chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Moderna Covid-19 vaccine (lot number 013L20A and expiration date is not known (right arm).) on 21-Jan-2021, Moderna Covid-19 vaccine (lot number 016M20A expiration date is not known (right arm).) on 20-Feb-2021, Moderna Covid-19 vaccine (lot number 035C21A expiration date is not known (right arm).) on 29-Oct-2021, Moderna Covid-19 vaccine (lot number 056M21A expiration date is not known (right arm).) on 22-Apr-2022 and Moderna Covid-19 vaccine (lot number A57144B expiration date is not known (right arm).) on 12-Sep-2022. Past adverse reactions to the above products included No adverse reaction with Moderna Covid-19 vaccine, Moderna Covid-19 vaccine, Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2023, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The patient had not yet had the most recent Moderna Covid-19 Spikevax vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-746555 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746555:wife case
Phantom smell of cigarette smoke, started 2 days after my shot off and on.  It keeps increasing in frequency and duration.  I?ve had symptoms for 10 days now.
Information has been received from a consumer concerning her 12 month old daughter with no pertinent medical history or drug reactions or allergies who in December 2008, was vaccinated SC with the first 0.5 ml dose of MMR II. There was no concomitant medication. In December 2008, "one week after the vaccination", the patient had "the standard reaction, just more extreme". It was reported that the patient had "crusty eyes that wouldn't open, she produce a lot of yellow mucus, she was really itchy and had a fever of 104 degrees". In December 2008, "3 weeks after the vaccination", the patient had recovered. No lab tests were done. Unspecified medical attention was sought. No further information is available.
1/5/21:  Developed redness and warmth around vaccine site 1/7/21: Began treatment with clindamycin 300 mg TID x 7 days
Mom called stating 24 hrs p/immun pt cried constantly for @ least 3 hrs; started @ 4-5 PM on 15AUG91 until 11PM on same date; Took pt for ride in car & pt fell asleep; had been fussy all day mom states run no fever;
Myalgia Narrative:  day 2 and 3:Pain, Redness, Chills, Muscle or body aches, fatigue or tiredness
Severe headache, severe SI joint pain, and lower back pain. Temp 100.1 stiff neck. Took Motrin 800 mg with very little relief then Tylenol ES. Injection site hot red swollen. All the above still present.
all food and drink caused strong distaste, enough to halt all eating for 3 days leading to dehydration and weakness. Mental confusion persisting even now. Could not stand for long, had to lie down. Admitted to hospital ER on 3rd day for fluids and observation, diagnosis was "toxic metabolic encephalopathy."
loss of consciousness; slumped on the floor/going down; nausea; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (COVID 19 Pfizer), dose 2 via an unspecified route of administration, administered in right arm on 10Apr2021 13:00 (Lot Number: ER8729) as single dose for COVID-19 immunisation; and trazodone, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 50 mg for insomnia. Medical history included high blood pressure and low thyroid from an unknown date and unknown if ongoing. The patient had unspecified medication for high blood pressure and low thyroid. The patient previously received codeine and experienced allergies. The patient previously received 1st dose of BNT162B2 COVID19 Pfizer, lot = EN6207, on 16Mar2021, 06:30 pm, in the left arm for covid-19 immunization. About 36 hours after injection of 2nd dose and about six hours after taking 50mg of Trazodone for insomnia, awoke to get a drink of water. Experienced sudden onset of nausea so he didn't take the drink but went to the bathroom to urinate instead. Came to (regained consciousness) finding self slumped on the floor. No advance feeling of lightheadedness. No memory of going down. Out for an unknown period of time. Hadn't had a lot to drink after receiving the injection. No prior occurrences of loss of consciousness. Onset of events was 12Apr2021 01:00 am. Outcome of events recovered with no treatment. The patient was not diagnosed of COVID prior vaccination and has not been tested for COVID post vaccination. The action taken in response to the events for trazodone was unknown.
History of migraines years ago.  After 1st HPV she had more migraines.  Some with left eye blurriness.  Not sure if related to the vaccine.
Lower part of my arm like close to my arm pit started swelling and I cannot really move my arm; Lower part of my arm like close to my arm pit started swelling and I cannot really move my arm; Had been so close to the body since like the arm pit was swelling; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. It was reported that the day after receiving the vaccine, the patient's lower part of arm like close to the arm pit started swelling and the patient could not really move the arm or it had been so close to the body since like the arm pit was swelling and it lasted for about four days and then it came down. The patient was recovering the events.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
No additional adverse event reported; GARDASIL 9 vaccine that underwent a temperature excursion was administered to a patient; This spontaneous report as received from a Registered nurse refers to a patient of unknown age and gender .  There was no information about the patient's medical history, concurrent conditions or concomitant medication.    On 05-NOV-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) that underwent a temperature excursion , Lot number/batch number: T026234, expiration date reported as: 22-FEB-2023 is an invalid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9). Lot number: T026234 does not match any Company product as confirmed, for prophylaxis (dose, route of administration, were not reported). There was no adverse effect reported. No product quality complaint was involved.
Information has been received from a consumer concerning an 8 year old male with attention deficit/hyperactivity disorder who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy was an unspecified ADHD medication. Three days after vaccination, the patient subsequently came into contact with shingles and developed chickenpox on the trunk, about 30 pox. There was no fever. It is unknown whether medical attention was sought. Patients outcome status was unknown. No product quality complaint reported.
Initial unsolicited report received from a Consumer on 21 November 2016. This case involves a 22-year-old female patient who was vaccinated percutaneously with a first dose of ACAM2000 (Lot number-VV04003A, expiry date, dose, dose in series were unknown) in left deltoid and a dose of INFLUENZA VACCINE (Lot number, expiry date, dose, dose in series were unknown) in right deltoid on 24 October 2016. The patient's Illness at time of vaccination was reported as Stuffy nose and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none. The patient's Concomitant medications were reported as none. On 17 November 2016, 24 days following the vaccination, the patient developed raised areas around he vaccination site, also experienced a red hot area with a pus like drainage and it was below the vaccination area and there was a second site on her elbow. The patient's laboratory investigation and Corrective treatment was reported as none. The patient required emergency visit after events on an unspecified date. The patient was not recovered from the event. List of documents held by sender: none.
Patient received Rabies IM and Japanese Encephalitis IM vaccines on 28AUG and 04SEP 2015 on R arm. He reports new distal R hand tingling that has progressed up arm. Endorses gradual progression and new instrinsic R hand mild weakness.
Patient reported not being able to move her arm right arm with lots of pain this morning. It started with pain around the injection site then radiating down her neck and back starting the night she received the vaccine. Pt was unable to sleep lying down due to the pain in her arm. Took Tylenol for pain but seems to not have helped with pain. Pt says the pain is getting better from when it initially happened.
Soreness at injection site, fatigue, fever, chills, nausea, muscle pain; gave ibuprofen (2 tablets) every 6-8 hours; fever broke 6/17 AM.
Fever, treated with Tylenol Chills Body Aches Fatigue Symptoms  lasted about 24 hours
experiencing "allergies"; nose is stuffy; scratchy throat; sinus drainage; sinus infection; bad headaches; felt tired / stayed in bed off and on for two weeks / feels tired; felt like she had the flu; the injection made her sick; had weakness; had dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu), VACCINATION COMPLICATION (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness) and SINUSITIS (sinus infection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy, Hypertension, Heart disease, unspecified (with heart palpitations) and Migraine headache.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), VACCINATION COMPLICATION (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness), HEADACHE (bad headaches) and FATIGUE (felt tired / stayed in bed off and on for two weeks / feels tired). On 11-Mar-2021, the patient experienced SINUSITIS (sinus infection). On 18-Mar-2021, the patient experienced HYPERSENSITIVITY (experiencing "allergies"), NASAL CONGESTION (nose is stuffy), THROAT IRRITATION (scratchy throat) and SINUSITIS (sinus drainage). At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had the flu), VACCINATION COMPLICATION (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness), SINUSITIS (sinus infection), THROAT IRRITATION (scratchy throat), SINUSITIS (sinus drainage) and HEADACHE (bad headaches) outcome was unknown and HYPERSENSITIVITY (experiencing "allergies"), NASAL CONGESTION (nose is stuffy) and FATIGUE (felt tired / stayed in bed off and on for two weeks / feels tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported concomitant medications for her current medical conditions, not otherwise specified.  On 24-Feb-2021, the patient presented to her healthcare provider and allergy shots were administered. No additional treatment was reported for the events.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 52-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concomitant products included carvedilol, doxycycline, fluconazole, isosorbide mononitrate, lisinopril, omeprazole, COLESTID, PROTONIX and glimepiride. On 13th April 2018 20:08, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site lump (serious criteria disability), injection site pain (serious criteria disability), injection site itching (serious criteria disability), pustule (serious criteria disability), injection site erythema and injection site induration. On an unknown date, the outcome of the injection site lump, injection site pain, injection site itching, injection site erythema and injection site induration were not recovered/not resolved and the outcome of the pustule was recovered/resolved. The reporter considered the injection site lump, injection site pain, injection site itching, pustule, injection site erythema and injection site induration to be almost certainly related to SHINGRIX. Additional information was reported as follows: The pharmacist reported that, the patient came to his pharmacy one night prior to the date of reporting that is on 16th April 2018, with a hard, red lump with 6 inches in diameter on her injection site arm. The area was painful to touch and itchy. The patient stated that, a few days ago she had clear circles in that area that looked like eggs, yellow on the inside and clear on the outside, but that area is was just red at the time of reporting. The symptoms were painful enough that she could not lay on that side and she could not use her arm at full capacity. The patient has had similar reactions to various insulins in the past.
28 days (March 20th) following 1st Moderna shot which was given on Feb 23rd, felt dizzy, weak and lightheaded leading to fainting (syncope).  Ambulance arrived and determined to take me to hospital after having 2nd syncope in their presence.  Remained in hospital overnight.  All vitals, heart and bloodwork were fine as seen by cardiac doctor and  determined it was dehydration.  Followed up with primary physician and told him I was urinating excessively.  He put me on Flomax 0.4 mg.  I had the 2nd Moderna shot on March 23rd and again was taken to the hospital on March 31st with same symptoms and near syncope and again was told it was clinical dehydration.  They told me to drink a combination of pedialite and water which I have been doing and I am still experiencing the dizziness, lightheadedness and weakness.  Woke up on April 4th and felt like my soul was being ripped from my body.  I honestly thought I was going to die. Looked on line and found forums of people experiencing similar symptoms.  Went to pharmacy and they recommended meclizine and have taken a clonipin for anxiety.  I am feeling better now, but worried about how long I will be experiencing these symptons.
Pt notes that he had LE numbness (dead feeling) and heaviness 30 min after vaccination and then the Fri afterwards started to feel muscle stiffness which has resolved but he also has been having pretty steady lack of discriminatory sensation in the toes, he has intermittent periods of time where he has numbness and tingling that rapidly involves the upper body and face as well but is intermittent. these episodes last for   30 minutes. He had decreased sharp/dull in the ED in the toes, neuro was consulted and rec MRI which was normal, pt declined LP at that time, distant fam hx of MS potentially. Denies vision changes, HA, chest pain, SOB, wheezing.
Ischemic Stroke with acute left subdural hemorrhage.  I was in the ICU for 11 days where I underwent a craniotomy and evacuation of subdural hemorrhage.  Was discharged and completed occupational and speech therapy.  I was unable to return to work full time.
pregnant patient received a dose of Arexvy; inappropriate age at vaccine administration; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 36-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7942H, expiry date 02-MAR-2025) for prophylaxis.   On 27-OCT-2023, the patient received Arexvy. On 27-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: inappropriate age at vaccine administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient received a dose of Arexvy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 31-Oct-2023 The reporter noted that the patient was approximately 32 weeks along in her pregnancy.  No additional information was provided. The reporter consented to follow-up. A pregnant patient received a dose of Arexvy at an inappropriate age, which led to vaccine exposure during pregnancy and inappropriate age at vaccine administration.
Breakthrough covid case. Presented to ER on 6/18/22 with c/o of sore throat, fever, HA, cough and right ear pain. Hx of  2 doses of Moderna. DC home.
I had a sore arm for a couple of days after receiving the vaccine. In 04/2023, I went to see my doctor about swollen lymph nodes in my right-side armpit and breast. I see my gynecologist in a couple of weeks to discuss the issue.
Fatigue after COVID vaccine; Sore arm after COVID vaccine; Headache after COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue after COVID vaccine), VACCINATION SITE PAIN (Sore arm after COVID vaccine) and HEADACHE (Headache after COVID vaccine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   In June 2021, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FATIGUE (Fatigue after COVID vaccine), VACCINATION SITE PAIN (Sore arm after COVID vaccine) and HEADACHE (Headache after COVID vaccine). In 2021, FATIGUE (Fatigue after COVID vaccine) and VACCINATION SITE PAIN (Sore arm after COVID vaccine) had resolved. In October 2021, HEADACHE (Headache after COVID vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Humira found in system. It was unknown if patient was enrolled in a COVID-19 vaccine trial. No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Initial and follow-up information has been received from a 23 year old female for the pregnancy registry for GARDASIL who in APR 2007 was vaccinated with the first dose of GARDASIL. No information was received concerning the second dose of GARDASIL. In OCT 2007 the patient was vaccinated intramuscularly with the third dose of GARDASIL. The patient states that she discovered she was pregnant about 1 week after receiving the third dose of GARDASIL (LMP=23-SEP-2007). The pregnancy was confirmed with a pregnancy test. No adverse events were reported. The patient sought unspecified medical attention. On 01-AUG-2008 the patient reported that her pregnancy was fine, no complications. Per the patient, she delivered an healthy and normal boy on 03-JUL-2008 at 40 weeks 5 days by cesarean section. The patient had an elective induction with pitocin and an epidural and progressed to 8cm dilation, at which time she had developed a fever - though she wasn't sure why as there was no infection and both she and the baby had elevated heart rates and the decision for a cesarean section was made at that time. Her son weighed 8 lbs, 3.3 oz. At that time of reporting, the infant was almost one month old and doing well. The patient, reported that she was recovering well - no problems at all. Upon internal review, the patient's fever and increased heart rate and the fetal increased heart rate were considered other important medical events as the events lead to the delivery via cesarean section. Additional information has been requested.
A report has been received from a Pharmacist concerning a female. No information regarding relevant history, concomitant disease and concomitant medications were provided. It was reported that when administering the second part of the FLUMIST QUADRIVALENT (intranasal) dose in the second nostril (L) the second half-dose came completely out of the nose. No reactions were observed at the time of administration on 01-Oct-2014. The outcome of the event of second half dose of FLUMIST QUADRIVALENT came completely out of the second nostril was unknown. The reporter considered the event to be non-serious.
Dealing with moderate carpal tunnel symptoms, worse on non shot arm (right) mild symptoms in left arm. Shooting pains throughout left and right arm and hand as a result. Pressure and stiffness in right arm almost always.
After I got the vaccine a couple of days ago I noticed that my right eye was red inside the white of the eye, like an internal bleeding in the right eye. And it still continues to this day 05/29/2021.
Rash on her neck, chest, back, and pelvic areas; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her neck, chest, back, and pelvic areas) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced RASH (Rash on her neck, chest, back, and pelvic areas). At the time of the report, RASH (Rash on her neck, chest, back, and pelvic areas) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant medication was not provided.