chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients, after the manufacture date of expiration) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses of lot number 070H21A.  The vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to MOD-2022-581986 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received included non significant information of secondary reporter was added.
mild headache; arm pain; Patient had pain at the injection site that was sore and a little stiff; Patient had pain at the injection site that was sore and a little stiff; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received bnt162b2 (PFIZER COVID 19 VACCINE, Solution for injection, Lot Number: EW0217; Expiration Date: 30Sep2021(further not clarified) via intramuscularly, administered in left arm on 29Jul2021 morning like between 9 and 10 O clock (at the age of 60-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were none. Vaccination Facility Type was Hospital. Investigation Assessment was no. Prior Vaccinations, no medication received within 4 weeks. On 29Jul2021 in the evening, patient experienced arm pain and mild headache which went away after 2 to 3 days. The patient had pain at the injection site that was sore and a little stiff in 2021. The patient was reading online, and they said most patients can still get headaches months after the shot. The caller wants to know if this was normal. After the first dose the caller had pain at the injection site that was sore and a little stiff. The headache and the arm pain started the evening after the first dose. The event did not require a visit to emergency room and physician office. During his first shot he experienced little arm pain and mild headache, which went away after 2-3 days. Consumer stated that had been taking Aspirin. Consumer stated that the day would both go (voice not clear) like Tylenol and Motrin like he did not know. It might be of 25 milligrams of each (further not clarified). The patient underwent lab tests and procedures which included weight 155 lbs on unspecified date. The outcome of the event mild headache was recovered on 31Jul2021, event arm pain was recovering, and other events was unknown.  Follow-up attempts have been completed and no further information is expected.
PATIENT HAD SEVERE CHILLS, SEVERE MUSCLE PAINS. COULDN'T MOVE LEGS TILL 10/17 AND >101 FEVER AND BOWEL INCONTINENCE.
hurt her head; fell unconscious in the bathroom; trying to say few words; Flu like symptoms; chills and teeth were shattering; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEAD INJURY (hurt her head) and LOSS OF CONSCIOUSNESS (fell unconscious in the bathroom) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 medical history reported).    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (chills and teeth were shattering). On 07-Apr-2021, the patient experienced HEAD INJURY (hurt her head) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (fell unconscious in the bathroom) (seriousness criterion medically significant) and DYSARTHRIA (trying to say few words). The patient was hospitalized from 07-Apr-2021 to 08-Apr-2021 due to HEAD INJURY. On 06-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (chills and teeth were shattering) had resolved. On 07-Apr-2021, LOSS OF CONSCIOUSNESS (fell unconscious in the bathroom) and DYSARTHRIA (trying to say few words) had resolved. At the time of the report, HEAD INJURY (hurt her head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported getting an IV and other medications in the hospital, however not aware of which medications were given for treatment.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information is required. Causality for the events flu-like symptoms and chills is possible.
Vaccinated 12/26/2020.  On 01/02/2021 developed cough, nasal congestion, and sore throat.  Tested positive for COVID.
pt was given a booster dose of Bivalent vaccine on 12/6/22  after receiving first dose of bivalent on 9/6/22.  Booster was given earlier than approved to administer
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 27-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "1-x1 sdv" (Lot No. K001631, exp. 24-FEB-2017) (dose and site not reported). The vaccine was in excursion with a sum of hours of 16, 416, 336, 24, 80, 1172. The lowest recorded temperatures were of 30 and -3. The highest recorded temperatures were 49, 47, 59 and 58. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT BECAME DIZZY AND FAINTED FOR A FEW MINUTES. WHEN PATIENT WOKE UP HE WAS PALE AND I CHECKED TO MAKE SURE HE WAS BREATHING. HE SAID HE WAS BREATING FINE BUT WAS VERY DIZZY. HE GOT NAUSEAS WITH SENSATION OF VOMITING.
Pt deve hematochezia on 5/6/14 - diagnosed with intussusception, reduced with air contrast B.E.
Patient had a PNEUMOVAX 23 vaccine administered around 1142am on Friday March 22, 2019.  Patient called Saturday March 23, 2019 around 930am to report that her arm was red, itching and slightly swollen. The symptoms started the previously night and she self-treated with BENADRYL and ibuprofen. I advised patient to continue taking the ibuprofen and BENADRYL as needed and if symptoms got any worse to go to a physician.
01/20/2003 right deltoid was red and swollen, hard to touch. C/O pain Afebrile
About 1-2 days following 2nd dose, patient noticed a collection of fluid under left  and right axilla. Left side more pronounced that right. Patient reported to endocrinologist during in-office visit. Patient was placed on Levaquin. Levaquin began on 2/10/22.
Ever since the patient got the first COVID vaccine, she has had a headache daily that turns into a migraine. She was also agitated and nauseous. She is still having really bad migraines, shoulder pain, and neck pain. Over the last 3 days, she has been really short of breath and has been having severe stomach pain. She has had chills off and on. Her stomach pain gets worse every time she lays down. She is also very fatigued. She has been taking both tylenol and ibuprofen
recurring extreme fever blisters since receiving first vaccine date, continuining on one right after the other. Not a normal occurrence for me
GARADASIL injections- 8/21/07, 10/18/07 and 2-21-08. (1) soreness of arm around injection site; (2) abdominal pain (moderate) into the following day after injections each time. (Enough to stay in bed the next day after each injection). (3) Ha's -not constant but several times a month since September 2007. (4) Dizziness-off and on since September 2007 (5) Severe infections -strep throat 11/07, 12/07, 1/08, 5/08. Constant sore throats, ear pain, ear infections, hearing issues. (6) mono 1/08 (7) chronic fatigue since September 2007, gradually has gotten worse. (8) severe abdominal pain since 2/28/08-7 days after 3rd vaccine injection. Comes and goes-lasts 8 hrs or so -has to lay still in bed when gets pain. (9) vomiting/diarrhea/constipation off and on since 2/28/08. (10) constant "does not feel good" since 9/07-gradually has gotten worse. (11) increased in bleeding with periods 11/07, 12/07, 1/08, 2/08 bad cramping-spot bleeding between periods, was on BC Pills same one from around spring 2006 until 2/08 when gyn. changed them. Periods not as bad now. 9/2/08-records received-11/27/07-C/O sore throat. 1/5/08-fever 101, throat raw dry and tight, glands are swollen, vomiting mucus, slight cough. Acute tonsillitis. 1/11/08-fever, throat better, rules out URI. 1/29/08-Passed out . 3/18/08 status post mono, spleen enlarged, severe stomach pains, swollen lymph nodes. Status post MVA. 5/13/08-stressed out about school, anxiety. 6/3/08-IBS, pain with decreased appetite. Vague abdominal pain. Impression: Anxiety, recommend counseling. 6/10/08-C/O throat pain, ear ache. No abdominal pain.  9/10/08-records received for office visit 5/12/08-C/O abdominal pain and recent onset of constipation. 1/08 C/O intermittent abdominal pain in different areas of abdomen including epigastric area. Since the MVA C/O upper back and shoulder pain and headaches. Weight loss. C/O early satiety. 1/11/08 mono spot positive. Yasmin birth control pills. Victim of bullying at school. visit 7/17/08-Continues with same complaints. 6/23/08 required tonsillectomy and adenoidectomy for recurrent tonsillar infections. One episode of severe abdominal pain 7/4/08 but only 2 episodes since 5/12/08 visit. Continued weight loss and constipation.
Site of injection had swelling, was sore (hurt to move arm), and had a large red rash.
The patient stated she developed a rash after receiving her vaccines on 4/27 that has persisted to 5/1/22 without treatment of any kind. She had one vaccine in each arm with both arms being equally sore and no distinct difference in injection site reactions, just full body rash/hives
Whitehead Zit over injection site  Dry lips throat and mouth initial day Headache at 36 hours in Some low grade fevers
About two hours after my first vaccine, my arm was a little bit sore and I felt tired. The next morning I was fine. On day 11 around 6 PM I noticed suddenly that my left arm started becoming extremely sore again. Especially where I received the vaccine. A few minutes after that I started not feeling well and extremely lethargic. I stayed in bed all day the next day but luckily today I woke up and I?m OK again. Just wanted to let you guys know.
I had mild tinnitus in the left ear and after the first vaccine it became mildly worse . After the second vaccine it became markedly sharper in tone as well as louder in volume within 24 hours of the second vaccine. That was April 21st , a month ago and the tinnitus remains sharper in tone and louder in volume in the left ear , as well now a mild tinnitus in the right ear.
April 1 10:15am - Received vaccine. 12:30pm to 7:30pm - Sleep. 7:30pm - Woke to Mild fatigue, muscle aches in limbs, pain in injection site. 8:30pm - Lethargy, worsening muscle aches in limbs, loss of appetite. 9:00pm - Worsening of previous symptoms, plus headache and fever (unknown grade/temperature). An Excedrine is taken to counter headache, minimal effect. 11:45pm - Continuation of above symptoms, mild nausea.  Bed rest to mitigate nausea. April 2 12:00am - Nausea subsides, chills set in. 12:15am - Chills worsen, fever increases (unknown grade/temperature). 12:45am - Continuation of all symptoms (except nausea), severe pain of upper torso (primarily chest and shoulder muscles). 1:45am - Chills and upper torso pain begin to subside, fever begins to reduce. 2:25am - First time temperature taken - reads 102.2F.  Appetite returns. 5:00am - Fatigue, muscle aches, and headache continue.  Temperature remains at approximately 102F.  Excedrine taken again for headache, minimal effect. 12:00pm - Symptoms continue. Temperature falls below 101F. 8:00pm - Muscle aches diminish.  Fatigue reduced.  Continued headache.  Temperature falls below 100F. April 3 5:00am - Muscle aches end.  Fatigue gone.  Mild headache remains.  Temperature falls below 99F.  Excedrine taken again for headache, some effect. 12:00pm - All symptoms gone except for localized soreness of injection site.
Patient states she received pneumonia shot on 12/22/06 at 1:45 pm. She noticed her right arm began to swell and was red around 5:00 pm. She states the area around the site was red, swollen and warm to touch.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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 02Apr2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Apr2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. 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.
heat; Swelling; redness; itchy on the injection site; 2 inch wide tenderness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (heat), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE PRURITUS (itchy on the injection site) and VACCINATION SITE PAIN (2 inch wide tenderness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026120A and 030L20A) for an unknown indication.     The patient's past medical history included GERD (No medical history reported) and Shingles. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], OMEPRAZOLE, ASA, VITAMINS NOS and BOSWELLIA SERRATA RESIN, COLECALCIFEROL, COLLAGEN (OSTEO BI-FLEX EASE).   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 04-Jan-2021, the patient experienced VACCINATION SITE WARMTH (heat), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE PRURITUS (itchy on the injection site) and VACCINATION SITE PAIN (2 inch wide tenderness). On 11-Jan-2021, VACCINATION SITE ERYTHEMA (redness) had resolved. At the time of the report, VACCINATION SITE WARMTH (heat) and VACCINATION SITE PAIN (2 inch wide tenderness) outcome was unknown, VACCINATION SITE SWELLING (Swelling) had resolved and VACCINATION SITE PRURITUS (itchy on the injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 03-Apr-2021: FUP information included, updated patient information and concomitant medications, dose 2 details.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded
About three days later, the patient noticed that her throat was swollen (described area of lymph nodes) and claims to have somewhat difficulty breathing, however reports no hives or itchiness of the throat. She also notes white spots on her foot/ankle that are about the size of a skin tag.  Advised patient that she may take benadryl if she feels like her throat is swelling closed, but if she gets any worse to visit an Urgent Care or Emergency Room.
Moderna COVID?19 Vaccine EUA 3" to 4" rash on upper arm appeared eight days after injection (1st shot)
Patient developed swelling, redness and itchiness 24 hours after vaccine which lasted for 5 days. She also noted an itchy rash on arm and thighs 3 days after. No treatment.
Fatigue, joint pains, muscle aches, shivering, redness at injection site.
patient felt lightheaded and felt the room spinning. no arm or leg weakness, no feeling of faint. no nausea or vomiting. no chest pain or sob. no loss of consciousness.
Shot #1     (036A21A) 03-16-21 Shot at 4:00 p.m. ? bad migraine that night 03-17-21 Bad migraine 03-18-21 Shingles outbreak Ongoing for3 weeks 04-17-21 IBS, Extreme Fatigue  (overlapping w/ Shot #2)  Shot #2      (042B21A) 04-14-21      Shot at 4:00 p.m. 04-15-21 --   I felt OK during the day, had the sniffles 9:30 p.m. ? I had a moderate head cold with sneezing and sniffles ? took Nyquil 04-16-21 Severe head cold, chest congestion, asthma flare, some trouble breathing ? took DayQuil and Sudafed all day   Migraine Ongoing and still today?.. 05-08-21 I still have chest congestion, trouble breathing, sinus congestion, cough ? taking DayQuil and Sudafed all day every day Still having more migraines than usual ? using more Imitrex Tablets and Spray than usual; More fatigue than usual; using Asthma inhalers more than usual
p/vax pt fainted & fell on the ground & hit the left side of forehead. also bled from the gums upper ?tooth loose
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 at 03:15 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: G57524, Location of injection: Arm Left), administration date: 30Sep2022, for COVID-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: FJ9943, Location of injection: Arm Right), administration date: 01Apr2022, for COVID-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FF2588, Location of injection: Arm Left), administration date: 17Sep2021, for COVID-19 immunization; bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EN6200, Location of injection: Arm Right), administration date: 19Feb2021, for COVID-19 immunization; bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EL9261), administration date: 29Jan2021, for COVID-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19; patient was given PAXLOVID.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.
PATIENT WAS IN OBSERVATION AREA AFTER  BEING VACCINATED. HE CALLED FOR HELP STATING THAT HE WAS HAVING SOME LABOR BREATHING, NUMBNESS OF HAND AND FEELING HOT. PATIENT TOOK SOME SIP OF COLD WATER THAT WE OFFERED BUT NOT GETTING ANY RELIEF. HE CONTINUED TO PANIC SO WE CALLED THE AMBULANCE. WHILE WAITING , HE WAS ASSISTED TO LAY DOWN ON THE SIDE ON THE FLOOR. THE PARAMADIC CAME AND ASSESSED THAT HE WAS JUST PANICKING.
Initial information received on 28-Mar-2018 regarding an unsolicited valid serious case received from a other health professional. This case involves a 4 years old male patient who was inadvertently vaccinated with an expired dose of DAPTACEL (lot C5157AA expiry date: 23-Feb-2019, via unknown route in the left deltoid) on 27-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to expired vaccine used. It was unknown whether the patient had any adverse event or not. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. List of documents held by sender: none.
Patient return to pharmacy on 11/30/19 at 5:23pm with a prescription for Prednisone 20 mg and Epi Pen Auto Injector. Patient stated she had allergic reaction to the vaccine. She stated she had problems breathing, bottom of tongue was swollen and throat closed up. She stated she went o the ER. Talked with staff in ER on 11/30/19 at 6:05pm. He stated patient was treated with Bolus IV dose of Prednisone 60mg and patient was released.