chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Period was 2 weeks late in June and 2 weeks late in September; Menstrual Cycle affected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Apr2021 09:30 (Lot number: EW0162) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: No, notes: No. Vaccination history included: Bnt162b2 (Dose:01, Anatomical Location : Arm Left   , Batch/lot number : EN6208   , Administration of time: 09:30 AM), administration date: 18Mar2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 18Jun2021, outcome "unknown", described as "Menstrual Cycle affected"; MENSTRUATION DELAYED (non-serious) with onset 29Sep2021, outcome "unknown", described as "Period was 2 weeks late in June and 2 weeks late in September". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder, menstruation delayed.  No follow-up attempts are possible. No further information is expected.
Narrative:  53 yo male with PMH of glaucoma, OSA, degenerative joint disease of shoulder, HLP, chronic pain, hemorrhoids, irritable bowel, rectal bleeding,  SAD, fibromyalgia reported feeling warm immediately after his second pfizer dose of vaccine. Temp 99.5; Baseline 97, BP131/72, HR 86, RR 16, 98% O2.  Patient did not have this reaction with first dose of covid-19 vaccine given on 2/12/2021 (pfizer). Symptom self-resolved.
Tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (non-serious) with onset 14Oct2022, outcome "unknown", described as "Tested positive for COVID". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that a patient got her Pfizer COVID-19 bivalent booster in 11Oct2022, Tuesday, tested positive for COVID today and was prescribed with Paxlovid. Caller wanted to know any interaction or contraindication for taking Paxlovid for a patient who recently had a Pfizer booster dose. Administration of an antiviral drug at any interval before or after COVID-19 vaccination is unlikely to impair development of a protective antibody response. Initiate Paxlovid treatment as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset. It is authorized for the treatment of mild-to-moderate coronavirus in 12 years of age and older with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Patient got Pfizer Covid19 Vaccine booster Tuesday of this week and tested positive for Covid today. Caller would like to know if it is ok for the patient to take Paxlovid and that there would be no interaction or contraindication when taking Paxlovid. Reporter Type was she is a pharmacy intern calling on behalf of the patient who is picking up the Paxlovid. Attempted to clarify and caller states she is not calling on behalf of the pharmacy or pharmacist. Caller doesn't think the patient is a healthcare professional. Patient was not admitted to hospital and primary care prescribed the Paxlovid but got it filled there at hospital. Prior Vaccinations (within 4 weeks) was unknown and AE following prior vaccinations was unknown.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient administered a 2nd booster dose. He was not eligible. Did not experience any side effects from vaccination.
Information has been received from a healthcare worker (immunization official) referring to a 4 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 10-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K015970 (expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
pregnancy; pain at the site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) and VACCINATION SITE PAIN (pain at the site) in a 40-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Gestational diabetes. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Pre-eclampsia, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, LEVOTHYROXINE for Thyroiditis NOS, CALCIUM, DOCOSAHEXAENOIC ACID (DHA), VITAMIN D NOS and MAGNESIUM for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 04-Apr-2021. On 04-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). In February 2021, the patient experienced VACCINATION SITE PAIN (pain at the site). On 04-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (pain at the site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: (normal) At 12 weeks; normal, (normal) At 20 weeks ; normal and (normal) At 31 weeks; normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient previously had live full-term child birth on 19JUL2016 and 21 AUG2018.  Treatment medications were not provided by reporter.
11/20/03-Tylenol given following imm.  No symptoms. 11/21/03-12:00 P.M. No swelling noted.  Vomiting, very pale. 11/22/03-1:00 P.M. Swelling to left thigh that progressed to knee.  Taken to E.R. @ 7:00 P.M.  DX-Cellulitis
Break out of itchy hives all over that will go away and come back, and move along the entire body. Taking antihistamines and a steroid which helps, but has not yet solved the issue
Episode of EKG device confirmed atrial fibrillation initiated 13 hours after vaccination. Treated with metoprolol and flecainide., resolved in 2 hours .
small patch of missing hair on top right of scalp started the size of nickel 3 weeks ago. Two days ago,  it got bigger in the size of quarter.
Redness and swollen at injection and surrounding site. Pain in the arm where he received the vaccine. Advised patient to take Benadryl in case he is allergic to vaccine and Alleve for pain and swelling.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
FLUBLOK being administered to 7 years old child, with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 years old male patient and it was reported that flublok(INFLUENZA QUADRIVALENT RECOMBINANT VACCINE) being administered to 7 years old child, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2022, the patient received a  dose of 0.5 ml of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE, injection (strength: unknown) lot UJ887AA, expiry date: 09-Jun-2023, via intramuscular route in the right deltoid as Immunization.  On 23-SEP-2022 the flublok being administered to 7 years old child, with no reported adverse event (product administered to patient of inappropriate age) same day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (FLUBLOK being administered to 7 years old child, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event   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 the 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.
Symptoms included flu-like symptoms of headache, nausea, body-aches, fatigue and soreness at injection site.
I tested positive after I came into contact with someone that had covid on 28Apr and immediately went on paxlovid; I tested positive after I came into contact with someone that had covid on 28Apr and immediately went on paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Apr2022, outcome "unknown" and all described as "Patient tested positive after patient came into contact with someone that had covid on 28Apr and immediately went on paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: patient tested negative a few days after and was negative for a week with no symptoms; (08May2022) Positive, notes: I started getting symptoms again and testing positive on 08May; (13May2022) Positive, notes: patient still experiencing symptoms now (13May) and testing positive as of this morning. Therapeutic measures were taken as a result of covid-19.  Clinical course:  The patient reported that she was on triple vaxxed. This form is ridiculous. No wonder no one is reporting it. I tested positive after I came into contact with someone that had covid on 28Apr and immediately went on paxlovid. I tested negative a few days after and was negative for a week with no symptoms. I started getting symptoms again and testing positive on 8May and am still experiencing symptoms now (13May) and testing positive as of this morning. I have typical cold symptoms but no fever or chills. No known allergy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
MENACTRA + VARIVAX given on 1/19/09.  On 1/20/09 seen in office for vertigo feeling of weakness in legs, headache, vomiting.  Was seen in ER in AM at hospital 1/19/09.  Follow up visit 1/23/09 c/o persisting dizziness, headache.  Adv. neurology consult.  1/30/09 Pt 70% better.  Adv. CT head. 22/2/09-records received with report-presented to ED on 1/21/09 with C/O dizziness and lower extremity weakness. Acute headache. Office notes 1/20/09-received vaccine and C/O headahce weakness, PE normal. Office note 1/23/09-Feeling tired, decreased appetite but feeling better. Improving dizziness and headaches. 1/30/09-not fully recovered, headaches continue. Neurology appointment to be scheduled along with CT scan.  /13/09-neurology report received for DOS 1/21/09-feeling well. PE unremarkable. Neuro exam WNL. Patient has recovered from vaccine adverse reaction, it is not necessary to perform neuro imaging scan. No evidence of Guillain-Barre. Relexes normal and strength normal.   8/21/09 PCP medical records received DOS 1/19/09 to 1/30/09. Mother reports child taken to ER c/o fever, dizziness and weakness. Vomited, headaches. C/O persistent dizziness, frontal headache. Feeling tired, decreased appetite.
This spontaneous report was received from a nurse refers to an 8 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 20-FEB-2017, the patient was vaccinated with first dose of GARDASIL 9, lot # M035486, expiry: 05-JUN-2019 (dose, route, anatomical location not reported), for immunization. The patient was one month short of his 09th birthday at the time of vaccination (Drug administered to patient of inappropriate age). No adverse effects reported. No product quality complaint (PQC) involved. Additional information has been requested.
Allergic reaction (hives) to vaccine; possibly Hep-A. Improved on 4/6/01.
Member was immunized by 3 vaccines. FLUARIX. PNUps. VAR (varicella).
last 24 hours was pretty rough/ feeling absolutely horrible; fever; sweats; This case was reported by a consumer via interactive digital media  and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 31st August 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced feeling unwell, fever and sweating. On an unknown date, the outcome of the feeling unwell, fever and sweating were unknown.   It was unknown if the reporter considered the feeling unwell, fever and sweating to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had second Shingles shot. And although the patient was feeling much better at the time of reporting. The patient reported that the last 24 hours was pretty rough no itching and no sign of shingles or anything like that the patient just went through a period of fever sweats and just plain feeling absolutely horrible. The patient was on the mend now, and the patient agreed to get the shots. The follow-up would not possible as no contact details were available.
Patient presented to the emergency department early March 28, 2021 after experiencing 5-7 hours of chest pain. The chest started when the patient went to bed the evening of March 27, where he began having substernal non-radiating chest pain with inspiration. The pain was relieved by sitting upright and by taking some acetaminophen. He received his 2nd dose of the Pfizer COVID-19 vaccine on March 25 (first dose was March 5). He was initially treated with ketorolac 15mg IV and given 1 liter of lactated ringer's solution via IV.  His chest pain resolved after this. He was eventually given colchicine 0.6mg twice daily and ibuprofen 600mg 3 times daily due to concern for myopericarditis. He was ultimately found to have no evidence of pericarditis after undergoing a cardiac MRI, thus colchicine and ibuprofen were discontinued. Due to findings of mildly reduced ejection fraction on imaging, he was started on metoprolol XL 25mg once daily at discharge.
This spontaneous report was received from an 84 year old female consumer with high cholesterol, thyroid disorder and allergy to lidocaine reporting on herself. On 09-APR-2008, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # not reported) subcutaneously. Concomitant therapies included an unspecified thyroid medication and CRESTOR. The consumer reported that on 20-DEC-2015, she experienced shingles. The patient visited her doctor and received an unspecified antiviral medication as treatment. There were no Lab diagnosis or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Have constant pain in right upper arm shoulder, have taken Ibuprofen 800mg per day reliefs pain for about 12 hours. My arm movement seems to be good and is not painful when I move it. I have to elevate my arm in a sling type position as the day goes on it gets more painful otherwise. I have called my doctor but have not  heard back from him, I am expecting  him to call me today, so I can get his opinion on what might be wrong with my shoulder. I have my second virus short scheduled for Feb. 25,2021 at 9:30 am at the same place.
2? diameter red area surrounding injection site that is itchy and painful upon pressure ( ?COVID arm?)
On 11/14/2001 the patient developed swollen and painful lymph nodes behind the ears. On 11/19/2001 a rash appeared on the trunk, arms and legs.
Sensitive Skin, entire Body; Headache; sore or swollen throat; Muscle Ache; Lack of Energy; loss of appetite
Flu-like symptoms starting 12 hours after vaccine: myalgias, chills, headache, fatigue--severe first 24 hours, then about 50% better the next 24 hours; continued aching and headaches through the rest of the week--not back to baseline until day January 16, 2021--vaccine given 1/8/2021; also had severe bruise at site with surrounding  erythema extending out to the outline of the deltoid muscle and slightly more distally down the arm with skin tenderness extending into this area of redness
Induration of the skin, local warmth in deltoid. Generalized rash on trunk.
Muscle "knot" 2 days out from vaccination (improved with massage). Red "spots" -> hives at injection site 6-7 days after vaccination. Tx prescribed: BENADRYL.
Same day as injection, the subject developed a rash from the injection site, spreading up her neck, into her chest and stomach and down the forearm of the injected arm. Treated with Benadryl cream and resolved. Since that time the rash has returned on many occasions. The rash usually involves her arms, legs and neck.
Memory impaired; Hand itching; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Memory impaired) and PRURITUS (Hand itching) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free pen. In April 2021, the patient experienced PRURITUS (Hand itching). On an unknown date, the patient experienced MEMORY IMPAIRMENT (Memory impaired). In April 2021, PRURITUS (Hand itching) had resolved. At the time of the report, MEMORY IMPAIRMENT (Memory impaired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.    This case was linked to MOD-2021-186011 (Patient Link).
Approximately 10-15 minutes post vax, pt looked pale then passed out. Pt then made mild guttural noises with slight jerking of upper body and arms. He then became very stiff for 10-15 seconds. Diapharetic. He was responsive again in 20-30 seconds. He was resitng on exam table when physician noticed. The follow up states on 7/10/00, the pt was vaccinated with the second dose of hep A vaccine. Concomitant vaccines that same day included the third dose of hep B vaccine. It was noted by a nurse that the pt was well and alert at the time the immunizations were given. The nurse stopped out of the room and returned to the room about 5 minutes after the vaccinations were given. The pt became pale and had a little perioral cyanosis. It was noted that his eyes rolled back into his head and he slumped onto the floor. He subsequently had some jerking movements of his upper extremities and then became quite rigid. He then relaxed and gradually regained consciousness. The physician was called into the room and noted that at that time he was somewhat diaphoretic and had a thready pulse. It was noted that his color was somewhat pale. The physician reported that the pt's blood pressure was 96/58 and his pulse was 100 while he was lying on the exam table. The physician sat with the pt for 10 minutes. The pt became increasingly more lucid and appropriate. It was noted that he was amnastic for having received his shots. The physician had the pt sit up and then stand up slowly. The physician reported that he walked with the pt out of the clinic and he seemed to be doing fine. The pt's experience was stated to have been a seizure. The physiican reported calling the pt's mother the next morning and she reported that on the way home, the pt had an unusual expression on his face and his arms flew up which was noted to have been a second seizure. It was reported that the pt has been fine and has not had any further seizures and there has not been a further work-up since he recovered. The pt's seizure was considered an "other medical event" (OMIC). Additionally it was noted, by a woman in the physician's office, that there was a causal relationship between the hep A vaccine and the pt's experience because the pt did not have any trouble with the first dose of hep B vaccine. No further info is expected.
Pt fainted and then said her head hurt and started vomiting about 5 minutes after vaccine. Pt was given water and appeared to recover.