chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a rather severe and hacking cough that was so bad that I had a hard time catching my breath at times. After a day of dealing with the cough I called the doctor and went in to see him. He ran both a COVID-19 test and influenza A and B both came back negative. I was prescribed benzonatate. I am feeling better and not coughing.
Area to right upper arm anterior deltoid of approximately 20 cm in length going distally from deltoid towards anticubital joint but not involving joint, and 16cm in width at widest point lateral to medial with irregular demarcated borders pink/erythematous in color, with warmth to touch, superficial edema.
This is a spontaneous report from a contactable nurse reporting on behalf of a physician. This nurse reported similar events for 3 patients. This is the 3rd of 3 reports. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration in the arm, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe arm pain following the injection on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016503342 Same reporter/drug/event, different patient; US-PFIZER INC-2016503345 Same reporter/drug/event, different patient.
L DELTOID PAIN AND SWOLLEN, FATIGUE Narrative:  Other Relevant History:
NECK WAS PAINFUL; EARS WERE PAINFUL; BAD CASE OF THE FLU; DIFFICULT TO SLEEP; FEELS AWFUL; BODY ACHE; LETHARGIC; SEVERE CHILLS; PAINFUL JOINTS; HEAD WAS PAINFUL; PAINFUL MUSCLE; NAUSEA; FATIGUE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 140 (pound), and height was 167.64 (centimeter). The patient's concurrent conditions included shellfish allergy, alcohlic, artheriosclerosis, cholesterol, non smoker, and contrast dye allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse. The patient experienced mild adverse events when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 10-MAR-2021 10:00 on right arm for prophylactic vaccination. Batch number was not reported and has been requested. Concomitant medications included rosuvastatin for cholesterol, ascorbic acid, colecalciferol, fish oil, magnesium, sambucus nigra, and zinc. On 10-MAR-2021, the subject experienced neck was painful. On 10-MAR-2021, the subject experienced ears were painful. On 10-MAR-2021, the subject experienced bad case of the flu. On 10-MAR-2021, the subject experienced difficult to sleep. On 10-MAR-2021, the subject experienced feels awful. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced lethargic. On 10-MAR-2021, the subject experienced severe chills. On 10-MAR-2021, the subject experienced painful joints. On 10-MAR-2021, the subject experienced head was painful. On 10-MAR-2021, the subject experienced painful muscle. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced low grade fever. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) low grade fever of 100. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ears were painful, bad case of the flu, feels awful, body ache, head was painful, nausea, and low grade fever on 13-MAR-2021, and severe chills, and fatigue on MAR-2021, had not recovered from lethargic, and the outcome of neck was painful, painful joints, painful muscle and difficult to sleep was not reported. This report was non-serious.
shortness of breath; headache; Tested positive after first vaccination; Cough/ dry cough; Flu like symptoms; diarrhea; body aches; Low grade Fever after first vaccination; fatigue; chills; Sore arm  after first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), COUGH (Cough/ dry cough), COVID-19 (Tested positive after first vaccination), DIARRHOEA (diarrhea) and MYALGIA (body aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Skin cancer. Concurrent medical conditions included Asthma since 2000, Latex allergy and Sulfonamide allergy. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), MONTELUKAST SODIUM (SINGULAIR) and SALBUTAMOL (VENTOLIN [SALBUTAMOL]) for Asthma, LOSARTAN for Blood pressure, ATORVASTATIN for Cholesterol, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for GERD.    On 03-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), DIARRHOEA (diarrhea), MYALGIA (body aches), PYREXIA (Low grade Fever after first vaccination), FATIGUE (fatigue), CHILLS (chills) and VACCINATION SITE PAIN (Sore arm  after first vaccination). On 04-Jan-2021, the patient experienced COUGH (Cough/ dry cough). On 05-Jan-2021, the patient experienced COVID-19 (Tested positive after first vaccination). On an unknown date, the patient experienced DYSPNOEA (shortness of breath) and HEADACHE (headache). On 15-Jan-2021, COUGH (Cough/ dry cough) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), COVID-19 (Tested positive after first vaccination), DIARRHOEA (diarrhea), MYALGIA (body aches), PYREXIA (Low grade Fever after first vaccination), FATIGUE (fatigue), CHILLS (chills), VACCINATION SITE PAIN (Sore arm  after first vaccination), DYSPNOEA (shortness of breath) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test: Positive.         Treatment medications included tylenol and zithromax 500 mg/1st day and 250 mg Day 2-5 orally for COVID-19 infection from 05-JAN-2021 to 08-JAN-2021. It was reported that patient isolated for 10 days.   This case was linked to MOD-2021-065029 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: adverse events have been added, treatment drug for Covid-19 infection updated, dose 2 information provided, allergies updated; Sender's Comments: Covid-19 in this patient is unlikely to be due to Moderna's mRNA-1273 vaccine. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded.
zoster rash erupting on back; acute zoster / Zoster reaction; This case was reported by a physician via sales rep and described the occurrence of rash zosteriform in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic lymphocytic leukemia.   On 1st September 2020, the patient received Shingrix. In September 2020, less than a day after receiving Shingrix, the patient experienced rash zosteriform and herpes zoster. The patient was treated with antivirals nos. On an unknown date, the outcome of the rash zosteriform and herpes zoster were unknown.   It was unknown if the reporter considered the rash zosteriform and herpes zoster to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got Shingrix and inside of 12 hours had zoster rash erupting on back and had acute zoster. The patient was started on antivirals.  No further details were provided.  The reporter consent to follow up. This case has been linked with case US2020178099 and US2020178096 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178096:same reporter US-GLAXOSMITHKLINE-US2020178099:same reporter
Pediatric client was with Mom.  Earlier had 2 primary series doses of Pfizer 5-11 without any complications.  Vaccinated without incident by staff  While seating next to Mom in post-vax client said he was nauseous then slumped in chair & lost consciousness.  Mom supported his body so never fell from chair.  Face appeared pale, pulse strong and regular .   He shortly regained consciousness (2-3 min) and was escorted to a cot to lie down.  Remained on cot an additional 15 minutes until able to sit & walk without difficulty.  Mom said he was very nervous about being vaccinated today.  No prior history of a vasovagal response.
passed out; felt dizzy; Felt fatigue; headache which lasted about 10 hours; This is a spontaneous report from a contactable consumer report for self. A 48-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0170), via an unspecified route of administration, administered in left arm on 23Apr2021 08:30 as single dose for covid-19 immunisation. None Medical history reported. No covid prior vaccination. No other vaccine in four weeks, no Other medications in two weeks. Patient received first dose of bnt162b2 (Lot number=ER8733) on 26Mar2021 03:30 PM in left arm. About 20 hours (on 24Apr2021 04:00 AM) after injection felt dizzy, passed out. Felt fatigue and headache which lasted about 10 hours. No treatment received, Patient recovered from the events. Patient has not been tested for COVID-19 Since the vaccination.
This case was reported by a nurse and described the occurrence of an approximately 18-year-old male subject who was inadvertently given a repeat dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix) for prophylaxis.  Concurrent medications included Tuberculin (TB skin test) (PPD) and Triaz.  The subject received Boostrix on 22 February 2006.  On 05 June 2006 at 14:30, the subject inadvertently received a repeat dose of Boostrix (.5 ml, unknown).  At the time or reporting, the subject had no problems with the repeat dose of Boostrix, but his current status was unknown.  On follow-up, it was noted that the subject experienced soreness at the injection site with no redness or swelling.  The event resolved on 08 June 2006 and the nurse considered that the events were probably related to Boostrix.  Per the Boostrix prescribing information, Boostrix should be administered as a single injection.  There are no data to support repeat administration of Boostrix.
3/10/20221    l:26 AM     STILL having severe pain around the kidney area on left side.
Migraine; Received first dose on 01-Feb-2022 and second dose on 22-Mar-2022 which was more than 25-35 days; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (Migraine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 01-Feb-2022 and second dose on 22-Mar-2022 which was more than 25-35 days) in a 40-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 084J21A and 084J21A) for COVID-19 prophylaxis.     The patient had no known drug allergies.  The patient's past medical history included Migraine (no recent changes in condition status) on 01-Mar-2018 and Migraine (no recent changes in condition status) on 29-Oct-2021. Concomitant products included FAMOTIDINE, IBUPROFEN (DUEXIS) from 29-Oct-2021 to an unknown date, IBUPROFEN from 01-Mar-2018 to an unknown date and FAMOTIDINE from 18-Mar-2022 to an unknown date for an unknown indication.   On 01-Feb-2022 at 12:47 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 22-Mar-2022 at 10:25 AM, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 22-Mar-2022 at 10:25 AM,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 01-Feb-2022 and second dose on 22-Mar-2022 which was more than 25-35 days). On 18-May-2022, the patient experienced MIGRAINE (Migraine). At the time of the report, MIGRAINE (Migraine) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 01-Feb-2022 and second dose on 22-Mar-2022 which was more than 25-35 days) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient weight was reported as 180. No treatment medications were reported.   This case was linked to MOD-2022-503443 (Patient Link).
About 1 week post injection patients arm started swelling and turning red at the injection site. It is also hot to the touch, itchy, and has a dull ache sporactically.  It has gotten progressively worse/covering a bigger area over the last week.
This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MYALGIA (Mild sore arm) and EXPOSURE DURING PREGNANCY (Patient received the Moderna COVID-19 vaccine while pregnant) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination. No medical history was provided by the reporter,. Concomitant products included Prenatal Multivitamins. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 25-Jan-2021 and the estimated date of delivery was 01-Nov-2021. On 03-Jun-2021, the patient experienced MYALGIA (Mild sore arm) and EXPOSURE DURING PREGNANCY (Patient received the Moderna COVID-19 vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the eighteenth week of the pregnancy. At the time of the report, MYALGIA (Mild sore arm) and EXPOSURE DURING PREGNANCY (Patient received the Moderna COVID-19 vaccine while pregnant) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Treatment medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up information received it includes First dose of Moderna vaccine, Date of last menstrual period, estimated due date.
Patient had moderate-severe reaction after administering 4 yr old vaccines including puffy facial features, breathing difficulty and hives. Dr. treated with O2 and BENADRYL.
allergic reactions; Fever; chills; Headache; her left arm (vaccine arm) developed soreness and pain.; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not reported), via an unspecified route of administration, administered in left arm on 17Apr2021 as Dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The concomitant medications were not reported. On an unspecified date the patient experienced allergic reaction, fever, chills, headache and pain in arm. The patient received treatment for the event her left arm (vaccine arm) developed soreness and pain with oinments and put some ice directly. The patient reported that she was advised by the pharmacist to "put some ice directly" to manage the bruise and consulted a day before with her doctor, and diagnosed the "pain in arm" as a burn- was given ointments. And added an ampule asked if it it a possible AE. The patient asked for her future health, she would like to know if she was allergic or if she should not have had the vaccine. Offered to transfer to Safety, but she declined due to work. Asked for Physician information, gave contact number but did not provide other information. E-transmitting AE for review (Response: Spoke from attached documents and as per the Pfizer-BioNTech COVID-19 EUA PI ,6 Overall Safety Summary and 6.1 Clinical Trials Experience, LAB-1457-7.0, Revised: 06 April 2021, explained to patient that Pfizer cannot assess causality, and referred to HCP for further guidance). The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
I am not sure that this is a result of the vaccine but I have been diagnosed with shingles and I did take the shingles vaccine in 2014 and was waiting the required two weeks to take the shingrix vaccine when I started to have issues that made me think I might have shingles. I had cataract surgery on my left eye on March 17 but I don't think that had any bearing on me getting shingles. I have heard that others have developed shingles after being vaccinated for covid-19.  That is only hear say and i have no direct information about that, So far my case of shingles is moderate.
5/11/06 Mom calls to report on 5/10/06 50 cent piece dark swollen area Rt thigh. 5/11/06 5" in diameter, red, hot and swollen. No fevers, Mom declines to have child seen. MD recommends to monitor for fevers, may apply cold pak to site, may give Motrin or Tylenol and see MD if further problems occur.
Information has been received from an RN concerning a child who on 1/4/02 was vaccinated with the 3rd dose of Hep-B vaccine recombinant (yeast). It was reported that the child subsequently developed hives. Unspecified medical attention was sought. No further info was provided at the time of this report. Conflicting follow-up from the RN stated that the child did not experience an adverse reaction. No further info is expected.
3.25 inch x 2.5 inch redness/edema itchy and tender to touch.
Pt received a flu injection and pneumonia injection in left deltoid the next day complained of fever, nausea, body aches and left arm with erythematous, indurated and measuring 10.0 x 5.0 C.
Patient presented to emergency room on 6/7/21 with chest pain, chills and fatigue. His troponin was noted to be elevated concerning for myocarditis. He was hemodynamically stable. He was admitted to Pediatric ICU for close monitoring and remained stable on admission. Initial echo was concerning for low normal function, however cardiac MRI showed normal function. His troponins trended down with ibuprofen therapy for anti-inflammation and he was discharged to home on 6/9/21.
This is a spontaneous report received from noncontactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed a mass (lump on side of their neck after getting the COVID-19 vaccine), with outcome of unknown. Additional information: Reported this to their physician. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
1hr p/vax pt exp fever, chills & somnolence. When father arrives to receive dose #3 he reported that the child had fever & chills although less severe than after first dose and simultaneous administration of Rabies Immune Globulin
Initial misuse report received from a healthcare professional on 08 October 2013. The patient had received PPD (M) 5 Tubersol and FLUZONE. Patient received 0.5ml Tubersol intramuscularly instead of FLUZONE. (No information was provided reqarding the patient). List of documents held by sender: none.
Patient received the vaccines on 9/14/20 on his left tight. Next day after the vaccine patient presented with swollen on the back of his left call the size of a golf ball with some redness. No bug bites or trauma reported. Per mom patient progressed with improvement and at the time of the evaluatio by telemedicine ( 3 days after the event) no more concerns.
The day of my 2nd vaccination, I felt a heavy pressure being forced down on myself. It started as a weakness that begun in my left arm. I felt I had unequal strength and my arm felt numb. This begun minutes after my injection. Soon after the sensation went to my whole body. I had difficulty moving from the chair to a wheelchair. I was moved to a treatment bed and layer down in the supine position. I felt extremely weak and hot. After an hour I was released home. The evening of my injection, I started to become extremely tired. My appetite disappeared and all I wanted to do was go to bed. While sleeping I was awoken due to an heating issue inside the home.  I woke up, tried to eat something, but had no desire to. I went back to bed, after taking some Tylenol. My body was starting to ache. While in bed, I begun to experience severe muscle spasms, cramps, etc. These caused me to cry. I began experience extreme changes in temperature. I went from hot to cold quickly. My mouth became very dry, and the weakness persisted. I began to experience severe pain at the injection site that radiated down into my armpit and left breast and my left shoulder blade. I could barely lift my arm. It feels as though the muscle is very ridge, hard and I have point tenderness. I continued to experience severe fatigue and after waking up this morning around 10am or so, I felt extremely hot. My temperature is reading 100.1 Tympanic. I've taken Motrin this time as I have been alternating between the two pain relievers.
Cramps, stroke like symptoms, headaches, quickly get tired, back aches, can't stand straight, knee pains, assistance with getting up and laying down, numbness, blood clot in left hand,  left knee swells and pains , unable to do the things that she used to do