chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: The patient received two doses Pfizer COVID 19 Vaccine in Mar 2021. The patient tested positive for COVID 19 on 3 Jan 22. The patient presented to the ED with cough, chills, fever, malaise, and nausea and vomiting. The patient was admitted on 3 Jan 22 with sepsis and COVID 19. The patient was discharged on 4 Jan 22 in stable condition. Reported per EUA.
PULMONARY EMBOLISM; This spontaneous report received from a consumer concerned a multiple females patient's of unspecified age. The patient's weight, height, and medical history were not reported.  The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown) dose, 1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date after vaccination, the patient's experienced pulmonary embolism. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210446568.; Sender's Comments: V0: 20210450133-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Pulmonary embolism. This event is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Per RN patient received the Pneumoccal vaccine in her left arm. The next morning there was redness, swelling, and warmth at injection site. Patient received 25 mg po Benadryl the following day 8/27/14. We followed the patient until discharge and the injection site returned to normal.
Feel a lump it is exactly where they gave the vaccine; Swelling at injection site; Redness at injection site; Arm felt heavy like 100 pounds the first day; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm felt heavy like 100 pounds the first day), VACCINATION SITE MASS (Feel a lump it is exactly where they gave the vaccine), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced LIMB DISCOMFORT (Arm felt heavy like 100 pounds the first day). On 03-Mar-2021, the patient experienced VACCINATION SITE MASS (Feel a lump it is exactly where they gave the vaccine) and VACCINATION SITE ERYTHEMA (Redness at injection site). 03-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site). On 04-Mar-2021, LIMB DISCOMFORT (Arm felt heavy like 100 pounds the first day) had resolved. At the time of the report, VACCINATION SITE MASS (Feel a lump it is exactly where they gave the vaccine), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.
w/in a few hr p/vax pt began to feel fatigued & devel dark colored circle under eyes w/small hives (about 6);devel a h/a;grade fever (99-100) & joint pains;23OCT97 fatigued w/hives;eyes feeling hot;
Dizziness, she was pale, feeling cold, blood sugar level - 76 at 4:30 pm gave "EPIPEN Inj" - patient feeling better after 15 minutes, gave her some water and 1 granola bar.
This is a non serious case from a physician in the USA of Urticaria:(labeled, USA). The reporter causality is possible for FluMist. This case is submitted according to the VAERS safety surveillance accelerated  reporting agreement for FluMIst. This is a spontaneous case report sent by a physician that refers to a female aged 19 years. She received FluMist on 02/10/2005. The patients concomitant medication included drospirenone. Sometime on 02/15/2005 the patient developed a urticarial rash. On 02/20/2005 she developed pain when walking and pain in many joints especially her knee. She presented in the reporters office on 24Feb05 for an initial consultataion and was diagnosed with reactive arthritis. She received toradol for treatment and ultracet for pain. The reporter stated he was not sure of the events were due to FluMist. Attempts to locate the vaccine facility and lot number have been unsuccessful. The reporter state that the patient was lost to follow up. No further information is available. 23Apr05 Additional information received from the reporter and incorporated in the narrative: Patient's date of brith, confirmation that the reported vaccine facility was incorrect, and the patient was lost to follow-up,
Patient received 3 dose of Moderna vaccine with first dose administered 3/26/2021 and second dose 4/23/2021.
J96.00 ACUTE RESPIRATORY FAILURE 11/9/2021 ATRIAL FIBRILLATION, PAROXYSMAL
Initially he became very irritable. He had multiple episodes of inconsolability within the week after the vaccine and would cry for hours. He also developed a severe case of seborrheic dermatitis within a week of the vaccine. He had gross motor changes including involuntary repetitive slapping movements of his right arm and bilateral wrist twirling.
pt recv vax & exp high pitched cry, vomiting-3 days temp of 105, dehydration;
Severe cellulitis of arms bilaterally necessitating hospital admission for intravenous antibiotics.  02/09/07-records received and reviewed for DOS 01/12-01/15/07 DC DX:right upper arm cellulitis left upper arm cellulitis asthma PMH:intermittent asthma Day after vaccination developed redness and swelling mostly in right arm. Fever up to 102.  PE:WNL except for 18x22cm area of redness, warmth, swelling and induration on right upper ar, 2x2.5cm area of redness and warmth on left arm without induration. Treated with IV antibiotics.
Information has been received from a physician, via a company representative, concerning an 11 year old female patient with no known allergies and no pertinent medical history, who on 29-JUL-2007 was vaccinated with a dose of Gardasil (lot #658556/1060U). The physician noted that the patient was healthy at the time of vaccination, and no other vaccines were administered. On 28-SEP-2007, the patient had unspecified blood work drawn and was diagnosed with "acute lymphocytic leukemia (ALL) Pre-B cell." The patient visited the hospital, but it was unknown if she was hospitalized. At the time of this report, the patient had not recovered. The physician considered ALL B-cell leukemia be immediately life-threatening. Additional information has been requested.  08/13/2008 Vax rec and labs received from PCP. Labs c/w acute leukemia.   Referred to regional med ctr. 8/28/08 MR received for DOS 9/29-10/15/2007 with DX: Acute Lymphblastic Leukemia. Pt presented with 2 week hx of bruising and hematoma formation on sacral area, knees, groin. Labs concerning for Leukemia done by PCP, sent to ER for eval and tx. PE (+) for large hematomas on lower extremities and groin.  Bone marrow bx c/w leukemia. Broviac cath placed. Hepatosplenomegaly on exam with high LDH. Chemo initiated on 104/07 completed on day 12.  Required platelet transfusions. D/C 10/15/07 to f/u as outpt.
After vaccine was given, pt. reported redness and swelling at injection site app. 10 - 12 hrs later. The following morning, redness and swelling were worse with pain and firmness at injection site. Indurated area of app. 3" in diameter noted with redness.
Information has been received from a certified medical nurse concerning a 4 month old male who on 04-DEC-2007 was vaccinated PO with a dose of ROTATEQ (lot# 657048/0909U).  Concomitant vaccinations administered on that same day included a dose of PEDVAX HIB (OMPC) (MSD), a dose of PREVNAR, a dose of DtaP (unspecified) and a dose of poliovirus vaccine inactivated (unspecified).  Upon vaccination the infant spit ROTATEQ into the nurse's left eye (WAES# 0712USA01346).  It was unknown whether medical attention was sought.  Follow-up information indicated that on 04-DEC-2007 upon administration of ROTATEQ (lot# 657048/0909U) the 4 month old male gagged and spit out a "spray" of the vaccine into the nurse's face.  No medical attention was sought.  The patient was recovered.  Additional information has been requested.
4 year old female previously healthy with no significant PMH was in clinic for 4yo preventive/ well check and immunization. Pt given MMR 2, DTaP #4, IPV #4. Approximately 30 min after, patient developed pruritus, congestion. Given Benedryl, pruritus improved but developed urticarial rash on face, trunk, upper thighs--given subcutaneous Epi; with no eventual resolution of rash. Patient did not have any edema or wheezing/ respiratory distress. Flu 24 hrs later--no problems, no previous history of any problems with other vaccines. Follow-up note. Other patients have received vaccines from the same lots without any problems. The patient was referred to allergist for testing. Patient received MMR #1 no problems and no history of egg allergies.
This case was reported by a healthcare professional and described the occurrence of possible allergic reaction in a 32-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline) for international travel. The subject's medical history included anxiety disorder and penicillin allergy. There was also possible pre-existing fatigue. The subject received no concomitant vaccinations and was not taking any medications. On 29 March 2010 at 11:27 the subject received 1st dose of TWINRIX (1 ml, unknown route, left deltoid). On 29 March 2010 at 13:10, less than one day after vaccination with TWINRIX, the subject experienced possible allergic reaction. She had arm tingling, tremor and difficulty breathing. The subject was treated with oxygen and ADRENALINE, and was placed in Trendelenberg position. Ambulance personnel administered BENADRYL and IV fluid(s). The subject also experienced throat tightness, but was vocal, verbal, anxious and shouting. She was stable, without respiratory distress, but very upset. The subject was taken to the Emergency Room and on arrival pulse oxygen was 99% on room air, blood pressure was 140/71, pulse rate was 122 and respiratory rate was 22. Later the pulse rate was 103, blood pressure 120/73, respiratory rate 16 and pulse oxygen 99% on room air. The subject was alert, oriented and upset. There was no wheezing, no cyanosis, no spleen or hepatic swelling, and no muscle weakness. The subject was treated with PEPCID and ATIVAN. She was discharged from ER after midnight that same night in stable condition. The subject experienced shortness of breath the next morning (30 March 2010) and treatment with PEPCID resulting in resolution of symptoms. At time of reporting, the events resolved on an unspecified date. Follow-up information received 04 May 2010: On 03 May 2010, the subject informed the healthcare professional that she continued to feel unwell. She had visited several physicians and had been treated with additional steroids. Blood tests, liver enzyme tests and autoimmune tests were negative. Ultrasound of the liver and gallbladder and a CAT scan of the liver were without significant findings. The subject also experienced lack of appetite, easily fatigued and pain in right upper quadrant below the right rib; at the time of reporting, these events were unresolved. The subject reported that her physician has discontinued all medications and is looking to see "why her body is acting like she has Hepatitis". This case was assessed as medically serious by GSK. This case was assessed as medically serious by GSK. At the time of reporting, the events of feeling unwell, lack of appetite, easily fatigued and pain in right upper quadrant were unresolved. The outcome of the hepatitis-like symptoms was unspecified. The vaccination course with TWINRIX was discontinued. The healthcare professional reported that two other patients were administered TWINRIX on the same day as this subject and from the same batch, without any complications.
Swollen top lip the day after vaccines. Mom put lip balm on and monitored. Decreased swelling today.
Patient received monovalent Moderna 0.5ml blue cap purple label.  Patient was intended to receive Bivalant Moderna 0.5mlblue cap gray label.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Colonoscopy.    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 HEADACHE (headache). At the time of the report, HEADACHE (headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided. Treatment medication not provided.
feeling blah; really sore arm first dose, like a flu shot, a little worse; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 (Lot Number: EP7534) as SINGLE DOSE for COVID-19 immunisation. Medical history included breast cancer female from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously had flu shot on unspecified date. The patient experienced really sore arm first dose, like a flu shot, a little worse on 17Mar2021 and was feeling blah (as reported) on 19Mar2021, both reported as non serious. The event really sore arm recovered on 19Mar2021. The outcome of the event feeling blah was recovered on 23Mar2021.  Information on Lot/Batch number was obtained.
This spontaneous report as received from a pharmacy intern refers to a female patient of unknown age. The patient's relevant medical history, concomitant medications and past drug history are unknown. On an unknown date, the patient started on VAQTA (dose, frequency, route, start date and indication were unknown) as a series of hepatitis A shots because she was going out of the country. On 17-AUG-2015, the patient received a VAQTA vaccine that expired on 01-AUG-2015. It was unknown if there was any relevant lab data. As of 17-AUG-2015, it was unknown if the patient continues on the VAQTA and the outcome of her receiving the expired VAQTA was unknown. Additional information has been requested.
My left arm is stiff and sore.; My left arm is stiff and sore. It hurts to raise it like a chicken wing.; My left arm is stiff and sore. It hurts to raise it like a chicken wing.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the arm left on 12Feb2021 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included vilazodone hydrochloride (VIIBRYD) for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9261) via an unspecified route of administration in the arm left on an unknown date in Jan2021 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021, the patient's left arm was stiff and sore. It hurt to raise it like a chicken wing. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events left arm was stiff and sore. It hurts to raise it like a chicken wing was not resolved at the time of this report.
10 hours after vaccine administered. Started with cloudy vision and a headache. Went to bed. Awoke two hours later with a fever of 102 and severe chills. That lasted 6 hours. Body temp went down  to normal.  Ate a little breakfast. Tired and achy. Went back to bed. Awoke several hours later. Fever was back. Though not as high, 100. Entire body hurt. Joints, head, abdominal pain, pain in left armpit. Stayed for several hours. Went back to bed about 4:00PM woke up an hour later fever down to 99. Ate a little supper. Acid reflux uncontrollable. Went back to bed. Awoke at 8:00PM  . Fever still at 99. Stayed awake until 10:30. Went to bed. Tossed and turned with body aches all night. Had to get up every two hours to urinate. Awoke at 7:30AM. No fever. Feeling somewhat better. Still pain in left armpit.  Headache almost gone. Joint pain almost gone, abdominal pain still present.  Worst is over.
rashes/blotches on skin; Hair loss; This is a spontaneous report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # (21K-163-4022416-00) via a contactable consumer (patient). A 14-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0173), via intramuscular route, administered on 08Jun2021 (age at vaccination 14-year-old) as DOSE 2, SINGLE for COVID-19 immunization and adalimumab (HUMIRA 40mg/0.4ml (40 Milligram, Solution for injection in pre-filled pen) (ADALIMUMAB)) via subcutaneous route for Crohn's disease from 01Apr2021 and ongoing. The patient medical history included non-smoker and abstains from alcohol. The patient had no known allergies. Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0161, expiration date: Jul2021) via intramuscular route, administered on 15May2021 (age at vaccination 14-year-old), as single dose for COVID-19 immunization. On 21Jun2021, the patient experienced rashes/blotches on skin and hair loss. The patient underwent lab tests and procedures which included blood work on 21Jul2021: normal. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
This case was reported by a consumer via other manufacturer and described the occurrence of shingles in a 69-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, several weeks after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The patient received Flu vaccine in October (unspecified year) and after few weeks experienced shingles from his belly button around the middle of his back.
rash; headache; fatigue; chills; slight fever; sore arm; hot to touch around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills), PYREXIA (slight fever) and PAIN IN EXTREMITY (sore arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 reported medical history). Concomitant products included LEVOTHYROXINE and ASCORBIC ACID, FERROUS FUMARATE (VITRON C) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills), PYREXIA (slight fever), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE WARMTH (hot to touch around the injection site). On 23-Jan-2021, the patient experienced RASH (rash). At the time of the report, HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills), PYREXIA (slight fever), PAIN IN EXTREMITY (sore arm), VACCINATION SITE WARMTH (hot to touch around the injection site) and RASH (rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took Lidocaine and Motrin for the symptoms.
All over body rash diagnosed as pityriasis rosea. Occurred 20 days after second vaccination (2/24/21) presenting as acute and worsening to all over burning, hive like rash that has lasted for one month. symptoms are changing but not improving.
On 12/23 patient developed fever up to 104 at home. Presents to hosp ER and noted document that left arm demonstrates an area of erythema about the size of a silver dollar, tender to touch and indurated. Fever continued per patients about 12 days. Admitted on 12/31 for evaluation meningitis. Follow-up: Red swollen.
Red rash to neck and injection site still red and warm. Called Dr. office. Took temperature and was 98.1.  No difficulty breathing or swelling of tongue or throat. Was advised to report rash and I felt confident to have her office call later in the day to check on me.
This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. The healthcare worker reported that ROTATEQ dose 2 ml, route oral that was exposed to 0C for 30 minutes on 12-FEB-2014 had been administered to an unspecified amount of patients. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the cases 1405USA007978, 1405USA007982, 1405USA007990, 1405USA008052 via same reporter link. Additional information has been requested.
Within 5 minutes: dizzy, racing heart, lump in throat, strange feeling in face, exacerbated tinnitus.   I think develop significant vestibular dysfunction - felt like I had been on a carnival ride or boat.  It was acute for about 5-6 days and mild for 3-4 weeks following.
ARM SORENESS; FEVER; FATIGUE; HEADACHE; LIP/MOUTH TINGLING; This spontaneous report received from a patient concerned a 54 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: 25/MAY/2021) dose was not reported, administered on 11-MAR-2021 15:15 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced lip/mouth tingling. On 11-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced arm soreness. Laboratory data (12/mar/2021) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lip/mouth tingling, and headache on 11-MAR-2021 19:00, arm soreness on 13-MAR-2021, fever on 12-MAR-2021, and fatigue on 14-MAR-2021. This report was non-serious.