chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was having like sore throat but not very severe almost like a tight throat; I was having like sore throat but not very severe almost like a tight throat; Difficulty swallowing; I began to have a stuffy nose; Sleep restless; Upon swallowing I had increased amount of mucus going down; Since getting the second dose, I have been breathing more shallow; I have had tiredness, body aches, just not feeling well; I have had tiredness, body aches, just not feeling well; I have had tiredness, body aches, just not feeling well; I noticed my heart rate, it seems to be irregular; I feel like mine is like speeding up and just an irregular; Weakness, I have been super weak, I have not been able to do much physically/I have just been sleeping, just resting, my body is getting weak from that; This is a spontaneous report from a contactable consumer (patient).  A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL3246), via an unspecified route of administration, on 05Jan2021 at 9:40 am at single dose for COVID-19 immunisation. Age at vaccination was 29-years-old. Medical history was none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Dec2020. Concomitant medications included multivitamins. He is a very health conscious individual. He is very healthy. On same day of getting the vaccine, 05Jan2021, on that evening the patient began to have a stuffy nose and then he had a very restless sleep. He woke up the very next day. On 06Jan2021, with difficulty swallowing. He was having like sore throat but not very severe almost like a tight throat. He noticed that he had, upon swallowing he had increased amount of mucus going down and then he noticed yesterday and today as well, it was like not difficulty breathing but very shallow breathing. He is typically a deep abdominal breather. Since getting the second dose, he has been breathing more shallow. He has noticed increased amount of tiredness. He has body aches, he is not sure about body aches because he has just been sleeping, just resting, his body is getting weak from that. He is not sure but he has had tiredness, body aches, just not feeling well. He is still able to eat and he is still able to drink. he noticed his heart rate, it seems to be irregular, not alarming but it was like, he is not sure if you are a coffee drinker but sometimes when you take caffeine your heart rate speeds up. He feels like his is like speeding up and just an irregular. Also, weakness, he has been super weak, he has not been able to do much physically. Outcome was unknown.
Pain on the foot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on the foot) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain on the foot). At the time of the report, PAIN IN EXTREMITY (Pain on the foot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant and treatment information were not reported.    This case was linked to MOD-2021-035550 (Patient Link).
Headache, Myalgia, Arthralgia, Fever, injection site pain, chills, fatigue Narrative: Employee reports fever (100.6 F), chills, fatigue, body aches, joint pain, fatigue, headaches, and injection site pain/discomfort. Rep/discomfort. Reports took Tylenol (dose/frequency not reported).
tongue swelling; jaw clenching; pain in nerves in mouth at times; gum sensitivity; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EWD151) via an unspecified route of administration, administered in arm right on 08Apr2021 (at the age of 28-years old) as DOSE 1, SINGLE for covid-19 immunisation at hospital. Patient medical history was reported as none. Patient had no known allergies. Concomitant medication included marijuana. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not having covid prior vaccination and has not been covid tested post vaccination. On 08May2021, the patient experienced tongue swelling, jaw clenching, pain in nerves in mouth at times and gum sensitivity. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with steroids for the events. The outcome of the events was not recovered. The case was assessed as non serious.  Follow-up attempts completed. No further information expected.
Appendicitis; Chills; Stomach pain; Diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of APPENDICITIS (Appendicitis) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.  On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced CHILLS (Chills), ABDOMINAL PAIN (Stomach pain) and DIARRHOEA (Diarrhea). On 05-Apr-2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized for 2 days due to APPENDICITIS. The patient was treated with Surgery (appendectomy) for Appendicitis. On 06-Apr-2021, APPENDICITIS (Appendicitis), CHILLS (Chills), ABDOMINAL PAIN (Stomach pain) and DIARRHOEA (Diarrhea) had resolved. Not Provided    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.   Company Comment Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
dizzy; felt like her throat was closing; rash on her neck; slight headache; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (COMIRNATY), (at the age of 61years old) via an unspecified route of administration, administered in Arm Left on 15Oct2021 (probably around 10:00 O'clock in the morning, 10:30) (Batch/Lot Number: FE3590) as dose 3 (booster), single for covid-19 immunisation. Medical history included allergic to shrimp. The patient stated, "sometimes I am sensitive to take properly you know I wanna knew antibiotics and some I might be sensitive but that I not know". There were no concomitant medications. The patient has no prior vaccination within 4 weeks. The patient had BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 on 09Jan2021 (at the age of 60 years old) (Batch/Lot Number: EK5730) and dose 2 on 30Jan2021 (at the age of 60 years old) (Batch/Lot Number: EN5318) for COVID-19 immunization, both were administered at a pharmacy. The patient called and stated that she had the booster vaccine on Friday at work and on Saturday (16Oct2021) had a slight headache, on Sunday (17Oct2021) woke up with a rash on her neck and on Monday (18Oct2021) felt like her throat was closing and went to the doctor on Monday. The patient stated that It felt like her throat was closing and she had a headache and dizzy and they gave her a shot of cortisone in her arm and she was put on a steroid pack. The patient wanted to know how long it takes to get better. She does feel better since having cortisone and being on the steroid, but she gets lightheaded and dizzy and wanted to know how long that would last. The outcome of the events was unknown.
Sore throat; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on unspecified date 12:00 AM (Lot Number EN9009) (at age 42 years old) administered in arm right as a SINGLE DOSE for covid-19 immunisation.  Medical history was none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient's concomitant medications were not reported.  On 15Feb2021 02:00, the patient experienced sore throat. No treatment was received. Outcome of the event was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
2ND VACCINE DOSE GIVEN 14 DAYS AFTER FIRST DOSE, 1 WEEK EARLY
Systemic: Dizziness / Lightheadness-Mild, Additional Details: PATIENT REPORT FEELING LIGHT HEADED AFTER VACCINATION, PATIENT EXPLAINED THAT SHE HAS A HISTORY OF FEELING FAINT WHEN GIVING BLOOD AND OTHER VACCINATION. PATIENT LAID DOWN AND ELEVATED LEGS, AND IMPROVED WITHIN A FEW MIN. PROVIDED PATIENT WITH OJ TO HELP WITH SUGAR. MONITORED FOR 30 MIN. FOLLOW UP CALL WITH PATIENT AT END OF THE DAY, PATIENT REPORT NO SYMP AND BACK TO NORMAL
On 03/20/2002 at 12pm, urticaria after Infanrix and IPV. Prescribed Benadryl.
Patient presents to Medical Center on 01/03/2022, a week after being diagnosed with Covid-19.  He presented with c/o worsening SOB, cough and chest congestion.  He was noted to be hypoxic with SPO2 of 85% on 15% non rebreather.  CXR showed diffuse bilateral infiltrates.  Patient was admitted to hospital.  He was transferred on day of admission to ICU and placed on BiPAP at 70% FiO2, and continued on BiPAP for several days with minimal improvement.  He was treated with Remdesivir, steroids, vitamin C, D and Zinc.  On 01/16/2022 patient deteriorated and required intubation.  After 14 days of intubation, a Trac was placed, he continued to require extensive vent support.  On 02/03/2022 patient was made comfort measures with palliative care.  Patient expired on 02/03/2022.
she had minor headaches after the 1st dose; This is a spontaneous report from a Pfizer-sponsored program. A Contactable female consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 28Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 28Feb2021, patient experienced minor headaches.The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
On 1/25/00, the pt developed conjunctivitis with redness and discharge of the left eye and chickenpox-like areas on her face. She later developed redness in both eyes, otitis with drainage of the left ear, and a rash on her abdomen. There were no lesions and no fever.
arm where she got the injection hurt so bad; chills; ran a temperature; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm where she got the injection hurt so bad), CHILLS (chills) and PYREXIA (ran a temperature) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced INJECTION SITE PAIN (arm where she got the injection hurt so bad), CHILLS (chills) and PYREXIA (ran a temperature). On 13-Feb-2021, INJECTION SITE PAIN (arm where she got the injection hurt so bad), CHILLS (chills) and PYREXIA (ran a temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Patient called to say she received the 2nd dose with no issues to report.
Seen 6/9/06 at office; rash on legs, trunk and arms. No new exposures but received Hep A 6/6/06. Rash began 6/7/06; no fever, chills.
Received both Pfizer COVID vaccines - both he and his wife have tested positive for COVID-19 this week
2 episodes of pass out whom got the second dose; 3 patients felt unwell whom got the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (2 episodes of pass out whom got the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (2 episodes of pass out whom got the second dose) (seriousness criterion medically significant) and MALAISE (3 patients felt unwell whom got the first dose). At the time of the report, LOSS OF CONSCIOUSNESS (2 episodes of pass out whom got the last dose) and MALAISE (3 patients felt unwell whom got the first dose) outcome was unknown. Not Provided      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.   Treatment was unknown.  This case concerns an adult patient of unknown age and gender with a serious unexpected event of loss of consciousness, and nonserious unexpected malaise. Latency within 1 day after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Significant: No of patients and events given
This was my Booster shot (The previous shots were in March 2021 and April 2021, both Moderna). 5 days after the booster I noticed under my skin on my outer legs something that felt like bumps. It was not visible to the eye, you could only feel them.. It did not itch and it as not red. Every day these bumps  (size of  grain of rice) got more and the outer legs area was getting bigger. I felt them on my arms also. The Third day they became visible and are slightly red (no itching). They got worse at night. I took benadryl which helped but they come back even more the next night. I tried allegra did not work. Only benadryl seems to help. But If I stop takijg it, it comes back. I also have dry eyes. Today after 10 days I got a panic attack which resolved after a couple of hours. This was my first panic attack in over 20 years.
Woke up with Flu like symptoms. Felt like he would pass out for about 30
My heart rate and blood pressure went really high so I went to the heart doctor. The heart doctor put me on medications to try to lower it, but that didn't work. I was diagnosed with an atrial flutter. I ended up going to the hospital for an ablation procedure about 3  weeks ago. I also had flu like symptoms after receiving the vaccine for a day.
Red firm rash on leg. Varicella was administered x4 days. Red pinpoint rash on torso last wk, that has since resolved.
2 days p/vax 16OCT93 pt started to feel achey; 3 days p/vax 17OCT93 body aches, fever (didn't measure); 4 days p/vax 18OCT nausea, fainted x 2; 5 days p/vax 19OCT queasy;
Approximately an hour and half after patient received his 2nd covid vaccine, pt contacted pharmacy asking if lower back pain and muscle spasms was a common side effect from the vaccine. He reported having lunch with his friends but could not stand and needed help walking to his car, could not walk on his own. I asked if he has any history of back pain or a similar situation and he denied any previous experience similar to this. I advised patient to contact his doctor as soon as possible for observation.
I started breaking up into hives. Little red dots that itch from the inside like I was on fire. It kept getting worse and spreading all over. It was in my hands, chest, arms, down my back, legs, ankles. I went to several doctors and they said I had bed bugs but I did not think I had that. I did all the stuff to get rid of bed bugs but that did not seem to get rid of the hives. I finally went to a doctor that I could trust and they referred me to a dermatologist. All of my doctors did blood work which show I was very anemic and my inflammation was high. I did a short run of prednisone and that did not help. The dermatologist gave me some topical cream and if that did not work to call him to give me a heavier dose of prednisone. He gave me that heavy dose prednisone and most of them went away but I still have to use that cream every day on my back.
stayed in the hospital over a month with Covid; stayed in the hospital over a month with Covid; started on with pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (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 series of immunization completed, Manufacturer name unknown), for COVID-19 immunization. The following information was reported: SUSPECTED COVID-19 (hospitalization, medically significant), DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown" and all described as "stayed in the hospital over a month with Covid"; PNEUMONIA (medically significant), outcome "unknown", described as "started on with pneumonia". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective.  Clinical course: When caller was reporting about her own experience with the Pfizer Covid vaccine booster, she mentions that  her cousin had all three and she knows it don't keep you from getting the virus. She knows it is supposed to keep from going in the hospital but her cousin stayed in the hospital over a month with Covid and had to go home on oxygen. She states they can't tell her the vaccines are perfect. she does not have any further details to provide regarding her cousin's experience. She states he started on with pneumonia, that is all she knows. He just had his booster shot too. No further details were provided. description of product complaint: got all three vaccines and got the Covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number, expiration date, dose and route were unknown). The vaccines were exposed to 30.2 F for an unspecified amount of time. No adverse effects were reported. No PQC was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Not able to get  her 2nd dose on the due date because she was sick; she was sick; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not able to get  her 2nd dose on the due date because she was sick) and MALAISE (she was sick) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis and Paralysis.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not able to get  her 2nd dose on the due date because she was sick) and MALAISE (she was sick). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Not able to get  her 2nd dose on the due date because she was sick) had resolved and MALAISE (she was sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Baseball width hard subcutaneous swelling, itchy, warm to the touch, onset 7 days after vaccine administration
Severe migraine; body ache; lymph nodes swollen in arm pit, neck, jaw
Vaccine not removed from freezer at 2 wk mark- at 3 wks and administered at  consult with Dr. Notified pt offer repeat dose
pt recv vax 21NOV88 & pt devel paralysis of the lt,lower extremity & atrophy of the lt gluteus,psoas,iliac,obturator,internus,rectus femoris,sartorius,& adductor muscles;pt was hosp for this condition & has not recovered;
This case was reported by a healthcare professional and described the occurrence of headache in a 54-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medications included Atenolol, Spironolactone and LEXAPRO. On 28 April 2011 the subject received 2nd dose of TWINRIX. On 28 April 2011 (a couple of hours after administration of TWINRIX) the subject experienced headache. The healthcare professional considered the event was disabling. At the time of reporting the event was resolved and probably attributable to TWINRIX vaccination. It was also reported that the subject experienced a headache following the 1st administration of TWINRIX. The outcome of this event was not indicated. It was noted that the headache following the 2nd dose of TWINRIX was worse and lasted a couple of days. Follow-up information was received on 24 May 2011. It was reported that the first event of headache occurred at an unspecified time following 1st dose of TWINRIX administration. Headache onset was on 31 March 2011 and ended on 02 April 2011. On 28 April 2011, the subject received a 2nd dose of TWINRIX and one day later on 29 April 2011 the subject again developed a headache. The event ended on 01 May 2011. In the reporter's opinion, both events of headache were probably related to treatment with TWINRIX. On follow-up, the events were not considered to be serious/disabling.
Nurse came to me and asked " what is the booster dose for Moderna. How many ml". I told nurse that the booster dose for Moderna is half the regular dose of 0.5. At that point nurse said to me she had just given patient 0.5ml instead of 0.25ml.  Patient had no adverse effects from the vaccine.
Itchy, red rash from the end of shoulder to elbow.  It lasted 7 days. I used benadryl lotion to help with the itching.