chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 15 years old male patient who received expired vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUARIX. On 19-Oct-2018, the patient received a single 0.5 ml dose of suspect MENACTRA lot U5712AA (expiry date: 11:Oct-2018) via intramuscular route in the left arm. It was a case of actual medication error due to expired vaccine used. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
5 hours after shots given, baby fell asleep, hard to  rouse or wake for 3 days (7/5-7/8) Would take 2-3 oz of formula and fall back asleep, when awoke cried, No fever, Took only 12-15 oz formula 24 hour period X 3 days. rest of time deep sleep.
Pt given PREVNAR 13 vaccine on 9/24/14 and 10/15/2014.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9, either lot number L037554 with expiration date of 25-DEC-2017 or lot number M009116 with expiration date of 13-JUN-2018 (strength, route of administration and dose were not reported), which was stored at 48.6 Fahrenheit degree for 128 hours and 15 minutes. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases from the same reporter. Additional information has been requested.
Myalgia Narrative: sore arm 2nd and 3rd day, then it went away, but then had a sore arm for the 2nd through 3rd week.
09Oct90 pt vax w/ hepta B; exp achiness in shoulder, arm.  Pain persisted in muscle of injected arm. Will not complete vax series.
JUST A FEW SMALL BUMPS ACROSS BACK, THEN ITCHING, SWELLING/WELPS, BUMPS ABOVE SKIN BREAKING OPEN.....SEVERE ITCH. ALSO ACUTE KIDNEY FAILURE, 2 STONES.  WENT WED TO ER LEFT HOSP. FRI. 29TH, BACK ON SUN. TIL WED.
pt recvd vax;pt noted itching,redness & swelling of inject site;pt instructed to notify PMD,use cold compresses & dph cream;
This case was reported by a physician via call center representative and described the occurrence of myelitis transverse in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced myelitis transverse (serious criteria GSK medically significant), diarrhea, feels awful, sleepiness, numbness in feet and sensory loss. On an unknown date, the outcome of the myelitis transverse, diarrhea, feels awful, sleepiness, numbness in feet and sensory loss were unknown. It was unknown if the reporter considered the myelitis transverse, diarrhea, feels awful, sleepiness, numbness in feet and sensory loss to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who was a retired Doctor of Medicine (MD). The age at vaccination was not reported. The day after the shot, the patient felt terrible and slept all day. A few days later, he had severe diarrhea. A week later after vaccination, he had numbness in his feet. The patient was diagnosed with transverse myelitis of the spinal cord at the T3 T4 level. The patient described it as sensory loss. The reporter consented to follow up.
Used a 5/8" needle tip instead of 1" but gave in IM fashion. No adverse event reported.
This spontaneous report was received from a physician and refers to a multiple unspecified patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates between August 2016 and November 2016, the patients were vaccinated with improperly stored doses of VAQTA lot # I015460 with an expiration date 20-JUL-2017 for (dose and route of administration were not reported). No adverse effect was reported. Administered doses of VAQTA experienced temperature excursion of 0 degrees Celsius for 285 hours and 20 minutes in August 2016, 285 hours an 20 min in September 2016, 223 hours and 20 minutes in October 2016 and 200 hours in November 2016. There was no previous temperature excursion. Digital data logger was involved. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received 4 month vaccines at PMD office in AM. Seizure activity started around 6:00 PM. Patient sent to ER by ambulance and treated with 0.9mg IV Ativan (2 doses) and 190mg IV Fosphenytoin. Temp 99.7; symptoms started about 7.5 hours post vaccination. Normal EEG, negative cultures (CSF, blood, urine).
pt recv vax & exp soreness & heat @ the inj site, devel redness @ the inj site, & exp muscle aches to a point could not lift arms;
Continued constant dull pain and extreme pain when extending arm that vaccination was administered. It has been 41 days since vaccination.  No treatment yet.  Appointment has been made for this week to see the doctor who administered vaccination.
4 /30 /2022 I woke up that morning and it felt like a really bad cold. I had a lot of aches and pains, more than usual. I lost my sense of taste, maybe my sense of smell. My nose was so stopped up, so I am not as sure if that is what caused it. I went to the Urgent Care. They tested for COVID-19 and it was negative. The rest of the week, I got progressively worse...The cold was really bad. I had to wait to find DAYQUIL and NYQUIL. I did not take it after I received it several days later because I felt really bad. I went back to Urgent Care and my COVID-19 test was positive. I started Remdesivir, NYQUIL and DAYQUIL. I started feeling a little better mid-morning today.
received a dose of PENTACEL post excursion with no reported adverse event; lowest temperature reached 31.5 F and lasted 24 hours, highest temperature reached 47.1 F and lasted 24 hours with no reported adverse event; Initial information received on 08-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and gender patients who were administered a dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] post excursion with lowest temperature reached 31.5 f and lasted 24 hours, highest temperature reached 47.1 f and lasted 24 hours with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patients received a dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, suspension for injection (batch number: UJ666AAA; expiry date: 04-May-2023) via unknown route in unknown administration site for immunization post excursion with no reported adverse event (poor quality product administered) (same day latency).  On 07-Feb-2023 the lowest temperature reached 31.5 f and lasted 24 hours, highest temperature reached 47.1 f and lasted 24 hours with no reported adverse event (product storage error) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
bad jaw pain; This is a spontaneous report from a contactable consumer who reported for a female (patient). A adult female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if patient was pregnant at the time of vaccination. Allergies to medications, food, or other products was unknown. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient diagnosed with COVID-19 was unknown. It was unknown if the patient been tested for COVID-19 since the vaccination.The patient experienced really bad jaw pain on an unknown date in Feb2021. It was unknown if patient received treatment for the adverse event. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Runny Nose, Post Nasal Drip x 1.5 weeks Narrative:  Other Relevant History:
Chronic abdominal pain - very sharp - hard to walk.  Went to ER diagnosed with infection and poor blood count, although previously considered good.  Diagnois:  intestinal infection.
Patient starting having chest pain two days after receiving the first dose of the COVID-19 vaccine.  Symptoms persist to this day.
VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's medical history included drug abuse, and four previous pregnancies resulting in one elective abortion, one spontaneous abortion, and two normal births of infants.  Concurrent medical conditions included drug abuse on methadone.  The subject was not using contraception prior to becoming pregnant.  On an unspecified date the subject received a dose of Boostrix (intramuscular, unknown site), and experienced vaccine exposure during pregnancy.  Gestational age at the time of vaccination was unknown.  The conception was reported to be normal.  Date of last menstrual period was 19 January 2011 and estimated date of delivery was 26 October 2011.  Prenatal testing including ultrasounds on 22 April 2011 and 28 June 2011 and sequencial screening had revealed no evidence of a defect.   Upon internal review done on 18th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound on 22 April 2011 and 28 June 2011 revealed no evidence of a defect. Sequencial screen revealed no evidence of a defect.
Extreme chills, fever, severe body aches, dizzy even when laying down, lightheaded when standing up. Skin hurt. Bones and muscles hurt. Not mild at all. All these things were very severed. Took Advil, waited it out.
2021-01-28  Received the 1st shot of COVID-19 vaccine Pfizer and noticed on or about February 1, my farsighted vision began to change for the better in that I was able to read fine print and view the computer screen without wearing prescription glasses.    2021-02-19  Receive the 2nd shot of COVID-19 vaccine Pfizer and subsequently my vision changed where my  nearsightedness  became worst and I began to see halos when looking at lighted objects, especially at night.  **Later I researched and found the Pfizer vaccine can cause symptoms of illness that can lead to high glucose levels.
Local redness, hot, inflammation. Doctor unsure if it is cellulitis or just a local reaction. Fever and chills.
Unilateral rash, on right side of face (lower jaw) and neck. Same itchy rash on lower posterior arm (palm facing up). Lasted two days but went away with Benadryl.
fainted; This spontaneous report was received from a physician via company representative who was reporting on teenage female patient. Her exact age was unknown. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.   On an unknown date, in late August 2020, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, anatomical location, strength, lot number and expiration date were not provided) as routine vaccination. During the same visit, she was also vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) and unspecified meningococcal vaccine (manufacturer unknown) no details were provided regarding those vaccines. After the vaccination the patient was told to remain seated for 15 minutes, but she stood up immediately after receiving the vaccines. The nurse caught her when she fainted. There was no additional adverse events reported. The patient recovered from the event on the same day.  The casual relationship between the patient's faint and suspected vaccines was not reported. Upon internal review, faint was determined to be medically significant.
Two weeks after taking the Morderna vaccine, I developed rash on parts of my body.  The rash caused itching, sticking, and burn marks on neck and chest area.  It is has been 3 months since I took the 2nd vaccine and the rash has minimized but is still there.
This case meets criteria for vaccine breakthrough review. SxS include COVID exacerbation with hypoxia and PE.  Was dx at Medical center 11/6/21 for COVID and hospitalized there. New admission to hospital for exacerbation of COVID and PE.
C/o chest pain with radiation up posterior neck and thoracic area. Mild SOB  Sent to CTH 5/19/21 and returned 5/23/21 TTE shows reduced LV function with large apical aneurysm and a layered non-mobile LV thrombus. Additional medications added upon return- Coumadin 7.5mg, Losartan 25mg, Lasix 40mg, Lovenox 150 mc/ml, coreg 6.25mg, Lipitor  80mg,  D/c'd amlodipine, ASA
Patient experienced pain in shoulder/upper arm after the vaccination was administered. After check up with his provider and an MRI, patient says his rotator cuff was torn due to the shot being administered too high on the arm near shoulder.
Extreme debilitating  Fatigue and Nausea,  Saw doctor at time started but was advised to wait and call him back in two weeks..  Will call him 02/22/2021  This is horrible and has totally kept me from performing  most of my daily activities.  It has now been three weeks with no relief.
Left arm - redness, swelling, C/O soreness, warm to touch at site; Placed cold compress on site.
patient received a three days expired dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired drug administered in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 10-MAY-2023, the patient received Kinrix. On 10-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired drug administered (Verbatim: patient received a three days expired dose of Kinrix). The outcome of the expired drug administered was 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: 11-May-2023 A nurse reported that a 4 years old patient received a 3 days expired dose of Kinrix, which led to expired dose administered. The reporter consented to follow up.
Narrative: Patient received Moderna COVID vaccine #1 on 4/20/21. On 8/4/21, he was seen in a ER for shortness of breath and COPD and was discharged. On 8/8/21, he was seen in our ER with c/o right anterior chest wall pain with coughing and breathing x 6 days. He was found to have a pneumonia and admission was recommended; however he was signed out AMA instead and was given a RX for Augmentin and ibuprofen. On 8/27/21, he was seen in the GI clinic for nausea of unknown origin and this same day he also received COVID #2 vaccine. On 9/1/21, it was reported  by his wife that he passed away at home. No autopsy report available. There were 5 days from time of second vaccine to date of death.
Narrative: 77 yo with PMH of fracture of ankle, HTN, HLP, obesity, shoulder pain reported pain in left knee that occurred 13 days after his second dose of Moderna vaccine on 3/24/2021. Pt required cane for ambulation due to pain in left knee. Patient denied injury. X ray was done which showed no fracture, mild osteopenia, and left knee joint effusion (4/12/2021). Exam of the left knee finds swelling with sl. increase in warmth, and tenderness to palpation to the area inferior to the patella. Labs-Uric acid level 7.4, Sed rate 10 and WBC 6.8. Pt was discharged with naproxen 500 mg BID, dx of pain in left knee, follow up prn. Unsure if it event was vaccine related.
Fever to 104F, not able to console child, insomnia/irrational; all 4-6 hours, post vax. Diffuse rash at 3 days into recovery.
(1) Adacel given (2) red bump on left deltoid (3) Keflex given (antibiotic)
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 1/19/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
fatigue; headache; I am having flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (I am having flu like symptoms), FATIGUE (fatigue) and HEADACHE (headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (I am having flu like symptoms) and HEADACHE (headache). On 01-Apr-2021 at 9:00 PM, the patient experienced FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (I am having flu like symptoms), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.            No concomitant and treatment drugs were reported.
Patient was admitted 4/16/2021 and tested positive COVID on 4/16/2021. Was vaccinated with Pfizer on 2/17/2021 and 3/10/2021.
headache, fever-low grade temp at 99.0, dry cough, sore throat, chills, body aches, loss of taste, loss of smell, sinus congestion, nasal congestion, post nasal drainage. starting 12/17/21
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 03-JUN-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Moderna was received from deep freezer on 8/6/21. Was placed in refrigerator on 8/6/21. 30 day expiration date was 9/5/21. Moderna was left in refrigerator and used until 9/13/21. On 9/14/21 we realized we were beyond the 30 days and immediately notified the facility for direction. The facility pharmacists are in communication with Moderna to see if the doses are considered valid or invalid. One department is involved to decide on the best course of action and if we notify the patient before we hear back from Moderna.
Pt. states that after receiving the 2nd dose of Phizer 08/27/2021, started experiencing symptoms 08/29/2021 of fever, fatigue, weakness, lack of sleep, pain throughout the body, and nausea. Primary communications 09/07/2021 recommended course of Tylenol and ice packs. Now experiencing scratchy/sore throat. Still continuing to experience symptoms.
Pt was sitting in post vaccination area and got up to leave 15 minutes later. She walked outside and was reported to have fainted but was still standing up (?if husband was holding her up?) Pt was brought back to EMS area via wheelchair. BP 125/80, HR 82. Pt recovered and was released to her husband at 4:15pm
Pain and sores at injection site and arm, pain in left side of neck, lower pain in left hip, pain in backheadache in back of head , chest discomfort, running, left arm pain
flu shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of WRONG PRODUCT ADMINISTERED (flu shot) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: influenza on 15-Mar-2021.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (flu shot). At the time of the report, WRONG PRODUCT ADMINISTERED (flu shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.      Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: TCR attached - NNI
Missed 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No allergies, current illness, lab data and medical history was reported by patient.  No concomitant medications were reported.  No treatment information was reported.
This 77  year old  male received the Covid shot on  1/26/21 and went to the ED on 4/14/21 with the following diagnoses listed below.  U07.1 - COVID-19.
p/vax given mom remembered egg intolerance causes GI sx but not hives, etc;pt recv vax w/o known rxn;p/vax pt used DPH x 3 does: diarrhea x 2p/DPH stopped;
Retinal Blood clot in right eye; This is a spontaneous report from a contactable consumer.  A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on right arm on 18Mar2021 11:30 (Batch/Lot Number: EN6024) at single dose (at the age of 72 years old) for COVID-19 immunisation.  Medical history included known allergies: Penicillin, afib, stroke and covid-19 before vaccination. The patient experienced retinal blood clot in right eye on 20Mar2021.  Therapeutic measures were taken as a result of retinal blood clot in right eye (thrombosis). The outcome of the event was not recovered.
Mother state patient started twitching on the right side of his torso. It only lasted seconds. Patient had no recollection of what just happened.
Neuropathy in hands and up to elbow od left arm and both feet up to knees.