chrisvoncsefalvay/vaers-outcomes huggingface dataset:
thrombosis after both doses of Moderna COVID-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS (thrombosis after both doses of Moderna COVID-19 vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hyperlipidemia.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced THROMBOSIS (thrombosis after both doses of Moderna COVID-19 vaccine) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (thrombosis after both doses of Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Physician stated that she did a literature search and found one case report from June from 29-Jun-2021 where the patient developed thrombosis after receiving both doses of the Moderna COVID-19 vaccine.  No treatment information provided.  Company Comment: This case concerns a 65-year-old male patient with relevant medical history of Hypertension and Hyperlipidemia , who experienced the unexpected serious event of Thrombosis.The event occurred unknown days after the first and second dose of Spikevax. The rechallenge is unknown since there's no information about the doses.  The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-334622 (Patient Link).; Sender's Comments: This case concerns a 65-year-old male patient with relevant medical history of Hypertension and Hyperlipidemia , who experienced the unexpected serious event of Thrombosis.The event occurred unknown days after the first and second dose of Spikevax. The rechallenge is unknown since there's no information about the doses.  The benefit-risk relationship of Spikevax is not affected by this report.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 70 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Report adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Report adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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. On an unknown date, the patient experienced VACCINATION COMPLICATION (Report adverse event). At the time of the report, VACCINATION COMPLICATION (Report adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Patient experience allergic reaction to Flu Mist vaccine three minutes after vaccine was administered. Patient's reaction was small hives. Patient was assesed by physician and treated with Benadryl, observed for 30 mins. until patient was cleared.
Vaccine was given 7 days past beyond use date. Per Pfizer "Stability assessment indicates there is no product quality impact and the vaccine was suitable for use."
Vaccine was given on 04/23/2003. Patient complained of soreness on 04/24/2003.  On 04/25/2003 they noticed swelling in her thigh and she complained of it hurting.
Within 2 days experienced increased intensity of neuropathy from 1-2/10 to 8/10 at times awakening from sleep and limiting her ability to run (triathlete). Constant, daily pins/needles with regions of electrical impulses in lower legs
Client returned to work. Adverse reaction was reported by co-workers difficulty breathing / throat closing MD's were in the building and reported to provide care. 2 voice msg no return call per reports (co-workers).
Pt developed left axillary lymphadenopathy/mass approx 2 weeks after receiving the vaccine in his left arm. The swelling cont to incr. He had a  ultrasound done that showed concern for lipoma vs inflamed tissue. The mass continued to increase in size. Pt saw a surgeon who thought it should be removed. The day of surgery, (9/23/21) the mass was about the size of a grapefruit. Pathology showed lymph node with adipose tissue. Post op, the area continued to swell and remains swollen. Pt is being observed for now. The area remains tender to touch and is affecting his ADLs due to pain and swelling.
Three weeks after second dose I had a cyst on my left breast felt like a mass. Then in July 2021 I had a smaller cyst under my left under armpit. The  cyst under my left armpit came back in the beginning of September 2021 subsided and came back end of September 2021. The cyst on my left breast comes and goes every month since April 2021. The imaging doctor stated that the cyst under my left armpit are dense tissue have discussed possible surgery to remove has me very concerned.
Red rash on my upper right arm near where shot was administered. Swollen as well. Feels hot, slightly itchy, and sore. Rash measures about one inch by one inch.
been tired, with decreased energy; been tired, with decreased energy; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from Novartis. (Manu-facturer Control No:NUS2021US104132_NC). A 81-year-old age male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as single dose for COVID-19 immunization. No medical history reported. No concomitant medication reported. Patient reported that he had been tired, with decreased energy and stated that these symptoms began after he received the COVID-19 vaccine in April. The outcome of Events was unknown.  Information on Lot/Batch number has been requested
I started bleeding vaginally 10 days after the vaccine and still bleeding  9/23/21. 13 days of bleeding. My menstrual cycle is normal and predictable because I am on oral contraceptives. This is bleeding outside of my normal cycle. During my normal cycle I only bled for 3-4 days.
Chronic spontaneous urticaria on both arms from wrist to underarms, prescribed 4 Zyrtec a day, and given steroids through injection in my upper right butt check
Pt was given Varivax dose after being reconstituted in the fridge for greater than 30 minutes. No adverse reaction noted.
Patient is under treatment for a condition of unknown onset; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient is under treatment for a condition of unknown onset) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient is under treatment for a condition of unknown onset). At the time of the report, VACCINATION COMPLICATION (Patient is under treatment for a condition of unknown onset) outcome was unknown.            No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter   Reporter did not allow further contact
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 38-year-old male. Neither medical history nor concomitant medication were reported. On an unspecified date in Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customer not discarding product form previous season and 20 product expiring during the peak of flu season resulting in some medical error that occurred shortly after the product expired. Additional information was received on18-Mar-2009 that indicated no adverse events were reported through the medical clinic. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
dose given after vials stored in dry ice box ran out of batteries.temperature therefore unable to be monitored, thus deemed compromised by Agency
Stiffness; Pain; Pain in toes; Stiffness in hands in mornings; Minimal hip pain (P1 joint); This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN (Pain), PAIN IN EXTREMITY (Pain in toes), MUSCULOSKELETAL STIFFNESS (Stiffness in hands in mornings) and ARTHRALGIA (Minimal hip pain (P1 joint)) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic 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 and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN (Pain), PAIN IN EXTREMITY (Pain in toes), MUSCULOSKELETAL STIFFNESS (Stiffness in hands in mornings) and ARTHRALGIA (Minimal hip pain (P1 joint)). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness) and PAIN (Pain) outcome was unknown and PAIN IN EXTREMITY (Pain in toes), MUSCULOSKELETAL STIFFNESS (Stiffness in hands in mornings) and ARTHRALGIA (Minimal hip pain (P1 joint)) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported. The reporter did not provide any causality assessment for the events of limbs stiffness, pain in toe and pain in hip with Humira. The reporter assessed the events of pain and stiffness to be not reasonably possible to Humira. The reporter did not provide any causality assessment for the events of limbs stiffness, pain in toe and pain in hip with Moderna vaccine. The reporter assessed the events of pain and stiffness to be possibly related to Moderna vaccine. 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.
ST, FEVER, BODY ACHES, NASAL CONGESTION, COUGH
Site soreness; Generalized muscle soreness; This is a spontaneous reporter from a contactable consumer. A 65-year-old male consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6201) via an unspecified route of administration on 04Mar2021 at 01:15 PM (age at vaccination: 65 years ) on left arm at single dose for COVID-19 immunization. The patient's medical history included hypersensitivity(allergies) to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient Concomitant medications were not reported. It was reported that patient received other unspecified vaccine in four weeks but did not receive other medications in two weeks. On 05Mar2021, the patient experienced site soreness and generalized muscle soreness. No treatment was received for the events. The outcome of events was resolving. No follow-up attempts were possible. No further information was expected.
Fever, Vomiting , Severe Headache, Severe pain in joints to the point that I could barely walk. Since vaccine I have trouble with short term memory.  Still have not gotten appetite back
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 2/4/2021 and 3/4/2021. Presented to ED with complaints of shortness of breath, admitted for acute respiratory failue due to Covid PNA c/b CHF. Treated with: dexamethasone, antibiotics, enoxaparin, and remdesivir. On 2/1/2022, respiratory status decompensated and became less responsive. Per family request, transitioned to DNAR/AND. Patient expired 2/3/2022 at 1750.
The second dose has not been administered yet, most likely due to the pandemic; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: The second dose has not been administered yet, most likely due to the pandemic). The outcome of the social problem was unknown.   Additional Information: GSK receipt date 24 Jul 2023: The pharmacist stated that a patient received her first dose of Shingrix in December 2020. The second dose had not been administered yet, most likely due to the pandemic.  The reporter did consent to follow up. The Vaccine administration facility was the same as primary reporter. The VAERS details reported for 1st dose. The patient did not received 2nd dose most likely due to the pandemic, which led to social problem.
patient had sudden onset of dizziness, lightheadedness and difficulty in standing. Sx lasted about 30 seconds
Pt experienced localized redness @ injection site- no swelling, itching noted @ that time. Advised to use cool compress prn. Nurse mgr spoke with parent this am and states that pt awoke with increased localized redness and itching; advised to apply cool compress and topical cortisone cream to site- parent then called back and states symptoms relieved with above.
Case previously recorded as MA2009-4568. Case report received from an office manager via physician, via MedCom, on 12 NOV 2009. 11-month-old patient was vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. 102045P1) i.m. into right thigh on 10 NOV 2009. No adverse effect was reported. MedCom reference no.:NA09-008038.
On Fri. 10-7-11, I went to get my annual flu shot. When asked if I wanted the air shot or needle, I told them I didn't know the difference so it didn't matter. I got the air shot. 11:30 AM - I went on with my shopping but about 15 minutes later my arm began to hurt - I rubbed it a little through my jacket and could feel a bump - thinking it was the cotton ball under the band aid I tried to ignore it. I got home about 12:30 PM - took off the band aid and no cotton ball - it was a large red bump with a black center. I called the pharmacist and told him how hot and swollen my arm was and he said to ice it. That I did. It still continued to swell, was red hot and hard. The next morning my upper arm was all colors - red, pink, splotchy purple beginning to look like bruises. I returned to show my arm to the pharmacist and he looked stunned. He called someone and gave my name and phone # - but no one ever called me. I just continued to ice it and take aspirin. To this day 11-6-11 I still have a small lump with a black center and its still tender.
Employee complained of runny nose following receiving vaccination. Dr aware. Follow-up with employee done in the afternoon and employee advised symptom has resolved with no other issues.
Patient called about 30 minutes after vaccination to report hives on leg. He remained in pharmacy for 15 minutes (following vaccination) with no issues. He called about 15 minutes after he left to report hives. I questioned him if he was having trouble breathing or felt as if his tongue was swelling. He stated he felt fine except for the hives. Discussed he should take Benadryl and monitor for trouble breathing. If so, report to ER. Discussed severe allergic reaction normally occurs within 15 minutes of vaccination, but he should still be cautious and monitor symptoms.
Mother stated that patient received large lump at the injection site 24 hours after vaccine. Patient was not in any discomfort. Mother took patient to urgent care where she was treated with allergic reaction with Benadryl which dissolved lump.
After pt receive DTaP/IPV he developed cellulitis at injection site, pt was febrile and received IV Antibiotics. Nurse follow up on 05/19/04 states: Per review of hospital d/c summary, diagnosis of cellulitis is confirmed and has already been coded.
Vision issue; Difficulty in breathing due to anxiety; Thyroid was swollen however, today it is back to normal; Taste bud are decreased where food does not taste the same; Brain fog; PSTD; Visional dreams where she relives them during the day; Anxiety issues/High levels of anxiety; Emotional issues were she has uncontrollable crying; Lack of sleep; Acne break out that is painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISUAL IMPAIRMENT (Vision issue), DYSPNOEA (Difficulty in breathing due to anxiety), GOITRE (Thyroid was swollen however, today it is back to normal), TASTE DISORDER (Taste bud are decreased where food does not taste the same) and FEELING ABNORMAL (Brain fog) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045ABLA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Oral surgery in February 2021. Concurrent medical conditions included Post-traumatic stress disorder and Anxiety.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (Vision issue), DYSPNOEA (Difficulty in breathing due to anxiety), GOITRE (Thyroid was swollen however, today it is back to normal), TASTE DISORDER (Taste bud are decreased where food does not taste the same), FEELING ABNORMAL (Brain fog), POST-TRAUMATIC STRESS DISORDER (PSTD), DAYDREAMING (Visional dreams where she relives them during the day), ANXIETY (Anxiety issues/High levels of anxiety), CRYING (Emotional issues were she has uncontrollable crying), INSOMNIA (Lack of sleep) and ACNE (Acne break out that is painful). On 19-Apr-2021, GOITRE (Thyroid was swollen however, today it is back to normal) had resolved. At the time of the report, VISUAL IMPAIRMENT (Vision issue), DYSPNOEA (Difficulty in breathing due to anxiety), TASTE DISORDER (Taste bud are decreased where food does not taste the same), FEELING ABNORMAL (Brain fog), POST-TRAUMATIC STRESS DISORDER (PSTD), DAYDREAMING (Visional dreams where she relives them during the day), ANXIETY (Anxiety issues/High levels of anxiety), CRYING (Emotional issues were she has uncontrollable crying), INSOMNIA (Lack of sleep) and ACNE (Acne break out that is painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Information has been received from a health professional concerning a female patient (age unknown) who on 15-NOV-2006 was vaccinated with a dose of Pneumovax 23 (lot # 651406/0620F), intramuscularly.  On 09-NOV-2006 between 14:30 and 15:30 the patient was vaccinated in the other upper arm with a dose of FLUVIRIN (Lot # 72005).  Subsequently, "one hour after vaccination", the patient developed swelling and redness at the injection site, "terrible pain: worse than when I broke my arm in half!" and splotchiness in the arm in which the patient was vaccinated.  The symptoms increased over the next few days.  The patient saw the doctor and when the swelling had increased over a half inch beyond the circle he had drawn around the site, the patient was placed on KEFLEX and LORTAB for 10 days.  The symptoms went away after 5 days.  On approximately 20-NOV-2006, the patient recovered.  Additional information is not expected.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26 year-old female patient received bnt162b2 (BNT162B2), administration date 28Aug2021 (Lot number: FC3184) at the age of 26 years as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 2021, when the patient was 26 years old, for COVID-19 immunization, reaction(s): "Whole arm pain", "Intense vomiting"; Bnt162b2 (Dose: 1), administration date: 2021, when the patient was 26 years old, for COVID-19 Immunization, reaction(s): "numbness in hands and leg and foot". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "arm pain"; BACK PAIN (non-serious), NECK PAIN (non-serious), PAIN (non-serious) all with onset 2021, outcome "not recovered" and all described as "muscle pain in upper back and neck"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "finger numbness"; VOMITING (non-serious) with onset 2021, outcome "not recovered", described as "Vomiting"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "flulike symptoms"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "not recovered", described as "Weakness in legs"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Fatigue". The events "arm pain", "muscle pain in upper back and neck", "muscle pain in upper back and neck", "finger numbness", "vomiting", "flulike symptoms", "weakness in legs", "fatigue" and "muscle pain in upper back and neck" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, back pain, neck pain, hypoaesthesia, vomiting, influenza like illness, muscular weakness, fatigue, pain. Additional information: No other vaccine in four weeks and No Covid prior vaccination. AE treatment just started muscle relaxers and steroids. Clinical course: Whole arm pain in injected arm. numbness in hands and leg and foot. Intense vomiting after first dose. After second dose arm pain then intense muscle pain in upper back and neck radiating into arms and some finger numbness. Vomiting and flulike symptoms. Weakness in legs. Fatigue. Follow-up attempts are completed. No further information is expected.