chrisvoncsefalvay/vaers-outcomes huggingface dataset:
miscarriage; This is a spontaneous report from a Pfizer-sponsored program reported by a contactable consumer (patient's mother). A female patient unspecified age received BNT162B2 (COMIRNATY, formulation: solution for injection) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Reporter stated that both reporter and her husband received both doses of product. No side effects, "everything was good". Travelled to visit daughter, daughter experienced a miscarriage. Daughter did not receive product, or "anyone else". Her daughter is pregnant and had a misscarriage while the mom went to visit her daughter, after receiving the vaccine. She wants to know if the vaccine causes shedding. She has ben hearing different stories about that.   Follow-up attempts are completed. No further information is expected.
Nausea; Chills; Fatigue; Body ache; Headache; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 24Apr2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 14:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 23:45, the patient experienced nausea, chills, fatigue, body ache and headache. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, chills, fatigue, body ache and headache was recovered on an unknown date in Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Client reported tightness when swallowing approximately 10 minutes after receiving the vaccination, but no shortness of breath or dizziness.  She felt flushing throughout her entire body as well as some tingling. At 7:05 pm, her oxygen saturation was 97% and her blood pressure was 115/80.  She also had red, irregular-shaped  spots on her right, upper arm  (non-vaccinated arm) and upper back.  At 7:13 pm her oxygen saturation was 98% and her heart rate was 111. She then described the tightness when swallowing from earlier as if the muscles in her throat were numbed, which made it hard to swallow, but not hard to breathe. The tightness improved slightly during the 30 minutes that she was observed, but it did not go away. She felt comfortable leaving and knew which signs to look for that would indicate that she needed to seek medical attention.
p/vax pt devel erythema multiforme; continued w/skin BX; symptoms were round red ring like 1-3cm plaques on both arms &  dorsum of hands (rt arm more than lt)
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 21-Jan-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-363731, MOD-2021-364488, MOD-2021-365189 (Patient Link).
Severe chills all day, headache, joint aches, very tired, & fever (100.6) in afternoon.  Today I feel like a cold is coming on still have mild headache and tired.  I just rested all day drank lots of fluids.  I did take in the late afternoon 2 tablets of Anancin which made my fever break.
Location site pain; Chills; Mild head ache; Low grade fever; Stomach cramping; Diarrhea; This is a spontaneous report from a contactable health care professional, the patient. A 63-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via unspecified route of administration in her left arm, on 18Mar2021 at 09:45 as a single dose for COVID-19 immunisation. Medical history included asthma and patient had allergies to sulfer medications and others are mild reactions. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included unspecified medications for asthma within 2 weeks of vaccination. On 18Mar2021 at 17:45 hours, the patient experienced location site pain (vaccination site pain), chills, mild head ache, low grade fever, and stomach cramping with diarrhoea. Patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care The clinical outcome of the events vaccination site pain, chills, headache, fever, stomach cramping and diarrhoea were resolving at the time of this reporting.   No follow-up attempts are needed. No further information is expected.
hives on trunk, legs, & arms when woke up in AM; irritable;partly resolved w/DPH;
Stiffness and muscle weakness on the right side of the face occurred next day.; Stiffness and muscle weakness on the right side of the face occurred next day.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 15:30 (Lot number: Ff2588) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pollen Allergy" (unspecified if ongoing), notes: Pollen. There were no concomitant medications. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), MUSCULAR WEAKNESS (non-serious) all with onset 29Sep2021 09:00, outcome "unknown" and all described as "Stiffness and muscle weakness on the right side of the face occurred next day.". The event "stiffness and muscle weakness on the right side of the face occurred next day." and "stiffness and muscle weakness on the right side of the face occurred next day." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of musculoskeletal stiffness, muscular weakness.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. List of any other medications the patient received within 2 weeks of vaccination: None. Relevant medical history and concurrent conditions: None. Relevant past drug history: Pollen. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Serious-ness criteria-Congenital anomaly/birth defect: No. Stiffness and muscle weakness on the right side of the face occurred next day. Hospitalization Prolonged: No. Treatment Received: Unknown. Doctor or other healthcare professional office/clinic visit. Prior to vaccination, was the patient diagnosed with COVID-19? No. Since the vaccination, has the patient been tested for COVID-19? Yes. Results of tests and procedures for investigation of the patient: Date: 30Sep2021 Test: PCR Test Result: Unknown Lab Notes: Nasal Swab.  No follow-up attempts are possible. No further information is expected.
Intussusception 7/22/07 requiring surgical reduction.  8/20/2007 MR received for DOS 7/22-27/2007.  Infant presented to ER with parental c/o vomiting and poor PO intake.  PE WNL.  Passed a large, loose, guiac (+), foul-smelling stool in ER.  Taken to OR for reduction of ileocolic intussusception and appendectomy. D/C DX:  Intussusception.  10/18/2007 Vax record received and reviewed.  Data same as VAERS report.
Information has been received from a lawyer concerning a male (age unspecified) who on an unspecified date received a dose of PNEUMOVAX23 (route, dose, site and lot number not reported). Subsequently the patient died. The exact cause and date of death was not reported. It was unknown whether the patient underwent an autopsy. The reporter stated that it is believed that the PNEUMOVAX23 caused the patients death. Additional information has been requested.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tinnitus-Mild
t102, screamed shrill cry x 3 days, leg swollen, wouldn't drink, severe irritability, became very lethargic & listless for an hr or so;rxn began approx 8PM same evening of getting vax;
Diarrhea followed by terrible nausea. Vomiting and diarrhea every hour for 12 hours straight. Extreme headache and muscle ache. Restless leg syndrome. Over all super intense feeling of being unwell.
extreme fatigue:nausea;vomiting;diarrhea;abd pain;anorexia;dizziness;h/a;sweating;flushing;weakness;malaise;diff concentrating;flu-like sx;neck, shoulder & back pain;hypersensitivity synd;
3/13/03 pain in R inguinal lymph nodes and down R thigh pain five on a scale of 1-10. 3/18-3/19 numbness noted (3/23) red area noted with blister like area noted in middle (3/22) several more areas broke out (3/23) last area broke out without hurting and burning and no itching. 3/20/03 post vaccination Vioxx, Aleva, Amoxicillin ? sinus 3/6/03.
developed a light pink spot around injection site that was about 5 inches; itchy spot; A Spontaneous report was received from consumer concerning a female patient of 66 age who received Moderna COVID-19 vaccine (m-RNA-1273) and experienced Injection site erythema, Vaccination site pruritus.  The patient has no medical history and no relevant concomitant medications.   On 04-Feb-2021, prior to the onset of the events the patient received their first of dose of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly for prophylaxis of COVID-19 infection.  Treatment for the event included Diphenhydramine hydrochloride.   The events Injection site erythema, Vaccination site pruritus were unknown. The outcome of the events is unknown.   Action taken with mRNA-1273 in response to the events was not reported.  Based on comment, Injection site erythema, Vaccination site pruritus were listed.
This is a spontaneous report received from a contactable consumer/patient or other non-HCP (005570). A patient (no qualifiers provided) received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Comirnaty), for COVID-19 immunization. The patient reported, "I am Pfizer fully vaccinated and had the booster as well. I now have tinnitus (ringing in ears)," with outcome of unknown. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
12/30/2021 Heart murmur/ Atrial Flutter. Mitral Valve Prolapse and AFib. Open heart surgery 01/26/2021 Repaired still in AFib awaiting conversion.
she experienced allergic reactions after receiving PNEUMOVAX:She developed hives, itching, drop in blood pressure and her voice was hoarse; This spontaneous report as received from a 66-year-old female patient concerning herself with allergic reaction to penicillin, gabapentin and other unspecified medications. Patient's historical conditions include allergic reactions.  Concomitant therapies included metoprolol, potassium, torasemide, acetylsalicylic acid (BABY ASPIRIN), vitamins nos and omeprazole. On 09-AUG-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On the same date, the patient developed hives, itching, drop in blood pressure and her voice was hoarse (Allergy to vaccine). When the blood pressure was measured, it was 90/50 (units not provided) and her face was pale like a "ghost". She had to get epinephrine (EPI-PEN) injection and take diphenhydramine (BENADRYL) to treat her allergic reaction. Her blood pressure was low for few more days but now she felt better. The patient sought medical attention by speaking with the physician.The outcome of allergy to vaccine  was reported as recovering.     The reporter considered allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).    The event of allergy to vaccine  was considered to be life threatening by the reporter.
Got the shot, but got shingles now/Suspected vaccination failure; Still got the shingles now for 3rd time; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. In September 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 17-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shot also but he/she still got the shingles now and it the third time just getting over them. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As per narrative patient still got shingles now therefore partial onset date was captured as September 2022 and outcome was captured as recovering based on just getting over them.
- After 13 hrs of receiving 2nd dose:  body aches, chills, shaking, severe headache, dizziness - After a couple of weeks of 2nd dose through present day:  daily headaches, primarily in afternoon - From 4-5 months after 2nd dose through present day:  chest pain/ache
Redness swelling hot and hard to touch, took Benadryl clairitin and put ice on it, started 7 days after shot
The afternoon after I got the second dose of the vaccine I started to have pain under my arm and along the left side of of my breast. It got more intense overnight and the next day. It started to localize in my underarm area. It was painful to put my arm down. It lasted for a week as intense pain and then it started to resolve. By ten days after the shot it was not painful. I was using ice three times daily and taking pain relievers. Currently the problem has resolved.
join pain; Difficulty breathing; fast heartbeat; dizziness; weakness; chills; diarrhea; nausea; vomit; tiredness; headaches; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 66-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 27Jan2021 12:30 as 1st dose, single (age at vaccination 66-years) for COVID-19 immunization. Medical history included depression and parkinsons disease from an unknown date and unknown if ongoing. Concomitant medications included donepezil hcl 5mg, sertraline hcl 50mg, and carbidopa taken for an unspecified indication, start and stop date were not reported (medications in two weeks before vaccination). The patient was not had Covid prior vaccination, and the test was not performed post vaccination. The patient did not take any other vaccine in four weeks. Patient stated that 4 days after her first dose (31Jan2021 12:00am) she felt tiredness and headaches. The next day (01Feb2021), patient had chills, diarrhea, nausea and vomit a lot until was dehydrated. On 04Feb2021 12:00am, the patient had difficulty breathing, a fast heartbeat, dizziness, weakness and joint pain. Patient thought she was going to die and she did not go to the emergency room because she really do not want to get die there. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The treatment was received for the adverse events. Adverse event treatment given with pedialyte to get hydrated. The patient underwent lab tests and procedures which included heart rate increased: fast on 04Feb2021. The vaccination facility type was reported as hospital. . The clinical outcome of the events was reported as recovering.  Information about lot/batch number has been requested.
myalgia; chills; fatigue; This is a spontaneous report from a non-contactable pharmacist. This pharmacist reported for 42-year-old female (pregnant: No) patient received 2nd dose of BNT162B2 (lot number=EL3246) Intramuscular on 12Jan2021 09:00 AM at single dose for covid-19 immunization. Medical history was Known allergies: sulfa, COVID prior vaccination. Concomitant drug was not reported. Historical Vaccine was 1st dose of BNT162B2 (lot number=EK5730, 22Dec2020, 09:00 AM, Intramuscular). No other vaccine in four weeks. After 12 hrs of taking 2nd dose of covid-19 vaccine (12Jan2021 08:00 PM), patient experienced myalgia, chills, and fatigue. The patient took Tylenol. All events resolved 24 hrs after. COVID tested post vaccination with unknown results.  No follow-up attempts are possible. Information about lot/batch number has been obtained.
patient developed rash around lips the following day in addition to body aches both got better in few days
On November 4, 2021 I went to the minor medical after having a headache on the right side of my head for 2 days and noticing my face was feeling abnormal. During my visit I was diagnosed with Bell's Palsy on the right side of my face. I have been taking Prednisone from 11/04/2021- 11/16/2021. Everything is still the same today. Dates of vaccinations:  1st dose Covid Vaccine Pfizer: 08/18/2021 2nd dose Covid Vaccine Pfizer: 10/09/2021 Influenza Vaccine: 10/05/2021
Patient was observed in observation area. Patient was sitting in a chair and fainted to the ground. Patient did not notify RN?s in observation that she was feeling faint, lightheaded or had any symptoms. Code was called for EMS to patient side and safety measures were taken.
About 1 min after injection, pt had a hard time breathing. I gave her a 0.3mg Epinephrine inj. in her right thigh. After about 1 min w/no relief, I gave her a second inj. of the same thing. 911 was called and they came shortly after Epi injections.
Erythema/warmth of 5cm around induration & blistering of nickel size. Occured less than 24 hrs post injection on Fluzone arm.
Patient called from clinic about 1 hr after receiving Covid vaccine. She had visible lip swelling and lip itchiness that was worsening. She had no SOB, no C/P, no dizziness, no generalized itching or rash. She has history of allergic reaction to unknown substance leading to ED visit. I advised she go to ED for eval, a friend accompanied her, she did not feel ambulance was necessary.I called report to the ED Addendum on 1/1/2021: When I called, she said that one week later she had a similar reaction of lip swelling to another area of lips.
JOINT PAIN, RIGHT HAND SWOLLEN, CAN'T BEND MIDDLE FINGER,  PAIN RADIATES TO WRIST, FINGERS START TO TINGLE IF USES RIGHT HAND FOR EXTENDED PERIOD OF TIME.
hives following both doses About a week 10 days following my first dose of Gardasil 9 I got hives. The second dose also gave me hives in March. They start on the back and the migrate to the breasts. I am taking the doses in the recommended time frame.
This spontaneous prospective pregnancy report as received from a nurse refers to approximately 18 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. On 28-FEB-2011 the patient vaccinated with GARDASIL dose 1. There were no concomitant medications. On 07-AUG-2013 the patient was vaccinated with second dose of GARDASIL off schedule when she was 4 months pregnant. The patient was pregnant with approximate last menstrual period (LMP) of 07-APR-2013, estimated date of conception of 21-APR-2013 and estimated date of delivery (EDD) of 12-JAN-2014. Initial exposure to GARDASIL was at 16 weeks (reported as 4 months). The pregnancy outcome was outcome pending. The patient sought medical attention and had an office visit. Additional information has been requested.
Vertigo; Lightheadedness; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 08Mar2021 at 09:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to Con. 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. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 15Feb2021 at 09:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient previously also received pethidine hydrochloride (DEMEROL) and doxycycline (MANUFACTURER UNKNOWN) and experienced drug allergy on an unknown date. On 09Mar2021 at 21:00, the patient experienced vertigo and lightheadedness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events vertigo and lightheadedness were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.