chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Elevated blood pressure both systolic and diastolic; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Elevated blood pressure both systolic and diastolic) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Bleaches & cleansers sensitivity and Allergic reaction to drug. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA 24 HOUR) for Allergy.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HYPERTENSION (Elevated blood pressure both systolic and diastolic). At the time of the report, HYPERTENSION (Elevated blood pressure both systolic and diastolic) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Heart rate: increased (High) slight elevation in pulse. On 17-Mar-2021, Blood pressure measurement: 168/89 (High) high. On 23-Mar-2021, Blood pressure measurement: 120/75 (normal) normal. On an unknown date, Blood pressure measurement: 122/79 (normal) normal and 167/85 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received contains significant information - Updated patient demographics, Allergic conditions, Concomitant medication, Outcome provided.
Local reaction to vaccine,  very red, swollen, painful. started abx 10/10/19, sx started to improve/ resolve 10/12/19,
Approximately 2 or 3 minutes after receiving vaccines, pt stated that he felt weird and started to sway. Then he passed out. After several minutes, he regained consciousness. He has never had a syncopal event before. He had not eaten breakfast on that day.
Pain at site injection point didn't clear, was spreading, also noticed slight pain in shoulder. Treated with ibuprofen. Continued to worsen until diagnosed 9/20/13 with frozen shoulder. After research and finding many same type injuries, decided to report. No other injuries.
Minor cough starting around 8:00PM. Chills and minor fever (100F) developed by 11:00PM. By 1:00AM (10/20/2016) I had developed significant nausea but did not vomit. I was nauseous for approximately 3-4 hours. Over the course of the day after vaccination I had loss of appetite and some nausea, but never vomited.
When I caught covid it started with a dry cough and feeling run down on a Friday. Then on Saturday I had a hard time staying awake. Then I eventually started to get sinus congestion, sinus pressure, a headache, extreme fatigue, and dizziness. I also slept a lot. I mostly had head cold symptoms. I have been taking 800mg of Advil for every 6 hours and Sudafed every 6 hours and Mucinex DM 2 times every 12 hours. I'm still not feeling 100% better yet.
Throat,lips, tongue became itchy and swollen. I had shortness of breathe. Left arm and right leg went numb. Severe vomiting and high fevers followed. Right leg and foot still very swollen, heavy and throbbing pain.
Sick for three and a half weeks; tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for three and a half weeks) and COVID-19 (tested positive for COVID-19) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick for three and a half weeks) and COVID-19 (tested positive for COVID-19). At the time of the report, ILLNESS (Sick for three and a half weeks) and COVID-19 (tested positive for COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was provided by the reporter  No treatment information was provided by the reporter.  Patient had primary vaccination series more than 6 months ago. The Sunday after the holiday patient tested positive for COVID-19.  Company comment: This case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the non serious unexpected AESI of COVID-19 after the second dose of mRNA-1273. The patient reported that tested positive for COVID-19 and was sick for 3.5 weeks, after primary vaccination series which received 6 months ago. No more information provided.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the non serious unexpected AESI of COVID-19 after the second dose of mRNA-1273. The patient reported that tested positive for COVID-19 and was sick for 3.5 weeks, after primary vaccination series which received 6 months ago. No more information provided.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
same day of vax, about 1 hr p/the vax devel a fever which persisted in spite of APAP & tepid baths; next day fever to 103 plus swollen extremity (vax site in arm swollen to the elbow);
On 1/7/21; has a large hive/lump; itchy; hot to touch; redness. Patient had no adverse symptoms until 1 week after the initial injection.
After the second shot within a week I noticed round patchy hair loss in my beard.  Never have had this before it was sudden  and the hair was gone.
Patient was under 18 years old and given a Moderna vaccine. Patient was informed and did not have any reactions thereafter.
pt found unresponsive w/o respiration rushed to hosp-pronounced DOA: pt found lying face down in vomitus w/o respiration rushed to ER-pronounced DOA:
Client received Moderna vaccine at about 2:45 pm.  At 3:04 observed to be vomiting.  Reported headache, feeling weak and nauseated.  Pulse 100.  BP 80 (systolic).  Had client lie down on floor with feet up on chair. After 30 minutes BP improved to 120 (systolic).  Sat on chair and BP held with systolic of 120. Drank juice and vomited a small amount after that.  After 15 minutes drank 6 oz juice, ate crackers, no nausea reported, headache eased.  Felt clear and able to leave at 4:15 pm.  Able to state medical resources she could contact if symptoms returned.
The 2nd day after the shot the Lymphnode on the left side of my neck began to swell. 5 days later it was the size of a baseball and was sensitive to the touch. Currently it is about the size of a golfball.
episodes of nausea; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and NAUSEA (episodes of nausea) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). In May 2021, the patient experienced NAUSEA (episodes of nausea). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved and NAUSEA (episodes of nausea) outcome was unknown.            No concomitant medications reported.  Treatment information not reported.
Patient seen for 4 year WCC 01/31/2022. Caregiver consented to Kinrix, ProQuad, and Influenza vaccines. Patient presented for acute visit 02/03/2022 with mother reporting child having immediate redness to left upper thigh the night after vaccines that increased in redness, warmth, itching, pain, and hardness, in which child was then seen in office with site measuring about 10x14cm and concerns for signs of cellulitis. Patient was treated with oral antibiotic course of Keflex with improvement after beginning course of antibiotic, awaiting follow-up in 1 week to check for resolution.
Case number PHEH2012US020587 is an initial spontaneous report received from a nurse on 10 Oct 2012, and with a follow up received on 10 Oct 2012. This case refers to a 16-year-old female patient. She was vaccinated with lyophilized A component of MENVEO vaccine (batch number: M10059, expiry date: Jan 2013) reconstituted with sterile water instead of the MenCYW-135 liquid component of MENVEO on 02 Oct 2012. No adverse event was reported. No other information was available. Follow up report received on 10 Oct 2012. Expiry date of the vaccine updated.
#4 Rabies vax 2NOV95;3NOV95 lt arm warm & swollen from elbow to shoulder; very itchy
My son had high fever and two low grade fevers of 94 degrees. So we took him to ER. We kept we him over night bc of the low grade fever and very low neutrophil level of .485. Normal is .1000  He was very tired and weak. He had thrown up as well.  He was not himself for over 3 weeks. And my doctor was worried that he developed neutropenia.
01/24/21 itching at the vaccine site started 01/25/21 baseball size red itchy rash, flu like symptoms (hot/cold, nasuea, headache) fatigue, body aches (took zyrtec and advil) 01/26/21 itching at vaccine site, rash decreasing. body aches and fatigue
the patient was seen in the office and the lesions appear to be caused by chicken pox; On an unspecified date last week a patient was administered an initial dose of VARIVAX and on an unspecified date since the administration he began experiencing lesions on an unspecified location on his body; This spontaneous report has been received from a physician via company representative, concerning a male patient around 4-years old. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On an unknown day in January 2020 (reported as last week), the patient was vaccinated with an initial dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, 1 dosage form (concentration, frequency, administration route, anatomical location, lot number, and expiration date were not reported) as prophylaxis (reported as varicella prevention).  On an unknown date in 2020 (since the administration), the patient began experiencing lesions on an unspecified location on his body. He was seen in the physician's office on 03-FEB-2020 and the lesions appear to be caused by chicken pox (rash vesicular, skin lesion). Laboratory test was ordered to confirm if the lesions were caused by chicken pox.   The causality assessment between varicella virus vaccine live (Oka/Merck) (VARIVAX) and the occurred event was not reported.
Vaccine was expired on 24-Oct-2021and administered on 25-Oct-2021/expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021and administered on 25-Oct-2021/expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021and administered on 25-Oct-2021/expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021and administered on 25-Oct-2021/expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 102 doses.   The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
Patient reported getting COVID arm, lung pain when coughing, hallucinations and fevers/chills that lasted from the day of immunization through four days later. Patient did not require prescription treatment nor a doctors visit. Patient did not state if OTC treatment was required to control symptoms.
I am aching; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (I am aching) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (I am aching) and HEADACHE (Headache). At the time of the report, MYALGIA (I am aching) and HEADACHE (Headache) outcome was unknown.            The concomitant medications were not reported.  The treatment information was not provided.
Shaking chills, fever lasted 4 hours then fatigue for 12 hours.
Yellow Diarrhoea; felt sick, felt more sick; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Yellow Diarrhoea), ILLNESS (felt sick, felt more sick) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced NAUSEA (nausea). On 14-Apr-2021, the patient experienced ILLNESS (felt sick, felt more sick). On 15-Apr-2021, the patient experienced DIARRHOEA (Yellow Diarrhoea). At the time of the report, DIARRHOEA (Yellow Diarrhoea) and ILLNESS (felt sick, felt more sick) outcome was unknown and NAUSEA (nausea) had resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. No treatment information were reported.
Fever within 1 day of immunization. Increased fussiness since immunization lasting approximately 1 week to the extent that the parents described him as "not my child." 2 seizure-like events lasting up to 3 minutes unassociated with feeding (note that the child has had similar seizure-like events prior to receiving the immunizations and has a past history of gastroesophageal reflux and aspiration).
She has red welts same size of an egg, and they hurt; same arm of the injection is hot and he feels like it burns; same arm of the injection is a little swollen; redness on same arm of the injection; same arm of the injection  itch but she don't want to scratch the zone.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (She has red welts same size of an egg, and they hurt), VACCINATION SITE WARMTH (same arm of the injection is hot and he feels like it burns), VACCINATION SITE SWELLING (same arm of the injection is a little swollen), VACCINATION SITE ERYTHEMA (redness on same arm of the injection) and VACCINATION SITE PRURITUS (same arm of the injection  itch but she don't want to scratch the zone.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06SF21A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concurrent medical conditions included Diabetes, Thyroid disorder, Hypertension, Arrhythmia, Cholesterol, Gastritis, Urinary infection and Cardiovascular disorder. Concomitant products included PROPRANOLOL for Arrhythmia, MONASCUS PURPUREUS (RED RICE YEAST) for Cardiovascular disorder, OMEGA-3 FATTY ACIDS and EZETIMIBE (ZETIA) for Cholesterol, METFORMIN for Diabetes, OMEPRAZOLE for Gastritis, LISINOPRIL for Hypertension, LEVOTHYROXINE for Thyroid disorder, CHLORTALIDONE (HIPREX [CHLORTALIDONE]) for Urinary infection.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced URTICARIA (She has red welts same size of an egg, and they hurt), VACCINATION SITE WARMTH (same arm of the injection is hot and he feels like it burns), VACCINATION SITE SWELLING (same arm of the injection is a little swollen), VACCINATION SITE ERYTHEMA (redness on same arm of the injection) and VACCINATION SITE PRURITUS (same arm of the injection  itch but she don't want to scratch the zone.). At the time of the report, URTICARIA (She has red welts same size of an egg, and they hurt), VACCINATION SITE WARMTH (same arm of the injection is hot and he feels like it burns), VACCINATION SITE SWELLING (same arm of the injection is a little swollen), VACCINATION SITE ERYTHEMA (redness on same arm of the injection) and VACCINATION SITE PRURITUS (same arm of the injection  itch but she don't want to scratch the zone.) outcome was unknown.            Treatment medication included: Prosenogel   This case was linked to MOD-2021-349728 (Patient Link).   Reporter did not allow further contact
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Investigational Conclusion of PQC: This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details: 7517780 Product Description: Compound BNT 162 Covid-19 Vaccine Suspension For Intramuscular 2ml Multiple Dose Vial X 1 Lot-#: FF2590 Conclusion of Previously Completed Investigation: The complaint for lack of effect of the pfizer biontech covid-19 vaccine injectable lot FF2590 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FF2590, fill lot FF2559, and the bulk formulated drug product lot FE5320. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. ID of Previously Complete d Inv: 6592171 Link (Previously Investigate d): 6582386  No follow-up attempts are possible. No further information is expected.
anxiety; This is a spontaneous report received from a contactable consumer (patient) by a Pfizer sponsored program.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient got the second dose and she felt very anxious after. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
PRESENTED TO HOSPITAL WITH MULTIPLE SYNCOPAL EPISODES THROUGHOUT THE DAY @APPROX 7PM 2/24/21. HAD SEVERAL EPISODES OF ASYSTOLE. CURRENTLY COMPLETE HEART BLOCK. PT HAS DNR AND IS IN HOSPITAL. INFORMATIO PROVIDED BY RN
On November 20th, Pt developed a severe headache.  She had a seizure on November 23rd and was diagnosed with Rhino/Entero and Adenovirus.  After several weeks of headaches, she was admitted to the hospital on December 26th and underwent testing which diagnosed MOGAD.
Intense muscle pain and soreness. Could not use my arm. Basically had to keep it in one position at my side. Tried Extra Strength TYLENOL with very little relief. I switched to 750 Mg Nabumetone twice a day. It took 3 days to feel better. There is still minor soreness when raising my arm above my head. I also had shivers the first evening and overnight. I had a dull headache for around 24 hours. I will not have the 2nd phase of the shot. I will not take a chance of going through that again.
Rash on left arm extending to neck and uper back. Soreness at site extending to lower left arm.
Initial report received from a consumer on 10-Oct-2013. An 11-year-old male patient whose concomitant medications was not reported, received a dose of FLUZONE ID (lot number, expiry date, route and site of administration was unknown). On 09 October 2013, patient noticed constant dull pain, difficulty lifting his arm when he started swimming. Patient saw doctor in the office and she called it a swollen lymph node. Patient had small red spot at injection site, not raised, not hot. Patient was 10 year old received FLUZONE ID. The events were not resolved. List of documents held by sender: none.
Generalized Vaccinia characterized by headache nausea and generalized erythematous papules sparing face and neck
pt recv vax & devel high fever &  febrile sz;pt recv valium to stop sx-stopped breathing;intubated;adm to hosp;pneumonia discovered-secondary to aspiration (?);ATB;