chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle pain; Headache; An overall feeling of lethargy; Slightly elevated fever; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced muscle pain causing myalgia on 14Mar2021 with outcome of unknown, headache on 14Mar2021 with outcome of unknown, an overall feeling of lethargy on 14Mar2021 with outcome of unknown, slightly elevated fever causing pyrexia on 14Mar2021 with outcome of unknown. Therapeutic measures were taken as a result of this with Advil   Follow-up (15Mar2021) this is a follow-up spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported that: She had both covid vaccines with 14Mar2021 being day 11 after her 2nd Pfizer shot. On 14Mar2021 she woke up with Muscle pain, headache, slightly elevated fever and overall feeling of lethargy. Took Advil and also reached Out to her physician. She is wondering if side effects this far out after receiving the shot is normal or if Something else could be going on.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Female patient that arrived to the vax site accompanied by her spouse. The patient came for her Pfizer booster and reported not having any allergic reaction to the previous doses. She also denied having any allergies. The booster was administered and few minutes after that the patient started to complain of feeling dizzy and tired. The paramedic was called and the patient was transferred to bed in a chair due to lacking of strength to walk. Patient referred having breakfast early in the morning. Water was offered and the patient referred starting to feel better after drinking it.  A physical examination was performed with negative findings. Patient presented tremors and she denied having them before. A Neurologic assessment was performed with negative findings. Was called. Gatorade was offered and improvement was observed after drinking it. Arrived and assessed the patient with no positive findings. Patient's spouse determined to transfer the patient to the hospital. Patient was taken to ER department.
Pain at injection site for 3 days R. arm chill, cold sweat, muscle aches 3 days
seizure; The initial case was missing the following minimum criteria: Identifiable reporter. Upon receipt of follow-up information on 15Jun2022, this case now contains all required information to be considered valid.  This is a literature report.  A 13-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "Seizure"; Bnt162b2 (Dose 2, Got the second vaccine in December, had another seizure.), for Covid-19 Immunization, reaction(s): "Seizure". The following information was reported: SEIZURE (medically significant), outcome "not recovered". Clinical course information: Pfizer dose had a seizure within 30 days. Got the second vaccine in Dec, had another seizure. Had the third booster, now has 4-6 seizures a day. She was an active soccer player and a good student, unable to play sports or attend class in person.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect BNT162B2 cannot be denied for the reported events.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
High fever (max. temp was 106.2).  After taking Tylenol, it came down to 104.xx for the day
Office visit on 05/18/05. Started on legs 3 days ago. Lesions spreading to face, abdomen and back. Fever 3 days ago, none since.
fever of 101.5; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101.5) 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 21-May-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 22-May-2021, the patient experienced PYREXIA (fever of 101.5). At the time of the report, PYREXIA (fever of 101.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2021, Body temperature: 101.5 (High) Fever.         Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
I was so faint/nearly passed out; so hot; very chilled for about 15 or 20 minutes; feeling sort "off"; weak; fatigued/very drained/exhausted; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176), via an unspecified route of administration on 19Jan2021 at 08:15 AM at single dose in right arm for COVID-19 immunisation. Patient age at time of vaccination was years 30 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no known allergies. The patient had no relevant medical history and received no concomitant medications. The patient reported the following: 'About 5 minutes after receiving the vaccine I was so faint I nearly passed out and was so hot I was given an ice pack to try and cool me down. It took about 45 minutes for me to be able walk across one room. I then was very chilled for about 15 or 20 minutes, and very drained. The rest of the day I was back and forth between feeling sort "off" and feeling like I was weak, exhausted, and fatigued'. Adverse events onset date was reported as 19Jan2021 at 08:15 AM. No treatment was received for the events other than ice pack for feeling hot. The patient was recovering from the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
excessive local rxn p/vax;redness & swelling >10cm 2 inj site onset w/in 48hr of inj;
Patient took the first dose on 02/20/2019 with no adverse reactions. She took her second dose on 02/23/2019 in the early morning and approximately 2-3 hours later, she vomited and had a syncopal episode and fell hitting her head and went to the emergency room and was diagnosed with a concussion.
Pt was given an adult dose of hepatitis A vaccine (Havrix) instead of pediatric dose.
Headache, Fever, Diarrhea, HYPERtension, flushing, pain and swelling in lymph nodes Narative:
still real weak, like a real bad flu; still real weak, like a real bad flu; cannot hear really well; really frustrated; Diarrhea; major chills; my whole body was shaking; Dizzy; almost fell twice; really sick; This is a spontaneous report from a contactable nurse (patient). A 73-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot/Expiration date: Unknown), via an unspecified route of administration on 30Mar2021 as single for covid-19 immunisation. Patient medical history included bone graft on18Mar2021. Patient concomitant medication included amoxicillin (500mg) taken for bone graft from 19Mar2021. Historical vaccine included patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Expiration date: Unknown), via an unspecified route of administration on 05Mar2021 as single for covid-19 immunisation. On 30Mar2021 patient experienced It was not until few hours later got severe diarrhea it was like pure water and then like 6 hours after that started having major chills, whole body was shaking and nurse had to get up to go the bathroom and patient was so dizzy, holding on to bed and she  almost fell twice, she had been holding on but she was really sick and she couldn't take temperature because she afraid coming downstairs and then the next day she was still real weak, like a real bad flu and she had no idea that If could took up the temperature because she couldn't come downstairs to take temperature. Nurse stated really frustrated, she cannot hear well. The patient reported that she just had dental surgery. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
13 month old patient was given second dose of MMR 25 days from 1st dose. As well as second dose of varicella 25 days from 1st dose. Hep A #1 was administered as well. Pt. did not have any symptoms 15 mins after administration of vaccines. Mom was advised that extra dose was given. No further treatment needed.
Was given Varicella vaccine on 3/12/07. Brother 01/26/1995 DX with chickenpox.
Patient stated that the vaccine was administered too high in the shoulder area and not in the muscle. Patient complaining of pain going down arm and up neck.
patient explains that on 2/10/21 small raised bumps occured. Her arm felt sore like she lifted something heavy. On 2/11/21 her arm has an area that is red and approx 3 inches in a circle. The area is itchy.  Orders to treat include Triamcinolone 0.5%  cream apply a small amount to the affected site twice a day  and Benadryl 25mg by mouth every 6 hours as needed
Band of itchy, burning, excruciating sparking pain on right side of back and abdomen. Shingles diagnoses, I have know idea it if is related, I've never had Shingles previously
Had an episode of SVT (previously healthy, no sx), 24-36 hrs after HPV and meningococcal vaccines.
Unspecific adverse event.; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Unspecific adverse event.) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Unspecific adverse event.). At the time of the report, ADVERSE EVENT (Unspecific adverse event.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
My son got the vaccine Bexsero before going to college. He was an amazing student and after getting this vaccine, since I can't relate his situation to anything else, he started having memory problems, he had to drop the university due to this. After researching what may have been the cause, this is the only chain I can tie with his lack of energy, mood swings, and memory problems.. My son was an A honor student at high school, learned Russian by himself, aside from German, English and Spanish. He was in a Magnet Engeneering program and now he is feeling more than depress and sad because he can't even solve an small problem!  I urge you to consider my e mail. I will continue investigating this and will urge you to give me a solution since the only event related to his problem is this vaccine which he got right before entering the university where all the problems started.
This spontaneous report received from a pharmacy technician refers to 76-year-old male patient. The patient's concurrent conditions and medical history were not reported. The pharmacy technician reported that on 23-SEP-2015 at 03:15 PM, the patient was subsequently vaccinated with an improperly stored dose of ZOSTAVAX (lot # L006382, an expiration date: 25-MAY-2016) (dose was not provided). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected because all scheduled correspondence was received.
Started getting sharp pain in upper right chest around 230PM that worsened with activity, got better with resting. Around 9P started severe nose bleed and coughing spitting blood, continued chest pains. Never had a nose bleed of cough blood before. Bleeding stopped around 15 minutes later but chest pains continued for 3 days.
Information has been received from a registered nurse (hematology case manager) concerning a 13 year old female with sickle cell anaemia who on 01-JUN-2006 was vaccinated with a dose of Pneumovax 23. On 02-JUN-2006 the patient developed pain, redness, and swelling from shoulder to wrist. The patient was referred to a hospital emergency department (ED). At the time of this report, the outcome was unknown. Additional information has been requested.
Had lump underneath my arm at the site of injection, large red spot and very very warm. Felt nausea at times, but passed. Finally went to urgent care on 11/04/2014 and they determined it was Cellulitis. Put on Clindamycin 300 mg x3 for 10 days. Area is much better today. Husband received the same shot by the same person, same place and never had any adverse effects. Person at pharmacy was the one who gave us the shots.
High fever; Headache; Vomiting; This is a spontaneous report from a contactable nurse via Pfizer sales representative. This nurse reported similar events for 4 patients. This is 2nd of 4 reports. A 16-year-old patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA), via intramuscular on an unspecified date at single dose, administered in arm 1 for immunization and meningitis , meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), via  intramuscular on an unspecified date at an unknown dose, administered in arm 2 for immunization. The patient medical history and concomitant medications were not reported. The nurse reported that the last 4 or 5 patients that they had administered both Trumenba and Menactra to experienced the same symptoms: high fever, headache and vomiting. The patients were each administered Trumenba injection in one arm and Menactra injection in the other arm at the same time. Caller was unable to verify if there was a 5th patient involved, so reports for 4 known patients provided. The affected patients were all 16 years of age at time of administration of these products. There were both male and female patients affected but number of each sex is unknown other than at least 1 of each sex. The outcome of the events was unknown (other than usually resolved and cleared up in about 24 hours).  The information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020279270 Same reporter,drug,event/Different patient
given an expired DAPTACEL, no AE; Initial information received on 01-Jul-2021 regarding an unsolicited valid  non-serious case from a other health professional and physician via Media Information  (under reference).  This case involves a 4-years-old male patient who was vaccinated with an expired dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  Concomitant medications included MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE (lot number and expiry date not reported) via an unknown route in an unknown site of administration for prophylactic vaccination.  On 24-Jun-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (total, lot number : C5624AA and expiry date 10-Jul-2021) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (expired product administered; latency: same day). Also reported that personal assistant (PA) spoke with the mom of a child who was given DAPTACEL. PA called to confirm if child should be revaccinated.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
76yr old patient presented to PCP on 10/8/18 for annual well visit. MD ordered for patient to receive PNEUMOVAX 23 and HIGH DOSE INFLUENZA vaccines. CMA prepared vaccines and administered PNEUMOVAX 23 vaccine IM in patient's right deltoid (LOT # R012550) and Influenza IIV3, IM High Dose vaccine IM in patient's left deltoid (LOT # UJ004AA). On 10/9, patient returned to office complaining of rash, erythema, swelling, itching & throbbing. Patient noted redness started at the site of injection on right arm and quickly spread circumferentially. Patient denied fever, chills, headache or drainage.  Patient did not take OTC medications for relief. MD noted "4 cm are MD noted "4 cm area of erythema and swelling noted over lateral aspect of right upper shoulder, tenderness to palpation. No fluid pockets palpated, no drainage". Per progress note diagnosis differential included cellulitis or clot or infection.  MD prescribed cephalexin 250 MG capsule; Take 2 capsules (500 mg total) by mouth 2 (two) times daily for 5 days. Patient instructed to report to ED or urgent care if need of ultrasound of right arm was needed. No further information available at this time.
On the night of vaccine, patient injection site was bright red and swollen. After 2 days, the rash move down to his for-arm and stay there for 3 days.  He went to see his doctor and got took 6 days of steroid.  Patient felt sore at the arm but didn't feel sick.
all my teeth hurt.  Sensitive to cold and heat.  Started after first shot and started to get better.  Got worse after second shot
Patient had flu mist prior to symptoms of upper respiratory congestion.  Intermittent hacking cough . Symptoms worsening
chest pain; upset stomach; fever , temperature of 102; sore throat; achy all over; stuffy head; chills; tired; Headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (fever , temperature of 102), OROPHARYNGEAL PAIN (sore throat) and PAIN (achy all over) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and DO1A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition reported.). Concomitant products included zenlafaxine, cholecaltif, METOPROLOL, DIPHENHYDRAMINE, FUROSEMIDE, NORTRIPTYLINE, MAGNESIUM OXIDE, POTASSIUM CHLORIDE, ALPHA LIPOIC ACID, BIFIDOBACTERIUM INFANTIS (ALIGN), SALBUTAMOL (ALBUTEROL HFA), FLECAINIDE ACETATE, ROSUVASTATIN, EZETIMIBE, Calcium / Vitamin D, BUPROPION, BENZTROPINE MESYLATE, ometrazole, RIBOFLAVIN, LEVOTHYROXINE, LORATADINE, VALPROATE SEMISODIUM (DIVALPROEX), L-LYSINE ACETATE and PIROXICAM for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 25-Mar-2021, the patient experienced CHEST PAIN (chest pain), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (fever , temperature of 102), OROPHARYNGEAL PAIN (sore throat), PAIN (achy all over), HEAD DISCOMFORT (stuffy head), CHILLS (chills), FATIGUE (tired) and HEADACHE (Headache). At the time of the report, CHEST PAIN (chest pain), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (fever , temperature of 102), OROPHARYNGEAL PAIN (sore throat), PAIN (achy all over), HEAD DISCOMFORT (stuffy head), CHILLS (chills), FATIGUE (tired), PAIN IN EXTREMITY (sore arm) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable.  Treatment medications included, Benadryl Dayquil Nyquil Tylenol
Six hours later hives. Next day like three different rashes on my body. I have been breaking out daily for 8 weeks and 3 days. I spent over a week in the hospital. I have been on steroids the whole ti; Six hours later hives. Next day like three different rashes on my body. I have been breaking out daily for 8 weeks and 3 days. I spent over a week in the hospital. I have been on steroids the whole ti; Six hours later hives. Next day like three different rashes on my body. I have been breaking out daily for 8 weeks and 3 days. I spent over a week in the hospital. I have been on steroids the whole ti; insane; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on 27Mar2021 14:30 (at 48-year-old) (Batch/Lot Number: ZR8733) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included lupus (antiphospholipid antibodies), diabetes, Gilbert's disease, fibromyalgia, and thyroid. Concomitant medication included insulin; lisinopril; simvastatin; and thyroid (ARMOUR THYROID). The patient previously took penicilin and experienced drug hypersensitivity. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. On 27Mar2021 19:30, the patient experienced hives six hours later (as reported). Next day like three different rashes on her body. She had been breaking out daily for 8 weeks and 3 days. She spent over a week in the hospital. She had been on steroids the whole itching and she's going insane. The patient underwent lab tests and procedures which included SARS-COV-2 test (nasal swab): negative on 07Apr2021 02:30 PM. Therapeutic measures (Steroids and other meds. Steroid creams) were taken as a result of events except mental disorder. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was not resolved.  Information on Lot/ Batch number was available. Additional information has been requested.
Patient was given PNEUMOVAX 23 along with FLUZONE HIGH DOSE and came in 3 days later presenting with red itchy reaction at the site of injection.