chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea began approximately 36 hours after 2nd Rotateq dose. (6 watery Bms per day) Blood streaked stool in Four bowel movements.  No vomiting.  Decreased appetite. Exam normal, questionable anal fissure. Green stool in office with maroon colored blood streaking, heme test positive. Treatment consisted of continuing breast feeding and giving pedialyte after diarrheal stools.  Infant was improved within 5 days.  Rotateq #3 dose was subsequently not administered.
sore and swollen arm; Fever; headache; nausea; sore and swollen arm; This is a spontaneous report from a contactable non-Consumer. This 68-year-old non-pregnant female consumer reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 11Feb2021 at 04:45 PM on left arm (at 68-year-old), as dose 2, single for COVID-19 immunization. Medical history of the patient included Cholesterols from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing and sulfonamide allergy from an unknown date and unknown if ongoing. It was mentioned that no other vaccine was received in four weeks. The patient received other medications in two weeks. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 21Jan2021 at 02:45 PM on left arm (at 68-year-old) as dose 1, single for COVID-19 immunization. On 12Feb2021 at 12:00PM the patient experienced fever, headache. slight nausea, sore and swollen arm. No treatment was received for events. The patient was recovering.  No follow up attempts were possible. No further information was expected.
Fever in excess of 102 degrees, general malaise, sore throat, pain in left axilla, no appetite.
The morning after the vaccine, started with dizziness and vertigo, progressed to burning sensation of skin. Felt like "burning from inside out." Went to hospital and was admitted on 4/9. Severe itching, nausea, vertigo. Spent 6 days in hospital. Given doses of steroids, Benadryl, pain medications, gabapentin. Discharged on 4/14. Symptoms have not improved.
Second dose not yet administered - more than 36 to 42 days from first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not yet administered - more than 36 to 42 days from first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not yet administered - more than 36 to 42 days from first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not yet administered - more than 36 to 42 days from first dose) outcome was unknown.        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 products were reported.  No treatment information was provided.
Swollen lymph nodes from left breast and under my left arm pit and hot to the touch.
Pt was scheduled for vaccines in office today. Vaccines from today's visit included Tdap, MENVEO, and GARDASIL 9. Pt had previously received Tdap vaccine with PE on 05/07/2018. No adverse event witnessed and no treatment needed - just a duplicate dose of vaccine given.
Intense arm pain that radiates up and down my arm still after a full month. My left side is still sore and the pain feels like it?s between my arm pit and breast on the left side which was the side I got the shot.
A few days after the injection my left arm went numb (from just above the elbow, down through all fingers). It was a "skin-deep" numbness that increased and decreased throughout the day. The muscles/tendons were still working ok and I didn't lose function of the arm.  Everything was just numb to the touch. This reaction persisted for about two or three months and finally went away sometime in July 2021. The issue has not returned since that time.  I had no such problem, in either arm, prior to that vaccination. Also hadn't had any vaccination for 10+ years prior to that. So not sure if it was inflammation of some kind  because of a foreign substance or was something in the J&J vaccine that caused it.
Patient had an ileo-colic intussusception which presented to the ER 2 days after vaccine administration.  It was reduced with an air enema and patient was admitted to the hospital.  4/13/2009 MR received for DOS 2/25-27/2009 with DX:  Intussusception. Pt presented with new onset projectile vomiting after eating. One blood streaked BM.  PE (+) for fussiness with palpation of the abdomen. Ileocolic IS dx with abd US.  Reduced with air contrast BE. Tolerated feeds post procedure and d/c.
This spontaneous report as received from a other health professional refers to a 6 month old female patient. The patient did not have any pre-existing allergies, birth defects or medical conditions and did not suffer form any illness at the time of vaccination. On 20-SEP-2017, the patient was vaccinated with PROQUAD lot # N016993, expiration date 29-NOV-2017, rHa, 0.5 ml, subcutaneously in the right arm for prophylaxis reconstituted with sterile diluent (STERILE DILUENT). On the same day, the patient also received PEDVAXHIB, hepatitis A virus vaccine (unspecified). Concomitant therapies included M-M-R II, HEPATITIS A VACCINE, INACTIVATED, PEDIARIX, PREVNAR 13 and and influenza virus vaccine (unspecified) (concomitant medications also reported as "none"). The patient was observed for 20 minutes after vaccination and no reactions were noted. The patient's mother called the day after vaccine was administered and provided that the child was feeling well.
Case number PHEH2012US003181 is an initial spontaneous report received from a pharmacist on 31 Jan 2012 and with a follow up received on 22 Feb 2012: This report refers to a 17-year-old female patient. She was given only the Men A lyophilized component of MENVEO vaccine (batch number: A100133) reconstituted with a sterile diluent intramuscularly on 24 Jan 2012. Hence she was vaccinated with full dose of MENVEO intramuscularly on 05 Feb 2012. It was reported that the patient had a complaint of dizziness two days later (unspecified after which dose) and she had recovered within one day. Follow up information received from the pharmacist on 22 Feb 2012: Updated event and date of revaccination with full dose of MENVEO.
This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 24-year-old female patient who received DTPa (Infanrix) (batch number yk2ff, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th December 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 17th December 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: The patient inadvertently administered Infanrix instead of Boostrix was intended to be given as a booster dose, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter did not consent to follow up.
26 yo primary vacinee received SPV vaccine 17 days prior to developing a pruritic macular/papular erythematous dermatitis to both arms and legs. There were no vesicles or pustules or lesions to his hands. He states he feels well no fever, chills, malaise, arthralgias or myalgias. He self treated with BENADRYL which has alleviated the pruritus and was overall much better. The site was dry and still had a scab. Dermatitis resolved three days later at followup. Diff Dx NVP vs. immune mediated. Lesion onset was late and more macular than typical for NVP.
Patient is DECEASED.  Hospitalized (12.19.21-1.17.2022); COVID-19 positive (1.6.22);  Fully vaccinated (no booster) Admission Date: 12/19/2021 Discharge Date: 1/17/2021   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Diabetic foot  Non-healing ulcer of left foot, unspecified ulcer stage  PAD  COVID  Acute ischemic stroke HOSPITAL COURSE: Patient had a history of severe peripheral vascular disease and was status post LLE balloon angioplasty on 12/28 as well as metatarsal amputation secondary to osteomyelitis on 1/4. Patient was initially under the service of General Medicine from 12/19/21-1/11/22 for care of these medical conditions. On 1/11/22 he was then admitted to the Medical Intensive Care Unit in the setting of acute hypoxic hypercapnic respiratory failure likely secondary to COVID-19 infection requiring intubation and hemodynamic support.  While admitted to the MICU, patient continued to receive IV antibiotics at for continued coverage of osteomyelitis per recommendations of infectious disease colleagues. He was given steroids and lung protective ventilation for COVID pneumonitis. His respiratory status improved with decreasing FiO2 requirements and sufficient intrinsic respiratory effort on spontaneous breathing trial to the point that he was successfully extubated on 1/16. Throughout the night of 1/16 however, patient had several episodes of respiratory distress with hypoxia which required he be placed on BiPAP for continued respiratory support. Repeat Chest X-rays following extubation showed evolving left lung consolidation which progressed to complete opacification of the left hemithorax. Given the chronicity and unilateral nature of the opacity, this was thought to be secondary to mucus plugging rather than a pleural effusion. Patient was alert and oriented at this time with wife at the bedside, patient confirmed goals of care and consented to therapeutic bronchoscopy. Bronchoscopy was successfully performed on the afternoon of 1/17 with evidence of significant mucus plugging of left main bronchus. CXR post-procedure showed improved aeration throughout the left lung field.  However, later in the afternoon on 1/17, MICU physician team was urgently called to the bedside at 16:56. Patient was found to be in PEA arrest and profoundly acidotic. He was intubated and resuscitated per protocol with 4x attempts to contact family. Repeat bronchoscopy confirmed a significant aspiration event as the likely cause of this arrest. Patient again arrested at 17:39, initial rhythm showed PEA. CPR was again initiated and protocol was followed. MICU fellow was able to get ahold of patient's daughter at this time and decision was made to discontinue further resuscitation efforts in the setting of several arrests with poor prognosis. Further resuscitation was then discontinued and patient expired shortly after.
Stye in left eye; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 15:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications were not reported. 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 23Apr2021, the next day after the vaccination, the patient had stye in left eye. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of the event and included treatment with antibiotic ointment. The clinical outcome of the event stye in left eye was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient states they have partial facial paralysis (right side of the face) that started Sunday, April 11th in the morning.  No other signs or symptoms. Breathing is normal, no rash, only reports paralysis of face. Patient has not reached out to a physician yet, so we recommended to see a doctor immediately and call us back with update.
Began itching around the nose and the mouth after about 8 to 10 minutes and the skin around nose and mouth began turning red. Continued getting worse she took a Benadryl tablet. She began mildly panicking. Then she felt goose bumps on her arms began getting hives, throat began itching and closing,  increased panic, trying to clear throat. Felt throat swelling. nurse administered epinephrine 0.5mg called ambulance.
Headache; I have a 101 something temperature; I am running a fever; Fatigue; Achy; This is a spontaneous report from a contactable consumer.  A 59-year-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL0140), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Medical history included High Blood Pressure, asthma, Double pneumonia and Covid from Jul2020 to an unknown date (Yes, I had pneumonia when I was in the hospital with the Covid.  it was 26Jul2020 was the discharge date and I was in there for 5 days/When probed for reason of hospitalization, consumer stated, "Double Pneumonia and Covid").  The patient's concomitant medications were not reported.  The patient stated, "I had the Covid shot, my wife asked me to give you guys feedback, so that is why I am calling. Some of my symptoms were similar to the Covid." When probed for the if any doctor prescribed the vaccine, consumer stated, "No but I was a little concerned with my symptoms that I had one because I already had Covid, they were very similar but not as intense. So, actually I went to have a Covid test tonight, a Rapid Covid test and I was negative." When probed for the dose and Route of administration, consumer stated, "It was the shot in the arm." When probed for any lab test performed, consumer stated, "They are supposed to give me another shot in 2 weeks." When probed for any treatment, consumer stated, "So I took Tylenol when I got very bad headache and I have a 101 something temperature so I am running a fever and fatigue, achy." Consumer further stated, "Just a question like I had the shot on 30th and I am sure these symptoms are going to "disappear" (not clarified) with the time, is there any recommended time period." The outcome of the events was unknown.
Gave 0.5ml instead of 0.25ml as a 3rd booster dose
Patient received the Janssen COVID vaccine (lot 205A21A, exp 9/21/2021) at approximately 1210. At 1219, patient reported to PHN and Paramedic that she felt lightheaded and sweaty. Patient transferred unassisted to zero-gravity chair, placed supine, and given juice. Vital signs: respirations 18l, blood pressure 150/96, pulse 88. Patient reported feeling anxious about vaccination. Patient reported allergies to penicillin, pea protein, and Diflucan. Patient takes Wellbutrin. Medical condition includes polycystic ovarian syndrome. Patient reported eating prior to vaccination. PHN encouraged patient to follow up with provider, when to call 911, and to stay for monitoring for 30min after report of symptoms. PHN offered patient Benadryl, patient declined. At 1223, patient reported no prior similar reaction. At 1230, vital signs: blood pressure 154/98, pulse 84, respirations 16. Patient reported symptoms had resolved and she wanted to leave against medical advice. PHN and Paramedic assisted patient to seated position at 1231, and monitored as patient stood without assistance at 1232. Patient continued to report symptoms had resolved. At 1232, patient left walking with steady gait.
Information has been received from a physician, via a company representative, concerning a female patient (age unspecified), who on 13-APR-2007 was vaccinated with the first dose of Gardasil (Lot # not provided). The patient later presented to the office for her second vaccination, however, she reported an irregular vaginal discharge, and the vaccine was not administered. A pregnancy test showed a "false" positive, as an ultrasound then confirmed she was not pregnant. At the time of this report, it was unknown if the patient had recovered. Additional information has been requested.
1st dose on 06-AUG-2022, 2nd dose on 19-jun-2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 7524T, expiry date 13th July 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 6th August 2020, (batch number CL335 and expiry date 23rd May 2022)).   On 19th June 2022, the patient received the 2nd dose of Shingrix. On 19th June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 27-JUN-2022 Reporter's comment: Pharmacist reported that the patient forgot to get second dose, so it was not administered until 19th June 2022. The reporter consented to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix vaccine later than the recommended interval, which led to lengthening of vaccination schedule.
Rec'd Hep A vaccine 08/23/2005 Diagnosed with Guillain Barre syndrome 10/11/2005. Treatment Plasmapheresis on going at this date.  2/1/06 Review of 3-page d/c summary indicates the final diagnosis was : GBS and abnormal liver functions  Review of 51-page medical record (H&P and test results) also confirms GBS.
Information has been received from a nurse concerning a 16 year old female patient who was vaccinated with a first dose of Gardasil, and subsequently developed flu-like symptoms. The patient also developed flu-like symptoms after getting the second dose of Gardasil. After getting the third dose of Gardasil, the patient developed kidney failure and underwent respiratory arrest resulting in hospitalization. At the time of the report the patient had not recovered. Additional information has been requested.  10/8/07 Patient demographics provided by CDC. 10/19/07 Reviewed hospital medical records which reveal patient experienced neck swelling, difficulty swallowing, cough, bloody sputum, facial pressure/pain, fatigue.  Admitted 5/25-5/31/2007.  ID & ENT consults done.  Tx w/IV antibiotics & developed red man syndrome, antibiotics changed.  Improved & d/c to home on continued IV antibiotics via PICC line.  To f/u w/ENT & ID, & have repeat CT scan done.  Records do not have evidence of respiratory arrest or renal failure reported by manufacturer. FINAL DX: Sinusitis, lymphadenitis, parotitis & Epstein-Barr virus. 11/16/07 Reviewed vax records from provider.  VAERS database updated w/same.
I have had the flu three times in my 56 years of living and two of the three were after taking the flu shot; Initial information received on 18-Oct-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer).  This case involved a adult patient of an unknown age and gender who got the flu (Influenza), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient stated why it that patient have had the flu three times in 56 years of living and two of the three were after taking the flu shot (Influenza).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown for the event of influenza.  There will be no information available on the batch number for this case.
Report from patient as follows:  Exactly 7 days after I received my vaccine, I woke up with a rash like red spot located on the injection site. It speads about 3-4 inchces across my arm. Hot to the touch and it has now formed a red ring my skin is raised from the swelling. I feel like a giant solid mass in my arm where I received the vaccine. I feel okay. I don't know if I have a fever.
patient who has only received the 1st dose of the Moderna COVID-19 monovalent primary series and never got a 2nd dose; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (patient who has only received the 1st dose of the Moderna COVID-19 monovalent primary series and never got a 2nd dose) and NO ADVERSE EVENT (No Adverse Event) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (patient who has only received the 1st dose of the Moderna COVID-19 monovalent primary series and never got a 2nd dose) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (patient who has only received the 1st dose of the Moderna COVID-19 monovalent primary series and never got a 2nd dose) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (patient who has only received the 1st dose of the Moderna COVID-19 monovalent primary series and never got a 2nd dose).    Concomitant products were not provided. Treatment medication were not reported.  Patient has only received the 1st dose of the Moderna COVID-19 monovalent primary series and never got a 2nd dose.
Pediatric dose given instead of adult dose of vaccine No adverse event occurred at time of administration or during wait period after administration
Abdominal cramping and severe diarrhea (difficulty taking in enough fluids to keep up) which lasted off an on for three full days following vaccination. No medical treatment was sought, took bland foods and fluids, resolved on its own after Sunday February 7th.
palpitations- night of immunization (also happened on my 2nd dose of Pfizer) rash- started 11/12 morning, more on bilateral arm, chest, neck, abdominal area
Patient developed cough 2 weeks after immunization. Per mother multiple visits at other facilities. Prior to our visit positive pertussis culture.
Started with shooting pain down my legs, followed by swelling and bulging veins. I haven?t been able to walk very well or up and down stairs I need assistance to get up from sitting or working on the floor.  I get shortness of breath quickly and sweating I am now unable to work.