chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/27/2015 - Appointment with Dr. Review cholesterol blood tests. Order for new blood tests given for Cholesterol/Prostate for 10/26/2015 appt. PREVNAR 13 (pneumonia) shot. 5/02/2015 - Started arm/shoulder joint and muscle pain. 5/06/2015 - Continuing arm/shoulder joint and muscle pain plus chills, appetite loss. Unable to lift both arms above waist. Started taking Ibuprofen for pain and inflammation. 5/08-10/2015 - Arm/shoulder joints and muscles extremely painful. 5/11-7/06/2015 - Unable to sleep in bed lying down. Sleeping in living room on couch and/or recliner. (Small naps 20-30 minutes). 5/11/2015 - Made appointment with Dr. for increasing pain. Order Blood tests and gave blood tests. 5/12/2015 - Test results all OK. 5/14/2015 - Dr. sent referral to Arthritis and Rheumatology for an appointment. 5/18/2015 - Dr. sent referral to Orthopedic for an appointment. 5/19/2015 - Made appointment with Dr. of Orthopedic for 5/29/2015. 5/20/2015 - Made appointment with Dr. of Arthritis and Rheumatology for 6/03/2015. 5/23/2015 - Made appointment with Dr. for increasing pain. Ordered more blood tests. Prescribed Indomethacin 50mg for pain. Told to reschedule appointment with Dr. of Orthopedic for 5/29/2015 to after appointment with Dr of Arthritis and Rheumatology for 6/03/2015. Gave blood tests and rescheduled appointment with Dr. of Orthopedic to 6/13/2015. 5/24-28/2015 - Still cannot sleep in bed due to severe upper arm, shoulder, and neck pain. 5/26-31/2015 - Swelling in left foot for unknown reason.
covid vaccine breakthrough  dose 1 moderna 2/14/21 038K20A dose 2 moderna 3/14/21 030K21A dose 3 Pfizer 12/2/21 FJ8757
FLUVIRIN administered intradermal in error. Pt aware, injection site evaluated by physician.
Got Tdap 10/02 seen in my office 10/16 with pain, red, swollen deltoid, nausea and vomiting.
Administration data from Pharmacy Computer System indicates your location administered doses of the affected lot after the Sept. 30 expiration date but on or before Oct. 19. For doses administered between Oct. 1 and Oct. 19, with manufacturer data to support the stability and efficacy, revaccination is not indicated, and patient notification is not required.
21 days after vaccine, parotid gland enlargement. No fever, amylase elevated. Mom stated head to toe rash 1 week prior. Resolved by office visit.
This spontaneous report as received from a pharmacist refers to a 74 year old male patient with no drug reactions/allergies. On 24-OCT-2013 the patient was vaccinated with a single dose of ZOSTAVAX (reported lot # J006830, expiration date 14-SEP-2014, dose not reported, subcutaneously). Concomitant therapies included VOLTAREN and CIALIS. On an unknown date in 2013 the patient experienced lower lip numbness. There was no treatment given for the event. No lab diagnostic studies performed. The patient sought medical attention via called pharmacy. The outcome of the event was reported as recovered/resolved on an unknown date in 2013. Additional information has been requested.
The Patient is a 34 year old female.  The patient is a 34 yo female with a history of hypothyroidism who received Pfizer Covid vaccine on 16 DEC (lot #EK5730) after work. She experienced no immediate adverse effects other than about 5 minutes after vaccine receipt she experienced a sensation of ' blood rushed to my ears.' No dizziness or syncope occurred. She had no oral/face/throat/tongue swelling, no urticaria, pruritis, SOB, Wheezing, dypsnea, cough, CP, n/v/d. The following morning she awoke with pruritus to eyes, face, and urticaria to arms, thighs, chest, face and head. She was treated with 8 mgs of decadron and a dose pack. The symptoms abated. The following morning she experienced recurrence which improved with next steroid dose. She took benadryl that night. Symptoms have continued to recur as steroid wanes.
Intermittently tinnitus starting on 1/15. Constant tinnitus on 1/17 and hasn?t stopped
Pt called back to report possible side effects from shot (2nd dose of GARDASIL). C/O nausea, stiffness in left arm. Left side of neck tight and throbbing.
It started where I felt tired and a little under the weather. I was really foggy headed. The symptoms started on Saturday but didn't get really bad until Tuesday. I couldn't work Wednesday through Friday because of it. I had Laryngitis, my throat was really swollen. I was so achy that I couldn't lie still, so it was really hard to sleep. I didn't have much of a temperature if I had one at all. Worse symptoms: No ability to speak and severe achiness- it was worse in my back, but it was everywhere. Treatment: recommended Children's Tylenol so I could drink it, and then I took Advil. I didn't go to any parties and started feeling better around July 6th. I think I started working on the 6th.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR. Past drug history included: Dilaudid, reaction(s): "Known allergies: Dilaudid". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received treatment of Paxlovid, Treatment start date: 09Jul2022, Treatment stop date: 10Jul2022, Lot number: .  No follow-up attempts were possible. No further information was expected.
Pt vaccinated smallpox 8/8/09; left arm. Pt referred to clinic with POS erythema and rash with circumfererencial distribution to torso, arms, thighs and feet. Dx adverse vaccine reaction. Pt treated with BENADRYL and ADARAX. Will f/u if condition worsens.
Hot to the touch Injection Site; Redness (3" around Injection Site); Borderline Diarrhea; Fever 100 F; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Borderline Diarrhea), VACCINATION SITE WARMTH (Hot to the touch Injection Site), VACCINATION SITE ERYTHEMA (Redness (3" around Injection Site)), PYREXIA (Fever 100 F) and NAUSEA (Nausea) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PYREXIA (Fever 100 F), NAUSEA (Nausea) and VOMITING (Vomiting). On 18-Feb-2021, the patient experienced DIARRHOEA (Borderline Diarrhea). On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch Injection Site) and VACCINATION SITE ERYTHEMA (Redness (3" around Injection Site)). At the time of the report, DIARRHOEA (Borderline Diarrhea), VACCINATION SITE WARMTH (Hot to the touch Injection Site), VACCINATION SITE ERYTHEMA (Redness (3" around Injection Site)) and VOMITING (Vomiting) outcome was unknown and PYREXIA (Fever 100 F) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from healthcare professional regarding a 4 month old female pt who experienced injection site redness and injection site lump. At 4 months of age, the pt received a dose on 24Aug05. Pt had no relevant medical history. Indication for Prevnar was immunization. Product was administered on 24Aug05. Dose regimen was 1 dose (IM). Concomitant medications were not reported. On 24Aug05, the pt received one dose of Prevnar. The very next day pt experienced a red lump at the injection site. Pt was treated with antibiotics and has since recovered.
pt recvd vax;inject site red & swollen,size of a nickel;3jun93 f/u:above rxn p/ doses 1 & 2;p/ 3rd vax,pt called w/ swelling at site more severe involving most of upper arm w/ a blistered area at inject site;blister broke p/ few days;
Patient received his COVID vaccine- 1st dose. Had to go get IV vancomycin later that day for a wound to ankle and went into cardiac arrest during infusion. Had received vanco before without any reactions. Patient was intubated and admitted to ICU.
Once child got home breaking out in rash and vomited x 2, erythema surrounding injection site and red papular rash on legs and trunk, vomited 3 times BENADRYL 18.625 mg given.
Upper left arm swelling, redness, inflammed, warm to the touch. patient was seen by two different providers. First time was 2 days after injection and again 4 days after injection as it was reactions were worsening.
Per Father, child started day care 2-3 weeks prior to shots. Client was sick that first week with runny nose, sneezing and fevers. Client seemed to recover and came for the child's first set of shots on May 25. Evening of May 25, child was vomiting and had diarrhea with fevers up to 102 degrees. Child to ER on May 26th or 27th, diagnosed with ear infection. Symptoms continued for 8 days. Returned to ER on May 31, diagnosed with virus. Still having symptoms - of a June 5.
Tingling in left hand pinky, left forearm and elbow area immediately after injection.  Left shoulder soreness within one hour after injection.
Patient did not go back to get the second dose; In the arm of the injection, soreness; a hot feeling that moved down the arm like someone poured hot water down their arm; This case was received via Regulatory Agency (Reference number: US-irms-MOD21-125987) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a hot feeling that moved down the arm like someone poured hot water down their arm), PRODUCT DOSE OMISSION ISSUE (patient did not go back to get the second dose) and VACCINATION SITE PAIN (in the arm of the injection, soreness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (a hot feeling that moved down the arm like someone poured hot water down their arm) and VACCINATION SITE PAIN (in the arm of the injection, soreness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient did not go back to get the second dose). At the time of the report, VACCINATION SITE WARMTH (a hot feeling that moved down the arm like someone poured hot water down their arm) and VACCINATION SITE PAIN (in the arm of the injection, soreness) had resolved and PRODUCT DOSE OMISSION ISSUE (patient did not go back to get the second dose) 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.
09May90 pt vax;  11May90 devel otalgia, h/a, & malaise, dx of Bell's Palsy was made.  Tx w/ Prednisone.  06Jun90 recovered w/out sequellae.
PCR confirmed Monkeypox; Case reference number US-BN-2022-004662, is a spontaneous case report initially received from a physician via company (reference number: USBAV22-1943) on 11-Nov-2022 and concerns a patient of unknown gender or age.  The patient's medical history included human immunodeficiency virus (HIV) with CD-4 lymphocytes at 766 (units not provided).  The patient's concomitant medication was not provided.  On unspecified date, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at unknown dose, route of administration and anatomical location, for indication reported as to decrease the incidence of monkeypox.  On unspecified date, an unspecified amount of time after the first Jynneos dose, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), at unknown dose, route of administration and unknown anatomical location.  On unspecified date, an unspecified amount of time after Jynneos vaccination, a polymerase chain reaction (PCR) test confirmed the patient had monkeypox. As reported, dates of vaccinations and event onset were unclear.  At the time of this report, outcome of event monkeypox was unknown.  The reporter assessed the event monkeypox as non-serious and related to Jynneos vaccination.   Additional information received from the physician via company on 11-Nov-2022: New information included seriousness and causality assessment for event monkeypox.  Additional information received from Bavarian Nordic on 14-Nov-2022 included the local BN case ID.  This case is linked with US-BN-2022-004663, US-BN-2022-004664, US-BN-2022-004665, US-BN-2022-004666, US-BN-2022-004667, US-BN-2022-004668, US-BN-2022-004669 (same reporter).; Reporter's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) unknown amount of time after the first and the second dose of Jynneos were administered. Monkeypox is unlisted per the CCDS v1 and the PI. The patient's medical history included human immunodeficiency virus (HIV). Concomitant medications were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos.; Sender's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) unknown amount of time after the first and the second dose of Jynneos were administered. Monkeypox is unlisted per the CCDS v1 and the PI. The patient's medical history included human immunodeficiency virus (HIV). Concomitant medications were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos.
patient administered acthib with expired diluent with no reported adverse events; Initial information received on 11-Apr-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a patient of an unknown age and gender who was administered HIB (PRP/T) VACCINE [ACT-HIB] with expired diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Apr-2023, the patient received an unknown dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (Vaccine-lot number: UJ653AAB; Expiry date: 24-Apr-2023) (Diluent: Lot number- U7261AD, expiration date: 07-Apr-2023) (with an unknown strength) via unknown route in unknown administration site for Immunization.  On 10-Apr-2023, the patient developed a non-serious patient was administered HIB (PRP/T) VACCINE with expired diluent with no reported adverse event (poor quality product administered) (Latency: same day).  It was reported, Caller states the expiration on the diluent and vaccine have different expiration dates. Caller states a physician was looking at the expiration date on the vaccine (24APR2023) and gave the vaccine to a patient not realizing that the diluent expired on (7APR2023). Wanting to know next steps to take and any harm to patient. Caller does not have patients information at time of call.This situation is reported as a medication error due to ACTHIB being administered to a patient that was reconstituted with expired diluent  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I had fever, chills, headache, dizziness, loss of appetite and extreme fatigue for 24 hours. I was in bed from 5pm 3-27-2021 to 6 pm the next day 3-28-2021. The dizziness lasted for one more day and I had injection site pain for 3 days.
right breast pain/swelling and right axillary tender  lymphadenopathy right arm pain
Muscle aches night of, a low grade fever 16 hours after. Took Tylenol and it went away. Small nose bleed. Painful red circle at point of entry of vaccine.
Pt has a 10cm x 10cm erythematous, warm, pruritic area surrounding the injection sites. Slightly tender, but itchy. No secondary infection. No treatment at this time. (L) Deltoid
Severe suicidal ideation. I acknowledge that I am bipolar, but my moods have been remarkably stable for the last several years. I have not been suicidal before this since 2007. I acknowledge that January's tend to be difficult, but this was extreme, and it started approximately 12 hours after the vaccine was given. There are a lot of arguments to be had about correlation vs causation.
Runny nose; broke out in a itchy rash over most of my body; This is a spontaneous report from a contactable consumer (patient, self-reported). A 72-year-old (non-pregnant) female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318 59267-1000-01 and expiration date was not reported), via an unspecified route of administration in left arm on 29Jan2021 at 13:00 (at the age of 72 years old) as a 1st dose, single for COVID-19 immunisation. The patient had past drug events with Iodine and hydrocodone. The patient's medical history included Arthritis. 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 has allergic to Iodine and hydrocodone. Concomitant medications included Protein Coffee, Famotidine. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021 at 13:00 the patient experienced, Runny nose 1-4 days on the 5th day Feb. 3rd she broke out in an itchy rash over most of my body. The patient did not receive any treatment for the events. The reporter reporting the events was non-serious. Facility where the most recent COVID-19 vaccine administered was pharmacy or drug Store. There was no treatment received for the adverse event. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient called the day after recieving his vaccine reporting vomiting. He states that the evening after receiving his vaccine he started to feel like he was being "placed under laughing gas" then around 12 am experienced stomach pain and felt nauseous but did not throw up until 1am. Spoke with him at 1130 the day after receiving his vaccine and he feels "off" and has a headache but is no longer vomiting
Immediate severe pain associated with pneumococcal vaccine redness, swelling, hive on the medial aspect of the injection site.
Patient calls pharmacy about 1 hour after administration complaining of painful right side from fingertips to jaw. Patient rates the pain 6 out 10.
This year had thimerosal free flu vaccine. Within 40 min had fainting spell, sweating, blurred vision, nausea, ringing in ears, dizzy, had to lay down 1 hr. Drove home slept 10 hr.
I had had a reaction of serious joint and skin pain to my second COIV dose. It was the same, but less severe.  I was still in bed for 2 days, taking the same meds as the first time, which is pain meds and Benadryl, I probably took some Valium as well...
Within 5 hours of injection, patient states the injection site was red and swollen to the size of an apple.  Within 24 hours of injection, patient states her arm was red and swollen to the size of a grapefruit.  Over the next several days, patient states her arm was progressively worse to the point that her arm was purple, and her fingers were swollen and her chest and neck were sore.  On 12/1/06, 17 days after the injection, patient visited the Emergency Department to r/o Hematoma.  She states an ultrasound was negative, and she was prescribed Cephalexin 500 mg x3/day for 10 days, ice and a sling.  Patient states within 24 hours of treatment, she experienced relief from pain and a reduction in the arm swelling.
Extreme pain in hands and feet, numbness/pins and needles sensation off and on in hands and feet
Tinnitus (continuous, stronger in left ear than right, more of a hum than a ringing); This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP6955) via an unspecified route of administration in the right arm on 28Mar2021 at 08:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high (HPB), asthma, hemochromatosis, arthritis, and overweight all from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN) all were the medication taken within two weeks of the vaccination for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6205) via an unspecified route of administration in the left arm on 07Mar2021 at 08:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Allergy to any medications, food, or other products were reported as none.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 03Apr2021 the patient experienced tinnitus which was continuous, stronger in the left ear than the right, and more of a hum than a ringing. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event tinnitus which was continuous, stronger in the left ear than the right, and more of a hum than a ringing, was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
Initial and follow-up information has been received from a certified medical assistant concerning a 16 week old hispanic male who on 21-JUL-2006 was inadvertently vaccinated IM with a 0.5 ml dose of Pneumovax 23 (lot #653283/0001F) instead of PREVNAR. Concomitant therapy included ACTHIB (lot #UE693AA) and PEDIARIX (lot #AC21B0G3AA). No symptoms of adverse event were noted. On an unspecified date the patient returned to the office for vaccination with PREVNAR. Additional information has been requested.
Information has been received from a LPN concerning a patient who was vaccinated with one dose of varicella virus vaccine live. Subsequently the patient experienced a rash. No further information is available.
Left side of face drawn upward, numbness of face, unable to close right eye. Dx - Bell's Palsy. Treated with steroids. Unknown at this time if permanent disability will result.