chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 24 hours screaming, agitated, tongue thrusting, grabbing at arms followed by urticaria.
pain in shoulder; Chills/Teeth chattering; body aches; fever (states he never took temperature); arm pain, the pain made it tough to sleep; Shaking; Malaise; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain, the pain made it tough to sleep), TREMOR (Shaking), MALAISE (Malaise), ARTHRALGIA (pain in shoulder) and CHILLS (Chills/Teeth chattering) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038b21a and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 19-Apr-2021 at 11:50 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain, the pain made it tough to sleep), TREMOR (Shaking), MALAISE (Malaise), CHILLS (Chills/Teeth chattering), MYALGIA (body aches) and PYREXIA (fever (states he never took temperature)). On 22-Apr-2021, the patient experienced ARTHRALGIA (pain in shoulder). On 20-Apr-2021, MALAISE (Malaise) and CHILLS (Chills/Teeth chattering) had resolved. On 21-Apr-2021, TREMOR (Shaking) and PYREXIA (fever (states he never took temperature)) had resolved. On 26-Apr-2021, MYALGIA (body aches) had resolved. On 04-May-2021, PAIN IN EXTREMITY (arm pain, the pain made it tough to sleep) had resolved. At the time of the report, ARTHRALGIA (pain in shoulder) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-100365 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Outcome of events changed. Second dose details was added.
interrupt sleep throughout the night; mild body aches; lightheadedness; fatigue; slight headache; injection site soreness; Chills; fever; This is a spontaneous report from a contactable pharmacist (patient) and a contactable other health professional.  A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), on 17Dec2020 at 14:30 and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 08Jan2021 at 12:30, each via an unspecified route of administration at right arm at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medication included bupropion XL at 150 mg. On an unspecified date, the patient experienced 12 hrs. after vaccine administration, chills and subjective fever began and lasted approximately 24 hrs. (until 36 hrs. post-vaccine) severe enough to interrupt sleep throughout the night. Mild body aches during this time, along with lightheadedness, fatigue, slight headache and injection site soreness. The patient didn't receive any treatment. The patient outcome of the events was recovered.
Migraines (2 since March 28th) with nausea and vomiting. Patient received nausea medication
This spontaneous report was received from a medical assistant, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of ROTATEQ with the following lot numbers and expiration dates: M041184/31-MAY-2018 and M042171/07-JUN-2018 (strength, dose, route of administration or anatomical location were not provided) for prophylaxis; which was reconstituted with a properly store sterile diluent (manufacturer unknown). The storage temperatures were 47 to 77 degrees Fahrenheit (°F) for a time frame of 21 minutes and 6 to 14 degrees Fahrenheit (°F) for 42 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. As of 25-AUG-2017, all telephone attempts to obtain follow-up information have been unsuccessful. Sender's Comments: US-009507513-1708USA013008: US-009507513-1708USA013009: US-009507513-1707USA005187: US-009507513-1708USA013011: US-009507513-1708USA013012: US-009507513-1708USA013013: US-009507513-1708USA013006: US-009507513-1708USA013005: US-009507513-1708USA013007.
The child had herpes zoster involving the C5, C7, C8 dermatomes.  Rash onset was 11/29/2006. PCR testing with strain identification was performed and positive for vaccine strain VZV.  The rash resolved without complication.
COVID 19; COVID 19; vaccine dose number: 16; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 16 (booster), single (Lot number: GA6206) at the age of 72 years 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown), as dose 6 (booster), single (Batch/Lot number: unknown), as dose 7 (booster), single (Batch/Lot number: unknown), as dose 8 (booster), single (Batch/Lot number: unknown), as dose 9 (booster), single (Batch/Lot number: unknown), as dose 10 (booster), single (Batch/Lot number: unknown), as dose 11 (booster), single (Batch/Lot number: unknown), as dose 12 (booster), single (Batch/Lot number: unknown), as dose 13 (booster), single (Batch/Lot number: unknown), as dose 14 (booster), single (Batch/Lot number: unknown) and as dose 15 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19"; OFF LABEL USE (medically significant), outcome "unknown", described as "vaccine dose number: 16"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid (Lot number: GA6206 ) from 10Jun2022 to 10Jun2022.  No follow-up attempts are possible. No further information is expected.
17DEC94 @ about 12AM pt reports becoming violently ill--passing out for 1.5 hrs sick for days; seen family physician who arranged for testing;
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 03May2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 22Nov2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing); "known allergies Contrast Dye" (unspecified if ongoing), notes: Known allergies: Ibuprofen and Iodine Contrast Dye. Concomitant medication(s) included: LEXAPRO; ATORVASTATIN, stop date: 22Aug2022; TYLENOL; RITALIN [METHYLPHENIDATE]. Past drug history included: Ibuprofen, reaction(s): "known allergies Ibuprofen", notes: Known allergies: Ibuprofen and Iodine Contrast Dye. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 01Sep2022, outcome "recovering"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested negative; Positive, notes: I am testing positive again; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. Clinical course: Patient received other medication in 2weeks. Birth Control medication took in 2weeks stop date was 22Aug2022. Treatment for Covid 19 included Paxlovid started on 23Aug2022 and stop date was 28Aug2022. Patient finished taking Paxlovid, symptoms improved and she tested negative. 5 days later, mild symptoms have returned and She was testing positive again. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On 1/26/2022 and 3/29/22 client was given a lesser dose of immunization. While doing an imms clinic  found a vaccine error x2  on the same client.  Gave vaccines to this client at her 2 month and 4-month shots. A dose of Kinrix was administered at both visits and Kinrix is only authorized for children ages 4-6 years.
Administration of FLUBLOK to patient under 18 years of age with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA393689(CLUSTER).  This case involves a 6 years old female patient to whom influenza quadrivalent recombinant vaccine [Flublok] administered to patient under 18 years of age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Sep-2022, the patient received 0.5 ml dose once of suspect influenza quadrivalent recombinant vaccine (strength and formulation not reported) (lot UJ887AA; Expiry date: 09-Jun-2023) via intramuscular route in the left deltoid for immunization to patient under 18 years of age with no reported adverse event (product administered to patient of inappropriate age) (latency; on same day).  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Shot hurt upon administration; she felt a tickling in her throat about 2 hrs after shot; site was warm, red by the end of her shift, & increased by late that evening. She went to her physician & got a steroid injection. This her first flu shot.
COULD NOT SLEEP WELL; ELEVATED PULSE; FELT LIKE HEARTBEAT WAS TOO FAST; ELEVATED BLOOD PRESSURE; FELT LIKE A FEVER; SORE BODY; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 120 pounds, and height was 62 inches. The patient's concurrent conditions included diabetes type 2, osteoporosis, allergy to statins, and abnormal cholesterol, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. Concomitant medications included sitagliptin for diabetes type 2, and cinacalcet for osteoporosis.  On 29-JUL-2021, the subject experienced sore body. On 29-JUL-2021, the subject experienced felt like a fever. Treatment medications included: paracetamol. On 31-JUL-2021, the subject experienced could not sleep well. On 31-JUL-2021, the subject experienced elevated pulse. On 31-JUL-2021, the subject experienced felt like heartbeat was too fast. On 31-JUL-2021, the subject experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 185/97 (unit not reported), and Pulse rate (NR: not provided) 114 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore body, and felt like a fever on 29-JUL-2021, and the outcome of could not sleep well, elevated pulse, felt like heartbeat was too fast and elevated blood pressure was not reported. This report was non-serious.
Fever of 101-103 degrees, irritability, crying, pain, inability to walk or bear weight on legs for 3 days.
Severe lethargy, refused feeds for 8+ hours, yelling out in sleep every 30 seconds to 1 minutes, alternating low body temp to high body temp (96 degrees to 102 degrees).
Heavy menstrual bleeding since 2nd dose. Still present at 11/2/2021.
Generalized itching, crawling sensation lower extremities, nose, neck, upper ext. No rash. Benadryl 50mg and solumedrol given, symptoms relieved.
Information has been received from a physician concerning his 69 year old white wife with no allergies or medical history who on 01 Dec 2006 at 5:25 PM was vaccinated SC in the "right" with a first dose of Zostavax (lot# 652936/0981F). Concomitant therapy included vitamins (unspecified). On 01 Dec 2006, the patient experienced an injection site rash. Immediately after vaccination, the patient noticed pain at the injection site. A few hours later on 01 Dec 2006, the injection site was red (red area about two inches in diameter), hot and itchy (felt like a bee sting). The rash was still present on 04 Dec 2006 but has decreased in size. It was still hot and itchy, but not painful.  No diagnostic laboratory tests were performed. Unspecified medical attention was sought. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been receive from a physician who reported that the patient had a minor local reaction. The patient did not call the physician or seek medical attention elsewhere. Additional information is not expected.
Pain and swelling at site of IM injection in right deltoid. Burning/flushing of skin. Reports feels "burning to the core." Has used ice and ibuprofen without relief. Face hot/flushed. Low fever.
Burning at injection site followed by tachycardia and lightheadedness within 2 minutes. Lasted over half an hour
Patient received TDap (Adacel) instead of DTap. No adverse outcome has been reported. Primary Provider has been notified.
Information was received from the mother of a 23 year old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On unspecified dates, reported as "between his 16th and 17th birthday", the patient was vaccinated with GARDASIL. On 16-JAN-2018, the patient was vaccinated with GARDASIL 9 injection (lot # and expiration date were not reported) for prophylaxis. The outcome of drug administered to patient of inappropriate age was unknown.
24 hours after receiving the 2nd dose of the Moderna vaccine, the injection site began to itch, then progressed to hot, red, raised, round, extremely itchy area about 2" in diameter. Progressed over the next 24 hours until it became a red, itchy band 1 1/2" wide encircling 3/4 around the upper arm.  Has now been 72 hours since vaccine and symptoms are still present, but subsiding.  I did have a slight itching 24 hours after the first dose on January 12, 2021, but the area affected was only about the size of a quarter and subsided within 24 hours.
Two days after receiving the second dose of the Moderna  Covid 19 vaccine on my left arm I developed a large swollen bump right underneath  the injection site approximately four inches wide and across.  Pain...swollen...itching...burning sensation.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. On 22-JAN-2015, the patient was inadvertently vaccinated with ZOSTAVAX (route and dose unspecified) which was expired on 17-JAN-2015. No adverse effect was reported. Additional information has been requested.
reddish rash; This spontaneous case was reported by an other health care professional and describes the occurrence of PITYRIASIS ROSEA (reddish rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PITYRIASIS ROSEA (reddish rash). At the time of the report, PITYRIASIS ROSEA (reddish rash) had not resolved.        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 concomitant medications were provided. No treatment information provided.
Employee had extreme fatigue, malaise for one week after receiving annual influenza vaccine. Also reported left arm where vaccine was given was so sore that she was unable to sleep on that side.
SOB, respiratory distress, non-cyanotic.  BP 136/73, Pulse 120, Pulse ox 95%Multiple reddened, swollen hived typed areas with petachie looking areas and welts and broken capillaries with distension of vessels as if they were blocked especially in feet with small knots on bottom of feet that were extremely painful. Look like chillblains pictures. The areas were severely painful, itchy. Patient took large doses Benadryl q 12 hrs and Tylenol x 5 days and cortisone otc topical which burned and he discontinued after first use. Patient refused to go to urgent care or ER or to have ambulance come due to financial constraints and no insurance.  Given referral to free clinics and refused to go. Symptoms resolved by 1/5/2021
Totally normal and healthy on 6/4/19. Had vaccine on 6/5/19. Woke up 6/6 feeling exhausted and weak all over. Progressed over the next 10days. Hard to stand up from chair, hoarse voice. To ER 6/17 with slurred speech and weakness. Weakness slowly progressed next few weeks. 7/17 diagnosed with viral bronchitis. Symptoms worsened. Short of breath, very hoarse voice. Went to ER 7/26. Hospitalized 7/28-8/2. Numbness in feet and right hand, weakness progressing, especially right hand. As of 8/10, symptoms are still gradually worsening. Can barely use right hand, barely walk and talk, short of breath.
evening of vax ache @ site-then inc pain radiating into neck, shoulder lt upper back limiting comfortable motion & anxious; minimal reddness below site; pinpoint trigger point plain; P70 grossly irregular;
Fever at 102.0, gave her a Tylenol reducer took fever to 99.0. Bad Stuttering started with 36 hours. Punctuation and diminished and length of sentences and declined. Not as sharp as she always has been.
small vesical w/2 tiny satellite vesicles @ inj site & erythema;non tender noted 10 days p/inj;
Administered the flu shot. The patient stood up, said she felt like she was going to faint, then went to sit down but fell over. She hit her chin against a sign and was slightly bleeding. Gave her water and first aid. She regained consciousness almost immediately. Her parents helped her up and they left.
pt recvd vax; red, swollen, erythema for 72 hrs, down to 1" above elbow at rt IM deltoid inject site;
Upper left arm red and swollen, 2 days after immunization.  Patient complains it itches.  Patient otherwise acting perfectly normal, per Mom.  Afebrile.
SHE HAD PAIN, BURNING, AND NUMBNESS IN RIGHT ARM, VOMITED THREE TIMES, AND HAD DIFFICULTY BREATHING.
did not received the full dose, partial dose was administered; 7 months old was administered Pediarix; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 7-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number 5N259, expiry date 5th October 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 1st and 2nd dose on an unknown date).   On 28th January 2022, the patient received the 3rd dose of Pediarix (intramuscular) and Pediarix Pre-Filled Syringe Device. On 28th January 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the underdose and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Reporter was a nurse manager at the health care facility. The nurse reported that, the patient did not receive the full dose of their Pediarix injection, which led to underdose. The partial dose that was administered was the 3rd dose in the Pediarix series and was administered into the right thigh. The nurse also reported the seven months old patient received dose of Pediarix, which led to inappropriate age at vaccine administration. The reporter consented to follow-up.
About 4 hours after vaccination, arm "swelled up like a grapefruit." Was red, hot and painful according to patient. The next morning the arm from elbow to shoulder was very swollen and painful per family member. The patient flew back to home and by that evening (3/13/07), the arm was double in size. She went to Urgent Care Center.
1/20/09 Client called to report 1/15 am experienced tingling sensation R side rib cage area into back. By 1/15/09 afternoon pain R mid rib cage into back. 1/16/09 small blisters R rib cage into back with increased back pain. Went to urgent care 1/18/09. Dx'd shingles. Tx'd with steroids, pain medication and antiviral medication. Much improved 1/20/09.
Information has been received from a registered pharmacist concerning a female (age not reported) who in November 2005, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. In November 2005, the patient had a reaction after receiving pneumococcal 23v polysaccharide vaccine. The pharmacist reported that the patient was seen by her physician and the physician told her that she should never get another dose of pneumococcal 23 v polysaccharide vaccine. The pharmacist did not know what kind of reaction the patient had experienced. Additional information has been requested.