chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine injection) was received from a physician via a company rep, regarding a 6 month old male pt who experienced a prolonged fever 103.7 deg F. The pt received the first dose on 22Jun04. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 22Jun04. Dose regimen was 0.5mL 1 time per day (IM). Concomitant medications were not reported. On 22Jun04, post immunization, the child developed a prolonged fever 103.7 deg F. Results of CBC, blood culture and urinalysis were not provided. The pt was treated with Oracef (cephalexin). It was reported that the child had 5 days of fever, and it did get better on Saturday, 26Jun2004. No additional information was available at the time of this report.
we'd given the 1st dose of the Moderna Covid-19 vaccine to a 16 yr old.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (we'd given the 1st dose of the Moderna Covid-19 vaccine to a 16 yr old.) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (we'd given the 1st dose of the Moderna Covid-19 vaccine to a 16 yr old.). On 07-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (we'd given the 1st dose of the Moderna Covid-19 vaccine to a 16 yr old.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information given.
Patient was seen in the regulatory authority for a one week follow up on 9/23/21. He was asked if he would like to receive a third dose of the covid vaccine as he is eligible based on being immunocompromised. The patient stated he wanted to receive the vaccine. Medical Assistant asked all of the screening questions prior to administration. Patient said Yes to ever having a positive Covid-19 test. Patient said No to convalescent plasma or monoclonal antibody infusion in the past 90 days. Dose of Moderna Covid vaccine was administered on 9/23/21.  Patient returned to the clinic on 9/30/21 for another 1 week follow up. During this appointment, he stated that he doesn't think he should have received this third vaccine last week because he received a monoclonal antibody infusion. Upon chart review, patient received casirivimab-imdevimab on 8/31/21. Medical Oncologist was notified and stated no intervention was needed. Clinical Research Associate was notified as this patient is currently on a clinical trial and CRA stated no intervention was needed from a clinical trial standpoint. Nurse Supervisor was notified of the error. Patient was aware of all of this.
Runny nose; Upset stomach; Extreme Headache; Fatigue; Chills; Body aches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Extreme Headache), FATIGUE (Fatigue) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M2014) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included ACETAMINOPHEN for an unknown indication.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Extreme Headache), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea). At the time of the report, RHINORRHOEA (Runny nose), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Extreme Headache), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea) outcome was unknown.            Concomitant product used included Acetaminophen.  No treatment information was reported. After the second dose of my Moderna Covid-19 vaccination on 26FEB2021 I had an extreme Headache, chills, fatigue, body aches, runny nose, nausea, upset stomach.
Irregular periods (ICD-10 - N92.6) since 13 March, 2021, with a one stop between days May 01 - 10, and bleeding continued until the current date.  The treatment indicated are Sprintec 28 0.25-35 MG-MCG (1 tablet Orally Once a day for 60 days)no good results so far. Among the symptoms: swelling of the left arm and hand right after the application of the vaccine, low fever for 2 days, change in oxygenation in the blood for 8 days (varying between 93 and 95%), swelling of the legs in the ankles, muscle pain and weakness in the legs, headache. The frame spans 84 days. And the tiredness, fatigue and aches and pains and swelling in the legs continue as well as continued period.
This case was reported by a physician via sales rep and described the occurrence of adverse reaction in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction, neck pain, shoulder pain, general body pain, lymph node pain, feeling of warmth and sweating. On an unknown date, the outcome of the adverse reaction, neck pain, shoulder pain, general body pain, lymph node pain, feeling of warmth and sweating were unknown. It was unknown if the reporter considered the adverse reaction, neck pain, shoulder pain, general body pain, lymph node pain, feeling of warmth and sweating to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient experienced systemic reactions. The reporter was agreed to FU from GSK.
Nausea, fever, muscle aches, headache, dizziness, body pain.
5/22/03: Swelling, redness, painful right arm. No fever, some itchiness. Pt to do cool compresses, ibuprofen for pain and to notify office if swelling worsens or lasts longer than 3 days.
Administered 0.2ml of the orange Pfizer cap. Incorrect dose for age.
Information has been received from a 71 year old female with allergies, nervousness to monosodium glutamate and subcutaneous redness all over who on 07-DEC-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included estrogen, PRILOSEC and ZYRTEC. A couple of months after therapy the patient had experienced a burning sensation from head to toe on the surface of the skin. It was more intense during the evening. She also stated that she was also experiencing ringing in her ear. She also had a slight redness on parts of her body and her eyes were very puffy in the morning. Consumer mentioned she had "subcutaneous redness all over" and noticed it more after getting vaccine. The patient was hospitalized. At the time of the report the patient had not recovered. Additional information has been requested.
Pt. experienced flushing, itching, throat tightness, increased B/P and heart palpitations. Given 50 mg. Benadryl IM. Sent to ED for observation.
I started to become very tired around 2:00 pm on Wednesday 12/30, with a mild/moderate headache. The fatigue and headache continued through the evening, and at around 7:30 pm I experienced stomachache and indigestion. I went to bed early at 9:00 pm, with the headache, stomachache, fatigue, and my arm feeling very sore. I slept very restlessly with horrible dreams, as if I were sick or had the flu. In the middle of the night, I'm not sure when, I woke up feeling very achy and sore and freezing cold. After using the bathroom, I passed out, and hit my head on the floor or wall, resulting in a bump/cut. My husband heard me fall and found me lying on the floor.  I kept repeating "help me" and "water", and he was thinking that I would likely need to go to a hospital. He elevated my legs, put an icepack on my head, and got me water, and I became more lucid and started to feel better. I took 2 ibuprofen and drank water, then was able to get back into bed. I was very very cold but at one point woke up sweating. I slept the rest of the night and woke up this morning at 7:00 am (12/31) feeling fine, aside from tiredness, with no temperature.
Had immunizations. Walked out into waiting room and became pale, lightheaded. Had client lay on the floor. c/o ringing in ear and seeing spots. Color gradually returned. Able to assume sitting position within 5 minutes and standing within 15 minutes.
Pain in left arm, Injection site redness, warm to the touch, swollen, hard lump
Vasovagal response near syncope. Did not fall or hit head. Vomited twice immediately after getting vaccines. Monitored in office for a few minutes until patient felt better and then was allowed to go home with parent.
This is my 2nd year of getting the 65+ Flu shot.  On Sunday Oct 23rd - received my Flu shot and was fine up until 7:00pm that evening. I started to tremble uncontrollably for about 2 1/2 hours with a temperature of 103 degrees.  The trembling of my entire body finally stopped - took first Advil and then Tylenol a few hours later for the temperature.  Was still running a low grade fever for about 24 hours and still not feeling well for 24 hours after that. I did have Covid, for the first time, on August 25th - also it was a mild case of Covid.  I have 3 Covid vaccines and this was my first sickness from it. Just wanted to let you know that I did have an adverse effect to the flu vaccine this time.  I have been receiving the flu vaccines for 6 years now and have never had any effects from them.  Not sure if it is because I had Covid 8 weeks before - but wanted to be a good citizen and report this.  I did speak with the pharmacist at location of the flu shot and she informed me that nothing like that has been reported.
This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A patient of unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced local reaction at injection site. The patient was seen at the doctor's office for the reaction. Therapeutic measures were taken as a result of local reaction at injection site and included treatment with applied ice and with unspecified over-the-counter medications. The outcome for the event was unknown.
Weird feeling in his head; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Weird feeling in his head) and HEADACHE (Headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 0391K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced HEAD DISCOMFORT (Weird feeling in his head) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (Weird feeling in his head) outcome was unknown and HEADACHE (Headache) had resolved.            Concomitant medications included medication for asthma NOS.
About 8 hours after my second shot, I developed a fever, headache and body ache. Those symptoms and general tiredness lasted about 36 hours and then vanished. Then, about two weeks after my second Moderna shot, the injection site (upper left arm) was itchy. There is now a red spot around the site, about 1-2 cm wide at the moment (17 days after). No pain.
everything the patient eats, including meat , chicken, hamburger, French fries,  smell wrong, nasty and disgusting; all food taste like chemical; if the patient try to swallow it  feels like gagging and vomiting instantly; has not been able to eat and drink except sugar, potatoes, lemonade and water since last 4 months; feels like gagging and vomiting instantly; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (everything the patient eats, including meat , chicken, hamburger, French fries,  smell wrong, nasty and disgusting), DYSGEUSIA (all food taste like chemical), DYSPHAGIA (if the patient try to swallow it  feels like gagging and vomiting instantly), FEEDING DISORDER (has not been able to eat and drink except sugar, potatoes, lemonade and water since last 4 months) and VOMITING (feels like gagging and vomiting instantly) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, 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 experienced PAROSMIA (everything the patient eats, including meat , chicken, hamburger, French fries,  smell wrong, nasty and disgusting), DYSGEUSIA (all food taste like chemical), DYSPHAGIA (if the patient try to swallow it  feels like gagging and vomiting instantly), FEEDING DISORDER (has not been able to eat and drink except sugar, potatoes, lemonade and water since last 4 months) and VOMITING (feels like gagging and vomiting instantly). At the time of the report, PAROSMIA (everything the patient eats, including meat , chicken, hamburger, French fries,  smell wrong, nasty and disgusting), DYSGEUSIA (all food taste like chemical), DYSPHAGIA (if the patient try to swallow it  feels like gagging and vomiting instantly), FEEDING DISORDER (has not been able to eat and drink except sugar, potatoes, lemonade and water since last 4 months) and VOMITING (feels like gagging and vomiting instantly) outcome was unknown.            Concomitant medications were not provided by the reporter Treatment information was not provided. The patient mentioned that salad and lettuce tasted like dirt and all drinks, including coffee, grape fruit juice tasted like an acid. The physician recommended the patient to drink water and lemonade.   This case was linked to MOD-2021-296659 (Patient Link).
Vaccine administered 6/9/16, mom noticed lump on (R) thigh the following day when bathing child. Denies fever. Lump was hard. Pt seen by doctor on 6/14/16. Treatment plan: Apply ice x 10 minutes 3x a day, acetaminophen as needed for pain.
Pt c/o pain/swelling/redness/warmth to site of Pneumovax. Obvious redness/swelling/warmth noted by RN.
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) (unknown route) 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.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided. No Treatment Information was provided.
right arm at site of injection sore/ache, underarm and side of torso on right side aching/sore (like a sore muscle), right shoulder, right side of chest at collar bone, right side of neck -- all sore/aching. Difficult to move and hurt enough to interrupt sleep. Started less than 24 hours after the dose, and persisted for approximately 80 hours.
Woke a bit dizzy which lasted all day.  Going to bed I coughed and searing pain flashed thru my body. After the initial pains my right hand felt like it'd been crushed by heavy object.  It's not as bad this morning but I'm using hemp creme to sooth the soreness.
Approximately 10 hours after receiving the vaccine, I had a sore arm.  Then experienced aches in my hip and knee joints, hot sweats alternating with chills, I did not take my temperature.  I woke up the next morning with a headache and skin sensitivity.  I took ibuprofen alternating with Tylenol and started to feel better.  I felt back to normal about 36 hours after receiving the vaccine.
The patient came into Pharmacy and stated he could not see for 30 minutes in the morning. The patient is blind one sided.
alump appeared in the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (alump appeared in the injection site) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced VACCINATION SITE MASS (alump appeared in the injection site). At the time of the report, VACCINATION SITE MASS (alump appeared in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.  No Treatment information was reported.
11/12/03  RAN LO GRADE FEVER; 11/13/03  RED PATCHES, SLIGHTLY RAISED, ON FACE AROUND EYES & CHEEKS; SPREADING TO WHOLE FACE; STILL RUNNING LO GRADE FEVER
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 05Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (04Jun2022) Negative; (05Jun2022) Negative; (06Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. Covid 19 treatment: Antiviral Paxlovid 30May2022 and stop date 03Jun2022. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11/10-ER visit-flushing of face, dizziness, chest pain, paraesthesia of both arms & face. 11/13-paresthesias of arms & legs, dizziness, lightheadedness near syncope "disconnected" feeling - Hospital admission 2 days.   12/15/2008  ER record received for DOS 11/10/20008 with DX: Chest pain r/o acute coronary syndrome. Dizziness. Pt presented with c/o dizziness, chest pressure and numbness in the arms.  PE WNL. D/C for outpt f/u of possible lung lesion.   12/31/2008 MR received for DOS 11/13-14/2008 with D/C DX:  Presyncope, lightheadedness, dizziness, hypertension and hyperlipidemia.  Pt returned to ER after a near syncopal event.  Continued to have lightheadedness. W/u (-).  Likely vasovagal event or possibly vertigo.
Patient was diagnosed in our office with Erythema Multiforma on 7/20/09. Rash started 7/18/09 on left deltoid where DTaP has been given on 7/13/09 then spread to entire left upper arm,right axilla,and all over trunk. Rash was itchy, initially raised then flat,circular and lesions varied in size from 4 to 5 cm.  No fever was noted.  Child was fully recovered 1 week later.
Pfizer-BioNTech COVID-19 Vaccine EUA 32-year-old male with history of anxiety and hypertension presents with possible reaction to the COVID vaccine.  He was in his usual state of health and doing well until he received his first dose of the Pfizer vaccine around 0740 this morning.  Around 10 minutes following the vaccine, patient became short of breath, lightheaded and had his vision gray out before losing consciousness for few seconds.  Patient was sitting in a chair at that time and did not fall or hit his head.  He was then given juice and was able to ambulate and felt better.  Patient was directed to the emergency department for evaluation.  He states that he now feels back to his baseline with no lightheadedness or difficulty breathing.  Patient states that he has passed out following blood draws in the past and usually lies down afterward. Patient's presentation is overall most consistent with vasovagal syncope, especially given his history of similar events following blood draws.   Patient was observed in the emergency department for nearly an hour and remained asymptomatic so he was discharged home with return precautions
Rash and swelling on both ears on Nov 6. Most likely not related to the vaccine but earrings being worn. Initial treatment was Benadryl and hydrocortisone, then changed to Benadryl and triamicinolone. One week later (Nov 14) scalp then forehead was swollen. After regular blood work no anolimies were found. Currently on prednisone 40mg to reduce swelling on face.
This spontaneous report was received from a registered nurse and refers to a 12-month-old male patient. The patient concomitant therapy included ferrous sulfate. The patient did not have any pertinent medical history and any drug reactions or allergies. On 13-SEP-2018, the patient was vaccinated with M-M-R II, diphtheria toxoid (+) pertussis acellular vaccine (unspecified)(+) tetanus toxoid; VAQTA, LIQUID PEDVAXHIB, PREVNAR 13, VARIVAX, PROQUAD (dose, dose number, site and route of administration, lot # and expiration date were not reported for all of them) for routine vaccinations. Subsequently on 14-SEP-2018, the patient experienced pyrexia, diarrhoea and vomiting. The patient had office visit. A treatment was given (unspecified) for the events. No laboratory diagnostics or studies was performed. The outcome of pyrexia, diarrhoea and vomiting was unknown. The relatedness between the events and the suspect vaccines were not reported.
Received pneumonia vacc. L arm Tuesday 11/27/07.  Tues. night became painful below injection site with redness & warm to touch, and swollen from below injection site on inner side of upper arm to elbow.  Says better today.