chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache  Cough Nasal Congestion  Patient is a 20 y.o. female presently 23 and 2/7 weeks gestation presenting for evaluation of cough with high risk Covid exposure to her significant other.  Endorses good fetal movement without regular contractions and without vaginal bleeding or leakage of fluid.  She is otherwise well and denies the presence of fever, chill, rigor, substernal chest pain, dyspnea, presyncope, syncope, anosmia, ageusia, myalgia, arthralgia, emesis, diarrhea, rash. No recent antibiotic use or hospitalizations. No treatment prior to arrival.  Estimated Date of Delivery: 12/7/21
Patient had redness, warmth and swelling at injection site. On 7/26 swelling was 5.5x2.5 on 7/28 swelling was 12x5.5. Physician ordered KEFLEX and MEDROL dose pack on 07/26 then patient seen in ER on 7/28.
Around 11pm (same day I got the vaccine, which was around 2pm) I noticed a rash forming that was probably around an inch or so big at the time. The injection site had a firm lump under the skin, and hot to the touch. When I woke up the next morning, I noticed multiple lumps (all under the skin) that were spread away from the initial injection site in addition to the original injection site. It gave me the impression the injection may have moved due to gravity (side sleeper). All of the lumps were painful, very red, and hot to the touch. My skin around the lumps was also red, and hot but less so. The redness continued to get bigger until Sunday (Nov 21st), which is when it started to show signs of fading. Currently my rash has faded some, but is still visible. It covers a large portion of my upper arm, and is around 6 inches around. It is still warm to the touch, itches, and feels similar to having a carpet burn. The lumps are still there, and are by far the most itchy. They also feel like a bad bruise when pressed on. I went to see the doctor on Nov 22nd, and was given a cream to put on my arm, but I have yet to start using it (need to pick it up).
A non-serious spontaneous report of 21-month-old received FLUMIST was received from a physician. No medical history or concomitant medications were reported. There was no adverse event associated with this medication error, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Rash along arm, swelling,  hot to touch, lump in arm,  pain in arm, right eye swollen
Headache; Arm pain; doesn''t feel good/well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date 21Sep2021 (Lot number: 301308A) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 21Sep2021, outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 21Sep2021, outcome "unknown", described as "Arm pain"; MALAISE (non-serious) with onset 21Sep2021, outcome "unknown", described as "doesn''t feel good/well".  Additional Information: The reporter states he is experiencing a headache, arm pain, and he just doesn't feel good or well. clarifies these symptoms started in evening, 21Sep2021. Patient's height: 5'6'' or 5'7'' and weight: 225-230lbs.   Follow-up attempts are completed. No further information is expected.
The symptoms started immediately after the shot was given I had pain in my arm. It moved into the shoulder and down my arms.  Within 2 weeks it crossed over to my right shoulder. The pain is not as heavy but it wakes me up at night.  I can still feel the pain where the injection was given. The pain started down my arm and then traveled up into shoulder. Then the crossed over into my right shoulder. I have lost mobility in my left arm along with strength. The doctor completed several test and was not able to find anything, I have seen 4 specialist and been seen in the emergency room. No abnormalities were determined. I am scheduled to see other doctors after this as I am still in pain.
Severe flare of Mast Cell Activation Syndrome Symptoms and joint hypermobilty,  resulting in severe joint pain in past injuries joints, and severe daily migraine. Unable to function.
This spontaneous case reported by a consumer, describes the occurrence of breast tenderness (some tenderness on left breast) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 004M20A) for COVID-19 vaccination. The patient's past medical history included no adverse event. On Feb 10, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced  breast tenderness (some tenderness on left breast). At the time of the report,  breast tenderness (some tenderness on left breast) outcome: unknown.
Had bruised from injection. Arm was sore a couple of days. itching started yesterday 1/15/21. Today 1/16/21 arm is very swollen ( welted) hot to touch and itching.  10 days after injection. By morning large raised welt, hot to the touch and itching. Headache
Irregular period; Excessive bleeding; Developed migraines; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 14Aug2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19.  The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Aug2021, the patient experienced irregular period, excessive bleeding and developed migraines. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events irregular period, excessive bleeding and developed migraines were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sore at the injection site; Itchy at and around the injection site; Red at the injection site; Slight lump at the injection site; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the right arm on 11Mar2021 at 18:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was unsure if the patient had any allergies to food, medications, or other products. The patient did not receive any medication within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021 at 16:00, after one week of vaccination, the patient experienced redness, soreness, slight lump and also itchy at and around the vaccination site. The adverse events result in a visit to the doctors or other healthcare professional office/clinic visit. The patient was treated with antihistamines for the reported events. The clinical outcome of the events redness, soreness, slight lump and, itchy at and around the vaccination site was not recovered. No follow-up attempts are needed. No further information is expected.
Kind of dizziness that lasted two hours; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Kind of dizziness that lasted two hours) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (Kind of dizziness that lasted two hours). At the time of the report, DIZZINESS (Kind of dizziness that lasted two hours) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Laboratory details not provided. Treatment details were not reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: No New Information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This 40 year old female nurse received annual flu vaccine at 1045am. She reported approximately 5 min after receipt of FLUARIX, her tongue and throat began to itch. She returned to the immunization clinic where she was walked down to ER with a sporadic macular rash to her right elbow and forearm (not at injection site). She denied any difficulty swallowing, breathing, or tightness in throat. She arrived in ER (1117am - seen by triage nurse 1131am and MD at 1142 hr (1 hour after vaccination)) with c/o right arm rash, and itching to face. While she denied any SOB, her exam identified mild bilateral expiratory wheezing with mild urticaria to right arm/elbow and forearm. BP 155/99, HR 78, RR 18 O2 sat 99% rm air, pain 0/10. She was treated with IV antihistamines (BENADRYL 25 mg IVP and PEPCID 20 mg/50 cc NS), IV steroids (DECADRON 8 mg IVP), 250 cc NS bolus and 2 Albuterol HHN with resolution of all symptoms. She was sent home with oral BENADRYL and ZANTAC which she used for next 3 days w/o return of symptoms. (NOTE: ER record documents first left then right arm hives/rash with MD documenting only right arm urticaria and nurses notes documenting rash to right arm and hives on left -- pt states had rash/urticaria to right arm and face, not left arm).
Information has been received from a consumer referring to her daughter, a female patient of unknown age. The information of concurrent conditions, medical history and concomitant medications was not provided. On an unspecified date in November 2014 and 28-AUG-2015, the patient was respectively administered her first and second dose of GARDASIL (strength, dose, frequency and route were not provided). No adverse effect was reported. Additional information is not expected as the reporter did not wish further contact.
extreme fatigue and lethargy, memory loss, low blood pressure, dizziness, rapid dehydration, symptoms similar to dysautonomia
Severe tendonitis and muscle pain in both shoulders and both hips.  Sustained up to 2nd shot and morning after 2nd shot could hardly move.  I get some relief with NSAID's.
COVID-related hospitalization after being vaccinated with Janssen vaccine 3/9/2021.  Per hospital Notes: Admitted 3/14/22  Discharged 3/16/22  Presented with shortness of breath that has been worsening over 5-6 days. Had a productive cough over the past 5 days, as well as fever.  Diagnosed with acute COPD exacerbation with possible bronchitis and COVID positive   Chest X-ray: no acute abnormalities  Given IV steroid (methylprednisolone) and inhaler treatments during admission   Rocephin and doxycycline were initially started then de-escalated to azithromycin on 3/15 to complete a 5 day course  At discharge-breathing back to backline  Discharged with azithromycin, MUCINEX, prednisone and Spiriva Respimat
Ongoing fever for 7+ days, 100.6 F 4/7 onset, weakness, fatigue
12 days after my first dose, I had significant upper lip swelling,without any other symptoms of an allergic reaction.  It took about 18 hours for the swelling to subside.  Since then, every 5-14 days I have either my upper or lower lip swell for 6-18 hours, without any other signs or symptoms of an allergic reaction.
Localized erythema/edema affecting left upper extremity and axilla beginning 24-48h after vaccine administration. Progressed to lip/tongue angioedema.  8/21/09 PCP medical records received DOS 8/14/09 to 8/14/09. Assessment: Angioneurotic Edema, Other Adverse Food Reactions, Allergic Rhinitis. Patient reports left upper extremity axilla and tongue/lip angioedema beginning 24-48 hours after Tdap left upper extremity.
Clot blood; Joint pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4348038-00 (AbbVie).  A 63-year-old female patient received BNT162b2 (BNT162B2), in Jan2022 as dose 3, (booster), single (Batch/Lot number: unknown) at the age of 63 years intramuscular for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous for psoriasis. The patient's relevant medical history included: "pseudo gout" (unspecified if ongoing), notes: pseudo gout; "Interchange of vaccine products" (unspecified if ongoing), notes: Janssen COVID-19 vaccine/Pfizer BioNTech COVID-19 vaccine/ were also considered suspect. The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (hospitalization, medically significant), outcome "unknown", described as "Clot blood"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain". The action taken for risankizumab was unknown. Clinical coarse: Patient felt that blood clot was related to COVID vaccine but her physician did not agree. She stated Skyrizi (Risankizumab) calmed her arthritis but still she had the symptoms. The reporter causality for the event of blood clot and joint pain with Skyrizi (Risankizumab) was not provided. It was not known if the patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "clot blood" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Joint pain everywhere weak fatigue  flareup of lipus or myasthenia gravis mid morning after sweeping garage and moving arm a lot after being in remission sunce 2009
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified date, the RECOMBIVAX HB had a temperature excursion of 24 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". On 29-JUL-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10 Pk 5mcg/0.5ml SDLLokCap Ped" which had a lot number of K018986 and expiration date on 03-APR-2016 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Projective vomiting (one time), 102 deg F temperature, unusual fuzziness, lethargy when she woke up this morning (11/19) when she is usually active. All these within 24 hrs period.
lack of effect; This case was reported by a consumer via call center representative and described the occurrence of hepatitis b antibody negative in a 35-year-old female patient who received Hepatitis B vaccine for prophylaxis.   The patient's past medical history included chickenpox (chicken pox outbreak in past). Concurrent medical conditions included ulcerative colitis (chrone's disease), hypothyroidism and immunocompromised (immunosuppressant therapy).   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced hepatitis b antibody negative. The patient was treated with thyroid medication {nos} (Thyroid Medication). On an unknown date, the outcome of the hepatitis b antibody negative was unknown.   The reporter considered the hepatitis b antibody negative to be unrelated to Hepatitis B vaccine.  Additional details were provided as follows: This case was reported by the patient's mother. The age at vaccination was not reported. The patient had a history of having chicken pox breakout in the past.  The patient's medical history of ulcerative colitis which was now Chrone's disease. The patient was on medications such as Humara, thyroid medication and she would be started on (azothiaprine) Imuran soon. Her physician wants to give her the shingrix shot (even though she would be started Imuran soon), along with the MMR, and HPV vaccine but the patient was concerned about getting these when taking immunosuppressants. The reporter mentioned that the patient had the hepatitis B injection series (unknown number of doses) and that because of her immunosuppressant therapy, the hepatits B vaccine had completed washed out.  the patient had to have both Hepatitis B injections again.  This was all the information collected.
Pt had symptoms of leg pain starting 03/30/21. Had a negative ultrasound at that time. Pt received vaccine 04/14/21. Then developed severe leg pain/swelling and cough a few days later. Was then subsequently diagnosed with a saddle PE and extensive lower extremity DVT requiring thrombectomy/thrombolysis on 4/30/21. She continues on full dose anticoagulation at this time.
had arm pain at injection site; her arm is numb to her hand on injection site side which is the left side.; From the injection site up to her neck is hurting; feels weak and tired; feels weak and tired; she can't feel her hand up to her fingers; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0198, Expiration Date: not reported) via an unspecified route of administration on 12Jul2021 as dose 1, single for COVID-19 immunization (at the age 16-year-old). The patient's medical history and concomitant medications were not reported. The patient experienced had arm pain at injection site, her arm was numb to her hand on injection site side which was the left side, from the injection site up to her neck was hurting, not horrible pain just aching, feels weak and tired, feels weak and tired, she can't feel her hand up to her fingers on an unspecified date in Jul2021. It was reported that, it was patient's first vaccine and getting the second dose on 02Aug2021. The outcome of the events was unknown.  Information about lot/batch number is requested.
No additional AE reported; the patient was vaccinated with GARDASIL 9 at age 54; This spontaneous report was received from a medical assistant referring to a 54-year-old female patient. The patient once had an abnormal pap smear. The patient's other medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were unknown.   On 01-MAR-2023 (also reported as "after having an abnormal pap smear"), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (0.5 ml, lot#: W021345, expiration date was reported as 01-MAY-2023 but upon internal validation indicated as 01-DEC-2024; strength, route of administration, and anatomical location were not reported) for prevention of human papillomavirus (HPV) (product use issue). No additional adverse events (AE) were reported (no adverse event).
Exposed to COVID-19 on either Nov. 13 or 14 per notification system on Nov. 16 AM after 5-day trip for a national conference with 6,000 people. Sore throat started on Tuesday, Nov. 15 PM after flying home. Tested negative at home on Wed, Nov. 16. Went to Urgent Care on Friday, Nov. 18 for PCR test with results provided on Nov. 19th as positive for COVID. Received Rx for Paxlovid and have taken all but final two doses to date (Nov. 23, 2022). Symptoms Nov. 18-22 included fever (100.1 highest), sore throat, cough, chest congestion, body aches, headache, diarrhea (for only 1 day), dry mouth. Felt mostly like a bad cold or the flu. Started feeling better on Nov. 20 after starting Paxlovid regime. Fever only lasted 1.5 day.s No fever since Nov.  19th, PM. Still minor coughing and chest congestion. Minor headache on 11/23/22.
Myocarditis. Troponin levels have been ranging from 7-13. Started with minor chests pain. Then he had very bad jaw pain and chest pain started again.
Information has been received from a medical assistant referring to multiple unspecified patients. On multiple unspecified dates the patients were vaccinated for prophylaxis with RECOMBIVAX HB (Lot # L039660, expiration date 04-FEB-2018), which was improperly stored at 61.03 F for 3 hours 38 minutes. The temperatures were not logged with a data logger and there were no previous excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA006816: US-009507513-1612USA006817: US-009507513-1612USA004271.
NO ADVERSE EFFECT REPORTED .   PATIENT IS 2 YEARS OLD  .. LOCAL LAW/PROTOCOL ALLOWS PHARMACIST TO VACCINATE KIDS AGE 3 AND UP
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 04-JUN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 24, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.