chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient tells me that on Wednesday she presented to dialysis and tells me this was completed. She normally has Monday Wednesday Friday dialysis. States that after returning home she was thought to be acting differently in an ambulance was called which time she was brought in to the emergency department at an outside facility. Her patient is being seen in transfer from that outside facility.  Per secondhand report for being found hypoxic in dialysis in the 70s.  Of note the patient was diagnosed with COVID-19 11/16/2021 in her assisted living at what sounds to be a standard screening test. She is vaccinated.  She states she has had some mild congestion but otherwise is asymptomatic.  Tells me that 2 other resdents were also positive.  Also has pertinent history of GI bleeding, renal artery stenosis, peripheral artery disease, diabetes mellitus, history of stroke, history of NSTEMI.   Patient was on 2 L of nasal cannula at the outside facility and saturating in the mid 90s.  Patient's blood pressure initially was in the 140 systolic however dropped to 80s though asymptomatic.  The patient was given normal saline boluses which her blood pressure was responsive.  Due to elevated procalcitonin was started on 1 g of ceftriaxone and 500 mg of azithromycin.  Was briefly on norepinephrine however this was weaned off without difficulty.  Patient was initially to be transferred to the ICU however with improvement was transferred to General Medicine.   On arrival the patient is 100% on 2 L. blood pressures are appropriate in the 120s to 130s.  She is awake, alert, and pleasant.  Denies chest pain, shortness of breath, dyspnea on exertion, pleuritic pain, abdominal pain, nausea, vomiting, diarrhea.  States she has had some fevers at her facility.  Tells me that she typically has low blood pressures.  Her biggest complaint is the neuropathy in her feet.
Patient has a large local reaction (redness, swelling) to injection site R anterolateral thigh.  The patient was vaccinated on 5May08 and noticed swelling on 6May08.  Patient is being treated with BENADRYL and KEFLEX.
pt recvd 1 dose of Engerix-B & on 4JUN92 & devel fever 102 which persists; tx APAP;
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for Red cell aplasia, hyperlipidemia, t2dm, HTN, angioimmunoblastic t-cell lymphoma, chronic hypoxemic respiratory failure. Pt presented to outside facility with cc of increased SOB and dyspnea on 4/21, was dc 4/27. On may 6th per note, wife reported that patient felt nauseous and restless. Patient deceased 5/6 at 1349.
we all get infected with a severe symptoms; we all get infected with a severe symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A 15-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "we all get infected with a severe symptoms".  Clinical information: For the second winter after got the vaccine patient got infected with a severe symptoms. Reporter reported "If you care about your business (let alone your families if you have any ) then you may not neglect my message. I'm sure it is not a unique one."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
dizzy; headache; nausea; puffy throat; This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3249), intramuscular at Arm Left on 12Jan2021 at the 56 years old at single dose for COVID-19 immunization. The medical history included bronchitis and palpitations. The concomitant medications were not reported. The patient experienced dizzy, headache, nausea, "puffy throat" all on 12Jan2021. There was treatment received for events dizzy, headache, nausea, "puffy throat". The patient underwent lab tests and procedures, which included Blood pressure (BP) 123/59, O2 Saturation 100%, Heart Rate70 all on an unknown date. The outcome of all the events was recovered in Jan2021.  No follow-up attempts are possible. No further information is expected.
Hives developed within 10 minutes of flumist administration. We gave him Benadryl 25mg & topical cortisone cream & they did diminish within one hour's time. No breathing difficulties noted.
Information has been received from a nurse concerning a 26 year old ex-smoker female with depression, anxiety, polycystic ovaries, codeine allergy and a history of headache with YASMIN, and pneumonia who on 20-SEP-2007 was vaccinated intramuscularly to the left arm with the first dose of Gardasil (lot# 0530U), 0.5mL. Concomitant therapy included YASMIN which the patient stopped taking on 11-OCT-2007 because she was experiencing headaches. The patient's last menstrual period was 04-OCT-2007. A pre-vaccination pregnancy test was administered with a negative result. After the first dose in approximately September 2007, the patient experienced pain going straight down her back (outcome not reported). On 15-NOV-2007 the patient received her second dose of Gardasil (lot#0530U) into the left arm. Immediately post vaccination, the patient experienced pain going straight down her back, tingling in the jaw and headache. The patient was being treated with TYLENOL, relaxing with a heating pad, and was being monitored. During follow up with the client, the physician in the office that day indicated to the nurse that it may have been an anxiety attack. Unspecified medical attention was sought. As of 15-NOV-2007 the patient was recovering. The product quality complaint unit was not involved. Additional information has been requested. Information has been received from a nurse concerning a 26 year old ex-smoker insurance agent female with depression, anxiety, polycystic, codeine allergy and a history of headache with YASMIN, and pneumonia who on 20-SEP-2007 was vaccinated intramuscularly to the left arm with the first dose of HPV (lot # 05300), 0.5ml. The patient's last menstrual period was 04-OCT-2007. A pre-vaccination pregnancy test was administered with a negative result. After the first dose on 20-SEP-2007, the pateint experienced pain going straight down her back. On 15-NOV-2007, the patient received her second dose of intramuscularly HPV (lot # 0530U) into the left deltoid. Immediately post vaccination, the patient experiwnced pain going straight down her back, midline upper thoracic region pain, jaw pain, tingling in the jaw, tingling in her checks, dizziness, and a headache. The patient was treated with TYLENOL, relaxing with a heating pad, and was monitored. After 20-25 minutes all symtoms resolved, except for headache, before leaving the office. During follow up with the client, the physician in the office that day indicated to the nurse that it may have been an anxiety attack. Unspecified medical attention was sought. The product quality complaint unit was not involved. Additional information is not expected.
Numb arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numb arm) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numb arm). At the time of the report, HYPOAESTHESIA (Numb arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Fever to 101.8, chills, body aches, headache, malaise. Lasted about 12 hours.   Took Ibuprofen
Patient tested positive for COVID-19 3 days post vaccination. Patient tested due to facility wide testing. Patient noted to have sore throat, low grade fever, and cough at the time of testing. Patient continues with these symptoms. Droplet isolation initiated.
From telephone correspondence received at manufacturer on 08/21/2002, it was reported that the pt was vaccinated with a second dose of Imovax Rabies (lot #U0511-2) and began to experience muscle twitching in fingers, toes, neck and lower legs. Onset date was not reported. It is not reported whether the pt recovered from these adverse events.
After two weeks from vaccine, she woke up with 102 fever and a blood red rash all over her body. Gave her BENADRYL for itching and MOTRIN for fever. After two hours of fever not going down, I rushed her to the Dr. They told me she was having a bad reaction to the measles shot. Told me to just "keep her comfortable" and give her MOTRIN. After getting home and eating very little for lunch she laid down for a nap. She slept from 3:00 pm till 8:00 am this morning. I did wake her up to change her diaper and to make her drink some juice. No fever this morning.
Seizure occurred involving shaking of head and torso, during otherwise normal sleep, for approximately 5 seconds.  Seizure continued as infant was lifted up out of bouncy seat, but halted as infant was put to the breast to nurse.  Nursing proceeded normally and no recurrence of seizure has occurred.  No fever, rash, or difficulty breathing have been observed.  The injection site has a small, red welt (pea-sized but fairly flat).  Mild diarrhea was noticed earlier in the evening (at approximately 7 PM) but has not recurred thus far.
large area of erythema, warm to touch, and firm of 5cm x 6 cm on upper left arm where Hepatitis A and Varivax injections were given
This patient had possible adverse reaction to the Smallpox vaccine. Pt reported to the ER complaining of chest pain. Patient was admitted to the hospital for 3 days. He  was discharged with the diagnosis of unspecified chest pain. Patient has fully recovered.
Patient got her vaccine around 3pm. She hadn't taken a nap yet for the day, so she fell asleep on the ride home which can be normal. By the time 8pm came around she was still sleeping, she slept all through the night and that is uncommon. Just a month ago her sleep cycle was changed and she slept the whole evening and was up at 3am and stayed up for four hours. So she has be lethargic for 48 hours. 5/8/15 patient woke up at 6am and was vomiting, she never does that. She complained about soreness in the injection area on 5/7/15, she did however sleep more than usual on the same day. Also at daycare, the following day, she wouldn't move around actively like she usually does, she was just playing with one toy, very uncharacteristic. I am at a very thin line with watching my child go through these so called side effect from these supposed "safe and effective" vaccines. As I am writing, my daughter is going to bed rather early. Also her naps seem to have been longer the last 3 days. You need to either tell the complete truth about the vaccines, or stop producing them until you can make them "safe and effective". These people that make the vaccines are now affecting our elected officials children. Those types of people bring to light these issues to the small people.
Information has been received from a physician concerning a 38 month old female with penicillin allergy and a history of tubes in her ears and otitis media who on 04Apr02 was vaccinated in the left arm with a dose of varicella virus vaccine live (lot 639488/0572L). On 07Jun04 the pt developed a rash with a dermatomal distribution C7-8 on left arm that had an erythematous base and clustered lesions. The following day she saw a dermatologist who agreed it was Herpes zoster. Interventions included Acyclovir orally and Acyclovir (Zovirax) topical cream. It has been reported that as of 14Jun04 the pt fully recovered from herpes zoster. There was no report of product quality complaint. The reporting physician considered herpes zoster to be an other important medical event (OMIC). Additional information has been requested.
Erythema, warmth and swelling of left proximal arm deltoid region extending toward elbow. Has flu appointment.
Shipment had been in transit to long with no AE; Initial information regarding an unsolicited valid Non-serious case was received from a pharmacist via The Agency (Reference number- 00325402) and transmitted to Sanofi on 21-Oct-2020.   It was reported that a 77-year old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT (lot number: UJ546AA, expiry date: 06/30/2021, Route: Via intramuscular in the right arm) which received delay shipment (Product distribution issue) on 19-oct-2020 and vaccine will administrated as soon as they received for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to product shipment delay.  At the time of reporting, no adverse event was reported.  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 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.
36 hours of slight symptoms; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (36 hours of slight symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (36 hours of slight symptoms). At the time of the report, IMMUNISATION REACTION (36 hours of slight symptoms) had resolved.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD22-020223 (Moderna), 145640 (Moderna). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Sep2021 as dose number unknown (booster) , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mono and dysplasia", start date: Jul2021, stop date: Jul2021; "mono and dysplasia", start date: Jul2021, stop date: Jul2021. The patient's concomitant medications were not reported. Vaccination history included: coviD-19 vaccine moderna (Dose 2 Lot# 020B21A), administration date: 01Apr2021, for Covid-19 immunization; Covid-19 vaccine moderna (Dose 1), for Covid-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got a Pfizer booster in September of 2021 & got sick again but only for a couple of days"; EPSTEIN-BARR VIRUS INFECTION (non-serious), outcome "unknown", described as "Epstein Barr". Relevant laboratory tests and procedures are available in the appropriate section. Additional information : Patient reporting her experiences after receiving two primary doses (2nd dose Lot# 020B21A on 01Apr2021) and of the Moderna COVID-19 Vaccine. Caller says she has not had COVID that she knows off. Within 24 hours of the 2nd dose she became sick with what she says are COVID symptoms. She couldn't breath, was out of breath just walking down the hall, chronic fatigue, and mouth and throat lesions. The breathing and COVID symptoms lasted for 19 days. The lesions and fatigue continued. She eventually went to an urgent care who told she has strep, for which they never tested her. She had thrush on her tongue, her throat was full, she had lesion on her tongue, the roof of her mouth and down her throat and she couldn't swallow. She had a horrible cough and lost her voice. Which she just got back after speech therapy for 4 months. She saw a dentist then eventually went to [Place name withheld] & was diagnosed with mono and dysplasia in Jul2021. She now has to take meds with pudding due to her continued swallowing issues. She got a Pfizer booster in Sep2021 and got sick again but only for a couple of days. On 04May2022 she had some specialized testing done and was diagnosed with Epstein Barr. She says the lesions have only been gone for a couple of months. Consent granted for follow-up by the safety team with her, her doctor, and the vaccination facility. Follow-up attempts are completed. No further information is expected.
Lump at site, redness, swelling and tenderness. Advised to take Motrin, ibuprofen, Benadryl and to use a cold compress.
Lymphadenopathy in injection (left) arm. Also body aches and fatigue but mostly swollen, painful and uncomfortable left deltoid and armpit.
quarter size local pruritic, erythema, rxn lt deltoid to flu vax;
Pain in shoulder of same side as vaccine administration starting 24 hours after given.  Exam consistent with subdeltoid bursitis and rotator tendinitis.
Redness and inflammation around the injection site.  No treatment sought.  Symptoms lessening each day.
HEART ATTACK; This spontaneous report received from a consumer via a company representative via a social media concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No adverse events reported post vaccination (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient received non-company suspect vaccine included: MRNA 1273 (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 17-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-DEC-2021, the patient experienced heart attack and died (dose number in series 2). It was unknown if autopsy was performed. The reporter stated not the first, not the last. The patient's wife and children were crying. The action taken with MRNA 1273 was not applicable. The outcome of heart attack was fatal. This report was serious (Death).; Sender's Comments: V0:20211261251-COVID-19 VACCINE AD26.COV2.S-Heart attack. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HEART ATTACK
PATIENT RECIEVED ROUTINE 4 YEAR OLD SHOTS ON FRIDAY APRIL 25, 2008. ON MONDAY APRIL 28 MOTHER BROUGHT CHILD WITH LEFT SWOLLEN LEG.  SHE STATED THAT THE LEG WAS NOTICED SWOLLEN, WARM, AND RED AS OF SATURDAY EVENING.  CHILD HAD NO COMPLAINTS OF PAIN AND WAS HIMSELF ALL WEEKEND.  LEFT LEG IS STILL SWOLLEN BUT NOT RED OR WARM TO TOUCH.  DR. WHO WAS THE DOCTOR IN CLINIC AT THE TIME EXAMINED THE PATIENT AND CLEARED THE PATIENT AS BEING OK.  NO FURTHER TREATMENT OR MEDICATIONS WERE NEEDED AT THE TIME. DR STATED THE DTaP WAS PROBABLY THE CAUSE OF IT.
Unsure of the exact onset. Patient complained of pain at injection site for 2 weeks after injection. Some time after the pain went away, there was a round eczema looking spot at the location of the injection. After watching the site for a month, with no changes, patient was taken to the Dr and treated for ringworm. With no changes noted after treatment, he returned to the Dr 2 weeks later, treated with topical steroids and a consult to dermatology was placed. Patient saw dermatology a month later, with no changes noted to the eczema site. Dermatology decided it was eczema and prescribed stronger topical steroid. At this time, his mother questioned if it could have been a reaction to one of his imms. Patient was treated with no change to the eczema spot. Once all topical steroids were stopped, the eczema spot healed. Now 6 months later, the area is still rough feeling but no longer red and itchy. The eczema spot was approx. 1/2 dollar size, located on the left thigh where the KINRIX was injected. After discussion at the Dr with the MA, it was determined which vaccine was placed where.
Sick all day Saturday felt better Sunday; arm still hurts and throbs from his elbow to his shoulder; hard time grinding cheese, making sausage, and lifting/hard time working/take time off from work/he had to sleep before work; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route on left arm on 26Mar2021 (Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he got the Pfizer vaccine 11 days ago and was fine when he got is. On an unspecified date of 2021, a week ago, on Saturday, the patient was sick all day and felt better Sunday and went back to work, the patient also stated that 11 days after the vaccination his arm still hurt and throbbed from his elbow to his shoulder. The patient stated he was having a hard time working.  As a corrective measure he tried heat, ice, Tylenol, and Ibuprofen 800mg for the pain; and none of it helped. The patient was having a hard time grinding cheese, making sausage, and lifting.  He was having a hard time working and nothing was helping the pain and throbbing. He was getting ready for his second shot but stated his arm was still in pain from the first one so he did not know if he should get it. The patient will have to take time off from work and he did not normally complain but this was painful.  The patient stated that it was no better than it was last Saturday and that the Saturday after next Saturday he was scheduled for his second shot.  Stated that he was left-handed and made the mistake of getting the shot in his left arm.  Continued to mention that he was having trouble working and will have to take time off. He stated he wanted to talk to someone but then he said he cannot be on hold anymore as he had to sleep before work. The outcome was recovered on an unspecified date in 2021 for sickness and not recovered for the rest of events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Erythema multiforme minor.  Rash involving the hands that started yesterday and then spread all over.  Course of her symptoms over time is worsening.  Skin sensations associated with rash: non-pruritic, painless.