chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 2 months after getting the second dose of the Moderna vaccine on February 11th, 2020  I began to feel a radiating numbness down my left arm into my hand. That symptom occurred for about two days. After the numbness I then had a very achy arm for two weeks until on May 20th, 2020 I noticed my arm was very swollen and there was a road map of my veins from my chest area down my arm. I admitted myself into the ER at Hospital around 8PM on May 20th where they did ultra sound imaging and I was told I have a blood clot in my left arm. I am now on blood thinners indefinitely for right now. I then consulted with my GP who referred me to the hematologist in his same building where Doctor ordered several blood panels for me to take, a CT scan of my neck, chest, and abdomen, and lastly and MRI of my liver. Everything came back normal except for very minor benign cysts that are supposedly common and normal for women my age to have.
Pt exp inject site pain 3 days following vax. Pt not seen by MD. He self-treated w/aspirin and warm/cold compress/no relief. Pt cont to exp pain w/certain movements.
Back problem; PROBLEMS GRIPPING THINGS; Cold symptoms; Hand pain; SORE ARM FOLLOWING SHINGLES/COVID VACCINATION; This spontaneous case was reported by a consumer and describes the occurrence of BACK DISORDER (Back problem), GRIP STRENGTH DECREASED (PROBLEMS GRIPPING THINGS), NASOPHARYNGITIS (Cold symptoms), PAIN IN EXTREMITY (Hand pain) and VACCINATION SITE PAIN (SORE ARM FOLLOWING SHINGLES/COVID VACCINATION) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication.    No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose and dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK DISORDER (Back problem), GRIP STRENGTH DECREASED (PROBLEMS GRIPPING THINGS), NASOPHARYNGITIS (Cold symptoms), PAIN IN EXTREMITY (Hand pain) and VACCINATION SITE PAIN (SORE ARM FOLLOWING SHINGLES/COVID VACCINATION). At the time of the report, BACK DISORDER (Back problem), GRIP STRENGTH DECREASED (PROBLEMS GRIPPING THINGS), NASOPHARYNGITIS (Cold symptoms), PAIN IN EXTREMITY (Hand pain) and VACCINATION SITE PAIN (SORE ARM FOLLOWING SHINGLES/COVID VACCINATION) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for co-suspect (SHINGRIX and RINVOQ) for the event(s) of back problems, sore arm following shingles/covid vaccination, hand pain, problems gripping things and cold symptoms was not reported.  No concomitant and treatment medication were reported.
LEFT SIDE UPPER BODY MUSCLE ACHES, HEADACHE, NAUSEA,PHOTOPHOBIA,PAIN 8/10.  TX: TYLENOL, PHENERGAN, BEDREST X 48 HOURS. SX'S RESOLVED IN 4 DAYS. PATIENT MISSED 2 DAYS OF WORK.
Based on the patient's age, she qualifies for the Pfizer 12+ vaccine, but she incorrectly received the Pfizer 5-11 vaccine in clinic.  Additionally, the wrong lot number was documented in the patient's chart.  She was documented as receiving the Pfizer 12+ vaccine (lot #FH8028), but this needs to be corrected to document in database the lot # she received for Pfizer 5-11 (Lot#FK5127).  A ticket was submitted to database by clinic manager to correct the lot # documentation on 11/21/21. Per communication with our medical director, the plan was to contact the patient's family, notify them of the incident, advise on the medical relevance of the incident, and offer the parent's family the option of either returning to clinic today for consultation or returning at her scheduled 3 week interval to receive her 2nd scheduled Pfizer 12+ dose.  Pt's parents were contacted by RN and she spoke with the family and they were advised of the incident, had all questions answered, and the patient's parents said they were most comfortable with retuning at the scheduled 3 week interval for the second shot with the Pfizer 12+ vaccine.  The family's decision was communicated to our medical director.
Patient received vaccines on 09/08/06.  Mom noted on 09/17/06 that child was stumbling and unsteady on her right leg.  Mom said child was keeping her leg stiff "like a peg leg".  Mother took child to Dr.  Dr. drew bloodwork on 09/19/06 and told Mom that the bloodwork indicated a "viral response".  Spoke with nurse on 09/20/06.  Dr. thought that she had joint pain in her right hip and right knee and was therefore keeping her right leg stiff.  He attributed her pain to the MMR vaccine.
Broke out in red rash on face, chest, arms and legs approx. 15 mins after Hep A vaccine was administered.
Coughing 10 min after admin. Vomiting 15-20 min after admin. Itching 30 min after. Rash 30 min after (widespread).
Moderna 9/3/21, 10/21/21. Positive on 8/7/22
5 expired- Doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 expired- Doses had been given at that point) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2022 at 9:23 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 expired- Doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 expired- Doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.  Moderna vaccine was pulled from freezer on 16/12/2021, BUD date of 15/01/2022, printed in red and taped to the box of the boxes.  On 26/1/2022, staff brought it to attention that it was still in the fridge and expired- 5 doses had been given at that point.  On 27/01/2022, remaining county sites checked. All other clinics were found to have same error of noticing the BUD date. Moderna contacted and report filed.  BUD date added to the daily COVID- usage and wastage report and staff reeducation was provided.  On 31.1.2022, Moderna responded, suggested to be revaccination as not required, but  asked to forward VAERS form.
urine issues/kept going to the bathroom to urinate; upset stomach; diarrhea; felt like she was going to faint, pass out at any second; dizziness; Had a funny taste in her mouth; felt very weird, strange; This is a spontaneous report from a contactable consumer (patient). This consumer reported same events for two patients (one is patient self). This is the first of two reports. This 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration to right arm on 13Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included allergies to Sulfas, Penicilins, and Avelox, Sulfa or Penicillin allergies since she was a child and had the Avelox allergies about 15-16 years ago. None concomitant medications. Patient did not receive any other vaccines that day or 4 weeks prior. Did get the original Shingles vaccine about 3 years ago and then they came out with the new one and she got the first dose of that and believes she had a reaction to that one, thinks it was a rash. Also had the flu shot and she usually gets sick with it, but didn't with this last one. Thinks her body is just delicate. No vaccines administered on same date. Patient had the Pfizer BioNTech vaccine on 13Jan2021 15:00 and she was fine. She had a reaction the following day (on 14Jan2021). At 11am the next day she got very dizzy and felt like she was going to faint, pass out at any second. Used cold compresses and drank water and took deep breaths, but she didn't pass out. She had a funny taste in her mouth. Then from that time until about 7pm she had urine issues and kept going to the bathroom to urinate and had diarrhea and upset stomach. Patient felt like she was out of her body, felt very weird, strange. Doctor stated she maybe had a reaction to the vaccine and recommended for her to take Tylenol. She didn't take it until right before going to bed. She was able to sleep on 14th night. Woke up the next morning and was fine. She didn't see any of these reactions listed and that happened. Patient explained to a friend of the reactions and the friend mentions that she also had a friend who had the vaccine and had the same exact reactions, everything. Everything improved and stopped the next morning she was fine, on the 15th. No Emergency Room or Physician Office visit. The events outcome was recovered on 15Jan2021. It was just a span of time and she has to assume that it was the vaccine since she has never had that before. Patient does not know if she should blame the vaccine because she also has a lot of allergies to a lot of antibiotics and does not know what caused her reactions.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021065869 Same reporter/ vaccine/ AEs, different patient
Both legs were swollen. Both legs had rash looking bumps all over. Child seem to be very uncomfortable & in pain. Benadryl 2x day for 3 days (It took 6 days for rash to disappear).
her period came back in less than the usual 28 days and was very heavy. It started on 06Feb2021 and was still ongoing (03Mar2021); This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on the left arm on 04Feb2021 (Lot Number: EL3247) at the age of 32 years old as 2nd dose, single for COVID-19 immunisation. Medical history included anxiety. Concomitant medication included buspirone and etonogestrel (NEXPLANON). The patient previously received BNT162B2, via an unspecified route of administration on the right arm on 14Jan2021 09:30 (Lot Number: EL3247) at the age of 32 years old as 1st dose, single for COVID-19 immunisation. The patient had no other vaccines in 4 weeks and had no known allergies. The patient didn't have COVID prior to the vaccination. The patient was not COVID tested post vaccination. The patient stated that with etonogestrel (NEXPLANON), her period came back in less than the usual 28 days and was very heavy. It started on 06Feb2021 and was still ongoing (03Mar2021). No treatment was done for the adverse event. The outcome of the event was not recovered.  information about lot/batch number has been requested.
Pain, erythema, inflammation, hives, fever, began night following injection, reported by mother next morning, worsened over next 48 hours. Follow up appointment 2/28/19. Patient begun on Prednisolone 15mg/5ml oral solution 6 ml BID by oral route x 2 days, then 6 ml once daily by oral route for 3 days;  Diphenhydramine 12.5mg/5 ml oral solution 7.5 ml TID by oral route, Zyrtec 5 mg at bedtime per MD order. Mother instructed to call and return to care if no improvement. Message left for mother to check on progress without return call.
Individual tested Covid positive on 9/27/21.  Advised to isolate from family in separate rooms for ten days and to update mgmt.  She works remotely from home.  She will callback on 10/7/21.  DOH has not contacted her yet.  She is agreeable to have antibody testing at any DLS after her isolation period is complete. Previously,  her daughter tested positive on 9/7/21 and was later released from isolation on 9/17/21 per DOH.  The individual was always asymptomatic throughout the entire period.
ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 5/1/2023 DM 2 W HYPERGLYCEMIA ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 5/1/2023 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
covid vaccine breakthrough   dose 1 1/29/21  EL9265 dose 2 2/18/21  EL9265
Hives and rash all over the body,  Angioedema like symptoms (significant swelling of the lips eyes, and face)
This is a spontaneous report from a contactable consumer (husband). A female patient, of an unspecified age, received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Mar 30, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient previously the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, for COVID-19 immunization. Reportedly, patient had a little bit of fever after the Pfizer COVID-19 vaccine the second dose (Mar 30, 2021). She wanted to know if that is alright to take Tylenol. The outcome of the event: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
pt recv vax 19DEC95 & 30APR97 pt devel mild case of chickenpox consisting of a rash w/less than a dozen lesions;pt recovered;
Patient was administered bivalent vaccine which was beyond the 30 use by date; no adverse event; Patient was administered bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine which was beyond the 30 use by date) and PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date).    No concomitant medications were reported.  The beyond use date was reported as 08-Jan-2023 and all of the patients were 12 years and above but HCP did not have the information if some of them were below17 years old.  No treatment medications were reported.  This case contains information for the 1st of 15th adult patients (1st of 4th patient, administered on 11-Jan-2023) described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698566.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698566:Master case
By the end of aprox. 2 weeks after the shots, my son had stopped all communication, social skills, physical skills & developed abusive, personally harmful behavioral problems. All he did was cry as if getting sick & squeal to show the need for things or excitement. He started toe walking, head banging, biting, uncontrollable compulsive behavior & sensory problems, (too many to list). He was later diagnosed with AUTISM. 2/27/06Records received from Dr., dev delay ped, which revealed recurrent ear infections, maternal medication, bleeding & injury during pregnancy which resulted in preterm labor.  Patient's behavior included very ltd speech, tantrums, head banging, rare eye contact, difficulty following simple directions.  DX: static progression of speech & neurobehavior w/significant regression during school breaks consistent w/autism.  Slowly progressed. 2/28/06 Received med records from Dr., wholistic ped.  Hx included: nasal allergies w/freq antibiotic use (30-40 rounds prior to 5yo), frequent constipation, night sweats, eczema, giardia.  Patients Mother w/ADD, mild depression & asthma, maternal family w/5 cases of Lupus. 3/16/06 Received med records from Dr., PCP which revealed also a dx of TCP in 12/02. Allergy testing + for 4 of 8 most common foods.  Child does live in older home w/lead pipes. 5/1/06 Received medical records from ped neurologist which reveal dx/speech delay, ADHD. & mild autism.  Tx w/Adderall & had favorable response but remains w/severe speech delay & autism.
pt recvd flu vax SC instead of IM; pt devel redness & induration @ the inject site;
Patient reported high fever, headache, malaise and swelling and pain on L deltoid since October 23 PM. Seen at the Center on October 24th. L deltoid: edematous, erythematous and warm 10x10 cm area. Tender.
This spontaneous report was received on 08-MAY-2017 from a licensed practical nurse and refers to a 4 month infant (gender not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 20-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. The administered dose of ROTATEQ experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1608USA012794: US-009507513-1608USA012908: US-009507513-1705USA004982: US-009507513-1705USA004977: US-009507513-1705USA004978: US-009507513-1705USA004979: US-009507513-1705USA004980: US-009507513-1705USA004981: US-009507513-1705USA004894: US-009507513-1705USA004895: US-009507513-1705USA004896: US-009507513-1705USA004897: US-009507513-1705USA004898: US-009507513-1705USA004899: US-009507513-1705USA004893: US-009507513-1705USA004892: US-009507513-1705USA004891: US-009507513-1705USA004890: US-009507513-1705USA004889: US-009507513-1705USA004888: US-009507513-1705USA004887: US-009507513-1608USA012916: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA004942: US-009507513-1705USA004944: US-009507513-1705USA004945: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004949: US-009507513-1705USA004950: US-009507513-1705USA004951: US-009507513-1705USA004952: US-009507513-1705USA004953: US-009507513-1705USA004954: US-009507513-1705USA004955: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004960: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004963: US-009507513-1705USA004964: US-009507513-1705USA004965: US-009507513-1705USA004967: US-009507513-1705USA004968: US-009507513-1705USA004970: US-009507513-1705USA004975: US-009507513-1705USA004971: US-009507513-1705USA004966: US-009507513-1705USA004972: US-009507513-1705USA004973: US-009507513-1705USA004974: US-009507513-1705USA005007: US-009507513-1705USA005006: US-009507513-1705USA005005: US-009507513-1705USA005004: US-009507513-1705USA004943:
passed away via embolism shortly; This spontaneous case was reported by an other health care professional and describes the occurrence of EMBOLISM (passed away via embolism shortly) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, 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 experienced EMBOLISM (passed away via embolism shortly) (seriousness criteria death and medically significant). The patient died in May 2021. The reported cause of death was passed away via embolism shortly. It is unknown if an autopsy was performed.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.  It was reported that patient's brother was looking to understand that his sister passed at a fairly young age as patient was extremely strong and healthy at the time it was reported and  She was unexpectedly passed away within 2 weeks of the last dose.  Company Comment: This spontaneous case concerns a 53-year-old female patient with no reported medical history, who experienced the unexpected, serious (fatal and medically significant) adverse event of special interest Embolism on an unknown date after receiving the second dose of mRNA-1273 vaccine. The event occurred within two weeks of vaccination and led to a fatal outcome shortly thereafter. Cause of death was reported as embolism. Autopsy report was not provided. Patient received the first dose of mRNA-1273 vaccine 33 days prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 53-year-old female patient with no reported medical history, who experienced the unexpected, serious (fatal and medically significant) adverse event of special interest Embolism on an unknown date after receiving the second dose of mRNA-1273 vaccine.  The event occurred within two weeks of vaccination and led to a fatal outcome shortly thereafter.  Cause of death was reported as embolism. Autopsy report was not provided.  Patient received the first dose of mRNA-1273 vaccine 33 days prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: passed away via embolism shortly
Reddened swollen area to (L) lateral upper arm - 3 1/2 cm x 3 1/2 cm. (L) lateral mid thigh reddened and swollen - 10 cm x 13 cm.
Vaccine (MMR) given on 7/9/04.  Developed aching and headache on 7/16/04.  Worse on 7/17/04--fever to 100.6-100.8, achy joints, headache, skin sensitive to clothing.  7/18 to 7/20--torso and back continue achy.  Taking Ibuprofen 600-800mg 2-3 times/day.  Seen in EOHD clinic 7/20/04--skin snsitivity (torso and back), aching (trunk), headache, non-productive cough.  Exam 7/20/04--no lymphadenopathy, temp 97.8, ears clear (cerumen occuluding right TM), nose & throat clear, breath sounds clear, AP 88.
Moderna inadvertently given to 17yo patient.  Moderna is only approved for >18yo.