chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up this morning feeling just fine, and I have not been sick, nor did I feel like I was getting sick.  I went to get a  flu vaccine this morning around 11:30 am. at my local store.   Following the vaccine, I felt normal tenderness in the location of the vaccine. I finished my errands and went home around 1:30 pm, at which time I noticed a few very obvious adverse reactions.   My face is flushed and hot to the touch and temp is 99.7.  My eyes feel watery, red and irritated.  My brain somehow feels like it has expanded, making my upper jaw feel very strange and enlarged.  My nose feels strange as well...and my head overall feels like there is a vise grip on it.  It is a strange tightening feeling, and it extends down the back of my neck.   I have a metallic taste in my mouth.  I called my family doctor's answering service and spoke to the doctor on call around 2:45.  She told me to take ibuprofen, and drink fluids, and said it is probably not due to the vaccine...but that if other symptoms should develop, I could call her back or go to the ER for evaluation. I do not feel that the symptoms I am having are a normal reaction to the vaccine, and I am concerned.  On my receipt,it says that the manufacturer of this vaccine is "fluzine"--which was not a choice in your list below, which is why I didn't choose a manufacturer.
1 day after injection 2, I became violently ill with fever, tremors, fatigue, dizziness, headache, and flashes of light in my eyes, and remained so for 4-5 days. 8 days after injection 2, I woke up with pain in my neck, and it became progressively worse in the days to come. I was diagnosed with cervical radiculopathy. Extreme pain, numbness, tingling, weakness and a burning sensation/loss of sensation are all over my neck, head, shoulders, trapezoids and much of my chest and back one month later. I?ve been prescribed painkillers and corticosteroids , and I have because of the nerve pain and the dizziness from the painkillers, I?ve exhausted all of my paid time off from work and I cannot sleep without prescription medications or THC edibles.
Patient experiences L posterior elbow urticaria and L arm and lower extremities swelling. No facial swelling. No drooling. Able to speak in full sentences.
On 10/25/00, the pt came to the clinic with bright red, warm, indurated area 3-4 cm diameter in the right deltoid. Dx with cellulitis. Treated with Deloxacillin.
c/o chills, t100, nausea, abdominal cramps, h/a; sx began 24 hrs p/recvd vax, lasted 5 days, no one in family w/similar sx;
pt recvd vax; febrile seizure approx 1 hr after vax;
After her first dose of the vaccine she developed red welt all over her body which lasted 3-4 days/ mother broke out in red welts, like rash welts; This is a spontaneous report from a contactable consumer or other non hcp. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 15Apr2021 (13:00-14:00) as dose 1, single for COVID-19 immunization. Medical history included Patient was on no medications, had a perfect clean bill of health, and the only thing the doctors have ever told her, was she is slightly overweight, that she's overweight, and to work on that. reporter adds that's the only bad stuff she's ever been told, as far as levels for diabetes and stuff like that they were normal and clarifies mother does not have diabetes. There were no concomitant medications. On 01May2021, at her nephew's birthday party, reporter stated that her mother broke out in red welts, like rash welts, all over her body. She told her then she needed to call the doctor, but reported her mother had ate some weird fruit that her brother had, called pine berries, and mother thought she was having a reaction to that because she had never ate that. Reporter states she told her it could be a reaction to the shot, but her mother said, no she was pretty sure. States it cleared up within 3-4 days, so she didn't worry about it. At the time of this report event outcome was recovered on an unknown date in May2021.   Information on lot/batch number has been requested.; Sender's Comments: Based on the information in the case report, A possible causal relationship between events urticaria and suspect drug BNT162B2 cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient states about 6 hours after vaccination she developed body aches not alleviated with Tylenol or ibuprofen, sweats and chills, fatigue and overall poor feeling.
This spontaneous report as received from a nurse refers to a 21 year old patient of an unknown gender. On 04-MAR-2015, the patient was vaccinated with improperly stored GARDASIL (lot # J013277 and expiry date: 06-AUG-201). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Discharge Provider:  MD Primary Care Provider: MD Admission Date: 8/25/2022 Discharge Date: 8/29/2022  PRESENTING PROBLEM: Severe sepsis [A41.9, R65.20] COVID [U07.1] Suspected COVID-19 virus infection [Z20.822] COVID-19 [U07.1] Sepsis  [A41.9]   HOSPITAL COURSE: Per ICU transfer summary: "Patient is a 73 year old with NIDDM, HTN, and GERD who presented to ED 8/25 with generalized weakness, fever and fall from standing.  In ED, she was febrile to 39.1C with stable vitals.  Labs were significant for LA 2.7, WBC 3800, and she was found to be COVID-19 positive.  CXR was clear.  She was given 4L NS and admitted for further care.  After admission, her BP dropped and she was brought to ICU where arterial line was placed which showed adequate BP.  She did not require vasopressors.  She had episodes of sinus bradycardia (HR down into 30s, similar to a previous admission in 2019 for Influenza A) with some associated hypotension that improved with volume, overall improved over time.  She continued to require only room air oxygen - CXRs did show some increased interstitial infiltrates 8/27 but improved by 8/28.  No therapy for COVID was started.  She has been very deconditioned - requiring assistance with mobility.  PT/OT ordered."   She was transferred to the Hospitalist service on 8/28/2022. She was evaluated by PT/OT who recommended home with assist as needed. Home valsartan-HCTZ was held on DC until she follow up with her PCP as an outpatient. She was discharged home in stable condition on 8/29/2022.
According to foster parent pt became agitated on way home from getting vaccines at home pt was screaming, drooling, (L) eye turned in toward nose, and turned purple from screaming. Pt taken to hosp ER by 1700 - not seen by PCP until around 10pm at that time pt wore out and asleep. PCP did not see any issues with pt at that time. Pt could also have possible fetal alcohol syndrome per foster parent. Foster parent denies issues this AM.
Extra Dose of Vaccine; 1st dose received on 6th october 2021 and 2nd dose on 21-october 2022; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 432T3, expiry date 18-AUG-2024) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 6th October 2021).   On 26-JUL-2023, the patient received the 3rd dose of Shingrix (intramuscular). On 21-OCT-2022, the patient received the 2nd dose of Shingrix. On 21-OCT-2022, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose received on 6th october 2021 and 2nd dose on 21-october 2022). On 26-JUL-2023, the patient experienced extra dose administered (Verbatim: Extra Dose of Vaccine). The outcome of the extra dose administered and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 26-JUL-2023 The reporter was the pharmacy student. The vaccine administration facility was the same as primary reporter. The patient received extra dose of Shingrix vaccine in error, which led to extra dose administered. The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule. The reporter did consent to follow up.
On the second day after the second Modera shot, I had a fever and chills. Within the week, I started having problems with holding down water or food. I have lost 40 pounds since March and continue to vomit most of the food and water I take in.
pt called , stating she got adacel vaccine on April 15th, and then on 16th she started itching all over body , by 18th she got hives all over body and site on injection is little swollen, red and hot. advice to put icepack over swollen part. pt said she use Benadryl but not that helpful. no shortness of breath so far. pt on vacation and will visit urgent care for evaluation may need steroid.
1 day after receiving her booster vaccine, the patient developed new non-bloody, non-bilious emesis x2, as well as new chest pain, which was pleuritic in nature. The patient presented to the hospital on day 3 of symptoms and was evaluated with a CT and ECHO and found to have pericardial and pleural effusions, consistent with a diagnosis of pericarditis.
I experienced a breakthrough case of COVID-19 with a runny nose, fever and fatigue.
Arthralgia fatigue, "little chill" Narrative:  Other Relevant History:
He started screaming, crying and could not be consoled for 8 hours straight. Loud and light pitch scream.
Shingrix shot on Friday. Extreme malaise, daytime sleepiness for one day  (Saturday) after Shingrix shot. I slept for twelve hours the next night (Saturday/Sunday). I woke on Sunday feeling very well.    One day of malaise is a small price to pay to reduce the chances of Shingles!
PFIZER COVID VACCINE #3 GIVE 11/27/21, LOT # NOT AVAILABLE; pt had a positive COVID test 1/10/22; no other records; pt passed away with COVID being a cause of death at home
Mistakenly took two doses of Vivotif one after the other on the same night; Spontaneous report received on 16JAN2020.  Based on the information obtained from the nurse two individual case safety reports PVX2020-120 (wife) and PVX2020-121 (husband) were created and cross-linked in the database.  In this case, a female consumer "mistakenly took two doses of Vivotif one after the other on the same night" (PT: Accidental overdose) while being on Vivotif capsule for immunisation. On 15JAN2020, she mistakenly took two capsules of Vivotif. She had taken her own last capsule, and then her husband's last capsule after returning from the restroom as she had forgotten that she already took her last dose. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took her last vivotif dose and then mistakenly took her husband's vivotif dose on the same night (Accidental overdose). Further details on the outcome of the event is limited. Considering the nature of the event, the causality of accidental overdose is assessed as not applicable to vivotif.; Sender's Comments: A consumer took her last vivotif dose and then mistakenly took her husband's vivotif dose on the same night (Accidental overdose). Further details on the outcome of the event is limited. Considering the nature of the event, the causality of accidental overdose is assessed as not applicable to vivotif.
The date that the vial was 30 days in the refrigerator was 05Sep2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The date that the vial was 30 days in the refrigerator was 05Sep2021) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The date that the vial was 30 days in the refrigerator was 05Sep2021). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (The date that the vial was 30 days in the refrigerator was 05Sep2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was stated that as a reminder, 13 doses of Moderna vaccine were inadvertently given past the vaccine beyond-use-date (i.e. past 30 days at fridge temperature) of 05-Sep-2021. Lot was 007C21A Manufactured date 12-Mar-21, NDC of box 80777-273-99, 00380777273990 and and Expiration date was listed online as 12-Oct-2021  No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-320340, MOD-2021-320876.
Pt recvd APAP soon p/immun; 230PM awakened vomited x 2; several hrs later vomited, also next day; had fever @ 230PM 100; no ther sx other than nausea, vomiting & fever;
left armpit gland swelling and pain; Fatigue; left arm soreness; left armpit gland swelling and pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 16:00 (Lot number: FH8027) at the age of 14 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Juvenile idiopathic arthritis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine"; Sulfasalazine, reaction(s): "Known allergies: sulfasalazine". Vaccination history included: Bnt162b2 (Dose 2, single; Lot Number: Ew0173), administration date: 16Jun2021, when the patient was 13 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, single; Lot Number: Ew0179), administration date: 29May2021, when the patient was 13 years old, for Covid-19 immunization. The following information was reported: AXILLARY PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 27Nov2021, outcome "recovering" and all described as "left armpit gland swelling and pain"; FATIGUE (non-serious) with onset 27Nov2021, outcome "recovering", described as "Fatigue"; PAIN IN EXTREMITY (non-serious) with onset 27Nov2021, outcome "recovering", described as "left arm soreness". Therapeutic measures were not taken as a result of axillary pain, fatigue, pain in extremity, lymphadenopathy. Additional information: Non-healthcare professional reporting for a patient. 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. No follow-up attempts are possible. No further information is expected.
HEART PALPITATIONS; NUMBNESS IN THE FACE; PREMATURE VENTRICULAR CONTRACTIONS; 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, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced premature ventricular contractions. On 10-APR-2021, the subject experienced heart palpitations. On 10-APR-2021, the subject experienced numbness in the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart palpitations, numbness in the face and premature ventricular contractions was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
violent, screaming, throwing things, crying, slept 3 days, diarrhea, chills, lost vision, shaking,
Patient has a history of nervousness with vaccinations and medical care. After receiving the vaccine, patient fainted. Emergency services were called and took vitals. Parent and EMT agreed further care was not needed and it was likely nerves.
I was diagnosed in February of 2008 with Stage Zero Chronic Lymphatic Leukemia
This spontaneous report as received from a nurse refers to a 3 patients of unknown age and gender. In approximately 2016, the patient was vaccinated with ROTATEQ (dose: 2 ml, lot # L033694 with expiration date: 16-JUN-2017, lot # M012495 with expiration date: 09-OCT-2017 and lot # reported as M019708 with expiration date: 25-OCT-2017). The administered doses of ROTATEQ had a temperature excursion on 25-JUL-2016 48.6 for 65 hours and where unsupported. No adverse effects were reported. Additional information has been requested.
Day of vaccine I kept waking up with headaches. Two weeks later on April 19th, woke up with bad headache and found it painful to breathe. I went to urgent care where they diagnosed me with an infection that caused inflammation around heart and lungs
Pfizer-BioNTech Covid-19 Vaccine EUA   One day after my first dose ( March 12 )  I got a large cold sore near the inside of my nose which lasted for 3 weeks.  One day after my 2nd dose ( April7 ) I got mouth sores on my gums, which I am still experiencing . Not sure if this is related to vaccine or not but thought i should report it .
Vaccine was over diluted when reconstituted. No adverse reaction reported by parents. Patient to be boosted per CDC guidelines.
This 48 year old male received the Covid shot on  12/22/20    and went to the ED on  1/5/21  with the following diagnoses listed below. J18.9 - Pneumonia, unspecified organism U07.1 - COVID-19
itchy rash; welt like rash; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 99D9F, expiry date 14th April 2020) for prophylaxis.   Concomitant products included benadryl (nos) (Benadryl).   On 11th May 2019, the patient received the 2nd dose of Shingrix. In May 2019, 5 days after receiving Shingrix, the patient experienced itchy rash and rash urticaria-like. On an unknown date, the outcome of the itchy rash and rash urticaria-like were recovered/resolved.   It was unknown if the reporter considered the itchy rash and rash urticaria-like to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had an itchy, welt-like rash formed on his arms down to his forearm bilaterally and back.  It occurred 5 days after the injection and had persisted for approximately 4 weeks.
The pt experienced erythema multiforme which began 5 days post vax. No other identifiable cause of erythema multiforme.
got vaccine at 6, rash started 9pm at home. Rash on neck, both legs bottom legs, more on left, some swelling
18OCT reports redness @ inject site approx 2 inch by 1 inch; red & elevated & hard to touch; temp 1 degree over nl; 19OCT site remains reddened; tem inc to 101; 20OCT site redness dec; no temp feels much better;
Right testicular pain, diagnosed R epididymititis, treated with levaquin 500 gm qd x10d
A non-serious spontaneous report of gave expired FLUMIST was received from a nurse concerning a 10-year old female. On 03-Feb-2010, the patient received FLUMIST that expired on 02-Feb-2010. There is no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 11-May-2010, and incorporated into the narrative: there were no associated adverse events.
Mom states that post immunizations the infant acted "normal" the "entire time". States she gave her a dose of Tylenol a short time after the immunizations, then again either on that Friday night (11/19/2021) or following Saturday afternoon (11/20/2021). States she noted that infant was a "little fussy on Saturday, but not unsual for having getting vaccines". Mom states that the infant was put to bed on Saturday night with her and that she awaken at 10:00 am on Sunday 11/21/2021 and noted that the infant was not breathing. "Her neck was warm, but her body was cold". She had "bubbles coming out of her nose". This provider asked if it was like "snot" and the mom stated "yes".
Trouble breathing; Dizziness; Heaviness in head; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty breathing in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 19th September 2021) for prophylaxis.   On 8th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, between 2 and 3 months after receiving Shingrix, the patient experienced difficulty breathing, dizziness and heaviness of head. On an unknown date, the outcome of the difficulty breathing, dizziness and heaviness of head were unknown.   It was unknown if the reporter considered the difficulty breathing, dizziness and heaviness of head to be related to Shingrix.  Additional case details were reported as follows: The patient came in to get her 2nd dose of Shingrix on day of reporting but reported having trouble breathing, dizziness, and her head felt heavy after receiving the first dose. The reporter enquired if there were any recommendations/safety precautions on a patient receiving the 2nd dose after having adverse reactions to the first dose. The reporter consented to follow up.
Arm was sore and difficult to move for 24 hours.  10 days after getting the shot my disabled young adult patient who is 29 years of age developed Herpes Zoster shingles as diagnosed by the hospital rquiring anti viral meds valtrex, gaperpetin and atarax for 7 days.  She is non vocallm wtih Phelan Mcdermid syndrome, Autism spectrum disorder, generalized seizures,  developmentally delayed at 18 months, intellectual disorder.  Prior to this her care givers were given Moderma vaccine and she experiences stroke symptoms and was admitted to hospital for 4 days her brain and ct scan were all negative and she was given physical therapy due to dragging her right leg and inability to move her arms.  She does have coordination issues and weak muscles with the PMS.  I am of the opinion the vaccines contributed to her symptoms.  Please see the magazine article I researched. April 28, 2021.  My daughter did not get the vaccine and I did not take the 2nd vaccine of pfizer due to this and alerted the infectious disease provider at the Medical Center along with my primary provider.