chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He was struggling with breathing; His O2 saturation was in the 80s; pneumonia bacteria from his lung; At some point he passed away; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 9-month-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYMBICORT. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "At some point he passed away"; DYSPNOEA (hospitalization), outcome "unknown", described as "He was struggling with breathing"; OXYGEN SATURATION DECREASED (hospitalization), outcome "unknown", described as "His O2 saturation was in the 80s"; PNEUMONIA BACTERIAL (medically significant), outcome "unknown", described as "pneumonia bacteria from his lung". The patient underwent the following laboratory tests and procedures: Oxygen saturation: in the 80s. Therapeutic measures were taken as a result of dyspnoea, oxygen saturation decreased. The patient date of death was unknown. Reported cause of death: "At some point he passed away". It was not reported if an autopsy was performed.  Clinical course: He was given nevulizer treatment and place on oxygen. He was placed on a ventilator in 2 hours after arriving at hospital.  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 current available limited information and a possible contributory role of the suspect product PREVNAR 13 to the reported events cannot be fully 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: At some point he passed away
Information has been received from a physician concerning a 67 year old male patient who "5 years ago", in approximately October 2005, was vaccinated with the first dose of PNEUMOVAX 23 without reaction. On 18-OCT-2010, the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot # reported as 667913/1021Z). On an unspecified date, the patient returned to the office with inflammation from injection site all the way down the arm. The area was red and hot "top" the touch. The patient did not look good. He appeared tired, looked drained and looked like he was getting sick. The patient was treated and was recovering at the time of the report. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Pt felt dizziness and fell on the ground but did not lose consciousness. Symptoms went away after 2 minutes. Pt was assisted to stand up, seated and observed for 45 minutes. Pt felt fine and he was sent home. Father declined going to emergency room.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown demographics. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored GARDASIL 9, lot # M041990 with expiration date on 28-JUN-2019 and lot # N000326 with expiration date on 14-OCT-2019 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 0 to 1 degree Celsius for 40 hours. Digital data logger was not involved. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001280: US-009507513-1706USA001284: US-009507513-1706USA001282: US-009507513-1706USA001283: US-009507513-1706USA001279: US-009507513-1706USA001281:
She got her vaccine, she had a red arm over a course of days the area got larger, about the size of a baseball, deep in color from reddish/purple in color.  This took weeks to dissipate.  Then on 5/10/21 she was out shopping and her husband noticed that her eye looked like it was bleeding (Hospital).  She had a CT scan of her head, was not feeling well, came on like a snap of a finger.  She was diagnosed with a subconjunctival hemorrhage of the eye.  The CAT scan also showed a lacunar stroke, which they felt she was OK and to FU with her PCP when she got home.  She saw an eye Dr. and he felt it was the same diagnosis and to FU with her eye doctor when she got home.  She did when she got home, had a rescan and it was OK.  She was not given any medication and/or eye drops for that.  She then got her third vaccine on 11/15/21, she cannot remember is she had a reaction from that.    Then in March of 2022 she was having high blood pressures, and went to the doctor, had another scan as she was complaining, and had a intra-parenchymal bleed in the basal ganglion of her brain.  She was diagnosed that same day as reversible cerebral vasoconstriction syndrome on 3/18/22.   Her medicines were changed during that time, and her brain died at that time, and by the time she reached the ER and watched her in the hospital for about 5 days, and the bleeding was stopped with that treatment.    She is going to get her 4th vaccine (2nd booster).    3rd vaccine on 11/15/2021, Moderna, lot# 939903, left arm.   Had Tdap on 7/24/19 and has had flu vaccines without any issues, as well as the Tdap.
fell to ground, didn't respond for short time pupils dilated- in Doc Rm felt warm, O2 given
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Chills; body aches; tired; bones in ribs hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 10:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BENADRYL. Vaccination history included: Bnt162b2 (Product=COVID 19 , Brand=Pfizer, Lot unknown=False, Administration date=23Mar2021, Administration time=10:00 AM, Vaccine location=Left arm, Dose number=1), administration date: 23Mar2021, when the patient was 34 years old, for Covid-19 immunisation, reaction(s): "Very cold fingers/cold ears, right leg and then entire body", "Numbness/numb fingers", "Tingling Fingers", "Cold ears, right leg and then entire body/cold feeling", "25Mar she developed hives all over her body in large welts". The following information was reported: CHILLS (non-serious) with onset 12Apr2021 15:00, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 12Apr2021 15:00, outcome "recovering", described as "body aches"; FATIGUE (non-serious) with onset 12Apr2021 15:00, outcome "recovering", described as "tired"; BONE PAIN (non-serious) with onset 12Apr2021 15:00, outcome "recovering", described as "bones in ribs hurt". Therapeutic measures were not taken as a result of chills, pain, fatigue, bone pain.No other vaccine taken in four weeks. No covid prior vaccination. No covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Patient ran low grade fever the night she received the vaccine.The next day she woke up in hives all over her body. Her whole body itched. She stated she took Benadryl every 6 hours and applied benadryl cream. The rash disappeared around 4/12/21 but her whole body still itches. She did not receive medical attention.
Client was given H1N1 nasal mist and she is 18 weeks pregnant but did not state that she was pregnant before given the vaccination. Client referred to physician. 11/2/2009 record from OB-GYN MD 10/21/2009 confirming a + PG test, there are no records addressing any side effects of vaccine which was given 10/23/2009. This record does state patient is 18 weeks pregnant, received H1 N1 vaccine at health department, did not notify of pregnancy before receiving vaccine.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Pt fainted after a couple minutes after vaccine administration. We were able to assist him down to the floor. Pt regained conciousness within a minute. Shortly after, we noticed a rash. Gave pt 50mg benadryl. Paramedics called. They checked pt's blood pressure and pulse. All were normal.
This spontaneous report as received from a physician refers to an 11 years old male patient with seasonal allergies and no pertinent medical history. The patient was vaccinated with dose 1 of GARDASIL (Lot # not reported) in January 2012 and dose 2 of GARDASIL (Lot # not reported) in April 2012. No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient developed motor tics post vaccination with GARDASIL. The physician stated that mother of child told her that 5 days after child received the first and second dose of GARDASIL in January 2012 and April 2012, he developed motor tics, which wax and wane. The physician reported that the patient had motor tics of the face, shoulder, hands. The third dose of GARDASIL had not yet been administered. The physician stated there was incapacity due to medication treatment was needed. The patient was prescribed topiramate on 18-JUL-2012. At the time of the report, the patient had not recovered. Additional information has been requested.
WIthin 12 hours of injection (11:00pm) felt "like a cold coming on" and felt worse through the morning. The next day, experienced extreme flu-like symptoms- achey, headache, exteme fatigue, no fever.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 11-JAN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Intussusception.  Abdominal pain started afternoon of 11-29.  Seen at ER, diagnosed by ultrasound, tried to reduce with air enema, but ultimately needed endoscopic reduction.
Low grade fever (100.0F); stuffy nose; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 30Apr2021 at 15:30 (at the age of 17-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included tretinoin (MANUFACTURER UNKNOWN) and fluticasone propionate (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates. The patient past drug therapy included azithromycin (MANUFACTURER UNKNOWN) taken for unknown indication on unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 09Apr2021 at 15:30 (at the age of 17-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Apr2021 at 21:00, the patient experienced Low grade fever (100.0F), stuffy nose and tiredness. The patient underwent lab tests and procedures that included body temperature on 30Apr2021 at 21:00, and the result was 100.0 degree Fahrenheit. The clinical outcome of the events low grade fever (100.0F), stuffy nose and tiredness was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Vaccines given 4/10/07 developed redness, mild erythema and heat at injection site on right deltoid . Slightly tender to palpation. Less common noticed by 4/12/07. No wheezing or other findings or syms.
Was very dizzy 2 days after getting the COVID shot and was dizzy for 3 days. Had to be very careful getting up to keep from losing my balance.
Mother reported that this infant developed red blisters on her right thigh and an elevated temperature (T 100.2 rectal and axillary) 24 hours after the injection. Currently right thigh has 40 mm x 45 mm induration. Rash on site. Site is healing.
erythema, ecchymosis, pain & edema @ inject site are reported in pt receiving 1 dose of fluogen sx occurred 12 hrs p/vax & resolved w/in 48 hrs;
Case number PHEH2015US019722 is an initial spontaneous report received from a consumer (patient's mother) on 25 SEP 2015. This report refers to a 6 years old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with RABAVERT (batch number: not reported) on an unknown date. Post vaccination, on 28 JUL 2015 the patient experienced pain and discomfort at the site of injection. The events recovered on 19 AUG 2015. The seriousness and causality of the events was not reported. The reporter declined to provide further information and hence the case was considered as lost to follow up.
I became very weak, nauseous, my skin hurt to touch, dizzy with a headache the day after the injection.  My left arm is so sore that I am still having difficulty lifting it over my head now 2 days after the injection.  This morning I broke out in an extreme cold sweat and it felt like needles were coming through my skin.
Bell's palsy affecting right half of face; dose number 2 administered on 21Apr2021; dose number 2 administered on 21Apr2021; This is a spontaneous report from a non-contactable consumer (patient). A 21-year-old female patient received second dose of bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 21Apr2021 12:00 as 2nd dose, single dose for COVID-19 immunisation. Medical history included asthma, eczema and known allergies included beef. Patient was not pregnant at time of vaccination. Concomitant medications included epinephrine and melatonin. No other vaccine was given in four weeks. The patient previously took first dose of bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), administered in right arm on 07Apr2021 10:00 (at age of 21-year-old) as single dose for COVID-19 immunisation. On 21Apr2021, the patient received dose number 2 and experienced bell's palsy affecting right half of face on 18May2021 12:00. The event bell's palsy resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of bell's palsy affecting right half of face with 60mg Prednisone daily for 7 days. No covid prior vaccination. No covid tested post vaccination. Outcome was not recovered for bell's palsy affecting right half of face and for remaining events was unknown.  No Follow-up attempts are Possible. Information on lot/batch number cannot be obtained.
6/13/03 Fever, arthralgia, rash, Temp 100.
The pt's arm was swollen X 2 days. Not seen by medical person on 8/7/02. Presented to clinic with erythema multiforme-type rash mostly target lesions with nothing palpable in inner groin and thighs and a little bit under his arms. Pt's wt 72.5lbs.
She got her vaccine, her left arm hurt as it does with her regular flu shot and normally goes away after a week.  The next day she read what to do, but she moved her arm slowly around to exercise it to get rid of the soreness.  On the 2nd day the pain went away.  By the 3rd day it was back with a vengeance, and stayed there and never got better.  Her joint and everything started to hurt.  It felt like she had to have rotator cuff surgery again, and it still feels that way.  She went to her doctor who gave her a steroid shot which helped but then it came back again.  Within a week she could move her arm, but in a certain position it hurts her extremely badly.  If she raises her arm it "bites" her and the pain does not cease.  Her groin area also she is having pain there as well that radiates to her knee.   The front top side is burning and sore all of the time, and does not want to quit.  She takes baby aspirin and was given Norco but she did not like how it made her feel and doesn't take that.  The 800 of Ibuprofen did not help with the pain, neither does Tylenol or Advil.  She states that the medicines make her muscles sting and burn and feel worse.  She feels that the vaccine got to her vulnerable places of pain from before that have healed and feels that it has reactivated that pain and the pain won't go away.   Her arm did not hurt her for years, and her leg pain had been gone for a long time, but since the vaccine she has had nothing but pain.  She got her 2nd vaccine on 3/25/21, she did not have any adverse reaction, just the reaction from the 1st one did not go away and it did not go away after the 2nd one and still has the same pain.  It did not bother the bladder where she had surgery, just the joints of her body where she had previous problems.    Her back has been out of place and could not walk for a year and a half, but this has not bothered her back.
She had her 2nd COVID-19 vaccine 2 days ago. Yesterday she developed sudden onset of weakness and tiredness. She had a hard time sitting up, trying to lift her arms, had a hard time articulating how she felt and what was wrong, her speech seemed a little slurred, and she felt nauseated. Her daughter denied facial droop and localizing weakness. She continued to be "out of it" and weak until her daughter put her in bed about 7 hours later. She slept well and got up twice during the night to use the bathroom and seemed ok. She is feeling better today. Pt reports she kept hearing the telephone ringing all night and thought she heard someone yelling about the phone.
Allergic reaction to the laundry detergent; Sore arm; mild flu like symptoms; A mild rash/hives; Moderate itching; A mild rash/hives; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (mild flu like symptoms), URTICARIA (A mild rash/hives), DERMATITIS CONTACT (Allergic reaction to the laundry detergent) and PRURITUS (Moderate itching) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Crohns disease aggravated (in the mid to late 1990's), Heart attack on 30-Mar-2020, Stroke on 12-May-2012 and CPAP. Concurrent medical conditions included Blood pressure high (currently under control), Sleep apnea syndrome and Immunocompromised. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ISOSORBIDE for Chest pain, ATORVASTATIN for Cholesterol, TERAZOSIN for Prostate infection, THIAMINE for Vitamin B1 deficiency, ACETYLSALICYLIC ACID (ASPIRIN N) and METOPROLOL.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced URTICARIA (A mild rash/hives), PRURITUS (Moderate itching), RASH (A mild rash/hives) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (mild flu like symptoms) and DERMATITIS CONTACT (Allergic reaction to the laundry detergent). On 07-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and INFLUENZA LIKE ILLNESS (mild flu like symptoms) had resolved and URTICARIA (A mild rash/hives), DERMATITIS CONTACT (Allergic reaction to the laundry detergent), PRURITUS (Moderate itching) and RASH (A mild rash/hives) had not resolved.            Patient had sore arm and mild flu like symptoms for 2 days. Within 12 hours of receiving the shot patient had hives, rash and moderate itching. The symptoms persisted on a daily basis up until received 3rd dose.  Treatment medication was reported.   This case was linked to MOD-2022-468607, MOD-2022-468891 (Patient Link).
Extreme swelling at the injection site which became worse and went to under her armpit. It became tight and tender.