chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Medium
Redness to vaccine site, tenderness and swelling.  Patient complain of pain and itching to area.
Headache, Arthralgia, HYPERtension, severe HA hypertensive 173/119 Narrative:
A few hours after I received the vaccine my heart began beating really fast and hard. I needed to take deeper breaths because of the discomfort. I also felt a bit of chest pain. Felt almost like an anxiety attack but it did not go away and the heart beats felt off. It was very uncomfortable and somewhat lightheaded. After 3 days I contacted to my doctor but could not get until the next day. I was worried so went to urgent care, they checked my vitals they and did an EKG- looked normal, blood pressure was elevated, pulse was low. Recommended I take it easy no strenuous activity. They referred me to Cardiologist. Next day, I saw my Primary Doctor, they drew blood in office, checked vitals- same as urgent care. Also referred me to Cardiologist. 4 days later I was able to see a Cardiologist the checked my vitals-ok, EKG, ultrasound, as of my I am waiting for my follow-up appointment.
Patient received Pneumococcal vaccine in right deltoid on 11/05/07 in the afternoon.  Patient informed wife on 11/06/07 that his inner right arm was swollen painful in the afternoon.  I spoke with wife at 3:20 PM on 11/06/07.  She stated that patient stated he had "inner" right arm swelling to his inner elbow.  The swelling was causing him pain.  Wife stated that patient does not normally complain of pain so to her this means that it was really painful.  I inquired if the patient has any other symptoms such as swollen tongue, difficulty breathing, rash, bumps, hives, other pain -  Wife stated "NO, he does not have anything else, no hives, just the swelling in the inner arm."  She was calling from the pharmacy counter at pharmacy so I told her that because patient had drug interactions with the treatment regime that I wanted to discuss my recommendation with patient's doctor prior to providing a recommendation.  I recommend a cold (ice) compress until I could contact Dr.  Dr. was out of the country so I contacted his other physician Dr.  Dr and I discussed and came up with the following treatment plan: Benadryl 25mg 1 po q 6 h, Tylenol 500mg 1 po q 6 h prn, and Ice compresses prn.  I then contacted wife with the treatment regime.  She stated patient was using the cold compress and she would begin Tylenol and Benadryl as soon as she purchased at pharmacy.  She asked if treament was urgent and I informed her that she needed to get the Tylenol to help his pain and the Benadryl would bring down the swellling and reaction.  She said she would go to pharmacy and pick up the medication. I then telephoned pharmacy and had the pharmacist document this intervention in the computer and located the medication for the patient.
Besides the usual fever, tiredness, achiness, I developed numbness and pins and needles the next day in my hands, my arms, spreading to my legs and feet and finally to my face and neck. On the face it's specifically my cheeks, mouth and nose.
Infection in gums where my right wisdom tooth was for a week, flu like symptoms for a day, knot in left breast for two weeks.
Had a early pregnancy loss at 7th week gestation, Spontaneous abortion, Having regular check ups and follow up with the doctors
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease stage 4, Congestive heart failure and Drug allergy (allergy to pain killers).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.No treatment information was provided.    This case was linked to MOD-2021-073000 (Patient Link).
Locally: itching, redness, warmth of arm overall; feeling of un-well shakiness lightheadedness.
Pt reports began having problems with throat closing approximately 3 hr. after receiving fu vaccine. Throat issue partly resolved and then became scratchy. Next sinuses became inflamed and swollen and she experienced red and draining eyes which persist to 10/29. Visited physician and received eye drops and BENADRYL.
3:20 c/o sore throat, tightness cough, tight;took Ibuprofen & felt better;27OCT97 states has been treated by chiropractor for past week for stiff neck muscles;chiropractor concerned may be r/t a virus;
Symptoms of hyperthyroidism began a couple of days after the 2nd dose.  Rapid heart rate, night sweats and weight loss primarily.  Blood test confirmed hyperthyroidism in May, 2021 and Graves disease was diagnosed by radioactive iodine test in July.  I am being treated with medication and the endocrinologist is recommending radioactive treatment or thyroid removal.  I had my testosterone and estrogen levels checked a couple of weeks ago and the test revealed the testosterone level to be 1720.  I am undergoing testing to find out what is happening to my adrenal and pituitary glands to cause this.  The only reason this was discovered is because of the unusual blood work.
At the unspecified time, the pt was vaccinated with Lymerix. Sometime afterward, the pt experienced paresthesias. Information received on 8/9/00 provided no additional details. Additional information has been requested. A follow up report received 2/2/2001 adds: This report was received from a primary care physician. On 7/9/2000 the pt was vaccinated with his 1st Lymerix 30 mcg with no untoward effects. One month later 08/09/2000, he received his 2nd dose of Lymerix. Afterward in August 2000, the pt experienced mild paresthesias in his legs and right mid back. The info received on 10/17/2000 reported the symptoms were ongoing but intermittent. The reporter indicated he believed the event was possibly related to vaccine. The event of paresthesia does not meet ICH serious criteria but is being submitted as an expedite report by special FDA request per 6/28/2000 letter.
Swelling, redness, erythema, pain for 8 days. Ice, topical 1% steroid cream.
Initial report was received on 25 February 2011 from a health care professional. A 42 year-old male patient with no reported past medical history, had received on 10 February 2011 at 6:30 PM an intramuscular upper right deltoid injection of ADACEL, lot number U3553CA (sanofi pasteur Ltd. lot number C3677) and an intramuscular lower right deltoid injection of FLUZONE, lot number U3796AA and at 12:00 midnight on 11 February 2011, developed an acute onset of left jaw pain and tightness. No further information was available at the time of the report. The patient's outcome was reported as recovered on 13 February 2011 at 6:30 PM. Follow-up information received on 25 March 2011 from a health care professional. No diagnosis was given for the symptoms experienced by the patient. The etiology is not known. No relevant diagnostic testing was completed, and there were no results of medical evaluation or impressions. The patient recovered without treatment or intervention. Documents held by sender: none.
flu; Initial information received on 26-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
I had a breakthrough case, I tested positive for COVID about 2 weeks after I received my 4th vaccine.
Approximately 8 hours after vaccine, patient noted to have swelling of eyelids (swollen shut) and both hands.  No other facial swelling
Welt red & warm to touch (L) leg pain. Chills, increase sleep. Currently icing area.
32 yo male with history of allergic asthma, had a syncopal event. shortly after being vaccinated. Felt lightheaded, a little nauseated. Has had similar reactions in the past with blood draws. Did not eat breakfast. Vitals wnl.  Likely vasovagal syncope.  Lasted about 5 mins. Pt given juice crackers, after 30 minutes of observation in medical tent, was sent home once symptoms resolved.
At 9:30 pm sudden onset of bad frequent cough. Cough stopped at 10:30. Woke up at 12:30 am with chills, fever, sore throat, racing heart, fast breathing, aches.
Symptoms appeared 6 days after injection.  Injection site (left arm) was swollen, red, painful, itching, rash. Symptoms have lessened over the past seven days, but still experiencing "rash" and itching.
Body aches, high fever, chills, horrible headache , i felt like i could not get enough to drink.  my tremors are also back.  started around 11pm on April 14th, 2021 and everything accept my tremors have went away within the 3rd day after the vaccine
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: Patient recevied vaccine in the pharmacy store. 24 hours after receiving the vaccine she reported to the ER with analyphlatic shock symptoms.
Patient received Pfizer COVID-19 vaccine on 12/2/21.  Patient reports the following adverse reactions: lip tingling, hoarseness and chest tightness.    Patient c/o of hoarseness, lip tingling, and chest tightness/itching after pfizer vaccine.  Patient with hx of anaphylaxis.  Dr. updated and orders to administer epi and call emergency.  Epi administer IM at 1544 and patient transferred to ED.  Report given to ED staff at bedside. - Pt received meds in ED: 0.9 % sodium chloride 1000 mL, dexamethasone sodium phosp/PF 10 mg, lorazepam 0.5 mg,  diphenhydramine HCl 25 mg, lidocaine viscous 2% 10 mL and maalox plus 30 mL... 40 mL, famotidine/PF 20 mg  - patient discharged from ED pt states she feels better and can breath normally
Pt. screened with written VAR & oral questions given by me, both asking whether he had dizziness or syncope event to prior immunizations.  Pt. denied that he had such event previously.  Vaccination, a Pfizer COVID booster, was given.  Patient was told to wait in store for 10 to 15 minutes.  Pt. was in front end of store when pt. reported not feeling well to a manager.  He reported feeling dizzy and nauseous, 10 minutes after vaccination.  Patient was given a chair to sit in.  Patient was given water to drink.  Patient began to vomit, leaning forward, into a garbage pail.  After 5 minutes or so, pt. began to feel better.   Patient did not lose consciousness while in store.  His mom was called to pick him up.  He remained seated until mom arrived to take him home.  Manager advised follow up with a medical doctor.
on day 12 I am experiencing injection site allergy. Red rash, swollen and raised. Hot to touch and spreading.
Feels dizzy; Weak; Stiff neck; Flu like symptoms; Fever; Nausea; Vomitting; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feels dizzy), ASTHENIA (Weak), MUSCULOSKELETAL STIFFNESS (Stiff neck), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CIPROFLOXACIN for an unknown indication.    On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced DIZZINESS (Feels dizzy), ASTHENIA (Weak), MUSCULOSKELETAL STIFFNESS (Stiff neck), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomitting) and HEADACHE (Terrible headache). At the time of the report, DIZZINESS (Feels dizzy), ASTHENIA (Weak), MUSCULOSKELETAL STIFFNESS (Stiff neck), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomitting) and HEADACHE (Terrible headache) outcome was unknown.            No concomitant medication was provided.
Some erythema around the injection site.  He had no difficulty breathing. Patient did take some Benadryl last night.  Also put some ice.  This morning there was some more redness.  He had a history of asthma.  He never had any difficulty of breathing.  He is not having much itching.  Due to the fact that the erythema is a little bit more than yesterday, he was brought to the clinic.  Again, no difficulty breathing, not much itching.
Patient called in and reported a side effect to her COVID-19 vaccine. This patient states that she received her first dose of the vaccine on 2/15/2021 and on 2/24/2021 @ approx. 4:30p she began to feel pain in the arm where her injection was given. The patient reports that within 2 hours she had excessive swelling and redness in her arm. She called in and spoke to CNP about her symptoms.  The patient also states that this morning she followed up with her PCP and was told that she was having a reaction to two stabilizers in the vaccine, Thromethamine and Thomethamine Hydrocholoride. At this time her arm was excessively swollen and the Dr. could visualize it through her clothing as well as excessive redness.    The patient denies any numbness, tingling, or skin changes (color/temp) in her arm. The patient is allergic to steroids so her the treatment regimen from her Dr. is Ibuprofen by day and Benadryl by night until the symptoms subside. The patient was also told not to take her second dose of the vaccine and wishes to cancel that appointment. Upon looking in the chart it appears that she was scheduled for her second dose of the vaccine on two separate days. I left the chart as is and will wait for further instructions.   The patient gave verbal permission to contact/speak with her PCP regarding this matter.
Tinnitus and  more hearing loss in my left ear,taking Flucicasone propionate nasal spray and waiting to see if there is any relief.
FLUZONE PFS, that was expired was administered to patient with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case US-SA-2022SA417187(CLUSTER).  This case involves a 6 months old female patient who was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], that was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (VAXELIS); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ), all for Immunisation.  On 07-Oct-2022, the patient was administered expired INFLUENZA QUADRIVAL A-B VACCINE with an unknown dose once (lot UT7378MA; expiry date: 30-Jun-2022; strength: standard) via intramuscular route in the left vastus lateralis for prophylactic vaccination (expired product administered)(latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This is in follow-up to report(s) previously submitted on 2/13/2009. Information has been received from a nurse practitioner concerning a 20 year old female patient with AZITHROMYCIN allergy and a history of seizures and a strong family history of cancer, who on 22-DEC-2008 was vaccinated with a dose of GARDASIL vaccine. Concomitant therapy included YASMIN. On an unknown date the patient developed a painful lump. It was reported that there is still a "knot" in the arm, tenderness and swelling.  An ultrasound was performed showing a subcutaneous small bruise and post inflammatory change. The patient was seen for an office visit. Follow-up information has been received from a nurse practitioner concerning the student. It was reported that the patient stated that she received GARDASIL vaccine in another office. On 15-JAN-2009, she was seen at this office, reporting a knot after receiving the shot that went away, then reappeared. It was described a small, tender subcutaneous lump on left upper arm. It is unknown if the patient recovered.  No further information is available.
Started having pain in right side on 14 June and broke out with shingles on 16 June.
Pt reports a small red bump on her arm and some soreness after injection. Bump and soreness went away after a few days. She reports the bump was hard and enflamed. The following weekend 1/23 a small rash the size of a quarter appeared. After 3 more days the rash has grown to be larger than her ID badge. She reports the rash as hot and itchy, but not puss forming.
Patient came 12/19/22 in and said they had arm redness from the shoulder to the elbow. She said she went to the doctor and he said it was possibly infected. I asked her what they did for her. She said they put her on an antibiotic.  I asked her how it was now and she said it was better
Approximately 12 hours after receiving the second dose, I spiked a fever of 101, felt body aches and chills. This lasted for about 1 day. On day 3, I woke with stiff, achy and sore joints in my right hand. On day 4, these symptoms remained in my right hand and moved to my left. Over the next week, stiff joints moved into my toes. EXTREME FATIGUE and mental fogginess also developed as did blood pressure spikes. On week 2, move joints started aching including knees, elbows and shoulder. On week 3, my fingers were so sore and stiff it became difficult to use door knobs. I contacted a virtual doctor to ask for direction. He assumed in was side effects and prescribed me Diclofenance Sodium 75 mg for pain. Two days later, I went to the emergency room as the pain, fatigue and fogginess was becoming very concerning. On week 4, I was finally able to see my family doctor. He assumes it is a overactive immune response to the vaccine and prescribe Prednisone 20 mg to overcome the symptoms. The course of Prednisone has decress the severity of my symptoms but on week 5 I continue to have stiff, painful joints, mental fogginess.
neurological/small tics; COVID-19; This unsolicited report was received from the patient's mother via pfizer regarding a 8-year-old male patient. The patient's concurrent conditions and concomitant therapies were not reported. The patient had 4 previous adverse reactions to vaccines.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) as prophylaxis (dose, route, lot # and expiration date not reported). Following the vaccine, the patient developed neurological tics (also reported as small tics). On an unspecified date in December 2021, the patient had coronavirus disease (COVID-19) with minor symptoms. Outcome for both events were not reported at the time of this report. The reporter stated that the tics were not related to the vaccine and she believed it was related to an immune disease; whereas causal relationship regarding COVID-19 was not provided.    This is one of several reports received from the same reporter.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 85-year-old male patient who received FLUARIX QUADRIVALENT. The patient's past medical history included stroke. Concomitant products included PROSCAR, ZETIA, amlodipine, carvedilol, clopidogrel, spironolactone, valsartan, warfarin and low dose aspirin. On 6th October 2016, the patient received FLUARIX QUADRIVALENT. On 6th October 2016, 6 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced muscle pain, mobility decreased, difficulty sleeping and pins and needles. On an unknown date, the outcome of the muscle pain was recovering/resolving and the outcome of the mobility decreased was not recovered/not resolved and the outcome of the difficulty sleeping and pins and needles were unknown. The reporter considered the muscle pain, mobility decreased and difficulty sleeping to be possibly related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the pins and needles to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: Approximately 6 hours after receiving FLUARIX QUADRIVALENT in his right arm, the patient experienced severe muscle pain around his collar bone going down through upper arm on the left side. The patient could not lift his left arm and was feeling like there were pins and needles in that arm. Due to pain, the patient had difficulty in sleeping that night. This was one of the 3 cases reported by same reporter.
Three days after I was vaccinated my arm became inflamed, red, hot, swollen.  I researched the symptoms and it appears to be ?Covid Arm? I took an Advil, Zyrtec?.and applied and ice pack.  Today is day 1.  Should I continue to report the  side effects the next few days
tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test positive: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No Treatments were provided.   Reporter did not allow further contact
Significant uncontrollable tremulousness/shaking, intermittent chills, intermittent flushing, Temp 100 deg F in ER