chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset Sep2022, outcome "unknown", described as "had a little more pain, but not a lot of pain either". Additional information: The patient got the shot on 16Sep2022. The patient had a little more pain, but not a lot of pain either. As the days went on, the patient was not real sore. The patient didn't have a lot of pain. The reporter was wondering to know whether these new shots were really sore and whether the vaccine were doing their job if not real sore. If it did not work, what Pfizer would do about it. The patient did not have any soreness (as reported). 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.
THE VACCINE GIVEN WAS STORED IN THE REFRIDGERATOR PAST THE 10 WEEK TIME FRAME
She had a reaction from the shot the area on her leg was wide, red and swollen-very bad
Depressed state; Crohn's disease; Anxiety; Sickness; Fatigue; Coughing; Diarrhea; 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-163-4435876-00.  A 24-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset Mar2022, outcome "recovered" (2022), described as "Coughing"; DIARRHOEA (non-serious) with onset Mar2022, outcome "recovered" (2022), described as "Diarrhea"; FATIGUE (non-serious) with onset Mar2022, outcome "recovered" (2022); ILLNESS (non-serious) with onset Mar2022, outcome "recovered" (2022), described as "Sickness"; ANXIETY (non-serious) with onset Jul2022, outcome "unknown"; CROHN'S DISEASE (medically significant) with onset Jul2022, outcome "recovered"; DEPRESSION (non-serious), outcome "unknown", described as "Depressed state". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "crohn's disease", "sickness", "fatigue", "depressed state", "coughing", "diarrhea" and "anxiety" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded.  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.
Shortness of breath . Was sent to Hospital  to have fluid drawn from lungs . patient has diagnosed with liver cirrhosis. patient was in the hospital for 14 days.
40 minutes after receiving shot, patient was home and felt swelling of the tongue, slight difficulty breathing. She called 911, EMS did full evaluation on her (vitals included) and said maybe she was just having an anxiety attack.  EMS instructed her to take Benadryl. Patient did not want to. Patient called pharmacy and explained symptoms to me, the pharmacist who administered the shot.  I told her it sounds like it was related to the vaccine and that I would report her reaction to VAERS. I told her it might be a good idea to take Benadryl.
Starting about 14 hours after vaccine administration, patient experienced difficulty concentrating with periods of hyperactivity, pain/soreness in bilateral hands with extreme pain at times with movement, soreness in bilateral feet, soreness across the back in the area of the kidneys, occasional mild dizziness, fatigue, mild nausea, hot flashes, a cold sore, poor sleep quality since vaccine, mild dyspnea on exertion, and increased temperature of about 0.5-1 degree F.
rash devel on lt arm-7 days post vax broke out w/one chicken pos on arm & one on the cheek (arm size large) (cheek size small like pimple);
This spontaneous report as received from a healthcare worker (also reported as medical assistant) refers to a 1 year old child patient of an unknown gender. The patient's concurrent conditions and medical history were not reported. On 18-SEP-2015, the patient was vaccinated with ZOSTAVAX (unknown strength, route and dose) instead of (Oka/Merck) VARIVAX. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
VACCINE ADMINSTERED TO PATIENT WAS EXPIRED - EXPIRED ON 5/2/22
fever X 2 days (as high as 102.4), swelling X 4 days, nausea X 2 days, diarrhea X 2 days, redness at injection site X 4 days, tingling in extremity that still continues as of today (ongoing)
Less than 5 minutes after administration while patient was sitting with wife he began to go in and out of consciousness. He was able to speak and his face went pale. Ambulance was called and patients HR and BP were checked. The ambulance personnel stayed with him sitting while he started to feel better. About 45 minutes after administration he left home.
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
This case was reported by a healthcare professional and described the occurrence of pinkie swollen in a 17-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). There were no concurrent medications. On 1 May 2012 at 15:00 the subject received two vaccinations for the 1st dose of HAVRIX (1 ml, unknown, right deltoid) and experienced overdose. On 3 May 2012, approximately 48 hours after vaccination with HAVRIX, the subject experienced pinkie swollen. On 05 May 2012, four days after vaccination with HAVRIX, the subject experienced skin discoloration, and pinky pain. It was reported that the facility uses the pediatric doses of ENGERIX B for adult patients due to cost and normally they draw up two syringes of pediatric doses of ENGERIX B to equal an adult dose. The medical assistant did the same thing for HAVRIX, not realizing it was an adult dose of HAVRIX already. The subject received two 1ml injections of HAVRIX in the right deltoid on 01 May 2012. About 48 hours after the vaccinations the subject developed swelling of his left pinky, the opposite hand of the side of injection. He denied any trauma. This past weekend he developed pain and pink discoloring on the same pinky as well. He has been requested to come into the office for medical attention. The healthcare professional reported they plan to draw a titre in about a month and will proceed from there if necessary. At the time of reporting the pinkie swollen, skin discoloration, and pinky pain were unresolved.
GOLF BALL SIZE BUMP, RED, TENDER AND WARM TO TOUCH.  SX LASTED 3 DAYS AND THEN STARTED TO DISAPATE UNTIL CLEAR.
mouth irritation; difficulty swallowing; throat swelling; This case was reported by a consumer via call center representative and described the occurrence of mouth irritation in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2020, the patient received the 1st dose of Shingrix. On 20th November 2020, 5 min after receiving Shingrix, the patient experienced mouth irritation, swallowing difficult and throat swelling. The patient was treated with antihistamine (Antihistamines). On an unknown date, the outcome of the mouth irritation, swallowing difficult and throat swelling were recovered/resolved.   It was unknown if the reporter considered the mouth irritation, swallowing difficult and throat swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in a pharmacy and it was unknown if patient received a vial or a prefilled syringe.  The patient reports that after about 5 minutes got into car and started to feel throat swelling, mouth irritation and difficulty swallowing.   The patient drove to an urgent care facility and was given antihistamines and monitored and then released.   All symptoms resolved in about two weeks after injection. The reporter did not consent to followup. Emergency room visit required.
Chills; Headache; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.            Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Pfizer-BioNTech COVID-19 Vaccine EUA  The vaccine was administered to the writer at 0800 on 1/5/2021. No immediate reactions were noticed for the 30 minutes observation period immediately after. The writer's muscle that received the vaccine began to become increasingly sore throughout the day; however, that was similar to the first dose of the same vaccine a few weeks prior. The pain was described as constant (2/10) but aggravated with motion. The pain did interfere with the writer's normal range of motion (specifically raising the writer's arm above shoulder height). From 0800-2200 on 1/5/2021 no noticeable symptoms except for the injection site pain occurred.   At 2200, the writer rapidly developed chills, body aches, a headache, fatigue, and a fever of 100.8. These symptoms were left untreated and continued through the night (the symptoms did not interfere with sleep). The writer woke up at 1300 on 1/6/2021; all previous symptoms had resolved by this time except for the injection site pain. By 1400 on 1/6/2021, the writer noticed pain near the right axillary lymph nodes. The pain can be described as moderate (1/10) and generally occurred only with motion. The writer was unable to palpate any swelling in the area. Around 1800 on 1/6/2021, the writer noticed it felt weird to swallow. Specifically, it felt as if there was a slight internal swelling 1-inch subhyoidally and 1-2 inches laterally within the right side of his neck when he swallowed. The swelling was not palpable from the skin's surface. The writer did not seek medical attention as breathing/eating/drinking were not made more difficult but monitored this closely. The swelling in the neck resolved by 2000 on 1/6/2021. The lymph node pain in the right arm resolved over the course of a few days and was no longer present by 1/9/2021 at 1300.
This report has been received from the consumer reporting of herself, a female of approximately 67 years old who is enrolled in a study. This report was received via Regulatory Authority. The patient's relevant medical history included a malignant lung neoplasm as concurrent condition, for which the patient was under concomitant treatment with KEYTRUDA. Further information about the patient's medical history and concurrent conditions was not provided. It was also unknown if the patient was taking other concomitant therapies. The patient reported that, on an unknown date, she was vaccinated with an unspecified pneumococcal vaccine for prophylaxis, considering that "any respiratory illness" would "exacerbate" her lung cancer. The patient could not confirm whether or not she received PNEUMOVAX 23 (suspect product trade name, formulation, dose, route and anatomical site of administration were not known). The patient reported that, on an unknown date, the vaccine "made her sick". Also, she stated that she was "terrible sore" at the injection site for 3 days and, that on day 5 after vaccine was administered, she "got the not so common side effects". Finally, she mentioned that it was a good idea to get the vaccination, but awareness was needed of the potential side effects. Information regarding the diagnostic test carried out for diagnosis, or any other, regarding the events was not provided. By the time of the report, the outcome for the patient from the events was unknown. The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). Upon internal clarification, the report type was updated to spontaneous as Pneumococcal Vaccine Polyvalent (23-valent) (manufacturer unknown) was not part of the Market research.
Dizziness Narrative: Employee was in vaccination clinic when she developed dizziness. Vital signs were stable and she was given water and was lying down on the exam table. She continue to fell dizzy and was sent to the ED at 8:30am via w/c. She was given juice/crackers and water in the ER and symptoms resolved.
received his first dose / on 12/29/2020. He reported left arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th December 2020, the patient received the 1st dose of Shingrix. On 29th December 2020, 4 hrs after receiving Shingrix, the patient experienced pain in arm. On 9th January 2021, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The patient received 1st dose of Shingrix in the left arm at pharmacy. The reporter consented to follow up. This case was 1 of 2 linked cases, reported by same reporter. Lot numbers and expiration dates for vaccine was not known.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021073779:same reporter (reporter´s case)
The patient was seen in my clinic for sharp left sided chest pain that is worse when supine.  Patient received Moderna booster 2 weeks ago and then received a flu vaccine one week ago.
Patient experienced difficulty swallowing 45 minutes following 1st dose (12/21/20 Pfizer Lot#EH9899 NDC#59267-1000-1).  No treatment needed, resolved on its own.  Patient would like to receive 2nd dose despite prior reaction.  Physician on -site providing oversight of 2nd dose administration and post administration observations.
Presented on 06/25/2003 with chicken pox/vescular lesions covering torso in scalp and on extremities.
Swollen lymph nodes under my armpit.  Once the swelling went down, I have two knots under my armpit and a round patch on my right breast.  I have regular mammograms once a year and I just completed one in October, 2020.
PATIENT COMPLAINS OF SEVERE SHOULDER PAIN AND INABILITY TO LIFT ARM. PATIENT EXPRESSED THAT SHOULDER PAIN INTENSITY INCREASES AT NIGHT. PATIENT DENIED ANY SWELLING, PAIN OR REDNESS IN THE AREA OF VACCINE ADMINISTRATION.
Started with redness, pain, swelling, and warmth of the injection site.  Progressed to feeling achy and tired with diarrhea.  The night of Monday, 10/07/2013, had severe chill-like shaking but no temperature.  The shaking was so severe it awakened me from sleep throughout the night and left me with sore muscles the next day.  Tuesday, 10/08/2013, had symptoms of tingling and heaviness in chest and neck, and went to ER.  Told was reaction to flu shot aggravated by my autoimmune status.  Continued to not feel well.  Thursday, 10/10/2013, had severe abdominal pain all day.  Went to ER at approximately 6:30 PM that evening and was admitted with blockage of my small intestine with inflammation and swelling of my stomach and intestines.  Was dismissed from the hospital on Friday, 10/11/2013 at approximately 5:30 PM.  On Saturday, 10/12/2013, began having extreme body aches.  Also developed a low-grade temperature of approximately 100 F.  Had the same aching and temperature on Sunday, 10/13/2013.  Began feeling better on Monday, 10/14/2013, in the morning, but by Noon was feeling achy and tired again and once again developed diarrhea.  Was feeling even better this morning (Tuesday, 10/15/2013), however, still have diarrhea and began feeling achy and tired again around Noon.  Starting Monday, have began to feel like I am slowly on the mend.
Low-risk pregnancy  Chronic nerve pain similar to fibromyalgia (still have flareups in 2021), foggy brain/inability to articulate certain words, dizzy spells, vertigo.  Treatments with Naturopath guidance: Chlorella taken internally (post-pregnancy), omega-3 supplements, detox baths.
Abrupt onset whole body myalgia, chills day following vaccine, persisting 5 dys; dyspnea on exertion for 1 day beginning 4th day post-vaccination, responsive to inhaled albuterol
5 days after first dose started getting extremely itchy hives on trunk of body (same side on which received shot) and arm on other side of body. Physician prescribed cortisone cream and antihistamines.
Pt was given Daptacel instead of Adacel. Patient was called 8/31 and asked how her arm was after vaccination. She said it was "quite sore" for 4-5 days. Arm is fine now. Pt was asked how she fe3lt after vaccination. She said ac couple days after the vaccine she had diarrhea.
I noticed it was warm, hard and it was red yesterday. It was really itchy yesterday but not today. I took some Benadryl last night. Today it is just red, warm and hard. I do not feel sick.   I did call my Doctor and let them know what was going on.
On day of immunizations had episode during feeding of "fast body shaking"-20 seconds, "out of it" Not responsive during event, Finished feeding and slept 3 hours after, acting fine since, No fever, Mom calls next day still active wekk
bones hurt; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (bones hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BONE PAIN (bones hurt). At the time of the report, BONE PAIN (bones hurt) outcome was unknown.            Concomitant product details were not provided. Treatment details were not provided by the reporter
Extreme back pain along spine; Excessive diarrhea, watery uncontrollable with cramping; Excessive diarrhea, watery uncontrollable with cramping; Tingling in both hands at time of injection; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 30Aug2021 at 14:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to adhesives, latex and non-steroidal anti-inflammatory drugs (NSAIDS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medication included daily probiotics (unspecified) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PA7484) via an unspecified route of administration in the left arm on 09Aug2021 at 14:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 30Aug2021 at 14:15, the patient experienced tingling in both hands at time of injection which lasted for 45 minutes. On 01Sep2021 at 08:00, the patient had extreme back pain along spine and the patient started to have excessive diarrhea, watery and uncontrollable with cramping, along with the other common side effects. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tingling in both hands at the time of injection was recovered on 30Aug2021 at 15:00. The clinical outcome of the events extreme back pain along spine and excessive diarrhea, watery uncontrollable with cramping was not recovered at the time of this report.
Initial pregnancy report received from healthcare professional on 13 JANUARY 2014. A 28-year-old female patient, whose medical history and concomitant medications were not reported, had received intramuscularly first dose of ADACEL, batch number: U467BBA (anatomical site of administration was not reported) on 13 JANUARY 2014. The patient's last menstrual period and the expected date of delivery were not reported. The patient did not experience any adverse event. The reporter did not have any information regarding patient's pregnancy except was 28 weeks Intra Uterine Pregnancy now. List of documents held by the sender: None
Patient complained of swollen arm, rash, hives, and fever. She is feeling better on 3/23/2019.
ringing is extreme/tinnitus; I have problems with tinnitus but now it is turned up in volume 10 fold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer booster"; TINNITUS (non-serious), outcome "not recovered", described as "ringing is extreme"; TINNITUS (non-serious), outcome "not recovered", described as "tinnitus"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "I have problems with tinnitus but now it is turned up in volume 10 fold". Additional information: Customer Verbatim: I am experiencing very loud tinnitus since my Pfizer booster. I have problems with tinnitus but now it is turned up in volume 10 fold. Are there others that are experiencing this? Please advise on steps to take to fix this as it is making my life miserable. The ringing is extreme.   The lot number for bnt162b2 was not provided and will be requested during follow up.