chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine (flu) lot # 765947 Evans 12/10/2003 RTC 12/11/2003 with approximately 1 1/2 inch induration - red & warm to touch.  Advised client to apply warm moist heat to site.  She states after 2 days the site was bruised and itching but swelling and redness were gone.
left arm deltoid region is erythemous, tender to touch, and warm. local reaction to at covid injection site.
trouble breathing, increased heartbeat, light headedness, severe exhaustion, hot/cold, problem with gurd, loss of appetite, frequent urination.
A non serious spontaneous report of inadvertent administration of expired H1N1 LAIV was received from a registered nurse/health professional concerning a 40-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the first dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
severe headache like a migraine; one side of my throat like the left side of my throat, I had severe severe pain; Neck pain; trouble swallowing; feeling like I was going to choke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2, solution for injection), administration date 01Dec2021 15:00 (Lot number: FH8027, Expiration Date: Feb2022) at the age of 37 years as dose number unknown, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administration date 01Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 02Dec2021, outcome "recovering", described as "severe headache like a migraine"; OROPHARYNGEAL PAIN (non-serious) with onset 02Dec2021, outcome "recovering", described as "one side of my throat like the left side of my throat, I had severe severe pain"; NECK PAIN (non-serious) with onset Dec2021, outcome "recovering", described as "Neck pain"; DYSPHAGIA (non-serious) with onset Dec2021, outcome "not recovered", described as "trouble swallowing"; CHOKING SENSATION (non-serious) with onset Dec2021, outcome "unknown", described as "feeling like I was going to choke". The events "severe headache like a migraine", "one side of my throat like the left side of my throat, i had severe severe pain", "neck pain", "trouble swallowing" and "feeling like i was going to choke" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, oropharyngeal pain, neck pain, dysphagia, choking sensation.  Additional information: Consumer stated, Patient woke up with a severe headache like a migraine then she develop something else which like was actually kind of rose strange which was on one side of her throat like the left side of her throat, she had severe pain and like trouble swallowing like feeling like she was going to choke so she went to the emergency room for it actually. They treated her, they gave her like some Ibuprofen and some pain medicine and take here there and monitored her and took x-rays, they didn't see anything with the x- rays but they sent her home. So she still have a little bit of like pain but it's definitely it's getting better but it's just like it's kind of weird it never had happened to her before. She still have some of this like neck pain actually, it's like difficulty swallowing. Consumer stated, No prior vaccination within 4 Weeks, just when she got her COVID vaccine on 02Dec, she also got my flu vaccine (Unspecified Vaccine). She was only taking like birth control (Further not clarified) that's the only other thing that she take. Treatment for Adverse Event received as Ibuprofen, Oral administration, 600 milligrams in every 6 hours.  No follow-up attempts are possible. No further information is expected.
Pt. states that after receiving the 2nd dose of Phizer 03/21/2021, started experiencing symptoms 04/12/2021 of arthritis in heels with severe pain.
1+ neck pain, throat pain, bronchospasm acute;2- collapse, then appears residual sz, flaccid paralysis of muscles upper & lower extremities diminished ear acuity & eye sight w/photophobia, speaks problem, radiculopathy sever GBS w/ dystroph
A BLOOD CLOT IN HER LUNG; VERY ILL; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: unknown) dose was not reported, 1 total, therapy start date was not reported administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced a blood clot in her lung and very ill. On an unspecified date, patient was hospitalized. Number of days hospitalized and discharge information was not reported. It was reported from the consumer that "A dear friend with a large business, felt pressure to get the vaccine after having Covid and the obvious antibodies. She chose the Johnson and Johnson vaccine and now in the hospital very ill with a blood clot in her lung. This is not okay, vax mandates are not okay". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very ill and a blood clot in her lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211115177-Covid-19 vaccine ad26.cov2.s- A blood clot in her lung. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20211115177- Covid-19 vaccine ad26.cov2.s-Very ill. This event is labeled and is therefore considered potentially related.
C/o right arm numbness occasionally for three weeks post-injection, along with headache.  Took ibuprofen as needed.
Information has been received from a physician concerning a 15 month old Caucasian female who on 05/15/2001 was vaccinated with the first dose of MMR II (lot 637431/0026L) IM. At the time of vaccination the child was status post resection of peripheral nerve "sweat" tumor in the abdomen. On 05/31/01, the pt presented to the physician with facial swelling over the parotid area, but no fever. The physician had the pt follow-up with a gastrointestinal physician. The pt was found to have acute amylase elevation, with amylase level of 490. With the facial swelling and amylase elevation, the physician "is diagnosing this as parotitis, possibly associated with MMR II." the pt was treated with Augmentin. On 06/06/01, the "facial swelling was going down." On follow-up, the physician reported that on 06/06/01 the pt recovered from the parotitis and the increased amylase level. Additional info has been requested.
swollen, red, hot arm at site of injection, still occurring after 96 hours headache, low-grade fever, extreme fatigue lasting 24 hours  fatigue still continuing
No adverse effect; the patients were vaccinated with improperly stored doses; Information was received from the vaccine coordinator and refers to 4 patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On an unknown date in 2019, between 16-APR-2019 and 02-MAY-2019, the patients were vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) for prophylaxis, lot number R021084 with expiration date on 14-JUN-2021 (strength, dose number, anatomical location and route of administration were not reported).  No adverse effects were reported.  The temperature was of 35.2 degrees Celsius (°C) for a timeframe of 30 minutes with a previous temperature excursion of 32.7 °C for 7 hours and 30 minutes. The temperature excursion was called because a digital data logger.  This is a non-valid case due to lack of patient identifiers.  On 03-FEB-2019, a phone call was placed to the primary reporter (physician assistant). A request was made for patient identifiers, lot and vaccine received and enquired about dates. Additional information has been requested.  On 03-FEB-2019, a returned telephone call was received from the primary reporter, who requested additional information to assist him in his research on patient information. Additional information has been requested.  Follow up information was received from the vaccine coordinator referring to an approximately 1-year-old male patient on 05-FEB-2020.  On 30-APR-2019, the patient was vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB).  This case was previously considered as non- valid due to lack of patient identifiers, but based on follow-up information received (patient's initials, date of birth and gender), this case was determined as valid.  This is one of the several reports received from the same reporter.
Headache, fever, severe diarrhea for 5 days, 8 lbs weight loss
Light headedness, Dizziness, Nausea, High blood pressure, Rapped heartbeat, body ache
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Started feeling unwell on Wednesday, two days after injection. On Thursday he said his left arm/shoulder felt weird. The following day he was taken to the hospital by ambulance, with loss of mobility in his left side limbs. He experienced 2 seizures in the following 24 hours, and MRI revealed bleeding on the brain.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster), single (Lot number: D1620) at the age of 29 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION; TURMERIC [CURCUMA LONGA]; SUMATRIPTAN; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication in 2 weeks Product: Multivitamin. Patient received Paxlovid from 30Jul2022 to 03Aug2022 for treatment of COVID-19.; Sender's Comments: ~~~
1st dose 13Oct2022, 2nd 02Nov2022; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 14-month-old patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 333N4, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 2nd November 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 2nd November 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Dec-2022 Reporter's comment: The reporter gave consent for safety team follow-up. Adverse event contains all reported information. The reporter consented to follow-up. Additional supportive information: The patient received second dose of Flulaval earlier than the recommended interval, which led to shortening of vaccine schedule.
Pt. reported a lot of pain at the site of injection; she also said she has very limited range of motion. She has been taking ibuprofen for pain and inflamm. and itching.
This case was reported by a nurse via call center representative and described the occurrence of chills in a 31-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On 19th September 2018 11:00, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 20th September 2018 11:00, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced chills, nausea, feeling unwell and fever. On an unknown date, the outcome of the chills, nausea, feeling unwell and fever were not recovered/not resolved. It was unknown if the reporter considered the chills, nausea, feeling unwell and fever to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The healthcare professional (HCP) reported her own experience. The patient started to experience chills, feeling sick feverish and nausea which were on-going at the time of reporting and felt worse as the day progressed. The HCP did not have the vaccine lot number or expiry date for this adverse event (AE). The HCP stated no intervention was taken but she called her primary care doctor and left a message. The HCP stated that, she never felt like this with a flu vaccine in the past.
Upper arm and shoulder very sore.  Limited mobility.  Shoulder freezes up after laying down for an extended period of time, or if circulation is diminished.  Takes lots of motion to get pain to go away, but still with limited motion.  Icy Hot, Ice, and Heat.  No lasting improvement.
more than 14 months since first dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 14 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that it was more than 14 months since the patient received her first dose of Shingrix.  The patient had planned on getting the second dose. Till the time of reporting the patient did not receive the dose, which led to incomplete course of vaccination. The reporter would like to remain anonymous and did not wish to provide any details.  The reporter did not consent to follow-up.
sinus infection with pain below the eyes; felt like he had a cold; dizzy; took a nap; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS, SOMNOLENCE, NASOPHARYNGITIS, and SINUSITIS in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products were not provided.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced DIZZINESS and SOMNOLENCE. On 14-Mar-2021, the patient experienced NASOPHARYNGITIS. On 15-Mar-2021, the patient experienced SINUSITIS. Not Provided.      Treatment products included Flonase, Afrin.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
24 hours after flu vaccine shot, client states her L arm was very sore, increasing pain over next few days.  By 11/14, she noticed enlarged nodes, axillary L.  Yesterday (11/18) she noted enlarged, tender nodes under R arm (axillary area).  11/19 some soreness in neck - feels like she has fever and increased fatigue.  11/20 MD visit/diagnosis - sinusitis & "breast problems" - "not from vaccine"  MD advised mammo.
Information has been received from a physician and a school nurse concerning an 11-year-old male who on 08-JUL-1998 was vaccinated with a dose of varicella virus vaccine live. It was also noted that the patient was vaccinated with a dose of MMR on 19-SEP-1995 and 14-JUL-2000. A school nurse reported to the physician that between 24-MAR-2005 and 09-MAY-2005, the child developed a mild case of break through varicella with less than 50 lesions. Unspecified medical attention was sought. The outcome was reported as recovered. A product quality complaint was not involved.  No additional information is expected.
covid positive infection; covid positive infection; This is a spontaneous report received from a contactable reporter (Nurse). A 56-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2023, outcome "recovering" and all described as "covid positive infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jan2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
severe swelling rt arm to wrist, tender to touch, moderate h/a x 5 days;tingling rt fingers;
Wheals, lip swelling, tongue swelling (vaccine given 10 am symptom onset 6pm, worsened 10pm)
Patient called pharmacy at approximately 2 pm on 12/9/12 to report the following events: 11/28/12: Received flu shot at approximately 8:40pm and per pharmacist instructions she remained in store 15-20 minutes after vaccination, due to unspecified adverse rxn to flu shot 20 years ago. She was fine when she left the store, upon arriving home she was experiencing an "anaphylactic reaction". Symptoms: SOB and her throat was closing. She self-administered injectable diphenhydramine in her right arm and called 911. Paramedics administered oxygen and she refused transport to hospital. She says her arm was red and swollen at this time. I spoke with pharmacist on 12/10/12 that administered flu shot, he recalls that patient called pharmacy after she returned home to report red/swollen arm. He confirmed that she did not have SOB and suggested she take a BENADRYL and explained this is common. She did not mention 911 call. Patient did not report this phone call to me. Her arm got progressively worse and on 12/8/12 she sought treatment at immediate care clinic because the pain was so severe, there were red streaks on her arm, she had a high fever plus she was experiencing chest pains. On 12/9/12 she was admitted to hospital with strep infection in arm. 12/10/12: patient called to report that she was still awaiting test results but her blood culture was negative and ultrasound had confirmed abscess in left arm. Treatment includes surgery and IV antibiotics. This is patient account of events, pharmacy personnel has not verified with physician, 911 report.
Systemic: swelling in hands and feet-Medium, Additional Details: pt complained of swelling in hands and feet in the evening after getting her flu shot
My arm hurt; I had a slight fever; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and fever. On an unknown date, the outcome of the pain in arm and fever were unknown.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient. Age at vaccination was not reported. The age grp was selected as an adult as vaccine indication. Patient reported that he/she decided to get the shingles shot after patient cousin had shingles and had to be hospitalized. Patient experienced arm hurt and slight fever. The reporter reported its better than the shingles pain.
Suffered mini stoke approximately 20 days after vaccine and a stroke 21 days after vaccine.; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Mar2021 09:30 (Batch/Lot number was not reported) as 1st dose, single for Covid-19 immunisation. Medical history included Covid-19 from Jul2020 (prior Covid 19 in July of 2020 with longhaul issues) and allergy to compazine and meperghan. Concomitant medications included gabapentin, rosuvastatin, colecalciferol and ubidecarenone (CO-Q10+VITAMIN D3). On 10Apr2021, the patient suffered mini stoke approximately 20 days after vaccine and a stroke 21 days after vaccine. The patient was released from urgent care on 10Apr2021 and went back 11Apr2021 after apparently having the stroke during morning hours of 11Apr2021. Transported around midnight of the 11th to hospital. The patient was hospitalized for four days and received Plavix and aspirin. The outcome of the event was recovering.  Information on the lot/batch number has been requested.