chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to the ER on 9/28/21 for SOB and dizziness. He reported "cold symptoms" for 4-5 days PTA. He received 2 doses of Pfizer COVID vaccine (1/29/21 and 2/19/21). In the ER, patient was hypoxic to 89% on room air.  He was started on supplemental O2, remdesivir, and dexamethasone since he tested positive for COVID on 9/28/21.  Patient's O2 needs continued to worsen, so Pulmonology was consulted and baricitinib was started on 9/30/21. Patient is currently on day 4 of hospitalization  and is requiring 50L heated high flow oxygen on a medical floor.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 17-NOV-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) lot # K010211, expiry date 17-JAN-2016, dose, route of administration and anatomical location were not reported (lot # was also reported as D592C). No adverse symptoms were reported. The temperature excursion was due to daily vaccine counts that caused the storage unit to have temperature fluctuations because of door opening. This is one of several reports from the same reporter. Additional information is not expected as no further follow-up is required.
Patient's arm swollen, red, painful, started night of immunization, 10/31/13.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: swelling, itching and redness radiating from the site of injection. extends to about the elbow. started out more localized and has grown
Left arm pain, swelling. Diarrhea fever chills. Was seen at ER and treated with TORADOL, UNASYN & Vancomycin for left upper arm cellulitis. *See attached.
By 9pm started feeling bad. Sat down on bed and got nauseous. Vomited violently for about 25 minutes to the point that had tears on eyes and stomach hurt above navel. Called poison control center in case there was something wrong with the vaccine. Did not take any medicine for problems. Next day, felt fine in the morning but was afraid to eat much. Had toast and omelette with  mushroom at night by 9pm the vomiting began again. Called pharmacy who verified that symptoms were on packet insert. Called triage nurse who advised pt to go to ER if violent vomiting continued. On Wednesday, did not feel like eating much. On Thursday felt fit as a fiddle but a little weak since had not eaten much the last couple of days. No fever during these days. No adverse events on arm. Was told by manufacturer that vax strain was sent of in August.
Within 5 minutes of vaccination patient noted they felt dizzy and then lost consciousness. Leaned over in chair and was held up by RN. Came back to consciousness within about 1 minute.
I received vaccine at 2:50 pm on Wednesday January 6th. I felt upper respiratory symptoms around 3:30 pm the same day. By the second day, I felt the pain in my back. On a scale of 1-10 the pain level has been at a consistent 6.
The patient experienced flu-like symptoms including fatigue, muscle aches, stiff neck, and headache.  Illness lasted until 3/29/03, and the patient missed 2 days of work.  This patient's vaccination site did not "take."
Patient was given Pfizer on 5/28/21 and Moderna on 6/28/21
LOW FEVER 100.0F ALL WEEK FEVER INCREASED TO 102.0F FOR 24-36 HRS ON 7/29/2012 LEFT ARM INCREASED REDDNESS 1" X 1" ACROSS ARM. SCATTERING OF PINK SPOTS. FEVER GONE THE NEXT DAY AND FEELS FINE.
I had several adverse side effects from the vaccine (which I was expecting given it was my second dose). I woke up with a slight fever that lasted two days (highest point being 102.5*F, but it ebbed and flowed throughout the period). I had nausea (threw up twice, was able to keep food down by the evening of the first day after getting the vaccine). I had chills as well, and standard body aches and headaches that often accompany fevers and chills. My arm was also sore at the injection site, as with most vaccines, but it was actually bizarrely most sore at my armpit, not at the injection site.
At first I had hives and they were raised and red.  Slowly, they expanded in size and flattened, then faded away.  Mostly on the arm I had the shot on. Not taking chances on the second or third dose.  Was dizzy for a little bit too, though this could just be overreaction.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 15-MAR-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M002418, expiration date 12-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported.    This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Pain at soft palate. Began morning following initial dose. Duration: 10 days. Pain scale: 6/10.
12/14/2003: Red lump size of 1/2 dollar, swollen, warm to touch, no itch, no fever, no red streaking.
reaction to the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to the second dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination.     Patient did not have any allergies. Patient has never been diagnosed/tested positive for Covid-19. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Ulcerative colitis (was symptom free for years). Concomitant products included MESALAZINE (APRISO) for Ulcerative colitis, SIMVASTATIN and CALAMINE for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to the second dose). At the time of the report, VACCINATION COMPLICATION (reaction to the second dose) outcome was unknown.            Patient did not seek medical care. No treatment medication were provided.   This case was linked to MOD-2021-019539, MOD-2022-535378, MOD-2022-535389 (Patient Link).
hives covering pt body;also around inj site, entire back covered also around hair line, neck, arms, legs;
DV made by pt to show nurse reaction. Pt told nurse that 8:30 A.M. 3/18/2009 - area became hot to touch & itchy. 1:30 P.M. - Pt went to see school nurse- pt was given ice pack. 3:30 P.M. - Pt was given 25 mg of BENADRYL po. Site of injection red raised 4 1/2 hr pt was given ice pack on dismissal.
Mom states his left arm was red, swelling and blistered at the injection site after receiving vaccines.
Pt mom called on 4/19 to report that child was having possible reaction to immunizations received in left arm. Child arm is swollen at shoulder with blisters surrounding the injection area. The site was inflamed and hot to touch. Pt has no local provider and mother states she will take child to SMC ER for possible treatment.
I started experiencing gastrointestinal distress. I lost 35lbs. In 10/2021 I had a visit with a walk-in clinic and was told I have irritable bowel syndrome. He provided medications to take with small meals. I did that for a month and did not get any better. I called the doctor and told him this wasn't helping. They advised I should go on a liquid diet. I requested a CT Scan. I did the CT Scan the next morning (10/29/2021) and by 3 days later I was told that I had a late stage of ovarian cancer. I was at the oncologists by the next day and have been undergoing a total of 6 chemo treatments and 2 surgeries. I see my surgeon on 04/28/2022 for a follow up.
Developed redness on her face that has spread to her neck. Her skin is warm and flushed. She reports that her eyes feel warm.
This spontaneous report as received from a 68 year old female consumer refers to herself. The patient also had unspecified allergies to CELEBREX (unspecified manufacturer/dose/frequency) and BENADRYL (unspecified manufacturer/dose/frequency). In November 2005 the patient was vaccinated with a dose of ZOSTAVAX (lot# and expiration date not specified), injection, one dose for prevention of shingles. Concomitant medication included unspecified thyroid medicine and unspecified eye drop. The patient stated they received ZOSTAVAX and then developed a "breakout" on her back in the 2009, and then the patient developed a second "breakout" on her back in the year 2011. The patient treated herself with VALTREX (unspecified manufacturer/dose/frequency). The patient reported she became "violently ill" after taking VALTREX (unspecified manufacturer/dose/frequency). None lab diagnostics studies was performed. On unknown dates, the patient was recovered from "breakout". The patient didn't seek medical attention. The outcome of "violently ill" was not reported. Additional information has been requested.
swelling around injection area; red around injection area; injection area hurts/ it hearts a lot; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In December 2021, the patient received the 1st dose of Shingles vaccine. In December 2021, less than a month after receiving Shingles vaccine, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter got his/her first shot before the holiday and the next shot was due on 30th Jaunuary 2022. The reporter stated that, it hurt a lot some swelling red around the injection area hurt for a few days but the thought of shingles was more painful that he/she could not stand. The reporter adviced to get the Shingles shots and it would be glad. The follow-up would not possible as no contact details were available.
pt stated that she felt a little funny and lightheaded after taking the covid vax.  Her skin started feeling a little prickly and she developed rash on her extremities and upper chest.  She started having trouble speaking, her voice got hoarse and she started coughing.  She had an intense headache, fatigue and could barely speak.  She was taken to the UrgentCare .  She was given EPI pen and steroids injections.  Paramedics were called and she was taken to a hospital, where she was monitored after getting those injections and given Pepcid and IV fluids.  She was diagnosed w/ Anaphylaxis from adverse reaction to vaccine.  She discharged and sent home to FU w/PCP.  Her appt w/ her PCP on 3/25/2021 she was taken next door by wheelchair to all allergist Dr.  She noticed that her respiratory symptoms were improving while she was there as her Pepcid medication was wearing off.  Pt is convinced that she is allergic to the ingredient Polyethylene Glycol.  She is still taking prednisone medication and continuing to improve.
First day, heart skipping every 5-6 beats.  Nausea..  Not able to stand up.  Excessive tiredness.
Rash over entire body. Fever. Pt was seen by Dr at American Falls Clinic.  Mother instructed to begin giving her Benadryl and Dr consulted with Allergy Specialist.  She was referred to Allergist for further testing to determine what caused rash.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/12/21 (en6201) Pfizer Dose 2 3/9/21 (EN6203) COVID Positive 12/10/21  12/9/21: Patient is a 93-year-old female with past medical history of AAA, chronic low back pain, history of CVA, chronic anemia, B12 deficiency, hypertension, cystocele, hyperlipidemia, irritable bowel syndrome, lumbosacral spondylosis, peptic ulcer disease, restless legs, uterine prolapse, tremor.  She presented to the emergency department on 12/09/2021 after suffering a mechanical fall at home and hit her head.  She states that her walker malfunctioned.  CT head and CT C-spine were unremarkable for acute changes with the exception of a left parietal scalp hematoma noted.  Patient had an x-ray of her lumbar spine that was notable for a T12 compression fracture new from previous scan performed approximately 1 month ago. The patient was also noted to have arterial bleeding from her scalp.  ED provider stated that it took some time to repair this due to high ED volumes.  Patient is believed to have lost a significant amount of blood.  The patient did become mildly tachycardic and hypotensive in the ED.  her hemoglobin on arrival was 11.4.  The remainder of her labs were otherwise unremarkable.  Patient was administered 1 L of fluid in the ED as well as 2 mg of morphine, Zofran, and tetanus shot.  She was admitted for further monitoring of her anemia and fluid resuscitation.  The patient confirms the story above.  She denies any current pain.  She also denies fever, chills, sweats, numbness, tingling, confusion, or changes otherwise.  She does admit to drinking beer occasionally.  She does not use tobacco or illicit drugs.  Family history is noncontributory.  12/14/21: 93-year-old female with past medical history of AAA, chronic low back pain, history of CVA, chronic anemia, B12 deficiency, hypertension, cystocele, hyperlipidemia, irritable bowel syndrome, lumbosacral spondylosis, peptic ulcer disease, restless legs, uterine prolapse, tremor. She presented to the emergency department on 12/09/2021 after suffering a mechanical fall at home and hit her head suffering left occipital laceration complicated by significant bleed requiring fluid resuscitation.  Patient did not require blood transfusion.  Was mildly hypoxic and found to have COVID-19 infection/pneumonia.  Was put on low-dose oxygen, received Decadron, received short course of remdesivir, he mental status got worse Decadron was discontinued.  Pt had elevated troponin and a complaint of chest pain that was transient at that time she had AFib with RVR, patient was started on heparin drip and amiodarone drip.  Transferred to CIU, cardiology were consulted and they recommended stress test however patient was refusing.  Upon my evaluation patient was chest pain-free, troponin were down trending.  She was normal sinus rhythm.  Discussed with Cardiology who recommended to discontinue amiodarone drip and heparin drip and treat the patient medically until seen in the office.
Severe sudden headache Friday evening, continues today... its been over 50 hours of nonstop pain. Took advil, tylenol, tylenol cold, day quil, night quil, benadryl, nothing is working totaled the headache away. The drs office gave me an injection of toradol. It took the edge off for about 30 minutes. Did not kill the pain. My temples feel very tight and veins are protruding from my temples
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headache". Additional information: The patient was asking if she can take aspirin to treat her headache since she had a headache since after getting the Pfizer covid-19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
flu like symptoms after her third dose; chills after her third dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms after her third dose) and CHILLS (chills after her third dose) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms after her third dose) and CHILLS (chills after her third dose). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms after her third dose) and CHILLS (chills after her third dose) outcome was unknown.            No Concomitant Drug details were reported.  No Treatment information was provided.   Reporter did not allow further contact
patient received 2nd dose of Moderna on 3/13/2021; reported by Police Department as having passed away on 3/14/2021.  No other details available.
When injected I felt cold liquid running down my arm from my deltoid muscle to midway down my upper arm. I remarked to the man administering the vaccine that I did not think I received the vaccine since so much fluid ran down my arm. He told me it happened all the time. I reported this at the time it happened to a representative of the health department. I was told they had had a staff meeting and were told not to readminister the vaccine if they could not verify how much was given. I emailed a complaint. I never got a response. I called health department. I was told an incident report would be filed & the person would be sent back to training. This resolution does not help as I am still not fully vaccinated.  What can I do?
got the flu, never again will I get a flu shot, that was the first flu I ever had; Initial information was received on 19-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender of patient who got the flu, never again will i get a flu shot, that was the first flu i ever had after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (formulation, strength, dosage, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  On an unknown date the patient who got the flu, never again will i get a flu shot, that was the first flu i ever had (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu, never again will I get a flu shot, that was the first flu I ever had).  At time of reporting, the outcome was Unknown for the event got the flu, never again will i get a flu shot, that was the first flu i ever had.
JACUTE RESPIRATORY FAILURE 8/3/2022 AGITATION ACUTE RESPIRATORY FAILURE 8/3/2022 AGITATION ACUTE RESPIRATORY FAILURE 8/3/2022 ENCEPHALOPATHY
Patient received a dose of J&J vaccine and came in to get the Moderna booster.  Communication we received from corporate looked like those who received J&J would get a dose of 0.5ml so that is the dose that this patient received.  We learned much later in the day that he should have received a dose of 0.25ml.  Spoke to patient to inform him of the incorrect dosage and he was fine with it and feeling fine as well.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-JAN-2018, the patient was vaccinated with an expired dose of PROQUAD lot # M007960; expiry date 15-AUG-2017 (dose and route of administration were not provided). The PROQUAD was reconstituted with sterile diluent. No adverse effect was reported.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose number, lot number, expiration date, route of administration and anatomical location not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles.   As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
I am having a reaction, rash on my right arm; it itch a lot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 21Sep2021 (Lot number: FC3182) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "I am having a reaction, rash on my right arm"; PRURITUS (non-serious), outcome "unknown", described as "it itch a lot".  Additional information: Patient was the reporter and informed about the Pfizer Medical Information and provided with the number and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday.Further probing could not be done as the reporter was not willing to complete the report. Hence, limited information available over the call.  No follow-up attempts are possible. No further information is expected.