chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 27-year-old female patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Apr-2021 at 10:48 AM, the patient received dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:48 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 27.42   Concomitant products were not provided.  On 30-Mar-2021, vaccines with batch number 030B21A were moved to the fridge. On 31-Mar-2021, 14 vials were moved to clinic. On the same day between 08 AM to 09 AM, vials underwent temperature excursion with temperature of 32 degrees Fahrenheit. On 03-Apr-2021, 20 vials were moved to clinic. On the same day at 09 AM, vials underwent temperature excursion with temperature of 34 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 29-Apr-2021.  It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.
SIMPLE SORENESS IN LEFT ARM AFTER VACCINE.  SPREAD TO ARMPIT WITHIN 4 DAYS.  THEN TO OPPOSITE ARMPIT.  EVERY DAY AFTER DAY 5 I HAD SORE JOINTS ON BOTH SIDES S FIRST KNEES, ANKLES, FEET, SHOULDERS, ELBOWS, WRISTS, FINGERS/KNUCKLES/HANDS.  PAIN IN JOINTS WOULD DISSIPATE, THEN MOVE TO ANOTHER AREA,  TODAY, 4/12, MY PAIN IS IN MY KNUCKLES AND FINGER JOINTS
Have been shrinking; Legs were paralyzed from feet to knees, could not lift legs, kind of worried about it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 89-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Handicap" (ongoing), notes: I am also a handicap (Intent: History). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; VITAMIN D3. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: DIPLEGIA (medically significant) with onset 2022, outcome "recovered" (2022), described as "Legs were paralyzed from feet to knees, could not lift legs, kind of worried about it"; WEIGHT DECREASED (non-serious), outcome "not recovered", described as "Have been shrinking". The patient underwent the following laboratory tests and procedures: Body height: Maybe 5'3; Weight: It's like 135, notes: Have been shrinking. Therapeutic measures were not taken as a result of diplegia. Clinical course: This report was not related to a study or programme. There were no investigations. Patient stated, well, she just had a question about the vaccine that she received last year, with the Pfizer and her problem with that one was, that her legs were paralyzed from her feet to her knees, and she could not lift her legs. She was wondering should she get another shot this year, she was kind of worried about it and don not know, if she should get another one or what she should do. Patient reported had 3 shots and then she thought, she had the Booster (later clarified as Pfizer Covid Booster Vaccine) and that was her last shot that she had a problem with. In regard to the vaccination card patient stated it was not handy. She was handicap (Intent: History) here so, it would take her a few minutes to get it. She was not seeing it handy. Regarding treatment patient reported: No, she did not took, it lasted only two days and she just sleep in her recliner because she could not get into bed so, she slept in her recliner for a couple of days and on the third day, her legs were ok. Patient did not ever have any Flu vaccine.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report was received from a healthcare worker and refers to a 11 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was not provided) lot # K016261, expiration date: 23-JUN-2016, orally. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 54-year-old female patient with diabetes mellitus and with no drug reactions or allerlgies. On 17-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml injected subcutaneously ("once"; lot 3 K015311 with expiry date: 17-DEC-2015). Other suspect therapies included DULERA. Concomitant therapies included ZOLOFT, LYRICA and hhdrocodone. On 19-APR-2015, the patient developed a "1 by 2 inch red, hard area" at the ZOSTAVAX injection site. The patient sought medical attention, she came into the pharmacist on 21-APR-2015 (reported as: today). No treatment was given and no laboratory test were performed. The pharmacist stated that the patient was currently taking DULERA and they warned the patient that it might cause problems with the ZOSTAVAX. The outcome of the events was reported as not recovered. The relatedness between the injection site red, hard area and DULERA or ZOSTAVAX was not reported. Additional information has been requested.
46-year-old female with no reported chronic medical problems presents to the emergency department sent over from the infusion clinic for oxygen saturation of 85% on room air.  Patient tested positive for COVID-19 on 11/1/2021 and began having symptoms on 10/29/2021.  Patient was referred to the infusion clinic to receive monoclonal antibody infusion however did not receive it due to her hypoxia.  Patient reports over the last 2 days she has had worsening shortness of breath and nonproductive cough.  Patient reports that she feels fatigued and easily winded.  Patient denies known sick contacts and is unclear where she may have contracted the virus noting that her family members have been tested and are all negative.  Patient is fully vaccinated for COVID-19 with 2 doses of mRNA vaccination received in December 2020 in January 2021.  Patient denies other associated symptoms or pain currently.  10 point review of systems otherwise negative.  Admitted to Respiratory Care Unit for monitoring.
Narrative: Patient passed away due to COVID-19. Pt had recieved three vaccines.
Paxlovid given as COVID 19 Treatment; Paxlovid given as COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Paxlovid given as COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive; (Aug2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was given Paxlovid from 27Jul2022 to 01Aug2022 as COVID-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a few weeks after the vacine she developed 'upper resp infection symptoms" lost of taste and smell not tested for covid.  decrease of appetite shortly came and since has not went away.  been hospitalized twice with weight loss issue, white cells are high despite antibotics given orally or iv.  blood pressure issues as now started and also heart rate issues.  had every test under the moon while in patient and nothing is found to cause these problems.  there was not a issue before the vaccine.  she was very active and mobile now she cant stand without her blood pressure dropping danagerously low
Fever: began 12 hours after injection - highest was 101.1 F - treated with acetaminophen  - remains at 99.5 F Aches: began 12 hours after injection - everywhere especially left arm  - treated with acetaminophen  - remains slightly painful Chills: began 12 hours after injection Nausea: began 24 hours after injection Vomiting: began 24 hours after injection Rash around neck: began 48 hours after injection Swelling: began 24 hours after injection - centralized around lymph node tissue closest to injection site
102.8F degree fever  Malaise Severe myalgia  Chills  Headache  Joint pain
Severe pain in shoulder when bringing elbow up and away from body. Limited range of motion. Pain varies in intensity but is always there. Have taken some ibuprofen which has dulled pain. Tried heating pad which has not helped. Pain is dull when shoulder is immobile but flares/shoots and stings when moving arm around.
Nerve Pains; Shoulder blade on the left side is in pain; Persistent muscle sort of back pain; Ribcage was hurting; Neck is in pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Ribcage was hurting), NECK PAIN (Neck is in pain), NEURALGIA (Nerve Pains), ARTHRALGIA (Shoulder blade on the left side is in pain) and MYALGIA (Persistent muscle sort of back pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Ribcage was hurting), NECK PAIN (Neck is in pain), ARTHRALGIA (Shoulder blade on the left side is in pain) and MYALGIA (Persistent muscle sort of back pain). On an unknown date, the patient experienced NEURALGIA (Nerve Pains). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Ribcage was hurting), NECK PAIN (Neck is in pain), NEURALGIA (Nerve Pains), ARTHRALGIA (Shoulder blade on the left side is in pain) and MYALGIA (Persistent muscle sort of back pain) outcome was unknown.            Concomitant medication was not provided Treatment medication include ER twice on 03may2021, muscle relaxants, whole series of steroids, and finally got some pain killers on 14April2021 .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-103458 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received on 04-JUN-2021. Additional AE as advised by a neurologist
Information has been received from a health care professional concerning a patient who in approximately December, 1999 was vaccinated with one dose of varicella virus vaccine live. In June, 2000 the patient developed a rash after exposure to his son. Additionally it was noted that the patient's wife experienced a similar reaction. Additional information has been requested.
Narrative:  Chief complaint: Nausea diarrhea sore throat and cough History of Presenting Illness: Patient is a 62 y.o. with history of CAD/history of MI 7 years back. Adrenal insufficiency/hypothyroidism, anxiety disorder He is transferred from Hospital for confirmed COVID-19 infection and hypoxia Patient presented to the outside facilities with nausea diarrhea sore throat and cough for the past 2 days, he was hypoxic at 87 on room air and required 2 L of oxygen, He received 2 doses of COVID19 Moderna vaccine the last dose was given on April 27, 2021 His spouse gave him 60 mg of hydrocortisone ( disease home dose of 30 mg today) due to acute illness Review of system positive for back pain which is aggravated by moving the lawn last week He denies fever chills urinary complaints abdominal pain, leg pain or swelling Labs and imaging reviewed CT WBC of 7.4 hemoglobin of 14.1 platelets 127 lactic acid 8.1?? Repeat test ordered Sodium 135 Potassium 4.2 CO2 of 25 BUN 13 and creatinine of 0.9 troponin of 0.015 Blood cultures pending EKG personally reviewed sinus rhythm chest x-ray clear Assessment and Plan Acute hypoxemic respiratory failure in the setting of COVID-19 pneumonia Patient is now saturating 96% on 1 L of oxygen Will start IV dexamethasone ( equal dose for 60 mg of hydrocortisone is 2.3 mg of DEXA ) Wean down oxygen as tolerated to goal saturation 90% Will check LFTs and consider remdesivir if persistent hypoxia Will also check D-dimer, procalcitonin CRP and proBNP Adrenal insufficiency- will hold off on hydrocortisone as patient is getting dexamethasone, if patient becomes hypotensive will order a small dose of fludrocortisone for mineral corticoid activity Hypothyroidism continue with replacement CAD- ? Documented allergy to statins and beta-blockers, on rosuvastatin DVT prophylaxis enoxaparin Bloodless medicine consulted Discharge planning has not been initiated at this time. Hospital Course: Patient is a 62 y.o. with history of CAD/history of MI 7 years back. Adrenal insufficiency/hypothyroidism, anxiety disorder. He is transferred from Hospital for confirmed COVID-19 infection and hypoxia. Patient presented to the outside facility with nausea diarrhea sore throat and cough for the past 2 days, he was hypoxic at 87 on room air and required 2 L of oxygen, He received 2 doses of COVID19 Moderna vaccine the last dose was given on April 27, 2021. Chest x-ray was clear, negative D-dimer, he was treated with IV dexamethasone and remdesivir, he clinically improved and has been off oxygen/ he is able to ambulate without desaturation maintaining an oxygenation of 93%, patient recommended to quarantine for 10 days from onset of symptoms Medically stable for discharge home
Upper lip swelling started over 24 hours after shot, worsened overnight and began clearing up round 42 hours after vaccination.
Patient is 74 yo female complained of dizziness after vaccination. Vitals at 11:40 B/P 179/104, HR 64, Temp 97.5, Respirations 16, O2 stats 97%. She complained of pain on her left side. She also informed us that she takes medication for A-fib usually in the afternoons which she hadn't taken yet.  Patient waited for over an hour. B/P at 11:58  161/96 HR 59 and then again  at 12:15 PM 165/99 HR 59. Charge Nurse walked with patient for a while before she left and no complaints of dizziness. Pt. felt safe to drive home will follow up with PCP on B/P readings.
A female pt (age unspecified) experienced muscle pain, nausea, pain in the legs, tiredness, and injection site pain after receiving her second dose of RabAvert for post exposure treatment (exposure remained unspecified). RabAvert was received IM in 1ml doses on 08Oct04, 11Oct04 and 14Oct04. Medical history included hep C. Concomitant medication included human rabies immune globulin (HRIG), one injection in each buttock on 08Oct04. On 13Oct04 (two days after receiving her second RabAvert injection), the pt experienced muscle pain, nausea, pain in the legs, tiredness and a sore arm where the injection was received. No further details were available.
Patient noted to have pruritic rash beginning 12/9/00 or 12/10/00. Small vesicles were noted on her lower torso, abdomen, back and in the right inguinal area. On physical exam, patient noted to have many excoriated papules in above mentioned areas. There were a few small vesicular lesions on erythematous base. Patient had about 30-50 lesions total.
Atrial Fib with tachycardia, pericarditis  Treated with ibuprofen, colchicine, prednisone and metoprolol - oral medications  Went to the Emergency Department on 10-3-2023 and admitted to hospital.  Was discharged on 10-5-2023.
PATIENT REPORTED ON WEDNESDAY MORNING OF 06/28/23 THAT THE SITE OF INJECTION HAS BEEN INFECTED ACCORDING TO HER DOCTOR. PER OBSERVATION OF INJECTION SITE AND PATIENTS DESCRIPTION, THE SURROUNDING RASH WAS ABOUT MORE THAN 2 INCHES IN DIAMETER, VERY ROUND, SWOLLEN, DARK BROWNISH-RED IN COLOR, ITCHY, WARM, AND DESCRIBED AS A HARD LUMP. DR. DID PRESCRIBE PATIENT ANTIBIOTIC THERAPY.
Mother informed staff on 8/17/06 that after pt received Adacel on 7/13/06 he had diarrhea, fever t102, nausea, headache, and arm was hot, hard as a baseball, red within 24 hours.
Area is red, warn and swollen first few days then it was better as of today all issues returned.
Information has been received from a pharmacist concerning a patient who had an unspecified date was vaccinated with a dose of  MEASLES virus vaccine live (Enders-Edmonston), MUMPS  vaccine live (Jeryl Lynn), RUBELLA virus vaccine live (Wistar RA 27/3). The pharmacist reported that the patient had blood work for MEASLES, MUMPS and RUBELLA immunity done (date unspecified) and the results indicated there was no immunity for MUMPS (results not reported for MEASLES and RUBELLA). No other adverse symptoms were reported. It is unknown if the patient sought medical attention. A product quality complaint was not involved. Additional information was received from a health care professional regarding the 36 year old female with a history of previous immunizations (DIPTHERIA TOXOID, PERTUSSIS vaccine (unspecified), TETANUS TOXOID and TRIVALENT POLIOVIRUS vaccine live oral who on 26-Sep-1972, was vaccinated with the first 0.5 ml dose of MUMPS virus vaccine live (Jeryl Lynn) (route not reported) (manufacturer unknown). Concomitant suspect vaccines include a first 2 drop dose of MEASLES virus vaccine live (Enders-Edmonston) (manufacturer unknown) and a first 0.5 ml dose of RUBELLA virus vaccine live (Wistar RA 27/3) (manufacturer unknown). On 15-Aug-2008, the patient had tilters drawn for MEASLES, MUMPS and RUBELLA. It was reported that the titer for the MUMPS titer was 0.86 (negative is 0.89 or less, equivocal is 0.9 to 1.09 to 1.09 and positive is 1.10 or greater) and a MEASLES titer of greater than 9.0 (positive is 1.10 or greater), RUBELLA titer was not reported. On 22-Aug-2008, the results were discussed with the patient and the patient was vaccinated with a dose of MEASLES virus vaccine live (Enders-Edmonston), MUMPS virus vaccine LIVE (Jeryl Lynn), RUBELLA virus vaccine live (Wistar RA 27/3) (dose, route and lot number not reported). Additional information is not expected.
Pt recvd 1st dose of Hep B vax approx DEC90; On approx 4JAN91 pt exp fine, papular, "fleeting" rash, present in the morning only; It was also noted that pt devel joint stiffness; The rash resolved by 19JAN91; joint stiffness still persisted
About twelve hours after shot (10pm) began to feel uncomfortable. By 10:30pm was shivering with temperature of 101 fahrenheit, headache, sinus congestion with clear liquid running out of nose and nausea. Took two acetaminophen at 11:00 pm. About two hours later, nose stopped running and just had nasal drip. Could not sleep. At 3:30 am  (Tuesday morning) nausea subsided. At 10:00 a,m Tuesday still in bed but felt better. Checked temperature and still 101. Continued to take acetaminophen every six hours as recommended. Checked temperature  in the afternnon and it was 99. Checked temperature again at 9:00 pm before going to bed  and it was exactly 98.6.  Decided not to take more acetaminophen. Got up around 3:00 am (Wednesday morning) to use restroom and  checked temperature. It was 100.2. Took two acetaminophen and went to bed. That was the last time I registered an elevated temperature. Still feel weak and tired six days later.
Previous gotten 1st and 2nd dose of the Pfizer Covid vaccine. Got Moderna Booster. Got rash on left arm. Swelling, Itching, burning, and sore and hot to the touch. Soreness and itchy at injection site.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient was unresponsive for few seconds less than a min and came back 911 paramedics evaluated him and took to emergency for further evaluation
This patient  who received a 3rd dose of Moderna on 8/4 . However, was fully vaccinated with Pfizer. This individual did list ?No? to the question of if this was their first vaccine dose when they registered on-site.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 17-MAR-2015, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (lot number reported as K001124, Expiry date: 16-OCT-2016) (dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I received the vaccine at noon 2/2/21. Took Tylenol ~8pm. At about 11 pm which was 10-11 hrs after receiving the 2nd dose of the Moderna vaccine I started with chills, body aches, and fever which gradually increased to 101. I took Tylenol again at 5:45am on 2/3 and then again every 6 hrs after. Chills and muscle/joint aches continued until my fever broke around 10:30am and was completely gone by 11am.  I continued with mild joint/muscle aches, significant fatigue, significant right arm pain at the injection site, and a headache the rest of the day. On 2/4 I was less fatigued but continued with a headache and there was a red sore and itchy blotch around the injection site that lasted another day. Redness is gone 2/6 but itch and mild soreness continue.
Redness, pain, swelling, warmth to skin at site of injection bil x 2d. 6 x 4cm (R); 4 x 4cm (L), 2 x 2 cm (L); no fever.
covid vaccine breakthrough case   dose 1 3/3/21 Pfizer EN6202 dose 2 3/24/21 Pfizer EN6207
18 year old male presented for 2nd injection of HEP A series, I was thinking injection was due in 2 months (like Hep B Series).  I authorized MA to give injection and found out later it was given 2 months early.  MA did not catch the error either before injection was given.