chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report based on the information received by Pfizer from Glaxo Smith Kline (Manufacturer Report Number: US2017GSK155522). This case was reported by a contactable consumer (the patient) and described the occurrence of bilateral pneumonia in a 63-year-old female patient who received Anoro Ellipta inhalation powder (batch number 7ZP4569, expiry date Jun2019) for chronic obstructive pulmonary disease. Co-suspect products included Breo Ellipta inhalation powder (batch number unknown, expiry date unknown) for obstructive pulmonary disease and Prevnar 13 for product used for unknown indication. Concurrent medical conditions included chronic obstructive pulmonary disease. In 2017, the patient started Anoro Ellipta (inhaled) 1 puff(s) once daily (1 puff(s) daily) and Breo Ellipta (inhaled) 100/25 ug 1 puff(s) once daily (1 puff(s) daily). On 15Sep2017, the patient started PREVNAR 13 at single dose. In 2017, an unknown time after starting Anoro Ellipta and Breo Ellipta, the patient experienced esophageal disorder. On 15Sep2017, the patient experienced bilateral pneumonia, serious criteria hospitalization (GSK medically significant), pain in arm and wrong injection technique. The patient was treated with Prevacid. Anoro Ellipta was continued with no change. Breo Ellipta was discontinued in 2017. On an unknown date, the outcome of the bilateral pneumonia and wrong injection technique were recovering/resolving and the outcome of the esophageal disorder and pain in arm were unknown. The reporter considered the bilateral pneumonia and esophageal disorder to be unrelated to Anoro Ellipta. It was unknown if the reporter considered the pain in arm to be related to Anoro Ellipta and Breo Ellipta. The reporter considered the bilateral pneumonia to be unrelated to Breo Ellipta. The reporter considered the esophageal disorder to be related to Breo Ellipta. Additional Information: The consumer was transferred from the GSK Patient Assistance Program. She reported she was previously on Breo for chronic obstructive pulmonary disease (COPD) for approximately 8 month, but her physician observed white stuff was building up in her Esophagus (esophageal disorder), so her doctor discontinued Breo, treated her with Prevacid, and switched her to Anoro Ellipta sometime in the past few months, although the exact dates were unknown. The patient was getting her flu vaccine (brand and manufacturer, lot and exp unknown) and PREVNAR 13 (lot and expiration unknown) on 15Sep2017. The patient did not indicate at which facility she received these vaccines. The person administering the vaccines hit a tendon and caused pain in her arm, so she was taken to the emergency room. While there, her healthcare providers noticed respiratory symptoms and did a chest X-ray. She was diagnosed with double pneumonia and stayed in the hospital for 18 days while taking Anoro Ellipta.
PATIENT HAD SHORTNESS OF BREATH FOR THE PAST 2-3 WEEKS DIAGNOSED WITH PULMONARY EMBOLISM AND PLEURAL EFFUSION
Muscle aches, joint pain, fatigue, nausea, chills, fever, delirium from fever. Symptoms lasted 22 hours.
vaginal spotting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 14:45 (Lot number: EW0170) at the age of 27 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 01 at 02:45 PM (Lot Number: ER8730) Anatomical location: Left arm), administration date: 23Mar2021, when the patient was 27 years old, for Covid-19 immunization. The following information was reported: VAGINAL HAEMORRHAGE (non-serious) with onset 2021, outcome "unknown", described as "vaginal spotting".  Additional information: No other vaccine in four weeks. No prior covid vaccination. No known allergies. Patient had vaginal spotting for 3-4 days after her second dose.  Follow-up attempts are completed. No further information is expected
Case reluctant to receive first covid shot but stated it was needed for new job.Denied allergies;Case walked short distance into lobby where he was told to wait as a safety precaution after vaccine.Within 5 minutes he was at the counter feeling sick wanting help.Nurse rushed over to him where he was on verge of completely passing out.He was standing and wavering;nurse held him and lowered him to the floor.He never lost complete consciousness and was able to answer questions after being lowered to floor and ammonia packet applied under nose.He was pale;diaphoretic on face ,pulse thready with a manual BP of 72/54.After approximately 10 minutes he was feeling tingling sensation in both arms and started to feel both legs "feel heavy".He was oriented to person,place,and time and he was able to move all extremities equally upon command.BP came up to 100/66 gradually.Pulse continued thready for approximately 20 minutes upon which strong pulse present at rate of 82 and sl.irregular.Ambulance arrived 30 minutes after incident  and case transported to Hospital.His legs continued to feel heavy with arm tingling and facial diaphoresis easing.Pupils equal and reacted briskly to light.
Received MMR on 7/31/17 was seen in the office on 8/11/17 for rash x24h. Red and maculopapular lesion in the trunk w/upper extremities some face. Fussy!
Patient experienced tingling in her tongue and itchy throat about 20 minutes after receiving the vaccine.  Patient stated she has an allergy to certain types of fruit and she can have  this same reaction when she eats those fruits.  Nurse administered 100 mg benadryl PO.  Patient stated she felt better and would have her husband drive them home for safety.  Patient left in stable condition with instructions to call MD or 911 for any other health concerns.
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 02-FEB-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336, the expiration date: 17-AUG-2017 (dose and route were not reported). The total cumulative hours out of range were 360 hours with 34 C and 168 hours with 33 C as the lowest recorded temperature and the storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint(PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Mother stated patient cried unusually for over 3 hours, then on and off for over 2 days.
Rash, itchy started on site of vaccination and moved to scalp, waistline and top of thighs.
Day after vaccine, parent noted, left leg redness, swelling and tenderness. Patient seen by provider 3 days after vaccination and 10 cm X 6 cm, red area of edema, no induration or fluctuance noted. Hydrocortisone 2.5% cream prescribed, TYLENOL/MOTRIN recommended as needed.
Severe intense shoulder pain. Range of motion gone have taken ADVIL, ALEVE and TYLENOL to attempt to reduce pain unsuccessfully.
Post injection the pt developed an injection site reaction characterized by a raised, red, hard area at the injection site.
Developed chalazion in right eye 4 days after 2nd dose given then in left eye developed chalazion after 1 week 2nd dose given; This is a spontaneous report from a contactable nurse (the patient). A 32-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) via unspecified route of administration in the right arm on 16Mar2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) via unspecified route of administration in the left arm on 16Feb2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, four days after receiving the second dose the patient developed chalazion in right eye; then in the left eye a week after receiving the second dose. The patient had no recent history of chalazion. No therapeutic measures were taken for the event. The clinical outcome of the event chalazion was recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Chills, fever, sore throat, cough, nasal congestion, fatigue, headache - 2/27/21 - 3/3/21
Armpit is swollen; Armpit is hurting; Redness at the injection; Arm swell up the size of a silver dollar at the injection/swelling about 6 inches in diameter; Hotness,warmth at the injection; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Armpit is swollen), VACCINATION SITE WARMTH (Hotness,warmth at the injection), AXILLARY PAIN (Armpit is hurting), VACCINATION SITE ERYTHEMA (Redness at the injection) and VACCINATION SITE SWELLING (Arm swell up the size of a silver dollar at the injection/swelling about 6 inches in diameter) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hotness,warmth at the injection), VACCINATION SITE ERYTHEMA (Redness at the injection) and VACCINATION SITE SWELLING (Arm swell up the size of a silver dollar at the injection/swelling about 6 inches in diameter). On 01-Mar-2021, the patient experienced PERIPHERAL SWELLING (Armpit is swollen) and AXILLARY PAIN (Armpit is hurting). At the time of the report, PERIPHERAL SWELLING (Armpit is swollen), VACCINATION SITE WARMTH (Hotness,warmth at the injection), AXILLARY PAIN (Armpit is hurting) and VACCINATION SITE ERYTHEMA (Redness at the injection) outcome was unknown and VACCINATION SITE SWELLING (Arm swell up the size of a silver dollar at the injection/swelling about 6 inches in diameter) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  No treatment information was reported.
I developed a week later redness, swelling moving up and down my arm.  I went to the Dr. they thought it might be an acute reaction or a deep tissue infection and gave me antibiotics.  This lasted about a week.
8/8/02 2:45 client in clinic for immunizations. Assessed immunization record. No contraindications to shots per screening questionnaire. Administered Td lot U0525AA L deltoid and Hep B lot 0196M R deltoid using 3cc x 1inch needles. After approx two minutes noticed clients face looking slightly pale skin, warm to touch. Client stated she felt nauseous and dizzy. Stated she had not eaten all day. Vomited small amounts of fluid (clear). Cool paper towels applied to throat and forehead. Followed by an ice pack to the throat BP 80/50. Coached to slow deep breathe. Was given one piece of peppermint candy to suck. 2:50pm Facial skin color less pale. Client stated she felt less dizzy, was nauseous, no vomiting. 3:00pm States she is no longer dizzy. Ice pack removed from throat. Stand slowly to assess equilibrium assisted to sit in waiting area with parents for thirty minutes.
Information has been received from a medical assistant referring to a 6 month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. The patient was vaccinated with doses of PEDVAXHIB (intramuscular; dose, lot # and expiration date were unknown) on 01-FEB-2001, 04-APR-2001, 06-JUN-2001 and 20-MAR-2002. On 14-NOV-2016, the patient was administered another dose of PEDVAXHIB (intramuscular, lot # M032147, expiration date 14-APR-2019; dose was unknown). Additional information has been requested.
joint pain got worse; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain got worse) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Joint pain. Concomitant products included TOFACITINIB CITRATE (XELJANZ XR) for Joint pain.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ARTHRALGIA (joint pain got worse). At the time of the report, ARTHRALGIA (joint pain got worse) outcome was unknown.            Patient reported that she missed XELJANZ doses for 4 weeks in feb-2021 and got Moderna Booster last week & as per MD she stopped taking the XELJANZ for 1 week after the vaccine and resumed therapy. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Per mother, reported that patient was "lethargic" within two days after administration of vaccine.  She did not seek care or evaluation during that time.
pt recv vax 20JUN05; 22JUN95 had severe sz; no hx of pre sz;
Moderate soreness at injection site, continuing for 11 hours currently but fading. (Treated with ibuprofin/acetominophin)
Insomnia as if I had a caffeine high. I never have a problem falling asleep. I was up all night. My head didn't feel right but it wasn't a headache.
Mother states that after 1st immunization 6/28/02-child experienced inconsolable crying for approx 3 hrs on 6/29/02, no fever. Mother had regularly adm Tylenol 6/28+6/29/02. Child had no other problems and was fully recovered 6/30/02.
Pt reports within 20 minutes of leaving the office he felt like he had the flu. Reports dizziness, fatigue, and vomiting that last until the following day at 6pm. Pt contacted office to inform, let illness took its course, and rested, no other treatment occurred. Pt today 9/19/2018 felt back to normal.
a drop in blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (a drop in blood pressure) 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 BLOOD PRESSURE DECREASED (a drop in blood pressure). At the time of the report, BLOOD PRESSURE DECREASED (a drop in blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned.  No treatment details were reported.
eye pain/tremendous amount of pain in my right eye; Little bit of swelling I guess from the ocular nerve she called it soft tissue swelling; lot of pressure behind the eye/my eye was going to explode out of my head; Very painful especially eye lid; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer(patient).  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient had eye pain, behind the eye after getting the dose and he want to know he should still get the 2nd vaccine or not. The patient was due to get 2nd dose on 19th and he was just really nervous because everyone said that side effect can be more severe and he said that at one point his eye was going to explode out of his head, he mean it was not red but lot of pressure behind the eye. So finally 5 days later he went to ophthalmologist and she dilated his eye and so she could see the more, little bit of swelling he guess from the ocular nerve she called it soft tissue swelling. But it continued to get better every day, he still have it just little bit some part left, to the right but basically it almost gone, that morning he got up he got the vaccine by 2 o'clock he woke at 7:30 with tremendous amount of pain in his right eye so yeah that's his question did you have any reports like this at all. When further paraphrased, consumer stated, very painful especially eye lid. The outcome of the evens was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Approx. 7 days after the 2nd injection, the pt saw her physician on 1/31/00 and from that date on, it has been one referral after another to ascertain whi I got this sudden onset of swelling and pain in her joints. She also has had general malaise. She is presently in physical therapy. She continues to be treated for swelling and pain in her extremities and arm. She takes codeine when pain is bad and Naprosyn Sodium during the day. Both meds are PRN. She also had a large reddened area on her arm that lasted 2 weeks after this vaccine. The 3rd dose resulted in a large red and swollen area at the site of the injection.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75-year-old male patient received BNT162b2 (BNT162B2, Vaccine brand unknown, Vaccine lot unknown, Vaccine dose number unknown: False), on 25Jan2021 at 08:30 as dose 1, single (Lot number: EL9262), in left arm, on 18Feb2021 at 14:30 as dose 2, single (Lot number: EN6201), in left arm and on 28Sep2021 at 14:30 as dose 3 (booster), single (Lot number: 30135BA) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Positive; (24Jul2022) Positive; (25Jul2022) Positive; (26Jul2022) Positive; (27Jul2022) Positive; (28Jul2022) Positive; (29Jul2022) Positive; (30Jul2022) Positive; (31Jul2022) Positive; (01Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 17Jul2022. Treatment stop date: 17Jul2022, Indication: Treatment of COVID-19 (Adverse Event: Rebound infection after taking Paxlovid. Testing positive from 23Jul to 01Aug. Adverse event start date: 23Jul2022, 08:00AM, If patient recovered: Recovering. Other medication details: Other medication in 2 weeks product: Lisinopril-Hctz 20-25 mg tab. Other medication in 2 weeks product: Allopurinal).  Information on the Lot/Batch number has been requested.
Pt recvd Engerix-B in MAY91, JUN91, & NOV91 & p/3rd dose pt exp pain, erythema & induration @ inject site; these events occurred in 2 pts (see also EBU911256); no tx was given;
mild myocharditis; dull uncomfortable gripping feeling around heart under left breast spreading to my left shoulder and rib cage.
Information has been received from a Nurse Practitioner (N.P.) concerning a 15 year old female patient who was vaccinated IM with a second dose of Gardasil. The NP reported that the patient developed syncope and seizure type activity after receiving her second Gardasil. The patient was described as feeling "groggy" for 24 hours after the syncopal episode. The patient recovered fully. Upon internal review, "seizure type activity" was determined to be an other important medical event. Additional information has been requested.
On 10/12/18 patient claimed that she felt the syringe hit her bone upon administration of the PNEUMOVAX 23 vaccine into her right arm and that it hurt. I pulled the syringe back slightly to administer the vaccine properly into the muscle but had a difficult time getting it in. On 10/16/18 the patient saw her doctor because it was painful to move her right arm above shoulder level. The doctor prescribed KEFLEX and advised her to take ALEVE over-the-counter.
RIGHT UPPER ARM WAS VERY HOT, FEVERISH, RED, ITCHEY, BURNING AND SORE, WENT TO THE ER 7/15/21 AT AROUND 315AM TO BE SEEN, THE ER DOCTOR ORDERED THE NURSE TO GIVE ME  A SHOT OF TORADOL IN MY RIGHT HIP AND THEY GAVE ME A BENADRYL PILL AS WELL AND SENT ME HOME.CAME BACK TO WORK THE NEXT DAY 7/16/21 RIGHT ARM NOT AS HOT AND FEVERISH BUT STILL RED, AND LITTEL HOT, AND SORE ALSO MORE ITCHEY AND BURNING.
Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a female patient with no pertinent medical history and no known allergies who in March 2009, was vaccinated IM with the first 0.5 ml "standard dose" of GARDASIL (lot number not reported). In May 2009 the patient was vaccinated IM with the second 0.5 ml "standard dose" of GARDASIL (lot number not reported). There was no concomitant medication. Subsequently the patient became pregnant. The last menstrual period (LMP) was 01-JUN-2009. A home pregnancy test was performed. The physician saw the patient on an unspecified date. The patient's outcome was not reported. Follow-up information has been received from the physician reported that the patient decided to terminate her pregnancy in the first trimester of 2010. Upon internal review, abortion was determined to be an other important medical event. Additional information has been requested.
Broke out in itchy, red rash on lower left side of face & chin.  Small bumps also noticed on inner part of each thigh.
Patient received Moderna booster of 0.5mL instead of 0.25mL. No adverse reaction reported when Wellness Director was notified on 10.29.21
Pharmacist reports an AE for MMRII stating a patient complains of rash on her legs after receiving MMRII vaccination on 4/19/2023; This spontaneous report has been received from a pharmacist referring to a 60-year-old female patient. The patient's pertinent medical history, concomitant therapy, and drug allergy or reaction were not provided.  On 19-APR-2023, the patient received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), therapy type rHA, 0.5 ml, subcutaneously (Quantity: 1) as prophylaxis (valid lot number: U039548, and the expiration date was reported on 14-DEC-2023).  On the same day, the patient complained of rash on her legs after receiving Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccination. No additional information was provided. The patient had sought medical attention. The outcome of the event was not provided. The action taken was not applicable.  The relationship between the event and the vaccine was not provided.
Approx 1 wk post Hep A and Hep B vaccines, PT developed migrating arthritis. Responded partially to NSAIDS. C-reactive protein 2, (+) Rheum. factor at 28. Steady imprompt. Resolved 8/13/02.