chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bilateral Pulmonary embolism; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 (2-3 weeks prior to 15Nov2022) as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Drug allergies: PCN" (unspecified if ongoing), notes: Drug allergies: PCN; "Drug allergies: Sulfa" (unspecified if ongoing), notes: Drug allergies: Sulfa. The patient had no drug or alcohol abuse. The patient had no related family history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PULMONARY EMBOLISM (caused and prolonged hospitalization, disability, medically significant, life threatening, congenital anomaly (as reported)) with onset 15Nov2022, outcome "recovering", described as "Bilateral Pulmonary embolism". The patient was hospitalized and prolonged hospitalization for pulmonary embolism (start date: Nov2022, discharge date: 21Nov2022, hospitalization duration: 6 day(s)). The event "bilateral pulmonary embolism" required physician office visit. Therapeutic measures were taken as a result of pulmonary embolism with anticoagulants.  Patient was low risk for blood clot so BNT162b2, BNT162b2 omi ba.4-5 also suspected. The vaccine may have increased her risk or caused the clots.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event pulmonary embolism with the suspect drug BNT162b2, BNT162b2 omi ba.4-5 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.
Event: Expired vaccine given 11 days past the beyond use date.  Outcome: None for the expired dose that was administered. Pt developed a rash after first dose was given. She was then evaluated by Allergy/Immunology prior to receiving the 2nd dose. No known symptoms after second dose was administered.
Patient was admitted to the hospital with myopericarditis. Presented to the ER with chest pain. He was admitted for trending troponin levels and monitoring for arrhthmia/cardiac function. Troponin peaked at 10.8 on 5/15.
severe Weakness,  and body fatigue limiting ability to conduct normal activities of daily living .additionally tachycardia and hypotension
This is a spontaneous report from a contactable consumer who reported for his mother.  A female patient of an unspecified age and race received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced some redness and swelling. Some days later, the swelling started to worsen compared to before and the redness increased to where it is covering almost the entire arm. Also, she began experiencing itching at the injection site. The outcome of the events was not recovered.
she broke out in hives from her  hands to the arches of her feet, it was progressive; This is a spontaneous report from a contactable Other Health care professional reported that: A 66-years-old female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EM9809; Expiration Date: 30Jun2021), via intramuscular, administered in Arm Left on 06Feb2021 as single dose for covid-19 immunisation. Medical history included chronic idiopathic urticaria, scrombid poisoning. There were no concomitant medications. Vaccination Facility Type: Hospital. The caller states she is a long-time retired nurse. The caller wishes to report an adverse event 74 hours after receiving the first Pfizer COVID-19 vaccine. The caller mentions she would appreciate some follow-up. Caller declined to include a healthcare professional for the report at this time. Today, 09Feb2021, at 11am, she broke out in hives from her hands to the arches of her feet, it was progressive. She took one Benadryl at that time and she had to take a second Benadryl over-the-counter dosage an hour later because the hives had not subsided. Right now, the hives are resolved but of course she is still covered by the second Benadryl she last took which was at noon. When probed for UPC, Lot number or expiry date for the Benadryl, the caller states it's over the counter, and she doesn't have that. Caller explains 2 years ago, she experienced hives, but it was diagnosed quite after when she returned (she was traveling at the time). She was diagnosed with "scrombid poisoning", 35 people had the same fish she and she was the one who was hypersensitive to it. It's basically a fish that was about to turn bad, but it isn't. She got hives and ended up in ER. She was tested for multiple food allergies and all were negative. Through the process of elimination, she was given a preliminary diagnosis of chronic idiopathic urticaria which was diagnosed over 2 years ago. The caller explains she thought of the vaccine after 5pm so she will call her physician tomorrow regarding this reaction. Of course, she had her paperwork, so she wanted to get it on Pfizer's records. Of course, if there is a other that have had hive experiences, she would be greatly appreciative if someone followed up with her about it. She is hoping this is just a strange little hive breakout and not a true reaction to the vaccine. She also would like to know if there is any guidance on second dosage. She is scheduled to receive her second dose on 27Feb2021. Outcome of the event was recovered.  No further details were provided or obtained.
Inappropriate Schedule of Vaccine/ not had any prior vaccinations; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 5-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   In JUN-2023, the patient received the 1st dose of Kinrix. In JUN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Inappropriate Schedule of Vaccine/ not had any prior vaccinations). The outcome of the inappropriate schedule of vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JUN-2023 The physician reported that the patient received Kinrix vaccine in clinic this past week.  The reporter stated that afterward it was realized that the patient did not had any prior vaccinations.   The reporter did not have exact date of administration, lot number or expiration date. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received Kinrix as a first dose of IPV and DTaP series, which led to inappropriate schedule of vaccine administered. This case had been linked with US2023088087 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023088087:1 of 2
fluid retention; inflammation; This is a spontaneous report from contactable consumer via Pfizer. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported) via an unspecified route of administration on an unspecified date as dose 1, single and received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on 01Sep2021 as dose 2, single for COVID-19 immunisation. The patient medical history included immune system disorder, inflammation and infection those from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. It was reported received her second dose of Pfizer Covid-19 Vaccine on 01Sep2021. She has heard a lot of different recommendations of when to get the booster or third dose. she is asking to clarify when to receive her additional dose of the Pfizer COvid-19 Vaccine. She has a compromised immune system, not technically classified, but her body does not function properly. She has a hell of a time healing from infections. She takes a lot of supplements, some for inflammation, and ever since her Pfizer Covid-19 Vaccine, she has had more issues with fluid retention and inflammation in her. She reported all this after her first dose. Possible duplicate AE details E-transmitted. Response: Disclaimer provided, spoke from the attached documents and referred caller to her HCP. LAB-1457-14.0 on 22Sep2021. The patient experienced fluid retention and inflammation on 2021. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No follow-up attempts are possible.
Soreness in left arm at sight of injection within 12 hours, joint pain in left shoulder within 12 hours, slight headache within 14 to 16 hours and fatigue / general weakness within 24 hours lasting approximately 12 hours.  All side affects gone within 48 hours of initial injection.
Information has been received from a registered nurse concerning several infants who were vaccinated after the age of 12 weeks with an oral dose of Rotateq. No problems were  reported. It was not reported if medical attentions was sought. There was no product quality complaint involved. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. 04/6/2010 Follow-up information from the registered nurse indicated that she would look for additional information regarding this caes. Attempts are being made to obtain additional identifying information to distinguish the individual patientd mentiond in this report. Additional information will be provided if available.
Pt received flu shot in an outreach clinic on 11/21/03.  Within a few days she had pain in arm and difficulty in using "right arm".  Unable to reach in closet.  Has pain day and night.  Not always consistant at time can do a motion and it's ok, but next time causes pain.
1. Immediately sore arm a shot site.  Still sore 48 hrs. later.  2.  Onset within 8 hrs. - high fever, headache, chills, muscle ache, fatigue, cough, lung irritation (flue like symptoms).  Could not eat or get out bed for 18 hrs.  Starting to feel a little better at time of reporting (48 hrs. later).  Feeling sick is a rare event for me.  The only two times I've felt sick in he last 10 yrs. is after the second and third Moderna shots, the third (booster) being the worse.
Slight redness about 3/4 inch radius still remains at injection site one week post injection.
Second dose: Stinging as injected. Soreness  across shoulders and neck. Over the next hour soreness turned to stiffness. In 8 hours was having chills and a very bad headache. Sleepy,  body aches and shortness of breath when walking. Very tired. Next day still felt bad. The same symptoms.  Over counter medications did not help the headache.   I never had a fever.  The last month i have brain fog, confusion, forgetfulness and mistakes I never made before the vaccine.  Its an effort to get through work.
I received my first Covid Booster on December 16, 2021.  Within the first two days I began to experience extreme ringing in both ears.   This has been constant and not subsided since that time (now 5/12/22).
Patient started feeling dizzy/faint right after administration, she was sweating and felt hot to the touch, then she convulsed and shot up out of her chair for a few seconds before sitting back down. As she sat back down she vomited and then seemed to get better after. 911 was called and she was better by the time they arrived and blood pressure and vitals where all good.
Patient has severe itching at site of adminstration. It was raised about 2 inches in diameter on day 4, looked red. Patient used warm compression, oral diphenhydramine, topical diphenhydramine and hydrocortisone. On day 6, the size of the raise was about 4 inches. Still itching.
Had facial swelling especially of the lips. Respiratory Stridor - Respiratory difficulty. Redness of face and neck, explosive diarrhea. Respiratory Arrest - No pulse - Nonresponsive.
1 sore right arm beginning about 8 hours after vaccination       2.  Joint pain about 32 hours after vaccination   45 hours after vaccination no more joint point  3.  Coughing up clear fluid from lungs for approximately two hours    about 39-41 hours after vaccination
Respiratory Infection - Dx with croup Weezing, bark-like cough, congestion Treated with epinephrine nebulizer and steroid
Couldn't get up of bed; sore arm; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Couldn't get up of bed), PAIN IN EXTREMITY (sore arm) and MYALGIA (muscle ache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Hypertension, Multiple allergies (Patient is allergic to everything.) and Acne. Concomitant products included AZELAIC ACID for Acne.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (Couldn't get up of bed), PAIN IN EXTREMITY (sore arm) and MYALGIA (muscle ache). The patient was treated with DIAZEPAM for Anxiety, at a dose of 1 dosage form. At the time of the report, BEDRIDDEN (Couldn't get up of bed), PAIN IN EXTREMITY (sore arm) and MYALGIA (muscle ache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had an appointment in November to get some cardiac test such as ECG, cardiac test, cardiac enzymes.  Other concomitants include Tersac.  Patient takes Treatment medicines she is on blood pressure pills.   This case was linked to MOD-2021-370454, MOD-2021-371161, MOD-2021-370575 (Patient Link).
Chills, sweating, body aches, headaches, blotches (rash), itching, vomiting, fatigue, constantly sleeping, joint pain, nauseous, swollen lymph nodes, sore throat
Information has been received from a physician concerning an 8 year old male who on 22-APR-2002 and 20-FEB-2006 was vaccinated with the first and second doses of MMR II (lot# not reported) respectively. On 17-DEC-2009 the patient experienced mumps. On 18-DEC-2009 the patient was diagnosed and afebrile. Parotitis was on the left. The first blood work on 18-DEC-2009 revealed serum IgM <1:10, serum IgG 2.83 and serum amylase 352. Additional information has been requested.
I woke up early the next morning after vaccination and my chest/heart pain started feeling uncomfortable and unusual. No shortness of breath or sweating. It lasted maybe 15 minutes. The same thing happened with my 3rd dose of Moderna in which I also filed a VAERS report. I am fully recovered now.
Information has been received from a medical assistant concerning a three elementary school aged patient about the age of 8 or 9 who received the second dose of VARIVAX (Oka/Merck) (lot# "0996 Y or X") on the same day the patient developed a raised knot, reddened area and about three inches in diameter. The onset of the symptoms was not specified. The symptoms resolved in an unspecified period of time. No other symptoms resolved in an unspecified period of time. No other symptoms or treatment reported. Follow-up Information has been received from a medical assistant who identified one of the patients as a 15 year-old female patient who received the second dose of VARIVAX (Oka/Merck) The medical assistant reported she could not remember any other information on the patient. This is one of several reports received from the same source. Additional information has been requested.
Left arm pain going down to elbow since the 2nd shot. Now experiencing numbness down the entire arm-feels like a pinched nerve
Muscle spasms High fever (liquid acetaminophen lowered)  Soremuscles Severe headache
No symptoms reported; One patient recieved an improperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant referring to a 6-month-old infant of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported.  On 19-NOV-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) via route defaulted to oral for prophylaxis (lot # R033251 and expiration date: 29-JUN-2020) (product storage error). The administered dose of the vaccine experienced temperature excursion at 32.36 degree Farenheit for a timeframe of 134 hours. There were no previous temperature excursion reported. No symptoms were reported. The call was due to digital data logger. No product quality complaint (PQC) was involved.
The patient stated that the next day (tuesday morning) she had fever, chills, aches and pain.  On Tuesday night she had a panic/anxiety attack.  The paramedics were called to her home.  She used albuterol and that helped with her attack.  Her Osat level was 99% with albuterol usage but her heart rate was 115-120.
Product administration error; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Product administration error) in a 56-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Product administration error). At the time of the report, PRODUCT ADMINISTRATION ERROR (Product administration error) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported.
syncope within minutes of receiving booster shot.  Patient lost consciousness for less than 1 minute
mouth that was dry; mouth that was rashy; problems with my skin; breakouts (mostly on my face) and one area around my mouth; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (mouth that was dry), ORAL MUCOSAL ERUPTION (mouth that was rashy), SKIN DISORDER (problems with my skin) and RASH (breakouts (mostly on my face) and one area around my mouth) 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.   In April 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 an unknown date, the patient experienced DRY MOUTH (mouth that was dry), ORAL MUCOSAL ERUPTION (mouth that was rashy), SKIN DISORDER (problems with my skin) and RASH (breakouts (mostly on my face) and one area around my mouth). At the time of the report, DRY MOUTH (mouth that was dry) outcome was unknown and ORAL MUCOSAL ERUPTION (mouth that was rashy), SKIN DISORDER (problems with my skin) and RASH (breakouts (mostly on my face) and one area around my mouth) had not resolved.            No relevant concomitant medications were reported.  Patient reported that the second dose of vaccine was received in late Apr-2021, since then there was skin problems. The reaction was not severe but the rash did not resolve despite seeing a doctor and taking unspecified medicine.
pruritic rash along the forehead and behind the ears; started approximately 6 hrs after 2nd vaccine administration. Mild, no dysphagia, wheezing, fevers.
This spontaneous case was reported by a patient and describes the occurrence of SEIZURE (Bad seizures) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 106B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included VSD (patient had heart and lung problems when he was born (VSD ). heart murmur.), Bronchopulmonary dysplasia (patient had heart and lung problems when he was born (BPD-bronchopulmonary dysplasia)), Epilepsy, Prematurity, Aspiration pneumonia, Gastroschisis, Inappropriate schedule of vaccine administered and Breathing arrested. Concomitant products included TOPIRAMATE (TOPAMAX) and GABAPENTIN (NEURONTIN) for Seizures, QUETIAPINE FUMARATE (SEROQUEL), SERTRALINE HYDROCHLORIDE (ZOLOFT), CLONAZEPAM (KLONOPIN), LACOSAMIDE (VIMPAT), TRAZODONE, BACLOFEN (LIORESAL), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), CIMETIDINE (TAGAMET [CIMETIDINE]) and EPINEPHRINE (EPIPEN) for an unknown indication. On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced SEIZURE (Bad seizures) (seriousness criterion medically significant), CHEST PAIN (Chest Pain), URTICARIA (Big old welts / Hives), HEART RATE INCREASED (elevated heart rate) and PYREXIA (On and off fever). On an unknown date, the patient experienced CONDITION AGGRAVATED (condition aggravated/ seizures). The patient was treated with HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) at a dose of 50 mg three times a day. At the time of the report, SEIZURE (Bad seizures), CHEST PAIN (Chest Pain), URTICARIA (Big old welts / Hives), CONDITION AGGRAVATED (condition aggaravted/ seizures), HEART RATE INCREASED (elevated heart rate) and PYREXIA (On and off fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Heart rate increased: high (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was born between twenty two and a half and twenty three and a half weeks. Mother states she had German measles/Rubella while pregnant and was bleeding every week. patient was born with his intestine outside which had to be put back inside. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.