chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a health care worker referring to a 16 year old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 18-SEP-2015, the patient was vaccinated with unspecified improperly stored doses of GARDASIL 9 (lot # L016428, expiration date 30-JUL-2017), (routes, doses and anatomical sites of vaccination were not provided). It was reported that the temperature of excursion were the following: 53.6 F for 392 hours, 58.5 F for 465 hours and 46.2 F for 15 hours, respectively. The outcome of excursion was not supported. Co-suspect therapies or concomitant medications were not provided No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This previously happened to patient when he got the first dose of Shingrix, including the same symptoms. He reported redness and heat on day 2 after receiving the vaccine. This occurred below the injection site. He went to urgent care and they reported that he had an infection and gave him keflex 500 mg.
Presented to ED w/gen weakness, lethargy, SOB x 2 days; admitted for COVID-19 pna; tx w/abx, remdesivir, zinc, mag; did not need O2 therapy; dc'd home
Guillain?Barré syndrome - AIDP, Hospitalized eight days at local Hospital with constipation,  numbness,  paralysis, weakness, blurred vision, erratic blood pressure, slurred speech, blurry vision.  Liquid diet, couldn't close mouth or eyes due to paralysis. 90% recovered at this time. Treated with 5 days of plasma infusions.
Pt vaccinated with Hepatitis -B two hrs later developed vomitting, fainting, severe, headache, & fever 101.6.
This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding the patient's pertinent medical history, drug reactions/allergies and concomitant therapy were not provided. On 16-NOV-2000, the patient was vaccinated with M-M-R II (dosing details, lot # and expiration date were unspecified). Nurse reported that on 04-DEC-2000, the patient was inadvertently administered with VARIVAX (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Inflamation and pain on left side of the body, beginning in the arm/shoulder and spreading to neck and left tonsil.  Tonsil swelling was quite pronounced by 2am (nearly twelve hours after the injection) and blocked the airway when head was turned to the left, necessitating a makeshift pillow brace to keep head turned to the right overnight.  Tonsil swelling began to diminish by about 6am and only slight enlargement remains thirty hours after injection.  Additionally, a low-grade fever began at about 10 pm (~7 hours after injection) and reached a maximum of 100.5 degrees F approximately twenty-four hours after the injection.  By twenty-eight hours, temperature was within normal limits (though still nearly a degree higher than typical for this patient).  As of this writing, some thirty hours after the injection, headache, neck ache, and eye-ache persist, but none is severe.  Symptoms appear to be continuing their improvement.  I (the patient/recipient) hope the second installment of the vaccine is no worse than this one.  The only truly alarming symptom was the swollen tonsil and some thought was given to seeking medical attention, but the pillow brace seemed to do the trick for keeping the airway open, so no assistance was sought.   I have no doubt that these short-lived symptoms are much better than actual disease and I will not hesitate to follow up with the second vaccine installment?but I will monitor the tonsil situation very carefully.
This report was received from a consumer on 27 March 2008.  A 53-year-old female patient, with a history of asthma, received a right deltoid intramuscular injection of FLUZONE (lot number U2489AA) on 08 February 2008.  Approximately one week after vaccination, on 13 February 2008, the patient began experiencing a severe headache.  Her vision initially became blurry, then deteriorated so that she was only able to see shadows and light.  She was seen by her physician, who prescribed Prednisone and ordered a series of tests including MRI, lumbar puncture, temporal artery biopsy, and blood work (results not provided).  She was subsequently seen by an ophthalmologist, who noted that her "optic nerve was swollen".  Per the reporter, the patient's pupils were dilated for six weeks.  Her vision was reported to be slowly returning.  At the time of the report, the patient was being treated with Prednisone 60 mg/day for five days, then 40 mg/day for five days.  She was scheduled to follow-up with the treating physician after Prednisone therapy had concluded.  No change in vision had been noted since the previous office visit.  This consumer also reported that the patient's sister experienced flu-like symptoms following vaccination with FLUZONE; this non-serious event is captured in case 200800894.
felt achy after both shots of vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "felt achy after both shots of vaccines".  Additional information: Event took place after use of product. Reporter information Available. Patient information available.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, body tremors with teeth chattering, dizziness, fatigue. The dizziness and fatigue lasted 4 days. The body tremors woke me up at 5AM 6/15 after the vaccination at 2pm 6/14. The injection of the vaccine itself was very painful. And I barely had any of these symptoms after the first dose except some symptoms of malaise. But the tremors and fever that woke me up at 5 a.m. after I received my 2nd injection the previous day at 2 p.m. were severe. My teeth were chattering and my whole body was shaking. I could barely hold my cup of tea to my mouth. I went back to bed with 2 blankets to recover. It took me 5 - 6 days to recover. Then I caught a cold afterwards which I believe was a consequence of my immune system being compromised. I am fully recovered now after 2 weeks. In spite of all this, I still would rather get the vaccine vs. getting the disease. Please make people aware that these symptoms are possible.
Itchy rash; Stiff neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck) and RASH PRURITIC (Itchy rash) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.    Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event.    The patient's past medical history included No adverse event (No relevant medical history reported).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On 02-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck). On 03-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck) and RASH PRURITIC (Itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported.
Administered Flumist to 4 children on 1-14-04. Children sneezed with administration- started having increased tightness in chest, and shortness of breath. Low grade fever headache, sore throat, nasal stuffiness on 1-17 to 1-19-04 was confined to bed. Went to doctor on 1-22-04 and felt like I was going to die. Started on antibiotics, inhalants and Predinisone.
administered  frozen vaccine/ranging -8.2 to  -13.4 C for 7 hrs; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 2-year-old patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis and flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2021, the patient received Havrix, Havrix Pre-Filled Syringe Device, FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 6th May 2021, unknown after receiving Havrix, Havrix Pre-Filled Syringe Device, FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details were provided as follow: The patient was administered with frozen vaccine Flulaval Quadrivalent and Havrix which was kept on temperature ranging from negative 8.2 to negative 13.4 Celsius for 7 hours, which led to incorrect storage of drug. The mobile cooler went too cold. The medical assistant wanted to know, if the patient could be re-vaccinated. Vaccine details were available for this patient. The reporter consented to follow up. This case is one of the several cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021100517:same reporter US-GLAXOSMITHKLINE-US2021100514:same reporter US-GLAXOSMITHKLINE-US2021100518:same reporter US-GLAXOSMITHKLINE-US2021100515:same reporter US-GLAXOSMITHKLINE-US2021100519:same reporter US-GLAXOSMITHKLINE-US2021100521:same reporter
got the flu every year; Initial information received on 21-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/ non-health care professional via Digital Media.  This case involves an adult female patient who experienced got the flu every year while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patients received a dose of suspect influenza vaccine produced by unknown manufacturer (dose, route, strength, formulation, frequency, batch lot number and expiry date: unknown) in unknown administration site for immunization. Information on batch lot number is requested.  On an unknown date, the patient developed a non-serious event got the flu every year (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported that the man is 78years old, he have never had a flu shot, but his  wife got flu shot every year, and guess what, she got the Dam flu every year.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza).  At time of reporting, the outcome was Unknown for the event influenza.
administering Menactra after expiration with no reported adverse event; Initial information received  on 09-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 20 years old female patient who experienced administering menactra after expiration with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) vaccine [MENACTRA].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  On 09-Jun-2022, the patient received a  0.5 ml dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine (lot U6921AA; expiry date: 07-Apr-2022)  (strength, formulation: unknown) via intramuscular route in the left deltoid for immunization.  On 09-JUN-2022 the patient reported administering Meningococcal A-C-Y-W135 (D CONJ) vaccine (Menactra) after expiration with no reported adverse event (expired product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event (expired product administered).  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.
PATIENT stated she experienced nausea, vomiting, dizziness, joint ache, tachycardia, blurred vision, chills, she stated she wanted to die
FELT LIGHTHEADED WHEN STOOD UP AND EVEN WHILE WALKING; BODY FELT DIFFERENT; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced felt lightheaded when stood up and even while walking, and body felt different. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt lightheaded when stood up and even while walking, and body felt different. This report was non-serious.
Restless through the night,did not sleep well,feels like hit by a truck; Sinus drainage; Throat was sore; arm feeling tender; Fever of 102.7 F; A spontaneous report was received from a nurse concerning a female patient of 56 years old, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sinus drainage, sore throat, restlessness, myalgia and pyrexia.  The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 29 Dec 2020, at 1 pm, prior to the onset of events, the patient received their first of two planned dose of mRNA-1273 (Lot number: unknown) vaccine intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, couple of hours later, patient experienced sinus drainage, sore throat, patient woke up her arm feeling tender, fever of 102.7 F, restless through the night, did not sleep well, felt like hit by a truck.  Treatment information for the event was not reported. On 29-DEC-2020 the body temperature of the patient was 102.7 degree F.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event sinus drainage, sore throat, restlessness, myalgia and pyrexia was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Hives at many locations over the body.  Looks like chicken pox in some ways.  Started as itchy skin iterations but is progressively getting worse.
Patient received Janssen (LOT#: 207A21A) on 6/29/21. Patient alerted EMT and stated that he noticed red dots on his arms thinking it was a rash. Patient stated that he had completed his observation time at 1210 and was walking home when he noticed small red dots on his arms. Patient decided to walk back to vaccination site and let EMT know what was wrong. EMT alerted PHN. PHN assessed patients arms. PHN was not concerned of the red dots on his arms. Patient stated that the red dots were not itchy or painful. PHN observed that the red dots did not resemble a rash. PHN educated patient on worsening signs and symptoms of an allergic reaction to the COVID vaccine and when to seek EMS. Patient verbalized understanding of education. Patient left vaccination site at 1250 unassisted and with a steady gait.
Soreness, redness, itching at the injection site; and surrounding muscles, body aches fever, chills off and on, headache, vomiting, runny nose, sneezing nonstop.
Information has been received from a receptionist concerning an over 65 year old female patient with no pertinent medical history who was vaccinated on an unspecified date with a dose of Zostavax (Oka/Merck). There was no concomitant medication. It was reported that the patient developed "a couple of spots" within 3 weeks of administration in unknown locations. The spots went away in 4 days. A few weeks later. The patient developed shingles around her hip and other unspecified areas. After few weeks it cleared. At the time of the report the patient had recovered. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested.
MODERATE PAIN IN THE RIGHT ARM WHERE PATIENT GOT INJECTED; MUSCLE SORENESS; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Right Arm for prophylactic vaccination. The batch number was not reported and had been requested. No concomitant medications were reported. On MAR-2021, the subject experienced tiredness. On 08-MAR-2021, the subject experienced muscle soreness. On 09-MAR-2021, the subject experienced moderate pain in the right arm where subject got injected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness on 08-MAR-2021, and muscle soreness on 09-MAR-2021, and had not recovered from moderate pain in the right arm where patient got injected. This report was non-serious.
NO ADVRSE REACTION REPORTED.  PATIENT WAS GIVEN RIGHT VACCIN E BUT WRONG LOT NUMBER WAS ENTERED
I, the pharmacist on duty, administered a dose of Pfizer-BioNTech pedi vaccine 0.2ml without diluting the vial. I have tried to call the patient's father and have not been able to reach him yet. I will continue to call him until I reach him.
This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE RASH (Injection site rash), MYALGIA (General body aches), PYREXIA (Fever) and CHILLS (Chills) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20a and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Dose #1. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to Dose #2. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE RASH (Injection site rash), MYALGIA (General body aches), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE RASH (Injection site rash), MYALGIA (General body aches), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown. Treatment information was not provided.  Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the events is not applicable. This case was linked to MOD-2021-014361 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Received a flu vaccine in her R arm. When she came home from school mother said had a "rash from the top of her neck to the bottom of her stomach". No problems until bedtime when her skin began to itch and she could not sleep. (her  6 year old brother ad a similar reaction following the injection). The ER doctor prescribed BENADRYL. A dose of 25mg of BENADRYL was given at 9:00 pm and child slept through the night. The next morning she developed itchiness again. Mom picked her up at 11:00. A second dose of BENADRYL resolved the itchiness.
First vaccine dose was given on 12/29/2020. Patient had moderate swelling to injection site on first dose and was treated with prednisone. Patient was placed on prednisone as pretreatment for second dose. She took the first dose of prednisone on 1/28/2021. Received the second vaccination on 12/29/2021. Patient called ED nursing station one day after (1/30/21) receiving the second vaccine dose stating she had a fever of 102 and did not feel well. She treated it at home with ibuprofen and Tylenol. Her last dose of prednisone was on 01/30/2021. She went to work on 02/01/2021. Staff said they tried talking to her but it was like she was not hearing them. Shortly after she was found unresponsive in the bathroom. She was brought to the ED. She was responsive to voice but was aphasic and had left sided deficits. In  past records, she has had episodes of neurological symptoms that were unexplainable. Unable to obtain an accurate history on her due to aphasia so it is unknown what this could have actually started from. Reporting due to previous reaction to vaccine and recentness of second dose in relation to this incident. Did try Keppra to cover for possible seizure. Consulted with transferring physician and she is not a candidate for TPA.  She was transferred out to a facility with higher level of care.  During time in this ED, neurological symptoms did not improve.
15 minutes after receiving injection, I began feeling very warm and it felt like I had a lump on the right side of my throat. I was monitored in the ER, seen by the doctor and given 25 mg of Benadryl.  My BP was high. I was discharged after approximately an hour and a half after incident. THESE WERE MILD SYMPTOMS. I was told to take Benadryl for the next 48 hours, which I did.