chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm soreness; Extreme tiredness; Sore throat; achy joints; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme tiredness), ARTHRALGIA (achy joints), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Arm soreness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ARTHRALGIA (achy joints). On 09-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On an unknown date, the patient experienced FATIGUE (Extreme tiredness) and PAIN IN EXTREMITY (Arm soreness). At the time of the report, FATIGUE (Extreme tiredness), ARTHRALGIA (achy joints), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Arm soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications reported.    Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: No specific follow-up information recorded.
She says that she had a fever for like 1 day after each of the 1st two doses; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (She says that she had a fever for like 1 day after each of the 1st two doses) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025S20A) for COVID-19 vaccination.     The patient's past medical history included Coronavirus disease 2019 (Patient had coronavirus at the end of Oct-2020) in October 2020. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PYREXIA (She says that she had a fever for like 1 day after each of the 1st two doses). In 2021, PYREXIA (She says that she had a fever for like 1 day after each of the 1st two doses) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.   This case was linked to MOD-2022-468527, MOD-2022-468589 (Patient Link).
nausea (bad); exhaustion/fatigue (bad); pain in arm; headache; Diarrhea; body aches; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in arm left on 05Apr2021 at 17:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's and Celiac disease, known allergies: Gluten, dairy and eggs, all from an unknown date and unknown if ongoing. Concomitant medications included citalopram and levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop dates were not reported. The patient experienced nausea (bad), exhaustion/fatigue (bad), pain in arm, headache, diarrhea and body aches on 05Apr2021 at 19:30. There was no treatment received for the events. The outcome of the events was recovered on an unspecified date.
DIARRHEA; VOMITING; FEVER; FEELING WEAK; HEADACHE; This spontaneous report received from a consumer concerned a 60 year old white Not Hispanic/Latino female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: not reported) .5 ml, administered on 07-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 15-JAN-2021, Laboratory data included: PCR (NR: not provided) negative. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced feeling weak. On 08-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced diarrhea. On 11-MAR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and headache, had not recovered from diarrhea, and vomiting, and the outcome of feeling weak was not reported. This report was non-serious.
Case number PHEH2013US008451 is an initial spontaneous report received from a nurse on 11 Apr 2013 with a follow up received from the physician on 29 May 2013. This report refers to a 6-months-old female patient. Her medical history was not reported. Her concomitant medications included vaccinated with PEDIARIX (other manufacturer, diphtheria, hepatitis b vaccine, pertussis, polio, tetanus vaccine, batch number: not reported) PCV 13 (other manufacturer, batch number: not reported) both at a dose of 0.5 ml into left and right thigh respectively and with rotavirus vaccine at a dose of 2 ml orally on 10 Apr 2013. It was reported that she was inadvertently vaccinated 0.5 ml intramuscular dose of MENVEO (batch number: A11076, expiry date: Apr 2014) into the left thigh on 10 April 2013. It was reported that physician spoke with her mother on 15 Apr 2013, and mother reported that there were no symptoms. No adverse event was reported. Follow up received from the physician on 29 May 2013: Updated patient demographics (height, weight), concomitant medication, vaccination anatomical location and reporter comments.
No Adverse event witnessed or reported; however, no wheal achieved when vaccine administered initially intradermally, therefore 2nd dose of 0.1 ml, ID administered and wheal achieved.
Medication Error:  Pfizer-BioNTech 12 years of age or older formulation was administered to a person age 12 years.
On Sunday Dec 5, my daughter felt breast tenderness and redness to her L breast. While showering, she felt a lump around her areola, the size of a quarter. I took her to pediatrician the next day, Dec. 6, 2021 and they sent me immediately for an ultrasound. Her 2nd covid vaccine was given to her 11/30/21. This lump appeared 6 days later, after 2nd dose.
Rapid Heart Beat; chest pain; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration in right arm on 04Jun2021 at 16:00 at age of 40-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Relevant medical history was none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive any other medications within 2 weeks of vaccination. On 07Jun2021 at 02:00 AM, patient experienced rapid heart beat and chest pain. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Outcome of the events was not recovered. No treatment received for the events. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Came in for dose #2 of Pfizer Covid19 vaccine, reports severe allergy type reaction to dose #1.  States waited 15 minutes in office after vaccination #1 then walked to her car.  When arrived at her car, felt "heat" and "fullness" swelling of throat, chest, upper airway. States had fast heartbeat and severe dizziness and weakness, spinning.  Denies rash, itching or hives or difficulty breathing. Because she was able to breathe, she stated she decided not to return to the hospital, went home. States resolved on its own, dizziness lasted into the next day.   Per fact sheet for Recipients and Caregivers, this describes a severe allergic reaction to previous dose of Pfizer vaccine and dose #2 is contra-indicated.  Discussed at length. Verbalizes understanding.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Joint Pain-Medium
Initial report received on 17 March 2010 from a local health authority for the above-mentioned trial. This reported was received from a phase II trial with investigational product MONOVALENT FLU A/H1N1 PRESERVATIVE or FLUZONE SV 2009-2010 or PLACEBO for which sanofi pasteur is not the sponsor.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Between 16-OCT-2014 and 06-NOV-2014 the patients were vaccinated with an improperly stored dose of VAQTA (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Follow up has been received on 21-NOV-2014: A telephone call was placed to the medical assistant, but she was unavailable at the time of the call. Another certified medical assistant, was available and took the call. The reporter medical assistant was provided lot number and expiration date for VAQTA (lot# K008252, expiration date 24-OCT-2014). The number and gender of the patients who received the vaccinations for this report: 1 female patient. The date range of vaccination administration was 15-OCT-2014 through 27-OCT-2014. This is one of several reports received from the same reporter. 1411USA007510, 1411USA007508, 1411USA007509, 1411USA007507, 1411USA003086, 1412USA005214. Additional information has been requested, regarding the reported incident of incorrect product storage become available.
At the time of adverse event under 32 weeks pregnant scheduled to deliver on 7/22/2021 and I delivered on 7/03/2021. I was on a trip with my husband started to exp bleeding. We drove to hospital did ultrasound couldn't figure out the cause of bleeding. I was hospitalized on May 29,2021 for a week given Steroid, Magnesium drip diagnosed with partial placental abruption and discharged on June 5, 2021 after a week with no additional treatment. I cointinued to bleed up to week with a vaginal delivery. Upon examination my placenta seem to be in tact. I had a DNC at Hospital.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild, Additional Details: pt fell from chair and felt dizzy and fainted .Rph got water and gatorade . she felt  better and went home . Rph checkecd  on pt .Mom have taled tp pedtricaid . she was much better . no too much concerned
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 18-NOV-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
DX: Pericarditis  01/20/2021 S/S: Neck pain, acute chest pain or pressure, Chest pain, more on the left side at the anterior axillary line radiating across the chest while watching a movie occurred previous day and again day of admission while walking.  Possible alternative etiology: Initial concern for ischemia given history (prior MI with stenting, significant residual disease), but pharmacologic stress perfusion study did not show change from prior. One note describes pain reproducible with palpation, raising question of chest wall pain, but not mentioned elsewhere in notes, so appears pericarditis was considered the most likely etiology.  60 year old male with extensive CAD history with new chest pain.  Was hospitalized with new diagnosis of probable pericarditis.  Reported first dose vaccine given 01/14/2021, 4 days prior to initial symptoms. Of note, would not meet case definition for pericarditis (has chest pain but no other finding), but would meet myocarditis case definition (chest pain and troponin elevation); potential myocarditis is not discussed in the clinical notes, perhaps because the troponin elevation was fairly minimal.
100.4 degree fever, severe swelling & inflammation of left arm from injection site to elbow, fatigue. No treatment reported, symptoms have mostly resolved at this time.
Lethargic; slight throbbing headache on the left side; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic) and HEADACHE (slight throbbing headache on the left side) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced LETHARGY (Lethargic) and HEADACHE (slight throbbing headache on the left side). At the time of the report, LETHARGY (Lethargic) and HEADACHE (slight throbbing headache on the left side) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included extra strength Tylenol.
pt recv vax 26OCT95 & devel a red & swollen arm,body aches & numbness from shoulder,around back of neck & down to lt arm,as well as stuffy nose & sore throat;sx persisted for about 5-6 days;pt was fully recovered as of 30NOV95;
In February I began noticing that one of my heels would not loosen up after exercise. I went to PCP and was diagnosed with bone spurs in my right heel. Was told to use ibuprofen and ice. If that doesn't work I am to return to PCP. Seems to be improving but time will tell.
Patient brought to the ED by EMS on 11/2 for evaluation of a fall. The patient's wife found patient lying on the floor next to his bed, possibly down for two hours. Patient reported he rolled out of bed onto the floor. Patient was unable to get up, so EMS was called. While in the ED, he was found to have a temperature of 100.5 F and O2 sats around 89%. Additionally, his COVID PCR test came back positive in the ED. Patient was admitted 11/2 - 11/4 for evaluation of the fall/generalized weakness and mild hypoxic respiratory failure secondary to COVID-19 pneumonia. Patient was placed on 2L O2 but was quickly weaned off oxygen.  He has received the primary COVID vaccine series and two boosters.
localized edema, rash. started day after injection and  localised reaction spread from shoulder to above elbow.  no fever, breathing difficulty, or movement limitations....just swelling and redness
Since 5 February he has complained of recurrent episodes of localized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body and also occur at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affect his soles, and resolve without post-inflammatory changes. He reports prior episodes of throat swelling which led him to present to the ER on two occasions (5 and 10 February) where he was treated with Benadryl, Pepcid, and Prednisone. He denies pulmonary, GI/GU, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 21 January, 15 days prior to onset of symptoms. He has used oral antihistamines with limited control of symptoms. He denies constitutional symptoms. UCT score today is 7 (0, 0, 0, 1, 1, 1, 2, 2).
Information has been received from a health professional concerning a 2 patients (twins) who were vaccinated with a first, second and third dose of Rotateq on 18 Oct 2006, 14 Dec 2006 and in March 2007. The third dose was administered greater than ten weeks after the second dose. No adverse experience were related to this event. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Severe Full body rash and extreme itching, had to have a steroid shot and take 5 days of oral steroids.
Patient is a 65-year-old female with history of lung cancer and COPD on 4 L nasal cannula at home, previous TIA, hyperlipidemia, chronic anemia presenting to the emergency department via EMS from home for coughing and feeling short of breath.  Patient states approximately 5 to 6 days ago she tested positive for COVID at home.  She states she has been coughing, and now states she has a brown sputum.  She denies abdominal pain, nausea, vomiting or diarrhea.  Denies chest pain.  This morning she felt more short of breath, so her daughter called 911.  Upon arrival to the ED, patient is 100% on her 4 L nasal cannula. Associated Symptoms: cough, fatigue, shortness of breath, sputum, wheezing
I received my first Moderna shot on April 1, 2021. On April 12th, I began experiencing what felt like air pressure issues in my right ear on and off throughout the day until April 14th, then I felt like I was loosing hearing on my right ear. On April 15th, exactly two weeks after recieving my first Moderna dose, I completely lost hearing on the right side of my ear and had awful ringing in my ear. I went to see a PCP and they could not diagnose me. On Monday, April 19th I went to see an ENT specialist, they did not find an infection or ear wax built up and said I may have Sudden Sensorineural Hearing Loss (SSHL) and prescribed me Prednisone. They were not 100% sure if the vaccine could be the cause but said it is a possibilty, especially as the number of people keeps increasing. My left hearing is perfect but my right is almost nonexistent.   I am 27 year old, female, petite and healthy. I have never had any hearing problems in my life and this occured within 2 weeks of my vaccination. It is difficult to hear and my quality of life just in the last week had diminished as it is overwhelming to drive, be in meetings, or even listen to music.
Patient developed numbness, tingling, weakness and discoloration of left upper extremity 6 hours after receiving this vaccine. He also developed dizziness, lightheadedness and dyspnea on exertion associated with these symptoms.
I had shot Tuesday evening at 1:22 PM. By 6:00 PM I had pain that became more severe as the nite went on. By 8:00 PM, pain in left arm reaching down arm to fingers.  Radiating into shoulder area to throat. Slight swelling on left side of neck.  Also some rapid heart beats.  Pain lasted through Thursday morning to a soreness in joint where should joins arm. Any pressure on should would cause pain to radiate down to elbow with stringing feeling. (Pain on a scale of 1-10) was at times very severe, being a 9 or 10. Ice pack, Excedrin or pain patches didn't help.
Low fever; This is a spontaneous report received from a contactable consumer, Pfizer employee. A male patient of an unknown age received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was not reported that the patient received any medication within two weeks prior to the COVID-19 vaccine. It was not reported that the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, it was not reported that the patient was diagnosed with COVID-19. Since the vaccination, it was not reported that the patient had been tested for COVID-19. On an unknown date, the patient experienced low fever. The clinical outcome of the event low fever was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Supplier updated as Pfizer; Narrative was updated for Concomitant drugs, vaccine in four weeks and COVID-19 Prior to the vaccination and after the vaccine.  Follow-up(27Jul2021):This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of a query. The response included: It would be 04Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
C/O light headedness, dizzy, sweating, nausea, weak, "sore all over". "Shivering" V\S throughout.
Irregular menstruation starting 1/25. I track my temperature, so I was supposed to menstruate and felt cramping but no bleeding. The same thing happened in February. I did resume menstruation in March.  I realize this isn't a serious event, but I saw an article today that is linking the Covid vaccine with menstruation changes.
Swelling in area, stiff neck, head ache, fever, aching all over body, dizziness and tired. I will go to ER if not gone by tonight.
She got her vaccine, she received it from the pharmacy manager, which it is usually the pharmacist but it was administered by the manager.  I put up her sleeve and she like stabbed her with her.  She has had a lot of injections and lab draws but it hurt.  She did really quick, and she felt that it hurt when she stabbed her, and it hurt while injecting the material, and it got worse and worse.  The knot got bigger and bigger.  She tried to distract herself and use it.  It was hurting her a lot, took some Tylenol as it was hurting.  She woke up in the middle of the night she felt feverish and had chills.  From that day, Wednesday she woke up with a runny nose, headache, nausea.  She tried to eat something bland and had had diarrhea.  She nausea was still there.  She kept pushing the knot down on Friday, Saturday and Sunday the same thing.  She went to chuch online as she was not well enough to go to church.  She finally started feeling better, the nausea was gone by this morning, and the diarrhea was gone by yesterday afternoon.  She felt like she had the flu.  She talked to her doctors office last year and she went to store as they had run out of the vaccine.  She was diagnosed last year with flu, but the symptoms were not as severe as it was with this vaccine.  She had never had the flu before last year, and she was able to compare to her symptoms from the vaccine, and felt that she had the flu.  she feels that there was something in the vaccine that did not agree with her.  She drank a lot of fluids and did not get a high fever.
I tested positive for COVID-19. I had a sore throat; fever of 100.5; horse; fatigue; headache; running nose; wheezing and coughing. I talked to my doctor through telehealth portal. She prescribed me PAXLOVID and prednisone because of my wheezing and asthma. My symptoms lasted for 5 days. I caught COVID-19 again on July 31st 2022 and I had fatigue and  sinus problems lasted until August 5th.
Redness, warmth at injection site.  Pain under left arm very tender in axillary area.  10/16/2003: Developed whelps from deltoid radiates under arm.
3 hours following vaccines (5PM), began to feel "chilled", achy. (Temperature not evaluated with thermometer).  8PM- Headache becoming severe, mainly in frontal area. 325 mg TYLENOL taken. Headache, and lethargy continue all 10/26/18, and called off work. Fever (? temp) continued until 1a on 10/27/18. Redness beginning 10/27/18 to injection site- approximately 2"x2", with bruising. Not as severe discomfort at site as with dose #1.