chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She was not getting the second dose; dizzy; sharp stabbing pain on the left side of her back; lack of appetite; ankles were a little swollen; heart burn; right side/middle of her stomach felt a little hard; right knee pain; convulsive shaking in her legs/convulsive shaking in her arms; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (convulsive shaking in her legs/convulsive shaking in her arms), DIZZINESS (dizzy), BACK PAIN (sharp stabbing pain on the left side of her back), DECREASED APPETITE (lack of appetite) and JOINT SWELLING (ankles were a little swollen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included High cholesterol (controlled by diet).    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced DIZZINESS (dizzy), BACK PAIN (sharp stabbing pain on the left side of her back), DECREASED APPETITE (lack of appetite) and JOINT SWELLING (ankles were a little swollen). In July 2021, the patient experienced TREMOR (convulsive shaking in her legs/convulsive shaking in her arms), DYSPEPSIA (heart burn), ABDOMINAL RIGIDITY (right side/middle of her stomach felt a little hard) and ARTHRALGIA (right knee pain). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (She was not getting the second dose). In July 2021, DYSPEPSIA (heart burn) had resolved. On 16-Jul-2021, BACK PAIN (sharp stabbing pain on the left side of her back) had resolved. At the time of the report, TREMOR (convulsive shaking in her legs/convulsive shaking in her arms), DIZZINESS (dizzy) and JOINT SWELLING (ankles were a little swollen) was resolving and DECREASED APPETITE (lack of appetite), INTENTIONAL DOSE OMISSION (She was not getting the second dose), ABDOMINAL RIGIDITY (right side/middle of her stomach felt a little hard) and ARTHRALGIA (right knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided by the reporter.  Company Comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.  Patient reported that she was going to see her doctor if symptoms do not subside.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: significant Follow up appended; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
c/o soreness @ site 24SEP92; next am c/o lt side pain w/stiffness in neck & back; progressed to numbness & tingling in hand; @ times interrupting sleep; 2OCT92 seen by MD for constant ache; 9OCT92 MD visit c/o dull pain;
Extremely itchy eyes and face with some swelling within 30 minutes of vaccination.  Last for about 2 hours
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Additional Details: Patient had short fainting spell post vaccination while seated, immunizer was a registered nurse who provided immediate care, checked blood pressure, 100/60 then 125/90 10 minutes later, patient was upright and responsive after being assisted.  after observation period left on own ability with mother.  left message with pcp office post event, spoke with patient following morning, no issues feeling fine.
Cough; body aches; shortness of breath; tired; felt flushed; not ever red but tingly; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205), via an unspecified route of administration in left arm on 25Feb2021 10:00 (at the age of 72-years-old) as dose 1, single for COVID-19 immunization. Medical history included Sick from 30Jan2021, fever and COVID-19 from 02Feb2021 (started getting sick on 30Jan2021, health department cleared her on 14Feb2021, she was still dealing with the residual lingering effects). Prior to vaccination, the patient did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient experienced cough, body aches, shortness of breath, tired, felt flushed and not ever red but tingly on 25Feb2021. It was reported that patient had shortness of breath dealing with oxygen, more body aches than she had with COVID. The patient heard that people react to the second dose more than first, asked how long she should wait to get the second dose of the vaccine. Events started later the evening of vaccination. She can get up out of the chair, still has a cough, residual breathing, and tiredness. She was trying to build up stamina by doing more around the house. After a day and half, she started feeling better and she was much better at the time of this report. Patient stated that she thinks she shrunk a little bit. Outcome of events was resolving.  No follow-up attempts are possible. No further information is expected.
No adverse event; given the adult dose of the booster dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (given the adult dose of the booster dose) and NO ADVERSE EVENT (No adverse event) in a 10-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose ,lot number FL0894) on 09-Apr-2022, Pfizer (2nd dose and lot number FL8095) on 03-May-2022. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 27-Nov-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (given the adult dose of the booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (given the adult dose of the booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant information was reported. It was reported that at the time of call the patient was okay. No treatment information was provided.
Sore vaccine arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient received a dose of Shingrix and experienced sore vaccine arm. No further details were provided.
Runny nose; Sneezing; Injection site burning; Vaccination site burning; Injection site papule; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), SNEEZING (Sneezing), INJECTION SITE PAIN (Injection site burning), VACCINATION SITE PAIN (Vaccination site burning) and VACCINATION SITE PAPULE (Injection site papule) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Psoriasis vulgaris.    No Medical History information was reported.   On 14-Jul-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 160 milligram. In July 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In July 2021, the patient experienced RHINORRHOEA (Runny nose), SNEEZING (Sneezing), INJECTION SITE PAIN (Injection site burning), VACCINATION SITE PAIN (Vaccination site burning), VACCINATION SITE PAPULE (Injection site papule) and VACCINATION SITE ERYTHEMA (Injection site redness). The last dose administered for ADALIMUMAB (HUMIRA) was on 22-Jul-2021. In July 2021, INJECTION SITE PAIN (Injection site burning) and VACCINATION SITE PAPULE (Injection site papule) had resolved, VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown. At the time of the report, RHINORRHOEA (Runny nose), SNEEZING (Sneezing) and VACCINATION SITE PAIN (Vaccination site burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No known drug allergy. No concomitant drugs taken. The reporter's causality for the event(s) of burning with moderna vaccine with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of injection site burning, injection site red/raised with HUMIRA(ADALIMUMAB) was a reasonable possibility. Treatment information was not provided.  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.
Pt presented to pharmacy with localized reaction at injection site, which was red, swollen and a little warm to touch. Pt experienced no pain.
No further AE's reported; administration of an expired dose of VARlVAX; Temperature: 14°F to 46°F (46 F) max; This spontaneous report was received from a nurse referring to a male patient of unknown age. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   Concomitant therapy included sterile diluent (STERILE DILUENT) (lot# S038147).      There was a refrigerator at the place of business in which expired doses of varicella virus vaccine live (oka/merck) (VARIVAX) were stored. Another employee inadvertently took a varicella virus vaccine live (oka/merck) (VARIVAX) dose from this refrigerator which was placed into the refrigerator a year ago and had been in refrigerated temp range since, instead of the freezer where the non expired doses of varicella virus vaccine live (oka/merck) (VARIVAX) was kept. The temperature excursion was 14 Fahrenheit degrees to 46 Fahrenheit degrees (46 Fahrenheit degrees) max for 8760 hours. On 11-JAN-2022, the patient was vaccinated with the improperly stored and expired varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 ml one time, lot # S000132, expiration date 02-JAN-2021; strength and route of administration were not reported) for prophylaxis (expired product administered, product storage error). No further adverse event (AE) or product quality complaint (PQC) was reported.
Developed auto immune hives over entire body. Medication: Xolair and Doxepin. Resolved with noted medications.
Less than 24 hours later experienced severe dizziness, almost passed out. took me 20 minutes to regroup to be able to drive back to jobsite. The next day ,I was shakey ,but I got threw  half of the day. On friday ,I drove from Cape Cod to Maine. I was doing fine ,but I had another spell
Pfizer Dose 1 1/11/21 (EL1284 Pfizer Dose 2 2/2/21 (EL1283) COVID Positive 1/27/22  1/27/22: Patient is a very pleasant 68-year-old female who is an ARNP for Oncology group, no significant past medical history apart from osteoarthritis for which she was started on meloxicam 2 weeks ago.  Fully vaccinated for COVID-19 presented to the emergency department with a complaint of worsening cough, shortness of breath related since Monday. Patient was having some fever, flu-like symptoms associated with cough and some shortness of breath, yesterday she had a positive at home COVID test.  Today she noticed epistaxis and petechiae and decided to come into the emergency department.  Patient is very pleasant, healthy individual, no recent illness, she was recently started on meloxicam due to osteoarthritis otherwise no issues.  No history of cancer, not on chemotherapy, no history of any blood disorder in the family, no recent use of antibiotics. Prior to Monday she has been in her usual state of health.   Upon exam patient was having  some epistaxis, she has diffuse petechiae, she also complained of black tarry stool.   In ED, platelet count 4 K, WBC 1.8 K, hemoglobin 11.9 grams/deciliter, ED provider discussed with Oncology who recommended starting IVIG and giving Decadron 20 mg x 1.  1/30/22: 68-year-old female no significant past medical history presented with cough, shortness of breath and flu-like symptoms, tested positive for COVID-19.  Patient had epistaxis, petechia and melena so presented to the emergency room and found to have severe pancytopenia with platelet count of 4000. Admitted for possible ITP, received IVIG , steroids and platelet transfusion. Epistaxis resolved, platelet count improved. Hematology to following on pending work and will call patient to arrange follow up and possibly bone marrow biopsy. patient deemed stable for discharge and discharged home.
Vaccine was inadvertently given 12 hours after vaccine's expiration date of 10/08/2023.  Patient was contacted 10/10/2023 and reported arm pain, fatigue, and "not feeling well".  Per GSK and CDC, patient was informed that dose is considered invalid and it is recommended that she repeat the dose in 28 days. She stated she will be contacting her provider's office for further information.
Hives/ allergic reaction to Moderna vaccine with a reaction of hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives/ allergic reaction to Moderna vaccine with a reaction of hives) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 URTICARIA (Hives/ allergic reaction to Moderna vaccine with a reaction of hives). At the time of the report, URTICARIA (Hives/ allergic reaction to Moderna vaccine with a reaction of hives) outcome was unknown.            No concomitant medications were reported No treatment medications were reported Patient received the Moderna COVID vaccine series and she had a reaction of hives. patient had said that she would like to knowif the Pfizer COVID vaccine has any Tramadol ingredients in it because she is allergic to that medication.   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.
Insufficient titers for hepatitis B; 5th dose of hepatitis B administered/pediatric Engerix-B received.; 19 year old female patient was given dose of pediatric Engerix-B; This case was reported by a nurse via sales rep and described the occurrence of therapeutic response decreased in a 19-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 5th dose of Engerix B pediatric, the 4th dose of Hepatitis B vaccine, the 3rd dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 1st dose of Hepatitis B vaccine. On an unknown date, not applicable after receiving Engerix B pediatric and unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapeutic response decreased, underdose and adult use of a child product. On an unknown date, the outcome of the therapeutic response decreased, underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 23-AUG-2022 Reporter's Comment: The reporter was a nurse. The patient received pediatric Engerix-B vaccine. And it was patients 5th dose of hepatitis B due to insufficient titers. The reporter consented to follow up.  Additional supportive information: The patients received four doses of Hepatitis-B vaccine series and had insufficient titers of Hepatitis-B, which led to therapeutic response decreased. The adult patient was administered a pediatric dose of Engerix-B which led to, adult use of a child product and underdose.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 31-JUL-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (strength: 0.5ml, lot # K020188, expiration date 22-OCT-2016, route unspecified). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 24 hours with lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 32 hours with the highest recorded temperature of 48 Fahrenheit degree. The total cumulative excursion time of the third time was 168 hours with the highest recorded temperature of 7 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R) for the first and the second excursion and Frozen (F) for the third excursion. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
herpes zoster; benign paroxysmal vertigo; bilateral tinnitus; hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age.  No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 04-AUG-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered herpes zoster along the left side of abdomen, benign paroxysmal positional vertigo, bilateral tinnitus and hearing loss(deafness).  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product.  The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition.  As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries.  Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events were considered not recovered/not resolved.  The events were considered related to zoster vaccine live (ZOSTAVAX).  All the events were considered to be disabling.  Upon internal review, the event deafness was considered to be medically significant.  Additional information has been requested.
Nausea; Stomach discomfort/bowel discomfort; This is a spontaneous report from a contactable consumer reporting for himself.   This 20-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on unknown date at a single dose on the left arm for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included postural orthostatic tachycardia syndrome. No relevant concomitant medications were provided. On unknown date, after vaccination, the patient developed nausea and stomach discomfort/bowel discomfort. The patient was not treated for the events. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was recovering from the events.  Information on the lot/batch number has been requested.
at the injection site and below the injection site became extremely red and swollen; at the injection site and below the injection site became extremely red and swollen; This spontaneous report was received from an office manager via company representative and refers to a female patient of an unknown age (reported as "in her 70s"). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in July 2021 (reported as "within the last 3-5 days"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T033663, expiration date 21-MAR-2022 (dose, route of administration and anatomical location was not reported) for prophylaxis. On an unknown date in July 2021, the patient's vaccination site and below the vaccination site became extremely red and swollen. The physician thought there might have been a blood clot. On an unknown date in July 2021, an ultrasound was performed but nothing was found. It was reported that the patient sought medical attention. The outcome of the events was reported as recovering.  Causality assessment was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033663; expirationdate: 21-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent