chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 24-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA205710, 2018SA207528 and 2018SA207544, related case from same reporter with same vaccine. This case involves a 27 years old patient who was administered expired 0.5 ml dose of TENIVAC lot U5280AA, expiry date 16 Mar 2018 via intramuscular route in the left deltoid on 02-Jun-2018. The patients past medical history and family history were not provided. No other vaccines were administered concomitantly. It was reported that patient was vaccinated with TENIVAC on 02 Jun 2018, which expired on 16 Mar 2018. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender- none.
rheumatoid arthritis breaking through; rheumatoid arthritis breaking through; Feeling a little slower; This is a solicited report based on the information received by Pfizer. A non-contactable consumer (patient) reported that a 60-year-old female patient received first dose of bnt162b2 (Batch/Lot number was not reported), intramuscularly on an unspecified date as single dose, received second dose intramuscularly in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneously, start and stop date, batch/lot number and dose were not reported for moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced rheumatoid arthritis breaking through on an unspecified date, feeling a little slower in 2021. Solicited report from by a consumer of a 60-year-old female with events of non-serious feeling a little slower and at the end of Humira cycle felt the rheumatoid arthritis breaking through before her next injection with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced at the end of Humira cycle felt the rheumatoid arthritis breaking through before her next injection. In 2021, the patient experienced feeling a little slower. Covid-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown date, patient received 1st dose COVID-19 Vaccine manufactured by unknown, lot number unknown, expiration date unknown. In 2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown, expiration date unknown.  The action taken in response to the events for adalimumab was unknown. The outcome of events for feeling a little slower was resolving, for other events was not resolved. Causality of Humira (Adalimumab): The reporter's causality for the events of feeling a little slower and at the end of Humira cycle felt the rheumatoid arthritis breaking through before her next injection unknown onset was not provided. Causality as per reporter (Drug/Vaccine) for all events was not reported.  The reporter's assessment of the causal relationship of all events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, Rheumatoid arthritis cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate.
Information has been received from physician concerning a 13 year old female patient with asthma who on 08-SEP-2008 was vaccinated with the first dose of GARDASIL vaccine (site and route not reported). No other vaccines were administered at this time. On 9-SEP-2008, the day after she received the vaccine, the patient went to the physician's office due to was the mother felt was an asthma attack. The patient was treated with levalbuterol and Orapred. The patient was not hospitalized. Additional information has been requested. Follow up information was received from a nurse who reported that they can not find any information about the patient. No further information is available.
Pt experienced tachycardia and was monitored.  This returned to normal in a few minutes.
Fever over 100 degrees with muscle aches. Took tylenol to treat the fever and aches. Both fever and aches persisted for 1 day.  Next day I had no problems.
pt had pox mainly on upper torso, head & ears, less than 50 pox on body;no fever detected;no antipyretics given;no complications;mom called MD but MD did not see pt;
Hives widespread over body two and a half days after dose. Pediatrician unsure if related. Wanted reported.
Doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.   Date the vial was initially stored in the refrigerator on 14-JAN-2022. Patient took booster dose in February 2022.  No Treatment information was reported.
PATIENT REPORTS EXTREME TENSION HEADACHE WITH EXTREME PRESSURE IN THE FACE AND EYES. PATIENT REPORTED THE HEADACHE LASTED FOR 4 DAYS. PATIENT ALSO REPORTED SERIOUS ARM PAIN.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old male patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 2nd dose of SHINGRIX. On 12th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 16th September 2018, the patient experienced injection site inflammation, injection site erythema and macular rash. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site inflammation, injection site erythema and macular rash were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site inflammation, injection site erythema and macular rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced soreness at the injection site on the day of the injection. The patient described soreness at the injection site as sore and tender. The soreness at the injection site was not as tender as on the day of reporting. However a day before the reporting date, the soreness at the injection site looked red and blotchy and inflamed.
developed localized skin reaction rt. upper extremity with small aaxillary nodes, low grade fever
Site of vaccination became hot, red and itchy. The redness extended around arm about 4" in length and 2" in width.
Slep for 3-4 hours after administration of vaccine. After awakening, drank 7oz of Prosable, vomited 1 hour later, became limp and pale x5 min. and episode repeated 15 min. later. Lips were blue mom states. Denies fever. Discharge summary states dysphagia. msv
jawpain; stomach ache; cannot open jaw all the way; backpain; spasms in back by muscles; rashes; joint pain; muscle pain; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 11 years old female patient who experienced jaw pain (pain in jaw), stomach ache (abdominal pain upper), cannot open jaw all the way (trismus), back pain (back pain), spasms in back by muscles (muscle spasms), rashes (rash) and joint pain (arthralgia), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Aug-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  On unknown date, the patient developed a non-serious jaw pain (pain in jaw), stomach ache (abdominal pain upper), cannot open jaw all the way (trismus), back pain (back pain), spasms in back by muscles (muscle spasms), rashes (rash) and joint pain (arthralgia), three week following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Other relevant tests were not reported.  Final diagnosis was muscle pain, joint pain, rashes, spasms in back by muscles, back pain, cannot open jaw all the way, stomach ache and jaw pain.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for all the events.  Information on the batch number was requested.
ITCHY; GIVEN EXPIRED FLUMIST; SNEEZED EVERYTHING OUT\NOT SURE HOW MUCH WAS SNEEZED OUT; A spontaneous report has been received from a health professional. The report concerns a male patient (age not provided) (height 105 cm, weight 17 kg).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist (influenza vaccine live reassort 3v) (batch number NH3062) (expiration date 14-DEC-2021) once/single administration, via nasal route, on 17-DEC-2021.     No malfunction has been reported for FLUMIST.    The report described a medication error for Flumist. The reported term was given expired flumist (Preferred term: Expired product administered). The reported term was sneezed everything out\not sure how much was sneezed out (Preferred term: Product dose omission issue).     On 17-DEC-2021, the patient experienced itchy (preferred term: Pruritus).     It is unknown if any action was taken with Flumist (influenza vaccine live reassort 3v).     The outcome of the event(s) of itchy, given expired flumist and sneezed everything out\not sure how much was sneezed out was unknown.     The events were considered non-serious.     The reporter considered that there was a reasonable possibility of a causal relationship between Flumist (influenza vaccine live reassort 3v)and the following event(s): itchy, given expired flumist and sneezed everything out\not sure how much was sneezed out.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray   Product Role: Suspect
ARM SORENESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022,expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm soreness. This report was non-serious.
Pfizer 9/2/21, 9/23/21. Positive on 12/12/22
morbiliform pruritic rash w/anterior lymphadenopathy 24hr p/vax;no other sx;
the full dose instead of the half dose; Her daughter got it and has a lump under her armpit which she did not get after either of her first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (the full dose instead of the half dose) and AXILLARY MASS (Her daughter got it and has a lump under her armpit which she did not get after either of her first 2 doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced AXILLARY MASS (Her daughter got it and has a lump under her armpit which she did not get after either of her first 2 doses). On 22-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (the full dose instead of the half dose). On 22-Oct-2021, ACCIDENTAL OVERDOSE (the full dose instead of the half dose) had resolved. At the time of the report, AXILLARY MASS (Her daughter got it and has a lump under her armpit which she did not get after either of her first 2 doses) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-366021 (Patient Link).
Myalgia, NauseaVomiting, Pain at the insertion site. Missed work d/t symptoms. Narrative:
ANTHRAX VACCINE, SC 11/28/2003, 12/18/2003, 01/28/2004, & 06/21/2004  Received first 11/28/2003 at sea with second and third AVA while in on land, prep for deployment w/o remembered adverse events. Received fourth AVA vaccine 6/2004 off coast. Wk as chief master of arms on ship....no uncommon adverse events remembered. She began to experience neck pain April/May 2004 running on ship. she awoke with a stiff neck thinking she slept wrong, saw medical and given Naprosyn. Upon return from deployment in 7/04 moving to new house, work, etc thought joint pain (legs, arm, lower back) attributed to activity. took Motrin for discomfort w/some relief. Describes discomfort as a dull constant ache to joints themselves. Scale 2-3/10 and pain resolved, movement made better.  Pain worse upon awakening and initial movements. October 2005 reached up while shopping raised hand overhead and felt sharp stabbing pain in lower back, thought was going to pass out, was assisted to floor by bystander, drank some water then able to drive home...c/o severe pain across upper back in neck, c/o radiating pain with tingling to right arm, unable to use arm due to pain but could move fingers and grip.  Came to ER in 10/2005 where MRI diagnosed cervical herniated disc x 3.
This case was reported by a physician via market research programs and described the occurrence of SLE flare in a adult patient who received Herpes zoster (Shingles vaccine unknown) for prophylaxis. Concurrent medical conditions included systemic lupus erythematosus. On an unknown date, the patient received Shingles vaccine unknown. On an unknown date, less than a year after receiving Shingles vaccine unknown, the patient experienced SLE flare (serious criteria GSK medically significant) and fever. On an unknown date, the outcome of the SLE flare and fever were unknown. The reporter considered the SLE flare and fever to be possibly related to Shingles vaccine unknown. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter's SLE patient who had real but short-lived events that the reporter interpreted as lupus flares, with fever. This case has been linked to the cases US2018GSK182344, US2018GSK183955, US2018GSK183956, US2018GSK183957 and US2018GSK183959, reported by same reporter.
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 02-APR-2022 14:22; Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 02-APR-2022 14:22; This spontaneous case was reported by an emergency medical technician and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 02-APR-2022 14:22) and EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 02-APR-2022 14:22) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 2:22 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 2:22 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 02-APR-2022 14:22). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 02-APR-2022 14:22). At the time of the report, PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 02-APR-2022 14:22) and EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 02-APR-2022 14:22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient ethnicity reported as white.  Concomitant product use was not provided by the reporter.  Vaccine administration time was reported as 14:22:28. Patient received booster dose. The patient received moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  No treatment information was provided.
Emp described N & V, abdominal pain, diarrhea & tiredness. Day received & progressively got better in 7 days on & off symptoms of abd. pain & diarrhea.
went home immediately had sharp stomach pain like I had never experienced before. I started passing blood through my stool that night.
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 08-JUL-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
One and a half hour after receiving the vaccinations, the patient experienced two episode of jerking, cyanasis. She was rushed to Oakwood Hospital's ER. Her temperature was 102 degrees F. The diagnosis was that she had had a seizure. The patient was afebrile and have no cough. She had received a chest exam prior to immuinization.
Approximately 15 hours after injection, felt very mild dizziness and sore arm.  Arm soreness went away within 24 hours, but dizziness progressively worsened.   By Day 3 dizziness was accompanied by cognitive impairment/ brain fog, profuse sweating with temp of 99.0 - 99.5 deg F and tachycardia to 120s upon standing with no change in blood pressure and resting HR in the 60s.  As a Registered Nurse, I was unable to care for patients in this condition.  Contacted PCP.  Symptoms intensified on Days 4-5.  Blood work done, pending results. Follow up care to be provided by PCP.  Will not be receiving second vaccine.
Pt called stating she has having increased swelling and redness at injection site since administration of her second Moderna vaccine on 9/25/21. Pt stated she has tried oral/topical Benadryl, Tylenol, and iced down the area. She stated she had a bit of swelling after the first vaccine, but it is worse this time. She also stated that she has an adhesive allergy and she took off the bandage sooner after the first vaccine than she did after the second vaccine. I advised that injection site swelling/redness are common side effects but recommended she follow-up with her pcp regarding this. I also recommended she try ibuprofen as well for pain/inflammation. I requested pt follow-up with us to let us know how she is doing, she stated she would.
D135QW5 3:30pm 1/14/22  At approximately 3:30PM, the minor (14 year-old male) client received his first dose of the Pfizer 12+ vaccine, administered by our vaccinator in his Right Deltoid (IM). The client sat in the observation area with his mother and within three minutes complained of light-headedness. The mother reported that he ate within the hour. The Clinical Lead gave the client a bottle of water and checked his vital signs, which were normal. The client was alert and said ?I don?t feel good?. The Clinical Lead decided to assess the client?s ambulatory status by standing him up with support on both sides when she noticed his legs were weak and that he was lethargic. He was immediately transferred to a stretcher while the clinical lead activated EMS at 3:43PM. While on the stretcher, the patient complained of chest discomfort and numbness to the right extremity. The Clinical Lead continued to monitor the client?s vital signs until EMS arrived.   When EMS arrived, at approximately 4PM, they took the client?s vital signs and performed an EKG. They informed the client?s mother that he required further medical evaluation. EMS departed with the client and his mother at approximately 4:15PM to a local Medical Center.
Started with chills at 8 pm on 03/06/21 that lasted until 4 pm on 03/07/21 even with staying in bed underneath two comforters. Temp got up to 102.3 at 230 pm on 03/07/21. Was alternating Tylenol with Advil every 4 hours starting at 8 pm 03/06/21. Fever finally broke, temp down to 99 around 830 pm with sweats that resulted in a bed linen change. Temp at 7 am on 03/08/21 was 99.1.
No reaction occured. MMRV only licensed for patients age 12 mos-12 years. Patient was 19 years at time of admin.
He was shaking uncontrollably, complaining of chest pain and a racing heart.  The chest pain lasted 2-3 days, decreasing in severity as time went on.  Approximately 20 hours after vaccination, he vomited.  He was very uncomfortable for 2-3 days
Headache, sinus pain and nausea.  Body fatigue and muscle pain in  shoulders, back and limbs.
Initial report was received 12 October 2011 from a health care professional which involved a case of misuse/medication error (inappropriate age at time of vaccine administration). A 10-year-old male patient had received an injection of DT ADS PED USP (lot number, route, site and date of administration not reported) and an unspecified amount of time later, the patient developed diffuse erythema multiforme. The patient had previously experienced the same event after receiving a DTAP vaccination (manufacturer unknown) six years prior. No additional information was provided at the time of the report. Outcome was not reported. This patient experienced another event which has been captured in case number 2011-09950. Documents held by sender: None.
Received call from his exwife that patient had passed away.  Death Certificate states date of death as March 14, 2021.  Causes of death are listed a. Cardiac Pulmonary Arrest. b. Myocardial Infarction
Rash present intermittently since 8/3/05 am.  Itching at the rash. Rash is present on the face, back, chest, abdomen, arms and legs.  No difficulty breathing.  Denies fever.  Doctor notes.  Erythematous wheals present on the left side of the face, abdomen and medial thighs and medial knees bilaterally.  No vesicles or petechiae, no fluctuant mass or drainage.