chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of autoimmune hepatitis in a 59-year-old female patient who received SHINGRIX (batch number NR4Z4, expiry date 11th October 2020) for prophylaxis. The patient's past medical history included polymyalgia rheumatica (diagnosed in 2014, however the patient was otherwise normally healthy and active). On 1st June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, 1 day after receiving SHINGRIX, the patient experienced autoimmune hepatitis (serious criteria GSK medically significant), feeling bad, influenza-like symptoms and presyncope. On 25th June 2018, the patient experienced light headedness and fatigue. On an unknown date, the patient experienced weakness, increased activity and excessive eating. SHINGRIX was discontinued (Dechallenge was negative). On an unknown date, the outcome of the autoimmune hepatitis, feeling bad, influenza-like symptoms, presyncope, light headedness, fatigue, weakness, increased activity and excessive eating were recovering/resolving. It was unknown if the reporter considered the autoimmune hepatitis, feeling bad, influenza-like symptoms, presyncope, light headedness, fatigue, weakness, increased activity and excessive eating to be related to SHINGRIX. Additional details were details were provided as follows: It was reported that the patient generally felt bad the next day after administration however began developing flu-like symptoms over the next couple of days (several days) which eventually led to a near syncopal event. The patient slightly recovered however while traveling on 25th June 2018 (24 days after receiving vaccination), the patient became light-headed and fatigued. Less than a year after receiving vaccination, thereafter the patient was seen for a physician visit on 13th July 2018 reporting interval episodes of light-headedness and weakness which was exacerbated by increased activity and eating however symptoms lessened with rest. The health care professional performed laboratory test, inclusive of liver function panel which results yielded "elevated liver enzymes and decreased liver function. At this time it was reported that the patient was recovering, however symptoms had not completely resolved. No further information was reported regarding the event. The health care professional reported there was no plan to continue with second dose in series based on patient's reaction to initial dose. Lab Comments: Liver function panel was done, which resulted yielded elevated liver enzymes and decreased liver function.
PT IS IMMUNOCOMPROMISED, HE IS SUPPOSED TO GET THE ADDITIONAL DOSE (0.5 ML) BUT HE GOT THE BOOSTER DOSE (0.25ML). PT WAS CONTACTED TO GET THE ADDITIONAL (0.25ML), HE IS OUT OF TOWN, WILL BE BACK 11/22.
Headache, muscle weakness in legs, tingling in fingers and legs, facial paralysis. Physical, occupational, and speech therapy required.  Diagnosed as Guillain-Barre Syndrome.  7 sessions of plasma exchange required.  Intensive care req., catheter, and iv required.  First and only flu shot ever received.  12/26/2007 Vax record received.  Info updated in database:  GSK AFLUA321CA./pc 01/07/2008 MR received for DOS 11/28-12/06/2007 with Discharge/Transfer DX:  Guillain-Barre Syndrome.  Depression.  Bi-polar disorder. Pt presented to ER with c/o progressive generalized weakness.  Sx began 5-6 [[name]]s prior to admission with lower extremity tingling which progressed up to the tongue.  Generalized weakness also progressing from lower extremities upward, resulting in falls. Upon PE DTRs were absent in the LEs with unsteady gait and decreased vibratory sensation. Respiratory status remained stable.  Developed 7th cranial nerve involvement with facial droop, difficulty smiling and raising eyebrows.  Some urinary retention resulting in [[name]] cath placement. Txd with plasmapheresis with slow improvement. Pt initially had some anxiety due to psych meds being held, but this improved on resumption. Pt transferred for further rehab. Per 60 [[name]] follow up: Some residual speech and facial symptoms related to GULLIAN [[name]] felt like due to influenza vaccine approx 2 wk prior to onset of symptoms. Patient continues to have improved resolving symptoms and findings from her GUILLAIN [[name]].
No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 05-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Patient was administered PNEUMOVAX in the right arm and FLUZONE in the left. The right arm is extremely swollen and tender. Left arm is swollen as well.
Received a Johnson&Johnson COVID-19 vaccine 7 plus weeks after receiving the first dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received a Johnson&Johnson COVID-19 vaccine 7 plus weeks after receiving the first dose of the Moderna COVID-19 vaccine) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received a Johnson&Johnson COVID-19 vaccine 7 plus weeks after receiving the first dose of the Moderna COVID-19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received a Johnson&Johnson COVID-19 vaccine 7 plus weeks after receiving the first dose of the Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment information was not reported  Patient had received a Johnson & Johnson COVID-19 vaccine after 7weeks of first dose and also not entirely sure that the first dose was Moderna/Pfizer
Headache ,  lightheadedness, dizziness, tingling from upper arms  all the way down to the fingers on the first 2 days then tingling is localized only to the fingers on the 4th day
Diagnosed with superior mesenteric vein thrombosis about one month after receiving second covid vaccine. Had what sounds like food borne illness. Platelet count was not low.
Headache, nausea,  muscle pain, dizziness, fatigue, cognitive issues, fever/chills I'm taking Tylenol but don't know if it's doing much. Symptoms are ongoing  I may go into my doctor's office if symptoms persist.
Pt did not wait 15 min after immunization. Pt walking in hallway with mother and was witnessed fainting. did not lose consciousness. Doctor assessed patient. Blood pressure,  117/98, heart rate 103 beats per minute, blood sugar 101. Patient provided with snack and water and laid on exam table. Doctor reassessed after 20 minutes and discharged patient
Tachycardia, Shortness of breath, Fatigue, Dizziness/lightheadedness
VACCINE ADMINISTERED ON MONDAY MARCH 22ND AND  .SUFFERED A STROKE TO THE PONS REGION OF THE BRAIN ON FRIDAY MARCH 26TH. SYMPTOMS WERE RT SIDED WEAKNESS/SLURRED SPEECH AND UNSTABLE GAIT. HOSPITALIZED AT  HOSPITAL, CT/MRI/ECHOCARDIOGRAM/LABS/CHEST XRAY DONE. IS CURRENTLY HOSPITALIZED AND AWAITING TRANSFER TO 2 WEEK INTENSIVE REHABILITATION CENTER FOR COMPLETE RT SIDED HEMIPLEGIA/APHASIA. OUTCOME TO BE DETERMINED.
None. Patient was given KINRIX to a 19 month old on 3/9/17.
Patient's left arm is extremely swollen between the area of his left shoulder to left elbow, it is also distinctly red.
Right after injection of the BOOSTRIX and PNEUMOVAX vaccines on the left arm, patient mentioned that she needed a moment before receiving the third vaccine. She reported feeling nauseated and dizzy. I asked if there was anything I could get for her and she asked for water. After drinking some water and taking time to sit and relax, patient felt better and was able to continue with the final vaccine. Patient described to me that the catalyst to her feeling nauseated was injection of the PNEUMOVAX, which seemed to have caused an irritatin nerve sensation to run through her arm.
"Worse flu she ever had"; Chills; Headache; Shortness of breath; Aches; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), PAIN (Aches), INFLUENZA ("Worse flu she ever had"), CHILLS (Chills) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 061A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to antibiotics.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath), PAIN (Aches), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced INFLUENZA ("Worse flu she ever had"). At the time of the report, DYSPNOEA (Shortness of breath), PAIN (Aches), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown and INFLUENZA ("Worse flu she ever had") had resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
A non-serious spontaneous report of FLUMIST was administered to a pregnant female was received from a registered nurse concerning a 24-year-old female. Neither past medical history nor obstetrical history was reported for this patient. On 05-Oct-2010, patient received FLUMIST. As per the reporter, patient was in her first or second trimester of pregnancy. The reporter indicated that the patient was in good health and seemed to be doing fine. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
three doses on the Pfizer vaccine; Bell's palsy; non-stop diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for Covid-19 Immunization; Bnt162b2 (second dose), for Covid-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "three doses on the Pfizer vaccine"; BELL'S PALSY (medically significant), outcome "unknown", described as "Bell's palsy"; DIARRHOEA (non-serious), outcome "not recovered", described as "non-stop diarrhea". The event "bell's palsy" was evaluated at the emergency room visit. The patient received three doses on the Pfizer vaccine and a few days later, developed Bell's palsy. Not knowing what it was and thinking it was a stroke, the patient went to the emergency room and was told this was a direct effect of vaccine. Along with the non-stop diarrhea this has also caused.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Lt. arm red area/lateral Lt arm/knot on arm/pain/throbbing/unable to lift arm.  He stated he applied ice on affected area, started prescription antibiotics and took pain medications.
This was a vaccine administration error.  I used a syringe/needle combo that was not tightly connected, and I didn't realize it until the vaccine leaked out and down the patient's arm.  The amount that leaked out looked significant,  so I readministered the dose in her other arm.
Within 24 hrs had redness and swelling to left thigh area and after 48 hours had progressed redness and swelling with red streaks, warmth, tenderness and fever and cellulitis. Treated with Keflex.
Began vomiting while in the office; This spontaneous report was received from a respiratory therapist and refers to a 2 year old male patient. The patient had no pertinent medical history, drug reactions and allergies. The patient's concomitant therapies included cetirizine hydrochloride (ZYRTEC).     On an unknown date, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5, dose 1, intramuscular (strength, anatomical location, lot # and expiration date were not provided) for hepatitis A prevention. On 27-AUG-2019, the patient was in the physician office to receive a second dose of hepatitis a vaccine, inactivated (VAQTA), and began vomiting while in the office. It was reported that the patient did not receive the dose of hepatitis a vaccine, inactivated (VAQTA). No treatment was given for the event. No laboratory diagnostic studied were performed.  The outcome of vomiting, as well as, the causality between the event and the suspect therapy were unknown.
Pt came in requesting the new Pfizer booster.  His vaccine card stated he had already received 4 primary doses of Pfizer.   Completed screening process and administered Pfizer Bivalent Booster to patient, providing appropriate patient education.  While creating new Covid vaccine card for patient, noted from his chart that he had also received a dose in Sept 2022. Also found   second card in his vaccine holder listing that dose.  Pt was feeling well at the end of his 15 minutes of observation after the vaccine and I gave him his new vaccine card.  In later review and charting, I found that this Sept 2022 dose was a bivalent booster dose, not a monovalent booster.
HEADACHE; FATIGUE/ FEELING TIRED; UPSET STOMACH; ITCHINESS; TINGLING LIPS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to antibiotic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fatigue/ feeling tired. On 09-MAR-2021, the subject experienced upset stomach. On 09-MAR-2021, the subject experienced itchiness. On 09-MAR-2021, the subject experienced tingling lips. On an unspecified date, the subject experienced headache. Treatment medications (dates unspecified) included: cetirizine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fatigue/ feeling tired, upset stomach, itchiness and tingling lips was not reported. This report was non-serious.
Patient told us this was her first COVID-19 vaccine despite having 2 previous J&J doses.
After the vaccine, the wife verbalized her husband felt lightheaded and dizzy.  He was evaluated by Fire Rescue and released home at 2:32 pm.
when I had the first shot I was having I thought allergic reactions/They didnt ask me after the second shot but it was even worst; when I had the first shot I was having I thought allergic reactions/They didnt ask me after the second shot but it was even worst; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had a lot of allergies to lot of things. Patient had shot its the Pfizer shot, patient allergic to about 15 different things already. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date for COVID-19 immunisation. It was reported that patient had the first shot and thought was having allergic reactions that patient heart doctor have kept patient on different cholesterol (Unspecified medication) and patient told them that my father was dead, but patient did have to take some Benadryl (Taken as treatment) after the first shot. They did not ask me after the second shot but it was even worst. Patient had to take about 3 Benadryl after that kept that on hand all the time. It was better tonight. The Outcome of event was unknown. No follow up attempts are needed. Lot/batch number can not be requested. No further information is expected.
Moderna COVID-19 Vaccine EUA Awoke morning of 1/1 (about 36 hours after receiving vaccine) with mild fever and general malaise
The patient developed a red rash on her right arm (about the size of a nickel) which spread and covered a portion of her abdomen and upper right chest.  In addition to being red, the rash was intensely pruritic and predominately flat, with some small, fluid-filled papules (similar in appearance to acne).  The patient also reported being achy and tired.  The patient self-medicated with alegra, clemastine, and topical benedryl.  Dr.  with the CDC was consulted, and it was determined that the illness was a non-specific rash requiring no additional treatment or management unless further symptoms developed.  By 4/8/03 the rash, fatigue, and aches had resolved, but the patient also developed persistant headaches and a stiff neck (onset 4/5/03), for which Tylenol (650mg) and Ibuprofen (600mg) were taken.  The patient also presented to her primary care physician. The physician administered a neurological examination to the patient and ruled out encephilitis.  Duration of headaches was ~5 days.
Administered 0.25 Moderna Monovalent as booster dose.  No adverse reaction noted.
Night of immunization mac/pap rash of face and neck with some swelling of face with erythema and itching. Resolved in 2 weeks time with Zyrtec. No vesicles. Brother received varicella at same time.
8 hours after the vaccine I could not stand. I was dizzy and nauseous. Excruciating body pain generalized over the whole body. I had taken Ibuprofen prior to the reaction and during. Fever, Headache, Chills, for hours. the next morning I tried to make soup to eat and i couldn't stand for more than 15 seconds without feeling like I was going to pass out. I couldn't eat more than a few bites. Really bad headache. My arm was sore like I had been punched 10 times. Very Bruised. It was hardened at the sight.
vial was moved from freezer to refrigerated conditions on 28Dec2021; 5 expired vaccine doses administered after manufacturer date of expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 expired vaccine doses administered after manufacturer date of expiration) and PRODUCT STORAGE ERROR (vial was moved from freezer to refrigerated conditions on 28Dec2021) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 expired vaccine doses administered after manufacturer date of expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was moved from freezer to refrigerated conditions on 28Dec2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 expired vaccine doses administered after manufacturer date of expiration) and PRODUCT STORAGE ERROR (vial was moved from freezer to refrigerated conditions on 28Dec2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. Vial was removed from freezer and stored in refrigerator on 28-Dec-2021. HCP reported that five Moderna COVID-19 vaccine expired doses were administered which was a mix of doses for those patients. It was confirmed that the vial had not undergone any temperature excursion issue. No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2022: Significant follow up appended-secondary reporter, refrigeration date and narrative updated.
Nurse assisting another staff member in giving child a vax & vax was inadvertently squirted into the nurse's eye-exp redness,burning,& blurred vision in lt eye;addtl info recv 14OCT96;eye was flushed w/water for 20min & all sx resolve
1/2-1hr p/vax pt devel large nodes-has cont x 1wk;
Feeling flu like ill/body aches/fatigue? 7 days  Fever of 101f - 24 hours  Headache - 4 days Stroke - 3/8/2021
Information has been received from a physician concerning a 59 day old female, with no medical history and no allergies, who on 13 Nov 2006 was vaccinated with a first oral dos of rotavirus vaccine (lot 654664/0726F). Concomitant vaccines administered on the same day included a dose of Prevnar, a dose of Hib vaccine, and a dose of Pediarix. On 23 Nov 2006, 10 days later, the patient experienced septic meningitis, which was diagnosed by cerebrospinal fluid. The patient was admitted to the hospital for 4 days. On 27 Nov 2006 the patient was considered to be recovered. no product quality complaint was involved. No other information was provided. Additional information has been requested.
A non-serious spontaneous report of inadvertently gave H1N1 vaccine to person above age 49 was received from a registered nurse concerning a 75-year-old male. On 29-Oct-2009, the patient inadvertently received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
103.5 Fever that wouldn?t come down with Tylenol, chills, sharp headache, tachycardia, site pain, dizziness, body aches, nausea  All symptoms started 11 hours after first dose of vaccine (3AM), went to hospital 15 hours after symptoms started and was treated for 9 hours until all symptoms abruptly stopped
Received VARIVAX #2 on 7/22/09, developed a 2x2.5 inch, firm, erythematous, warm area at injection site. (Lot# 0694Y)