chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This report describes sensorineural hearing loss in an approximately 42 year old male who received Lyme disease vaccine recombinant. Medical history, concurrent conditions, and concurrent medications were not specified. The vaccinee received his second injection of LYMErix approximtely in April 2001. An unspecified time post-immunization, he experienced sensorineural hearing loss. Unspecified "scans of the temporal" not reveal a cause for the hearing loss, which persisted s of April 2002. The vaccine provider considered the event to be possibly associated with the LYMErix administration, and the LYMErix immunization series was discontinued. This report of sensorineural hearing loss is considered medically serious.
C/o f increased lower extremity weakness and difficulty ambulating. We recommended the patient come into the office for evaluation, however, his wife was unable to get him here. His wife indicated that symptoms were consistent with prior flares of his multiple sclerosis, and his symptoms were consistent with such. Patient was subsequently treated with 1 g of methylprednisolone IV for 5 days followed by 60 mg prednisone taper for 5 days..        He presented to the ED on 11/9 for worsening of his lower extremity weakness and developed inability to walk or roll over in bed. The provider at the emergency department was in contact with our office. It was recommended that they proceed with MRI scan of the brain, cervical, and thoracic spine with and without contrast to assess for enhancing lesions. They also performed MRI scan of lumbosacral spine. No significant abnormalities were identified. Patient's wife advocated that the patient be admitted to the hospital. Patient was subsequently evaluated by a neurologist who noticed that the patient had lost his reflexes and did not feel his presentation was secondary to his multiple sclerosis or steroid-induced myopathy. Subsequent lumbar puncture positive for elevated proteins which was diagnostic for Guillane-Barre. He was treated with a 5 day course of IVIG which provided some improvement of his symptoms. Patient and his wife endorse all of his new symptoms developed secondary to obtaining his second COVID-19 vaccination.
Around 12/22/2022, I started feeling under the weather and thought I may be coming down with the flu. We were out of town at the time visiting a dying family member at a nursing facility. By the time we returned to where we were staying, I was feeling really run down. I continued to feel worse through to the morning. I had a very sore throat, body aches, and fever. I tested myself for COVID-19 and it was positive. I scheduled a telehealth visit and decided to take PAXLOVID. My doctor called that in for me and I began to take that and isolate. I continued to feel achy and have a sore throat, like really strong flu symptoms. Toward the end of my second day of PAXLOVID, I began to feel better. My doctor advised that I could end isolating after five days if wearing a mask. I felt better by the five days and returned home. Two other family members also developed COVID-19 at that time. I have not had any lingering symptoms.
swelling in her eye; swelling in her face/ swelling in her cheek; chills; injection site pain - left arm; A spontaneous report was received from a healthcare professional concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, vaccination site pain ( injection site pain - left arm), eye swelling (swelling in her eye) and swelling face (swelling in her cheek).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 032L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 21 Feb 2021, the patient experienced chills and injection site pain. On 22 Feb 2021, the patient experienced swelling in her face, swelling in her eye and swelling in her cheek. she also stated that on 23 Feb 2021, the swelling of the face had worsened.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills and Injection site pain are consistent with the known safety profile of mRNA-1273.
flu sx also wheezing & a feeling of lungs full of water, persisted till the end of December; no MD seeing feels fine now; advised to se MD a/next flu shot;
Pain from the neck down to the body; Throat is feeling stuffed; swallowing discomfort due to throat irritation; Pain at injection site; Muscle and Joint pain; Muscle and Joint pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain from the neck down to the body), OROPHARYNGEAL DISCOMFORT (Throat is feeling stuffed), THROAT IRRITATION (swallowing discomfort due to throat irritation), VACCINATION SITE PAIN (Pain at injection site) and MYALGIA (Muscle and Joint pain) in a 65-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.     Concurrent medical conditions included Arthritis and Heart disease, unspecified (heart disease). Concomitant products included METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SIMVASTATIN and VITAMIN D3 for an unknown indication.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN (Pain from the neck down to the body), OROPHARYNGEAL DISCOMFORT (Throat is feeling stuffed), THROAT IRRITATION (swallowing discomfort due to throat irritation), VACCINATION SITE PAIN (Pain at injection site), MYALGIA (Muscle and Joint pain), ARTHRALGIA (Muscle and Joint pain) and NAUSEA (Nausea). On 16-Mar-2021, PAIN (Pain from the neck down to the body), OROPHARYNGEAL DISCOMFORT (Throat is feeling stuffed), THROAT IRRITATION (swallowing discomfort due to throat irritation), VACCINATION SITE PAIN (Pain at injection site), MYALGIA (Muscle and Joint pain), ARTHRALGIA (Muscle and Joint pain) and NAUSEA (Nausea) had resolved.            Concomitant medications included unspecified dietary supplement and chewable vitamins.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Significant follow up-outcome of the events updated
dry lips; chapped lips; bleeding lips; swollen lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP DRY (dry lips), CHAPPED LIPS (chapped lips), LIP HAEMORRHAGE (bleeding lips) and LIP SWELLING (swollen lips) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced LIP DRY (dry lips), CHAPPED LIPS (chapped lips), LIP HAEMORRHAGE (bleeding lips) and LIP SWELLING (swollen lips). At the time of the report, LIP DRY (dry lips), CHAPPED LIPS (chapped lips) and LIP HAEMORRHAGE (bleeding lips) outcome was unknown and LIP SWELLING (swollen lips) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
I HAD A PAINFUL VESSICULAR RASH IN THE RIGHT C4 OR C5 DERMATOME CONSISTENT WITH HERPES ZOSTER.  I HAD CHICKEN POX AS  A CHILD, AND NEVER HAVE HAD SHINGLES BEFORE THIS.
This case was reported by a nurse via sales rep and described the occurrence of injection site abscess in a patient who received BEXSERO (batch number 166901A, expiry date unknown) for prophylaxis. On an unknown date, the patient received BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site abscess. On an unknown date, the outcome of the injection site abscess was unknown. It was unknown if the reporter considered the injection site abscess to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced abscess at the injection site of BEXSERO. This event was occurred in past 6 weeks from the date of reporting. This is 1 of the 3 linked cases reported by the same reporter for different patient.
Chills (2 hours) then headache, nausea and weakness (16 hours)
17Jul1995 pt recv 1 dose vax. 16Feb98 pt devel chickenpox. Pts sister also reported WAES98022063.
Pt states that after H1N1 vaccine he has had progressive soreness in his L deltoid and is now having cervical neck pain. Reported problem on 2/17/10.
Patient presented to the ED and was subsequently hospitalized twice within 6 weeks of receiving COVID vaccination. First visit was 2/23/2021 and second visit was 3/14/2021. Patient died on 4/8/2021
Patient was given Moderna Bivalent Booster 0.25mcg not 0.5mcg. Wrong dose given.
Seen in office on 4/26/06, vesicular spots surrounded by redness in different corps. Dx'ed Varicella.
Mom reports stuffy nose and temp 100.9 at 9PM 3/25/05. Took infant to ER on 03/26/05 AM because she was acting sick and crying alot. She also has a fever (temp unk). 4 month old c/o severe diffuse wheezing, worse at night, improved with OTC meds onset 4 days with fever.  Impression: Acute respiratory distress, pneumonia, diaper dermatitis. Tx: Blood culture, O2 mist treatment, Aerosol Tx, IV hydration, W/ph swab for RSV. To follow up with Doctor.
pt recvd Hep B vax on 13APR92 & w/in 1 to 1 1/2 hrs following vax pt returned to MD couldn't walk, legs felt heavy & numb, couldn't think straight, felt funny & clammy, lethargic & exp hot & cold sensations & sweating;
Blurring of vision; Ringing of ears; Headache; Chills; Fever; This spontaneous case was reported by an other caregiver and describes the occurrence of VISION BLURRED (Blurring of vision), TINNITUS (Ringing of ears), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Grass allergy and Environmental allergy. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced VISION BLURRED (Blurring of vision), TINNITUS (Ringing of ears), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 12-May-2021, TINNITUS (Ringing of ears), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, VISION BLURRED (Blurring of vision) and HEADACHE (Headache) had not resolved.
This spontaneous report as received from a medical assitant, refers to a currently 4 month old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored ROTATEQ per oral, (which had a lot # of N030366 and an expiration date of 13-MAR-2019; however, dosage number was not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA006354:
Patient was given a Moderna Bivalent Vaccine on 04/05/2023.  However, the vaccine was moved from Freezer to regular Refrigerator  on 02/27/2023 and has a expiratory date of 03/29/2023.  Pharmacist did not realize that the vaccine had expired on 04/05/2023 and a dose was administered to patient.  Moderna was contacted regarding the error and they will inform us if a second dose is necessary to be administered.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with a total of 5 dose (unspecified in series) of improperly stored RECOMBIVAX HB, lot # L0428646, expiration date 15-SEP-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature was 58 F, time frame was 72 hours, there was no previous temperature excursion and call was because of data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt has red swollen area where Dtap administered. Area hot to touch, painful. No fever, good appetite, Child fine otherwise per mom.
approx 2-3 mins p/vax pt became hypotonic-lasted 5 mins; VS stable;
The team gave him Anthrax vaccine shot # 4 on 18 JAN 2020. 2 days later on 20 JAN 2020, he began to experience bilateral leg swelling, shortness of breath and significant joint pain. He contacted me and I recommended he be seen at a hospital or with his PCM. Patient saw his PCM at the Clinic on 23 Jan 2020 who put him a short course of oral steroids, for an unknown diagnosis. He finished the steroids, but had a relapse of the same symptoms around 1-2 FEB 2020. He contacted me again and I recommended an evaluation on an emergent basis. Patient was evaluated at the Hospital ED, on 3 FEB 2020 and was discharged home. His symptoms worsened less than 24 hours later and he contacted me again and I recommended going to a larger medical center for a more in depth evaluation. Patient was seen at the Medical Center on 4 FEB 2020  and admitted. He was diagnosed with serum sickness and discharged the following day.  He has missed several days of work due to this and took personal time off (PTO) from his job for recovery. These are the dates: 23-24 JAN and 3-7 FEB 2020.  He is scheduled to be released to work on 10 FEB 2020.  He has since fully recovered and is asymptomatic presently.
extreme dizziness to passing out stage when standing; numbness in arms; sweats; chills; fever; severe headache; extreme dizziness to passing out stage when standing; loose stools; joint pain in the arm where she received the shot; Mild fatigue for 2 days; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered on the left arm, on 16Apr2021 10:15 (Batch/Lot Number: ER8729) as 1st dose, single for covid-19 immunisation. Medical history included cortical basal degeneration and allergies. Patient was not pregnant. No other vaccines were received in four weeks. Unspecified concomitant medications were received in two weeks. 15 days after injection on 01May2021 08:00, patient had numbness in arms, sweats, chills, fever, severe headache, body pain, extreme dizziness to passing out stage when standing and loose stools. The eve of injection on 16Apr2021, patient had joint pain in the arm where she received the shot, but no other issues other than mild fatigue for 2 days. No treatment was received for the events. Outcome of the event of fatigue was recovered on 18Apr2021 while for the remaining events was not recovered. Patient was diagnosed with covid prior to vaccination and had not been tested post-vaccination. The reporter considered the events non-serious.  No follow-up attempts are needed. No further information is expected.
Breakthrough case admission after 3 vaccines Pfizer 3/10/21 Lot# EN6199;  Pfizer 3/31/21 Lot# ER8733;  Pfizer 11/2/21 Lot# 301258A
Fever, chills, joint pain, muscle pain, headache, nausea my symptoms started 10 hours after my 2nd dose  injection.
client notified medic he wasn't feeling well after receiving 1st dose of Moderna vaccine. he appeared pale and diaphoretic.  He vomited x2. Local EMS called. he was evaluated and refused transport via EMS. his condition improved and he was released.
Heat, swelling, induration, itching onset 7 hours after injection. Treated with antihistamine and cold compress.
28 year old male with no past medical history who presents to the hospital with acute onset right arm and leg weakness and numbness, and weakness and numbness of the tongue, given alteplase for concern for stroke, now returned to baseline neuro function with no deficits.
pt recv vax;was "sore";rt arm sore & there is redness from shoulder to elbow;deltoid is edematous & slightly discolored as a mild bruise; has slightly dec motion in that arm;
Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: DAYQUIL; NYQUIL. The following information was reported: COVID-19 (non-serious) with onset Dec2022, outcome "not recovered", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Additional information: The patient received other medications in 2weeks. Patient had no known allergies. The patient received treatment for COVID-19 from 13Dec2022 to 18Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt developed rash on arms, face and scalp approx Oct 27. rash became more widespread areas subsequent weeks. Unresponsive to topical and systemic steroids. Skin biopsy revealed nonspecific changes with Eosinophil, suggesting a drug eruption.
patient experienced rapid heartbeat and a rash that spread down her arm and a bit of shortness of breath.  Started appx 15 minutes after vaccine,  applied cool compress called 911 and observed patient.  Paramedics did note PVC abnormalities on patient EKG and advised her to take 50 mg of Benadryl and follow up with medical care
Vaccine was retrieved from pharmacy on the morning of 12/9/2021.  It was mistakenly grabbed from the area of the refrigerator that had been partitioned off for recently expired vaccine that is separate from the active vaccine refrigerator area.  Vaccine was brought to clinic in a temperature-controlled cooler that stored the vaccine at refrigerated temperatures (36F to 46F).  Vaccine was reconstituted and drawn up to administer.  Pharmacist gave vaccine and documented for CDC and Immunization Information Systems data.  It was discovered that vaccine was expired at this time.  Any additional vaccine from expired vials planned to give was postponed and remaining vaccine wasted.  No adverse effects noted post administration. Called pharmacy who ensured expired vaccine was removed completely to prevent any further errors.  Notified facility administration and patient of error.  Followed up again in less than 3 hours with patient who had no adverse effects noted and felt fine.  Patient questioned if additional vaccine would be needed.  Followed CDC guidance to contact manufacturer regarding error and gain additional information (Form CS-321629-AS).  Will follow-up with facility and patient tomorrow to make sure there have been no adverse effects/events post administration.
This was my 5th COVID vaccine.  Symptoms began @11 hours after injection on 12 October. Fever 101F, joint pain, fatigue.  Took 500mg acetominophen and went to bed at 2200h.  Experienced insomnia -- couldn't sleep for more than 2 hours at a time.  The next morning (Friday 13 October)  I had the usual achy joints and profound tiredness.  This persisted through Saturday, 14 October.    Saturday night just before midnight my lower back began to ache -- very much like sciatic nerve pain, but just in the lower back area just above the buttocks.  When I awoke on Sunday morning (15 October) I was unable to bend over -- the nerve pain was intense.  I took 400mg naproxen at 0830, and another 200mg naproxen at 1445h.    Monday morning 16 October the nerve pain was still present and again I took 400mg naproxen to see if it would help.  Tuesday morning 17 October  was a little better, and I did not take any pain relief medication all day.  Wednesday morning (today, 18 October) the pain was back, but it was less like sciatica and more like a lower back muscle pain.    As of 1629h 18 October, it has not subsided.  Spikevax was very different from any of the other COVID vaccines I have had. I got the usual fever, joint pain and exhaustion, but   I did not get the usual lymph node swelling (collarbone and underarm) and I had insomnia.   The back pain, I must say, is alarming as I can find no cause for it other than vaccine related.
18-19 cm induration & redness & warm. Rxn to vaccine vs infection. Rx: Keflex & Benadryl.
Fever (102.9), chills, increase heart rate,  increase B/P, and increase breathing.
Initial and follow-up information has been received from a registered nurse and a nurse practioner for the Merck pregnancy registry of GARDASIL vaccine (yeast) concerning a 17 year old white female with depression and allergies to amoxicillin and clavoloe acid and a history of marijuana abuse, and a smoker until she found out that she was pregnant, who on 29-NOV-2006 was vaccinated with a 0.5ml dose of GARDASIL vaccine (yeast), (lot# 653735/0388F). Concomitant therapy included minerals (unspecified) (+) vitamins (unspecified) (Precare). It was reported that the patient was pregnant (LMP = 01-DEC-2006) when vaccinated for the first time with GARDASIL vaccine (yeast). The patient had prenatal labs (results not reported). On 13-FEB-2007 the patient had an ultrasound that revealed a 10 week fetus. As of 27-FEB-2007 the pregnancy was normal to date. On 17-APR-2007 the patient had an ultrasound for anatomy scan that was normal. The patient did not have any previous pregnancies. The estimated date of delivery was 08-SEP-2007. On 28-AUG-2007 the patient gave birth to a liveborn male infant. The infant weighed 7 pounds and 5 ounces, the length was 19 3/4 inches, and the apgar score was 9/9. The infant was normal. there were no congenital anomalies and no other complications or abnormalities. The patient had no complications during pregnancy and gave birth 38 weeks from her last menstrual period. During labor and delivery there was a repair of a primary laceration. The patient did not experience any infections or illnesses during pregnancy. Additional information is not expected.
upper right leg pain that moved to different locations from center to left side of leg, pain so intense that subject couldn't sleep for several days for more than a couple hours at a time, visited doctor on Day 4 of pain, Naproxen prescribed, after about a week pain went away
06/23/06 mom stated that pt face started to swell 8am around nose and neck. Denies difficulty breathing. Complain also of rash on trunk of body. Referred immediately to ER for evaluation.