chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received the 2nd dose less than 28 days after the 1st dose,( i.e. D22); This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose less than 28 days after the 1st dose,( i.e. D22)) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose less than 28 days after the 1st dose,( i.e. D22)). On 09-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose less than 28 days after the 1st dose,( i.e. D22)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  Action taken with mRNA-1273 in response to the events were not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up received on 09-JUN-2021 included non-significant information
Information has been received from a physician concerning a 60 year old female with no allergies, hyperlipidemia, multinodular goiter and a history of chickenpox (1952) who on 20-MAY-2008 at 1700 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merk) (lot # 659759/1873U) in the left deltoid. There was no illness at the time of vaccination. Concomitant therapy included SYNTHROID and LIPITOR. On 27-MAY-2008 the patient developed pain in her chest, back, right arm and also had a headache. The pain was rated 8 out of 10. On 27-MAY-2008, the patient still had post-herpetic neuralgia. On 29-MAY-2008 the patient developed rash. Other systemic symptom included chest/back pain, headache and right arm pain. The pain was treated with VALTREX 100mg, three times a day for one week and LIDODERM patch for pain. The type of rash was vesicular erythematous, the number of lesions was multiple and the lesions distributed to right upper to right upper chest. The patient visited the physician's office. The patient had Shingles. On 06-JUN-2008 vesicle specimen was obtained. At the time of the report patient's Shingles and post-herpetic neuralgia persisted. No product quality complaint was involved. The patient was enrolled in the VZVIP program: the vaccine Zoster virus identification program enables biological samples to be analyzed by PCR to identify if VZV is present and it is present to identify if it is associated with the wild type strain or with the Merck vaccine strain. The sample of the lesion was collected on 06-JUN-2008. The sample was taken form a vesicle. The result for the specimen was negative for B-Globin, no strain identified. The samples were noted to be inadequate. Follow-up information was received from a health professional which reported the patient still with some neuropathy. Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2008.  follow-up information was received from a health professional which reported the patient still with some post herpetic neuralgia, but it is definitely better. Follow-up information was received on 21-OCT-2008 from a health professional which reported the patient still with same symptoms no change from last report. Follow-up information was received on 08-JAN-2009 from a registered Nurse (R.N) which reported the patient still with some post herpetic neuralgia and off. Follow-up information was received on 19-MAR-2009 from a Registered Nurse (R.N) who reported that the patient still had occasional post herpetic neuropathy. Additional information has been requested.
develop inflammation around his heart; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "congestive heart failure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CARDITIS (death), outcome "fatal", described as "develop inflammation around his heart". The patient date of death was unknown. Reported cause of death: "develop inflammation around his heart". It was not reported if an autopsy was performed. Clinical course: Reporter's brother died from this vaccine and she was trying to understand why. Reporter wanted to know that even if someone had an underlying condition, what made him develop inflammation around his heart. Are they even notifying people with heart conditions to not get this vaccine. Because it's making the underlying condition worse. Reporter's brother died from this vaccine, he had congestive heart failure. They were telling people with heart disease to get this vaccine, and they should never had been vaccinated. Caller stated that she wanted to know what does Biontech mean. Called about the Pfizer vaccine. Wanted to speak with someone. Her brother died from this. Wanted to speak with a lawyer about this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: develop inflammation around his heart
Patient was given DTAP and is 9 years of age. She should have receveid TDAP
pt recv vax & devel an inj site rxn characterized by swelling, tenderness, & warmth;pt recovered p/2 days;
pt called 15FEB95 to c/o inc kidney pain; states it hurt to get out of & into my car today encouraged pt to call own MD immed; pt is planning to depart for costa rica on 24FEB95 & needs assessment first;pt requested TD on 6FEB95;
I had received 2 Pfizer doses previously. Typical body aches, sore arm occurred with both. I opted for Moderna as my booster shot. I had similar symptoms with it lasting 24 hours. After the booster and before 12/09, I had 3 menstrual cycles. In talking with a worker, they felt I should submit this to VAERS. The following month, I had 2 menstrual cycles.
10JUL97 phone call made by pt mom gave pt APAP;12:30 pt  awoke from nap w/unconsolable cry 20min;lt anterior thigh appears reddened, both calves & feet are reddened;pt afeb mom called MD;
FEBRILE SEIZURE ACCOMPANIED BY 104.5 FEVER FOR 2 DAYS AND FEVER FOR 4 DAYS TOTAL. FEVER 7 DAYS AFTER VACCINATION. COVID TEST NEGATIVE.   RASH ON BODY AS WELL.
the patient experienced seizures 8 days after receiving the MMR II vaccine; This spontaneous report was received from a consumer referring to her son (a child) with asthma. The patient's medical history included urticaria. Concomitant therapy included albuterol. He had reactions/allergies to oxytocin (PITOCIN).  On an unknown date in 2012, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), one shot in arm for prophylaxis (reported as prevention of mumps, measles and rubella) (strength, dose and frequency were not reported; lot# and expiration date were unknown by the reporter).  On an unknown date in 2012, 8 days after receiving the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine, the patient experienced seizures, which lasted for about 30 to 60 seconds. In the end of the day in 2012, the patient recovered from seizures. The patient did not seek medical attention and no lab diagnostics/studies were performed.   The reporter did not provide the causality between the event seizures and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). Upon internal review, the event of seizures was determined to be medically significant.
woke up this morning feeling slight numbness on my left cheek.  The sensation is very similar to when I receive a numbing shot from my dentist for dental work.  The feeling of numbness comes and goes with varying levels of intensity.  Sometimes twitching my cheek can make it go away; but it keeps occurring.
Arm pain from wrist up through Left shoulder, up the neck and into the ear, numbness and tingling on the skin of L leg, enlarged axillary lymph nodes and neck nodes bilaterally, fevers over 101, general malaise, heachache, redness and swelling of site 3 inches in diameter.
Patient treated by EMT for hives and itching 10 minutes post-vaccine. BP 247/132, HR 95, RR 20, PSO2 90-94%. Benadryl IM 25. Transport requested; Rescue arrived, assessed pt who had been given IM benadryl and stated that the pt declined transport. Patient transported by her daughter. Education by staff: Speak to her doctor about HTN, which appears uncontrolled; speak to MD whether she should have second vaccine or not. Note left in her Luminere profile.
The evening after I got my last pfizer covid 19 shot , I felt a red , hot rash, on my right buttock.   It was not raised.  I did not seem like hives.  I took Benadryl .  I slept the night.  It was a little less red the next day.  Then, around 2pm the next evening (4/7) I had another red patch on my other buttock.
Patient reports the following symptoms: 8/31/21-9/2/21 mild headache, nausea, flushed, and anxious feeling.  09/03/21 onset of 'woozy' feeling (like on a boat), Headache improved. 09/04/21-09/16/2021 onset of tinnitus, continued woozy feeling /dizziness.   Treatment: Prednisone, Meclizine, referral to ENT  09/18-09/28 Woozy feeling improved with prednisone, tinnitus persists. 09/28/21 increased fatigue and headache  x2 days, persistent tinnitus. Follow up scheduled for 10/1/021 tomorrow for next steps.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 18:00 as dose 1, single (Lot number: HF9275) at the age of 71 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment from 30Sep2023 to 04Oct2023. Clinical Course: Patient had no Known allergies.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300322558 same patient, different drug/AE (Paxlovid case);
Starting the evening of the shot, after physical therapy, I started feeling woozy and shaky. I got home and felt nauseous so I had to lie down. Also, my nose was runny and congested. Almost suddenly, I felt like I got hit by a truck. Most of my joints felt like they were on fire and I could not even make a fist. I couldn't think straight and couldn't get out of bed. I felt totally out of it and everything really hurt. I attempted to use my phone and couldn't function. It was not as bad as the 2nd dose and I was feeling better by Saturday evening.
Fever, resulted in febrile seizure. Went to ER via ambulance. Dx with febrile seizure, ear infection. Given AMOXIL 250mg/5mL, TYLENOL and MOTRIN.
brief probably psychomotor seizure followed by 24 hrs of altered mental status w/ inc reflexes, no focal signs, fever 104;
Feeling faint, extreme fatigue, vomiting without nausea (no warning)--foul/sour. Kept complaining that she felt like she was crawling in her own skin, all through her arms and her chest, like an itch from the inside.  NO HIVES. No difficulty breathing.  Kept her home from school and she slept a lot. Only vomited the one time. She was fine by late afternoon and all symptoms seemed to have resolved by then.
nl discomfort w/initial inj- became inc painful over several days; severe pain radiating down into arm & hand w/inc activity of arm; went to MD in JAN95; placed on ATB & is to begain PT
I woke up around 4am Sunday morning with extreme pain in my right jaw and behind right ear.  The right side of my face, neck, lips and ear were numb to the touch like I had a novacane shot and my right arm was numb but could feel it when I touched it.  I contacted a nurse I know who had me perform some tests at home to see if she thought it might be a stroke. She did not, but recommended I go to a facility.  I took some ibuprofen and fell back asleep when it started to work and when I woke up a few hours later the pain was mostly gone and the numbness had lessened.  I sent my doc a message to ask about his thoughts and he wanted to see me monday morning. By monday the pain was still gone but the numbness lingered somewhat. Dr. performed some testing and did not see signs or stroke or impairment and felt like it is a side effect from getting the shot in that arm. He has ordered bloodwork and said if it gets worse he will order an MRI. The numbness is less today on Tuesday and no further pain in jaw or ear.  I contacted the nurse at the health department and she asked that I fill this report out.
Localized allergic skin reaction after subcutaneous administration of PNEUMOVAX in (R) upper arm - pain, swelling, redness and itching. Starting after 1 day of vaccine.
Coffee doesn't taste right; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Coffee doesn't taste right) 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 TASTE DISORDER (Coffee doesn't taste right). At the time of the report, TASTE DISORDER (Coffee doesn't taste right) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.  No concomitant and treatment medications were reported.
beyond the 42 day window; missed second dose,first dose given to patient 28MAY2021 was told second dose can be given anytime; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (beyond the 42 day window; missed second dose,first dose given to patient 28MAY2021 was told second dose can be given anytime) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (beyond the 42 day window; missed second dose,first dose given to patient 28MAY2021 was told second dose can be given anytime). At the time of the report, PRODUCT DOSE OMISSION ISSUE (beyond the 42 day window; missed second dose,first dose given to patient 28MAY2021 was told second dose can be given anytime) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up received on 16 Jul 2021. updated reporter details, product details added.
severe body, muscle and joint pain/ache, fever, fatigue, weak, dizzy, fuzzy, nausea, headache, loss of appetite, unable to go to school  Tylenol every 4-6 hours
pt recvd vax 25AUG95 & 27AUG95 pt exp a generalized rash w/20-30 lesions;29AUG95 pt devel severe varicella characterized by normal appearing lesions & large (1-1.5inch) fluid filled bullae on trunk & extremities;11SEP95 pt recovered;
Got MMR vaccine on Friday at 1130. On Friday night, noticed to have rashes in neck, chest, abdomen and arms. It was itchy. On Saturday, the rashes and itchiness were bad. Took Benadryl. On Sunday, took another Benadryl and took the irritation away. Today, the rashes are slightly but very itchy. Diagnosed to have Avirulent Measles from Measles Vaccine.
Getting Hives through out the body with Itching and burning sensation.; Getting Hives through out the body with Itching and burning sensation.; Getting Hives through out the body with Itching and burning sensation.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Getting Hives through out the body with Itching and burning sensation.), PRURITUS (Getting Hives through out the body with Itching and burning sensation.) and BURNING SENSATION (Getting Hives through out the body with Itching and burning sensation.) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 25-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Getting Hives through out the body with Itching and burning sensation.), PRURITUS (Getting Hives through out the body with Itching and burning sensation.) and BURNING SENSATION (Getting Hives through out the body with Itching and burning sensation.). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) at an unspecified dose and frequency. At the time of the report, URTICARIA (Getting Hives through out the body with Itching and burning sensation.), PRURITUS (Getting Hives through out the body with Itching and burning sensation.) and BURNING SENSATION (Getting Hives through out the body with Itching and burning sensation.) had not resolved.            The patient's height was reported as 167.64 cm.  No concomitant medication information was provided.  Patient took the steroids (unspecified) prescribed by the doctor but still the events exists.   The doctor suggested Xyzal over the counter medication but that also not helping much.
fever 102 w/APAP x 72 hrs; inconsolable crying for more than 3 hrs off & on for 72 hrs;
On August 5, 2021 the left side of my body felt numb that started out with my lips. I had a fuzzy feeling in my head going down the left side of my body including my arm, trunk, legs, and feet. The entire left side of my body felt numb. It lasted for about 30 minutes and then stopped. It happened intermittently about 3 or 4 times a day over the period of  a week. I went to the ER at Hospital on August 8th where the doctors observed me. They ran different tests on me, but the tests came back normal so they couldn't find anything wrong.  I haven't had the numbness feeling anymore since about August 11th or 12th.
pt recvd vax 2MAR95 starting w/a h/a w/in 30mins of shot; had abd cramps; AM nauseous w/abd cramps, vomiting & t102 & diarrhea;
Initial report received from a healthcare professional on 12 November 2014. A 76-year-old female patient had received a dose of FLUZONE HD batch number - U5023BA, Expire date - 27 April 2015, intramuscularly in left deltoid on 09 October 2014. The medical history was not known (denied by patient) and concomitant medication was not reported. On 09 October 2014, after vaccination, the patient experience pain at the injection site and cannot lift her arm over her head. Laboratory investigation was not reported. It was reported that the patient was not evaluated or treated by a physician. The patient states she takes TYLENOL and the symptoms resolve but come back when the TYLENOL wears off. At the time of this report the outcome of the event was unknown. Documents held by sender: none.
Reaction reported 8/2/06 from IZ received on 7/31/06. C/o lt lateral thigh swelling with minimal redness. 4x2cm swelling area.
Extreme fatigue. Joint pain. Muscle aches.  Extremely low energy/quickly depleted energy levels.
Started hives around socks on Tuesday (next day after shot).  Wednesday, hives up to knees and on Thursday (Jan 7th), hives on forehead, scalp and ears.  Migraine also noted on 1/7/21.  Took Imatrex and vomited.   Took 2nd Imatrex and H/A relieved. Overnight, itching started but relieved with Benadryl.  Low grade fever noted and hives returned between doses of Benadryl.  Saw PCP on 1/7/21 and was given steroid Rx.  On 1/18/21, went to dermatologist and was given 80 mg Kenalog injection and 9 days tapered-dose steroid Rx.  No issues since completing the steroids.
Discoloration on my face; Facial skin rash/had a bit of reaction in regarding my face; actual rash on my face; Itching; Fever; Body aches; Chills; Burning sensation; tingling feelings; 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. Other Case identifier(s): US-PFIZER INC-202101358264 (Pfizer).  A 43 year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Lot number: EW0173) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Lot Number:EW0158), administration date: 16Apr2021, for COVID-19 immunization. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset Oct2021, outcome "unknown", described as "Discoloration on my face"; PAIN (non-serious) with onset May2021, outcome "recovered" (2021), described as "Body aches"; PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "tingling feelings"; CHILLS (non-serious) with onset May2021, outcome "recovered" (2021), described as "Chills"; BURNING SENSATION (non-serious) with onset 2021, outcome "unknown", described as "Burning sensation"; PYREXIA (non-serious) with onset May2021, outcome "recovered" (2021), described as "Fever"; RASH (non-serious) with onset Oct2021, outcome "unknown", described as "Facial skin rash/had a bit of reaction in regarding my face; actual rash on my face"; PRURITUS (non-serious) with onset Oct2021, outcome "unknown", described as "Itching". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Chills, body aches, tiredness, congestion, flu-like symptoms, lack of hunger, mild headache