chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHES; DIARRHEA; FEVER; HEADACHES; NAUSEA; This spontaneous report received from a physician concerned multiple patients. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The patient vaccinated at left deltoid. No concomitant medications were reported. On 19-MAR-2021, the subject experienced body aches. On 19-MAR-2021, the subject experienced diarrhea. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021, the subject experienced headaches. The batch number was not reported and has been requested. On 19-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, diarrhea, fever, headaches, and nausea on 20-MAR-2021. This report was non-serious. This case, from the same reporter.
had lost her appetite, could not eat; felt anxiety; tired; had chills; feels very very weak/the strength is not coming back/extremely weak; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (had lost her appetite, could not eat), ASTHENIA (feels very very weak/the strength is not coming back/extremely weak), ANXIETY (felt anxiety), FATIGUE (tired) and CHILLS (had chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive on 31-Dec-2020. Concurrent medical conditions included Blood pressure high, Cholesterol, Thyroid disorder and Allergy.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced ASTHENIA (feels very very weak/the strength is not coming back/extremely weak), FATIGUE (tired) and CHILLS (had chills). On an unknown date, the patient experienced DECREASED APPETITE (had lost her appetite, could not eat) and ANXIETY (felt anxiety). At the time of the report, DECREASED APPETITE (had lost her appetite, could not eat), ASTHENIA (feels very very weak/the strength is not coming back/extremely weak), ANXIETY (felt anxiety) and CHILLS (had chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medication, Cholesterol medication, allergy medication, thyroid medication.     Treatment details included Tylenol and anxiety medication.
Injection site itching; Injection site welt; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE URTICARIA (Injection site welt) in a 69-year-old male 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.    Concurrent medical conditions included Rheumatoid arthritis.   On 27-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE URTICARIA (Injection site welt). At the time of the report, INJECTION SITE PRURITUS (Injection site itching) outcome was unknown and INJECTION SITE URTICARIA (Injection site welt) was resolving.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. 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.
Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.  No Concomitant medication was reported.
Warm to Touch Sensation - Near Injection Site; Pain - Near Injection Site; Redness - Near Injection Site; Swelling - Near Injection Site; Itchy Sensation - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to Touch Sensation - Near Injection Site), VACCINATION SITE PAIN (Pain - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to Touch Sensation - Near Injection Site), VACCINATION SITE PAIN (Pain - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site). At the time of the report, VACCINATION SITE WARMTH (Warm to Touch Sensation - Near Injection Site), VACCINATION SITE PAIN (Pain - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Initial report received from a non-healthcare professional on 23 OCTOBER 2014. A 7-years-old male patient, whose concomitant medication was not reported, had received a dose of FLUZONE (batch number U4694CA, expiry date, site and route of vaccination were not reported), on 23-SEP-2013. The patient has two mutations for cystic fibrosis, being monitored for this, does not have cystic fibrosis. On 26-SEPTEMPBER-2013, 3 days after vaccination developed audible and head  jerk type tic. Illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects and medical conditions were not provided. Corrective treatment and laboratory data were not reported. The patient required ER visit. At the time of this report the patient was recovered. List of documents held by sender: none.
SITE REACTION ONLY: REDNESS AND SWOLLEN, ITCHY BUMP FOR 12 DAYS. PEAKING ON DAY 10 AT 2 INCHES ACROSS. THEN RECEEDING.
Sneezing; head feels stuffy; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing) and HEAD DISCOMFORT (head feels stuffy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001a21a and 030l20a) for COVID-19 vaccination. Concurrent medical conditions included Cancer and Allergy. Concomitant products included GANCICLOVIR, METOPROLOL, PREGABALIN and MONTELUKAST for an unknown indication.On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-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 SNEEZING (Sneezing) and HEAD DISCOMFORT (head feels stuffy). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (DAYQUIL COLD & FLU) for Sneezing, at an unspecified dose and frequency. At the time of the report, SNEEZING (Sneezing) and HEAD DISCOMFORT (head feels stuffy) outcome was unknown. Concomitant medication also included bupropion XR, allergy medications. Patient had experienced the following symptoms: sneezing, and head felt stuffy. Patient was about to have cancer surgery the following day 12-Nov-2021, diagnosis was received before receiving the first dose of the Moderna COVID-19 vaccine. This case was linked to -MODERNATX, INC.-MOD-2021-387014 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Significant follow up appended on 15-Nov-2021 event occurred on 3 dose were provided. New case was created for booster dose (MOD-2021-387014). Sender's Comments: -MODERNATX, INC.-MOD-2021-387014:Case link to same patient containg dose 3 information.
Presented with epigatric pain and abdominal pain with nausea and vomiting.  covid + and aqute kideny injury treated with iv fluids and bicarb. Kidney function improved pt discharged home.
Tinnitus in both ears. Continuous since onset. Contact with PCP via "MyChart"/email
Diagnosed with a tumor after receiving the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of neoplasm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced neoplasm. On an unknown date, the outcome of the neoplasm was recovering/resolving.   It was unknown if the reporter considered the neoplasm to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient diagnosed with a tumor after vaccination.  The patient has been treated and now not immunocompromised. The reporter consented to follow up. On 29th August 2018, the patient received second dose of the Shingrix vaccine that to be administered. The patient came in for the second dose of Shingrix, been one year.   Lot number 3HX44 and expiry date  15th November 2021 , reported for 2nd dose.
"Went to get flu injection, given in LD, did not have any discomfort or pain the day of the injection. The morning after the injection my arm started to have a heavy feeling (which did not both me) by the evening my left shoulder joint was painful... It is with certain articulation of the joint that prompts the pain".
Erythema w/in 5 min around inject site area about size of .50 cents piece; Blotchy erythema of neck w/in 15 min; Hives type rash on back w/in 20min; Arm sore -couldn't lift arm; MD notified given meds & sx relieved; sl aching remained;
Patient's left arm started hurting on ~12/22/2019.  Constant sharp pain traveling back and forth from injection site down to elbow.  Pain lasted about 6 weeks.  About 4-6 weeks after the injection, patient noticed she was losing grip strength in left hand.  Patient visited an acupuncturist 4 times in February 2020, with no improvement in grip strength.  Patient contacted primary care physician, on or about 03/18/2020, whose office referred patient back to the Pharmacy where vaccine was administered.
burning, irritation, painful and tearing sensation in the left eye with blurred vision and was later diagnosed with Zoster Keratitis of the left eye; Information has been received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 03-APR-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a burning, irritation, painful and tearing sensation in the left eye with blurred vision and was later diagnosed with zoster keratitis of the left eye. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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 zoster vaccine live (ZOSTAVAX), 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 event was considered to be not recovered and causal relationship was assessed as related.  The lawyer considered the event to be disability.  Upon internal review, the event was considered to be medically significant.
I didn't have a rash around the injection site (COVID arm), but I'm having skin breakouts/itching on other parts of my body.  I initially used OTC hydrocortisone cream, however, my Dr later prescribed triamcinolone acetonide 0.5 % Cream
Over body itchy rash, but mainly on thighs, legs and ankles. Taking BENADRYL. Now beginning to recede (10/19). Took many flu shots previously, but never the High Dose. Never had a reaction of any note.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 10-JUN-2010, patient received improperly stored VARIVAX dose 2, from lot # 665413/1128Y expiry date: 07-AUG-2011. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
patient received bexero  number1   vaccine on 1/15/21 .she seemed ok for 2 days .Then began with around 2cm diameter raised rash on 1/18/21.patient complained that her arm was hurting slightly an d stiff and that she had some minor difficulty in lifting that arm her symptoms went away in 2 days she stated that rash  was on and off since then she does not c/o itching
The pt developed rash in the groin areas, abdomen, and chest. He was taken to the physician and treated with Benadryl.
5/29/13 fever spiked to 102.6, febrile convulsion x 15 seconds. TYLENOL given before seizure. Taken to hospital remained over night, fever fluctuated 101-102 degrees 5/31/13 acute visit T 100.4, before and after seizure baby acted normal.
This case was reported by a consumer and described the occurrence of muscle pain in a male patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain and joint range of motion decreased. On an unknown date, the outcome of the muscle pain and joint range of motion decreased were unknown. It was unknown if the reporter considered the muscle pain and joint range of motion decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the first shot experienced shoulder muscle pain in both arms limiting his range of motion. The patient was not happy with this lingering side effect. The patient reported that he would not be getting the 2nd dose of SHINGRIX.
Pt devel fever, chills, myalgias which progressed to arthritis & synovitis 10 days p/vax; Hospitalized; culture are neg; MD suspects serum sickness, however indirect & direct Coombs test looks nl; pt found to have polyarticular pseudogout;
Case number PHEH2014US018205 is an initial spontaneous report received from a consumer on 09 SEP 2014. This report refers to an adult female patient of unknown age. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145402) intramuscularly at a dose of 0.5 ml on an unspecified date. It was reported that FLUVIRIN was stored at temperature of 32 degrees F (0 degree C) for 10 hours. No adverse events reported after the maladministration.
The patient received an extra third dose on 1/5/2023 due to the patient's immunization record not being properly abstracted in to the EMR chart. The patient had already received 2 doses of HPV on 8/27/2019 and 12/18/2020, so she did not need the third.
Pt. told mom didn't feel well approximately 2-3 min after adm. Hep A and HPV (pt standing with mom at check out window) pt assisted to chair and given granola bar. Appeared pale. Pt assisted to exam room to lay down - given fruit juice BP 90/68 at 9:45/AM. Color returned - juice taken. DC 10AM with mom assisting. BP 94/48 at 8:30/AM.
Received immunizations on 3/16/04. DTaP+IPV in right arm. Next AM developed pain, swelling and redness and fever. Treated for possible cellulitis with Keflex.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The vaccine was placed in refrigerator on 21-Sep-2021.  The vaccine did not go any temperature excursion and patient did not experience adverse event.  No treatment information was provided.
Pt reported a red bump at the injection site and some swelling in the arm extending down to the elbow.
numbness of his right ear and right side of the face; little bit blood in his nose; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number: EP6955) via an unspecified route of administration in right arm on 16Mar2021 (at the age of 28-years) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. On 16Mar2021 (after one hour of vaccination) patient's right ear got numb, then experienced right face numbness after a few hours he thinks, and then a little bit blood in his nose (nose bleeding). Duration of reaction/event was reported as 1 day for events. Patient wants to know that what should he do for second vaccine. On 17Mar2021, the outcome of all events was resolved.  No follow-up attempts are possible. No further information is expected.
Patient needed Pfizer BioTech 2nd dose and received Pfizer Bivalent Booster
Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unspecified dates, an unspecified number of unspecified patients may have received improperly stored doses of VARIVAX (strength, dose, frequency and route were unknown; lot number M023380 with expiration date 11-MAY-2018). No adverse effects were reported. Additional information is not expected as there is no consent to contact the physician.
Almost 2 yrs p/Hep B vax completed employee tested & found to be negative for Anti HBs; Given 3 doses 5OCT88, 3NOV88, 21APR89 lot #s 1893P;
Drug ineffective; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 5 (booster), single (Lot number: G15342) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Jun2022 as dose 4 (booster), single (Lot number: FM0992), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Jan2021 as dose 1, single (Lot number: 028120A), in left arm, on 23Feb2021 as dose 2, single (Lot number: 01A21A) and on 22Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Jun2022, outcome "unknown"; COVID-19 (medically significant) with onset Jun2023, outcome "unknown", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset Jun2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid treatment from 21Jun2023 to 26Jun2023. Unknown allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300229539 Same patient, different event/drug;
Patient received 1st dose of moderna vaccine 4/11/21 and that evening reports having arm tenderness and the formation of some swelling. The next morning there was the formation of a well-formed bump which has remained despite the use of ice packs. 3 days later she reports the beginnings of localized itching which has continued, but not expanded past the vaccination site. She denies any pain unless she applies a decent amount of pressure to the area, and states that it only itches.
fever, body aches, chills, and red halo around injection site. Had vaccine on 01/07 and adverse symptoms began on 01/09 have continued through 01/11 but have gotten better.