chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 1/28/03, school doctor gave HBV to pt. Pt immediately felt faint, dizzy and couldn't stand up. After 40 mins, pt began to wheeze as a result of asthma condition. Pt was taken to ER where physician's diagnosis was adverse drug reaction and pt is hospitalized. This case was received on 1/25/03. This case was reported by school health on 1/24/03. The index is a 15 year old male who had an adverse reaction to HBV. T/C to mother of index 1/25/03 3:30pm. As per mother, index had taken HBV on 1/23/03 at school. As per mother, she was not aware that index would be given HBV. Index had refused the vaccine, but doctor forced him to take it. Index had no adverse reaction to a vaccine prior. Pre-existing condition is asthma. Given asthma medication and nebulizer. On 1/23/03, index was taken to the ER. As per school health, the ER physician's working diagnosis was adverse drug reaction. The child had an altered mental status, rigidity and a slightly elevated temp. Index was hyperreflexic and had a flat affect. He had been shaking, but this had improved. He was unable to move freely. As of 1/24/03 in the evening, index was still in ER. Index had improved some and was able to speak slightly with his family (some words, no complex sentences or thoughts) and index was more alert and coherent, his tone had improved some, and he had some agitation. School health spoke with the resident on the floor, who reported that index had regressed somewhat-index was non-verbal, index's tone had some rigidity and index was more agitated/combative. Index's head CT was normal (preliminary reading), electrolytes and LFT's normal and urine tox (-). Psych is not seeing child. 1/27/03 T/C to school nurse 9AM. Index took previous dose of HBV on 7/31/01. Stated that index's mother signed a consent form for the HBV on 12/30/03 and index brought his immunization card to school on 1/16/03. Stated that after index received HBV, index felt faint, dizzy and couldn't stand up. Index's BP, which was normal, then took BP again in 20 mins, and it was normal. 60 Day follow up states pt has not recovered. As of 07/01/2003, vaccine recipient is under the care of a psychiatrist. Father states that vaccine recipient is doing better, but that he is nervous and shakes. Mother stated that vaccine recipient will see psychiatrist in another two weeks. As of 5/25/2004, according to father, vaccine recipient is under the continuous care of a psychiatrist. Father states that vaccine recipient is taking medication for asthma and other symptoms of vaers. Father says that when vaccine recipient does not take medication, he can't talk and gets angry with memories of having taken vaccine. Mother stated that vaccine recipient is seeing a physician on a regular basis and is doing a little better but is still experiencing some problems.
Patient was tired after his first vaccine/lasted for one day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Patient was tired after his first vaccine/lasted for one day) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced FATIGUE (Patient was tired after his first vaccine/lasted for one day). On 05-Jun-2021, FATIGUE (Patient was tired after his first vaccine/lasted for one day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Contact dermatitis. at site of shot, which has progressed to the entire left side of arm and torso
2-3 days after the vaccine patient broke out in shingles on right arm (same as vaccination site) from shoulder to right thumb
Patient was administered the vaccine after the beyond use date, which was 8/15/2022. There was no symptoms or adverse reactions, however the vaccine was administered 12 days after its beyond use date.
Left supraclavicular and left anterior cervical lymphadenopathy mildly tender and mobile. Started 6 days after vaccine to the left deltoid and persisting
High grade fever 104.2 degrees first night, started at 2230 hrs with extreme chills, felt freezing, then fever started around 2 AM. Fever lasted till mid afternoon,  then subsided to low grade fever. During high and low fever duration, extreme fatigue and headache. Symptoms subsided by third day, however fatigue and headache and still consistent as of reporting time of 10/22/2021 3pm
Per patient (trauma nurse practitioner),  injection was placed too high and  closer to shoulder joint than in my deltoid. About 3 hours after the vaccine, patient developed  intense pain in  left shoulder. 24 hours later, patient could not abduct left arm above head without excruciating pain in left shoulder. Three weeks later, patient still experiencing constant mild pain in left shoulder that intensifies with use. She also reports waking up every night from pain in my left shoulder that radiates behind my scapula and down  deltoid. Before the vaccine, she never had left shoulder pain.
Right knee swelling and pain, mass behind right knee 48 hours following receipt of AVA #1 on 2/1/2008.  Symptom: Joint Pain, Isolated.  Start: 02/03/2008.  End: 02/22/2008.  Comment: right knee.  Symptom: Swelling.  Start: 02/03/2008.  End: 02/22/2008.  Comment: right knee.  Symptom: Cyst.  Start: 02/03/2008.  Comment: cystic mass posterior right knee
I had heavy menstrual bleeding (2-3 pads/day) when I supposed to not have a menstrual period as I am on birth control pills taking it to prevent recurrence of Endometrial Cyst. I am taking birth control pills all the 3 rows continuously and start a new pack in order to not have a menstrual period continuously. That is the advise of my OB-Gynecologist and I have been doing it ever since I gave birth 5-25-19 to my first son. This is the first time I had menstrual bleeding and it lasted until now same intensity and its been 3 weeks now. It's very alarming and wanted to have a resolution for this.
This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. On an unknown date the, unspecified number of patients were vaccinated with GARDASIL (dose, frequency and lot # were not reported) which were improperly stored. No adverse events were reported. No product quality complaint was reported GARDASIL. This case is linked to case # 1501USA007447 (same reporter link). Additional information has been requested.
pt c/o redness, swelling & pain @ inj site ;pt states swelling/redness is increasing every day;
TOOK SECOND DOSE ON DAY 4; This spontaneous case report was received from a pharmacist (PVX2019-055) on 07-Jan-2019. The report describes a consumer who "took second dose on day 4". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took the first dose of Vivotif on 04-Jan-2019 and the second dose on 07-Jan-2019 instead of 06-Jan-2019.  The action taken with Vivotif with respect to the event "took second dose on day 4" was not applicable.  The clinical outcome of the event "took second dose on day 4" was unknown.  Company's Comment: The causality of the event "took second dose on day 4" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose on day 4" was considered as not applicable.
p/vax 3.5 x 1.5cm defect in lt thigh w/complete loss of subcutaneous fat;sent to plastic surgery;
AFTER 5-10 IMUTES AFTER RECEIVING THE VACCINES PATIENTS BOTH CHEEKS WERE REDDISH  ACCOMPANY WITH WHITE RASHED .  THE IRRITATION SLOWLY DECREASE. SHE RECEIVE 5 ML OF BENADRYL., THEN SHE WAS FEELING MUCH BETTER AND NO MORE RASHED OR REDNESS
Three days after vaccination patient developed diarrhea and it has continued for a few days. Patient reports no fever or chills. Patient said he has experienced lack of energy and loss of appetite.
Allergy issues; Eyes are swollen; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergy issues) and EYE SWELLING (Eyes are swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergy issues) and EYE SWELLING (Eyes are swollen). At the time of the report, HYPERSENSITIVITY (Allergy issues) and EYE SWELLING (Eyes are swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
They diagnosed the hives as shingles (which I've never had before) and provided anti-viral prescription.; They diagnosed the hives as shingles (which I've never had before) and provided anti-viral prescription.; Headache; Sore neck; Chills; slight fever; This is a spontaneous report from a contactable consumer (reporting for himself). A 40-year-old male patient received first dose of bnt162b2 (COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 17Mar2021 at 13:00 (Batch/Lot Number: EN6206) as single dose for COVID-19 immunization. The patient's medical history included Known allergies: Penicillin. The patient's concomitant medications were not reported. On 19Mar2021 at 03:00, the patient experienced headache, sore neck, chills, slight fever. Friday evening, the patient noticed hives. The patient went to the emergency room (ER) Saturday morning at 3 AM, to be sure hives were not concerning. They diagnosed the hives as shingles (which the patient never had before) and provided anti-viral prescription, Valtrex 1000 mg 3 times per day for 7 days. The outcome of the events was recovering. The patient did not had COVID-19 prior to vaccination and was not tested post vaccination.
right ankle joint so much in pain; couldn't walk for 24 hours; elbow pain; neck pain on the left side; wrist pain; severe pain in his left shoulder; fingers pain; pain left cervical; severe pain in his left arm; weakness left cervica; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRALGIA (right ankle joint so much in pain), GAIT DISTURBANCE (couldn't walk for 24 hours), ARTHRALGIA (elbow pain), NECK PAIN (neck pain on the left side) and ARTHRALGIA (wrist pain) in a 56-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.     Concurrent medical conditions included Blood pressure high.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced ARTHRALGIA (right ankle joint so much in pain), GAIT DISTURBANCE (couldn't walk for 24 hours), ARTHRALGIA (elbow pain), NECK PAIN (neck pain on the left side), ARTHRALGIA (wrist pain), ARTHRALGIA (severe pain in his left shoulder), PAIN IN EXTREMITY (fingers pain), NECK PAIN (pain left cervical), PAIN IN EXTREMITY (severe pain in his left arm) and ASTHENIA (weakness left cervica). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (right ankle joint so much in pain), GAIT DISTURBANCE (couldn't walk for 24 hours), ARTHRALGIA (elbow pain), NECK PAIN (neck pain on the left side), ARTHRALGIA (wrist pain), ARTHRALGIA (severe pain in his left shoulder), PAIN IN EXTREMITY (fingers pain), NECK PAIN (pain left cervical), PAIN IN EXTREMITY (severe pain in his left arm) and ASTHENIA (weakness left cervica) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided
Large oval shaped itchy rash on left shoulder that showed up on 2/1/21 and mostly gone by 2/3/21, although a vestige remains as of this submission
Several hours after injection arm became sore at injection site, approximately 24 hours after receiving vaccine I had sharp pain radiating from left shoulder to left elbow. Several hours later pain progressed, became numb, 01/03/2021 I went to urgent care to seek medical attention for pain and numbness. I was given toridol for pain relief. 01/04/2021 I contacted chiropractor and was seen from 01/04-01/08/2021 with no relief. On 01/11/2021 contacted PCP Dr. and was seen on 01/12/2021 and prescribed Gabapentin, at this time there has been no relief of pain from shoulder to wrist and numbness.
21AUG95 soreness-redness & swelling started 23AUG95; inc size to size of golf ball hard & red & hot to touch
Extremely Swollen eye on right side of Body. Pain on right buttocks and back of leg. All over achy. Stuffy and flu like symptoms
This spontaneous report as received from a medical assistant refers to a 18 year old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 29-NOV-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 with lot number M028323 and expiration date of 26-SEP-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168:Original Case : 1701USA004150; US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: patient was administered vaccine, was feeling well and walked to waiting area. patient \"lost balance\" and fell to floor, hitting his face and began bleeding from his nose and upper brow area. Technician retrieved an ice pack from pharmacy, and in the meantime, worker aided patient to sitting position, which was when patient began to seize. worker called EMS while holding patient's head steady. Patient regained consciousness and EMS arrived. Whole event lasted around 5 minutes.
calling in regards to expired pentacel/therapy date: 21Jun2022 with no other reported adverse event; Initial information received on 22-Jun-2022 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves a 2 years old male patient who was administered expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] with no other reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation.  On 21-Jun-2022, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (lot number: UJ425AAA, expiry date: 21-May-2022; formulation, strength and route not reported) for immunization.  On 21-JUN-2022 the patient was administered expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] with no other reported (expired product administered).   Action taken was not applicable.  Outcome: Unknown   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.
24 hr post-vaccination noted to have tense swelling, redness, warmth of entire upper arm (left). Tx w/ cool compresses, benadryl see at 48 hrs with raised pale central papule at injection site, all but posterior upper arm pink, moderate swelling, non-tender. Zyrtec cleared 24hr. Local questionable urticarial.
Pt occurred over night. Received DTaP #5 on left arm (IM). Woke up with swelling and hot to the touch.
Cramps, ache joins and muscles, anxiety, acne loss of concentration, depression, fatigue, rectal bleeding thinking abnormality, somnolence, vision blurred etc..
Nausea, headache,  fever, chills. Injection site pain (which moved to my underarm area) body aches, fatigue
10Mar07 bruise-like skin discolorations began to appear. She had them on her shoulder, forearm, breast and thigh.  They were not painful.  She had no temperature but was extremely tired.
Information has been received from a medical assistant concerning a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On a unspecified date, the patient was vaccinated with a dose of improperly stored M-M-R II lot # M045401and expiration date of 14-NOV-2018, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 9 Celsius degrees to 25 Celcius degrees (10.7 Celcius degrees) for 50 minutes. No previous temperature excursion was reported.  No adverse effects were reported. No digital data logger was involved.
extremely sick from shingles shots; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient got extremely sick from the shingles shots, both of them.but glad I got them. The follow up would not possible as no contact information was available. for tolerance of second dose refer linked case US2021AMR230977, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR230977:second dose, same reporter
Chills; Body ache; Fever; Headache; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (batch/lot number was EL1284, expiration date was unknown) via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Jan2021, patient was fine and then today (on 13Jan2021), this morning, patient had the symptoms of having the chills, body ache, fever and headache. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient reporting chills, mild fever, lethargy, low blood pressure, rash/hives on arm, feeling faint, dizziness
- left eye aura & partial blindness - blood pressure became erratic - dizziness & unsteady gait - headache on right side - body rash on hands & neck
She fainted about 3 minutes after the injection. She was sitting on the couch in the vaccine office and then collapsed/fell onto the floor. She was only on the floor for a second before her sister picked her up from off the floor and sat her back onto the couch. She looked pale and a little confused, but was able to answer questions from her mother. She stayed sitting on the couch for about another 10 minutes before she was taken out of the room by her mother under her own power. She seemed weepy and crying the rest of the night per her mother and "did not seem like herself. The next morning she was normal and "back to herself" per her mother and has not noticed anything out of the ordinary since then.
Zaria receied 5 injections 12/18/2006 and had reactions associated with IPC. There was a dime sized selling on her (L) arm with redness as reported by mother. Child was fussy, mom took child to Primary Provider 12/24/2006. Zaria was started on Amoxcillin for 6 days after the shots. Broght child toHD 1/4/2007 with mom's FP visit to let nurse look at arm. Arm still swollen red-child did not cry when arm touched. Mother instructed by nurse not to receive shots in arm.
No adverse effects; administered improperly stored doses of VARIVAX; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 31-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034392, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of -11.4 degrees Celsius (C) for 9 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA001815: US-009507513-1906USA001214:
Case number PHEH2011US04184 is an initial spontaneous report received from a consumer on 14 Sep 2011: This report refers to a male patient of unknown age group. He was given a "flu" shot (manufacturer and batch number; unknown) about ten years ago on an unspecified date. He stated that the flu shot had "about killed him". Since two weeks after vaccination, he became a weakling and now he could not see, could not balance and was worthless to everybody. He weighed 200 pounds at the time of vaccination and now he weighed 150 pounds. No further information was provided.
1 week after, the injection site is now hot to the touch, bright reddish/dark reddish, itchy,  and achy/still some residual soreness in the area. I hadn?t noticed it all week besides for the immediate 1-2 days post injection so it is odd that it just started happening today and the only location on my body is at the injection site.