chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: 62 year old female who had previouly received one dose of Moderna in April where she experienced tongue and lip swelling and was treated for anaphylaxis. Was told by her provider to get a dose of Janssen instead of second dose of Moderna. After getting the Janssen vaccine, she got weak, felt like her whole body was going to give out, and was going to pass out. They gave epi shot at that point. She was taken to ER where she reported her heart was pounding and had anxiety. No SOB, CP, lip/throat/tongue swelling. She was given solumedrol 125 mgIV x1, Benadryl 50mg PO x1, lorazepam 1mg IV x1 and sent home with a prescription for prednisone 40 mg daily x 5 days and 2 epi pens.
Chills, fever of 101, body aches, sore arm of injection,  and very tired
Patient described a large red lump and bruising underneath the injection site.  He also experienced fever and dizziness.
Talked to mom 9:00 am- completely recovered per mom- Mom left clinic without having pt scheduled. Pt rec'd Varicella to (R) arm. Immediate wheal with reddened area occurred 80 mm x 65 mm. Dr. examined pt no tingling, c/o arm soreness. Cool pack to arm.
Monday August 9th, my daughter received her1st vaccine at 1:00pm.  By 5:00pm she noticed a red, itchy, patchy area on her neck, shoulders and face  that resembled hives or some type of allergic reaction.  Within a couple of hours, her face, and upper body were covered.  By morning of August 10th,  it had spread all over her face, back,  legs and arms so we went to Urgent Care at 8:00am.  The doctor there determined she was definitely having some type of reaction and provided a steroid injection and Benadryl.  Throughout the day, the rash seemed to spread and become more inflamed.  She itched uncontrollably and the discomfort was unbearable.  8:00am August 11th, we had no choice but to take her to Pediatrics.  The nurses there  provided Hydrocortisone and stated not to scratch.
Fever  Chills  Diarrhea  Headache  Sore body  Stuffed nose  No taste or smell Lasted all for 9 days
Ringing in ears and headaches.  Diagnosed with tinnitus. High pitch ringing in both ears. Never stops. Did not have this before vaccine.
Fever 100.7-102F 2:30AM unresolved at 12:55PM; no treatment at this time.
Admitted with covid pneumonia, Acute hypoxic respiratory failure, currently in ICU ventilator dependent respiratory failure.   Patient tested 1/26 with 1/29 positive results. never symptomatic. presented to receive covid vaccine and received it on 2/1, ( reportedly discussed with a physician to make sure getting vaccine was ok) Then hospitalized 2/11 with urosepsis and discharged 2/14. 2/15 presented to oncology office with o2 sats 78% on RA. transported to Hospital.
Moderately severe vertigo onset 1 week post vaccination and duration over 1 week (still ongoing but mild 9 days post onset).
Dizzy; Ringing in both ears, I cant get relief from this noise in my ears; Fever; Chills; Very tired; No energy; Now trouble sleeping because of the noise, this is depressing; Now trouble sleeping because of the noise, this is depressing; After second shot very very sore arm, could not left my arm until the next day then sore; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 01May2021 at 14:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history reported as the patient had no health issues. 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 vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in May2021, the patient experienced after the second shot very very sore arm, could not left her arm until the next day then sore. On 03May2021, second day, the patient got fever, chills, very tired and no energy. On 04May2021, third day, the patient felt dizzy then got ringing in both ears and it was then 22May2021 and she could not get relief from that noise in her ears and her doctor could not help. Also, she never had ringing in her ears, tinnitus, before that shot and now (at the time of this report) on an unknown date in May2021, the patient had trouble sleeping because of the noise, that was depressing. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were 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 after the second shot very very sore arm, could not left her arm until the next day then sore, fever, chills, very tired, no energy, dizzy and got ringing in both ears, she could not get relief from that noise in her ears and now trouble sleeping because of the noise and that was depressing was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Low blood pressure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOTENSION (Low blood pressure) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 immunisation.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced HYPOTENSION (Low blood pressure). At the time of the report, HYPOTENSION (Low blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  The patient was given an additional blood pressure medication to regulate blood pressure.
FLUZONE 0.25mL pediatric given as an age inappropriate dose. No injury.
I have continued stiffness and pain in my left arm.  I have limited range of motion.  I can't lift my arm or put it behind my back without considerable pain.
Presented w/ fatigue, weakness, SOB. Pneumonia-covid +. Tx dexamethosone, O2.
Redness and swelling rt arm at injection site, limited arm movement (pain, control). 3rd day after injection- fever (mild, unmeasured), generalized muscle and joint pain, headache. 4th day side effects lessened.
Modern vaccine rec'd 1/27, about 3-4 days later she started itching across her shoulders. It was itching really bad and there were small bumps and she was red from one shoulder to the other. I applied a itching cream and it only lasted a couple hours so we tried many different creams but nothing seem to stop the itch. The rash is from her shoulders to her neck line and from nick to waist line and it itches tremendously.  The NP stated it was Shingles and she was prescribed meds and took them for 10 days and it cleared up for a few days. today it's broken out again and its itching. She's scheduled to get the 2nd dose and don't know if she should get the next dose
I came down with Shingles about 12Apr2021. I have no idea if this is a side effect of the vaccine, but felt I should report it because of seeing this on the news.; This is a spontaneous report received from a contactable consumer or other non hcp. A 77-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EN6205),via an unspecified route of administration, administered in Arm Left on 09Mar2021 14:00,at the age of 77 years old, as Dose 2,single for covid-19 immunization.Medical history included atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medications included rivaroxaban (XARELTO), metoprolol taken for an unspecified indication, start and stop date were not reported.The patient experienced she came down with shingles about 12apr2021,13:00. Patient had no idea if this is a side effect of the vaccine.Therapeutic measures were taken as a result of shingles.The outcome of the event was recovering.The patient was treated with Valacyclovir.The patient had not received any other vaccine within 4 weeks.The patient was not diagnosed with covid prior vaccination and not tested post vaccination.The patient previously received her 1st dose of Pfizer covid vaccine on 18Feb2021 02:30 PM, lot number EM9810.The patient had no allergies.
None adverse symptoms of signs Tdap given instead of Td to 7 yr old.  0 adverse event onset or reaction just that vaccine given (TDAP) to a 7 yr old.  TD should have been admin.
Reports to ED department on 4/19/18 itchy, swelling and redness on the outer aspects of left thigh (site of Varicella injection). Started on 4/18/18 not oozing, spreading symmetrically. No fever, no weakness, no fatigue.
I got the shot and got shingles, too / Suspected vaccination failure; I got the shot and got shingles, too; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingles vaccine and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Swollen lymph node, supraclavicular Saturday -Tuesday followed by rash on left side of neck extending down chest
Tongue pain on Friday 09/02/22 worsening symptoms (on Saturday 09/03/22) Tongue Pain, Gum and jaw inflamation, Eye swelling, Muscle stiffness & soreness - specifically legs, tunnel vision, halos in vision, extreme fatigue,  (09/04/22) woke to swollen and numb hands including no sensitivity in hands, and continued fatigue. Went to urgent care on Sunday 09/04/22. Was given Prednisone in Right Arm to counteract. immediate sensitivity to hands returned. muscle pain and stiffness also decreased.
pt recv vax & w/in min of vax & began to twitch & moving hands & legs up & down;head between legs (was in seat belt)-color pale, did not answer lasted 1min;mom called MD-no fever, no more sz activity;
Pt received dose second Pfizer COVID vaccine. Reported pruritus all over her body - patient was noticeably scratching herself. Patient was given 12.5 mg benadryl and was observed for an additional 15 minutes. Patient reported still having pruritis and was given an additional 12.5 mg benadryl, and was observed again for an additional 15 minutes. At the end of the 15 minutes she reported feeling much better and was sent home.
This spontaneous report as received from a physician refers to an 18 year old female patient. She past complained of allergic rhinitis, exercise induced asthma. The patient had seasonal allergies and rhinitis. On 22-AUG-2012 the patient was vaccinated with her first dose of GARDASIL (lot number 0518AE exp date 21-NOV-2014) in her right arm. That day she also received MENACTRA her left arm. The physician reported that the patient's mother had stated, that soon after the first dose, the patient began experiencing headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity. After the second dose of GARDASIL (lot number reported as H015859, exp 26-JUN-2013) on 23-NOV-2012, the symptoms intensified. The patient was seen by an unspecified ear, nose and throat specialist and was diagnosed with perennial rhinitis and sinusitis, based on rhinoscopy. She was given several rounds of unspecified antibiotics, with no relief. She was seen by a gastroenterologist who did not make a definitive diagnosis. The mother stated that "last week" she was seen at a neurologist's office to have a spinal tap performed to "find the root of her neurological problems". The reporter physician had stated that she had not received any reports from these specialists, information was only from the patient's mother's report. The outcome of headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity and neurological problems was unknown. The causality was not provided. Additional information has been requested.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: Approximately 5 minutes after injection patient reported feeling faint. Pharmacist was at patient's side. Patient appeared pale, started sweating then fainted.  Pharmacist kept patient safely in chair, patient was unconcious for approximately 2 minutes before regaining conciousness.  EMS was called, they evaluated patient on site. Vitals were normal, blood sugar normal.  Patient felt better and refused transportation to the hospital.  Patient left pharmacy after approximately 30 minutes.
pt recv vax;exp guillain-barre synd and was hosp;at time of rpt, pt was paralyzed; no further details provided;
Patient was given the vaccine 7 days early. Staff contacted CDC as well as Pfizer Medical Hotline. Per CDC guidelines there is no need to repeat the 2nd dose. Representative from Pfizer said they would email any further needed information. Mother of patient was contacted. The patient was scheduled to come in for 2nd dose on 6.15. Mom's mother went in for emergency surgery and mom mixed up dates of 2nd dose. Spoke with mom on 6.10 and patient is doing well. No symptoms.
first 24 hrs fever, vomiting, fatigue, confusion  day 2 on... shortness of breath, chest pain, heart fluttering, head pain, neck pain,dizziness,anxiety Feb 14.... better still feeling chest pain, shortness of breath, visited family Dr., diagnosed with slight heart enlargement,  RX 10mg steroid started at 12pm heart rate dropped to 42bpm around 9pm oxygen level 99
was drowsy; chills; headache; fever; felt like was getting the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like was getting the flu), SOMNOLENCE (was drowsy), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like was getting the flu). On an unknown date, the patient experienced SOMNOLENCE (was drowsy), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever). At the time of the report, INFLUENZA LIKE ILLNESS (felt like was getting the flu), SOMNOLENCE (was drowsy), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.            No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-376977 (Patient Link).
Small Red Area on arm just below injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Small Red Area on arm just below injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Small Red Area on arm just below injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Small Red Area on arm just below injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drug information was provided.  Patient age was reported as 22 years and 8 months.  It was reported that vaccine was administered beyond use date to patients. There was no adverse reaction noted or reported regarding these administrations. Vaccine number 1 code was reported as 80777027399.  No treatment drug information was provided.
patient received expired vaccine of FLUZONE QUADRIVALENT with no adverse event; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional, physician, non-healthcare professional via regulatory authority (under reference: 00814513).  This case is linked to cases 2021SA344343, 2021SA344107 and 2021SA345249 (CLUSTER).  This case involves a 14 years old male patient who received expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered).   The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 14-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (0.5mL, once, total, lot UT7108MA, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual case of medication error due to expired vaccine used (latency: same day).  It was reported "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14OCT2021 to 15OCT2021 that expired on 30JUN2021. Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine."  At time of reporting, no adverse event was reported.  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 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.
Pt received more than 30 mcg of Covid 19 modRNA. When administering 1.8 ml of 0.9% sodium chloride into the the vial of covid 19 the syringe leaked. Only 5/6 doses were able to be drawn out.  There wasnt enough for  the 6 th dose by 0.06 ml,
Blood in stools.  Patient was taken into hospital on 02/05/12. From there they were taken to another hospital who had the pt taken by ambulance to the final Hospital.
Pain started in my left shoulder that lasted for about a week and progressed to pain in my the lower end of my lungs. I also experience sharp pain when I run out of breath. I am currently scheduled for a follow up visit with a Cardiologist to rule out any heart conditions. However I do believe that it may be due to muscle pain.
Patient had fever 100 degrees( subjectively at home) ( current otitis media). Presented with erythematus macules , vesicles over lower extremities, near diaper area which were absent at the time of vaccination, rest of skin was spared. These lesions resolved over 5 days with topical CALADRYL lotion.
Severe headache that felt like my head was going to explode, temp that varied from 101.3 -104.5, severe muscle, bone, and joint pain, severe fatigue with difficulty to be awake. Began taking tylenol 1000mg PO every 6 hours until symptoms subsided. Symptoms onset was very sudden, lasted 48 hours, then disappeared just as suddenly.
Day after vaccine was administered, patient had a rash on upper arm down to elbow. Two days after, she presented with muscle/joint aches and diarrhea.
This case was reported by a healthcare professional and described the occurrence of medicine-like taste in mouth in a 42-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). There were no concurrent medications. On 23 August 2012 the subject received 1st dose of TWINRIX (1 ml, unknown, right arm). On 23 August 2012, immediately after vaccination with TWINRIX, the subject experienced medicine-like taste in mouth. Within one minute of vaccination with TWINRIX, the subject experienced feeling of numbness of the nose and lip felt numb. The healthcare professional reported the subject experienced a medication taste in her mouth immediately after TWINRIX was administered on 23 August 2012. Within one minute, the subject complained of nose and lip numbness. The subject was monitored and symptoms resolved without sequalae within 15 to 20 minutes on 23 August 2012. No additional information was known at the time of the report.
Patient presented to emergency department on 2/14 complaining of neck swelling and vomiting, without associated shortness of breath. Received methylprednisolone, epinephrine, diphenhydramine, and famotidine and admitted for close observation. In the ICU, patient did not require supplemental oxygen or further medications.  Symptoms resolved the next day and patient transferred out of the ICU. Patient received Moderna COVID-19 Vaccine on 2/12 (~48 hrs prior to symptoms of angioedema). Per patient report, she restarted her outpatient lisinopril a week prior to vaccination after being off of it for a year (was previously on lisinopril for several years prior to that). Of note, on 2/12 she had a negative COVID-19 test, however she did test positive for COVID-19 on 2/14. Patient was also taking metronidazole and ciprofloxacin when she received COVID-19 vaccine, however she has previously taken those medications without adverse reaction.