chrisvoncsefalvay/vaers-outcomes huggingface dataset:
infant received their second Flu vaccine yesterday and administration was 25 days after their first Flu vaccine no reported adverse event; Initial information received on 15-Nov-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 15 months old male patient who received their second influenza quadrival A-B vaccine [Fluzone QIV] yesterday and administration was 25 days after their first flu vaccine no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR); and HIB vaccine (Haemophilus influenzae TYPE B).  On 14-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine once  with standard strength (form, lot number, expiry date: unknown)  via intramuscular route in the right deltoid for Immunization.  On 14-NOV-2022 the patient who received their second flu vaccine yesterday and administration was 25 days after their first flu vaccine no reported adverse event (inappropriate schedule of product administration) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
First dose. Immediately spiked heart rate. High blood pressure with bottom over 100. Rash   Flushed. Physical chills (could be seen) head to toe felt drunk. Nausea. Dizzy.  Chest pains. Since the first dose I have been getting these tremors and spasms when I sit or lay to relax. My neck arm etc jolts.  Second dose. Spike in heart rate and elevated blood pressure bottom 98   Dizziness. Rash. Arm pain and rash (and now heat and 3? bruise on arm site with rash) Chest Pains. Had twitches on the left side in my neck and head.
8/2/2021: presented to ED with CC of shortness of breath.  Symptoms began 4 days prior to presentation, patient began experiencing shortness of breath & cough productive of white sputum, body aches, and fever/chills. Patient endorses intermittent headaches, nausea, and diarrhea for the past 2 days and intermittent left flank pain he attributes to his recurrent nephrolithiasis.  Diagnosed with acute hypoxic resp failure 2/2 COVID-19 Note: patient previously vaccinated with Pfizer COVID-19 vaccine on 3/3/21 and 4/13/21. 8/12/2021: patient discharged
I am reporting that I nearly fainted early in the morning. I woke up feeling uncomfortable and hot and went to the kitchen for an ibuprofen. I immediately felt wobbly and nauseous. I sat on the floor a minute in the kitchen. Took the ibuprofen and walked back upstairs to my bedroom. Again I felt nauseous and then felt my face get hot, lips tingle, vision get grey, realized I was about to faint and lied down on the floor. A minute later I went back to bed feeling the chills,  slept two hours and felt fine when I got up. Checked my Blood Pressure and it  was normal. I don't normally faint. It was unexpected.
Pt called in complaining of swelling and redness in one arm and stated that the dr diagnosed her with staph. infection when she visited the urgent care 3 days after receiving the vaccine on 6/10 and was given antibiotic for it and did pick up the antibiotic but did not mention about the reaction to me but called in a day later about it
Diverticulitis; A spontaneous report was received from a nurse who was an 53-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced serious event of diverticulitis.  The patient's medical history was not provided. No concomitant medications were reported.  On 22 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011S20G) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the same day, the patient experienced diverticulitis.  She was hospitalized and the treatment of the event given was iv antibiotics.   On 15 Jan 2021, the patient reported that the symptoms started again.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the event, diverticulitis, was not resolved.; Reporter's Comments: This case concerns a 53-year-old, female patient. The patient's medical history was not provided. The patient experienced a serious, unexpected event of diverticulitis. The event occurred the same day the patient received the first dose of mRNA-1273 (Lot number: 011S20G). Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a 32 years old female social worker referring to herself. The patient had no concurrent condition, pertinent medical history, drug reactions/allergies or concomitant medication. On an unknown date the patient was vaccinated with an unspecified number of M-M-R II (strength, dose, frequency, route, lot # and expiration date were not reported) for routine vaccination. On an unknown date in September 2018 (reported as last month), the patient's blood work result stated she did not have immunity to measles. It also reported that the patient didn't have lab diagnostics/studies performed. She didn't seek medical attention. No treatment was given to the patient. The outcome of therapy was reported as not recovered. The causality between the event and suspected therapy was unknown.
Right ear itchy after getting vaccine. Around 3 pm Right ear itchy, throat tight , sore under jaw like when you swallow clearing throat .No problem eating dinner.7 pm Trouble swallowing feels stuck when swallows food, esophagus tight. 10 pm took Benadryl . Panicky at 12 midnight. Benadryl helped still feels tight  did not want to take second benadryl . Watched until 1:30 am felt tightness under chin but esophagus relaxed. Ringing in ears Saturday all day and still has it. Started Friday but has gotten worse. was told to inform patient to go to PCP.
Flu vaccine administered on 9/6/2012. On 9/8/2012, patient called into office triage and stated she had developed hives on 9/7/12 and swelling of hands on 9/8/12. Triage RN, per protocol, sent pt. to Hosp. ER for further eval. Pt. has NEOSPORIN allergy.
Disruption in period. It arrived a day early, bled a little, then it stopped for a day, then bled a little more than the first time.  Now it has stopped again. I normally have a perfect cycle. I am very fit and healthy and eat a completely non processed diet.
Client states itching and rash on chest/neck in the waiting room approx. 5 min after receiving vaccines. Pt assessment done. 50 MG of Benadryl was given within a few min of patient reporting symptoms. Patient was assessed for half an hour. After a half hour patient self reported feeling better via translator and left the clinic.
This spontaneous report as received from a pharmacist via company representative refers to "about 4 or 5" patients of unknown age and gender. On an unspecified date the patients were vaccinated with a dose of ZOSTAVAX (lot# unspecified) (dose, route and location unspecified) respectively. The reporter stated that on an unspecified date, "about 4 or 5" patients developed shingles after receiving the ZOSTAVAX. The pharmacist informed that his case was already reported to the Food and Drug Administration (FDA). At the time of report, the outcome of the event was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had a syncopal episode approximately 10 minutes after receiving vaccinations today. He quickly came back around and was examined by staff. He was kept in the office for approximately 30 minutes after the episode and had no further adverse effects after the initial incident.
Diarrhea 6x / vomit 12x. Dehydration.
Around 08:40 am, during administration, less than half of the authorized amount of the vaccine squirted out of patient's arm.  Per CDC guidelines, the vaccine does not need to be administered again at this time. Patient will get the authorized amount of vaccine at her scheduled date for the second dose on April 2, 2021.  Two weeks after administration of her second dose, patient will return to clinic for antibody testing.  Pt was notified of this information and agreed with plan.
waited 15 min at clinic then headed home and half way -about 10 or so later- felt his face and checks start to swell from right to left as well as facial glands. He then took 2 Benadryl at home and 20 min later felt swelling going down and had no further problems,just started to feel side effects of vaccine that night. Next day felt fine.
Received Pediarix #2, HibTiter#2, Prevnar#2 on 11/14/05. There was no fever or sign of localized reaction but that evening he had a 45 min generalized seizure. EEG nl, MRI of brain, benign extracranial fluid; cultures neg. He has had recurrent seizures on 12/20/05, 12/31/05 and 1/7/06. -DC Summary Patient seen in ED 11/14/05 with partial seizure at home. No fever, no GI, no resp symptoms. No HX of seizure disorder.  PMH: negative. Hospital course: improved less twitching when aroused. Transfer to another hospital.  DC DX: new onset seizures.  8/14/06-Diagnostic test reports received fromhospital. CT Head 11/15/05: unremarkable non-contrast CT. Preliminary report from outside hospital describes abnormally low attenuation within white matter tracts. I disagree. EEG:Normal EEG in wakefulness stage I and II sleep. MRI Brain without contrast: 11/15/05-Impression: slight prominence of extra-axial spaces in bifrontal regions extending to the high convexity. Appropriate myelination for age.
micro haemorrhaging in the brain; pneumonia/ fever/ difficulty breathing; dizzy; unable to walk without help; chills; standing asleep; incoherent unable to form sentences; incoherent unable to form sentences; did not know family; cognitive disabilities; This is a spontaneous report. A contactable consumer (patient's daughter) reported that female patient of unspecified age received dose 2 of BNT162B2, via an unspecified route of administration on 09Mar2021 as single dose for COVID-19 immunization. The patient previously took the dose 1 on an unspecified date. Medical history and concomitant medications were not reported. The patient received her 2nd dose of COVID vaccine on 09Mar2021. Immediately after 2nd dose (unknown date), dizzy and unable to walk without help 2-3 days after second dose chills, (4-5 days) standing asleep incoherent unable to form sentences. Admitted to hospital diagnosed micro haemorrhaging in the brain. Thursday fine, developed fever, as far as cognitive ability one week later relapsed after diagnosis fever. Friday night difficulty breathing, diagnosis pneumonia relapsed of cognitive disabilities. Went for brunch, did not know family. Clarified home but with home aide support. The outcome of the events was unknown.  Information about lot/batch number has been requested.
I felt weak with headache and chills and muscle aches and at the site of injection it was red, swollen, and sore for 2 days.
Vital Signs: BP 142/98 HR 119 O2Sat 97 Skin Signs: Warm and dry  Resp: Breath sound clear bilaterally  At 14:57 HR 112 O2Sat 99 At 15:08 HR 112 O2Sat 99 BP 138/88 Continued monitoring  Disposition: Home By Self
Systemic: Fainting / Unresponsive-Mild, Additional Details: after receiving his vaccine passed out and eventually came to was pale for awhile but got better over time
The patient developed a hard, red, painful lump on upper right arm and a rash. Patient given 3 shots on same day, 2 in right deltoid, 1 in left deltoid. Patient does not know which vaccines went into her right arm and no notation was made on her immunization record. This form mailed to health department after being faxed to VAERS.
Painful administration of Flu injection to left deltoid followed by severe impaired range of motion with pain for 3 weeks. Continued impaired range of motion with pain but not to the degree.The extent of injury is unknown. (Administered during employee  flu vaccination clinic)
muscle ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle ache) and HEADACHE (headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 045121A) for COVID-19 vaccination.     No Medical history reported.  Concomitant products included VERAPAMIL and LEVOTHYROXINE for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle ache) and HEADACHE (headache). At the time of the report, MYALGIA (muscle ache) and HEADACHE (headache) outcome was unknown.            Other concomitant medication includes losartan/HCTZ 12.5 mg.  No treatment details reported.
Pt presents 06/20/2002 to clinic with right leg 4X6.2 cm erythema and swelling. Diagnosis: Local vaccine reaction at site of injection. Benadryl, Ibuprofen treatment.
started with unusual tired and nausea and headache approx. 22 hours after injection.  a few hours later fever and chills lasting approx. 12 hours and  another 48 hours of extreme tired.
Intermittently productive cough, dyspnea, body aches, HA, neck pain 3 days after dose.  CXR in ED found LLL pneumonia and enlarged heart; given ABX and isolation.
SORENESS IN ARM; INJECTION SITE REDNESS; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's 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, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced soreness in arm. On 24-MAR-2021, the subject experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site redness on 26-MAR-2021, and had not recovered from soreness in arm. This report was non-serious.
Headache, Myalgia, Arthralgia, Fever, chills, fatigue, diarrhea Narrative:  Employee received vaccine on 01/04/2021 and did not experience symptoms until the following day. On 01/05/2021, employee began experiencing fever (100 F), chills, headache, joint and muscle aches, fatigue, and diarrhea. Of note, employee reports attended a football game on 12/26/2020. Reports using Dayquil and Nyquil currently for symptoms. Symptoms have not yet resolved.
Fever; Physical exhaustion; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0151) via an unspecified route of administration in the arm left on 28Apr2021 at 18:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included fluvoxamine (MANUFACTURER UNKNOWN) at a dose of 150 mg, levomefolic acid (L-METHYLFOLATE) at a dose of 15 mg; both were taken for unspecified indication started on an unspecified date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ew0169) via an unspecified route of administration in the arm left on 07Apr2021 at 18:00 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 07:00, the patient experienced fever, physical exhaustion and sore arm but that was not abnormal with any shot. The clinical outcome of the events fever, physical exhaustion and sore arm was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Rash like SJS, fever 102, severe diarrhea, abdominal pain 19 hrs after dose. Had to go to Hospital ER for blood work and IV fluids.
pt recv vax;site became swollen & warm;by noc swelling extended over proximal biceps;itching & warmth at site of injection;to return to clinic if no improvement of rash;
After about a week, started hearing ringing in both the ears. Now I have suffered some hearing loss.
Day after receiving 2nd dose, patient developed facial congestion, burning eyes, scratchy throat.; Day after receiving 2nd dose, patient developed facial congestion, burning eyes, scratchy throat.; Day after receiving 2nd dose, patient developed facial congestion, burning eyes, scratchy throat.; This is a spontaneous report from a contactable pharmacist reported a female patient. A 51-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: unknown), via Intramuscular route of administration, on 18Jan2021 03:15 PM (at the age of 51 years old) as a single dose on left arm for COVID-19 immunisation at a workplace clinic. Relevant medical history included thyroid removed 30+ years (onset date unknown). Historical vaccine included fist dose of BNT162B2 (Pfizer Covid-19 vaccine, lot#/exp. date unknown)  via Intramuscular route of administration on left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021, the patient stated that day after receiving 2nd dose, she developed facial congestion, burning eyes, scratchy throat. She proceeded to get COVID Nasal Swab test on 19Jan2021 with unknown result at time of report. Patient stated workplace did not believe they were adverse reaction to vaccine. The patient received treatment no treatment. The outcome of the events facial congestion, burning eyes, scratchy throat was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This case was reported by a physician via sales rep and described the occurrence of vaccination site swelling in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 22nd August 2018, the patient received SHINGRIX. On 23rd August 2018, 1 days after receiving SHINGRIX, the patient experienced vaccination site swelling. On an unknown date, the outcome of the vaccination site swelling was recovered/resolved. It was unknown if the reporter considered the vaccination site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The patient experienced severe swelling in the arm. Lasting days and was started 24 hours after administration.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (They have temperature excursion 57 degrees F), EXPIRED PRODUCT ADMINISTERED (they still continue to vaccinate people even after the temperature rise.) and PRODUCT STORAGE ERROR (temperature excursion where the vaccine went to 57 degrees F for 40mins. They noticed it around 4Pm PST but they still continue to vaccinate people) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (They have temperature excursion 57 degrees F), EXPIRED PRODUCT ADMINISTERED (they still continue to vaccinate people even after the temperature rise.) and PRODUCT STORAGE ERROR (temperature excursion where the vaccine went to 57 degrees F for 40mins. They noticed it around 4Pm PST but they still continue to vaccinate people). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (They have temperature excursion 57 degrees F), EXPIRED PRODUCT ADMINISTERED (they still continue to vaccinate people even after the temperature rise.) and PRODUCT STORAGE ERROR (temperature excursion where the vaccine went to 57 degrees F for 40mins. They noticed it around 4Pm PST but they still continue to vaccinate people) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication and treatment information was reported.
This Non-Valid spontaneous report as received from a registered nurse regarding an unknown number of patients (gender and age were not provided). The patients' pertinent medical history or concurrent conditions were not provided. On an unknown date, the patients might have received improperly stored vaccines of GARDASIL 9, lot # M041990 and expiration date on 28-JUN-2019) (route, anatomical location, dosage were not provided); and doses of M-M-R II, lot # N026828 and expiration date on 27-SEP-2019) (route, anatomical location, dosage were not provided); both therapies administered as prophylaxis. The doses were storage at 11.8 grades centigrade, for one hour and 45 minutes. The report was identified via "data logger". No further information is available.
Feeling numbness, tightness, hotness, warmth, spotting and discoloration in right and alternates to the left leg today. Also started feeling some tightness in the left eye today. Have a Dr appointment but on May 17th and going to urgent care today. Advised to go to HCF instead of urgent just to ensure they can get imaging, US and appropriate testing's to r/o all cause of complications.  4/20-f/u pc to caller; couldn't sleep last night; used a heating pad on her leg but didn't work; states both legs hurt; feel tight; 4/10 pain; worried when also saw spots on her left leg and became concerned because saw news of clots; the episode started with tightness of her right leg which progressed to most of leg as well as left leg. Has not gotten worse today and denies any concominant effects. Normally healthy. Did not go to the hospital because says she wouldn't be able to afford it. Has appointment with primary care in 2 weeks.   rec'd that since she is still ok today then it's likely ok to skip the ER and go see MD as planned; warned to go to the ER right away or dial 911 if any of the following effects: sudden shortness of breath, severe headache, vision changes, loss of motor or/sensory function, chest pain. Call us back if having any effects at all besides the ones already noted so we may help determine if needs ER care.