chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This 39 year-old received his primary Smallpox vaccination on 07 September 2005.  He reported a dull left axilla pain "as if hit" with site tenderness (1-2/10 if left alone and 5-6/10 if touching site) beginning approximately September 9-10, 2005.  By 12 September 2005 he developed a fever, headache, chills with hot and cold sweats, and nausea. He advised medical who gave him Tylenol for his fevers and attributed his complaints to the Smallpox vaccination.    On 17 Sept 2005 he awoke with severe chest pain thinking he had "extreme gas".  Drinking soda did not help the pain nor make him burp.  He returned to his bunk, laid down and his pain worsened.  He described the pain as midsternal over his heart radiating down his left shoulder as if "I was having a heart attack."  "Someone was sitting on my chest" and "it hurt to breathe ... my lungs were being squeezed."  He complained of diaphoresis, nausea without vomiting, fevers of 102 degree Fahrenheit, and constant left axilla pain (5-6/10). He returned to medical where treatment began and he was transferred to hospital by ambulance.  Enroute the ambulance gave him SL NTG x 1 and morphine without relief of his symptoms.  Upon arrival to the hospital his EKG "looked funny" with a possible MI.  He was sent for a cardiac catherization which was normal. He spent one day in the hospital where Indocin was administered with partial relief of his pain. Morphine and Tylenol were used to supplement the Indocin without relief of breakthrough pain.  He stated only Indocin eased his discomfort.  He reported pain with breathing resolved by 19 Sept 2005, while the radiating shoulder pain resolved about 21 Sept 2005.    He reported a follow up exam by a cardiologist, 28 Sept 2005 where he reported a normal echocardiogram. He still complained that his "legs are swollen, hands feel numb and tingle as if dangled or leaned on too long" without pain.  He has an intermittent mild headache since discharged from the hospital he is unable to describe.   Review of available medical records noted the SMPX evaluation form was marked "NO" to question #12 concerning "having" chest pain, MI, angina. Further review located complaints of chest pain with negative echocardiogram, EKG and evaluations in 2001 and May 2005.  This service member did not advise anyone of past history of chest pain possibly due to the "wording" of the question. This service member had risk factors of race, HTN, family history CAD, obesity (wt 225 lbs), and elevated chol in December 2004 of 220. 12/22/05 Review of d/c summary. Final diagnosis was mild pericarditis likely secondary to viral syndrome. Pt stated he had low-grade fever and minor cough prior to admission. 12/22/05 Review of medical record - chest pain, fever & chills experienced a few days ago. Diagnosis was probable pericarditis.
Site: Pain at Injection Site-Severe, Additional Details: pateint is still having pain at the injection.  has been ongoing since first administered and has gotten worse.  informed pt to go see their doctor.
flu-like symptoms; 102+ degree fever; headaches; body aches; This is a spontaneous report from a Pfizer Sponsored Program. A 74-year-old contactable female consumer reported that she received  the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on 11Feb2021 at single dose for COVID-19 immunization. The patient had received the first dose of vaccine BNT162B2 on 24Jan2021.  Medical history included a very rare auto-immune disorder, and strictly limits her contact with other persons. Concomitant drugs were unknown.  After receiving the 2nd dose of vaccine she began to experience flu-like symptoms including 102+ degree fever, headaches, and body aches. She is questioning if receiving the vaccine early is what caused her to experience these symptoms since she was scheduled for second dose on 11Feb2021 instead of 14Feb2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Nausea-Mild; symptoms lasted for 7 days
Patient returned to office on 1/31/11 complaining of leg pains for 1 week duration, worse the last 3 nights.  Also complained of stiffness in legs. Symptoms progessed to weakness, enuresis and patient eventually diagnosed with Guillain-Barre sydrome.  Although some symptoms preceded vaccine, the concern is that the influenza vaccine contributed to the development of.
couldn't breathe at all; heart issues; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), has been sick for so many years, pulmonary distress, 100% disabled. The patient's concomitant medications were not reported.  During the call caller stated her husband got his 1st shot and the next day was in the ICU struggling for his life. States he has very bad COPD and he also got the Pfizer Covid-19 vaccine Wednesday morning and by 4am Friday he couldn't breathe at all and they called 911 and he went to the hospital. States they wanted to intubate him but he knew because of his COPD he would not get off the vent so they used CPap and got him back breathing. States that such pulmonary distress has created heart issues and he is now on heart medications, he also had a reaction to the vaccine and he has very bad COPD. Caller states her husband was not going to get his 2nd shot, she is the one that wants to make sure she is somewhat better protected. States he is 100% disabled plus the COPD. Caller states her husband has been sick for so many years and she has dealt with so many health professionals for her husband that when your mind is used to this type of thinking it automatically goes there and that is where it has been since. Therapeutic measures were taken as a result of events. Emergency Room Visit and Physician Office Visit for events. The outcome of events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
first dose of GARDASIL 9 on l 7NOV2020 and has not received his second dose yet.; No additional AE; This spontaneous report was received from a pharmacist and refers to a 30-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 17-NOV-2020, the patient was vaccinated with a first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 dose, lot # R030456, expiration date 23-JUL-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The patient did not yet receive his second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at the time or reporting (inappropriate schedule of vaccine administered). No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R030456; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Nausea, diarrhea, fever, chills, lethargy, body aches
It was reported that a female pt received a Fluzone SV '99-'00 vaccination on 10/29/99. Approx. 24 hours, post vax, the pt developed a generalized rash on both legs. The pt was reportedly seen by a NP. From additional information received on 12/9/99, it was reported, "no follow-up; pt wouldn't return phone call".
mom brought the child in with wheezing starting right after the injections and the rash 2 days after the injections  Drs. office came in for the shots.
Pt. reported bruising immediately and swelling/ redness/ itching/ within 1 week after shot. I advised her to see MD and she did. MD prescribed antibiotic and reported she had a localized infection.
SORENESS AT SITE OF INJECTION, SENSITIVE SKIN, BODY ACHES, HOT/COLD CHILLS, AND FEVERISH.
Fever; Chills; Ache; Pregnant; A spontaneous report was received from a consumer concerning his wife, a 35 years old, pregnant, female patient, who received Moderna's Covid-19 Vaccine (mRNA-1273) during pregnancy (vaccine exposure during pregnancy) and experienced chills (chills), fever (fever) and ache (myalgia).  The patient's medical history was not provided. No allergy was reported. The patient had one prior pregnancy. The first pregnancy ended on 22 May 2016 with a live, full term birth. Concomitant product included vitamin once a day via oral route for multiple use (from 12 Jan 2020).  On 26 Jan 2021, approximately 10:00 am the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Her last period on 19 Jan 2021 and estimated conception date was 02 Feb 2021. The patient's estimated due date is on 14 Sep 2021.  On 26 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine and experienced adverse events. Symptoms included pregnancy, chills, fever and ache. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the events, fever, chills and myalgia were resolved on 30 Jan 2021. The outcome, pregnant (vaccine exposure during pregnancy) was considered resolved on 26 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of chills, pyrexia and myalgia, a causal relationship cannot be excluded.  The causality for the event of exposure during pregnancy is not applicable. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
I woke up that morning with a lot of sneezing, 24th of May 2021, coughing and sore throat etc. Those were like the main primary symptoms, I also was sneezing as well. Basically head cold symptoms. I contacted the DR on May 27, 2021. The DR gave me Prednisone and Fluticasone. The DR basically thought I was having allergies.
Swelling to right lower eye lid, left upper lip, lip tingling, entire body itching, swollen nodule to forehead; symptoms began a day after vaccination and within 15 minutes of eating a dehydrated egg product containing eggs, egg yolk, and egg whites
(R) arm injection - that night (R) hand numbness and tingly that persisted until today. No pain at the site or in the shoulder region.
ended up in bed/Weak; Shaky; Migraines/ triggering migraines that took weeks to go away; stiffness went up her arm to the back of her head; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (ended up in bed/Weak), TREMOR (Shaky), MIGRAINE (Migraines/ triggering migraines that took weeks to go away) and MUSCULOSKELETAL STIFFNESS (stiffness went up her arm to the back of her head) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Migraine (She states she's had migraines since she was 30 years old.). Concurrent medical conditions included Thinking abnormal NOS.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced ASTHENIA (ended up in bed/Weak), TREMOR (Shaky), MIGRAINE (Migraines/ triggering migraines that took weeks to go away) and MUSCULOSKELETAL STIFFNESS (stiffness went up her arm to the back of her head). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (ended up in bed/Weak), TREMOR (Shaky), MIGRAINE (Migraines/ triggering migraines that took weeks to go away) and MUSCULOSKELETAL STIFFNESS (stiffness went up her arm to the back of her head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided.  The patient received her Moderna booster (lot 051F21A) on 10Nov2021 in right arm. The patient received second dose (lot 029K20A) on 06Feb2021 in right arm and Moderna booster (lot 051F21A) on 10Nov2021 in right.  The patient stated she had brain fog, but she doesn't remember whether it started after the first or second dose. She could not think straight. She states the brain fog has improved slowly,but she is not back to what she was before the first dose. She was so debilitated that she was in bed for months. It wasn't until evening that she could get out of bed. The patient states she does not know if anything could be done. She stated she was totally not functional she was still weak. She was scared to take another Moderna shot in the future.   This case was linked to MOD-2021-409950, MOD-2021-410013 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Significant follow up events updated
Patient reported cardiac symptoms (heart tightness 9/10) within 15 minutes following the injection. Tachycardia symptoms on and off ever since.  She also has severe sensitivity to EMF's and cannot be on her phone for more than 1 minute without intense tightness in her chest/heart.
Rigors in one hour. Took Benadryl and symptoms subsided in 30 minutes. Small fever for 15 hours, body aches and felt faint. Feeling normal after 48 hours.
Patient reports horrible pain in shoulder joint that has not subsided for over 2 weeks. She claims she developed a huge itchy bump at the injection site that eventually burst and appeared as a nickel sized circle of raw skin. No report of fever.
received my 2nd dose 19 days after my first; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received my 2nd dose 19 days after my first) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received my 2nd dose 19 days after my first). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received my 2nd dose 19 days after my first) had resolved.            No concomitant medications were reported.
Based on additional information received on 23 MARCH 2015, this case is considered as medically confirmed. Initial report received from a Consumer on 20 OCTOBER 2014. A 48-year-old female patient, whose medical history included allergic to sulfa and phentanyl, and concomitant medication ere not reported, had received a dose of FLUZONE (batch number: UT4993BA (site and dose in series not reported) on 17 OCTOBER 2014. The patient had experienced burning in her legs from the thigh to the mid calves, redness and swelling at the injection site, felt achey, pain in her legs from the thigh to the mid calves and rash has spread to about 5 inches long and 3-4 inches, the swelling was larger than a half dollar after vaccination in the evening on 17 OCTOBER 2014. The patient visited the emergency room. It was also reported that the patient had no illness at the time of vaccination. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the events was not resolved. List of documents held by sender: none. Follow-up information received from physician on 23 MARCH 2015: It was reported that, patient had received FLUZONE via subcutaneous route into left arm. Patient's relevant diagnostic tests/laboratory data was none reported. At the time of this report, the outcome of the events was reported as recovered.
-Post vaccination conversation with patient Revealed that he had already Received a "vaccine" -When checking with Registration we discovered that pt Had Received J&J on 3-10-21. -during completion of checklist, pt stated he had no vaccine - but when he was reminded of return date pt states this was his second dose but that nobody had called him for second.
"Flu shot reaction": sore muscles right side of back. Developed when exposed to cold. Was not feeling well a day or so after receiving the shot. Finally subsided on 10/23/04.
Wheal like bumpy rash without redness, without welting, on arms, legs, tops of hands and feet. Few bumps on the trunk and lower back. Appearing about 5 days after injection.
Sore throat and headache on 11/12/09. On 11/13/09, developed fever in addition to severe sore throat and headache.  Seen by pediatrician on 11/13/09 and informed the symptoms were a reaction to the H1N1 nasal spray.
Patient was given the wrong dose of Influenza .  She s/h/b given the 0.25mg.  This was her first influenza vaccination.
Information has been received from a health professional concerning a 19 month old white male pediatric pt with an ear infection at the time of vaccination, no past medical history and no known drug allergies who on 9/5/01 was vaccinated SC in his right leg with his 1st dose of MMRII (dosage not reported, lot 639918/0743L). Concomitant therapy that day, included a dose of HIB (mfr unk), DTP and poliovirus vaccine. Other concomitant therapy that day, included amoxicillin for an ear infection. On 9/12/01, the pt's cheeks were red and he had a blanching, red, macular rash on his trunk and upper extremities. There was little rash on the lower extremities. He developed conjunctival redness and rhinorrhea. The pt also had a temperature of 100.3F. The pt sought unspecified medical attention. On follow-up, the pt's physician reported that the pediatric pt had recovered. No further information was available.
Pt. came to clinic requesting Tdap and influenza vaccines. Denied any hx of adverse reactions to any vaccinations in the past. States her last flu vaccine was 5 years ago which she had tolerated well, pt. also had 1 Tdap dose when she was 12 years of age with no known reaction. Pt. was counseled by clinician and both vaccines were administered by staff. Pt. showed no S/s for the first 10 minutes. However, while walking out of the room, pt. reported she has difficulty breathing. Pt. was brought back in the room for further assessment during which pt. reported she cannot breathe. 911 was called. Benadryl 50 mg IM was administered by clinician. Pt. stated she felt a little better with Benadryl. EMS arrived, assessed pateint. VS - 139/94 BP, 114 HR, 18 RR, O2 Sat 100%. Pt. has hx of anxiety and panic attacks and states she got little anxious when she received the vaccine. Pt. is currently taking no medication for anxiety. Pt. refused to go to ER stating "I feel better now". VS before leaving clinic - BP 130/85 sitting L arm, Pulse 112 regular, RR 18, O2 Sat 100% Room air. Pt. left clinic with Family member. Pt. was advised to follow up with PCP.
Elevation in body temperature (recorded @ 100.1° F. by oral thermometer), chills, headache, diminished appetite, pain @ injection site. These symptoms presented within 12 to 14 hours after the injection.
C/O sore throat. Nausea/vomiting. Headache. Fever and tiredness.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or medical history was reported. On unspecified dates the patients were administered unspecified number of improperly stored doses of MMR II (lot number J006137, expiration date 24-MAY-2015 and lot number K008814, expiration date 19-JUN-2016) (strength, route and dose were unknown). No adverse event was reported. Follow up information has been received from the registered nurse on 27-JUL-2015 concerning a patient of unknown age and gender. On 24-APR-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot# J006137, expiration date: 24-MAY-2015, strength, route and dose were unknown). This is one of several reports received from the same reporter. Additional information has been requested. Patient's information, products and narrative were updated.
pt devel a sore inside-possibility of surgery-fibrosis?;shots were given in same leg;lump is between where the 2 shots were given;reporter believes shots would not have been given in same leg;
Varicella & Tdap given on 2/27/13 in (L) arm. Patient pulled away when varicella injection given so nurse had to re enter the needle. Patients arm hurt after the immunizations. On 2/28 felt slightly faint and had headache. That evening noted to have redness & swelling of the varicella immunisation site. Even showed 10 cm area erythema & slight induration. No treatment.
Mother came into clinic for booster DtaP on child and explained to nurse severe rash reaction in child post 2/8/02 MMR. Child had no fever, seizure-only rash covering body 12-24 hrs after imm. took child to PMD immediately-no recommendation from PMD or to further MMR's. M statees child not allergic to eggs.
INCORRECT PRODUCT STORAGE; ADMINISTRATION OF VACCINE OUTSIDE OF THE RECOMMENDED HOLD TIME; This spontaneous report received from a pharmacist concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: 11-APR-2022) dose was not reported, administered on 17-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-NOV-2021, the patient experienced administration of vaccine outside of the recommended hold time. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine outside of the recommended hold time and incorrect product storage was not reported. This report was non-serious. .
Severe migraine headache lasting 48 hours. Fatigue. Sore arm. Sleepiness. Body aches and pains. Prolonged fever not responsive to Tylenol. Fever peaked at 104 degrees at 10 pm (36 hours after injection). At the same time, my blood pressure was elevated to 200/100.  Severe symptoms passed after 48 hours. Minor symptoms lasted for 3 full days.
Patient devloped 40-50 vessicular lesions over her face, neck and trunk after receiving the varicella vaccination.  She did not have fever, malaise or pruritis associated with the rash.
August 6th I started showing symptoms of a Pulmonary Embolism. Started having shortness of breath, and a hard time breathing, heart palpations. I went to the Urgent Care and they did and EKG and and X-Ray. The Dr. there thought I had a blood clot so I went to the ER of August 9th, they did an EKG, blood work, and they said no one was able to see me for 7 hours so I left. I was diagnosed finally on August 11th, after they did a CT scan on top of more blood work. They confirmed that I had multiple blood clots in both of my lungs but they sent me home the same day due to the clots not being hazardous. Then that it could be treated within 6 months. So now you are undergoing treatment for these said clots.