chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She has immune issues and stress/ methylprednisolone for immune issues; She has immune issues and stress/ methylprednisolone for immune issues; severe headache/ pain in the base of her skull; nausea; vomiting; had pain at the top of her spine where the spine meets the skull; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (BNT162B2, lot number: EL9264) via an unspecified route of administration, on 01Feb2021 12:45PM at a single dose on top of left arm for COVID-19 immunization. The vaccine was given at a Clinic which is an off shoot of the hospital. The patient did not receive any vaccinations within 4 weeks prior to receiving BNT162B2. Medical history included Wegner's disease, immune issues and stress. She stated that there would be one doctor providing medication for stress and other doctor providing other medications. She has immune issues and stress. Concomitant medications included buspirone from an unspecified date and ongoing (been on it for quite a few years), clonazepam from an unspecified date and ongoing (been on it for quite a few years), fluticasone propionate (FLOVENT) from an unspecified date and ongoing (been on it a little over a year or two and it was prescribed by her pulmonologist), hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) from an unspecified date and ongoing (has been on it for more than 5 years and was prescribed by her primary care), methylprednisolone for immune issues, bupropion hydrochloride (WELLBUTRIN), and nebulizer for saline for Wegner's disease (It is prescribed by her ear, nose, and throat doctor). The patient previously received a flu shot in 2020 and experienced sore arm and achy feeling. On 01Feb2021 18:45, the patient experienced severe headache, nausea, vomiting, and pain in the base of her skull. A lot of people thought it was throwing her into a migraine. She has never had a migraine in her life. It was awful and pretty extreme. Severe headache, nausea, vomiting, and pain in the base of her skull started about six hours after the shot (at 18:45) and proceed a good 24 hours later. She also had pain at the top of her spine where the spine meets the skull. She would say that the symptoms stopped on 02Feb2021. She has recovered almost completely. She is still not quite completely 100 percent. The reported adverse events did not require a visit to emergency room or physician office. Some relatives said she should have gone in, but she did not. Outcome of the events was recovered on 02Feb2021.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): unknown.     MEDICAL HISTORY (Patient): Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 29-Nov-2020 and the estimated date of delivery was 05-Sep-2021. On 27-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy.  On 24-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Pregnancy test: positive Positive. On an unknown date, Ultrasound scan: normal (normal) normal.         The patient denied consent to contact her doctor because she wants to get contacted first.  Action taken with mRNA-19 in response to the event was not applicable.  No treatment information was provided by the reporter.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279268, 2018SA279273, 2018SA279274 and 2018SA279276 (same reporter). This case involves a five years old patient (gender not reported) who was vaccinated with a 0.25 ml dose instead of 0.5ml dose of FLUZONE QUADRIVALENT (batch number UT6259KA and expiration date 30-JUN-2019) via unknown route in unknown administration site on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to vaccine underdose. No adverse event had been reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender: none.
Evening of vaccine administration and still ongoing  2 weeks later - headache, chills, fatigue, achy, SOB on exertion, occasional tremors, dry cough which has subsided considerably. 1 1/2 weeks out hives again covering entire body and not subsiding with 50 mg Benadryl every 6 hours. 2 weeks - sore throat and swollen glands
Rash on feet (went away after 10 days).  Severe headaches. Rash at injection site. Went away in 3 days.  Weakness, difficulty breathing, shivering, fatigue - ongoing after 12 days.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (he experienced fever), CHILLS (chills) and MYALGIA (achiness) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PYREXIA (he experienced fever), CHILLS (chills) and MYALGIA (achiness). At the time of the report, PYREXIA (he experienced fever), CHILLS (chills) and MYALGIA (achiness) outcome was unknown. No concomitant information were reported by the reporter. No treatment information were reported by the reporter. This case was linked to MOD-2022-531517, MOD-2022-531761 (Patient Link).
soreness; nausea; headache; body ache; flu like symptoms; not feeling well; diarrhea; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm, nausea, headache, general body pain, influenza-like symptoms, feeling unwell and diarrhea. On an unknown date, the outcome of the pain in arm, nausea, headache, general body pain, influenza-like symptoms, feeling unwell and diarrhea were unknown.   It was unknown if the reporter considered the pain in arm, nausea, headache, general body pain, influenza-like symptoms, feeling unwell and diarrhea to be related to Shingrix.  Additional details were provided as follows: This case was reported by the pharmacist on behalf of her co-worker who spoke about another patient who had similar side effects, however, her co-worker had no details to provide. The patient demographic details were not provided. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient experienced pain in arm, nausea, headache, general body pain, influenza-like symptoms, feeling unwell and diarrhea, after vaccination with dose of Shingrix. The reporter consented to follow up. This case has been linked with case US2019158433, reported by same reporter.
the day after receiving her vaccine she lost all strength in her right arm for 1 week. unable to scoop ice cream at her place of employment.
Resident developed increased confusion on 01/30/2021 that may have been related to vaccine or to residents other medical conditions including dementia, anxiety, shortness of breath, history of lung cancer, and COPD.  Sustained a fall with fracture and was transferred to Hospital.  Surgical intervention performed to repair hip.  Resident returned to Skilled Nursing facility.  Did not recover after surgery and family chose palliative measures.  Resident died/ expired on 02/09/2021.
Given a series of 3 lyme vaccines from 5/00 till 5/01. complaints of persistent muscle muscle, and joint pain.
VACCINE ADMINISTERED ON 10/14/02.  ON 10/15/02 THE PATIENT DEVELOPED FEVER, MALAISE AND CHILLS. LATE IN THE DAY, THE PATIENT DEVELOPED A VESICULAR RASH.  ON 10/16/02, A GENERALIZED VESICULAR RASH WAS NOTED.  ON 10/17/02, A RASH, MALAISE, AND CHILLS STILL PRESENT.
patient had syncopal episode 20 minutes after vaccine administration-mom reported patient unconscious for 20 seconds, but no issues since --EMS contacted and assessed patient
Macular-papular, vesicular lesions on feet and hands, scattered on abdomen and in buccal mucosa.
Severe fatigue/sleepiness - slept 16/24 hours for two days, itchy papular rash on legs
Tingling in legs and hands, pain in both wrists and hands, arm pain. New symptom cold sore and loss of vision.
Vomiting, headache, R arm swelling, rash, R arm pain 8-15-2013 vaccine was given - Pt came back for OV 8-15-2013 with complaint of above symptoms.
positive COVID-19 after first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (positive COVID-19 after first dose) 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 06-Jan-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (positive COVID-19 after first dose). At the time of the report, SARS-COV-2 TEST POSITIVE (positive COVID-19 after first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Information has been received from a physician referring to a 14 month old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent. On 10-SEP-2018 or 11-SEP-2018, the patient was inadvertently administered a dose of PROQUAD (route, strength, dose, frequency, batch/lot # and expiration date were not reported) instead of an intended dose of M-M-R II, concomitantly with a dose of VARIVAX (route, strength, dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis. Physician reported the nurse mistakenly administered PROQUAD believing it to be M-M-R II because she had previously worked in a clinic that did not use PROQUAD, and therefore she did not realize that the product she was administering was PROQUAD instead of M-M-R II. No adverse effect was reported.
24 hrs p/vax broke out in rash-1-2 mins white papule lesions (look like bites) w/red welts & hives all over head trunk & extremities; fever 101, irritability; given Epi; appeared to be acute allergic reaction;
patient received a third dose at 6 months of age.; no adverse event; This spontaneous report was received from a registered nurse, concerning a 6-month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On an unknown date reported as "when the patient was 2 months of age", they received the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported). Subsequently, they received the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported) on an unknown date reported as "when the patient was 4 months of age". On an unspecified date reported as "a few weeks ago", the patient was administered a third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported) at 6 months of age in error (product administered to patient of inappropriate age). The three doses were administered as prophylaxis. No other adverse events were reported.
Patient had considerable cough and sneezing after dose was given on 9/16/2009. Within 24 hours patient developed low grade fever. By 48 hours after dose, patient developed headache, stomach ache and vomiting ( no further fever). Patient had intermittent emesis for 24-36 hours then recovered.
Pain redness and swelling at injection site; Pain redness and swelling at injection site; Pain redness and swelling at injection site; This is a spontaneous report from a contactable pharmacist (reporting for his wife) received via a Pfizer sales representative. A female patient of unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not reported. On an unknown date the patient experienced pain, redness and swelling at injection site, all with unknown outcome.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe chills and body aches at midnight. Took 2 CVS extra strength acetaminophen around 12:40 AM.   Temperature in normal range (98.6) at this time. Around 3 AM, chill broken, sweated it out. Still body aches. 4:45 AM through 10 PM - nausea, body aches, head aches. Took 2 acetaminophen as suggested on bottle.  Most symptoms were gone by 10 pm Friday but still felt tired on Saturday and Sunday.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. Product storage error; no adverse event; This spontaneous case was reported by another health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medicine was reported. It was reported that Approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment medicine was reported.   This case was linked to MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-696122:Master case
Dizziness, fatigue, lightheadedness, sensation of sore/tight throat.  HR and BP wnl for patient age, good air exchange all lung fields, OP exam benign.  Resolved after 25 minutes, tolerated sips water without difficulty.
Received Varivax Wednesday morning. Started getting some bumps with itching that evening. Covered with blistering spots from head to toe by Friday morning. Went to Dermatologist and diagnosed with chicken pox. Was given Atarax and Zovirax.
Information has been received from a health professional concerning a 47 month old female with no pertinent medical history and no allergies who on 02 May 2003 was vaccinated subcutaneously with a first dose of Varivax (lot # 638367/0198M). Concomitant vaccination included a first dose of MMR II (lot # 644646/1230M). There was no illness at the time of vaccination.  On 10 Apr 2006 the patient developed 20-30 varicella lesions (previously reported as 10 itchy varicella lesions and no other symptoms). Medical attention was sought. Treatment included Benadryl and Aveeno. There was no labs or diagnostic studies performed. At the time of this report the patient recovered. No product quality complaint was involved. Additional information is not expected.
No adverse side effects were reported; TE for vaccines, which was also administered to a patient on 06/01/2023; This spontaneous report was received from a medical assistant referring to 9-week-old female patient. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 01-JUN-2023, the patient was vaccinated with improperly stored doses of: pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (0.5 mL in right thigh, formulation pre-filled syringe, lot#W039033, expiration date 01-OCT-2024, route of administration was not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (2 mL, orally, lot #1968385, expiration date 22-MAY-2024) for prophylaxis (Product storage error).  On unknown days, the suspect vaccines experienced a temperature excursion of 49.1 degrees Fahrenheit (F) for 34 minutes, 35.9 F for 2 minutes and again 35.9 F for 2 minutes. No adverse side effects were reported with the administration of the vaccines. No additional adverse event (AE) or product quality complaint (PQC) information provided.
after one week, about 5 cm down the injection site ( not on the injection site but lower) my skin was hot, red, inflamed and painful to touch. I took zyrtec and the redness and hotness subsided after 2-3 days
Information has been received from a physician concerning a male who two years ago, in 2004, was vaccinated with a first dose of varicella virus live vaccine (Oka/Merck). Subsequently, the patient experienced a shingles-like symptoms and a rash. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Two days after pt received Pfizer COVID 19 vaccine he received a MMR vaccine and a Flu vaccine from a doctor. He is unable to recall the name of the doctor.  Pt reports he started having SOB, chest pain, heart spasms, swelling of feet and legs, and his blood pressure was rising. Was seen by a Dr. at the hospital on 3/14/2022. Pt said he had blood work and a CXR. Pt was Dx with congestive heart failure. Pt said he was prescribed Furosemide 20 mg one tablet a day for 30 days. Since ER visit pt said his feet and legs remain swollen and he feels like he has fluid around his heart. He continues to hav SOB and is fatigued. He is having frequent urine output with the Furosemide medication. Pt has a follow up appointment with his PCP on 4/5/2022.
Shingrix burst capillaries in  arm; This case was reported by a consumer via interactive digital media and described the occurrence of broken capillary in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced broken capillary. On an unknown date, the outcome of the broken capillary was unknown.   It was unknown if the reporter considered the broken capillary to be related to Shingrix.  Additional Information: GSK Receipt Date: 11-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, the Shingrix vaccine burst many capillaries in his/her arm.  The reporter wanted to know whom he/she should report this to. Additional Supportive Information: The follow up would not possible as no contact details were available.
Extreme flu symptoms including headache, vomiting, fever, muscle fatigue, aches, chills, and soreness. Then I developed swelling in the arm pit on the arm I was injected.
For about six days I was miserable and not feeling very good. Fever,  fatigue, headaches and just felt like crap. I had a fever of 100.5 (highest) for three or four days. It broke and then it started feeling better on the 6th day. I had very sore shoulder for the first two days. I have regular side affects of medicine that affects me daily. I felt very miserable.  (This was worse symptoms than after I got  the second vaccine.) I have long term COVID - low oxygen issue - I went to Hospital - 11 liter 02 and 60% pressure. I was still dealing with low 02 during the day; I have insulin issues - still out of whack - doctors are monitoring it. My blood pressure has been up in the 200 range - they got it into the 160's or so but they are increasing the heart meds - they are doubling the heart meds (have some new ones - Metoprolol was ended - and  Carvedilol 25 mg take one tab twice a day; Mepacrine ER Osmtic - 30 mg one, twice a day now )- my heart is still unstable - electrical tachycardia is the name for it and that is affecting me. Inflammatory of the voice box caused by what they don't know - it comes and goes (the voice) -I will get it examined it soon - it is also causing Thrush - burning redness of the tongue. Monday the 19th of April - was in ER for 15 hours before they got me upstairs - admitted the 20th. (Have a previous spinal cord injury, hip injury etc. from work related.) Potassium - was taking one a day and I'm taking four a day now - they are not sure why but I need to take that many  now. I am also going thru a Respiratory therapist - every couple of weeks I'm going through that to strengthen my lungs.