chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received for this unsolicited report on 09 February 2015 from a consumer who is the patient. This reporter also reported two other events, one for her husband and one for her infant. These cases are captured in 2014SA172624 and 2015SA017180. A female patient with an unknown medical history was vaccinated with Influenza vaccine, manufacturer, batch, route and site of administration were not reported on an unknown date. On Wednesday last week (04 February 2015), the patient began to get sick and on Thursday she went to the doctor. She was swabbed and she found out today that she tested positive for the Flu. Laboratory test was not provided. She was vaccinated at the same time as her husband at the clinic and feels that she would have had the same vaccine as her husband. She has requested the information from the health clinic and will report it once she has received the information. The patient outcome was not reported. Documents held by sender: None.
Pt experienced adverse reaction to varicella vaccine given on right arm, swelling and irritation appears with no other symptoms.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 62-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 08-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804084 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Sudden hearing loss; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 5, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: SUDDEN HEARING LOSS (medically significant), outcome "unknown".  Clinical course details: Patient states she wants to ask about sudden hearing loss after the vaccination and states she experienced this after the 5th dose. She also stated that there is a lot of information on the internet about sudden hearing loss. Patient states it was the bivalent vaccine that was given last year, confirmed she received the bivalent.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BODY ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of body aches was not reported. This report was non-serious.
On the following day after the vaccinations, her fever became higher but it was controlled with tylenol.  She also devolped a cough that same day and and her skin was pale.  I didnt realize it was coming from the shots but the following day feburary 9th she wouldnt eat or drink anythning and her color was even paler.  Then on the 11th of Feburary she broke out in red and purple hives that started to blister, so i took her to the Emergency Room immediatly.
After being well all day long, at about 6:30pm my daughter started to feel extremely tired. At 7:00pm she vomited. At 8:00pm she vomited again and her whole body was shaking and she was sweating. At 10pm she vomited again. She then slept till 1pm after which she started vomiting again and did so every hour until the morning. We counted ten episodes of vomiting. We were advised to take her to ER the next morning to treat for dehydration. During this day she did not vomit again, but the following morning she vomited again. She has had no fever or other pain or symptoms other than extreme fatigue. We think she is recovering now but will have a better sense in the next few days.
Patient got 1st Moderna Covid vaccine on 3/24/21. On 3/29 patient started getting a runny nose. By 4/2 patient started getting fatigue with loss of appetite and on 4/3 started getting right sided abdominal pain with movement.   Seen in the clinic on 4/5 with tachycardia 112 apical and temp 99.1, abdominal pain was feeling a little better and only reproducible with use of abdominal muscles. No resp symptoms except intermittent runny nose. Patient appeared very dehydrated on exam, IVF were offered but patient declined. Labs were done and patient was encouraged to aggressively hydrate at home. US abdomen was ordered STAT. Patient declined US on 4/6 because he was busy so it was scheduled 4/7. Covid test scheduled for next available apt.   On 4/6: Labs showed mild increase in WBCs and dehydration but otherwise no major abnormalities. Patient reported new onset swelling, redness, and pain in his R leg and concern for DVT. He reports family history of DVT in his mother. US of the leg was added to his testing on 4/7. He also reported on and off chills.   4/7: Report called for US Abdomen was negative but patient did have extensive DVT in the right leg. Eliquis was called in and patient instructed to pick up and begin immediately. He denies any respiratory symptoms today but still intermittent chills. He reports that abdominal pain has resolved.
Leg aches two hours after vaccine; Neck ache; Felt like flu; Aching all over body; Feels like on the verge of dying; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg aches two hours after vaccine), NECK PAIN (Neck ache), INFLUENZA LIKE ILLNESS (Felt like flu), PAIN (Aching all over body) and FEELING ABNORMAL (Feels like on the verge of dying) in a 76-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.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Leg aches two hours after vaccine), NECK PAIN (Neck ache), INFLUENZA LIKE ILLNESS (Felt like flu), PAIN (Aching all over body), FEELING ABNORMAL (Feels like on the verge of dying) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Leg aches two hours after vaccine), NECK PAIN (Neck ache), INFLUENZA LIKE ILLNESS (Felt like flu), PAIN (Aching all over body), FEELING ABNORMAL (Feels like on the verge of dying), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
pt reports  "vaccine reaction."  Veteran received influenza vaccine in left deltoid in clinic on 10/2/19. States left arm is "hard as a rock, swollen, itchy. Happened within 15 minutes of shot. Red 5" from top to  bottom. Have chills & fever" - received Shingrex vaccination same date, right deltoid. Reports "about the size of an egg, firm,  doesn't itch"
Patient was administered vaccines stated in section #13 on 10/30/02. PPD (tuberculin skin test lower forearm) placed on same day. Patient returned to clinic 11/1/02 for skin test reading with erythemic area on left upper arm 8cmx6cm. Warm, non-tender to touch. Instructed to call MD over weekend of increased swelling, color change, complaints of pain or worse. Follow up on 11/4/02, but no visit. Spoke with guardian 11/12/02, no redness, no pain, doing well.
Same day post vax, the pt developed fine rash on palms, arms, and back. Pt also had paresthesia of hands and feet.
Patient developed symptoms of a cough and low grade fever on 3/16/21.  He was diagnosed on 3/19/21 with double pneumonia and is taking a course of a z-pac and has two more days left to complete the therapy.   He follows up with the physician on Thursday.  The patient said he is feeling better now.  I asked him to have the Dr. clear him to get the vaccination upon the follow up.
chills, tiredness, headaches, body aches,  dry cough, loss of appetite, congestion, runny nose, diarrhea, some nausea, dizzy I received the moderna vaccine on Saturday, 13 Mar @ 9:00am and my systems started on Sat, 13 Mar @ 10:00pm and I felt better the morning of Wed, 17 Mar around 9:00am.
Patient developed a large red bump on her arm which was warm to the touch where the vaccine was administered. It started the day after she received the immunization and was worse the following morning. The area is not painful, it is only slightly itchy for the patient.
Extremely swollen lymph nodes in both underarms; painful; red; aggravating a pre-existing wound in the areas; aggravating a pre-existing wound in the areas; Vomiting began about 12 hours after second dose and onset of period (11 days after end of last period); Vomiting began about 12 hours after second dose and onset of period (11 days after end of last period); This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in Arm Left on 16Apr2021 09:15 (at the age of 37-year-old) as dose 2, single for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder and hidradenitis suppurativa from an unknown date and unknown if ongoing. Patient has allergy to latex. The patient concomitant medications included Wellbutrin and doxycycline. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included Wellbutrin and doxycycline. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7533) via an unspecified route of administration, administered in Arm Left on 26Mar2021 12:15 (at the age of 37-year-old) as dose 1, single for covid-19 immunisation. The patient experienced vomiting began about 12 hours after second dose and onset of period (11 days after end of last period) on 16Apr2021, extremely swollen lymph nodes in both underarms, painful, red, aggravating a pre-existing wound in the areas on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken because of adverse events (details not provided). The outcome of all events was not recovered.  No follow-up attempts are needed. No further information is expected.
Right cheek inflamed; redgums on the right side inflamed; hurt to chew; Slight and constant pain/ pressure on right ear drum; Fever 99.3; Felt hot to touch but no fever; Slight runny nose; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 11Apr2021 at 13:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history reported that the patient was obese and had allergies to food with soy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 12:00, the patient had her right cheek inflamed and red gums on the right side inflamed and hurt to chew, slight and constant pain/ pressure on right ear drum, fever 99.3 was the highest, felt hot to touch but no fever and slight runny nose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events right cheek inflamed, redgums on the right side inflamed, hurt to chew, slight and constant pain/ pressure on right ear drum, fever 99.3, felt hot to touch but no fever and slight runny nose were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (burning sensation on his skin/burning sensation on his neck and chest/burning sensation on his back/at night the burning sensation gets worse/Not worse but persistent), URTICARIA (developed a welts/hives on his arms/developed a welts/hives on his back.), FRUSTRATION TOLERANCE DECREASED (is frustrated) and HYPERSENSITIVITY (some sort of allergic reaction) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 045B21A) for COVID-19 vaccination. No Medical History information was reported.On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN BURNING SENSATION (burning sensation on his skin/burning sensation on his neck and chest/burning sensation on his back/at night the burning sensation gets worse/Not worse but persistent), URTICARIA (developed a welts/hives on his arms/developed a welts/hives on his back.), FRUSTRATION TOLERANCE DECREASED (is frustrated) and HYPERSENSITIVITY (some sort of allergic reaction). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN BURNING SENSATION (burning sensation on his skin/burning sensation on his neck and chest/burning sensation on his back/at night the burning sensation gets worse/Not worse but persistent) had not resolved and URTICARIA (developed a welts/hives on his arms/developed a welts/hives on his back.), FRUSTRATION TOLERANCE DECREASED (is frustrated) and HYPERSENSITIVITY (some sort of allergic reaction) outcome was unknown. No concomitant medications were reported. Patient had other OTC medications for treatment.Two weeks after  the booster patient started to experience what he believe to be some sort of allergic reaction. Patient was  affected by these symptoms for roughly 50% of the day and at night the burning sensation gets worse. During the day it was  not so bad but during the night it was bad. On 13 Jan 2021,patient went to specialist and did some sort of scratch test.
Redness cover 4-5 inches around. No problem in the past. Patient is getting better.
Flushing 10 minutes after vaccine, rash and feeling of throat swelling 20 minutes after vaccine. Called primary care doctor and was advised to go to the ER.  ER administered prednisone and Benadryl. Released after 3 hours of observation.
No adverse event; Received  0.25ml  instead of 0.5ml for bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 15-Sep-2022, the patient experienced UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose).    No concomitant medications were reported. The age of patient was more than 18 years. The patient had received 2 primary and 2 monovalent booster of Moderna COVID-19 Vaccine. No treatment medications were reported.  This case contains information for the 2nd of 7 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-648798 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648798:
delusional thinking; lost 25 pounds in less than a month; night sweats; knuckles were swollen; now it is becoming a scar; slept very little; terrible verbal memory recall; This spontaneous case was reported by a physician and describes the occurrence of DELUSION (delusional thinking), WEIGHT DECREASED (lost 25 pounds in less than a month), NIGHT SWEATS (night sweats), SWELLING (knuckles were swollen) and SCAR (now it is becoming a scar) in a 66-year-old male 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. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    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 DELUSION (delusional thinking), WEIGHT DECREASED (lost 25 pounds in less than a month), NIGHT SWEATS (night sweats), SWELLING (knuckles were swollen), SCAR (now it is becoming a scar), INSOMNIA (slept very little) and MEMORY IMPAIRMENT (terrible verbal memory recall). At the time of the report, DELUSION (delusional thinking), WEIGHT DECREASED (lost 25 pounds in less than a month), NIGHT SWEATS (night sweats), SWELLING (knuckles were swollen), SCAR (now it is becoming a scar), INSOMNIA (slept very little) and MEMORY IMPAIRMENT (terrible verbal memory recall) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
After 15 min, pt stated her breathing was not quite normal and she broke out in hives 25 mg Benadryl administered
pediatric dose was given to an adult; pediatric dose was given to an adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 46-year-old female patient who received HBV (Engerix B pediatric) (batch number 97KT7, expiry date 15th March 2024) for prophylaxis.   On 15th November 2022, the patient received Engerix B pediatric. On 15th November 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: health care professional (HCP) called and stated that a pediatric dose was given to an adult patient.  Adverse event (AE) filed. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the adult patient received Engerix B pediatric dose, which led to underdose and adult use of a child product.
Immunization injection, 3 days later pt had swelling and redness at the site, went to the ER, diagnosed with cellulitis, given oral antibiotic treatment and sent home
I became dizzy and nauseous about an hour following the shot and developed a headache about the same time.   On the second day, I developed a fever which reached 102.1 F twenty-eight hours after the shot.  My temperature decreased to 100 F by the evening of the same day and was normal by the next morning.    The dizziness, headache and nausea continued for a total of four days, and I felt tired throughout that period.
Client received a booster dose of Pfizer even though they are only 17 years old.
Rotateq (rotavirus) vaccine given vinitial dose at 19 weeeks of age, after the recommended start age of 15 weeks, by mistake. No physical reaction to infant according to parent when nurse checked back on day after and 4 days after vaccine administration. When error reported to mother of child. No adverse reaction reported by parent as of 04/06/09.
local reaction 2x2 cm swelling, redness & hematoma on left upper thigh for 7 days  Treatment - cold compress
Partial seizures (repetitive head turning), progressed to grand mal seizure 12/11/2014, 12/14/2014, 1/10/2015, 1/21/2015, 6/4/2015. DILANTIN effective to control, switch to KEPPRA not effective, addition of VIMPAT effective to control seizures. Missed dose 6/4/2015 caused seizure.
5/21/06 Local redness 6cm with warmth and pain x02 days with swelling T 36 to Emergency dept TX with PO antibiotics for cellulitis mild, right arm deltoid
On 02/14/2002, vaccinee's mother reported that the child has rash. Sys some on back which looked like chicken pox, but others are around ankles and back of legs. Says looks more like an allergic rash. Varicella vaccine was given on 01/15/2002. Advised mother to phone her doctor. Mother syas the rash itches.
Patient called back the evening of the shot and said his arm was swollen, hard itched, and a rash was forming around the site of the injection.  Said it was unusual enough that he felt it should be reported.
Fever and chills. Headache. Fever and headache only lasted the day after the shot was taken.  Large redness on left arm, with swelling and aching. Redness appeared 2 days after vaccine was taken and has not disappeared yet (has been swollen for more than 24hours already)
Redness, swelling, itching - Dr ordered BENADRYL & TYLENOL/f/up as needed w/office.
I developed pain on the left side of my face followed by a rash on my left side of face.
Low grade fever,  chills, extreme body aches,  nausea, tiredness, dizziness