chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He had experienced no adverse events following receipt of his 1st injection of Engerix-B. On 8/14/02, the subject received his 2nd injection of Engerix-B (lot 5305B6). A "few" hours later, he complained of nausea and numbness in the arm. He was found to have a fever of 102F and decreased blood pressure (84/60mmHg). He was treated in the infirmary with unspecified IV fluids, Tylenol for fever and Vistaril for nausea. The subject spent the night in the infirmary and was discharged in the AM of 8/15/02. At that time, his temperature was 97.8F, his blood pressure was 120/80mmHg and he had no redness or soreness at the injection site. As of 8/15/02, the events had resolved. The Engerix-B immunization series was discontinued. The nurse mentioned that the subject ran every day and he did run on 8/14/02. The reporting nurse stated that the events were not related to Engerix-B administration. She said that the weather in her locale was very hot and humid on 8/14/02 and questioned whether the subject's running might have caused these events.
Patient stated within 24 hours throat felt tight, sore and she became hoarse. Patient also stated she felt nauseated, body aches and had a low-grade fever. Within the first 5 days, she also experienced nasal congestion and swollen lymph nodes under arms. She continues to have nasal congestion and swollen lymph nodes. Took OTC Benadryl, Motrin, Advil and Aleve.
Patient arm bleed more that usual for her (reported by patient) and a knot appeared under the skin.
This case was reported by a healthcare professional and described the occurrence of hepatitis b antigen positive in a 59-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On 5 April 2011, 6 January 2011, 2 December 2010 and 4 November 2010 the subject received 4th dose, 3rd dose, 2nd dose and 1st dose of ENGERIX B at 40 mcg, intramuscularly, 20 mcg in each arm. On 26 may 2011, 51 days after vaccination with the 4th dose of ENGERIX B, the subject experienced had a positive Hepatitis B Titer on a lab test. The subject was positive for hepatitis B antigen. This was considered to be vaccination failure. At the time of reporting the outcome of the events was unspecified.
Vomited the first dose of Vivotif; Spontaneous report received on 16DEC2019.  A nurse reported that a 16-year-old female consumer "vomited the first dose of Vivotif" (PT: Vomiting), following immunisation with Vivotif (lot number: 3003297). On 12DEC219, the consumer took first dose of Vivotif that had been thrown up. It was reported that the nurse had given another dose from a new pack of Vivotif so that she could complete four doses. She had not vomited again after the first dose. Action taken with Vivotif with respect to reported event was none. On 12DEC2019, the event was resolved.  Company Comment: A consumer vomited the first dose of Vivotif (Vomiting). In response to the event, the consumer took another dose from a new pack of Vivotif so that she could complete four doses. The consumer did not vomit after taking the dose from a new pack. The causality of the event is assessed as possible due to the potential of Vivotif to cause vomiting.; Sender's Comments: A consumer vomited the first dose of Vivotif (Vomiting). In response to the event, the consumer took another dose from a new pack of Vivotif so that she could complete four doses. The consumer did not vomit after taking the dose from a new pack. The causality of the event is assessed as possible due to the potential of Vivotif to cause vomiting.
Muscle pain in left arm, chest and left back at shoulder blade.  Tingling in left arm.  Started on 8/19/2021 and continues, as of 8/25/2021.  Had ultrasound and EKG, both negative.
HEADACHE EYE PAIN--PHOTOSENSITIVITY PAIN/SWELLING/REDDNESS AT INJECTION SITE GRADE 3 FATIGUE,GRADE 3
Patient reported muscle pain/soreness in the arm he got flu shot in. He reported taking Tylenol to alleviate the pain, but that did not help. He did not tell us until 10/26/2015. Patient Primary MD started him on cephalexin on Friday to help alleviate the pain. I left MD a voicemail for pain prescription medication recommendation.
swelling and redness at the injection site; swelling and redness at the injection site; Nausea; overall flu-like symptoms; This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site swelling, injection site erythema, nausea and flu like symptoms. On an unknown date, the outcome of the injection site swelling, injection site erythema, nausea and flu like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, nausea and flu like symptoms to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's comment: The duration for events injection site swelling, injection site erythema, nausea and influenza like illness was reported as 3 days. Patient experienced swelling and redness at the injection site, nausea, and overall flu-like symptoms. Also reported all symptoms lasted approximately 3 days. The consent to follow up was given.
vaccine was administered to patient, and patient immediately fainted. Her head drooped, and she was not conscious. The technician who administered the vaccine caught the patient so she didn't fall out of the chair. The pharmacist on duty was alerted, and 911 was called. The pharmacist ran out to the patient to check vitals. Patient was already conscious again, but looked pale and weak. Pharmacist and technician stayed with patient to make sure she did not pass out again. EMT arrived shortly after call and took over the situation. Patients blood pressure was taken, and was very low 80/50 for several minutes. EMT stayed and monitored patient until she regained normal vials, and sent patient home with her mother so did not have to drive.
Reactions appearing ~12 hours later and lasting more than 48 hours (currently on day 7). Days 1-6: Severe body aches, headache, fatigue, and low grade fever (100.2 at highest). Day 2 only: Severe diarrhea with the above reactions Days 5-6 only: Unusual brain fog with the above reactions (forgetting thoughts in mid-sentence; short-term memory issues; lack of focus). Day 7 (today): Headache, Fatigue, with low grade fever in afternoon. Will call medical provider if symptoms persist or worsen.
After receiving his pneumonia shot (PPv23) patient arrived at the pharmacy on the next day in the morning to report that he could not move his left arm.
rash on arms, legs, neck, back 1 day p/vax;rash is still present on legs, neck, back, arms @ the time of observation 5/3/99;skin marking dark where rash appeared;
Pt has felt sick since getting the Flu shot. Body aches, night time cough, runny nose, fatigue, poor appetite, sweats, swelling at the site of injection, pain and bruising.
pt recvd vax; 2-3 hrs p/ dose 3, exp muscle ache & lt shoulder pain;unresolved;
The patient received first dose in the gluteal region; Case reference number US-BN-2021-002476 is a spontaneous case report initially received from a health care professional via Agency (reference number: USBAV21-0597) on 29-Nov-2021 and concerns an adult male patient.  The patient's medical history was not provided.  The patient's concomitant medication included HRIG (human rabies immunoglobulin)  On 27-Nov-2021 the patient was vaccinated with first dose of Rabavert (inactivated rabies virus vaccine; batch number: not provided) at a dose reported as one vaccine per dose in the gluteal region (explicitly coded as 'Vaccine administered at inappropriate site'), for post exposure immunization due to possible bat bite.   On 27-Nov -2021 the patient was vaccinated with second dose of Rabavert (inactivated rabies virus vaccine; batch number: not provided) at a dose reported as one vaccine per dose via in the deltoid region, for post exposure immunization due to possible bat bite.   The reporter assessed 'Vaccine administered at inappropriate site' as not related to Rabavert but as administration error.   The reporter considered 'Vaccine administered at inappropriate site' as serious life threatening (potentially, due to maladministration).  At the time of the report, it was unknown if the patient experienced any adverse event due to Rabevert.   Additional information received from regulatory authority on 30-Nov-2021: Added local RA case id.  No further information was provided.; Reporter's Comments: The 24-year-old male patient was vaccinated with first dose of Rabavert in the gluteal region for post exposure immunization due to possible bat bite, which is considered as product administered at inappropriate site, and with the second dose of Rabavert in the deltoid region. No associated adverse events have been reported with the reported medication error. The product administered at inappropriate site is considered as listed per convention. The patient's medical history was not provided, and concomitant medication included HRIG (human rabies immunoglobulin). The product administered at inappropriate site has been considered as not related to Rabavert, but to a human action. This case is considered as serious due to life-threatening criteria.; Sender's Comments: The 24-year-old male patient was vaccinated with first dose of Rabavert in the gluteal region for post exposure immunization due to possible bat bite, which is considered as product administered at inappropriate site, and with the second dose of Rabavert in the deltoid region. No associated adverse events have been reported with the reported medication error. The product administered at inappropriate site is considered as listed per convention. The patient's medical history was not provided, and concomitant medication included HRIG (human rabies immunoglobulin). The product administered at inappropriate site has been considered as not related to Rabavert, but to a human action. This case is considered as serious due to life- threatening criteria.
A bad welt on the arm; Rash all over the top of the arm; Extreme headaches both times; Temperature elevation; Could not eat; Was sleeping a lot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (A bad welt on the arm), RASH (Rash all over the top of the arm), HEADACHE (Extreme headaches both times), BODY TEMPERATURE INCREASED (Temperature elevation) and EATING DISORDER (Could not eat) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tachycardia. Concomitant products included ATENOLOL for Tachycardia.    On 10-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 URTICARIA (A bad welt on the arm), RASH (Rash all over the top of the arm), HEADACHE (Extreme headaches both times), BODY TEMPERATURE INCREASED (Temperature elevation), EATING DISORDER (Could not eat) and SOMNOLENCE (Was sleeping a lot). At the time of the report, URTICARIA (A bad welt on the arm), RASH (Rash all over the top of the arm), HEADACHE (Extreme headaches both times), BODY TEMPERATURE INCREASED (Temperature elevation), EATING DISORDER (Could not eat) and SOMNOLENCE (Was sleeping a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Atenolol for tachycardia. Treatment medications were not reported.   This case was linked to MOD-2021-314916 (Patient Link).
Within about twelve hours, I started noticing hyper sensitivity to my nerves.  Later that evening when I went to sleep and set my AC as normal,  I woke up shivering incredibly hard, and had to turn up the temperature three degrees before I was not shaking HARD.    I see a chiropractor every other day.   I could feel my joint dislocations MUCH more intensely.   My teeth were incredibly sensitive.   My muscles that were recovering from working out were in much more recovery pain than they have ever been.     The first two days were pretty intense.  I used tylenol to calm them down, but still noticed my nerves felt not sensitive, but the feeling I was getting was much more intense.   I wasn't feeling things I shouldn't, I was feeling what I expected at what seemed like a multiple of about three.    It reduced slowly over the course of a week.   After a week, I still feel like it is slightly heightened.      My first shot had similar affect, but not as bad.  I want to say it lasted 3-4 days the first time.
Pain in the arm a t the injection site, now having shoulder pain. woke up with headache and dizziness.
muscle spasms; severe nausea; chills; exhaustion; Sick as dogs; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick as dogs), MUSCLE SPASMS (muscle spasms), NAUSEA (severe nausea), CHILLS (chills) and FATIGUE (exhaustion) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026a21a and 031M20A) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia. Concurrent medical conditions included Cholesterol, Drug allergy (sulfa drugs, dilaudid, erythromycin, tobramycin) and Bee sting. Concomitant products included CEFIXIME (FLEXERIL [CEFIXIME]), LISINOPRIL, OMEPRAZOLE, LOVASTATIN, UBIDECARENONE (COQ10 [UBIDECARENONE]), CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE + D3) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ILLNESS (Sick as dogs). On 13-Mar-2021, the patient experienced MUSCLE SPASMS (muscle spasms), NAUSEA (severe nausea), CHILLS (chills) and FATIGUE (exhaustion). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 13-Mar-2021 for Adverse event, at a dose of 1 dosage form. On 13-Mar-2021 at 3:00 PM, NAUSEA (severe nausea) had resolved. On 17-Mar-2021, MUSCLE SPASMS (muscle spasms) and FATIGUE (exhaustion) had resolved. At the time of the report, ILLNESS (Sick as dogs) and CHILLS (chills) had resolved.            Concomitant medications also included blood pressure meds, muscle relaxer and cholesterol meds.   This case was linked to MOD-2021-117025, MOD-2021-117025 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Reporter information updated and outcome of the event illness was updated from unknown to recovered. On 08-May-2021: NNI On 10-May-2021: Added concomitant drugs, medical history, allergies and 4 new events. On 08-Jun-2021: NNI On 09-Jun-2021: NNI
10 minutes after vaccination she developed mid-sternal chest tightness.  No other allergic symptoms or SOB
Inflamed lymph nodes in armpit area, pain and redness at injection site, body aches.
Hot, sore - by the next day headache. Onset of body pain, joint pain, nausea, vomiting, diarrhea.  RUQ pain - felt like gallbladder dysfunction.  GB dysfunction is being ruled out - fatigue, concentration deficit, myalgia, numbness and tingling.
Malaise; Low energy level; Tenderness around right armpit of upperarm, chest and in armpit; Stiffness, shoulder stiff; muscular and joint ache and pains, Knee soreness; Muscular aches and pains, soreness in arm and shoulder; Intestinal distress; Drowsiness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (muscular and joint ache and pains, Knee soreness), MYALGIA (Muscular aches and pains, soreness in arm and shoulder), SOMNOLENCE (Drowsiness), ABDOMINAL DISCOMFORT (Intestinal distress) and MALAISE (Malaise) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B214 and 081L2014) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product COFFEA ARABICA, PHOSPHATIDYL SERINE (NEURIVA BRAIN PERFORMANCE) for an unknown indication.    The patient's past medical history included COVID-19. Concomitant products included FLUOXETINE for Anxiety, ROSUVASTATIN CALCIUM (CRESTOR), ROSUVASTATIN, MULTIVITAMIN [VITAMINS NOS], VITAMIN D3 and CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.   In 2020, the patient started COFFEA ARABICA, PHOSPHATIDYL SERINE (NEURIVA BRAIN PERFORMANCE) (unknown route) 1 dosage form. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced SOMNOLENCE (Drowsiness). On 03-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Intestinal distress). On 05-Apr-2021, the patient experienced ARTHRALGIA (muscular and joint ache and pains, Knee soreness) and MYALGIA (Muscular aches and pains, soreness in arm and shoulder). On 24-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness, shoulder stiff). On an unknown date, the patient experienced MALAISE (Malaise), ASTHENIA (Low energy level) and TENDERNESS (Tenderness around right armpit of upperarm, chest and in armpit). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (muscular and joint ache and pains, Knee soreness), MYALGIA (Muscular aches and pains, soreness in arm and shoulder), SOMNOLENCE (Drowsiness), ABDOMINAL DISCOMFORT (Intestinal distress), MALAISE (Malaise), ASTHENIA (Low energy level), MUSCULOSKELETAL STIFFNESS (Stiffness, shoulder stiff) and TENDERNESS (Tenderness around right armpit of upperarm, chest and in armpit) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: significant follow up
Patient states that at 8 pm the evening after receiving his second dose of SHINGRIX, he immediately felt intense flu like symptoms. He suffered with body aches, nausea, insomnia, arm tenderness. Day 2, patient said that he remained in bed as he had no energy or appetite and drank Powerade and Pedialyte. He reported that he was feverish, had light and sound sensitivity, which would send waves of pain throughout his body, dizziness, uncontrollable body aches and was smelling something metallic. He couldn't bend over because of pounding in his head. He eventually began to walk a little later in the day. On Day 3, he began to feel better but was not back to 100%. He was no longer shivering uncontrollably, no pounding headache. He added that at the injection site, he could not lift his arm above his head until today which limited performance of normal/daily tasks. He said that he has a red rectangular whelp that is approximately 3 x 3.5 inches in size.
pt recvd vax; exp febrile sz which caused foaming at mouth & eyes to roll back in head; lost consciousness during sz & taken to er & was hosp;was 2 1/2 yrs old at time of report, could not speak & was in speech therapy;
Approximately 10 minutes after injection, felt an unusual sensation up my right arm, neck, into left ear. While driving home my face became warm, after arriving home face/cheeks extremely red/flushed.  Have a picture taken at 3:54 for documentation. Not sure if from anxiety, but felt jaw tightness and a thick tongue.  No itching, swallowing problems etc.   lasted approximately 15 minutes. By 4:57 pm redness had faded.   Picture documentation. 9:15 pm had right ear pain and mild reddened of right cheek.   Picture documentation.
Patient admitted 8/29/21 for generalized weakness and debility.Patient was negative for COVID on admission. Patient's ill wife was visiting patient. Patient documented to be COVID positive 9/10/21. Patient is currently still admitted for treatment at the time of this report.
The following day after I got the shot I felt like I fell off a mountaintop. My whole body was in pain. I lost my sense of taste and smell. I was so sick that I missed two days of work. After returning to work, I had to go to the hospital due to a horrible sore throat. The doctor said I was reacting to the vaccine. The doctor gave me a pain relief medication. It subsided the pain and after a while I returned to normal.
neck,arms, bone pain; arm pain; pain in bone; feeling unwell; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received Shingrix. On 15th May 2019, less than a day after receiving Shingrix, the patient experienced neck pain, pain in arm, bone pain and feeling unwell. On 16th May 2019, the outcome of the neck pain, pain in arm, bone pain and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the neck pain, pain in arm, bone pain and feeling unwell to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The reporter stated that, her husband also had a Shingrix injection in left deltoid and the patient reported feeling the fluid go into his arm during the injection and that the day following the injection, he reported that his neck, arms, and bones were hurt and that he did not feel 100%. These events did not stop the patient from doing things. The day after that, the patient felt better. The reporter did not consent to follow-up. A call back was done to the consumer to obtain physician's information but no one answered.
OXIDISED LOW DENSITY LIPOPROTEIN ABOVE 2500; This spontaneous report received from a parent concerned a 23 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced oxidised low density lipoprotein above 2500. Laboratory data included: Blood test (NR: 10 - 170) Oxidized Low Density Lipoprotein Above 2500. The action taken with covid-19 vaccine was not applicable. The outcome of oxidised low density lipoprotein above 2500 was not reported. This report was non-serious. This case, from the same reporter is linked to 20210601462 and 20210601430.