chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt called today. Started having some back pain/discomfort 3 days ago. Wife looked and he has a pimply rash on his back. Looks like small pimples. Rash on right side only at this time. Getting increasingly uncomfortable. Has not gone to see a physician yet. Recommended pt keep rash covered (loose t-shirt) at night so wife does not come in contact with. Also watch rash and follow up with MD if worsening pain. Call back to pharmacy if any other questions.
Got vaccine Thursday 2/18/21  Friday, a day after the vaccine: my left arm was sore.   Saturday and Sunday, 2-3 days after vaccine: my left arm was painful and very weak. I couldn't easily lift it over heart level.  Monday, four days after vaccine: Not much pain. Got back into regular exercise routine.   New weird side effect on Friday 2/26/21.  (8 days after vaccine): There is a red space around injection site about 2.5 inches in diameter. It is warm and itchy. It is also a little bit hard underneath it. Woke up with it. Doesn't hurt.
pt was brought to ED (Medical Center) with AMS and dyspnea; found to be positive for COVID; COVID PNA; ICU: septic shock with multiorgan system failure; family decided on GIP hospice; admitted to Hospice on 9/17/21 where she passed away 9/19/21.
fatigue; nausea; Loose biles; injection site issues; headache; Achy injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 77-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Feb2021 14:12 (Lot number: EL9266, Expiration Date: 31May2021) at the age of 77 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Time (24hr): 02:12pm, Site and Route of injection: upper left arm, Route of administration: Intramuscular, Batch/Lot number: MHSVMC: Lot EL9265; Exp: 31May2021), administration date: 30Jan2021, when the patient was 77 years old, for COVID-19 Immunisation, reaction(s): "flu-like symptoms", "injection site pain", "redness", "pain/soreness", "itchiness", "Fatigue", "Nausea", "achy", "Injection site swelling", "Headache".The following information was reported: FATIGUE (non-serious) with onset 21Feb2021, outcome "unknown", described as "fatigue"; NAUSEA (non-serious) with onset 21Feb2021, outcome "unknown", described as "nausea"; DIARRHOEA (non-serious) with onset 21Feb2021, outcome "unknown", described as "Loose biles"; VACCINATION SITE REACTION (non-serious) with onset 21Feb2021, outcome "unknown", described as "injection site issues"; HEADACHE (non-serious) with onset 21Feb2021, outcome "unknown", described as "headache"; Vaccination site pain (non-serious) with onset 21Feb2021, outcome "unknown", described as " Achy injection site ". Therapeutic measures were not taken as a result of headache.Additional information: AE term about 24 hours. Batch number. Vaccination facility type was hospital. No prior vaccinations. No relevant tests. The patient experienced events in a.m on 21Feb2021. It was reported that AE required visit to: In bed fatigue, nausea, Loose biles, Achy injection site issues, headache.  No follow-up attempts are possible. No further information is expected.
COVID Breakthrough. Patient developed weakness at home and was brought to the hospital on 11/26/21 where she tested positive for COVID.
patient was administered expired MENACTRA that expired 8 days ago with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 12-year-old female patient who was administered expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] that expired 8 days ago with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  On 16-Feb-2023, the patient received dose 1 at 0.5ml total of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Strength: standard; formulation: unknown) (lot number: U7207AA, expiry date: 08-Feb-2023) via intramuscular route in left deltoid for Immunization and on the same day patient was administered expired menactra that expired 8 days ago with no reported adverse event (expired product administered).  It was reported, caller requesting information on MENACTRA. Wanting to know next steps to take. This situation is reported as a medication error due to expired MENACTRA being administered to a patient   Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  At time of reporting, the outcome was Unknown.  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.
Patient's arm was sore; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Patient's arm was sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Patient's arm was sore). At the time of the report, VACCINATION SITE PAIN (Patient's arm was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-275210 (Patient Link).
Patient called the pharmacy this morning complaining of chills and body aches.  She was going to take some Tylenol for the symptoms. She said her temperature has gone down from 101 to 99, by 4pm this afternoon.
Lymph nodes of  swollen where the ear meets the neck Next Day Sunday 2- 7 Monday 2-8 rash & Body covered in Hives
This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer-Sponsored Program. A male patient of unspecified age and ethnicity received the second dose of PREVNAR 13 at single dose and the second dose of tetanus vaccine (unknown manufacturer), both via an unspecified route of administration on an unspecified date. Medical history included ongoing stage 6 kidney failure/kidney issues, he was trying to skip dialysis and to directly go to a transplant, he was hospitalized. The patient's concomitant medications were not reported. The second doses of PREVNAR 13 and of tetanus vaccines were given in error as documented by the doctors office, given 2 full strength PREVNAR 13 within a 35 day period, along with 2 tetanus vaccines full strength during the same time frame. On an unspecified date the patient experienced pneumonia and cough. Outcome of these events was unknown. Follow up (24May2016): New information reported from the same contactable consumer (patient's wife) includes: Patient gender, details on patient medical history, reaction data (new event of pneumonia and cough was reported). Follow-up (20JUL2016): Follow-up attempts are completed. No further information is expected.
she can't sleep; Discolored; Injection site sore; swelled up; Headache; Fatigue; Muscle sore; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (she can't sleep), VACCINATION SITE DISCOLOURATION (Discolored), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE SWELLING (swelled up) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 842L28A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced INSOMNIA (she can't sleep), VACCINATION SITE DISCOLOURATION (Discolored), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE SWELLING (swelled up), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Muscle sore). At the time of the report, INSOMNIA (she can't sleep), VACCINATION SITE DISCOLOURATION (Discolored), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE SWELLING (swelled up), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Muscle sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
He felt very nauseous; This spontaneous report has been received from a consumer regarding to a male patient of unknown age. The patient's concurrent condition, medical history, concomitant medication, drug allergies or reaction were not provided.   On 30-JUL-2020 around 3:00 pm, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, strength, dose, route of administration and anatomical location of vaccine were unknown) for prophylaxis. On the same date, 1 to 2 hours after vaccination, the patient felt very nauseous. The reporter stated that the nausea lasted well into the night, till he went to bed around 9 pm, on the same date. Additionally, the reporter stated     that the patient did not presented this symptom when he received the first and the second dose. At the reporting time, the outcome for the event was unknown.   The causality assessment between nausea and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was unknown.   This is one of two reports from the same reported.; Sender's Comments:  US-009507513-2008USA000493:
whole chest was achy; chills; achiness in both arms, then calves; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (whole chest was achy), CHILLS (chills) and MYALGIA (achiness in both arms, then calves) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 631B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and MONTELUKAST for Allergy, ASA and CLOPIDOGREL for Anticoagulant therapy, MIRTAZAPINE for Anxiety, GABAPENTIN for Foot pain, PANTOPRAZOLE for GERD, ATORVASTATIN and FENOFIBRATE for Hypercholesterolaemia, AMLODIPINE, LISINOPRIL and METOPROLOL TARTRATE for Hypertension, MELATONIN and TRAZODONE for Sleep disorder, FINASTERIDE, LEVOTHYROXINE and TAMSULOSIN for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced CHEST PAIN (whole chest was achy), CHILLS (chills) and MYALGIA (achiness in both arms, then calves). At the time of the report, CHEST PAIN (whole chest was achy), CHILLS (chills) and MYALGIA (achiness in both arms, then calves) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
This spontaneous report was received from a medical assistant, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, an unspecified number of patients were vaccinated with and incorrect stored dose of ROTATEQ lot # M046000 with expiration date on 27-JUN-2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. Other suspect therapies incorrectly stored reported were GARDASIL 9 Lot # N013695 with expiration date on 21-MAR-2019 and Lot # N018273 with expiration date on 17-JUN-2019; PNEUMOVAX 23 lot # N011305 with expiration date on 20-JAN-2019 and Lot # M029681 with expiration date on 22-JAN-2018; VAQTA lot # M031806 with expiration date on 30-MAR-2018; M-M-R II lot # reported as R56789 (expiration date not reported); RECOMBIVAX HB lot # M033096 with expiration date on 31-MAR-2018 , Lot # M020926 with expiration date on 11-AUG-2018 and ) lot # N009802 with expiration date on 19-DEC-2019. Also PROQUAD vaccine with lot # reported as # E98765 and ZOSTAVAX with reported lot # as E34567. It was reported that the vaccines were exposed to temperature of 9°C to 25 °C centigrades grades range for a time frame of 45 hours and 17 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. Lot # E34567 is an invalid lot number for ZOSTAVAX. Lot # E98765 in an invalid lot number for PROQUAD. Lot # R56789 is an invalid lot number for M-M-R II.
CDC reports: 6 mo infant developed fever to 106 & convuls following DTP/OPV/MMR immunization. Duration of illness 2 days.
Patient was administered Pediatric Dose of Hep A vaccine (Vaqta). Provider stated that patient could come back in a week and get the adult dose.  Patient was notified and asked to come back in 1 week for correct dose.
03/02/2023 I started having lower back pain, fatigue, body aches and fever 101.5. I took a home COVID test and was negative. My symptoms lasted for 2 more days and I reached out to Urgent Care on 03/04/2023. I took another COVID-19 test and tested positive. I was prescribed and completed a course of Paxlovid. 03/15/2023 tested negative.
Ten days, post vax, pt had swelling develope at site of injection in right arm. Swelling gradually resolved. There was no report of another source of swelling as an insect sting/bite. Erythema also cleared. There was no pain, lymphangitis or fever. Site was almost completely cleared today, 4/26/01.
Came down with a breakthrough COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Came down with a breakthrough COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (Came down with a breakthrough COVID). At the time of the report, COVID-19 (Came down with a breakthrough COVID) outcome was unknown. Not Provided          Concomitant products were not provided. Treatment medication were not reported.  No medical history was provided by the reporter.  Patient had a two-shot Moderna series (no booster) and recently came down with a breakthrough COVID case.  Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced non serious,  unexpected event of COVID-19 (AESI). The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced non serious,  unexpected event of COVID-19 (AESI). The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Initial unsolicited report received from a consumer on 12 February 2016. This case involves 41-year-old female patient who was vaccinated with injection of Fluzone tiv mdv (batch number not reported) intramuscularly on right deltoid on 28 October 2015. The patient's medical history includes vaccination with many doses of Fluzone tiv mdv vaccine and illness at the time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergy. The patient's concomitant medications were not reported. On 28 October 2015, eight hours following the vaccination, the patient's right arm was on fire, bright red, raised and lumpy. On 29 October 2015 (reported as next day), one day following the vaccination, the patient's arm was very sore and redness was going up to neck and face. It was reported that, the injection was given up to high on deltoid. The patient required ER/doctor visit. Laboratory data was not reported. The patient had received steroids (unspecified) as corrective treatment. The patient was recovered from events (3 weeks) on an unspecified date. List of documents held by sender: none.
Patient was given a booster dose of the Moderna vaccine. Patient was under 18 years old at the time the dose was given. He did not experience any side effects from the vaccine. There is nothing else to report at this time.
approx 5 mins p/vax pt fainted & fell to floor; VS pulse 64; resp 20; BP 100/70; skin in taact; oriented to person & place, but not time; stated felt weak & dizzy;
Patient's left arm was swollen, red and warm to touch. Patient received a PNEUMOVAX injection in left arm. Patient was told to apply cold compact and see MD if not better.
Daughter reported that on 4/13/21 pt had increased weakness and difficulty breathing, taken to ER for x-ray of lungs, small amount of fluid noted.  On 5/11/21 Pt with weakness, shortness of breath, increased edema in lower extremities, taken to ER, admitted to the Hospital with Pneumonia.  Pt now home on Hospice.
PATIENT STATED SHE WOKE UP AT NIGHT WITH SWELLING REDNESS, WARM ON ARM BUT NOT EXACTLY AT SITE OF INJECTION, SHE CALLED MD WHO TOLD HER TO APPLY ICE, SHE WAS NOT PRESCRIBED ANTIBIOTICS OR OTHER MEDICATIONS FOR REACTION. SHOWED PICTURE OF REACTION TO PHARMACIST- ARM APPEARED AS DESCRIBED (RED, SWOLLEN, POSSIBLY INFECTED).
Narrative: Patient reported lip swelling and rash over body about 18 hours after receiving both the pneumococcal and influenza vaccine.
Patient presented to clinic at 4:15pm, stating she was experiencing shortness of breath & difficulty swelling, eyes were red & swollen. Examined by Nurse practitioner,  Called EMS, but patient declined any treatment. Left clinic ambulatory.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. The nurse reported that an unspecified number of patient's were administered improperly stored ROTATEQ. The lots involved are: # L004466, exp *02-AUG-2016), # L008996, exp (01-DEC-2016) and # L013190, exp (16-NOV-2016). The outcome of incorrect product storage is unknown. No symptoms reported. No further information provided. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Medium, Additional Details: Pt had a seizure about 3 minutes after receiving the second Moderna vaccine. He previously reported to adverseve reaction with 1st vaccine. Per mom who is a RN, pt first stated that he was lightheaded and she had him sit down. Then his eyes rolled back and he had a seizure. Mom shouted to me that he was having a reaction and she called 911 from her cell phone. A few minutes later he was able to talk to his as we waited for the paramedics.
Dysphagia, difficulty swallowing medications in pill form; This is a spontaneous report from a contactable consumer (patient). A 65-year-old patient of an unspecified gender received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: El9261) via an unspecified route of administration in left arm on 12Feb2021 08:15 as single dose and had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3248) administered in left arm on 22Jan2021 08:00 as single dose for covid-19 immunization. The patient was 65-years-old at the time of vaccination. The patient medical history and concomitant medications were not reported. On 14Feb2021, the patient experienced dysphagia, difficulty swallowing medications in pill form. Vaccination facility type was doctor's office/urgent care. No other vaccine in four weeks. No treatment received for adverse event. No vaccination prior to covid. No covid tested post vaccination. The outcome of event was not recovered.
Patient received SHINGRIX on 5/30/18. He returned to pharmacy 5/31/18 and reported he had experienced chills on 5/30/18 and vomiting on 5/31/18.
Information has been received from a physician concerning a 21 year old female who on 28-NOV-2007 was vaccinated intramuscularly in the left arm with her first dose of GARDASIL (lot # 658556/1060U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 19-FEB-2008 the patient was vaccinated intramuscularly in the left arm with her second dose of GARDASIL (lot# not reported).  While in the office, the patient experienced soreness down her arm to her fingers and intermittent numbness in her hand all in the left arm. The patient used ibuprofen (MOTRIN) intermittently and was offered physical therapy, but declined. The patient recovered after 6 weeks. The patient sought medical attention in the office. Additional information has been requested.
6/3/09 office visit:  Red, warm area on left thigh, painful (to touch),
patient had left, sub-mandular lymph node, severe pain; Initial information received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 71 years old male patient who experienced patient had left, sub-mandular lymph node, severe pain (lymph node pain) , while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 01-Oct-2020, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 02-Oct-2020, the patient developed a non-serious patient had left, sub-mandular lymph node, severe pain  (lymph node pain), 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event lymph node pain at the time of reporting.  There will be no information on the batch number for this case.
Systemic: Abdominal Pain-Medium, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Nausea-Severe