY (very sore arm), DEHYDRATION (dehydration) and VOMITING (vomiting/ like a kid that went out drinking and threwup alcohol) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient did not take any medication to treat the side effects but thought about taking a rapid release Tylenol. the patient had comorbidities, a couple of surgeries, and bone issues, joint disorders and has been menopausal in Jan-2011. Patient was not currently on any medications.  No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2022-446928, MOD-2022-446932 (Patient Link).
Fever - 100.4. Dizziness. Vomiting. Soreness on arm. No medication given.
The patient reports some arm pain, but nothing extreme. She feels it in her right arm, where she got the COVID vaccine; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (The patient reports some arm pain, but nothing extreme. She feels it in her right arm, where she got the COVID vaccine) in a 20-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 0661122A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TETANUS VACCINE for an unknown indication.    No Medical History information was reported.   On 21-Apr-2023, the patient received fourth 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 received dose of TETANUS VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (The patient reports some arm pain, but nothing extreme. She feels it in her right arm, where she got the COVID vaccine). At the time of the report, VACCINATION SITE PAIN (The patient reports some arm pain, but nothing extreme. She feels it in her right arm, where she got the COVID vaccine) outcome was unknown.        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 medication was reported. No treatment information was reported.   This case was linked to MOD-2023-720811 (Patient Link).
Child was given MMR#1, Hib#4, Prevnar#4 and DTap#4 in the office.  5-6 hours later, she developed rash( wheales and hives) and fever Tm 102.  The fever lasted for 2-3 days and rash x 6-7 days.  Benadryl was given( 12.5mg/5ml, 2/3TSP po q6h prn itchiness).
Patient was brought to the ED by EMS on 7/19 from his living facility because he appeared confused and lethargic. He tested positive at the facility prior to being seen in the ED. When in the ED, he had a blood pressure of 62/49 and had a temperature of 101.3.  He additionally was slightly hypoxic and was placed on 1-2L O2.  Patient had an additional COVID-19 PCR test on 7/19 which was positive. He was admitted from 7/19-7/27 with multiple diagnoses, notably COVID and ESBL Kelbsiella UTI. Patient is vaccinated and has one booster. This meets criteria for vaccine breakthrough case review.
Parents fed infant @ 430AM, put back to bed; Went in between 5-6AM, found Pt face down, stiff- called 911 prononuced dead @ 851AM;
No adverse event; 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.; 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 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, 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.). On an unknown date, the patient experienced 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.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 medicine were reported. lot 042J21A should have been reported with a BUD of 17-Feb-2022. No treatment medicine 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 significant follow up: Updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Lymphadenopathy axillary/Woke up to swollen lymph node in armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymphadenopathy axillary/Woke up to swollen lymph node in armpit) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymphadenopathy axillary/Woke up to swollen lymph node in armpit). At the time of the report, LYMPHADENOPATHY (Lymphadenopathy axillary/Woke up to swollen lymph node in armpit) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient experienced with third COVID Vaccine dosage woke up to swollen lymph node in armpit.  No concomitant medications were reported. No treatment medications were reported.  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.
Seizure per parents Fainted  Pale white skin  Clammy skin  Nausea and vomited  Shivering  Treatment applied cold compress to head, checked blood pressure 119/81 bpm 77 at 1715and again 1729 bp 98/76 bpm 78 Give sugar lollipop and water Family history of seizures  Sent patient to emergency room to be further evaluation.
Patient given DTaP-IPV intended for 4-6 y.o children. No AE reported; contacted Manufacturer of vaccine who states no contraindications or risks to infant and vaccine would still be valid.
Somewhere to a reaction I had to injectable Bill Abilify I broke out and have skin lesions For about 2 weeks enough so that I won't take the shot again
08/18/2015 at about 3:45 PM patient was seen at Dr's office for 13 yr old physical check up. Patient received Hepatitis A 2nd dose at Right arm and MENACTRA at left arm given by Dr. At about 6-7 pm patient was at home. While talking to mom and sister, he suddenly fell backward to wood cabinet countertop behind him. The cabinet was about 3 feet high. His whole body and all extremities became stiffed, stop talking, with eyes roll up, sweating, urinating. Face turned dark and lips pale and grinding teeth. Incidences last 1-2 min. Patient didn't have shaking of the body. Patient didn't collapse down to the floor. No vomiting, no fecal incontinence. Mom didn't recall pt stopped breathing. Patient denied being hit to head. Patient woke up by himself and mom and sister took him to the bed. As per patient, he can hear everything during the event. He can recall everything. But he can't see and move at that time. Mom didn't call 911 nor take him to ER. As per mom, she just hold and hug him and pray for him for his recovery. As per mom patient looks tired. Patient has headache after that at top of head, sharp pain grade 6-7/10 but no medicine taken. Patient also complaint of pain, bruise at the left arm but able to move and lift up the arm. 8/19/15 less pain at the top of the head. 8/20/15 at about 4:30 pm mom called to office and spoke to her. Mom reported to Dr the incidence which occurred in 8/18/15. As per patient feeling ok except still headache but less frequent. Pt was scheduled appointment to see Dr. on 8/21/15. 8/21/15 patient was seen at doctor's office. As per patient, still headache not all the time, just on - off.  But now no headache, pain level 4/10. No more sharp pain. He feels well. No nausea/vomiting/dizziness/vision changes/hearing loss. No changes in taste and smell. No numbness/weakness/no tiredness. Eat/sleep well. No abdominal pain/cough/RNO/diarrhea. Sleep well. Eat well. Still c/o pain over left arm but no redness. C/O tenderness less and able to move arm and also the head. On exam on 8/21/15 left arm mild swelling at injection site. No redness. 1 cm size bluish discoloration. Sl. tender.  No blister/vesicle/pustule. Treatment none. Referred to Peds Neurologist for rule out seizure disorder.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient stated he has history of vasovagal syncope. EMS was called. Patient was fine after 30  minutes
Proximal lateral half of left arm probably erythema unable to move left shoulder because of pain. Seen at ER 3 days after given IV steroids which resolved the pain but rash persist.
Onset fever 19FEB92 t101-102-hives onset 21FEB for 24 hrs period tx w/DPH listless decreased appetite APAP given; cont through 24FEB91 t102; pt seen by MD twice 21FEB & 24FEB;
Patient states she went to her hair dresser and the hair dresser noted visicles on forehead and in hair line.  Patient states she had itching on abdomen and on head.  She continues to have itching but it is decreasing.  She has done nothing to treat this up until this point.  States she will treat with Benadryl once she is at home.
Morning of 4/14/23 woke up with bad headache and fever, swelling and soreness of left shoulder and axillary lymph nodes. Around 10:30a would have upper body twitching every few seconds to every 30 seconds. Head and neck and upper body would flex forward like a myoclonic contraction. Motrin helped with pain but not the twitching. Went to a stand alone ER for evaluation afternoon of 4/14/23. Was given Valium 5 mg that stopped the movement. Twitching would return about 8 hours after dose but would resolve with Valium being given again. Last dose of Valium was on 4/15/23 at 3:15pm. No twitching after that. Arm swelling and lymph node swelling has resolved as well.
Received 2 doses of vaccine and subsequently diagnosed with mononucleosis and Epstein Barr. Then 5/6/21 experienced spontaneous pneumothorax. CT scan showed no bullae or evidence of emphysema.  Did fly 24 hours previously and also had acupuncture on back. Divorced husband living in another state who got Pfizer vaccine 1st dose also experienced spontaneous pneumothorax.
Afternoon of 2/9/10 felt light headed - had to pull over off highway, "fell asleep" for 15-20 min.  Then drove rest of way to cabin - utterly incapacitated for two days, no appetite, slept around the clock, arm (L) useless, unable to lift arm for 7 days, much pain.  Lungs seem sensitive chronic cough.
Pt got blisters at sight of band-aid. Achy in upper arm. Blister broke days after vaccination it was wet, red discharge.
Post vaccine rash (from MMR-V), maculopapular rash all over body - more deuse on chest/abdomen/back.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks was reported as no. Patient received Paxlovid treatment from 21Sep2022 to 25Sep2022 for Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lasting deep muscle tenderness in region of injection site; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 23Apr2021 (at the age of 36-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 14May2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included samters triad- asthma, non-steroidal anti-inflammatory drug (NSAID) allergy, nasal polyps and allergy to NSAIDs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications received within two weeks of vaccination included fluticasone propionate/salmeterol xinafoate (ADVAIR), beclometasone dipropionate (QNASL), montelukast sodium (SINGULAIR) and cetirizine hydrochloride (ZYRTEC); all from unknown date for unknown indication and unknown if ongoing. On an unknown date in 2021, the patient experienced lasting deep muscle tenderness in region of injection site. It seemed to be getting more prevalent over time. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lasting deep muscle tenderness in region of injection site was not resolved at the time of the report.  Follow-up (14Sep2021): Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: For suspect vaccine, Dose 1 was re-ranked as Primary Regimen. Vaccine Facility Information captured.
3-4 RED SPOTS APPROX HALF DOLLAR SIZE, WARM TO TOUCH.
severe pelvic cramps 1 day after vaccination drug rash 5 days after vaccination on back, arms, chest & leg
arthritic pain in fingers, toes, hip, knees. Painful and swollen, unable to close hands or feet. Pain and swelling subsided over 4 days. Some bruising on toes under the nails after swelling and pain subsided.  Trouble sleeping
Client was 17 years old at the time of vaccination with Moderna vaccine. No adverse events noted following  vaccination
Patient had typical local arm pain/soreness that began the day of after the injection. It continued and she began to have neck pain 4 days after.
Peed on my pants; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Peed on my pants) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B2114) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (Patient is on Blood pressure medication).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced URINARY INCONTINENCE (Peed on my pants). On 26-Apr-2021, URINARY INCONTINENCE (Peed on my pants) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was a Speaker and reported that they received the 1st dose of the Moderna vaccine on 08-Apr-2021 and had their 2nd dose on 26-Apr-2021. The patient reported that when they went to have their 2nd dose appointment, they peed on their pants and had to go to the bathroom and lost their appointment. The patient wanted to reschedule their 2nd dose appointment.   Reportedly, the patient had no side effects post receiving the first dose of Moderna vaccine.  Concomitant medication used included blood pressure medication and 5 other pills which was unknown to patient. No treatment information was provided.
A report has been received from a Health Professional concerning a 3 year old, female subject, Height: 38.8 Inches; Weight: 32.6 Pounds, who had been receiving FLUMIST (Intranasal), 0.25 Milliliters, Monthly. Concomitant medications included OSELTAMIVIR for INFLUENZA. FLUMIST (Intranasal) started on 16-Oct-2013. The patient experienced INFLUENZA which started on 17-Jan-2014. FLUMIST (Intranasal) was continued. The patient recovered from the event of INFLUENZA A on an unspecified date. The report was considered to be non-serious by reporter.
No additional adverse effect reported; Nurse called to report a patient received improperly stored ROTATEQ on 8/13/2020; This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history,concomitant medications, concurrent conditions, and drug reactions or allergies.  On 13-AUG-2020, the patient received an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 1660981, has been verified to be a valid lot number, expiration date reported and validated as 13-APR-2021) for prophylaxis (concentration, route of administration, frequency of vaccination scheme and anatomical location of vaccination were not reported) (product storage error).  The administered dose of the vaccine experienced a temperature excursion above 47 degrees Fahrenheit/ 9 degrees Celsius (8.9 degrees Celsius) for 33 minutes, as recorded by a data logger. No previous temperature excursion was reported. No additional adverse effects were reported.
Nausea, headache, stomach ache, fever, chills and sore eyes.
took Menactra in the past on a 5 year cycle with no reported adverse event; Initial information was received on 24-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case is linked to cases 2023SA031067 and 2023SA029739.  This case involves 61 years old female patient who took meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] in the past on a 5 year cycle with no reported adverse event.  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 Shingles, Asplenia with since Jun-2012 and Diabetes mellitus (has had DM for two years).  Concomitant medications included Aciclovir (Acyclovir [Aciclovir]) for Prophylaxis; pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) for Immunisation; and measles vaccine, MUMPS VACCINE, rubella vaccine (MMR) for Immunisation.  On an unknown date, the patient received a dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine Solution for injection (lot number, expiry date, dose, frequency, strength- not reported) via unknown route in unknown administration site for Immunisation.  On an unknown date the patient took meningococcal a-c-y-w135 (d conj) vaccine.in the past on a 5 year cycle with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.