chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Probably after 12 hours,  veins/nerves started pulling up near shoulder and jaws; Probably after 12 hours,  veins/nerves started pulling up near shoulder and jaws; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 08:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included fenofibrate (MANUFACTURER UNKNOWN) and simvastatin (MANUFACTURER UNKNOWN) all from an unknown date from an unspecified indication. On 17Mar2021 at 20:00, the patient experienced probably after 12 hours, veins/nerves started pulling up near shoulder and jaws. Patient stated that he took a hot shower and slept, when he woke up after 4 hours, it became much better. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events probably after 12 hours, veins/nerves started pulling up near shoulder and jaws was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed.  At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature.On 04 Jan 2021, th e patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room  temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.
Headache and Bad upper arm/shoulder pain the first night and second day.  Severe upper arm/shoulder pain - so bad that it kept me up at night and I couldn't lay on my left side.  Along with the shoulder pain the second night the headache continued on and off (took aspirin to try to help) the second day and through the night and a low grade fever 99.5-100. developed through the second night.
My face and neck turned bright red and became very hot. I have pictures for the progress of the redness if needed too.
Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L020003, expiration date 02-JUN-2017) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist (who was also the father of the patient) and refers to a 24 year old male patient. The patient did not have any pertinent medical history, drug reactions or allergies and concomitant therapies. On an unknown date in June 2017 (reported as on an unknown date two months before 21-AUG-2017), the patient was vaccinated with first dose of GARDASIL 9 intramuscular for prevention of Human papilloma virus (HPV) (exact dose, site of the administration, lot# and expiration date were not reported). On 21-AUG-2017, the patient received a second dose of GARDASIL 9 intramuscular for prevention of HPV, lot # M035486, expiration date on 05-JUN-2019 (exact dose and site of the administration were not reported). On an unknown date in February 2018 (reported as about a week ago (prior to 12-FEB-2018)), the patient experienced flu. On an unknown date in February 2018, the patient visited physician where a flu culture was obtained to confirmed that he did have an actual case of the flu. The patient was prescribed TAMIFLU and amoxicillin as a treatment. The patient was scheduled to receive his third dose of GARDASIL 9 on 12-FEB-2018. The outcome of flu was reported as recovered on an unknown date in February 2018. The relatedness between the event of flu and GARDASIL 9 was not reported.
No additional AE's and no PQC's were reported.; The nurse stated that improperly stored vaccines were administered to patients.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 11-APR-2022, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Albumin status rHA (recombinant Human albumin) (PROQUAD) lot# U022724, expiration date reported as 16-JAN-2023, use as directed to prevent measles, mumps, rubella and varicella infection (prophylaxis) (strength, dose, route and frequency were not reported) (product storage error).   The temperature excursion was of 7.5 Fahrenheit degrees (°F), during 15 minutes. A previous temperature excursion was not reported. No additional adverse event and no PQC's were reported.
After patient received the vaccine , he looked dizzy , when I spoke with him he was conscious and breathing. I had him lay down on the floor but he started having convulsions. Emergency 911 was called immediately and patient was taken to hospital.
Patient is an RN who received flu vaccine on 11/10/14. On 12/8/14 reported to clinical educator that she had reduced ROM and pain at arm.
This case was reported by a healthcare professional and described the occurrence of muscle pain in a 37-year-old female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  There were no concurrent medications.  On 20 August 2008 the subject received 1st adult dose of ENGERIX B in the left arm.  An unspecified time after vaccination with ENGERIX B, the subject experienced muscle pain which resolved.  On 23 September 2008, the subject received a 2nd adult dose of ENGERIX B in the left arm.  Three hours after 2nd vaccination with ENGERIX B, the subject felt sick with flu like symptoms and had to leave work and go home.  These events were unresolved at the time of reporting.  Relationship of all the events to ENGERIX B was not specified.  It was noted that when the subject returned for her 3rd dose of ENGERIX B, it was not administered due to the above events.  Follow-up information received on 24 March 2009 indicated that following 1st dose of ENGERIX B (20 mcg) on 20 August 2008, the subject reported muscle pain, flu like symptoms and feeling sick.  These events resolved and were reportedly thought to be related to treatment with ENGERIX B.  Three hours following 2nd vaccination with ENGERIX B (20 mcg) on 23 September 2008, the subject developed muscle pain and flu like symptoms and had to go home.  The outcome of these events was not reported.  The reporter felt that these events were related to treatment with ENGERIX B.  Again it was noted that the 3rd dose of ENGERIX B was not given.
Pt recvd 2 doses of Engerix-B & 12MAR92 @ bedtime pt exp numbness all over body; legs numb; pt feels pins & needles; tingling;
This spontaneous report was received from a registered nurse via company representative concerning an unknown number of patients (No patient demographics provided). On unspecified dates, the patients were vaccinated with the 3 doses of RECOMBIVAX HB, dose 1 ml, intramuscular route (frequency and lot numbers not provided). Co-suspect or concomitant therapies were not reported. On unspecified dates, the patients have had negative antibody titers after administration of 3 doses of RECOMBIVA HB. Antibody titers tests were performed. Patients sought medical attention through office visits. At the time of the report, the outcome of the event was unknown. The causal relationship between RECOMBIVAX HB and the event was unknown. Additional information has been requested.
Fever 103 degrees and twitching.  Went to the Emergency Room.  Ibruprofen given.
4 year old patient with swelling without erythema of right upper leg which was the site of IPV #4 and DTaP #5 eleven days after administration of vaccines. Motrin and warm compresses were recommended. The next day, 8/24/05, he continued to complain of increase leg pain so he was taken to ER where he was treated for abscess.
Site of injection, (L) arm, significant swelling to entire area up to shoulder, painful.
got the vaccine on Saturday 1/23/2021, started itching on Tuesday, Wednesday night, hives started showing all over my body. Went to urgent care, took some prednisone 50 mg. the next day, Thursday was worst. Had to go to the ER to get it looked at. prescribed me Benadryl and famotidine. went away that night.  It was super itchy. I was worried I was going to have a anaphylactic shock.
Evening of the vaccination, patient started to have swelling and redness to the left thigh where the shot was given. Mother gave patient Benadryl but symptoms worsened as days went on and eventually came into ED two days later. Patient was discharged with Keflex for what was found to be cellulitis.
Mom called clinic to report on 7/29/10 child's left arm became swollen from elbow to shoulder and itched over swollen area. No pain, rash or fever noted. Mom also reports very small sore injection site. MD aware. No treatment needed. Mom noted something swelling. Also reports that MD says child had a seizure in clinic after vaccines. No seizure activity was noted while child was in clinic. Mother would report of S/S to MD.
Irritable, increased sleepiness, 1 1/2 days after receiving vaccinations
1 of 4 pts vaxed from the same DTP lot# who had adverse event;pt exp an inj site rxn; no further info available
Fever 100.5 deg.  lasting about 24 hours; Body & Joint Aches Severity 7 for 24 Hours, Hot Red Skin over 80% body.  Somnolence, Fatigue. Unable to function normally all day Saturday, Bed rest. then although no fever or body aches during next 24 hours, took additional bed rest to regain strength by Monday
Administration of vaccine completed around 10.00 AM. At 2.00 PM onset of swelling around insertion site. Site warm to the touch and itchy.
Presented with SOB; previous Covid Dx and at home on 8 LPM O2; CXR Bilat opacities; Labs: D-dimer: 1.95, CRP 13.98, Tx: Started on maxipime, rocephin, decadron, lovenox, vanc, No Remdesivir as pt outside of timeframe, rec'ed actemra on 12/15; prone positioning;  Initially  on HFNC & NRB for O2, Intubated 12/15; SPO2 88-90%; REnal consult for AKI; levo started for septic shock; 12/16 vasopressors off; 12/30 pt with acute elevated B/P; slight neuro changes; Head CT negative; 12/31 slowly weaning vent; 1/1 bronch -- Coarse breath sounds noted and an increase in secretions overnight, bedside bronch performed per MD, thick brown/tan secretions lavaged, sample sent to lab; 1/3 extubated to face tent; FiO2 @ 2 LPM at d/c;
Sore for two-three days but she thought it was better until she rolled over onto her shoulder while in bed. Sore since and it hurts to lift her arm shoulder height or reach across her trunk.  No redness or swelling at the injection site noted.
At 2 weeks experiencing severe dizziness. Vestibular in nation with any change in head position. Falling to left. History of bppv but resolves with Eppley. This is constant  not improved with maneuvers or meclizine. Impeding daily living activities
Patient reports he received 2nd dose of Moderna on 11/02/21 and the next day (11/03/21) experienced ear pain, tinnitus and hearing loss. Patient did not specify which ear and call was cut off before I was able to obtain this information. Patient reports ear pain, ringing in ears and hearing loss continue and have not gotten any better since onset 11/03/21 (currently 11/06/21).
Vaccinated arm in pain, like being hit with baseball bat. Lasted two days. Severe pain moved to under shoulder blades. Still there as of 11/5/09. Vaccinated hand numb, can't hold pencil.
2/19/21 Second COVID Pfizer shot.  6/20/21 Severe shingles develops over and around right eye and forehead.  Patient hospitalized for a week to receive antiviral medication via vein. After hospital release, five months later, patient has severe swelling/pain at the site and continues receive physical therapy massage.    11/12/2021 Third COVID Pfizer shot given. One day later: The area around patients right eye where the shingles area occurred previously shows renewed redness, swelling and pain. This continues without relief as of the date of this report 11/22/2021. The patients physical therapist has noted the recurrence as well.
This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249, expiry date: not reported), via an unspecified route of administration on the right arm on 15Jan2021 08:00 at single dose for COVID-19 immunization. Medical history included GERD and tachycardia from an unknown date and unknown if ongoing, and known allergies: penicillin. Concomitant medication included cetirizine hydrochloride (ZYRTEC), omeprazole (PROTONIX), metoprolol. The patient received their first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140) on the right arm on 28Dec2020 at 08:00 for COVID-19 immunization. The patient experienced knot in the muscle of their upper right arm, approximately 3-4 inches by 1-2 inches on 16Jan2021 11:00. The outcome of the event was unknown.
Patient  had extensive swelling and redness of injection site within 24 hours of receiving Pediarix on 08/06/2019, no fever or other symptoms.  Ice applied to site.  Mother wanted reported
6 hours post vaccination- body aches, headache, fever 13 hours post vaccination- headache, tinnitus  24 hours post vaccination- weakness, tinnitus, dizziness, shortness of breath  36 hours post vaccination- tinnitus, SOB
woke up on Saturday with a headache, slight dizziness and nausea with a fever of 99.4. I took 2 Ibuprofen and the fever and other symptoms seemed to leave for the next 6 and a half hours until the headache came back. I took more Ibuprofen and the headache went away again.
Localized pain and redness to left deltoid area; fever 101.2 per father taken by school nurse today at approximately 1PM. Per the father described "lethargic" and was "foggy"-child just not himself; advised recovered other than quiet at time of exam in doctors office 12/14/16 at 3PM today vital signs oral temperature 100.0; heartrate 104; respiratory rate 22; b/p 100/66.
Slight swelling reddened area oval 2 1/2" x 3 approx. Within 12 hours no itch swelling & redness diminishing after 48 hours gone in 96 hours.
Patient presented to emergency department on 12/13/2021 with weakness and fatigue after reporting testing positive for COVID-19 on 12/11/2021. Patient was admitted for management of symptoms. She was treated with dexamethasone, remdesivir, and supplemental oxygen. Patient was discharged to post-acute rehab facility on 1/3/2022.
Severe muscle weakness (struggling to walk), extreme dizziness, vomiting (probably from dizziness), given IV fluid at ER, zophran,  and a non-narcotic analgesic through IV. Fully recovered about 2 days after ER visit.
4 days post vaccine, hives began in one place on the body. Started in the later afternoon. Hives have continued every day since. at Day 16 hives increased to many areas on the body starting in the late morning..  Day 4 to Day 16 took 2 Benadryl at night. Day 17 and onward taking 1 Benadryl every 4 to 6 hours during daytime and 2 at night. Taking 1 pepcid each days since day 14.  No throat swelling. Hives are severe including bottoms on feet, scalp, etc.
I had Bell?s palsy type symptoms within 45 minutes one eyebrow raised higher than the other. My face felt numb, tingled. Towards the evening my face was flush red, I looked like I had a chemical peel and it was streaking. Facial swelling. My hands looked like they were very read on the palms.
Dehydration; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and DEHYDRATION (Dehydration) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Glaucoma since an unknown date. Concurrent medical conditions included Hypertension. Concomitant products included VALSARTAN and METOPROLOL for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced DEHYDRATION (Dehydration). At the time of the report, DIARRHOEA (Diarrhea) and DEHYDRATION (Dehydration) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Stool analysis: no blood in stools (Inconclusive) No blood in stools.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Follow up received on 06-apr-2021 and does not contain any new information On 06-Apr-2021: TCR received on 06-Apr-2021 and does not contain any new information; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Arthritic pains; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4226476-00.  A 57 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "Influenza" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Janssen (DOSE 1, JANSSEN COVID-19 VACCINE (COVID-19 VACCINE NRVV AD26 (JNJ 78436735)) (COVID-19 VACCINE NRVV AD26), Daily Dose: (1 in 1 Once), Route of Administration: Intra-muscular, Indications for Use: PROPHYLACTIC VACCINATION, Therapy Dates (From/to): Unk), for COVID-19 immunization; Janseen (PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN), UNKNOWN, Daily Dose: 1) Booster dose (1 in 1 Once), Route of Admin: 1) Intra-muscular, Indication for use: 1) PROPHYLACTIC VACCINATION). The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Arthritic pains"; FATIGUE (non-serious), outcome "recovered", described as "fatigue". The action taken for adalimumab was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist concerning a 59 year old male patient with no drug allergies/reactions or medical history. On 20-FEB-2016 the patient was vaccinated with ZOSTAVAX (Lot# reported as L034727, unspecified expiration date), 0.65 ml, once, subcutaneously. No concomitant medication was taken. In February 2016 the patient developed an unspecified rash underneath both arms on the trunk of the body. The patient also experienced difficulty breathing for about 1 hour after the administration of ZOSTAVAX (onset date and stop date: unspecified date in February 2016), but the breathing difficulty was not severe. The patient called his primary physician, on an unspecified date, and the physician advised the patient to use an unspecified over the counter hydrocortisone (manufacturer unknown) cream as treatment of the rash, but the cream made the patient feel worse (capture into MARRS#1603USA001502). Lab diagnostics study was not performed. The outcome of rash was unknown. Action taken with ZOSTAVAX was not applicable. The relationship between the ZOSTAVAX and the two events was not reported. This is one of the two reports received from the same patient. Additional information has been requested.
The NDC Number is: 49281-400-89.  The morning after my vaccination I became tired, achy, then sweaty/hot with chills.  Had aches, chills, sweats for the next 3 days.  At the same time the injection site (top right arm) became inflamed and hard as a rock.  I could hardly lift my arm.  My arm felt "locked".  Then about 5 days after the vaccination, I noticed a large lump/mass on the inside of my bicep.  It was red, slightly itchy and very warm.  The top of my arm was also still extremely tight and the muscle was hard.  Went to Dr. and she said I had cellulitis and prescribed an antibiotic.
This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-JAN-2016, the patient was vaccinated with an improperly stored GARDASIL 9 lot # L016428, 30-JUL-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with VAQTA (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. The nurse reported that the VAQTA administered, reached a temperature outside the prescribing information. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
I started feeling nauseous at 4:00 in the morning the day after my vaccine. I got home from work and vomited. I called employee health and they put me in isolation and talked possibility of potential exposure. They had me stay in isolation for 5 days and then tested for COVID but it was negative. I then had to isolate again for 10 days due to policy and then test again and that was also negative.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 20-MAY-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVis 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 1176 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
pt recv vax 3JUL97 & 11JUL97 pt devel a rash w/15 lesions all scabbed over;
Patient was given a second dose of Moderna 5 days before the 4 week minimum interval. No adverse effects were noted. Patient was contacted and told to come back again in 4 weeks to receive a valid second dose.