chrisvoncsefalvay/vaers-outcomes huggingface dataset:
wheezing; stridor; breathing difficulties; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Right on 16Apr2021 09:30 (Lot Number: EW0169) at the age of 40-year-old, as 2nd dose, single for covid-19 immunisation. Medical history included asthma (Was diagnosed with this when the caller was 2 years old, 38 years ago), familial medullary thyroid cancer (The caller was diagnosed with this 30 years ago). Historical vaccine included first dose of bnt162b2 (lot: ER8733, Route of administration: left arm, appointment time was 1615) on 23Mar2021 and the patient had breathing difficulties, wheezing and coughing. Concomitant medication included salbutamol sulfate (PROAIR HFA) taken for an unspecified indication, start and stop date were not reported. The patient had breathing difficulties after the second dose Pfizer Covid 19 Vaccine: After receiving the second dose Pfizer Covid 19 Vaccine the patient stated roughly the same thing that happened after the first dose Pfizer Covid 19 Vaccine occurred, but it occurred a lot faster. The patient clarified she had breathing difficulties after the second dose Pfizer Covid 19 Vaccine. She had stridor and wheezing and was also injected with an epi pen in the ambulance and they put the patient on other drugs. The breathing difficulties began 15 minutes after the patient received the second dose Pfizer Covid 19 Vaccine. The patient stated the breathing difficulties were not ongoing now. The breathing difficulties subsided mostly, patient not 100% certain, but after the patient was given Benadryl in the ambulance. The patient started to feel better and was given O2 and albuterol through a mask. The patient stated the effects after receiving the second dose Pfizer Covid 19 Vaccine were much worse. The patient was not 100% certain this has gone away. The patient was using her inhaler significantly more often after this occurred. The patient was discharged from the emergency room on both occasions. The outcome of breathing difficulties was recovered, of wheezing and stridor was unknown.
Associate developed SOB on 2/12/21.  Taken to Hospital on 2/13/21.  Reported deceased 2/14/21.
Ovarian cysts; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 16Feb2021 (at the age of 33-year-old), as a single dose for COVID-19 immunisation. Medical history included anxiety, depression, tendonitis and allergy to cashews. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included citalopram hydrobromide (CELEXA), cetirizine hydrochloride (ZYRTEC), guaifenesin (MUCINEX), levonorgestrel (KYLEENA), cyanocobalamin (B12) and probiotics nos (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received cefaclor (CECLOR) and montelukast sodium (SINGULAIR); both for unspecified indication from unknown date and experienced drug allergy and received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in the left arm on 22Jan2021 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. On 01May2021, the patient experienced ovarian cysts (confirmed by transvaginal ultrasound on same day). The events had resulted in doctor/other health care professional office/clinic visit. Therapeutic measures were not taken as a result of the event. On 01May2021 the patient underwent lab test and procedures which included transvaginal ultrasound and the result was ovarian cysts. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of event ovarian cysts was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Redness, swelling itching and pain at injection site 8 days after injection treated with ice and Tylenol.  No improvement after 5 days 2/13/2021 till 2/17/2021
This case was reported by a physician via call center representative and described the occurrence of syncope in a 64-year-old male patient who received SHINGRIX (batch number 9XC39, expiry date unknown) for prophylaxis. On 9th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, less than a month after receiving SHINGRIX, the patient experienced red rash, abdominal pain, diarrhea, urticaria, fever, chills and low blood pressure. On 17th February 2018, the patient experienced syncope (serious criteria GSK medically significant), mast cell activation syndrome (serious criteria GSK medically significant), fall and alpha-gal allergy. On an unknown date, the outcome of the syncope, mast cell activation syndrome, red rash, fall, abdominal pain, diarrhea, urticaria, fever, chills, low blood pressure and alpha-gal allergy were unknown. The reporter considered the syncope, mast cell activation syndrome, red rash, fall, abdominal pain, diarrhea, urticaria, fever, chills and low blood pressure to be related to SHINGRIX. It was unknown if the reporter considered the alpha-gal allergy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Eight days after receiving SHINGRIX, the patient went to the emergency room because he fell and hit his head due to syncope. The patient was sent to the clinic and was diagnosed as having a mast cell activation syndrome -alpha gal allergy.  At the emergency room he was noted to has an erythematous rash, abdominal pain, diarrhea, global urticaria, fever, chills, and he had very low blood pressure which was believed to had caused the syncopal episode. The physician believed that the SHINGRIX vaccination triggered the event. In April 2018, the patient did go back to the clinic as a follow up checkup. The reporter was unable to obtain additional information. As per reporter the patient had the alpha gal allergy from a tick bite.
Recipient reports to staff member weeks after vaccine that she had numbness and tingling of lips following both first and second vaccine. She did not report this to anyone during her observation time post vaccination although told to report any changes in  current feeling of health that occurred while waiting. States that after first vaccine symptoms lasted for a few hours and after second vaccine symptoms lasted for a few days.
pt recvd vax 24AUG93 & following day seen w/temp to 102-104; pt had generalized sz;
temp elevation to approx 102,lasting about 15mins each time PM 26FEB,AM 27FEB & 2AM 28FEB;26FEB BC-staph sinulans;27FEB BC sterile;no other sx until sudden death 28FEB96 2PM;
Initial report received from healthcare professional on 19 December 2013. A 02-month-old male patient, who had no relevant medical history and no illness at the time of vaccination and whose concomitant medications were not reported, had received intramuscular first dose of DAPTACEL vaccine, batch number: C4457AA having expiry date 11 December 2015 in left thigh on 20 November 2013. It was reported that on 23 November 2013, 3 days after receiving DAPTACEL vaccine, the patient experienced staring episodes. The patient experienced 1-2 episodes per day, lasting 5-15 seconds each. Episodes increased to 30 events in one day and patient was admitted on 01 December 2013 and was discharged on 02 December 2013. 24 hour EEG was carried out but there was no change on EEG. Neurologist did not make a diagnosis. Treated child for reflux but treatment not specified. Child now 3 months old. Seizure went away for the most part, a week ago. The patient recovered on an unspecified date. Documents held by sender: none.
She stated: I received my 2nd dose of vaccine on 1/11 24hours after I experienced severe arm soreness which progress to body aches and tongue swelling. I took 50mg of Benadryl  and  40 mg of prednisone that I had at home and my symptoms resolve gradually and I felt better the next day
August 25, 2021, at 3AM, I woke up with abdominal pain like bloating. Discomfort. Felt like I needed to go to the rest room. Couldn't go and this continued throughout the night. Woke up maybe 11AM and the feeling and discomfort started to subside at the time. It just went away, and all the symptoms just went away. Since August 25, 2021, up until today, just depending. I get the same symptoms more often. The past week I've felt that way. 6 days now I've had this feeling and the feeling can be more severe than others. I can have a bowel movement and it does go away. 3-4AM after I go to sleep is when I start feeling this pain and discomfort. After I get up and sometimes have a bowel movement, it'll go away. Sometimes I can't have the bowel movement and I have to go back to sleep. It wakes me up at night and I have that discomfort and sometimes it goes away on its own, sometimes it goes away with a bowel movement. And this has been going on since August 25, 2021. Everything started after that 3rd dose. Maybe it's coincidence but I do not know. I have another follow up appointment on June 8, 2022. If it continues, I may need to do an MRI or CAT scan to take pictures and see what's going on.
Sharp pain when got the injection which continued for 3 days; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN via an unspecified route of administration in left arm on 21Mar2021 at 10:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On 21Mar2021, the patient experienced sharp pain when got the injection which continued for 3 days (First day after injection couldn't raise her left arm by the end of the day). The events had not resulted in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The patient had not received any treatment for events. The clinical outcome of event sharp pain when got the injection which continued for 3 days was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
ED to Hosp-Admission; 8/29/2021 - present (3 days); Hospital  Sepsis due to COVID-19; Patient presents with Cough, Diarrhea; Patient is a 85 y.o. male with PMH listed who presents from home complaining of feeling ill since Tuesday 8/24.  He states that his worst symptom has been severe fatigue.  Also admits to nausea/poor appetite, loss of taste and smell, diarrhea, and dry cough.  No CP, not particularly SOB.  He has not vomited, but he's wanted to.  The only elevated temp that he knows of was on Friday, 100.3F.  He was found to be hypoxic in the ER.  Heart is racing. Plan: Admit to IMCU for continuing care of sepsis due to COVID-19.  Respiratory symptoms are fairly mild, but he is hypoxic.  Start Decadron and remdesivir, titrate O2 as needed.  Given that he has been vaccinated, should not progress to ICU-level care.  Need for IMCU at this point is primarily due to elevated HR and mild elevation of trop/lactate.  Cont to trend these levels. Check procalc to rule out a bacterial co-infection. Cardizem gtt for Afib/RVR, continue IV fluids for another day (likely a little dehydrated due to diarrhea).  Hold home BP meds and Lasix. Diet as tolerated, antiemetics as needed.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 01-MAR-2018, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N005274, expiry date: 03-APR-2018) and GARDASIL 9 (dosing details were not reported) (lot # N020353, expiry date: 28-APR-2020) for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree fahrenheit to 77 degree fahrenheit (59.6 degree fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.
09/14/2005 Pt was seen in office with dx of chicken pox after previous vaccination with varicella (Varivax) 11/25/1997.
ERYTHYTHEMA MULTIFORME RASH ON 9/10/08 WITH LOCAL REACTION STARTED AFTER VACCINATION ON RIGHT THIGH. pATIENT ALSO HAS ANKLE ARTHRITIS FOR 2 DAYS pATIENT WAS ADVICED TO TAKE bENEDRYL 12.5 MG AS NEEDED OTC
One week of sore arm with lump and red. from the 2nd day for four weeks extreme itching  and burning from top of forehead down through the chest, skin peeled, no redness. Then loss of all my eyelashes.
Pfizer Dose 1 3/24/21 (ER8732) Pfizer Dose 2 4/14/21 (EW0161) COVID Positive 1/20/22 (pt reported)  1/22/22: This is a 52 years old female who presented to the emergency department today because of shortness of breath  The patient has a history of COPD, chronic oxygen dependent on 4 L of oxygen at home via nasal cannula, asthma, hypertension, type 2 diabetes, hypothyroidism  The patient states that she began having symptoms about 4 days ago which included shortness of breath, headaches, nausea, productive cough.  Denies any loss of taste or sense of smell.  Denies reduced appetite.  Patient reports recently tested positive for COVID-19 two days ago. Reports she has been vaccinated with 2 doses of COVID-19 vaccine however did not get the booster shot.  Chest x-ray shows mild pulmonary venous congestion.  The patient states she takes oral Lasix at home for lower extremity swelling. Denies history of heart failure.  She desaturated with ambulation to 84% on her home dose of oxygen, hence she was admitted to the hospital for further evaluation and treatment.  She was given IV Lasix, IV steroids in the emergency room. D dimer within normal limit. BNP within normal limit  1/25/22: 52-year-old female with history of chronic hypoxic respiratory failure on 4 L by nasal cannula, COPD, OSA not on CPAP, presented to the emergency department with worsening shortness of breath secondary to COVID-19 pneumonia complicated by acute on chronic hypoxic respiratory failure.  Patient was started on COVID-19 specific treatment, was started on IV antibiotics, did very well, oxygen back to baseline, she was stable for discharge.
Information has been received from a consumer's mother concerning  her 12 month old son with no prior medical history and no known allergies who on 10/29/98 was vaccinated with a dose of MMRII. Concomitant vaccinations included a doss of Varicella virus vaccine live (MSD) and a dose of poliovirus vaccine (manufacturer unknown). Subsequently , the patient developed nodules in his thigh under the area where the vaccines were administered. The nodules lasted for nine months. In approximately, 2000, at three year old, the patient was diagnosed with autism. The reporter stated that she "believes that he was autistic from birth, but was now diagnosed until he was three year old" Unspecified medical attention was sought. Upon internal review, autism was determined to be an other important medical event. Additional information has been requested.
After vaccine administration, patient left clinic room and went out to waiting room and sat down.  Upon getting up the patient felt dizzy but thought it was attributed to getting up too quickly.  Patient walked to car, accompanied by mother.  Mother described patient as becoming extremely pale while seated in the car.  Mother carried child (patient) back into clinic. Patient very pale, not very responsive but breathing.  Sat patient down on chair and elevated legs on another chair.  Applied ice pack to head.  As color came back, patient described the event as feeling very dizzy, unable to see, seeing "black spots", unable to hear "sounds were muffled", unable to really walk or remember what happened.  Patient's hands were clammy, gave water to drink.  Monitored child for almost an hour thereafter.  Gave a watermelon italian ice to put some sugar in the patient's system.  Patient also felt nauseous and had a loose bowel movement while in the office after the event.  When patient's color came back to normal, blood pressure was checked 104/82. Lungs were clear and heart rate was normal.  Mother and patient left the office at around 3:30pm.  Called the mother prior to close of the office to check on the patient.  Mother explained the child feels extremely tired and was laying down.  Advised mother if child continues to feel excessive tiredness to seek medical care. Received a call 6/12/14 from mother, child is doing better, but kept her home from school for the day.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting,  pain at injection , chills
Fever >101, rigor, chills, 15 hours post administration Cough from 6-18 hours post administration Fatigue from 6 - 20 hours post administration Muscle aches from 15 - 36 hours post administration Joint pain from 24 - 36 hours post administration
my facial paralysis significantly worsened; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 26Apr2021 (Lot Number: EW0170) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications included unspecified products within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The patient previously received BNT162B2 lot EW0150 on 05Apr2021 14:00 at left arm for Covid-19 Immunization, 9 days later, on 14Apr2021, woke up with severe facial paralysis and MRI result determined it was Bells Palsy. He received 2nd vaccination on 26Apr2021, the following day on 27Apr2021 his facial paralysis significantly worsened. He cannot close his eye all the way, he cannot keep saliva in his mouth, his speech was impaired, it's difficult to eat and frankly he's mortified to go out in public and terrified that he might have to live this way for a while. The patient received Prednisone as treatment. The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the event was not resolved.
Elevated blood pressure, felt like her heart was raising, and shortness of breath. Patient went to ER and was treated with a breathing treatment and inhaler. ER visit was 7/30/2021. Diagnosed with allergic reaction resulting in acute asthmatic bronchitis.
really severe headache; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a really severe headache (headache).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, approximately 1 day prior to the onset of the event the patient received their second of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient experienced a really severe headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, really severe headache was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of headache, a causal relationship cannot be excluded.
My wife and I received the RSV and the Covid shot, on Wednesday 9/27/23, we were good all day until we went to bed at 12:30. It started as soon as we got into bed. We started feeling cold, we started to shake most of the night, we had to put on 3 layers of blankets, that's how cold we were. The other symptoms which were on me only, were a very stiffness in my neck, plus a headache. My wife also had a very bad headache and shivering. The next day, we still had headaches. The food was not tasting right and my wife woke up with diarrhea that morning. We have never had such adverse effect from any shots. I am 81 and my wife is 72. We are now just starting to get a little bit better. I am still getting headaches, and so is my wife. And myself, I now have a sore throat, I think is from the adverse effects I am getting. I do not wish this on anyone.
I got my Moderna booster for COVID-19 on 1/19/2022. On 6/26/2022, I was exposed to someone with COVID-19. On 6/28/2022, I began to have a runny nose, sore throat, and fever.  On 6/28/2022, 6/29/2022, and 6/30/2022, I tested negative for COVID-19 on some NAAT tests that I took at home. On 7/1/2022, I took another test, and this time I got a positive result. On that day, I got a prescription for a 5-day course of Paxlovid. The symptoms improved. I tested negative on 7/7/2022, and I had only had a little bit of a residual cough until 7/13/2022. On 7/13/2022, my symptoms suddenly worsened. I had fever and primarily chest congestion. On 7/15/2022, I tested negative, but the symptoms continued. On 7/17/2022, I tested positive again and started another 5-day round of Paxlovid. At the time of this writing, I am still in isolation and taking Paxlovid, but my symptoms are improving.
WEAKNESS; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 40 mg for rheumatoid arthritis. The patient medical history was not reported. Concomitant medication(s) included lisinopril; sildenafil citrate (ELEVE); cyanocobalamin/folic acid. On Mar2021, patient experienced weakness with outcome of unknown , fatigue with outcome of not recovered.  The action taken in response to the event(s) for bnt162b2 was not applicable , for adalimumab was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.