chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant, via a company representative, concerning a 14 year old female patient, who on 14-MAR-2008 was vaccinated with first dose, IM in the arm, of GARDASIL (lot # not reported). Concomitant therapy included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer not specified). On 14-MAR-2008 the patient became pale, dizzy, and clammy after receiving her first dose, she fainted and had a mild seizure. The patient stated that she had not eaten yet that day. The patient recovered after an unknown duration of time. The patient sought unspecified medical attention. Upon internal review, a mild seizure was considered to be serious as an other important medical event. This is one of several reports received from the same source. Additional information is not expected.
Information has been received from a physician concerning a 20 year old female who on 23-AUG-2007 was vaccinated with her third dose of Gardasil at approximately 11:40 am. After vaccination, on 23-AUG-2007, the patient was sitting in the waiting room of the physician's office and "passed out." She was woken up with smelling salts and then passed out again and began to have seizure-like movements. The office called the paramedics and when they arrived, they tested her blood sugar and it was 106. They started an intravenous line and took her to a hospital. The office was unable to contact the patient to find out if she was admitted to the hospital or released the same day. The office did state that the patient did not have anything to eat all day. It was unclear as to whether or not the patient had any experiences with the first and second dose of Gardasil (dates of vaccination not provided). "Passed out" and seizure-like movements were determined to be other important medical events by the reporting physician as an IV line was started by the paramedics. Additional information has been requested.
Headache, Myalgia, Arthralgia, Fever, UrticariaPruritus, Diarrhea,  Chills/ Fatigue
She developed a large pulmonary embolus, and she died on 3/17 at Hospital. She developed symptoms of SOB on 3/11, and was admitted to the hospital. She was initially stable and not requiring oxygen and was sent home on anticoagulation. However she returned the same day with worsening symptoms, troponin now elevated, and ECHO showing signs of right heart strain. Embolus on imaging had increased in just over days from previous CT scan. She became pulseless and died despite resuscitative efforts. It is my opinion (Dr.) that she died of a pulmonary embolus, and an autopsy is pending.
Also had .34 Troponin level; Atrial Flutter episode; Heart racing at 165 BPM; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 19Mar2021 at 16:00 (batch/lot number: EP7534) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included prucalopride succinate (MOTEGRITY) taken for an unspecified indication, start and stop date were not reported. Nine days post vaccine (as reported; pending clarification), the patient had a atrial flutter episode with heart rate at 165 bpm. She went to ER and the atrial flutter was confirmed via EKG. Also had .34 troponin level. She was kept overnight and multiple test were run. She was healthy, active with no other risk factors. The start date of the adverse events were reported as 03Apr2021 (as reported; pending clarification). The adverse events resulted in emergency room/department or urgent care. Treatment was received for the adverse events which included blood thinner, Lipator (as preventative). The events were assessed as serious with the serious criteria of hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, COVID-19 swab taken at ER on 04Apr2021 with negative test result. The outcome of the events was recovered on an unspecified date.
Dose #2 given on 12/05/22 from bottle opened on 11/30/22.
7/25/03: Eczematous flat topped papules elbows, knees, dorsal aspect both hands symmetrically (3-8mm diameter). Colescent on elbows, some urticarial qualities. 2 sm erosions on elbows, no vesicles or bullae. Temp 99.6. Headache. (2-7 days post vaccination red: 7/24 red palms-painful). 7/20 nausea, chills.
Upon waking up in the morning, day after 1st injection, I've been experiencing numbness on my chin, and pain behind my jaw, lower left side around where my tonsil is. Only hurts when I try to open jaw wide or stick my tongue out far. Pain level around 4 out of 10. Symptoms still present 4 days after injection and have my no change in severity.
Early onset of menstruation despite being on oral contraceptives (forgot to list on prior page) and severe menstrual migraine; severe menstrual migraine; This is a spontaneous report from a contactable physician. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the arm left on 05Apr2021 at 16:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome and hypothyroidism. The patient previously received ciprofloxacin (MANUFACTURER UNKNOWN) on an unspecified date for an unspecified indication and experienced drug allergy. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), metformin hydrochloride (METFORMIN) and drospirenone (MANUFACTURER UNKNOWN) from unknown date for unknown indication and unknown if on going. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm left on 15Mar2021 at 16:30 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 vaccination. On 09Apr2021 the patient experienced early onset of menstruation despite and severe menstrual migraine. Therapeutic measures were taken as a result of menstruation d and severe menstrual migraine and included treatment with Tylenol and Advil . The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events, menstruation despite and severe menstrual migraine was recovered on unknown date on Apr2021  No follow-up attempts are needed. No further information is expected.
Patient found to have completed J+J COIVD vaccine on 3/13/2021 with different vendor.  Patient received Pfizer COVID vaccine as listed here on 7/22/2021.
Severe Swelling in my left hand, elbow, armpit, groin, and knee that has  lasted 2 months and not yet resolved.
On  April 3, 2021 at 6 am I noticed 2 small lumps on the right side of my face next to my right eye area. I thought it was a bug bite, but I did not see any tiny spot of skin penetration? Today is April 4, 2021. I still have the 2 lumps but has gotten smaller in size, but still visible of a slight light redness on the 2 bumps?
Intussusception 8/5/22 with bilious vomiting, lethardy, anorexia
24 hrs p/vax was seen w/hot, erythematous lt deltoid w/tender, enlarged ax node, causing dec motion of arm;
Diplopia, nystagmus. Hospitalized, treated with IV steroids x 3 days, resolutions of symptoms.
Developed redness in injection arm with spot measuring approximately 3.5 inches in diameter.  The spot is hard, hot and tender to touch.
Client reported rapid heart rate and tingling in face.  BP 123/80  pulse 83 @12:59.  She stated feeling better before leaving.  Encouraged client to follow up  with PCP if  experienced any other symptoms.
Extreme muscle pain. Mostly in right neck/shoulder area that migrates down to mid-arm. Sensitive back muscles, if moved in a certain way, tenses up and causes extreme pain. Nausea and headache.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (didn't get second dose, coming in for second dose, first dose was given more than 3 months ago) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M21A) for COVID-19 vaccination. No Medical History information was reported. On 12-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 (didn't get second dose, coming in for second dose, first dose was given more than 3 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (didn't get second dose, coming in for second dose, first dose was given more than 3 months ago) outcome was unknown. 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. No concomitant medications were reported. No treatment information was provided by the reporter.
Extreme Anxiety and rapid heart rate.  Elevated blood pressure, hard to get a full breath some times.  Loss of weight
side effects after first and second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (side effects after first and second dose of vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (side effects after first and second dose of vaccine). At the time of the report, ADVERSE DRUG REACTION (side effects after first and second dose of vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment details were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080584 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080584:
This spontaneous report as received from a healthcare worker refers to a 13 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 21-AUG-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L010142 and expiration date 24-SEP-2016; dose and route of administration were not provided). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
asthma crisis; cough; shortness of breath; heartbeat also increased significantly; This is a spontaneous report from a contactable consumer (patient).  A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158), via an unspecified route of administration, administered in right arm on 09Apr2021 at 15:00 (at the age of 46-years-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included asthmatic. There were no concomitant medications.  The patient previously took quinolone and experienced drug allergy.  On 10Apr2021 around 23 pm, patient suddenly got asthma. That made her cough, and she experienced a shortness of breath. The crisis got away by itself. Patient didn't take any medication. Her heartbeat also increased significantly but that usually the case when she has an asthma crisis. The events were resolved on an unspecified date in Apr2021.
Chills, fever, nausea, pain at site of injection, fatigue. (all starting 12 hours after injection)
Fluvax and Prevnar - first dose of each for patient (my daughter).  Visit was for 15 month well-check.  Immunizations have been delayed so she has only received 2 doses HiB and 2 doses DTaP.  Within 10 minutes of receiving the vaccines, my daughter passed out; within 30 minutes she vomited twice; within 45 minutes she had vomited an additional 2 times.  Physician Assistant recommended we come back to the office to check her out.  Pulse-ox monitored and she was assessed to be "okay".  Doctor stated that it was either a reaction to something in the vaccine, or a shock reaction.
after a week of receiving vaccine, I no longer feel the same as before. The lack of energy, feeling fatigue, nauseous, dizzy, weak, short of breath, body ache and constant chest pain and headache.
Headache; Serious convulsion; Slight tenderness at the injection site; A spontaneous report was received from a consumer concerning an 81-years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced serious convulsion/seizure, slight tenderness at the injection site/vaccination site pain and headache.   The patient's medical history included blood pressure high, diabetes and rheumatoid arthritis. Concomitant medications included methotrexate.  The patient received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) on 04 Feb 2021. On 08 Mar 2021, prior to the onset of the event, the patient received the second of two planned doses of mRNA-1273 (batch number: 027A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 08 Mar 2021, the patient experienced slight tenderness at the injection site. On 09 Mar 2021, at 12.30 and 1.30 AM the patient experienced medically significant event of serious convulsion with no previous history of seizures. Since patient has a disabled husband, she didn't call ER (emergency room) and went to the neurologist next morning who told her to report it. On 10 Mar 2021, the patient experienced headache attributed to migraines. Treatment for the event headache included paracetamol. Treatment information for the events serious convulsion and slight tenderness at the injection site was not reported.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.  The outcome of the event slight tenderness at the injection site was resolved on 08 Mar 2021. The outcome of the event serious convulsion was resolved on 09 Mar 2021. The outcome of the event headache was resolved on 10 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The pt is a 2 month old female who presented to the clinic on the evening of 6/16/00 with an onset of bilious vomiting and extreme lethargy. There were no problems for a few hours after the vax, however towards the evening hours the child began vomiting.60 day follow-up dated 09/27/00 provided no additional data.
Vial was only diluted with one tenth of the specific amount of dilatant. Patient received a higher than normal dose of their booster vaccine. Patient was notified of the error at 1229 PM, and apologized and advised that they may have more reactions such as achiness, or fever, but if they have any concerns or concerning symptoms to please contact us. Patient understood, didn't have any concerns at this time.
Within a few minutes of the vaccine she could taste and smell a very strong medicine taste.  She did not notice until after another 10 minutes that her face was on fire.  She looked in the mirror and her face was red, much more on the left than the right.  It would decrease in intensity and then flare up again.  She then went to the doctor, tried to wait out getting into the doctor, but then decided to go to the ER.  Her blood pressure was 187/181, yesterday was 112/64.  They gave her a stronger Benadryl and Pepcid, monitored her and did her oxygen level which was 97%.  All other VS were normal.  Today, 2/18/21 the redness was gone by 10:00 the night of the vaccine.  Over the last 24 hours she has had a mucousy cough, and clearing of the throat, but otherwise feels back to normal.
Right lower leg pain, swelling, warmth, vein varicosities, chest pain, shortness of breath continuing over days
2/14/2021 Resp panel: COVID19 + Started on 2/14/21 Dexamethasone 6 mg po daily and on 2/15/21 Remdesivir 200 mg IV x1 dose then 100 mg IV daily x 4 doses. 89-year-old male presents to the emergency room with epigastric abdominal pain and shortness of breath and was found to have acute pancreatitis and COVID-19 pneumonia.
Large, hard bump the size of about a quarter developed underneath my leg on the injection site.  Does not move around, is tender and bruised. It is warmer than the rest of my body. I went to my doctors office, she examined me and had an ultrasound preformed. She believes this is either a Hematoma cause by the vaccine, or the vaccination itself was not injected into my muscle and it had no absorbed.
June 9th gallbladder and chest pain begain.  July 12th eR visit . July 15th Saw PCP . July 24th ER visit and was admitted . July 25th surgery done to remove fluid.
Information has been received from a pharmacist concerning a 64 year old female patient who on 22-APR-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported), SQ. Pharmacist stated that "after a week" on 29-APR-2010 of ZOSTAVAX (Merck) was administered the patient had noticed a rash all over her body. An unknown treatment was given for the event. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. No further information is available.
An adverse effect of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (An adverse effect of the Moderna COVID-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (An adverse effect of the Moderna COVID-19 vaccine). At the time of the report, VACCINATION COMPLICATION (An adverse effect of the Moderna COVID-19 vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were reported.
1/28/08 patient reported lower arm and hand sore from lifting her child. On 2/1/08 reported that entire arm and up into neck is sore. No c/o redness, warmth, or elevated temp since injection. No c/o discomfort when received injection or tingling in arm. Advised patient to go to her provider or urgent care center for assessment. 2/01/2008 patient reported to her supervisor that she went to Dr. who said that patient may have a muscle tear and is sending her for physical therapy to see if relief obtained. PT started on 2/04/2008.
Initial report was received from a consumer, who was also the patient, on 22 October 2012. A 75-year-old female patient had received a intramuscular injection in the right arm of FLUZONE High-Dose, lot number U4493AA, on 22 September 2012 and one hour later had a severe headache and pain at the injection site. The headache persisted but the pain at the injection site subsided. The patient was treated with FIORINAL and discontinued after one dose because the patient felt lightheaded. The patient also took TYLENOL extra strength and ATIVAN 0.5 mg. Headaches and tinnitus exacerbated. The patient was seen by a neurologist and treated with prednisone dose pack and CAMBIA powder for migraines. The patient took one dose but it made her headache worse so it CAMBIA powder was discontinued. The prednisone was discontinued after two days. The patient had no illness at the time of vaccination, allergies to AUGMENTIN, CIPRO and Iodine, and a past medical history of tinnitus, gastroesophageal reflux disease (GERD), hiatal hernia and arthritis. The patient's outcome was not recovered. Documents held by sender: None.
I have had a continual headache 9 months. It ranges from mild to unbearable but it is always there.
adult patient received pediatric dose of ENGERIX-B; adult patient received pediatric dose of ENGERIX-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 25-year-old female patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31-MAR-2024) for prophylaxis.   On 06-NOV-2023, the patient received Engerix B pediatric 10 ug. On 06-NOV-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: adult patient received pediatric dose of ENGERIX-B) and adult use of a child product (Verbatim: adult patient received pediatric dose of ENGERIX-B). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-NOV-2023 The reporter was a certified medical assistant. adult patient received pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter consented to follow up.
DAY OF INJECTION:  PATIENT DESCRIBED FEELING STIMULATED, ENERGETIC, "LIKE ON SPEED",  DAY 2 :  PATIENT DEVELOPED DIZZINESS, HEADACHE, HIVES FROM HEAD TO TOE.  CONTACTED LOCAL EMERGENCY ROOM BY TELEPHONE AND WAS TOLD TO TAKE BENADRYL.  PATIENT TOOK BENADRYL AND HIVES AND ITCHING WERE RELIEVED.  DAY 3:  SYMPTOMS MOSTLY RESOLVED WITH THE EXCEPTION OF EXPERIENCING LOOSE STOOLS.
Information has been received from a physician concerning a now 18 year old female who in approximately 1997, when she was 6 years of age, was vaccinated with RECOMBIVAX HB (manufacturer unknown). In approximately 1997, when she was 6 years of age, after vaccination, the patient experienced GUILLAIN-BARRE syndrome and was hospitalized. Date of hospitalization and hospital's name were unknown. The physician did not want to report the event because it happened a long time ago, it was already reported and she did not have the patient's chart. No further information is available.
One day after I received the Pfizer shot, in my left arm, I started to experience sharp chest pains. I was not able to take deep breaths without shooting pain, and the left side of my chest was sore.   The sharp chest pain lasted for a day, but I am still experiencing soreness.
July 19 Pfizer vaccine July 24 sore throat very tired, August 2 went to doctor she requested Epstein-Barr test because of the continuing sore throat and tired feeling , August 5 blood test August 6 test positive results are available EBVA IgG  >600 standard range 0 to 17.9 ML flagged as high EBV nuclear  antigen  Ab,IgG 252.0 U/ML standard Range .0 to 17.9 U/ML flagged as high. August 9 canceled 2nd Pfizer sore throat minor not as tired was afraid sore throat would come back  August 14 glands feel swollen again have a full head and congestion and feeling very tired my nasal passages are sore
Patient passed out in their seat in waiting area. Struck back of his head on window behind him. Responsive after 20 seconds. Ambulance called to assess patient further. No treatment required and patient's wife drove him home.