chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 76-year-old male patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 12-FEB-2020, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. Marrs# 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407 and 2003USA005408.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408:
Patient reports loss of peripheral vision in left eye on 8/30/19 upon awakening.  Vision gradually decreased and she saw eye doctor on 9/3/19. She was referred to an eye specialist on Wednesday 9/4/19. Almost all vision in left eye was lost on Friday 9/6/19. Stat MRI confirmed inflammation of ocular nerve. Patient admitted to hospital on 9/6/19.  Tumor, cancer, MS, lupus, bacterial and other infections were ruled out. Patient reports that physician states event was likely caused by influenza vaccine.     Vision recovery pending.
Suspected vaccination failure; Type A flu; This case was reported by a consumer via sales rep and described the occurrence of suspected vaccination failure in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   In October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. In October 2019, less than 2 months after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced influenza a virus infection. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza a virus infection was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza a virus infection to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had type A flu. This case was considered as suspected vaccination failure as details regarding time to onset for the event was unknown at the time of reporting. Limited information was available. This is 1 of the 2 linked cases reported by the same reporter.
Vomiting, dizziness, flushing/sweating, vitals wnl. Known h/o of anxiety and vomiting with vaccines.
Within 15-20 seconds of IM administration pt became flushed (face and neck only) and c/o nausea, dizziness and sob. B/P 194/104 right supine AP:100 vital signs recheck every 10-15 min for 90 minutes and recheck on by MD every 30. Vital signs slowly returned to normal with cessation of pt's symptoms, both objectively and subjectively.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age (no demographic details were provided). The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX. No further dosing information was provided. It was unknown if the patient took any concomitant medications and no other suspect medications were reported. On an unknown date, 5 days after administration of ZOSTAVAX, the patient presented with shingles. The outcome of shingles is unknown. The action taken with ZOSTAVAX was not applicable. The reporter provided no assessment for the causality between ZOSTAVAX and the shingles. Additional information has been requested.
Initial and follow up information has been received from a licensed practical nurse and a healthcare professional, concerning a 19 year old white female student, who at 3:15pm on 15-MAY-2007 was vaccinated IM in the left deltoid with the first dose, 0.5ml, of Gardasil (Lot #657736/0389U). There was no concomitant medication, nor illness at the time of vaccination. The nurse originally reported that the patient "passed out" after the vaccination was administered, but the healthcare worker, who also administered the vaccine, confirmed that the patient immediately (at 3:15pm) following the vaccination, became lightheaded, dizzy and pale, and began sweating. The healthcare worker took the patient to a room and gave her a drink and an ice pack; vitals included blood pressure of 98/68, heart rate of 72, and temperature of 98.1F. The patient laid down for 20 minutes and started feeling better. The healthcare worker advised the patient to call for a ride, but she refused; she recovered on the same day, 15-MAY-2007. The patient sought unspecified medical attention. No further information is expected.
Rapid uneven heart beat . Sore body, nausea, dead right arm (shot arm) lowered blood pressure,
A day after the vaccine, I started to get a lot of hives and then a red rash on the arm where I got my vaccine
After my daughter received GARDASIL shots she began to have auto immune disorders. Two of them! The first was TTP or chronic hives. It was uncontrollable with any treatment attempted. It eventually after a year of agony for her at age 12-13 years old had hives all over her face. On prednisone. It was very difficult emotionally for her. Then after that went away she got ITP which is an auto immune disorder where her own anti body's were attacking her BLOOD PLATELETS faster than she could produce. This can cause spontaneous internal bleeding and her platelet would be monitored n go so low as to unreadable on blood work. She was hospitalized about every 3 weeks. She had to go thru intravenous immune globulin treatments and would remain in there two to three days at a time. In the home times she suffered from side effects of treatments n had to get blood work frequently. After about 8 months to a year it disappeared. She's now 17 and still suffers low platelet levels and it's side effects. All from the immunization GARDASIL. I advise you beware in advising this product please.
Student presented to Health Services on 09/04/2011 with hive 6cm x 7cm at injection site, left deltoid. 3 red nodules noted Lt elbow.  2 red papules noted right elbow.
administered with a vaccine from a vial which has been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with a vaccine from a vial which has been punctured for more than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with a vaccine from a vial which has been punctured for more than 12 hours). On 21-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with a vaccine from a vial which has been punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was first punctured on 20-Jan-2022 at 11:53 AM.  Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-458066 (Patient Link).
Achy, headache progressed from moderate to severe, nausea, vomiting, rash, general malaise.  Symptoms are now on day 6 and beginning to recede.
I'm reporting just in case others had a mini stroke after receiving this Johnson and Johnson shot, doctors at hospital say they have seen it causing Big strokes but not mini strokes  but if J&J shots causes big strokes it can also cause mini strokes I believe, A stroke is a stroke.  My husband is a healthy 60 year old with no real heath issues.  all his test in hospital showed no reason for his stroke and they did them all...?..but test did show he had a stroke  His arm and leg went numb at about 8 pm Friday at home so I took him to hospital and test showed he had a spot on his brain saying it was a stroke, they kept him 2 days running test and they found no reason he had a stroke but he did and I believe it was caused by the COVID-19 vaccine shot from Johnson and Jonson
Patient reported feeling dizzy and lighted after vaccine administration was given. Patient was taken to the ER to be observed. Patient then called on 1/29/21 to report that her arm where she had the injection looked like she had a rash. it has been 8 days since she has had the vaccine. Advised her to go to her PCP if she was worried about it being an allergic reaction to the vaccine. Advised that vaccines can cause local reactions.
Pt's spouse came to us date after injection claimed pt really sick at home she can't move her arm. We advise her to take TYLENOL to see if it help. Up to now been over 2 weeks pt shoulder still hurt and swollen.
Pt felt lump &  tightness in throat 5 min after administration, lasted 15 min.
Vaccination was reported by patient and verified in state database - data feed in our system does not state where the vaccine was given (maybe pharmacy) but patient may have that information
Headache, Arthralgia, Fever, extreme fatigue, injection arm pain Narrative:
This spontaneous report was received from a consumer (patient's mother) regarding a 2 and a half year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. Patient had no allergies. On 19-JUN-2017 the patient was vaccinated with M-M-R II, lot # M047302 with expiration date: 30-NOV-2018 (dose and route were not reported), for prophylaxis. On 24-JUN-2017, in the early morning, the patient vomited once and developed a fever of 102 Fahrenheit (pyrexia). The patient was given Tylenol and within 24 hours, had recovered from her fever. On 30-JUN-2017, the patient experienced another fever that ranged from 100-103 Fahrenheit. The fever would decreased when the patient was administered Tylenol, however she did not recover from her fever until 03-JUL-2017. On 03-JUL-2017, the patient had an unspecified strep throat test administered and the test came back positive for strep throat (Pharyngitis streptococcal). The patient was then put on antibiotic amoxicillin, but as of 05-JUL-2017, the patient did not recovered. The outcome of vomiting was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
This spontaneous report was received from a Medical Assistant refers to a patient of unknown age and gender, who on 27-MAY-2015 was vaccinated with an improperly stored dose of GARDASIL (lot # K006960) (dose and route not reported). According to the reporter the vaccine dose administered underwent only one excursion of 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received.
A report has been received from consumer concerning a patient of unknown gender and age, who had been receiving Nasal FLUMIST (intranasal), 0.2 Millilitres, Unknown for FLU. FLUMIST (intranasal) started on an unknown date for FLU. The patient reported that four nurse received cuts on index and middle fingers when attempting to administer FLUMIST. Ears of syringe broke off when pressing syringe up. FLUMIST (intranasal) was continued. At the time of reporting, the event of CUT FINGERS was improving and the outcome of the event of EARS OF SYRINGE BROKEN OFF WHEN PRESSING SYRINGE UP was unknown. The report was considered to be non-serious.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 12:10 (Lot number: EN6004) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). There were no concomitant medications.The following information was reported: ILLNESS (non-serious) with onset 13Mar2021, outcome "unknown", described as "Very sick"; ASTHENIA (non-serious) with onset 13Mar2021, outcome "unknown", described as "Very weak"; FEELING ABNORMAL (non-serious) with onset 13Mar2021, outcome "unknown", described as "Doesn't feel like herself".Additional information: The patient had no additional vaccines administered on same date of BNT162B2. The patient had not received any other vaccines within 4 weeks prior COVID vaccine. The events did not require a visit to physician or ER.No follow-up attempts are possible. No further information is expected.
Guillian Barre Syndrome -- specifically AIDP superimposed on probable CIPD. Patient presented to ED with progressive bilateral upper extremity and lower extremity weakness. Symptoms began a few days after vaccination and progressed over months. Two weeks prior to admission, his bilateral lower extremity weakness acutely worsened to the point that he was unable to ascend stairs, prompting him to come to ED. Lumbar puncture was performed, revealing elevated protein and normal cell counts, consistent with clinical picture of Guillian Barre Syndrome. He currently remains in hospital and is undergoing IVIG infusions.
5 days after the first shot(12/24/2020), I started feeling extremely fatigued.  I had axilla lymphadenopathy, dizziness, nausea, joint pain, muscle pain and periods of tachycardia when standing.  This lasted for 7 days.  The lymphadenopathy was diagnosed in a routine mammogram/ultrasound screening 9 days after the vaccine.  I finally started feeling better the week I was scheduled to receive my second shot.  I got my second shot on 1/14/2021.  Within 12 hours, I had a 101 fever and muscle aches.  I also had axilla lymphadenopathy.  Within 3 days, I was feeling better, however about 8 days post vaccine, I started to experience bouts of tachycardia and dizziness again.  As time progresses, these symptoms are slowly improving.
9/3/03: pt had immunizations (DTaP, Hib, IPV, Prevnar). 9/10/03: mom states "startling easily". Legs drawn up, arms, out, eyes wide open. 9/16/03: same sxs. Neuro consult. 9/19/03:  EEG and neuro evaluation: see note. 10/13/03 normal EEG. 11/3/03: DTaP, Hib, IPC, Prevnar. 11/4/03: same sxs recurred. 12/18/03: neuro re-evaluation. Diagnosed Beurg myoclonic size of infancy. 3/30/04 Hib: sxs began again that evening only for a few hours.
Information has been received from a physician concerning a baby's grandmother who had rotavirus after her grandchild was vaccinated with a dose of ROTATEQ.  The baby's mother (WAES# 0804USA05564) also experienced rotavirus.  The physician was contacted by phone for medical attention.  The outcome was unknown.  No additional information at this time.  There was no product quality complaint.  Additional information has been requested. Follow-up information from the administering health professional in the reporting physician's office indicated that on 14-APR-2009 the baby was vaccinated (WAES #0805USA04720) and in April 2008, the baby's grandmother experienced rotavirus. Additional information has been requested.
patient  received the orange cap formulation of the Pfizer BioNTech Covid 19 vaccine that was not diluted before administration; patients received the orange cap formulation of the Pfizer BioNTech Covid 19 vaccine that was not diluted before administration; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 9-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 1(tris), 0.2 ml single (Lot number: FL8094, Expiration Date: Sep2021) at the age of 9 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: OVERDOSE (medically significant) with onset 12Apr2022, described as "patient  received the orange cap formulation of the Pfizer BioNTech Covid 19 vaccine that was not diluted before administration"; PRODUCT PREPARATION ISSUE (medically significant) with onset 12Apr2022, described as "patients received the orange cap formulation of the Pfizer BioNTech Covid 19 vaccine that was not diluted before administration".Clinical information:  Reporter made a mistake today and the vaccines went out not diluted,  just discovered it happened, and four children received the vaccines, ages ranging from 8-10. Reporter  doesn't have dates of birth, height, weight or ethnicity to provide for these patients. Reporter provides age, sex, and initials for the four patients. Four patients received the undiluted vaccine as their first doses.; Sender's Comments: Based on the known safety profile of vaccine and the information available the Causal relation between the event and suspect drug is assessed as N/A,Linked Report(s) : US-PFIZER INC-202200566505 same reporter/drug/AE, different patient
Dizziness; Headache; Weakness of the legs; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), DIZZINESS (Dizziness), HEADACHE (Headache) and MUSCULAR WEAKNESS (Weakness of the legs) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Macular degeneration since an unknown date, Glaucoma since an unknown date, Cholesterol since an unknown date and Hypertension since an unknown date. Concomitant products included ATORVASTATIN for Cholesterol, VALSARTAN for Hypertension, ACETAZOLAMIDE for Macular degeneration and Glaucoma, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 04-Feb-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 05-Feb-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headache) and MUSCULAR WEAKNESS (Weakness of the legs). On 06-Feb-2021, PAIN IN EXTREMITY (Arm soreness), DIZZINESS (Dizziness), HEADACHE (Headache) and MUSCULAR WEAKNESS (Weakness of the legs) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), DIZZINESS (Dizziness), HEADACHE (Headache) and MUSCULAR WEAKNESS (Weakness of the legs) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Macular degeneration since an unknown date, Glaucoma since an unknown date, Cholesterol since an unknown date and Hypertension since an unknown date. Concomitant products included ATORVASTATIN for Cholesterol, VALSARTAN for Hypertension, ACETAZOLAMIDE for Macular degeneration and Glaucoma, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 04-Feb-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 05-Feb-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headache) and MUSCULAR WEAKNESS (Weakness of the legs). On 06-Feb-2021, PAIN IN EXTREMITY (Arm soreness), DIZZINESS (Dizziness), HEADACHE (Headache) and MUSCULAR WEAKNESS (Weakness of the legs) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.
Covid arm.  Redness, Swelling , itching  days after vaccination. Resolving
induration; fever x 36 hrs; This case was reported by a physician and described the occurrence of induration in a 6-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number 934NJ, expiry date unknown) for prophylaxis.   Co-suspect products included HAEMOPHILUS B CONJUGATE VACCINE (MENINGOCOCCAL) (PEDVAX-HIB) for prophylaxis.   On 4th June 2020, the patient received Pediarix and PEDVAX-HIB. On 4th June 2020, less than a day after receiving Pediarix, the patient experienced induration. In June 2020, the patient experienced fever. On 19th June 2020, the outcome of the induration was recovered/resolved. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the induration and fever to be related to Pediarix.  Additional case details were reported as follows: The patient received Pediarix in left leg and Pedvax-Hib in right leg. From 4th July 2020 to 19th June 2020, the patient experienced Induration and fever for 36 hours.
left lateral thigh with a large area of redness around injection site, extends to upper medial thigh. Redness and warmth noted 2/4, stable today. No fever. No drainage, no trouble walking, no pain.  Recommend cool compress and ibuprofen
ADMINISTRATION ERROR  : Pt. was administered Pediatric dose 5- 11 age group 1/2 dose Previously 11/19/2021 1st dose 12-16