chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8/1/21: injection- normal pain, with muscle soreness all over. 8/2/21: woke with intense pain in all joints, muscles spasms in back and legs. Difficulty speaking and using lips to produce words. Feeling of mild paralysis all over body difficulty walking. Sharp moving pains under her left arm and down the left side of body predominately in the lower back up to the shoulder blade of the left side of the body. 8/3/21: Sharp pains continued under her left arm and swelling under left arm pit. Lower and upper back pains. Lethargic and difficulty speaking, remainder of the day.  8/4/21: Left arm-tingling. Racing heart rate causing slurred speech and difficulty speaking. Taken to the ER and ran an EKG and blood work nothing abnormal found. Set home to rest because of overcrowded ER area with Covid patients. Told to rest and breathe to prevent slurred speaking.  8/5/21: speaking is normal. Less lethargic. Back pain has lessened.
The patient was inadvertently given the 0.2 ml pediatric dose for children 5-11 years old instead of the 0.3 ml dose for children 12 and over.  No adverse events have occurred so far.
Client came in for #1 hepatitis B vaccination.  Given at 11:50 am. At ~11:52 am c/o feeling dizzy and a feeling of numbness on outside of throat, rising from lower neck on sides to around ears on both side and some in from of neck.  Numbness felt to be on "outside" of neck vs "inside" of neck, able to swallow sithouit difficulty. Became anxious at these feelings.  Called supervisor who called 911.  BP at ~11:52 144/78.  Ambulance arrived at ~ 11:55 am.  Evaluated client.  She stated she was starting to feel a little better by 12:02 pm.  BP at this time 128/70 and Bangs staff decided she could sign off going to ED because she didn't want to go.  Stayed here until 12:30 pm.  Sensations gone by about 12:15 pm.
with date of vax as day 0- 6 days a/reaction occured fever inc 103, rash face & upper trunk mostly-rash faded @ noc c/o aching joints, cranky; seen by MD x 2; put on ATB & APAP; fever broke w/APAP by day 8;
Cold symptoms and sore throat about 3am, Fever at about 6 pm on 5/13. 11 pm 5/13 at home rapid test positive. 5/14 cold symptoms got worse, and a headache was added. On 5/15 call doctor, provided prescription with Paxlovid. Cold like symptoms improved slowly over the course of the next week and fatigue caused me to stay in bed half of the day. On 5/19 I got a bad headache that lasted until 5/21 that was debilitating. Tylenol did not help the pain of the head ache. Tested Negative on 5/21 on an at home test.
Pt became fussy the afternoon after getting vaccs. At night she screamed constantly. This response continued through week-end (x 3d.) Temp. was elevated x d.s. Pt. was given Ped. Tylenol every 2-3 hours. Vacc. site on (L) thigh causes Pt. to cry. It is red. Pt. is lethargic 1st d. after shot. Advised warm soaks to leg/site u/s to tissue at site.
PATIENT IS WHEELCHAIR BOUND AND WHILE WHEELING OUT OF THE PHARMACY, HE TURNED RED, HAD TROUBLE BREATHING, CAME BACK INTO THE PHARMACY ASKING US TO CALL 911. HE SEEMED TO BE CONSCIOUS THE ENTIRE TIME. HE ASKED FOR AND WE GAVE HIM WET PAPER TOWELS AND ICE PACKS. AMBULANCE CAME, CHECKED HIM OUT AND HE LEFT TO GO TO THE HOSPITAL, BUT NOT IN AN AMBULANCE. HE SEEMED TO RECOVER BEFORE LEAVING. THIS WAS PNEUMOVAX, PATIENT HAS HAD PREVNAR BEFORE.
Fell and has wounds; Fell and has wounds; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell and has wounds) and WOUND (Fell and has wounds) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Parkinson's disease.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (Fell and has wounds) and WOUND (Fell and has wounds). At the time of the report, FALL (Fell and has wounds) and WOUND (Fell and has wounds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: No specific follow-up information recorded.; Reporter's Comments: Based on the current available information and the patient's underlying history of Parkinson's disease and  between the use of the product and the start date of the events, the events were assessed as Unlikely Related to study drug.  The Parkinson's disease could be a contributory factor to the reported events.
INFLUENZA TYPE A DIAGNOSIS; A spontaneous report has been received from a consumer. The report concerns a male patient of Unknown ethnic origin (height 75 in, weight 188 lb).    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine (live, attenuated)) 0.2 ml once/single administration, via nasal route, for flu prevention during OCT-2019.     The patient started treatment with Crestor (rosuvastatin calcium) 5 mg daily, oral, on an unknown date for high cholesterol.     On an unknown date, the patient experienced influenza type a diagnosis (preferred term: Influenza).     Treatment with Crestor (rosuvastatin calcium) was not changed.     At the time of reporting, the event was ongoing.    The event was considered non-serious.
I felt flushed but had taken double dose of Zyrtec. Second dose caused similar symptoms to first dose with more severe aches and pains. I had trouble getting up or moving. Tremors on the right side leg and arm were markedly worse than normal and I was unstable on my feet. Instability and fatigue lasted three weeks. Mood swings and brain fog were unusual and persisted for no reason for 2-3 weeks. For one day I had inflammation of glands on the right side of my throat. Phone contact with doctor to report that allergy did not occur.
2 half dose booster doses; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (2 half dose booster doses) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 032L20A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer since 2018, Penicillin allergy and Immunocompromised. Concomitant products included VENETOCLAX, DEXAMETHASONE and BORTEZOMIB (VELCADE) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (2 half dose booster doses). At the time of the report, ACCIDENTAL UNDERDOSE (2 half dose booster doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: no antibodies no antibodies.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient doctor took him off of his oncology medications to build up his blood members on 04Feb2022. After these three vaccinations patient had no side effects.   This case was linked to MOD-2022-485335 (Patient Link).
15:15: Voice became hoarse.  Went home.  She noticed welts above left hip.  Felt throat was closing.  She called clinic at about 16:30, nurse called back.  Recommended to come in, took 4 t. childrens Benadryl.  Saw MD.  She was given Benadryl and a white pill.  She developed more welts was slightly lightheaded.
dime size blister, full of liquid; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced blister. On an unknown date, the outcome of the blister was recovering/resolving.   It was unknown if the reporter considered the blister to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix vaccine and shortly after the vaccination experienced dime size blister, full of liquid. The patient asked if it could have caused by vaccine or something else. The patient stated that it went away in one week, but was still healing after two weeks. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Fever of 102 followed by facial swelling that looked like she'd been in a fight almost it was so swollen her eyes could barely open. Then her face looked like it was covered in burns and started to scab over. We photographed her over the next 3-days and the burn like marks on her face started to scab over and swelling went down. The doctor believed from looking at the photos that it may have been shingles. Also had major fatigue.
Patient received a booster dose (0.25ml) on 11/23/21.  Symptoms began at 9pm on 11/23/21.  Included chills, headache, muscle and joint pain.  Upon waking on 11/24/21, hips and both legs experienced excruciating pain, numbness, and tingling.  Numbness and tingling in legs were present as a result of MS, however, after injection, the numbness and tingling were greatly exacerbated and amplified.  Continued to worsen throughout the day.  Went to the emergency room at about 5pm (11/24/21).  Was unable to walk without assistance and could barely feel legs.  Due to  MS history, ER physician thought it was best not to give MS steroid protocol since patient had just received the booster less than 24 hours prior and that would negate the steroid's effects.  Was given a prescription for Duloxetine at discharge from ER to help with nerve pain.  No other tests or labs were ordered by ER staff.   The following morning (11/25/21), she noticed urine was dark brown.  Went to nearby clinic where a urinalysis was performed and was diagnosed with hemorrhagic cystitis without infection.  Physician prescribed nitrofurantion and told patient to follow up with primary physician if symptoms did not improve after 7 days.  All initial symptoms continued through Saturday (11/27/21) and continued to decrease each day thereafter.
Moderna COVID-19 Vaccine EUA pain in injection area at 5am (6/2/21) with severe headache, joint pain and chills (took 1,000mg of acetaminophen). Chills, hot flashes and cold sweats, body aches, fever, nauseas, soft stool (took 1,000mg acetaminophen). Went to bed around 1:30pm and slept. Felt better in the evening hours with a remaining slight headache and light body aches taking 500mg of acetaminophen at 5pm.
worm in touch; Injection site itchy; Injection site red round (like circle); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (worm in touch), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (Injection site red round (like circle)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (worm in touch), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (Injection site red round (like circle)). At the time of the report, VACCINATION SITE WARMTH (worm in touch), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (Injection site red round (like circle)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is taking blood pressure and diabetes medications concomitantly.   Treatment medications include cortisone and antibacterial creams.
Extreme fatigue, headaches, and body aches since day of vaccination given. Taken Tylenol. Symptoms go away for couple hours and then come back.
dryness in throat; nausea; temperature of 99.6; headache; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DRY THROAT (dryness in throat), NAUSEA (nausea), PYREXIA (temperature of 99.6), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 01-Dec-2020. Concomitant products included GLIMEPIRIDE (GLIMITAL), ROSUVASTATIN CALCIUM (CRESTOR) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRY THROAT (dryness in throat), NAUSEA (nausea), PYREXIA (temperature of 99.6), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, q4h. At the time of the report, DRY THROAT (dryness in throat), PYREXIA (temperature of 99.6), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm) outcome was unknown and NAUSEA (nausea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 26-MAR-2015 ("5 days ago") the patient was vaccinated with a dose of ZOSTAVAX at another pharmacy (lot#, expiration date, dose and route were not reported). On an unknown date of MAR-2015 the patient developed lesions around her eyes. Her unspecified physician diagnosed patient with shingles. Physician recommended VALTREX as treatment. The outcome of event was unknown. Additional information is not expected since the reporter did not want to be contacted.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 07-NOV-2012, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-APR-2014, the patient was treated by a family nurse practitioner at an urgent care clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. The patient was prescribed acyclovir and gabapentin for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Today we were administering the second dose of vaccine to our employees. I am the sole person responsible for setting up the dose. I diluted the vaccine with 0.8 of normal saline rather than the 1.8 cc.
Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were provided by the reporter
Client came to the immunization clinic requesting Pneumovax per physician recommandation. 5 hours after receiving vaccine Left arm began to swell. Client started taking OTC Benadryl. Symptoms continued to worsen. 11-11-11 Left arm hard swelling "twice the size of arm". Center white with red circle around. Pain increasing. At 1:00 pm she went to ER. She was given Prednisone and pain med IM. She was discharged home with PO prednisone, antibiotic, and pain med. 11-14-2011 the client was interviewed. At present the swelling and pain are gone. However, she continues to take medication as prescribed. At the time of vaccine she had denied previous Pneumovax, but after side effects occurred she remembering having the Pneumovax 2009 when turned 65yo. She confirmed the year with clinic's record. She has a follow up appt with her physician 11-14-11.
The next day I began feeling fatigued and short of breath. It has been about 4 weeks and I am still feeling these symptoms. I thought it was my fibromyalgia, but this is worse than before, especially the shortness of breath.
Fainting, convulsions, shakes, light headedness, rash on chest, difficulty breathing, neck and face on the second morning after second dose
Patient required hospitalization due to breakthrough infection. He received Pfizer vaccine second dose in series on 04/12/21. Hospitalization from 07/30/21 - 08/05/21. Below is copied from discharge summary:   Pt. is a 62 YO male with a paste medical history of HTN, DM, CAD and MI s/p CABG(2018). Pt presented to the ER with complaints of swelling in his left thigh near his groin for the past 10 days, which has become progressively larger, tender, red and warm. CT showed irregular rim enhancing fluid collection within the medial aspect of the proximal high measuring up to 11.8 cm with adjacent fat stranding concernin for abscess. Pt was taken to OR for I&D on 7/30 300cc of pus evacuated, culture grew klebsiella. Zosyn was given x 4 days ended on 08/02. Wound vac was placed on 08/02 and changed out on 08/04. Additionally pt was found to be COVID + however is fully vaccinated as of April. Pt hospital course was otherwise unremarkable. Pt is currently medically cleared for discharge with instructions to follow up with surgery clinic on 08/10.
patient received an Expired VARlVAX (S021928, 7/15/2021); This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 10-AUG-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S021928 was confirmed to be valid, expiration date 15-JUL-2021, 0.5 milliliter (route of administration and anatomical location were not provided) for prophylaxis.
Patient came back about 1 week later reported that she developed cellulitis at the injection site immediately after immunization
Patient called 9/20/23 around noontime to inform us that she woke up feeling funny this morning.  She stated having no appetite, being constipated, and experiencing chills.  She did not take her temp so unsure if she had a fever.  She did check her blood glucose before eating anything and it was 177.  Patient is not experiencing any pain at site of injection.  She reported feeling better at the time when she called but still just weak and no appetite.  Patient stated she has not had this type of response to vaccines in the past. After she got off the phone with me she was going to also call her PCP office to inform them as well.
Ringing in one of her ears; This spontaneous case was reported by a physician assistant and describes the occurrence of TINNITUS in a female patient of an unknown age 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 TINNITUS. At the time of the report, TINNITUS outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact.
Product storage error; No adverse event; Single dose of expired Moderna Covid-19 was administered on 27-Nov-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Single dose of expired Moderna Covid-19 was administered on 27-Nov-2022), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Single dose of expired Moderna Covid-19 was administered on 27-Nov-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Single dose of expired Moderna Covid-19 was administered on 27-Nov-2022), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Single dose of expired Moderna Covid-19 was administered on 27-Nov-2022) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported. Vial size reported as 5.5 mL. Vial was initially stored in the refrigerator 27-Nov-2022.. Vial did not undergo any temperature excursions. No treatment information was provided.
Stomach pain, headache, shivering, fever, dizziness, weakness, fatigue, sweating, and a fast heartbeat.  No treatment, once the adverse reactions started, I got into the bed and stayed in bed for approximately 16 hrs.
had Covid-19; This spontaneous report was received from a retired dentist who was reporting on himself as a male patient of an unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date (reported as "just before Covid happened"), the patient was vaccinated with one dose of  zoster vaccine live (ZOSTAVAX) (strength, lot #, expiry date, and route of administration were not provided) for prophylaxis. On an unknown date, the patient had Covid-19.  On an unknown date, the patient recovered from the event. The causal relationship between had Covid-19 and zoster vaccine live (ZOSTAVAX) was unknown.
Itching, knot at site of injection, redness of the arm. Left deltoid is warm, has a 95x70 mm red area on left deltoid with indurated are of skin near the supeior aspect of the rash.  Given Keflex and told to use warm compresses or heat.